Generiske legemidler, legemidler som inneholder samme virkestoff i samme styrke, og som dermed er medisinsk likeverdige. Når produsenten av det opprinnelige legemidlet ikke lenger har enerett, kommer ofte rimelige generiske legemidler på markedet. (Kilde: Store norske leksikon.)

Legemiddelprodusenter betaler leger for å skrive studier som kritiserer generiske legemidler (kaisernetwork.org 9.5.2006)

- Kan bli sykere av kopimedisiner (nrk.no 31.7.2008)

– Ingen klinisk forskel på kopipræparater og originalpræparater (irf.dk 5.2.2009 (INSTITUT FOR RATIONEL FARMAKOTERAPI (IRF))

Firma anklaget for å utnytte unike legemiddelegenskaper for å beholde markedsandel (BMJ 2008;336:576 (15 March))

Forsinkelser av generika utløser granskning Lovgiverne ønsker å stramme inn reguleringer som tillater merkeprodusenter å betale generiske rivaler millioner av dollar for å forsinke introduksjon av lavkostkonkurrenter på markedet (indystar.com 8.2.2007)

The "doughnut hole" The excess profits of the prescription drug industry are the main factor that led to the need for the doughnut hole. (cepr.net/publications (August 2006))

The Origins of the Doughnut Hole: Excess Profits on Prescription Drugs

The combined excess profits earned on the two dosages for Zocor, a cholesterol lowering drug, are more than $1.6 billion. (cepr.net/publications (August 2006))

Legislation calls for cheaper biotech drugs (usatoday.com 14.2.2007)

Obamas vinst påverkar läkemedelsindustrin (lakemedelsvarlden.se 5.11.2008)

The Center for Economic and Policy Research (CEPR) (cepr.net/pages/cepr_info_page)

- Legemiddelfirmaer betaler for å hindre generisk konkurranse. (- Pay-for-delay.) (- Banebrytende norsk studie åpner for viktige kopimedsiner.)

Medicinindustrien blander sig utidigt i myndighedernes arbejde
jyllands-posten.dk 28.1.2014
Myndighederne i både EU og USA tæppebombes med klager og indsigelser mod kopimedicin. Det er obstruktion mod kopikonkurrence, mener de. (...)

(Anm: Overpriser på medicin skal nu granskes på Christiansborg. Flere politikere vil nu bede justits- og sundhedsministeren om at undersøge, om det skal være nemmere at rette erstatningskrav mod medicinselskaber, der holder kopikonkurrenter ude. (jyllands-posten.dk 22.12.2015).)

(Anm: EU to suspend hundreds of drug authorisations after doubts over clinical studies in Hyderabad. BMJ 2015;350:h574 (Published 02 February 2015).)

(Anm: Brasilien bötfäller tyska Merck KGaA Det tyska läkemedelsbolaget Merck KGaA ska böta 12 miljoner kronor i Brasilien. Företaget ska ha försökt förhindra generisk konkurrens. (lakemedelsvarlden.se 13.8.2014).)

(Anm: The rise and rise of generic prescribing. BMJ 2015;351:h5507 (Published 20 October 2015).)

(Anm: Mexico watchdog finds big pharma faces no competition on some drugs. (…) The report, released by Cofece on Wednesday, also said some of the companies used unspecified legal strategies to extend drug exclusivity after patents expire. It recommended the government tighten rules on issuing secondary patents and actively promote generic alternatives. (reuters.com 9.8.2017).)

- EU-Kommissionen mener, at medicinalvirksomhederne Teva og Cephalon brød konkurrencereglerne, da det israelske selskab modtog betaling for at forsinke kopiprodukt.

(Anm: Vestager: Medicinalvirksomheder indgik ulovlig aftale. EU-Kommissionen mener, at medicinalvirksomhederne Teva og Cephalon brød konkurrencereglerne, da det israelske selskab modtog betaling for at forsinke kopiprodukt. (medwatch.dk 17.7.2017).)

- Legemiddelindustriens fortjeneste var nesten det dobbelte av utgifter til forskning og utvikling (FoU-utgifter) i 2013, 2014 og 2015.

(Anm: Legemiddelindustriens fortjeneste var nesten det dobbelte av utgifter til forskning og utvikling (FoU-utgifter) i 2013, 2014 og 2015. (Pharmaceutical Industry Profits Are Nearly Double R&D Costs in 2013, 2014 and 2015) (…) En primær unnskyldning som legemiddelindustrien bruker for «prisøkning» er de høye kostnadene for forskning og utvikling (FoU) som disse firmaene betaler for å få nye legemidler på markedet. (citizen.org 27.3.2017).)

(Anm: States seek to expand lawsuit against generic drugmakers. HARTFORD, Conn. — Connecticut’s attorney general and 45 of his colleagues are seeking to expand a federal antitrust lawsuit against generic drugmakers to include more manufacturers and medications, as well as senior executives at two companies. Led by Connecticut, the states sought a federal court’s permission Tuesday to widen their complaint, which alleges a number of illegal agreements among 18 manufacturers to fix prices and divvy up the market for specific generic drugs including treatments for high blood pressure, arthritis and asthma. (washingtonpost.com 31.10.2017.)

- Dette skjoldet av patenter beskytter verdens bestselgende legemiddel.

(Anm: Dette skjoldet av patenter beskytter verdens bestselgende legemiddel. (- Produktet med 16 milliarder dollar i årsomsetning. (...) - Det har dessuten vært tilgjengelig i nærmere 15 år. (…) Den virkelige utfordringen var den tilsynelatende ugjennomtrengelige festningen av patenter som AbbVie metodisk har bygget rundt sin verdsatte pengemaskin. (…) Humira, som står for mer enn 60 prosent av AbbVies inntekter har en listepris på mer enn 50 000 dollar per pasient. (bloomberg.com 7.9.2017).)

(Anm: Patenter (mintankesmie.no).)

- Novo-begæring til FDA: Victoza-kopier skal gennemgå kliniske forsøg. Novo Nordisk anmoder de amerikanske sundhedsmyndigheder, FDA, om at kræve kliniske test for kopier af selskabets storsælgende diabetesmiddel, Victoza.

(Anm: Novo-begæring til FDA: Victoza-kopier skal gennemgå kliniske forsøg. Novo Nordisk anmoder de amerikanske sundhedsmyndigheder, FDA, om at kræve kliniske test for kopier af selskabets storsælgende diabetesmiddel, Victoza. Argumentet er, at produktionsprocessen for midlet er så kompleks, at man ikke kan være sikker på at lave en rigtig kopi uden kliniske test. Det skriver branchemediet FiercePharma, efter at Novo Nordisk i sidste uge indsendte en begæring, der anmoder FDA om at afstå fra at godkende liraglutide-indeholdende kopimedikamenter, hvilket inkluderer kopier af Saxenda, Xultophy og altså Victoza. (medwatch.dk 10.10.2017).)

(Anm: Novo petitions FDA to require Victoza copies to go through clinical trials, pointing to complex manufacturing. With one drugmaker already trying to pry patent protection off of Novo Nordisk’s blockbuster Victoza before its 2022 expiration, the insulin specialist has taken new steps to deter copies. The Danish drugmaker has filed a citizen petition arguing the manufacturing process for its drug is so complex that equivalence of a copy couldn’t be certain without clinical trials. (fiercepharma.com 9.10.2017).)

- Spørsmål reist etter to dødsfall i AbbVie artrittstudie. AbbVies legemiddel mot reumatoid artritt, upadacitinib, er firmaets store plan for å håndtere det uunngåelige tap av salg for Humira, idet biotilsvarende begynner å ta markedsandeler.

(Anm: Questions raised after two deaths in AbbVie arthritis study. AbbVie’s rheumatoid arthritis drug, upadacitinib, is the company’s big plan to manage the inevitable loss of sales from Humira, as biosimilars begin to take chunks out of its market space. Only last month, the FDA approved Boehringer Ingelheim’s Cyltezo as a biosimilar to the drug – joining Amgen’s Amjevita. These plans have not been derailed but safety concerns are now going to dog the drug until further data is released after two patients were reported to have died whilst receiving upadacitinib in a Phase 3 trial. AbbVie reported that one patient in the 30mg dose group exhibited symptoms including fever and diarrhoea who then suffered heart failure. On the other patient, AbbVie could not give any reasons for the cause of death. (pharmafile.com 12.9.2017).)

(Anm: Statlig legemiddelkontroll (Statens legemiddelverk etc.) (mintankesmie.no).)

(Anm: Statlig hvitvasking av legemiddelinformasjon (Tidsskr Nor Legeforen 2010; 130:368 (25.2.2010).)

(Anm: Forskning bliver farlig, når de negative resultater glemmes. (…) Nyt dansk studie viser problemet. (...) For få negative resultater leder til falske konklusioner. (…) Manglende negative resultater har kostet liv. (…) Vores model viser, at vi er nødt til at få publiceret mindst 20 procent af de negative resultater, der produceres inden for hvert forskningsfelt, hvis vi skal undgå at lave falske antagelser om videnskabelig fakta. (videnskab.dk 5.1.2017).)

- Banebrytende norsk studie åpner for viktige kopimedsiner.

(Anm: Banebrytende norsk studie åpner for viktige kopimedsiner. Biologiske medisiner har revolusjonert revmatiske sykdommer som leddgikt, og tarmsykdommer som Chrons og Ulcerøs kolitt. Medisinene er svært kostbare, men en ny norsk studie åpner for langt billigere kopimedisiner. (…) En av disse medisinene er Remicade. Kopien – eller det såkalt «biotilsvarende» preparatet – heter Remsima. Og nå er det klart: Billigkopien er like bra som originalen. Den koster under halvparten og sparer alene Norge for 200 millioner kroner årlig. (nrk.no 12.5.2017).)

(Anm: Merck, Upsher-Smith to pay $60 million in 'pay-for-delay' drug case. Merck & Co Inc and Upsher-Smith Laboratories Inc have agreed to pay $60.2 million to resolve a lawsuit that said they entered into a deal to unlawfully delay the availability of generic versions of potassium supplement. (…) The class action lawsuit, by direct purchasers of K-Dur including drug wholesalers and hospitals, said the companies violated antitrust laws through the unlawful delay of generic K-Dur. K-Dur. (reuters.com 16.5.2017).)

- Britisk vaktbikkje sier MSD kan ha blokkert «biotilsvarende» Remicade.

(Anm: UK watchdog says MSD may have blocked Remicade biosimilars. Merck, Sharp & Dohme is in trouble with the UK’s competition watchdog, which has said it may have broken competition laws with a discount scheme for its inflammatory diseases drug Remicade (infliximab) amid competition from biosimilar rivals. (pharmaphorum.com 23.5.2017).)

- Pfizer saksøker J & J over Remicade-kontrakter.

(Anm: Pfizer sues J&J over Remicade contracts. Dive Brief: - Pfizer Inc. is taking rival Johnson & Johnson to court, filing a lawsuit in the U.S. District Court for the Eastern District of Pennsylvania that alleges the multi-national conglomerate has been conducting anticompetitive practices to prevent biosimilar competition. - The big pharma released a statement Wednesday morning claiming J&J "denied U.S. patients access to therapeutic options and undermined the benefits of robust price competition in the innovative and growing biologics marketplace." - Pfizer goes on to charge that J&J’s contracting practices for its rheumatoid arthritis treatment Remicade deliberately boxes out biosimilar competitors, violating antitrust laws and undermining "the principal goals of the federal Biologics Price Competition and Innovation Act (BPCIA)."(biopharmadive.com 20.9.2017).)

- Legemiddelfirmaet Aspen graskes grunnet økning av generiske priser.

(Anm: Legemiddelfirmaet Aspen graskes grunnet økning av generiske priser. Drug company Aspen faces probe over hiking generic prices. The European Commission has launched an investigation into increased prices on cancer drugs imposed by Aspen, a South African company. Aspen acquired five drugs from GlaxoSmithKline (GSK) in 2009 in a deal worth $2.2bn (then about £1.4bn) in cash and shares. Aspen increased the UK price of busulfan, a leukaemia drug, from £5.20 to £69.02 a pack. Chlorambucil, also used in leukaemia treatments, rose from £8.36 to £42.87. BMJ 2017;357:j2417 (Published 18 May 2017).)

- Endnu en kopikonkurrent fejet af banen for GSK. (- De amerikanske lægemiddelmyndigheder, FDA, fortsætter med at feje kopikonkurrencen til en af GlaxoSmithKlines storsællerter af banen. Dermed ser det ud til, at GSK er fredet for kopikonkurrencen resten af året.)

Endnu en kopikonkurrent fejet af banen for GSK
medwatch 16.5.2017
De amerikanske lægemiddelmyndigheder, FDA, fortsætter med at feje kopikonkurrencen til en af GlaxoSmithKlines storsællerter af banen. Dermed ser det ud til, at GSK er fredet for kopikonkurrencen resten af året.

2-0 til orginialproducenten. Sådan er stillingen mellem GlaxoSmithKline (GSK) og en række kopiproducenter efter de amerikanske lægemiddelmyndigheder, FDA, har afvist endnu en generisk version af GSK's blockbuster Advair.

FDA afviser kopi af GSK's lungeblockbuster

I følge Reuters er det nu Hikma, der sammen med partneren Vectura nu må skyde en hvid pind efter at lancere en generisk udgave af Advair på det amerikanske marked i år. Hikma har modtaget et såkaldt Complete Reponse Letter , der blev kategoriseret som "større". I følge Reuters betyder håndteringen af et stort ændringsforslag i en registreringsansøgning, der omhandler et generisk lægemiddel, en forsinkelse på 10 måneder.

Tilbage i marts blev også Mylans generiske version af Advair afvist af FDA. Selskabet afslørede i sidste uge, at myndighederne har krævet en større ændring i dets registreingsansøgning. Dermed ser det ud til, at der ikke kommer kopikonkurrence til GSK's Advair i år.

GSK’s Advair er en to-delt inhalator til behandling af astma og kronisk obstruktiv lungesygdom (KOL). I 2015 solgte lungemidlet for 5,6 mia. dollars, hvoraf halvdelen af salget lå i USA. (...)

(Anm: Legemiddelindustrien (Big Pharma) (mintankesmie.no).)

(Anm: Legemiddelindustriens fortjeneste var nesten det dobbelte av utgifter til forskning og utvikling (FoU-utgifter) i 2013, 2014 og 2015. (Pharmaceutical Industry Profits Are Nearly Double R&D Costs in 2013, 2014 and 2015) (…) En primær unnskyldning som legemiddelindustrien bruker for «prisøkning» er de høye kostnadene for forskning og utvikling (FoU) som disse firmaene betaler for å få nye legemidler på markedet. (citizen.org 27.3.2017).)

(Anm: GSK is fined £38m for delaying generic paroxetine. GlaxoSmithKline, the United Kingdom’s biggest drug maker, has been fined more than £37.6m (€48m; $55m) for striking deals between 2001 and 2004 to stifle competition from generic drug manufacturers with its blockbuster antidepressant paroxetine. The UK’s Competition and Markets Authority has fined GSK for entering “pay for delay” deals with smaller manufacturers to keep generic forms of paroxetine off the market. BMJ 2016;352:i917 (Published 12 February 2016).)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

(Anm: Myndigheder gransker medicinalselskabers forhold til PBM'erne. Statsadvokaten i New York vil undersøge de kontraktlige forhold mellem medicinalselskaber og de store pharmacy benefits managers i USA, og især tre firmaer er i søgelyset. (…) Arbejdsgivere og andre kunder betaler pharmacy benefits managers som eksempelvis Express Scripts og CVS for at holde udgifterne til lægemidler nede ved at skifte patienter over til generiske versioner af lægemidler.. (medwatch.dk 12.5.2016).)

(Anm: Lundbeck appellerer EU-dom. Den danske medicinalkoncern afslører i onsdagens kvartalsregnskab, at selskabet vil appellere den historiske EU-dom, som blev stadfæstet i september. (…) Lundbeck blev i sommeren 2013 idømt en historisk stor bøde af EU på 700 mio. kr. Lundbecks brøde var, at selskabet havde indgået aftaler med fire konkurrerende kopiproducenter om at forsinke lanceringen af billigere generiske versioner af Lundbecks lægemiddel Cipramil på det europæiske marked. Lundbeck havde patent både på det aktive stof i lægemidlet og på fremgangsmåden, men patentet på det aktive stof var udløbet i Europa, da aftalerne blev indgået i 2002. (medwatch.dk 2.11.2016).)

- Vi beskytter bare vores rettigheder.

Vi beskytter bare vores rettigheder
jyllands-posten.dk 12.1.2014
Medicinselskabernes brug af retssager og hemmelige forlig følger reglerne og er nødvendige for at beskytte dyrtkøbte rettigheder, mener sektoren. (...)

(Anm: Vårdförbundet sågar nej till substansnamn på recept. Läkemedelsverkets nej till att använda substansnamn istället för läkemedelsnamn på recept får hård kritik från vårdanställda. Vårdförbundet anser att myndighetens analys är grund. (netdoktor.se 10.4.2015).)

(Anm: Legemiddelnavn som årsak til feilmedisinering (mintankesmie.no).)

(Anm: US FDA: Generic pills must look similar to reference drugs to minimize patient safety risk. Generic pills are a safety risk if they are too different from their reference drug according to the US FDA, which wants developers to consider physical characteristics when making copycat meds... (in-pharmatechnologist.com 23.6.2015).)

(Anm: »Lundbeck har ikke medvirket loyalt til oplysning af sagen«. Baggrund: Det danske medicinflagskib Lundbeck har konsekvent modarbejdet, at alle relevante oplysninger er kommet frem i et større slagsmål om patentrettigheder. Derfor bør Danske Regioner nu gå efter et erstatningskrav i den trecifrede millionklasse , mener amerikansk storkoncern (jyllands-posten.dk 13.12.2015).)

- FDA overrasker med avvisning av Pfizer's Epogen biosimilar.

(Anm: FDA surprises with rejection of Pfizer's Epogen biosimilar. Dive Brief: - Pfizer has hit a surprise roadblock in its bid to win approval of a biosimilar version of epoetin alfa, disclosing Thursday the Food and Drug Administration rejected its proposed copy to the anemia drug. - In a complete response letter, the regulator cited a previous warning letter sent to the pharma giant about manufacturing violations at its McPherson, Kansas plant. Pfizer had listed the facility as a potential production site for the biosimilar candidate on its Biologics License Application. -  No additional clinical data was requested, nor did any violations flagged in the February warning letter directly relate to production of biosimilar epoetin alfa. Approval of the copycat biologic had been expected after a FDA advisory panel recommended approval in a May meeting. (biopharmadive.com 23.6.2017).)

- Danska landsting vill ha skadestånd av Lundbeck.

Danska landsting vill ha skadestånd av Lundbeck
lakemedelsvarlden.se 24.1.2014
Lundbeck ska ha försenat tillgången till generiska kopior på de antidepressiva medlen Cipramil och Cipralex. Nu överväger danska regioner att stämma företaget.

Danska regioner undersöker möjligheten att vidta rättsliga åtgärder mot det danska läkemedelsföretaget Lundbeck, skriver Jyllands-Posten. Regionerna vill ha skadestånd för de höga läkemedelskostnader som de fått då Lundbeck medvetet försenat tillgången på generiska kopior av Cipramil och Cipralex.

Anledningen till regionernas rättsliga efterforskningar är att generikaföretaget Actavis nyligen fått rätt mot Lundbeck i högsta domstolen och att företaget av EU-kommissionen dömts till böter på 93,8 miljoner euro för konkurrensbrott. Båda rättsfallen handlade om förseningar av generiska varianter av de antidepressiva läkemedlen. (...)

(Anm: Cipralex (Lexapro) (escitalopram) - Cipramil (Celexa) (cipramil) (citalopram) - H. Lundbeck A/S (mintankesmie.no).)

- Lundbeck har betalt konkurrenter for at holde sig væk (- Men vi har en stor stak $$$ ved vores side," lyder det i et internt dokument fra Lundbeck.)

Lundbeck har betalt konkurrenter for at holde sig væk
medwatch.dk 5.2.2015
En ny afgørelse fra EU-kommissionen fastslår, at Lundbeck har betalt flere konkurrenter fra at sælge kopiprodukter af deres depressionsmiddel Cipramil i Europa.

Knap en halv mia. kr. har danske Lundbeck i 2002-2003 betalt fire kopiproducenter for at lade være med at sælge kopiprodukter af selskabets depressionsmiddel Cipramil.

Det fastslår EU-kommissionen i en 464 lang siders afgørelse. Ifølge Dagbladet Børsen betalte Lundbeck et beløb svarende til den indtægt kopiselskaberne kunne forvente for et salg af det generiske lægemiddel, hvilket betød, at kopiproducenterne ikke mistede penge og samtidig undgik et patenttvist.

"Vi havde kun interesse i at holde dem ude, så længe vi kunne opretholde vores eksklusivitet," siger Mette Carlstedt, juridisk direktør i Lundbeck til Børsen.

I et internt dokument fremgår det, at det var Lundbecks intention at "holde markedsprisen på Cipramil så høj som mulig inden lanceringen af Cipralex" for at sikre en høj tilskudspris for det. Samtidig ønskede man ikke, at "tabe mere salg til kopier end vi er nødt til."

Lundbeck selv betegner udfordringen som et pokerspil.
"Vi er blevet delt en middelmådig hånd uden esser, men et par damer og nogle små skæve kort."

"Men vi har en stor stak $$$ ved vores side," lyder det i et internt dokument fra Lundbeck. (...)

(Anm: Drug makers’ adverse event reports are often incomplete, US report finds BMJ 2015;350:h651 (Published 04 February 2015).)

(Anm: Institute for Safe Medication Practices. A critique of a key drug safety reporting system. QuarterWatch 28 Jan 2015.)

(Anm: Lundbeck: Vigtigt værdigrundlag er på spi. Den danske medicinalkoncern Lundbeck er absolut ikke tilfreds med den EU-afgørelse, der er blevet afsagt i dag, og som opretholder en historisk stor bøde til selskabet. (medwatch 8.9.2016).)

(Anm: EU-domstol fastholder dommen over Lundbeck. Medicinalkoncernen Lundbeck har ikke haft held i dets forsøg på at anke en EU-dom for konkurrencebegrænsende adfærd og skal altså derfor stadig betale den 700 mio. kr. store bøde (opdateret 15:37). (medwatch 8.9.2016).)

- Medicinalfirmaers tricks koster forbrugerne milliarder.

Forskere punkterer negative myter om kopimedicin
dagenspharma.dk 12.2.2015
Generiske kopipræparater har stort set altid samme effekt som originalpræparaterne, viser canadisk analyse af hjertekar-området. Alligevel er holdningen til generiske lægemidler ofte negativ, viser analysen.
Det er næsten altid ren spekulation, når patienter, læger eller myndigheder sætter spørgsmålstegn ved, om generisk kopimedicin har samme effekt som originalmedicinen. En gruppe canadiske forskere fra University of British Columbia i Vancouver konkluderer i en større analyse af markedet for hjertekar-lægemidler, at generiske lægemidler i langt størstedelen af alle studier lever op til myndighedernes […]

(Anm: Gilead anklagas för missbruk. Läkare i världen har vänt sig till europeiska patentverket för att få Gileads patent på hepatit C-läkemedlet Sovaldi upphävt. (lakemedelsvarlden.se 12.2.2015).)

(Anm: Terje fikk dyr behandling i tide – men ikke alle er like heldige. Rundt 30.000 personer i Norge har hepatitt C. Nå risikerer mange av dem å ikke få nødvendig behandling fordi det koster for mye. (nrk.no 19.2.2015).)

Company’s attempt to switch its patients to a new drug is foiled (Firmaets forsøk på å få pasienter over på et nytt legemiddel forpurres)
BMJ 2014;349:g7802 (Published 23 December 2014)
A drug company’s attempt to switch its patients to a new formulation of one of its old drugs before the old drug’s patent ran out has been foiled by a New York federal court. The company tried to “hard switch” its patients to the new formulation by ceasing distribution of the old drug.

The company, Actavis, has decided to appeal against the court’s decision to compel its recently acquired subsidiary Forest Laboratories to keep distributing the Alzheimer’s disease treatment memantine (which it markets as Namenda) in its original, twice daily immediate release format. The case, brought by the state of New York, is the first use of federal antitrust law against the industry practice known as hard switching.1

Namenda IR (immediate release) reaches the end of its patent protection in July 2015, and payment plans would normally switch existing prescriptions to cheaper generic competitors, but the manufacturer has a patent valid until 2025 for an extended release, once daily version, Namenda XR. If patients switched to the XR format before next summer, health plans would not switch them back to a twice daily generic. To ensure that patients switched to XR the company planned to stop producing and distributing Namenda IR this summer. (…)

Medicinalfirmaers tricks koster forbrugerne milliarder
business.dk 13.1.2014
Brintellix er udset til at blive den helt store vækstdriver for Lundbeck, der i disse år bliver ramt hårdt af patentudløbet på selskabet gamle depressionsmiddel Lexapro/Cipralex.

Store medicinalfirmaer bruger hemmelige aftaler, retssager og stormløb på myndighederne for at holde konkurrenter væk, så forbrugerne kommer til at betale milliarder i overpris for medicin.

Det koster hvert år forbrugerne og statskasserne milliarder, når medicinalfirmaerne indgår hemmelige forlig, hvor kopiproducenter bliver betalt for at holde sig væk, sagsøger konkurrenter for at afværge konkurrence og forsøger at påvirke myndighedsbeslutninger med kryptiske patentansøgninger. (...)

(Anm: Eisai sues FDA for ‘losing one year’ of marketing to generics rivals - Eisai has accused the US FDA of unlawfully shortening market exclusivity periods for Belviq and Fycompa by starting the countdown one year before either was scheduled by the DEA. (in-pharmatechnologist.com 20.8.2014).)

EU slår til mod medicinalgiganter
medwatch.dk 10.12.2013
Johnson & Johnson og Novartis får bøde af EU for at forhindre et generisk produkt i at komme på markedet.

Medicinalselskaberne Johnson & Johnson og Novartis har modtaget en bøde på lidt over 16 mio. euro af EU-Kommissionen. Det skriver kommissionen i en pressemeddelelse. (...)

Der var tale om en generisk version af midlet Fentanyl, der er et meget potent smertestillende middel, der blandt andet bruges af kræftpatienter.

"Johnson & Johnson betalte Novartis for at forsinke indførelsen af et generisk smertestillende middel. På chokerende vis har de to selskaber snydt patienter i Holland, inklusive mennesker ramt af kræft, for adgang til en billigere version af denne medicin," skriver EU-kommissionens vicepræsident Joaqin Almunia imeddelelsen.

Johnson & Johnson har fået 10,8 mio. euro i bøde, mens Novartis har modtaget en bøde på 5,5 mio. euro.

Lundbeck anker EU's millionbøde (...)

Lundbeck taber omstridt højesteretssag
medwatch.dk 30.10.2013
Højesteretten har ophævet det fogedforbud, som Østre Landsret havde nedlagt imod Actavis' antidepressiv-kopier til det danske marked. Dermed taber Lundbeck patentsagen og skal endvidere betale kopiproducenten et millionbeløb.

Efter flere års tvist i det danske retssystem er sagen mellem det danske medicinalselskab Lundbeck og den internationale kopigigant Actavis nu afgjort, og det blev sidstnævnte, der endte som sagens vinder. (...)

Lundbeck eller EU-Kommissionen lyver
medwatch.dk 23.9.2013
Lundbeck fik for nylig en rekordstor bøde på 700 mio. kr. af EU-Kommissionen for at have overtrådt de konkurrenceretlige regler. Begge parter anklager hinanden for at lyve om centrale, interne dokumenter.

Interne dokumenter fra Lundbeck, der refererer til ”a pile of $$$” og ”club”, står centralt i sagen om, hvorvidt Lundbeck har foretaget sig noget ulovligt i forsøget på at undgå krænkelse af afgørende og gyldige patenter for år tilbage. (...)

EU-Kommissionen fastholder dog, at dokumenterne er en del af en større sammenhæng og siger dermed også, at Lundbeck lyver. (...)

EU klar til kamp mod Lundbeck
medwatch.dk 2.9.2013
EU-Kommissionen er klar til kamp mod Lundbeck i retten, efter at den danske medicinalkoncern mandag ankede den bøde på 700 mio. kr., som kommissionen udskrev i juni for brud på konkurrencelovgivningen.

"Vi vil forsvare vores beslutning i retten," siger Antoine Colombani, som er EU-talsmand i konkurrencesager og for konkurrencekommissær Joaquín Almunia, til Ritzau, og over for MedWatch påpeger han, at kommissionen ikke i den nuværende fase har yderligere kommentarer. (...)

Lundbeck anker EU-Kommissionens gigantbøde
business.dk 2.9.2013
(...) Lundbeck forventer en afgørelse i ankesagen inden for to til tre år. En dom vil kunne ankes til EU-domstolen både af Lundbeck og Kommissionen, og der kan gå op til seks år, før der foreligger en endelig afgørelse i sagen. (...)

Lundbeck anker EU-Kommissionens gigantbøde
business.dk 2.9.2013
Lundbeck har besluttet sig for at anke den bøde på 700 millioner kroner, som medicinalkoncernen i juni fik for ulovligt at forhindre kopimedicin på det europæiske marked. (...)

Anklaget for ulovligt blokering af medicin
EU rejste sidste år sager mod Lundbeck - og en række andre medicinalselskaber - der beskyldes for, at have haft aftaler med kopiproducenter angiveligt med henblik på at blokere for billigere såkaldt kopimedicin.

Lundbeck har hele tiden hidtil afvist at have brudt loven og skriver i sin børsmeddelelse i dag, at EU-Kommissionen har misforstået konkurrencereglerne på området. (...)

Kopisterne øger medicinsalget
jyllands-posten.dk 2.8.2013
Europas største medicinalvirksomhed, den franske Sanofi, kan ikke længere holde kopiproducenterne fra døren. I 1. halvår faldt koncernens omsætning med 16 mia. euro sammenlignet med samme periode sidste år på grund af stigende salg af kopipræparater.

Medicin: Kopimedicin spiller en hovedrolle i regnskaberne for de store aktører i medicinbranchen, som er aktuelle med halvårstal. (...)

750 millioners bot for pillesvindel
nrk.no 19.6.2013
Det danske legemiddelfirmaet Lundbeck har fått en gigantbot på 750 millioner kroner av EU-kommisjonen for ulovlig samarbeid med konkurrenter.
Forbrukerne av citalopram tapte hundrevis av kroner for hver pakke de kjøpte i 2002.

Selskapet har ifølge EU konspirert med produsentene av legemiddelkopier for å utsette at billig-kopier av deres populære anti-depressive medisin kom på markedet.

Mye å spare på kopipreparater
Dermed kunne selskapet fortsatt være alene om å selge produktet, selv om de ikke lenger hadde eneretten. Billig-kopier av Lundbecks populære middel citalopram kunne vært på markedet i 2002, men ble utsatt.

Kopiprodusentene er ilagt bøter på rundt 400 millioner kroner for å ha gått med på å utsette produksjonen av kopi-medisinen.

I Norge i 2005 kostet den originale citalopram-medisinen 716 kroner, mens kopien, som da var kommet på markedet, bare kostet 263 kroner. (...)

Supreme Court Split on Pharma 'Pay for Delay' Deals (Høyesterett splittet om legemiddelindustriens "betal for forsinkelse"-avtaler)
medpagetoday.com 17.6.2013
Såkalte "betal-for-forsinkelse"-ordninger mellom generiske og originale legemidler (merkelegemidler) er ikke generelt lovlig og hvert tilfelle må vurderes på sak-for-sak grunnlag, avgjorde Høyesterett mandag. (So-called "pay-for-delay" arrangements between generic and brand-name drug companies are not inherently legal, and each instance must be considered on a case-by-case basis, the Supreme Court ruled Monday.)

In the 5-3 decision overruling the 11th Circuit Court of Appeals, Justice Stephen Breyer, writing for the majority, listed five reasons why the appellate court erred in giving blanket immunity to pay-for-delay agreements, in which brand-name drugmakers pay or compensate generic drug companies in exchange for a later entry date of the cheaper generic version of a drug: (...)

Supreme Court slaps pharma aside in pay-for-delay ruling
fiercepharma.com 17.6.2013
The U.S. Supreme Court has ruled in the big pay-for-delay case. In a 5-3 vote, the court ruled that the Federal Trade Commission has the right to challenge brand-name drugmakers' patent settlements with generics companies. It's a slap in the face for the drug industry, which has united behind the settlements, saying they speed generics to market rather than impeding competition. (...)

JAMA Forum: The Clash Between Industry and Civil Society Over Generic Drugs (JAMA Forum: Sammenstøtet mellom industri og sivilsamfunnet over generiske legemidler)
JAMA 2013 (May 1)
On April 1, India’s Supreme Court ruled against drug company Novartis regarding its claim for a patent on the lucrative and widely used cancer drug imatinib (marketed by Novartis as Gleevec in the United States and as Glivec elsewhere). To many, this high-profile 7-year legal battle, Novartis v Union of India, epitomized a vexed relationship between health advocates and the pharmaceutical industry.

Civil society believes that affordable access to essential medicines is an ethical imperative, even a human right. But industry sees the intellectual property system as a vital incentive for innovation. Both positions are undoubtedly true, but they often come into tension. Companies point to the high costs of research and development in bringing a lifesaving or life-extending drug to market. But this view collides with human morality and personal tragedy when a patient cannot access a life-sustaining medication. (...)

GSK paid smaller companies to delay generic versions of paroxetine, says fair trade body (GSK betalte mindre firmaer for å å forsinke generiske versjoner av paroxetine (Seroxat), sier kontrollorgan for fair trade)
BMJ 2013;346:f2566 (Published 22 April 2013)
The UK Office of Fair Trading (OFT) has accused GlaxoSmithKline of breaching competition law and abusing its dominant market in the supply of an antidepressant.

The competition watchdog said that it would investigate a series of deals the United Kingdom’s biggest drug maker made between 2001 and 2004 with three smaller companies that wanted to market cheaper generic versions of GSK’s blockbuster drug paroxetine (which it markets as Seroxat). (...)

Lundbeck hvirvlet ind i konkurrencesager mod kopiproducenter
business.dk 19.4.2013
De amerikanske myndigheder er efter medicinalindustrien, som eftersigende bevidst forhaler kopieringsprocessen af originalmedicinen i jagten på profit.

Myndighederne i USA vil finde ud af om Lundbeck forhindrer kopiproducenter i at komme på markedet, da det er kommet frem, at det canadiske selskab Apotex ikke kan få udleveret Xenazine, som bruges til en speciel form for epilepsi. (...)

Den anden sag Lundbeck er trukket ind i, er en sag om ulovlige aftaler med kopiproducenter, som EU Kommissionen annoncerede sidste sommer. Kommissionen beskylder Lundbeck for at holde de billige kopier af depressionsmidlet Cipramil væk fra markedet. Lundbeck nægter sig skyldig.

»Når man ser Lundbeck i nu to tilfælde om kopier og patentbeskyttelse, er det et udtryk for, at selskaberne forsøger at finde grænsen. De skal ikke tænke på samfundets nytte, men på aktionærernes afkast,« siger Jakob Kjellberg, seniorprojektleder ved forskningscenteret KORA til Jyllands-Posten. (...)

Legemiddelfirma nektes patent av Indisk domstol
aftenposten.no 1.4.2013
Indias høyesterett har slått fast at den sveitsiske legemiddelgiganten Novartis ikke får ta patent på kreftmedisinen Glivec. Dommen ansees som et stort nederlag for internasjonale legemiddelfirmaer, men en seier for syke i fattige land.

- Dette er en glad dag, sier kommunikasjonssjef Nils Mørk i Leger Uten Grenser til NTB. (...)

Patentstyret mente at den siste utgaven av medisinen ikke skiller seg tilstrekkelig fra tidligere versjoner. Det er bare reelle nyskapninger som blir patentbeskyttet, ifølge en lov fra 2005.

- De prøver alle muligheter for å beskytte patentene i all fremtid. Medisinen det er snakk om, er ikke ny, men en liten endring på et gammelt legemiddel, sier Mørk.

- Legemiddelfirmaer fortsetter å misbruke publikums begjæringer (underskriftsinnsamlinger etc.), forteller FDA Kongressen. (- Hvorfor? Vel, statlige lover krever at legemiddelkontrollen rettidig gjennomgår begjæringene i tilfelle at et folkehelseproblem er legitimt fremsatt. Samtidig er FDA ikke ment å forsinke godkjenninger med mindre etaten bestemmer at begjæringen faktisk har reist et folkehelseproblem.)

Drug firms continue to abuse citizen petitions, FDA tells Congress (Legemiddelfirmaer fortsetter å misbruke publikums begjæringer (underskriftsindsamlinger etc.), forteller FDA Kongressen.)
statnews.com 22.8.2016
File this under ‘Some things just don’t change.’

Once again, the US Food and Drug Administration filed an annual report to Congress about citizen’s petitions that can be used to ask the agency to refrain from approving a generic drug or a biosimilar. And once again, FDA officials reiterated complaints that many petitions generally do not raise valid scientific concerns and appear to have been filed to delay approval of competing medicines.

This is actually a long-standing issue for agency officials, despite having released new guidelines five years ago that were intended to limit such petitions. Congress, however, requires the FDA to respond to most petitions within 150 days. And as far as the FDA is concerned, this creates an unnecessary problem.
(…)

Hvorfor? Vel, statlige lover krever at legemiddelkontrollen rettidig gjennomgår begjæringene i tilfelle at et folkehelseproblem er legitimt fremsatt. Samtidig er FDA ikke ment å forsinke godkjenninger med mindre etaten bestemmer at begjæringen faktisk har reist et folkehelseproblem. Dette binder opp FDA. (Why? Well, federal law requires the agency to review the petitions on a timely basis in the event that a public health concern is legitimately raised. At the same time, the FDA is not supposed to delay approval unless the agency decides that the petition has, indeed, raised a public health issue. This puts the FDA in a bind.)

(Anm: AstraZeneca Pushes to Protect Crestor From Generic Competition. (…) No more than a few hundred American children have a rare disease characterized by ultrahigh levels of bad cholesterol. Yet to the giant drug maker AstraZeneca, this small group could be worth billions of dollars. (nytimes.com 27.6.2016).)

(Anm: Demokratene oppfordrer FDA til å godkjenne generiske versjoner av Crestor. (Democrats exhort FDA to approve generic versions of Crestor.)  (fiercepharma.com 8.7.2016).)

(Anm: Sanders, other lawmakers urge FDA approval of generic Crestor. In a pointed letter, US Senator Bernie Sanders and several other lawmakers urged the US Food and Drug Administration on Thursday to approve generic versions of the best-selling Crestor cholesterol pill. And they maintained that a successful legal challenge by AstraZeneca, which last week sued the agency to thwart lower-cost competition, would be “disastrous” for consumers. (statnews.com 7.7.2016).)

(Anm: Makers of Humira and Enbrel Using New Drug Patents to Delay Generic Versions. The best-selling drugs Humira and Enbrel have a lot in common. They both use biotechnology to treat rheumatoid arthritis, psoriasis and other autoimmune diseases. And they come with giant price tags approaching $50,000 a year. (nytimes.com 15.7.2015).)

(Anm: AbbVie Inc: New Drugs May Overcome Humira Loss. (…) Why HumiraIs In Trouble. Humira, which makes up more than 60% of the company’s topline, is approved to treat as many as 10 different conditions, including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, Crohn's disease (CD), hidradenitis suppurativa, ulcerative colitis, moderate-to-severe CD in children aged six or above and non-infectious intermediate and posterior panuveitis in adults. (…) Morgan Stanley’s David Risinger raised additional Humira-related issues in a June research report, saying: “Humira not only faces challenges from several biosimilar players (including Amgen (AMGN), Novartis’ (NVS) Sandoz, and Pfizer (PFE)), but also from novel branded injectables and orals.” These include drugs like Novartis’ Cosentyx and Eli Lilly’s Taltz and baricitinib. (bidnessetc.com 1.8.2016).)

High Court Weighs Drug Companies' Generics Policy (Høyesterett vurderer legemiddelfirmaers generiske retningslinjer)
pharmpro.com 25.3.2013
WASHINGTON (AP) — Federal regulators are pressing the Supreme Court to stop big pharmaceutical corporations from paying generic drug competitors to delay releasing their cheaper versions of brand-name drugs. They argue these deals deny American consumers, usually for years, steep price declines that can top 90 percent.

The Obama administration, backed by consumer groups and the American Medical Association, says these so-called "pay for delay" deals profit the drug companies but harm consumers by adding 3.5 billion annually to their drug bills. (...)

Giganter lobbyer for strengere lovgivning
medwatch.dk 31.1.2013
MEDICINAL & BIOTEK:
To store amerikanske medicinalselskaber har travlt med at skubbe på for at få indført lovgivning i USA, der vil sætte begræsninger for kopien af biologiske lægemidler, de såkaldte biosimilære midler. (...)

Biotech Firms, Billions at Risk, Lobby States to Limit Generics (Bioteknologiske firmaer, milliarder i fare, lobby-fremstøt mot staten for å begrense generiske legemidler)
nytimes.com 28.1.2013
Noen av landets største bioteknologifirmaer driver intensiv lobbyvirksomhet mot statlige etater rundt omkring i landet for å begrense generisk konkurranse for sine "blockbuster"-legemidler, som mulig kan gi milliarder av dollar i besparelser i legemiddelkostnader for helsevesenet i forbindelse med påtenkte lovendringer. (In statehouses around the country, some of the nation’s biggest biotechnology companies are lobbying intensively to limit generic competition to their blockbuster drugs, potentially cutting into the billions of dollars in savings on drug costs contemplated in the federal health care overhaul law.)

Rapport: Medicinalaftaler koster forbrugerne
medwatch.dk 22.1.2013
MEDICINAL & BIOTEK: En ny rapport fra den amerikanske Federal Trade Commission viser, at antallet af såkaldte 'pay-to-delay'-aftaler er steget markant i 2012. Det skævvrider konkurrencebilledet og efterlader den almindelige amerikanske forbruger med regningen, mener kommissionen. (...)

Supreme Court to decide whether payments by patent holders to delay production of generics are anticompetitive (Høyesterett avgjør hvorvidt patentinnehaveres betaling for å forsinke produksjon av generiske legemidler er konkurransehindrende)
BMJ 2012;345:e8464 (12 December 2012)
USAs høyesterett har sagt seg villig til å gjennomgå lovligheten av såkalte lønn for å forsinkelse avtaler der eieren av et merkevarelegemiddel betaler et annet legemiddelfirma for ikke å bringe en generisk versjon av legemidlet på markedet for en avtalt periode (The US Supreme Court has agreed to review the legality of so called pay for delay agreements where the owner of a branded drug pays another drug company not to bring a generic version of that drug to market for an agreed time period.)

AstraZeneca must pay €52.5m fine for anticompetitive tactics, rules European court (AstraZeneca må betale 52,5 millioner euro i bot for konkurransebegrensende taktikk, ifølge europeisk domstol)
BMJ 2012;345:e8396 (10 December 2012)
The drug company AstraZeneca will have to pay a fine of €52.5m (£42.4m; $68m) for trying to prevent the marketing of cheaper generic versions of its blockbuster ulcer treatment omeprazole (marketed in the United Kingdom as Losec) after its appeal against a ruling made by the European Commission was rejected in the European Court of Justice. (...)

Drug Makers' Settlements Get High Court Review (Legemiddelfimaers forlik opp for Høyesterett)
pharmatimes.com 10.12.2012
WASHINGTON (AP) — Høyesterett vil ta en nærmere titt på utbetalinger fra produsenter av merkevarelegemidler til produsenter av generiske ekvivalenter for å holde generiske produkter ute fra markedet med en estimert kostnad på 3,5 milliarder dollar i året for forbrukerne. (The Supreme Court will take a close look at payments from brand-name drug makers to manufacturers of generic equivalents to keep the no-name products off the market at an estimated cost of $3.5 billion a year to consumers.)

Dommerne sa fredag ​​at de vil vurdere konkurrerende appeller rettsavgjørelser om hvorvidt praksis kjent som reverserende betaling eller "betaling for forsinkelse" ulovlig reduserer konkurransen ved å fo rsinke salget av vesentlig billigere generiske legemidler. (...) (The justices said Friday they will consider competing appeals court decisions about whether the practice known as reverse payments or "pay for delay" illegally reduces competition by delaying the sale of substantially cheaper generic drugs.)

Top EU court upholds AstraZeneca fine over ulcer drug (Topp EU-domstol opprettholder bot for AstraZenecas legemiddel mot magesår etc.)
reuters.com 6.12.2012
(Reuters) - The European Union's highest court has upheld a 52.5 million euro ($69 million) antitrust fine levied against AstraZeneca for blocking the entry of cheaper rivals to its then bestseller ulcer drug Losec. (...)

FTC says drug patent settlements used to delay generics (FTC sier forlik for legemiddelpatenter brukes til å forsinke generiske legemidler)
reuters.com 13.8.2012
(Reuters) - The Federal Trade Commission said makers of branded drugs that settle patent challenges by promising not to launch their own generic alternatives are using such agreements to delay generic competition.

In a friends-of-the-court brief, the regulatory agency said such patent settlements in which drug companies agree not to launch their own authorized generic versions are a way of paying a generic rival to delay their entry into the market.

The assessment came as a federal court in New Jersey that oversees many lawsuits against drug companies weighs a private antitrust challenge to such an agreement between Pfizer Inc's Wyeth unit and Teva Pharmaceutical Industries Ltd, the world's largest generic drug maker. (...)

Lundbeck i hemmeligt forlig med kopi-rival
medwatch.dk 2.8.2012
Lundbeck har med en af firmaets største konkurrenter indgået et fortroligt forlig, der sikrer medicinalfirmaets topsællert mod patent-retssager. Det sker efter EU-anklager omkring ulovlige aftaler om et andet af Lundbecks produkter. (...)

Lundbeck har i lang tid og i mange lande haft tvister med kopi-producenter, der forsøger at få fingrene i Lundbecks profit-givende lægemiddel. (...)

Medicinalfirmaers amerikanske forretningsgange dømt ulovlige
medwatch.dk 27.7.2012
En mangeårig praksis, som medicinalselskaberne selv mener er en fornuftig måde at løse patentstridigheder på, er nu blevet dømt som værende konkurrenceforvridende af det amerikanske retvæsen. Sagen minder om den verserende Lundbeck-EU-sag.

Indtil nu har de store medicinalselskaber og generikaproducenterne haft en udbredt praksis i USA, der i al sin enkelthed gik ud på, at medicinalselskaberne betalte generikaproducenterne for ikke at sende deres billigere produkter på markedet.

Før medicinalselskabernes patent udløb vel at mærke. På denne måde kunne de store selskaber undgå langvarige retsstridigheder omkring, hvorvidt deres patent kunne udfordres eller ej. Og generikaproducenterne fik en pose penge og i visse tilfælde lovning på en form for anbefaling af deres produkt på et senere tidspunkt. (...)

For Big Drug Companies, a Headache Looms (Kan gi store legemiddelfirmaer hodepine)
nytimes.com 26.7.2012
WASHINGTON — Det ville være en næringslivsleder drøm: lovlig å betale en konkurrent for å holde sitt produkt ute av markedet i mange år. (It would seem a business executive’s dream: legally pay a competitor to keep its product off the market for years.)

Kongressen har unnlatt å stoppe det, og i mer enn et tiår har beslutningstakere for generiske legemidler og store legemiddelfirmaer vunnet rettssaker som har tillatt det. (Congress has failed to stop it, and for more than a decade generic drug makers and big-name pharmaceutical companies have been winning court rulings that allowed it.)

Inntil denne måneden. Den 16. juli fattet en føderal appelldomstol i Philadelphia en avgjørelse om at ordningen er konkurransehindrende. Det gjør det mulig at saken kommer opp for USAs høyesterett. Dersom saken aksepteres vil utfallet sterkt kunne påvirke legemiddelpriser og helsekostnader. (Until this month. On July 16, a federal appeals court in Philadelphia issued a decision that the arrangement is anticompetitive on its face. It potentially sets up a confrontation before the United States Supreme Court. If it were to accept the case, the outcome could profoundly affect drug prices and health care costs.)

(Anm: Patenter (mintankesmie.no).)

EU anklager Lundbeck for lovbrud
medwatch.dk 25.7.2012
EU-kommissionen har nu orienteret Lundbeck om dens indvendinger mod en angiveligt konkurrenceforvridende aftale, som medicinalselskabet har indgået med flere kopiproducenter omkring generiske versioner af firmaets medicin. (...)

"Kommissionens foreløbige vurdering er, at aftalerne har til formål at forhindre markedsføring af billigere generiske præparater, hvilket udgør en overtrædelse af EU's konkurrenceregler," skriver EU-Kommissionen i en meddelelse. (...)

Kopifirmaer fik penge i lommen
Klagen angår Lundbecks rettigheder til lægemidler baseret på det aktive stof citalopram mod depression.

"I princippet blev det muligt at sende generiske produkter på markedet, da visse af Lundbecks citalopram-patenter udløb. Men virksomhederne indgik aftaler, der medførte væsentlige overførsler af værdier fra Lundbeck til virksomhedens fire generiske konkurrenter, og disse afholdt sig efterfølgende fra at markedsføre generisk citalopram," skriver Kommissionen.

"Værdioverførslerne omfattede direkte betalinger fra Lundbeck til konkurrenterne samt tog andre former, som eksempelvis opkøb af lagre af generisk citalopram med henblik på destruktion eller garanteret overskud i distributionsaftaler," fortsætter Kommissionen. (...)

Pharma Can Pay for No Play, Supreme Court Says (Legemiddelindustrien kan betale for å holde generiske legemidler utenfor markedet, ifølge Høyesterett)
Medpagetoday.com 7.3.2011
Without providing comment, the Supreme Court decided not to review a federal appeals court ruling that allows pharmaceutical companies to pay competitors to delay the production of generic drugs.

Last year, the a New York-based federal appeals court dismissed a legal challenge to a 1997 deal in which Bayer AG paid Teva Pharmaceutical's Barr Laboratories not to develop a generic version of the antibiotic ciprofloxacin, saying that such an action does not violate antitrust laws.

The legal challenge was raised by several pharmacy chains, which appealed the ruling to the Supreme Court. (...)

Biotech Firms Fight Generics (Bioteknologifirmaer slåss mot Generiske legemidler (generika) (kopimedisiner))
online.wsj.com 13.1.2011
WASHINGTON—Brand-name drug companies are fighting to weaken a provision of the health overhaul that was designed to open up generic competition in biotechnology medicines and save billions of dollars.

The brand-name companies have drawn support from key lawmakers, raising alarms among generics makers who hoped to enter a huge market previously blocked to them.

"Biologic" drugs, which are proteins manufactured in living cells, account for some of the most lucrative products on the market and are increasingly used to treat difficult diseases such as cancer and rheumatoid arthritis.

Biologics can cost tens of thousands of dollars a year.

In contrast to traditional chemical drugs, biologic drugs have rarely faced competition from generics even as their patent expired. But the health law passed last March included a provision aimed at changing that, the result of years of negotiation in Congress. (...)

The biotech industry group's general counsel, Thomas DiLenge, said the language would protect companies' investment in research. "We're not asking for an extra 12 years exclusivity. We're asking for new exclusivity," he said. (...)

US sees jump in "pay-for-delay" drug settlements (Opplever stigning i "betaling-for-forsinkelse" ved legemiddelforlik i USA)
reuters.com 27.7.2010
FTC trying to crack down on pay-for-delay settlements
Despite efforts, such drug settlements are up this year

Lawmakers ask if FTC acted improperly during one probe

WASHINGTON, July 27 (Reuters) - Brand-name drug companies made a record 21 deals so far this fiscal year with generic firms that delayed production of cheaper generic drugs, the U.S. Federal Trade Commission told lawmakers on Tuesday.

The FTC is trying to crack down on so-called "pay-for-delay" settlements, highlighting that when generic versions of a drug hit the market, on average, the price of the medicine falls roughly by half. (...)

Big Pharma’s long tentacles (Big Pharmas lange tentakler)
Industry influence
BMJ 2010;340:c941 (16 February)
The BMJ gives two more examples of penetration by the pharmaceutical industry into what, in a better world, would be protected places: Harvard Medical School1 and the World Health Organization.2

In this atmosphere of hidden payments and conflict of interest, medical professionals still go with some confidence to journals such as the BMJ, and the general public to trusted media such as the New York Times. It is distressing therefore to come across an article in the New York Times calling into question the safety and effectiveness of generic medicines.3 It has already met with warm approval on the internet, especially on pharmaceutical industry sponsored websites.

But before suspicion of generic drugs becomes received wisdom under the imprimatur of the New York Times, the subject deserves a closer look. (...)

European Commission targets drug firms over illegal patent protection (EU-kommisjonen ser nærmere på legemiddelfirmaers ulovlige beskyttelse av patenter)
BMJ 2010;340:c268 (15 January)
The European Commission is stepping up pressure on drug companies it suspects of using illegal sweetener deals to protect their patents and prevent cheaper generic drugs from entering the market.

Just three weeks before she is due to stand down as European Union Competition Commissioner, Neelie Kroes has asked several European companies to supply her staff with copies of their patent settlement agreements.

The commission did not divulge the identities of the companies it had targeted. But several confirmed they had been contacted and asked to provide documentation, including annexes, of all agreements with generic drug producers concluded between 1 July 2008 and 31 December 2009. These included AstraZeneca plc, GlaxoSmithKline, Sanofi-Aventis, Novartis, and Roche. (...)

EU vil stoppe medicinalvirksomheders krumspring
epn.dk 18.8.2009
Årelange retssager, bagvaskelse af kopiproducenter og op til 1.300 patentansøgninger i flere europæiske lande på ét medicinsk præparat.

Kreativiteten er stor, når medicinalvirksomheder kæmper for holde kopiproducenterne ude af markedet. (...)

Samfundet taber milliarder på patent-krumspring
business.dk 10.8.2009
Når patentet på et bestemt præparat udløber, forsøger medicinalvirksomhederne ved hjælp af forskellige manøvrer at holde de billige kopiprodukter væk fra markedet så længe som muligt.

'Patent-krumspring'. Det lyder som en joke, men det er ikke desto mindre et begreb, som er vidt udbredt i medicinalindustrien. Når patentet på et bestemt præparat udløber, forsøger medicinalvirksomhederne ved hjælp af forskellige manøvrer at holde de billige kopiprodukter væk fra markedet så længe som muligt.

Og disse krumspring koster hvert år forbrugerne og samfundet dyrt, fortæller Jens P. Kampmann, der er institutleder på Institut for Farmakoterapi, der hører under Sundhedsministeriet:

»Det er helt klassisk for medicinalindustrien at finde måder at forlænge patenter på. Dermed bliver medicinen dyrere for både patienten og samfundet,« siger han til Dagbladet Information. (...)

EU kræver fair play i medicinalindustrien
business.dk 8.7.2009
Det skal være slut med patentfifleri og endeløse retssager for at holde billig kopimedicin ude af markedet. Det fastslår EU-kommissionen i sin endelige redegørelse om konkurrencesituationen i medicinalindustrien.

Konkurrencen halter kraftigt på det europæiske lægemiddelmarked, og den er især gal, når det gælder hurtig introduktion af billig kopimedicin. Det konstaterer EU-kommissionen i en konkurrenceredegørelse, som blev offentliggjort onsdag. (...)

EU “will act” against drugmakers over generic delays (EU "vil handle" mot legemiddelfirmaer som forsinker generiske legemidler)
pharmatimes.com 9.7.2009
The European Commission says it will not hesitate to act against “anticompetitive practices” by drugmakers which delay the market entry of generics, but has also called on member states to do more to boost generic uptake.

The entry of generics onto the European market is being delayed and there is also a decline in the number of novel medicines coming to market, the Commission concludes, in its final report on competition in the drug sector. EU officials are already investigating possible anticompetitive activities by drugmakers, but “regulatory adjustments” are also expected, said Competition Commissioner Neelie Kroes, announcing the investigation’s findings yesterday. (...)

EU pharma competition report “creates uncertainty,” say experts
pharmatimes.com 9.7.2009
Legal experts have criticised the final report of the European Commission’s inquiry into pharma sector competition for failing to tell drugmakers whether the strategies they use to protect their patents are lawful or not.

The suggestion that the Commission will now increase scrutiny of the sector is likely to have “a chilling effect and could lead to real uncertainty over normal commercial practices the industry considers legitimate,” says Nicola Holmes, senior associate at international law firm Eversheds. (...)

EU actively pursuing some drugmakers, official says (EU vil aktivt forfølge enkelte legemiddelfirmaer, ifølge ledere)
reuters.com 7.7.2009
BRUSSELS, July 7 (Reuters) - EU regulators are probing some drug firms over suspected anti-competitive practices that include deals with makers of cheap generics to delay medicines' market entry, a European Commission official said on Tuesday.

European Union Competition Commissioner Neelie Kroes will say in a report on the pharmaceutical industry on Wednesday that "we are actively pursuing a number of individual cases", the official, who has seen the 600-page document, said.

"The report will say that there are no final conclusions at this stage to those cases being pursued," the official said, adding that the document did not identify any companies. (...)

In its preliminary report last November, the EU's executive arm estimated that delays in getting generics on the market had cost healthcare providers 3 billion euros ($4.2 billion), based on a sample of medicines that lost patent protection in 17 EU states between 2000 and 2007.

The European Commission's final report will pave the way for increased regulatory scrutiny of settlement agreements in which brand-name companies pay generics makers for not competing with them or set restrictions on competition, the official said. (...)

Kroes kicked off her investigation in January 2008 with a series of raids on makers of brand-name drugs, including AstraZeneca (AZN.L), GlaxoSmithKline (GSK.L), Pfizer (PFE.N), Merck (MRK.N) and Sanofi-Aventis (SASY.PA). (...)

Sector Snap: Pharma stocks flat in wake of probe
forbes.com 7.7.2009 (Associated Press)NEW YORK -- Shares of major drug makers were mostly flat Wednesday after European regulators announced they plan to step up investigations of whether the companies are delaying the launch of cheaper generic drugs.

The European Union said it plans to monitor settlement deals between major and generic pharmaceutical companies, including some that include payments to delay drug launches. It launched its investigation in January 2008. (...)

Exclusion Payments ("Utestengelsespenger")
JAMA. 2009;301(18):1868. (May 13)
Companies producing patent-protected medications will not be able to guard their market shares by paying generic manufacturers to delay their production of similar pharmaceuticals, if a House bill introduced March 25 becomes law.

The Protecting Consumer Access to Generic Drugs Act of 2009 (HR 1706 [http://thomas.loc.gov]) is intended to clear up the misunderstandings of current laws following recent court rulings regarding the Hatch-Waxman Act of 1984 and involving such drugs as ciprofloxacin and tamoxifen. That law was designed to promote the production of generic drugs while maintaining financial incentives for research and development by proprietary manufacturers, said the bill's sponsor, Rep Bobby Rush (D, Ill). (...)

Generikaavtal kostar samhället miljarder
lakemedelsvarlden.se 2.4.2009
Avtal mellan olika läkemedelsföretag som försenar introduktionen av generiska läkemedel kostar de amerikanska konsumenter 12 miljarder dollar årligen. I amerikanska kongressen pågår nu ett arbete för att förbjuda avtalen.

När ett patent håller på att gå ut sluter originalföretagen avtal med generikaföretagen som gör att läkemedlet inte blir konkurrensutsatt förrän långt senare. Mellan åren 1993 och 2008 lyckades läkemedelsindustrin på det sättet skydda 20 olika läkemedel från billiga alternativ, vilket har kostat de amerikanska konsumenterna 12 miljarder per år. Det framkommer i en hearing i den amerikanska kongressen, skriver tidningen Pharmatimes. För att motverka liknande avtal arbetar flera amerikanska politiker nu med att få fram en ny lag.

I Europa arbetar EU-kommissionen också med att motverka liknande avtal. Enligt en delrapport från kommissionen som kom i höstas har företagens förseningsstrategier kostat de europeiska konsumenterna 30 miljarder kronor. (...)

US branded drug makers pay to prevent generic competition (Amerikanske legemiddelfirmaer, som produserer originalpreparater, betaler for å hindre generisk konkurranse)
BMJ 2008;336:1266-1267 (7 June)
Companies that make branded drugs make payments or beneficial agreements called "side deals" to prevent or restrict marketing of a generic form of a patented drug, the US Federal Trade Commission (FTC) reported last month.

The commission reported that there were 33 final settlements in the fiscal year 2007. Fourteen included payment to the aspiring generic manufacturer and a restriction on the generic company’s ability to market the generic drug, a number similar to the previous year. The report did not name the companies involved. (...)

Company accused of exploiting unique features of drug to retain market share (Firma anklaget for å utnytte unike legemiddelegenskaper for å beholde markedsandel)
BMJ 2008;336:576 (15 March)
Doctors, governments, and drug regulators must watch the way drug companies operate because the dearth of new medicines is taking profit chasing to new heights, an expert has warned. (...)

Professor Collier warned that whatever efforts were made to tighten the law or industry codes of conduct, drug companies would find a way to push their boundaries to the limit.

"Doctors, governments, and regulators of medicines have got to recognise that the industry may not have the best interests of patients or the NHS at heart. They should . . . try to force the industry to behave in a way that is socially responsible," Professor Collier told the BMJ. "But of course social responsibility does not bring profitability." (...)

The practice of switching patients is widely used in the drug industry. GlaxoSmithKline and Wyeth were forced to abandon schemes for paying a third party or practice staff to switch patients to new formulations of salmeterol (Serevent) and lansoprazole (Zoton) (BMJ 2004;329:875; doi: 10.1136/bmj.329.7471.875-a).

A spokesperson for the Office of Fair Trading said that it is aware of the case and is considering whether Reckitt Benckiser has breached competition laws. The health select committee is also expected to investigate the case.

In June 2005 the European Commission fined AstraZeneca €60m for supplying regulatory agencies throughout Europe with misleading information about when the patent of its drug omeprazole (Losec) was issued, in a bid to delay development of a generic version. The company is appealing. (...)

Drug giants 'swindle NHS by blocking cheap medicines' extending patents
independent.co.uk 8.3.2008
Britain's research-based pharmaceutical industry has been accused of using devious tactics to extend the life of drug patents, costing the NHS millions of pounds.

Manufacturers of generic medicines – cheap copies of brand-name drugs – hit out at the tactics adopted by major pharmaceutical companies of "evergreening" products to maintain their monopoly on the market after a patent expires.

The allegations were made as the makers of an indigestion remedy, Gaviscon, launched an internal investigation after being accused of cheating the NHS. (...)

European Commission looks into possible restrictive practices by drug companies
BMJ 2008;336:524 (8 March)
The falling number of new drugs coming onto the market has prompted the European Commission to launch its first major investigation into the pharmaceutical sector to determine whether manufacturers are engaging in illegal restrictive practices. (...)

Legemiddelindustrien granskes av EU
vg.no 17.1.2008
(VG Nett) EU mistenker brudd på konkurransereglene, og starter gransking av hele legemiddelsektoren. (...)

Generics' delays draw scrutiny (Forsinkelser av generika utløser granskning)
indystar.com 8.2.2007
Congress ponders limiting efforts by brand-name drug makers to stave off cheaper rival offeringsBy Maureen Groppe
Star Washington Bureau

Brand-name and generic drug makers compete over consumers' drug dollars, but some members of Congress think they've been colluding to share profits at the expense of cheaper drugs for the public. (...)

Lovgiverne ønsker å stramme inn reguleringer som tillater merkeprodusenter å betale generiske rivaler millioner av dollar for å forsinke introduksjon av lavkostkonkurrenter på markedet. (Lawmakers want to tighten regulations that have allowed brand-name drug makers to pay generic rivals millions of dollars to delay putting a low-cost competitor on the market.)

For consumers, getting a generic version can cut their drug bills by more than half.

For drug makers such as Eli Lilly and Co., losing the right to sell a brand-name drug can cost billions.

When Lilly's blockbuster antidepressant drug, Prozac, lost its patent protection in 2001 after 13 years on the market, the drug's share of antidepressant prescriptions fell from 22 percent to 8 percent in just three weeks.

By the end of the year, Prozac's sales had dropped by nearly 70 percent, forcing the company to tighten its belt.

Drug companies are under enormous pressure to protect their blockbuster products, which often account for more than half of their sales. (...)

Pharmaceutical Lobbying Groups Stall Legislation That Aims To Prevent Companies From Delaying Introduction of Generic Drugs to Market
kaisernetwork.org 13.11.2007
Legislation that would prevent brand-name drug companies from paying generic drug makers to delay market entry of generic medications "has stalled in Congress in the face of major lobbying by the drug industry," the AP/Houston Chronicle reports. The bill, sponsored by Senate Judiciary Antitrust, Competition Policy and Consumer Rights Subcommittee Chair Herb Kohl (D-Wis.), would ban settlements known as "reverse payments" in which generic drug manufacturers receive something of value for delaying market entry of drugs. (...)

- Sekundære patent

Eli Lilly i usædvanlig patentretssag
medwatch.dk 19.8.2013
I denne uge starter Eli Lilly en noget anderledes patentretssag, hvor man skal forsøge at opretholde et sekundært patent, der dækker den måde, som et af selskabets storsælgende lægemidler ordineres på. Udfaldet kan få store konsekvenser for selskabet og branchen. (...)

Men faktisk drejer det sig om to patenter – ét som dækker den kemiske opbygning af lægemidlet, og ét som dækker den måde hvorpå medicinen ordineres, nemlig sammen med folinsyre og B12 vitamin for at mindske negative bivirkninger.

Den kemiske forbindelse, som ligger til grund for lægemidlet, mister patent i 2017, men hvis Eli Lilly får medhold i retten, kan det sekundære patent holde kopivirksomheder fra fadet helt frem til 2022. (...)

Åbenlys opdagelse
I den aktuelle sag er Eli Lilly oppe imod en række kopiproducenter, heriblandt Teva Pharmaceuticals, som ønsker at markedsføre generiske varianter af kræftmedicinen, inden det sekundære patent udløber.

Kopiproducenterne mener, at patentet burde fjernes, da de fleste fagfolk med indblik i kræftbehandling og ernæring ville have nået til den konklusion, at medicinen burde gives i kombination med folinsyre og B12 vitamin.

Men Lilly forsvarer sig med, at da deres forskere første gang foreslog det, blev de mødt med ”hård modstand både internt i selskabet og fra omverdenen”, heriblandt fra de amerikanske medicinmyndigheder FDA. (...)

- Generisk svertekampanje - Legemiddelprodusenter betaler leger for å skrive studier som kritiserer generiske legemidler

Drug Makers Pay Doctors To Write Studies Criticizing Generic Drugs, Opinion Piece says (Legemiddelprodusenter betaler leger for å skrive studier som kritiserer generiske legemidler, ifølge innlegg)
kaisernetwork.org 9.5.2006
Daniel Carlat, professor ved Tufts University School of Medicine, skriver i et innlegg i New York Times at "selv den sløveste kritiker av etiske utfordringer i markedsføringen av legemidler vil bli overrasket over at produsenter av sovemidler nå betaler leger for å gå ut i media og kritisere generiske legemidler." Ifølge Carlat, har omfattende reklame for originale sovemidler, slik som Sepracors Lunesta og Sanofi Aventis' Ambien gjort navnene allment kjente," men "de fleste mennesker har aldri hørt om" trazodone, et mye forskrevet generisk sovemiddel som psykiatere ofte forskriver mot søvnvansker. Trazodone har ingen risiko for avhengighet, er effektivt som søvnmiddel, har "lenge vært ansett som sikkert" og koster så lite som 10 cents per tablett, skriver Carlat. I de senere år har flere artikler skrevet av leger dukket opp i profesjonelle tidsskrifter som kritiserer trazodone, som bruker "retoriske teknikker" som"minimaliserer [dets] fordeler" og "understreker ... dets negative kvaliteter," bemerker han. Carlat uttaler at artiklene, som "gir seg ut for å presentere en balansert gjennomgang av vitenskapelig litteratur for sovemidler," var sponset av legemiddelfirmaer slik som Sanofi-Aventis, Sepracor og Takeda Pharmaceuticals, de samme firmaer "som profitterer på at forbruket av trazodones faller." Den "måte man kan motvirke praksisen med negativ markedsføring forkledd som rettmessig vitenskapelige kommentarer på er å pålegge offentliggjøring av alle linker mellom legemiddelfirmaer og forfattere," skriver Carlat, som tillegger at legemiddelfirmaer "bør pålegges å offentliggjøre detaljerte opplysninger om legers deltakelse i utarbeidelsen av sponsede artikler, så vel som det pengebeløpet som han eller hun mottar." Han konkluderer at "jeg mistenker det ville være de færreste leger som ønsker at slik informasjon skal bli offentlig kjent" (Carlat, New York Times, 5/9). (In a "move that may astonish even the most jaded critics of ethically challenged pharmaceutical marketing, makers of sleeping pills are now paying doctors to publish bad things about competing drugs," Daniel Carlat, a professor at the Tufts University School of Medicine, writes in a New York Times opinion piece. According to Carlat, widespread advertising for brand-name sleeping pills, such as Sepracor's Lunesta and Sanofi Aventis' Ambien, have made the medications "household names," but "most people have never heard of" trazodone, a widely prescribed generic hypnotic that psychiatrists frequently prescribe as a sleep aid. Trazodone carries no risk of addiction, is effective as a sleep aid, has a "long safety record" and costs as little as 10 cents per pill, Carlat writes. In recent years, several articles written by physicians have appeared in professional journals that criticize trazodone, using "rhetorical techniques" that "minimiz[e] [its] advantages" and "emphasi[ze] ... its negative qualities," he notes. Carlat says that the articles, which "purport to present balanced reviews of the scientific literature on sleeping pills," were sponsored by companies such as Sanofi-Aventis, Sepracor and Takeda Pharmaceuticals, the same firms "that stand to gain from trazodone's downfall." The "way to discourage [the] practice of negative marketing disguised as legitimate scientific commentary is to mandate fuller disclosure of links between drug companies and authors," Carlat writes, adding that the companies "should be required to disclose the exact nature of a doctor's involvement in preparing a sponsored article, as well as the dollar amount of his or her fee." He concludes, "I suspect it would be the rare doctor who would want such information to come to light" (Carlat, New York Times, 5/9).)

Generic Smear Campaign (Generisk svertekampanje)
By DANIEL CARLAT
nytimes.com 9.5.2006
DET AT legemiddelfirmaer betaler leger for å si gode ting om deres legemidler er ingen nyhet. To tidligere redaktører for New England Journal of Medicine, Jerome P. Kassirer og Marcia Angell, har dokumentert legemiddelindustriens bruk av leger til å promotere nye legemidler igjennom faglige artikler og medisinske konferanser. (THAT pharmaceutical companies pay doctors to say good things about their drugs is no longer newsworthy. Two former editors of The New England Journal of Medicine, Jerome P. Kassirer and Marcia Angell, have documented the drug industry's use of doctors to promote new medicines through professional articles and at medical conferences.)

Men et trekk, som kanskje har overrasket selv de mest garvede kritikere av etisk utfordrende markedsføring av legemidler, er at produsenter av sovepiller nå betaler leger for å si dårlige ting om konkurrerentens legemidler. (...) (But in a move that may astonish even the most jaded critics of ethically challenged pharmaceutical marketing, makers of sleeping pills are now paying doctors to publish bad things about competing drugs.)

En måte å motvirke denne praksis med negativ markedsføring forkledt som vitenskapelig kritikk er pålegg om at det opplyses om forbindelser mellom legemiddelfirmaer og forfattere. (The way to discourage this practice of negative marketing disguised as legitimate scientific commentary is to mandate fuller disclosure of links between drug companies and authors. Several states now insist that drug makers report the gifts they give doctors.)

De samme firmaer bør pålegges å opplyse om eksakt hvilken tilknytning angjeldende lege har til utarbeidelsen av sponsede artikler, så vel som størrelsen på honoraret. Jeg antar at det er sjelden at leger ønsker at slik informasjon skal bli offentlig tilgjengelig. (These same companies should be required to disclose the exact nature of a doctor's involvement in preparing a sponsored article, as well as the dollar amount of his or her fee. I suspect it would be the rare doctor who would want such information to come to light.)

Daniel Carlat, professor ved Tufts Medical School, er redaktør for Carlat Psychiatry Report. (Daniel Carlat, a professor at Tufts Medical School, is the editor in chief of The Carlat Psychiatry Report.)

- I virkeligheten er brevet koordinert og skrevet av PR-firmaet Burson-Marsteller, betalt av legemiddelfirmaet

Antibiotics don't cure colds, so why do patients think they do? (Antibiotika kurerer ikke forkjølelse, så hvorfor tror pasienter at de gjør det?)
guardian.co.uk 20.3.2010
Leger som nører opp under pasientpress skaper etterspørsel (Doctors who cave into patient pressure create demand)

Sist måned forslo regjeringen å tillate farmasøyter å erstatte forskrivninger av originallegemidler med generiske alternativer. Et protestbrev ble publisert i The Times, signert av en rekke pasientgrupper og eksperter, med positiv dekning i flyveblader. The Times rapporterte at "eksperter sier at plan om å bytte til billigere legemidler vil skade pasienter". De viste til og med til en case studie: "Pasienter som fikk Seroxat-kopier i stedet for originalen følte seg uvel innen to dager." (Last month the government proposed allowing pharmacists to substitute prescriptions for branded medicines with generic alternatives. A letter of protest appeared in the Times, signed by various patient groups and experts, with positive coverage in the broadsheets. "Plan to switch to cheaper medicines will harm patients, say experts," reported the Times. They even had a case study: "Patient given Seroxat substitute felt unwell within two days.")

Men lege Margaret McCartney, som har gjort en gravejobb, skriver i British Medical Journal: i virkeligheten er brevet koordinert og skrevet av PR-firmaet Burson-Marsteller, betalt av legemiddelfirmaet Norgine. Til tross for at det var Norgines virksomhetsleder Peter Martin, som hadde størst innflytelse på kampanjen, signerte han ikke brevet selv. På spørsmål om hvorfor, svarte han: "Der var ingen konspirasjon. Den oppriktige sannhet, den redelige sannhet, er at jeg tenkte at det å blande inn et legemiddelfirma på en måte ville gjøre budskapet litt mindre troverdig. (...) (But Margaret McCartney GP, writing in the British Medical Journal, has been digging: in fact the letter was coordinated and written by the PR company Burson-Marsteller, paid by the drug company Norgine. Norgine's chief operating officer, Peter Martin, despite being the major influence behind the campaign, did not sign the letter himself. Asked why not, he said: "There was no conspiracy. The frank truth, the honest truth, is that I thought that having a pharmaceutical company in there would sully the message somewhat.")

(Anm: Generic drugs: protest group was not quite what it seemed. BMJ 2010;340:c1514 (17 March).)

Generic drugs: protest group was not quite what it seemed (Generiske legemidler: protestgruppe var ikke helt hva det synes som)
BMJ 2010;340:c1514 (17 March)
Sist måned publiserte The Times et brev fra leger og pasientgrupper som varslet mot generiske legemidler og støttet forskrivning av originallegemidler. Men hvem stod egentlig bak protesten? Margaret McCartney gransker (Last month the Times published a letter from doctors and patients’ groups warning against generic drugs and supporting branded prescribing. But who was really behind the protest? Margaret McCartney investigates)

Generics are good for us. That’s the mantra that is taught to doctors again and again: they are cheaper for the NHS but just as effective for the patient. So it was surprising to find a letter in the Times recently, signed by several doctors, decrying generics and pleading for doctors’ choice to prescribe branded drugs to be paramount. The letter, titled "Patient wellbeing at risk from substituted generic medicines," was also signed by patients’ groups such as the Cure Parkinson’s Trust and the British Liver Trust and carried the names of the media doctor Patricia Macnair, Stephen Kownacki, chairman of the Primary Care Dermatology Society, and Jean Mossman, former chief executive of Cancer BACUP (www.timesonline.co.uk/tol/comment/letters/article7037957.ece). (...)

- Noen leger insisterer på originallegemidler selv om generiske er tilgjengelige

Some doctors insist on brand-name drugs even when cheaper generics are available (- Noen leger insisterer på originallegemidler selv om generiske er tilgjengelige)
washingtonpost.com 11.7.2011
Three words to watch out for next time you get a new prescription: “Dispense as Written.” Scrawled across the prescription form in your doctor’s hand — or, more likely, ticked off on a check box — the words may seem innocuous enough. But they’re costing you.

In fact, a recent article in the American Journal of Medicine says they’re costing all of us $7.7 billion a year. Because what this note from your doctor to your pharmacist means is: “I won’t let you fill this prescription with a generic.” (...)

- Legemiddelprodusenter misbruker patenter til å blokkere generika

Medicinalindustrien fifler med patenter
business.dk 13.3.2009
Den forskende del af medicinalindustrien forsøger i stigende grad at forlænge levetiden for de mest populære lægemidler ved hjælp af patentfifleri og andre krumspring, viser en EU-rapport.

Den forskende del af medicinalindustrien er presset af mangel på nye storsælgende lægemidler og af myndighedernes voksende ønske om at fremme brugen af billig kopimedicin.

Derfor forsøger medicinalvirksomheder i stigende grad at holde deres lægemidler kunstigt i live ved hjælp af patentsystemet og med andre krumspring, når det løber af patent.

Det viser en foreløbig rapport om konkurrencevilkårene for udvikling af nye lægemidler. Rapporten, som er meget kritisk over for industriens forretningsmetoder, uden dog at kunne påvise direkte ulovligheder, har netop har været i høring hos såvel myndigheder som lægemiddelindustri i Europa.

Ifølge rapporten bruger den forskende del af lægemiddelindustrien, originalproducenterne, bevidst patentsystemet til at lægge hindringer ud for såvel andre originalproducenter som kopiproducenter.

Resultatet er, at kopimedicin introduceres langsommere på markedet end forventet. (...)

EU accuses pharma companies of adopting anti-competitive practices (EU anklager legemiddelfirmaer for innføring av antikonkurransepraksis)
pharmaceutical-business-review.com 2.12.2008
The European Union has blamed the drug makers for their role in the escalating healthcare costs. It has accused the pharma companies of indulging in anti-competitive practices that blocked the sales of low-cost generic medicines, reported The New York times. (...)

Legal tactics to delay launch of generic drugs cost Europe €3bn, report says (Rettslig taktikk for å forsinke generiske legemidler koster Europe 3 milliarder euro, ifølge rapport)
BMJ 2008;337:a2817 (1 December 2008)
Drug companies are bracing themselves for the launch of a series of antitrust investigations in Europe after the European Commission published a highly critical report on industry practices.

The 426 page preliminary report by the commission’s Competition Directorate, which is to be followed by a final version next spring, highlights widespread legal tactics by drug companies to defend their patents. The commission says that such tactics have delayed the entry of cheaper generic drugs, at a cost of 3bn (£2.5bn; $3.8bn) since the start of the decade. (...)

Pharmaceutical Sector Inquiry: Preliminary Report is at http://ec.europa.eu/.pdf. (...)

Drugmakers abuse patents to block generics, says EU, EFPIA objects (Legemiddelprodusenter misbruker patenter til å blokkere generika, ifølge EU, EFPIA tilbakeviser)
pharmatimes.com 28.11.2008
Tactics used by pharmaceutical manufacturers to delay or block the entry onto the market of cheaper generics mean that European Union member states spent around 3 billion euros more during 2000-2007 than they would have if the generics had been available without delay, according to the preliminary findings of an investigation by the European Commission.

On average, it takes about seven months for generics to reach the market, and four months for even the top-selling products to arrive, according to the report, which was presented this morning by Competition Commissioner Neelie Kroes. (...)

(Anm: EU-kommisjonen (Den europeiske unions høyeste organ) (mintankesmie.no).)

(Anm: Patenter (mintankesmie.no).)

EU-kommissionen till attack mot läkemedelsföretag
lakemedelsvarlden.se 28.11.2008
Originalföretagens strategier för att försena försäljningen av generika har kostat konsumenterna i Europa runt 30 miljarder kronor. Det hävdas i en rapport från EU idag.

Anklagelserna bygger på bevis som EU-kommissionen samlade in under oannonserade inspektioner under januari månad. Då fick Astrazeneca, Glaxosmitkline och åtminstone sju bolag till oväntade besök från kommissionens kontrollanter. (...)

”Jag förmodar att vi alla haft diskussioner om hur vi ska kunna hindra generikaföretagen”, är ett citat från dokumentation som kommissionens kontrollanter fann vid sin raid. ”Vänta inte för länge med att patentera nya salter, generikaföretagen startar allt tidigare” ett annat citat. (...)

Pharmaceuticals
Sector Inquiry

ec.europa.eu 28.11.2008
"Individuals and governments want a strong pharmaceuticals sector that delivers better products and value for money. But if innovative products are not being produced, and cheaper generic alternatives to existing products are being delayed, then we need to find out why and, if necessary, take action."

Neelie Kroes, European Commissioner for competition

Public presentation of preliminary findings on 28 November 2008
The Commission is presenting the preliminary findings at a conference on 28th November 2008 in Brussels. (...)

(Anm: Preliminary Report (28 November 2008) Executive Summary en - Preliminary Report.)

Krass kritikk av legemiddelbransjen
dn.no 28.11.2008
EU-kommisjonen anklager legemiddelbransjen for bevisst å blokkere billige medisiner.

Dermed bidrar bransjen til unødvendig høye priser for forbrukerne i Europa, mener EU. (...)

– Betaler konkurrenter
Blant papirene som Kommisjonen fikk se, fant man blant annet bevis for at de store selskapene i enkelte tilfeller har betalt kopiselskapene for ikke å lansere billige kopipreparater. Over 200 millioner euro, om lag 1,8 milliarder kroner, skal ha blitt brukt på slike avtaler.

I et annet tilfelle hadde et storselskap lagt inn ikke mindre enn 1.300 patentsøknader for ett enkelt preparat, for å hindre kopier å komme på markedet. (...)

Drugmaker Delay on Generics Cost EU 3 Billion, EU Says (Update2) (Legemiddelprodusenters forsinkelse av generika koster EU 3 milliarder, ifølge EU)
bloomberg.com 28.11.2008
Nov. 28 (Bloomberg) -- European Union regulators accused drugmakers of costing consumers in 17 countries as much as 3 billion euros ($3.9 billion) by using patent lawsuits and other tactics to keep cheaper generic medicines off the market.

The claim, part of an interim report by the European Commission today, was based on evidence collected during January raids at GlaxoSmithKline Plc, AstraZeneca Plc and at least seven other competitors. EU Competition Commissioner Neelie Kroes in Brussels said she “would not hesitate” to open antitrust cases when there’s evidence of restrictive business practices. (...)

Europe Accuses Drug Makers of Padding Health Care Costs
nytimes.com 28.11.2008
BRUSSELS — The European Union accused drug companies on Friday of adding billions of dollars to health care costs by delaying or blocking the sale of less expensive generic medicines. (...)

- Det generiske byttet

Bakeren, smeden og det generiske byttet
apotek.no (20.10.2008)
- Å antyde at det er apotekene og ikke staten som har den virkelig store motivasjonen for at generisk bytte skal gjennomføre i stor stil, det er å rette baker for smed, skriver adm.dir. Kai Finsnes, i et leserinnlegg i Dagens medisin 16. oktober. Les hele innlegget her.

”I Dagens Medisin 14. september skriver Erik. M. Larsen, Relis, at apotekene ikke må gjennomføre generisk bytte for enhver pris, og at helsepersonell i apotek må ta hensyn til om pasienten mestrer generisk bytte. (...)

NAV anslår at staten har spart mer enn 270 millioner kroner på generisk konkurranse for de to virkestoffene alendronat og sertralin alene. Den akkumulerte innsparingen for staten som følge av trinnprising av kopilegemidler beløper seg til flere milliarder kroner. Apotekene har forståelse for at det er viktig for staten å sikre seg disse innsparingene, og underkjenner heller ikke at generisk bytte har en verdi for apotekbransjen. Men å antyde at det er apotekene og ikke staten som har den virkelig store motivasjonen for at bytter skal gjennomføre i stor stil, det er å rette baker for smed. (...)

- Kamp om kopimedisin

The pharmaceutical industry
The bitterest pill

economist.com 24.1.2008
Drugs firms have found new ways to keep generic medicines at bay

“IF WE have the feeling that something is rotten in the state, then let's take the opportunity to find out.” So said Neelie Kroes, the European Commission's competition commissioner, seeking to justify a spectacular raid last week on big pharmaceutical companies. Officials are investigating whether sellers of expensive branded pills conspired together to delay the launch of cheap generic rivals. America's Federal Trade Commission (FTC) is also looking into it. (...)

Lobbying Stalls Generic Drug Legislation
forbes.com 13.11.2007
WASHINGTON - Legislation aimed at speeding the availability of cheaper generic drugs has stalled in Congress in the face of major lobbying by the drug industry.

The Senate bill would ban most settlements known as "reverse payments," in which a brand-name company pays a generic manufacturer to delay the introduction of the generic drug. The Federal Trade Commission, which has called on Congress to take action, says such settlements could cost American consumers billions of dollars. (...)

Drug sales worth 140 bln usd will lose patent protection by 2016 – report
forbes.com2.5.2007
LONDON (Thomson Financial) - Drug makers face a decade of 'unrelenting generic competition' with medicines worth nearly 140 bln usd in sales due to lose patent protection by 2016, according to a report from market analysts Datamonitor.

Global pharmaceutical sales reached 643 bln usd last year, according to IMS Health data. (...)

Big Pharma teaches old drugs new tricks
cnn.com 21.3.2007
Drugmakers hunt for new patents on old blockbusters to try and postpone the inevitable: generic competition.

NEW YORK (CNNMoney.com) -- As Big Pharma faces patent expirations on some of its most lucrative drugs, the industry is trying to reinvigorate sales by finding creative ways to land new patents - but on the same old drugs. (...)

Svindyre kopimedisiner i Norge
vg.no 20.3.2007
Kopimedisiner er i gjennomsnitt to til tre ganger så dyre i Norge som i Sverige. Enkelte medisiner koster fem ganger så mye her hjemme. (...)

Kamp om kopimedisin
dn.no 15.2.2007
Legemiddelkonsernet Novartis mener streng håndhevelse av patenter på medisiner vil bidra til økte investeringer i global helse.

Leger Uten Grenser kaller det sveitsiske konsernets oppførsel skammelig.
Novartis har saksøkt den indiske stat i et forsøk på å få underkjent en lov som forbyr patenter på visse typer mindre endringer i medisiner.

nneskerettsgrupper frykter at hvis konsernet får medhold, vil det gjøre en rekke medisiner altfor dyre for pasienter verden over.

– Patentlover i samsvar med internasjonal praksis vil anspore til investering i forskning og utvikling på det biomedisinske område i India. Det vil hjelpe Indias raskt voksende økonomi og hjelpe pasienter, myndigheter og industri, sier Thomas Wellhauer i Novartis. (...)

Pfizer threatens another philippine generic company with litigation to stop legal competition
secondview.blogspot.com 19.12.2006
Pfizer is striking the Philippines generic industry again. (...)

- Reseptbelagte legemidler er ensbetydende med store penger

Prescription drugs mean big money (Reseptbelagte legemidler er ensbetydende med store penger)
consumersinternational.org 26.3.2008
Research by the French consumer group Union Fédérale des Consommateurs-Que Choisir (UFC-QUE CHOISIR) has estimated that between 2002 and 2006 €1 billion has been wasted as a result of GPs prescribing branded rather than generic drugs.

The group claims that this colossal misappropriation is a result of drug industry pressure on doctors. (...)

- FDA's 2008 budget plan seeks user fees for generics

FDA's 2008 budget plan seeks user fees for generics
pharmatimes.com 8.2.2007
President George W Bush's FY2008 budget proposal includes nearly $2.1 billion for the Food and Drug Administration, up more than 5% over the agency budget submitted to Congress last year. Moreover, the Administration's request for nearly $444 million in industry fees includes, for the first time, user fees for generic drugs.

The FDA is asking for $5.6 million in budget authority and $15.7 million in fees from the generics sector to be able to conduct more expedited reviews, and faster. "Generic drugs generally cost 20%-70% less than their brand-name counterparts and thus offer an attractive way of reducing healthcare costs associated with prescription drugs," it says.

However, Kathleen Jaeger, chief executive of the Generic Pharmaceutical Association (GPhA), has warned that the FDA "can hire more reviewers and speed up reviews, but if it doesn't deal with barriers like authorized generics and citizen petitions, affordable generics won't reach consumers any faster." (...)

- The "doughnut hole"

The Origins of the Doughnut Hole: Excess Profits on Prescription Drugs
BY DEAN BAKER
The Center for Economic and Policy Research (CEPR)
cepr.net/publications (August 2006)
The Medicare drug benefit was not designed in a way to minimize costs to the government and beneficiaries. Instead, Congress designed a plan that ensures high profits for the pharmaceutical and insurance industries. One result of this design is that the Medicare drug benefit includes an unusual $2,850 gap in coverage, where beneficiaries are entirely responsible for their drug bills. The standard plan covers 75 percent of prescription drug costs until the beneficiary’s drug expenditures reach $2,250 for the year. The beneficiary is then fully liable for their drug expenses until they reach $5,100.1 At that point, the insurance kicks back in, covering 95 percent of additional drug costs.

This gap in coverage was put into the plan to save the government money. While the bill was intended to assist seniors with their drug expenses, Congress wanted to limit public spending on the program. The “doughnut hole” gap in coverage was the mechanism chosen. The excess profits of the prescription drug industry are the main factor that led to the need for the doughnut hole. This paper calculates the amount of excess profits of the 20 most commonly used drugs, and compares them to the size of the doughnut hole. (...)

The table shows that for several of the drugs the excess profits are substantial. For example, the excess profits earned on Protonix, a heartburn medication, are calculated as just under $1 billion. The combined excess profits earned on the two dosages for Zocor, a cholesterol lowering drug, are more than $1.6 billion. The combined excess profits for the two dosages of Lipitor, another cholesterol lowering drug, come to $1.2 billion. (...)

Petitions to FDA Sometimes Delay Generic Drugs
washingtonpost.com 3.7.2006
Critics Say Companies Misusing Process

A procedure designed to alert the Food and Drug Administration to scientific and safety issues is getting a hard look from members of Congress, who say they are concerned that it may be getting subverted by the brand-name drug industry. (...)

- Drug Industry Raises Concerns Over Potential Changes to Patent System

Drug Industry Raises Concerns Over Potential Changes to Patent System
Daily Health Policy Report [Aug 18, 2006]
kaisernetwork.org 18.8.2006
Pharmaceutical industry groups have had a "less than enthusiastic response" to a bill (S 3818) sponsored by Sens. Orrin Hatch (R-Utah) and Patrick Leahy (D-Vt.) that would revise the U.S. patent system, CongressDaily reports. The legislation would award patents to the first individuals who file for them, rather than first individuals who invent products, and would limit defenses in patent lawsuits filed over willful infringement or "inequitable conduct." According to CongressDaily, pharmaceutical industry groups "have been muted in their response to the measure" because "it could potentially threaten their bottom line, which is primarily based on a few money-making dugs." In a statement, officials of the Pharmaceutical Research and Manufacturers of America said the group will review the bill "to ensure that patent protection -- which is essential to the development of new medicines for millions of patients -- is not compromised." Officials for the Generic Pharmaceutical Association said they seek significant revisions to the legislation. Kathleen Jaegar, president and CEO of the GPhA, said that the bill would reduce penalties for companies that use fraudulent statements and misconduct to obtain patents. "This one provision does more harm to the integrity of the patent process than good," Jaeger said. The Senate likely will debate the bill next year (Swindell, CongressDaily, 8/17). (...)

Bill Daley's Big Pharma History: Drugs, Profits And Trade Deals (Bill Daleys Big Pharma-historie: Legemidler, profitt og handelsavtaler)
huffingtonpost.com 28.9.2011
This piece is a continuation of The Huffington Post's collaboration on trade issues with The Dylan Ratigan Show, called Trading Our Future.

WASHINGTON -- As commerce secretary under Bill Clinton, William Daley worked with U.S. pharmaceutical giants to curb the use of cheaper generic drugs abroad. As a board member for Abbott Laboratories, he had a front-row seat on a brutal clash between a major drug company and a developing nation over access to life-saving medication. And as White House chief of staff today, Daley has President Barack Obama’s ear.

Add up Daley’s power and experience, and experts who follow public health policy suspect his influence in the U.S. stance in negotiations over a major international trade deal -- a stance with hugely profitable implications for giant American drugmakers.

The United States is in talks with eight other Pacific nations to establish the Trans-Pacific Partnership, which the administration hopes will serve as a template for other trade pacts. According to leaked documents from the negotiations, the Obama administration is using the deal to push hard-line intellectual property standards that could drive up medicine prices overseas, boosting the bottom line for U.S. drugmakers like Abbott Labs at the expense of public health. (...)

- Leger stiller spørsmål ved legemiddelkontrollens tiltro til generiske legemidler sikkerhet og effektivitet

Physicians Question FDA's Confidence in Generic Drugs' Safety, Efficacy (Leger stiller spørsmål ved FDAs (legemiddelkontrollens) tiltro til generiske legemidlers sikkerhet og effektivitet)
Psychiatr News 2007;428(11) (June 1)
(...) Janicak explained that Food and Drug Administration (FDA) requirements around bioequivalence of generic products are fairly strict: a generic must have between 80 percent and 125 percent bioequivalency to its name-brand product—a window of 20 percent less or 25 percent greater potency. (...)

As Janicak explained, the FDA's method for using confidence intervals would seem to ensure that any drug approved would have a bioequivalency that would—for most patients—be closely equivalent in terms of efficacy and toxicity to the name brand.

Still, he cautioned, "most patients" is not the same as "all patients," and whether the 24 to 36 normal subjects used in the agency's bioequivalency tests represents the full range of individual variation in the way drugs are absorbed across the pharmaceutical using population is uncertain.

"There will always be outliers," Janicak said. "Those are the people who may be getting into trouble."

Janicak described a patient who had been stable on Zoloft (sertraline) for years, but had a dramatic relapse when switched to the generic formulation.
Jeffrey Lieberman, M.D., chair of APA's Council on Research, agreed. "Many clinicians have patients who have experienced variation in response when switching from a name brand to a generic," he told Psychiatric News. "In some cases these have been related to side effects; in other cases, it has been a difference in efficacy. We have some impressions, but we need systematically collected data." (...)

Udbredt brug af kopimedicin har reduceret praktiserende læger til købmænd
lifdk.dkn (5.11.2006)
Over halvdelen af den medicin, danske patienter anvender, er kopimedicin. Kopimedicin er billigere end de originale lægemidler. Men kopimedicin betyder hyppige skift mellem de forskellige mærker, og det kan give problemer for patienterne og mere arbejde til lægerne.

»Man er efterhånden mere købmand end læge, fordi det hele tiden handler om at spare penge.« Sådan lyder det fra praktiserende læge Tyge Ingerslev fra Grenaa, der nu mener, at grænsen er nået for, hvor mange ressourcer han og andre i sundhedsvæsenet skal bruge på at beskæftige sig med kopimedicin og de problemer for patienterne, der følger. (...)

Ødelegger for produsentene
aftenposten.no 16.8.2006
Norske legers utskriving av billigere legemidler møter motstand.

Den norske politikken med å oppfordre leger til å skrive ut resepter på billige medisiner har fått flere utenlandske ambassadører til å reagere.

Både USA, Storbritannia og Sveits beskylder Norge for å lage alvorlige problemer for legemiddelindustrien, melder NRK.

Salget av kopimedisiner går ut over salget av originale og patenterte legemidler, ifølge landenes ambassader.

– Vi er alle bekymret for patentlovgivningen slik den eksisterer i dag, sier den amerikanske ambassadøren Benson K. Whitney.

Flere internasjonale legemiddelprodusenter prøver å stoppe kopiprodusentene via rettsvesenet og ser ikke med blide øyne på den norske politikken for å presse ned prisene på legemidler. (© NTB)

Vil ha slutt på billigmedisiner
nrk.no 16.8.2006
USA, Storbritannia og Sveits prøver å få Norge til å endre dagens regelverk som tillater billige "kopimedisiner" på apoteket. (...)

Medicinalindustri i hårdt angreb på parallelimportører
berlingske.dk 2.7.2006
Den europæiske medicinindustri anklager parallelimportører for at være en kanal ind på markedet for forfalsket medicin. Parallelimportørerne afviser blankt kritikken og returnerer med en advarsel om, at producenterne selv leverer medicin med farlige fejl. (...)

Farlige fejl
Hans Bøgh-Sørensen henviser til, at hans pakkeri flere gange under ompakning af medicin har konstateret fejl og mangler ved medicinen fra originalproducenterne.

Seneste problem var, da piller i blisterpakninger med mavesårsmedicinen Nexium fra AstraZeneca indeholdt tabletter på 40 mg. i stedet for - som det stod på blisterpakningerne - 20 mg.

»Dermed mener vi faktisk, at vi er en ekstra sikkerhedskontrol for en industri, der ikke altid selv kan leve op til de standarder, de siger, de har,« siger Hans Bøgh-Sørensen.

Sanofi-Aventis topchefen, der er næstformand i Efpia, er i forvejen stærkt irriteret på parallelimportørerne, der hvert år henter medicin for milliarder i lande, hvor prisen er lav og sælger den videre i højprislande.

»De bidrager ikke med noget som helst. Jeg mener ikke, at de har ret til at være på markedet overhovedet,« siger Jean-François Dehecq. (...)

- Leger mener kvaliteten på lovlige kopipreparater er dårligere enn originalpreparater

Kopimedicin og original medicin virker ens
Indlægget er skrevet af direktør Jytte Lyngvig, Lægemiddelstyrelsen
Lægemiddelstyrelsen 14.9.2006
(...) Det vi skal vide og have grundigt dokumenteret er, at der er tale om de samme aktive stoffer, og at de optages på samme måde i kroppen. Måleenheden for dette kaldes bioækvivalens, og det er omfattende dokumenteret for kopiprodukter.(...)

Danske leger advarer mot kopimedisiner
aftenbladet.no 13.9.2006
Hyppige skifter av medisiner mellom forskjellige kopilegemidler kan gi alvorlige bivirkninger, hevder danske leger.

Myndighetene spiller hasard med pasientenes helse når de for å spare penger tvinger dem til å skifte mellom ulike kopimedisiner, hevder flere danske leger overfor Jyllands-Posten.

På samme måte som i Norge er danske leger pålagt å velge billigste alternativ mellom såkalte generiske, identiske, legemidler.

Men flere leger har erfart at kopimedisinene ikke alltid er identiske med originalen, selv om virkestoffene oppgis å være de samme. Leger har overfor Jyllands-Posten beskrevet depresjonspasienter som faller tilbake i dype depresjoner, epilepsipasienter som plutselig begynner å få anfall igjen, og hjertepasienter som får allergiske reaksjoner, skriver avisen. (...)

Kliniske bevis for generiske og originallegemidler brukt mot hjertesykdom

Generika lika bra som originalet vid hjärt-kärlsjukdom
lakemedelsvarlden.se 4.12.2008
Patienter som behandlas för kardiovaskulära sjukdomar blir lika hjälpta av generika som av originalprodukter. Men i artiklar framställs generika ofta som ett sämre alternativ visar en genomgång som amerikanska forskare gjort. (...)

Clinical Equivalence of Generic and Brand-Name Drugs Used in Cardiovascular Disease (Kliniske bevis for generiske og originallegemidler brukt mot hjertesykdom)
JAMA. 2008;300(21):2514-2526 (December 3)
A Systematic Review and Meta-analysis (...) (En systematisk gjennomgang og metaanalyse)

Konklusjoner Mens bevis ikke støtter oppfatningen om at originallegemidler brukt mot hjertesykdommer er bedre enn generiske legemidler, tilråder et betydelig antall lederartikler at man ikke bytter til generiske legemidler. (...) (Conclusions Whereas evidence does not support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs, a substantial number of editorials counsel against the interchangeability of generic drugs.)

- I virkeligheten er brevet koordinert og skrevet av PR-firmaet Burson-Marsteller, betalt av legemiddelfirmaet

Antibiotics don't cure colds, so why do patients think they do? (Antibiotika kurerer ikke forkjølelse, så hvorfor tror pasienter at de gjør det?)
guardian.co.uk 20.3.2010
Leger som nører opp under pasientpress skaper etterspørsel (Doctors who cave into patient pressure create demand)

Sist måned forslo regjeringen å tillate farmasøyter å erstatte forskrivninger av originallegemidler med generiske alternativer. Et protestbrev ble publisert i The Times, signert av en rekke pasientgrupper og eksperter, med positiv dekning i flyveblader. The Times rapporterte at "eksperter sier at plan om å bytte til billigere legemidler vil skade pasienter". De viste til og med til en case studie: "Pasienter som fikk Seroxat-kopier i stedet for originalen følte seg uvel innen to dager." (Last month the government proposed allowing pharmacists to substitute prescriptions for branded medicines with generic alternatives. A letter of protest appeared in the Times, signed by various patient groups and experts, with positive coverage in the broadsheets. "Plan to switch to cheaper medicines will harm patients, say experts," reported the Times. They even had a case study: "Patient given Seroxat substitute felt unwell within two days.")

Men lege Margaret McCartney, som har gjort en gravejobb, skriver i British Medical Journal: i virkeligheten er brevet koordinert og skrevet av PR-firmaet Burson-Marsteller, betalt av legemiddelfirmaet Norgine. Til tross for at det var Norgines virksomhetsleder Peter Martin, som hadde størst innflytelse på kampanjen, signerte han ikke brevet selv. På spørsmål om hvorfor, svarte han: "Der var ingen konspirasjon. Den oppriktige sannhet, den redelige sannhet, er at jeg tenkte at det å blande inn et legemiddelfirma på en måte ville gjøre budskapet litt mindre troverdig. (...) (But Margaret McCartney GP, writing in the British Medical Journal, has been digging: in fact the letter was coordinated and written by the PR company Burson-Marsteller, paid by the drug company Norgine. Norgine's chief operating officer, Peter Martin, despite being the major influence behind the campaign, did not sign the letter himself. Asked why not, he said: "There was no conspiracy. The frank truth, the honest truth, is that I thought that having a pharmaceutical company in there would sully the message somewhat.")

(Anm: Generic drugs: protest group was not quite what it seemed. BMJ 2010;340:c1514 (17 March).)

Generic drugs: protest group was not quite what it seemed (Generiske legemidler: protestgruppe var ikke helt hva det synes som)
BMJ 2010;340:c1514 (17 March)
Sist måned publiserte The Times et brev fra leger og pasientgrupper som varslet mot generiske legemidler og støttet forskrivning av originallegemidler. Men hvem stod egentlig bak protesten? Margaret McCartney gransker (Last month the Times published a letter from doctors and patients’ groups warning against generic drugs and supporting branded prescribing. But who was really behind the protest? Margaret McCartney investigates)

Generics are good for us. That’s the mantra that is taught to doctors again and again: they are cheaper for the NHS but just as effective for the patient. So it was surprising to find a letter in the Times recently, signed by several doctors, decrying generics and pleading for doctors’ choice to prescribe branded drugs to be paramount. The letter, titled "Patient wellbeing at risk from substituted generic medicines," was also signed by patients’ groups such as the Cure Parkinson’s Trust and the British Liver Trust and carried the names of the media doctor Patricia Macnair, Stephen Kownacki, chairman of the Primary Care Dermatology Society, and Jean Mossman, former chief executive of Cancer BACUP (www.timesonline.co.uk/tol/comment/letters/article7037957.ece). (...)

Diverse artikler

Medie: Novartis forhindrer konkurrents kliniske forsøg
medwatch.dk 7.4.2015
Schweiziske Novartis er under anklage for at forhindre læger i at deltage i kliniske forsøg med et billigere alternativ til schweizernes øjenlægemiddel Lucentis.

Medicinalvirksomheden Novartis er angiveligt ikke meget for konkurrence for deres øjenlægemiddel Lucentis til behandling af våd aldersrelateret maculadegeneration (AMD). I hvert fald er selskabet nu under anklage for at forhindre kliniske forsøg med det billigere alternativ Avastin fra Roche.

Det skriver Biospace.com på baggrund af afsløringer i The British Medical Journal.

Avastin er godkendt til behandling af kræft, men tidlige kliniske studier har vist, at det også kan være effektivt mod AMD. Men det er åbenbart ikke faldet i god jord hos schweizerne.

Ifølge The British Medical Journal har Novartis forsøgt at få flere læger til at trække sig ud af flere kliniske forsøg med Avastin ligesom en læge angiveligt skulle være blive opfordret til at trække sig fra et klinisk forsøg med "fremtidige personlige forskningsprojekter for øje."

Novartis afviser alle anklager om "bøllemetoder".

Du kan læse hele artiklen fra Biospace.com her. (...)

(Anm: Angiogenesis inhibitors undermined by immune cells, says study. (…) Angiogenesis inhibitors--a widely used class of cancer drugs designed to shrink tumors by preventing them from forming new blood vessels--often work in the short term, but usually become ineffective within months. (…) Angiogenesis inhibitors approved for clinical use, which include bevacizumab (Avastin), sunitinib (Sutent), and everolimus (Afinitor), work by blocking the vascular endothelial growth factor (VEGF) signaling pathway, which prevents the tumor from forming new blood vessels, thereby shrinking it. (medicalnewstoday.com 21.4.2015).)

Hand in Hand With US Government, Big Pharma Pushes for More Profits
By Mara Kardas-Nelson, Truthout | News Analysis
truth-out.org 29.4.2014
This story wasn't funded by corporate advertising, but by readers like you. Can you help sustain our work with a tax-deductible donation?

In January of this year, South African Minister of Health Aaron Motsoaledi cried foul: he was publicly pissed about a US-created astroturf campaign (a faux "grassroots movement" actually led by moneyed interests) meant to undermine the country's efforts to lower drug prices through amending its intellectual property (IP) legislation.(...)

190 miljoner dollar för gammal tvist
lakemedelsvarlden.se 23.4.2014
Läkemedelsbolaget Pfizer har gått med på att betala epilepsipatienter 190 miljoner dollar för att de inte haft tillgång till de generiska och billigare preparaten.

Sedan början av 2000-talet har Pfizer och grupper av epilepsipatienter mötts i domstolar för att förhandla om det pris Pfizer ska betala för att på olika sätt ha fördröjt introduktionen av generiskt gabapentin i USA.

Grupper av patienter har genom sina advokater hävdat att de genom Pfizers verksamhet, tvingats att betala allt för höga priser för epilepsiläkemedlet. Pfizer har avvisat anklagelserna men säger nu att man med den här uppgörelsen vill avsluta affären och koncentrera sig på verksamheten istället för rättstvister.

Redan två år efter att epilepsiläkemedlet Neurontin blivit en rättsaffär, 2004, betalade Pfizer 430 miljoner dollar till federala och statliga myndigheter och erkände olaglig marknadsföring av Neurontin. (...)

US drug regulator rejects accusations that it unfairly targets Indian generic firms
BMJ 2014;348:g1845 (3 March 2014)
The US drugs regulator has defended its actions against Indian generic drug manufacturers who flout safety and quality standards. The regulator said that product safety was its top priority and that it would take any action deemed necessary to protect consumers.

Margaret Hamburg, the US Food and Drug Administration’s commissioner, was in India for a 10 day visit from 10 February. She angered some Indian officials, who claimed that the FDA was unduly targeting Indian companies for substandard practices.

India supplies about 40% of the generic and over-the-counter drugs consumed in the United States, making it the second largest supplier (after Canada). But Indian drug manufacturers accounted for half of the warning letters issued by the FDA in 2013. (...)

Who Is Now Responsible for Discovering and Warning About Adverse Effects of Generic Drugs? (Hvem er nå ansvarlig for å oppdage og varsle om bivirkninger fra generiske legemidler?)
JAMA 2013 (September 11)
When a patient in the United States fills a prescription, the likelihood that a generic drug will be dispensed is overwhelming—and increasing. Generic drugs account for more than 80% of prescriptions, but only 20% of total drug spending, because of their lower cost. The move to generics is estimated to have saved more than a trillion dollars in the last decade.1

Although generic drugs are bioequivalent to their brand-name counterparts, important legal distinctions between the 2 categories have resulted from 3 Supreme Court decisions. The first, Wyeth v Levine, arose after a woman developed gangrene in her forearm caused by intra-arterial injection of Wyeth’s antiemetic Phenergan (promethazine); the patient was awarded $6.7 million in damages based on her claim that the drug’s label did not sufficiently warn about its risks. In 2009, the Court upheld the award, noting that brand-name manufacturers are primarily responsible for providing accurate safety warnings for the drugs they produce.2 The decision makes sense because premarket testing does not reveal the full range of a drug’s adverse effects, postmarket surveillance by the US Food and Drug Administration (FDA) is insufficient, and state tort liability incentivizes manufacturers to continue monitoring the safety of their products. (...)

USA: Kopifirmaer ikke ansvarlige for bivirkninger
medwatch.dk 1.7.2013
Den amerikanske højesteret har besluttet, at patienter ikke kan sagsøge kopivirksomheder pga. bivirkninger fra selskabernes lægemidler, så længe indlægssedlen er identisk med originalproduktets.

I en sag i den amerikanske højesteret er det blevet besluttet, at producenter af generiske lægemidler ikke kan sagsøges pga. bivirkninger, når bare medicinens label, eller indlægsseddel, er en tro kopi af originalproduktets. (...)

Nationale love foreskriver nemlig, at kopivirksomheder skal kopiere indlægssedlen præcist, og det overtrumfer altså en regional lov i staten New Hampshire, som kræver at medicinalselskaber garanterer, at deres lægemidler ikke er ”urimeligt farlige”.

Det mener i hvert fald højesteretten, som med de marginale stemmer 5 mod 4 gav selskabet Mutual Pharmaceutical medhold i den konkrete sag.
Patienten Karen Bartlett havde sagsøgt selskabet pga. alvorlige bivirkninger fra medicinen sulindac – bivirkninger, som der ikke blev advaret om i indlægssedlen. Og selvom en jury i staten havde givet kvinden medhold og tildelt hende 21 mio. dollar i erstatning, har højesteretten altså nu omstødt den beslutning.

Forfærdelig beslutning
Den amerikanske advokat William Havel, som avisen har talt med, kalder beslutningen ”forfærdelig for forbrugere”, som i mange tilfælde ikke længere vil have nogen juridiske muligheder, hvis de oplever problemer med bivirkninger fra lægemidler. Han mener, at kopivirksomhederne ikke længere vil have noget incitament til at ”holde øje med deres lægemidler”.

Han forklarer videre, at mange bivirkninger først bliver opdaget, lang tid efter medicinen er blevet lanceret. Og i nogle tilfælde er originalproduktet måske fjernet fra markedet, hvilket betyder, at kopivirksomheden slet ikke er tvunget til at opdatere indlægssedlen, selvom man senere bliver klar over bivirkninger.

En talskvinde for de amerikanske lægemiddelsmyndigheder, FDA, forklarer ifølge avisen, at man pt. overvejer en ændring af reglerne, så kopivirksomhederne får de samme forpligtelser som originalproducenterne. (...)

Generic drug companies safe from liability suits, Supreme Court rules
cleveland.com 26.6.2013
The U.S. Supreme Court ruled Monday that manufacturers of generic drugs cannot be sued if the labels on their drugs mirror those on the brand-name equivalent. (Associated Press file)

The U.S. Supreme Court ruled this week that makers of generic drugs cannot be sued by patients who experience adverse side effects if the drugs' warning labels copy those on their brand-name counterparts.

The decision could affect millions of Americans, based on U.S. Food and Drug Administration estimates that about three-quarters of prescriptions are for generic drugs, which are cheaper than their brand-name equivalents. (...)

In a 5 to 4 vote on Monday, the court overturned a $21 million jury award to a New Hampshire woman who experienced severe disfigurement and nearly went blind after taking a generic anti-inflammatory drug. Karen Bartlett sued Mutual Pharmaceutical, whose drug sulindac did not specify on its label the side effect that she experienced. (...)

"I would urge consumers to contact the FDA directly and make their concerns known, and perhaps that will allow the FDA to recognize the seriousness of the problem," Hawal said.

On Monday Senate Judiciary Committee Chairman Patrick Leahy, a Vermont Democrat, and six other senators and congressmen sent a letter to the FDA asking that generic drug manufacturers have the same obligation as brand-name companies to provide doctors and patients with updated safety information and to be held accountable if they neglect to do so.

"We are looking at regulatory changes," Sandy Walsh, a spokeswoman for the FDA, said Wednesday. "The discussions are underway." (...)

Safety warnings over US Supremes' generic drug ruling
pharmatimes.com 28.6.2013
The US Supreme Court has ruled that generic drugmakers cannot be sued by patients who suffer adverse reactions caused by their products, because the companies did not develop the drugs nor seek their initial approval.

Therefore, the generics makers cannot be sued for any defects in the original drug’s design, said the Court, ruling in the case of Karen Bartlett, who suffered serious adverse reactions after taking a generic version of Merck & Co's non steroidal anti-inflammatory drug (NSAID) Clinoril (sulindac) made by Mutual Pharmaceutical Co, a subsidiary of Sun Pharmaceutical Industries of India.

In 2010, Ms Bartlett was awarded $21 million by a federal jury in New Hampshire for developing Stevens-Johnson syndrome as a result of taking Mutual's sulindac, but the Supreme Court decision has now overturned that ruling.

Commenting, the Generic Pharmaceutical Association (GPhA) said the Supreme Court ruling upholds a key principle - that decisions about the safety and efficacy of prescription drugs should rest with the scientific experts at the Food and Drug Administration (FDA). The industry group also points out that sulindac has been on the market for more than 30 years, and was "was prescribed and dispensed more than 300 million times between 2007-12 with a typical safety profile."

However, in a dissenting opinion to the 5-4 Court decision, Justice Sonia Sotomayor comments that "the Court has left a seriously injured customer without any remedy, despite Congress's explicit efforts to preserve state common-law liability," while other critics argue that generic drugs are not necessarily bioequivalent with the original branded versions. (...)

FDA Updates OxyContin Label, Blocks Generics (FDA oppdaterer OxyContins preparatomtale, blokkerer generiske legemidler)
medpagetoday.com 16.4.2013
FDA har kommer med ny preparatomtale for OxyContin--på samme dag som patentet utløper på den opprinnelige formuleringen, og blokkerer dermed potensielle generiske versjoner av originalen som ikke har preventive egenskaper mot misbruk. (The FDA has issued new labeling information for OxyContin -- on the same day the patent on the original formulation expired, thus blocking potential generic versions of the original that do not have abuse-deterrent properties.)

Den nye preparatomtalen viser at produktet "har fysiske og kjemiske egenskaper som er forventet å gjøre misbruk via injeksjon vanskelig og redusere misbruk på intranasal måte (via nese) ," ifølge en pressemelding for FDA. (The new labeling indicates that the product "has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route," according to an FDA press release.)

I en uttalelse sier byrået (FDA) at de ikke vil godkjenne noen nye legemiddelsøknader for generiske legemidler som er basert på den opprinnelige formuleringen. (...) (In the statement, the agency said it will not approve any abbreviated new drug applications for generics that are based on the original formulation.)

Opana-produsenten, legemiddelfirmaet Endo Pharmaceuticals, hadde saksøkt FDA for å blokkere generiske versjoner av legemidlet, men søksmålet ble avvist. (Opana drugmaker Endo Pharmaceuticals had sued the FDA to block generic versions of the drug, but the lawsuit was dismissed.)

(Anm: Oxymorphone, sold under the brand names Numorphan among others, is a powerful semi-synthetic opioid analgesic (painkiller). (…) Brand names[edit] Numorphan (suppository and injectable solution) Opana ER (extended-release tablet) Opana IR (immediate-release tablet) O-Morphon (10 mg tablet and 1 mg/1ml injection) in Bangladesh by Ziska pharmaceutical ltd. (en.wikipedia.org).)

Drugs for Indian Poor Spark Pfizer Anger at Lost Patents
Bloomberg.com 27.3.2013
In trying to get sophisticated medicines to its neediest citizens, India is increasingly pitting its generic-pharmaceutical industry against international drugmakers, threatening their growth in emerging markets. (...)

Drug companies
Big brand pharma on the hook for generic problems
(Store legemiddelfirmaers merkeprodukter ansvarlig for generiske legemidler)
BMJ 2013;346:f1978 (Published 28 March 2013)
Ed Silverman looks into the Alabama ruling that says a brand maker can be sued for harms caused by a generic version of a drug

Will Alabama turn into a judicial hellhole for the drug industry? To listen to Pfizer and the trade group that represents the US drug industry, a recent ruling by the Alabama Supreme Court almost guarantees such an outcome. Why? The court ruled that Pfizer can be sued by a man who claimed he was injured by a generic version of its Reglan (metoclopramide) heartburn medicine. And the drug maker purportedly failed to warn physicians about the risks.

The 8 to 1 decision has brand-name drug makers on edge. This is one of the few instances in which a court has found that a brand-name drug maker can be sued even though a consumer had taken a generic, suggesting that consumers will be encouraged to file still more such lawsuits, especially in the wake of a 2011 ruling by the US Supreme Court that has limited claims against generic drug makers. (...)

(Anm: Metoclopramide, domperidone: sudden cardiac death, ventricular arrhythmia. The neuroleptics metoclopramide and domperidone have been used since the 1960s and the 1980s respectively for nausea and vomiting. Their limited efficacy and the severity of their adverse effects have slowly come to light over time. Results published in 2015 confirmed and quantified the risks of serious arrhythmia and sudden cardiac death with both drugs. Prescrire Int 2016; 25 (175): 238-240.)

Guest column on India & drug patents: Can the US force policy change?
apothecurry.wordpress.com 19.3.2013
The pharma giant Pfizer wants the US government to act more aggressively to defend the interests of the research-based pharmaceutical sector in India. Will it succeed?

The path from lobbying in Washington, D.C, to a change of policy in India is a long and uncertain one involving multiple steps. First, Pfizer needs to convince Congress that action against India is warranted. Second, Congress needs to get the United States Trade Representative (USTR) to apply pressures on the Indian government. And third, the pressures would need to be effective. In this post, I discuss the third link in the chain.

First, some background. On March 13, as part of hearings on U.S.-India Trade Relations, the Trade Subcommittee of the Committee on Ways and Means in the U.S. House of Representatives heard testimony from Roy Waldron, Senior Vice President and Chief Intellectual Property Counsel of Pfizer. (...)

A 'shocking' disregard for generics
mg.co.za 15.3.2013
Many drugs cost far more in South Africa than in countries with strict patent-vetting processes.

Two thousand four hundred and forty-two. That's the number of medicine patents South Africa granted in 2008.

In Brazil, only 273 patents were given between 2003 and 2008.

South Africa grants patents without substantially reviewing applications first and routinely gives patents for new versions of old medicine, thus in effect extending patent life beyond the normal 20-year period. Brazil, in contrast, examines each application before a patent is granted.

The result, say some health activists and academics, is high medicine prices, because excessive patenting prohibits cheaper generic medicines from coming on to the market.

The Treatment Action Campaign (TAC) and Médecins sans Frontières (MSF), which have launched a "Fix the Patent Laws" campaign, say there are several instances in which patents block generic entry of key medicine – antiretrovirals, tuberculosis (TB) medicines, antibiotics and cancer treatments among them.

"I am shocked by how much South Africans pay for many drugs, for example, the TB drug Linezolid," says Leena Menghaney, a lawyer who works with MSF's Access Campaign. "In India, generic Linezolid is available for less than R10 a tablet. In South Africa, Pfizer has a patent on Linezolid and to get it for patients in need MSF pays R660 per tablet." (...)

India Rejects Bayer Appeal On Compulsory License
By Ed Silverman
pharmalot.com 4.3.2013
In a blow to multi-national drugmakers, India’s Intellectual Property Appellate board rejected a closely watched appeal from Bayer, which was fighting a compulsory license that permitted the sale of a generic version of its Nexavar cancer drug. The license was issued last year after Indian authorities determined that Nexavar pricing was deemed too expensive for most people in India. The license was issued to Natco, a large Indian generic drugmaker.

A Bayer spokesman writes us that an appeal is planned. “Bayer is committed to protecting its patents for Nexavar and we will rigorously continue to defend our intellectual property rights within the Indian legal system. We will pursue the case in front of High Court in Mumbai with a writ petition.” The drugmaker argues that 73 percent of Nexavar patients are enrolled in a patient access program created five years ago to increase access. (...)

Bayer to Appeal India Ruling That Allows Copy of Cancer Drug
bloomberg.com 4.3.2013
Bayer AG (BAYN) plans to appeal a ruling by an Indian regulatory board that allows generic-drug maker Natco Pharma Ltd. (NTCPH) to make a low-priced copy of Bayer’s patented Nexavar cancer medicine.

India’s government last year allowed Natco to produce and sell cheaper copies of Nexavar, a decision that also pressures other brand-name manufacturers to lower prices. Bayer had appealed to the country’s Intellectual Property Appellate Board, and today was told that it had lost, the Leverkusen, Germany- based company said in an e-mailed statement.

“We strongly disagree with the conclusions of the Intellectual Property Appellate Board,” the company said. “Bayer is committed to protecting its patent for Nexavar and will rigorously continue to defend our intellectual property rights within the Indian legal system. We will pursue the case in front of High Court in Mumbai with a writ petition.” (...)

Medical regulator urges doctors to prescribe generic drugs
BMJ 2013;346:f564 (Published 28 January 2013)
The Medical Council of India has asked the heads of medical colleges and hospitals and the president of the state medical councils to ensure that all doctors prescribe generic drugs as far as possible.

The advice came in a letter circulated on 21 January 2013 and reiterates a circular from November 2012 that was based on provisions of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002. (...)

GlaxoSmithKline in $150 Million Settlement in Generic Nasal Spray Case -Reuters
foxbusiness.com 19.12.2012
GlaxoSmithKline PLC (GSK) has agreed to a $150 million settlement with a group of drug wholesalers who claimed the drug maker delayed the introduction of generic alternatives to Flonase nasal spray, Reuters reported Wednesday, citing court documents.

AmerisourceBergen Corp. (ABC), Cardinal Health Inc. (CAH) and McKesson Corp. (MCK) were among the companies reaching the preliminary settlement, approved by the U.S. District Court for the Eastern District of Pennsylvania. (...)

How the FDA forgot the evidence: the case of donepezil 23 mg
BMJ 2012;344:e1086 (22 March)
In the first of a new occasional series highlighting the exaggerations, distortions, and selective reporting that make some news stories, advertising, and medical journal articles “not so,” Lisa M Schwartz and Steven Woloshin challenge the claims made for the new 23 mg dose of donepezil

What is the difference between 20 and 23? If you said three, you are off by millions—of dollars in sales, that is—at least from the perspective of Eisai, the manufacturer of donepezil (marketed as Aricept by Pfizer).

A little context helps make the maths clearer. Donepezil, the biggest player in the lucrative market for Alzheimer’s disease treatments, was a blockbuster, with over $2bn in annual sales in the United States alone. But the drug, first approved in 1996, had reached the end of the road: the patent expired in November 2010. Investors call this “going over the cliff,” an anxious reference to plummeting sales as market share is lost to generic competitors. Necessity, however, is the mother of invention. Just four months before the expiry of the patent, the US Food and Drug Administration (FDA) approved a new dose for moderate to severe Alzheimer’s disease: donepezil 23 mg. Is 23 an odd number? Not really, when you consider that you cannot get to 23 mg using the 5 mg and 10 mg doses that were going generic. The “new” 23 mg product would be patent protected for three more years. (...)

EMA klar med retningslinjer for biologisk kopimedicin
dagenspharma.dk 24.1.2012
Det europæiske lægemiddelagentur EMA udsendte i fredags et udkast til en ny vejledning inden for biosimilære lægemidler, som er ’kopier’ af biologiske lægemidler, hvor patentet er udløbet, f.eks. insulin, EPO og væksthormon. EMA gør med detaljeringen af kravene for de biosimilære lægemidler klar til øget konkurrence på et marked, der forventes at eksplodere i de kommende år. I en ny prognose forudsiger farmaanalyse- og rådgivningsfirmaet IMS Health, at det globale marked vil vokse fra 310 mio. dollars i 2010 til 2-2,5 mia. dollars i 2015.

Et biosimilært lægemiddel er et lægemiddel, der svarer til et biologisk lægemiddel, som allerede er godkendt. Det aktive stof i et biosimilært lægemiddel svarer ligeledes til det aktive stof i det biologiske referencelægemiddel. (...)

EMA’s udkast er i høring frem til maj. Agenturet forventes at fremlægge sin endelige vejledning til biosimilære monoklonale antistoffer i marts eller april. Udkast til retningslinjer om godkendelsesprocessen for kopier af andre lægemidler vil følge i maj eller juni. Disse vil bl.a. indeholde lavmolekylært heparin, enoxaparin og moderne analoger af insulin.

Det har været muligt at få godkendt biosimilære lægemidler siden 2004, og de hidtidige retningslinjer har været gældende siden 2006. (...)

- Billigpiller er ikke farlig
byavisa.no 4.10.2011
Helse: Ved å velge den billigste ­medisinen, frigjøres penger til viktige formål. Men mange er ifølge farmasistudent Mohamed Kamara skeptiske og tør ikke kjøpe det billigste ­alternative

Per dags dato sparer trygdesystemet ifølge Statens Legemiddelverk to milliarder kroner årlig på at folk velger den billigste medisinen de får tilbudt på apoteket. Farmasistudent Mohamed Kamara mener enda mer penger kan frigjøres ved at enda flere velger det billigste alternativet.

– En av tre kunder er skeptiske til synonympreparater, men det er det ingen grunn til. Noen velger det dyreste produktet, selv om det er flere hundre kroner forskjell i pris, forteller Kamara.

Skeptisk
Han har for tiden praksis ved Apotek1 på City Syd, og har merket seg at mange er skeptiske til å kjøpe preparater som har et annet navn enn det legen skriver på resepten.

Ikke noen forskjell
– De vil ha akkurat den produsenten som legen har skrevet ut, sier Kamara som understreker at det ikke er noen forskjell på virkestoffene i synonympreparater eller Generika som er fagbetegnelsen for preparatene.

– Det er kun hjelpestoffene som gir farge og smak som kan være annerledes.

- Selvsagt kan noen reagere på andre hjelpestoffer, men det er mer sjeldent, sier Kamara.

– Når patentbeskyttelsen går ut for det ene firmaet, er det fritt fram for andre til å produsere den samme medisinen - og på den måten blir den billigere, forklarer Kamera. (...)

A Whitewash? Trade Talks And Access To Meds
pharmalot.com 13.9.2011
Amid increasingly controversial trade talks, the Obama administration has released a white paper that emphasizes a commitment to providing access to needed medicines as part of its goals for the current TransPacific negotiations. But the five-page missive was met with derision by patient advocates who maintain the White House has become a stalking horse for the pharmaceutical industry. (...)

Whistleblower: Drug Firms Stole From U.S. Gov't
manufacturing.net 7.9.2011
TRENTON, N.J. (AP) -- Three generic drugmakers are being accused in a whistleblower lawsuit of scheming to overcharge the government by tens of millions of dollars for medicines.

The U.S. Attorney's office on Tuesday joined in the lawsuit, brought by Chicago pharmacist Bernard Lisitza.

His attorneys alleged in a 162-page complaint unsealed Tuesday afternoon that Par Pharmaceuticals Companies Inc. of Woodcliff Lake, N.J., and two foreign generic drugmakers overcharged the Medicaid program by getting pharmacies to dispense different, more-expensive, dosage forms than what was prescribed.

Attorneys Michael Behn and Linda Wyetzner said the three companies got pharmacies to illegally switch from generic versions of Prozac and Zantac to Par's more costly products so it could charge Medicaid more. (...)

Generics makers have no duty to warn of side effects, US Supreme Court rules
pharmatimes.com 24.6.2011
The US Supreme Court has ruled that the duty of brand-name drugmakers to warn patients about side effects or complications with their products does not extend to the manufacturers of generic copies.

In a 5-4 ruling, the justices concluded that generics makers cannot be sued under state liability laws if they fail to warn patients of potential problems. This is because the federal Food and Drug Administration (FDA) has to approve any changes in the warning information supplied with the product.

The Justices added, however, that generics makers should alert the FDA and patients as soon as they receive reports of new side effects or complications with their products.

The conflict between federal and state laws has created "conflict," said Justice Clarence Thomas, presenting the Court's conclusions in a case brought against generics makers Pliva and Actavis by two women who developed tardive dyskinesia after taking metoclopramide for acid reflux disorder. (...)

(Anm: Metoclopramide, domperidone: sudden cardiac death, ventricular arrhythmia. The neuroleptics metoclopramide and domperidone have been used since the 1960s and the 1980s respectively for nausea and vomiting. Their limited efficacy and the severity of their adverse effects have slowly come to light over time. Results published in 2015 confirmed and quantified the risks of serious arrhythmia and sudden cardiac death with both drugs. Prescrire Int 2016; 25 (175): 238-240.)

Generics seen slashing global drug sales growth
reuters.com 18.5.2011
(Reuters) - Global sales growth of prescription drugs could be cut in half over the next five years as lucrative brands lose patent protection and cheaper generics and emerging markets become the only significant growth drivers, according to IMS Health

"Past patterns of spending offer few clues about the level of expected growth through 2015," said Murray Aitken, an IMS Health executive whose division conducted the study.

"There are unprecedented dynamics at play, which are driving rapid shifts in the mix of spending by patients and payers between branded products and generics," said Aitken, whose company tracks prescription drug sales and trends.

Average annual sales are expected to grow 3 to 6 percent during the period, reaching nearly $1.1 trillion by 2015. But the trend reflects a slowdown from annual growth of 6.2 percent seen during the past five years, the report said.

U.S. sales will grow only 0 to 3 percent a year over the period, while sales in Europe will rise 1 to 4 percent. Spending on branded drugs is expected to be little changed in such developed markets in 2015, with growth coming instead from higher demand for cheaper generics. (...)

Peering Into Pfizer’s Future
blogs.forbes.com 31.3.2011
In November, Pfizer, the world’s largest drug company, will face the biggest ever patent expiration of a drug, as the first generic copycats of its top seller Lipitor hit the market. This is just one in a wave of big patent expiries for the drug giant, which has already seen revenue from one-time top sellers like Norvasc and Zoloft disappear due to cheap, commodity-priced generics in the U.S.

This is what drug company analysts refer to as the “patent cliff” – because sales can literally fall off a cliff. Patent expirations of today’s blockbusters are what drove big mergers for Pfizer, Merck and, most recently, Sanofi-Aventis. They are also leading to industry-wide layoffs that have hit everyone from the aforementioned giants to Eli Lilly and GlaxoSmithKline. (...)

Trade talks on patent protection violate right to health, allege advocacy groups
BMJ 2011; 342:d1993 (29 March)
Eleven advocacy groups have filed a complaint with the United Nations’ independent expert on the right to health, alleging that a regional free trade accord being discussed in secret talks by nine countries violates human rights because it threatens to restrict access to cheap generic drugs.

The talks have “clearly ignored” right to health and access to drugs, the groups say, and “threaten to violate the right of hundreds of millions of persons to the enjoyment of the highest attainable standard of health.”

Last month aid agencies and patients’ groups from India and several Asian countries urged the Indian government to reject a free trade agreement it is negotiating with the European Union that they said may undermine India’s capacity to produce generic drugs (BMJ 2011;342:d1480, doi:10.1136/bmj.d1480). (...)

New European online clinical trials register is launched
BMJ 2011; 342:d1994 (29 March)
Health professionals and the wider public will soon have access to information on every clinical trial taking place in 30 European countries. The online system, which is being managed by the London based European Medicines Agency, was launched on 22 March.

The new EU clinical trials register already contains details of 3452 trials, of which 763 involve participants under 18 years of age. The European Commission expects it to eventually hold data on around 10 000 ongoing trials on the basis that each lasts two to three years and some 4000 trials are authorised each year. (...)

The EU clinical trials register is at https://www.clinicaltrialsregister.eu/. (...)

The production of generic drugs in India
BMJ 2011; 342:d1694 (22 March)
A new trade agreement with the EU would hinder access to drugs in developing countries

The European Union is negotiating a trade agreement with India, the consequences of which will be serious for billions of people living in developing countries. Government officials in India are focused on economic growth and are keen to complete a trade deal with the EU. In exchange for market access in other areas of the economy, the EU wants India, a country with very low per capita incomes, to embrace tough new rules on ownership and enforcement of intellectual property for medical inventions.

The negotiation is between two very different entities. The EU is now the world’s largest economy; its gross domestic product (GDP) was estimated at more than $16.4 trillion (£10.2 trillion; €11.8 trillion) in 2009—about 28% of the entire world’s GDP.

India has a large population—estimated at nearly 1.16 billion in 2009, or 17% of the world’s population. This is also about the same as the population of Europe plus all other countries in the Organisation for Economic Co-operation and Development combined. (...)

Forest Labs bets $1.2 billion on Clinical Data to beat patent cliff
pharmatimes.com 23.2.2011
Forest Laboratories is preparing to splash out $1.2 billion to acquire Clinical Data, getting access to the latter's recently-approved antidepressant Viibryd.

Forest will pay $30 per share in cash, which actually is down 12% on CD's closing price on Friday, and an additional $6 a share based on the success of Viibryd (vilazodone). The selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist was approved by the US Food and Drug Administration a month ago for the treatment of adults with major depressive disorder.

With Celexa (citalopram) and Lexapro (escitalopram), Forest notes that it has a "proven track record of successfully commercialising novel anti-depressants" and it plans to launch Viibryd in the USA during the second half of 2011. Importantly, it is expected to retain market exclusivity until March 2020 "including full patent term extension of its composition of matter...and anticipated paediatric exclusivity".

Forest is gambling that Viibryd will help offset the loss of earnings it will suffer when Lexapro goes off-patent in 2012. Chief executive Howard Solomon said that "this transaction is consistent with our strategy to acquire new products that will help offset the loss of revenues due to patent expiries". (...)

Kan du stole på apoteket?
nrk.no 18.8.2010
Dersom farmasøyten tilbyr deg en annen medisin, kan du spare inntil 85 prosent. (...)

Når de nye legemidlene skal godkjennes, stilles det de samme kravene til renhet, kvalitet og innhold. Det må gjøres studier som viser at middelet tas opp i kroppen på samme måte.

- Det nye produktet kalles et generisk legemiddel, og når det er godkjent vurderer Statens legemiddelverk om produktet et byttbart. De generiske legemidlene inneholder samme virkestoff som originalen, men kan se annerledes ut i form og farge, legger Hortemo til. (...)

Tusindvis må skifte medicin
politiken.dk 17.5.2010
Dyr medicin skal skiftes ud med billig. Det kan give syge en dårligere behandling, advarer patientforening. (...)

Området skal kulegraves
Styrelsen sætter nu fart på kulegravningen af området for tilskud til medicin. Målet er klart: Tilskuddet til dyr medicin skal væk, når der er billigere, ligeværdige alternativer.

Også borgere med depression, sukkersyge, betændelse og stærke smerter risikerer at skulle skifte til billigere medicin i år eller næste år.

Men allerede nu advarer landets største patientforening om, at konsekvensen bliver ringere behandling af de syge.

»Jeg frygter, at man – i sin iver for at spare penge – fjerner tilskuddet fra medicin, der nok er dyr, men også bedre end billigere medicin«, siger Lars Engberg, formand for Danske Patienter, der taler på vegne af 750.000 medlemmer. (...)

(Anm: Danske Patienter (danskepatienter.dk).)

EU-domstolen ger den brittiska myndigheten NHS rätt att rekommendera billigare generiska läkemedel.
lakemedelsvarlden.se 28.4.2010
BILLIGARE Beskedet från EU-domstolen kom efter att den brittiska läkemedelsindustrins branschorganisation, ABPI, vänt sig dit i generikafrågan. Organisationen som har 70 medlemsföretag, ansåg att den brittiska myndigheten NHS, som har hand om landets läkemedelssubventioner, gjort fel när de låter läkare förespråka generika stället för originalläkemedel. Generaladvokaten Niilo Jääskiknen har i ett tidigare utlåtande talat till läkemedelsföretagens fördel och vanligtvis går EU-domstolen på dessa rekommendationer. Men denna gång går den på NHS linje och ger den rätt. (...)

Incentives for Drug Development — The Curious Case of Colchicine
healthcarereform.nejm.org (NEJM • April 14th)
In July 2009, the Food and Drug Administration (FDA) officially announced what physicians have long known — that the drug colchicine can effectively treat acute flares of gouty arthritis. The plant from which colchicine is derived was first used as a therapeutic agent for gout more than 3000 years ago in ancient Greece, and the tablet form has been widely available as a generic prescription drug in the United States since the 19th century. On the basis of evidence that had built up over the years, numerous consensus guidelines recommended colchicine as an effective second-line treatment for gout — for example, in patients who had adverse effects from nonsteroidal antiinflammatory drugs.1 (...)

Schemes that reward GPs for prescribing generics may breach EU law (Systemer som bleønner allmennpraktiserende leger for å forskrive generika kan bryte EU-lover)
BMJ 2010;340:c1945 (9 April)
A ruling expected next month from the European Court of Justice in Luxembourg could deprive the NHS of millions of pounds in savings on drugs budgets.

If the judges follow the opinion of the court’s advocate general Niilo Jaaskinen, schemes that reward GPs in England and Wales for prescribing cheaper generic drugs instead of branded medicines will be held to breach European Union law. (...)

Kopimedicin overhaler ny medicin
business.dk 16.2.2010
For første gang nogensinde bruger EUs lægemiddelmyndighed, EMA, mere tid på markedsføringstilladelser for kopimedicin end på nyudviklet medicin, viser en rapport fra EMA. (...)

Varumärket viktigt på generika
lakemedelsvarlden.se 17.2.2010
Läkemedelsföretag med starka varumärken säljer billigare kopior av sina egna produkter när patentet gått ut. Framför allt satsas det på de så kallade växande marknaderna i fattigare länder. (...)

Biotech's Latest Failed Trials, Mishaps and Missed Targets
seekingalpha.com 18.1.2010
The European Commission has contacted Pfizer (PFE) as part of its antitrust investigation into patent settlements between pharmaceutical firms and generic drugmakers, according to various press accounts. Pfizer acknowledged it was among the companies involved in the probe and said it was cooperating and confident it complied with applicable laws. AstraZeneca (AZN), GlaxoSmithKline (GSK), Sanofi-aventis (SNY), Novartis (NVS), Roche (RHHBY.PK), and Boehringer Ingelheim have also said they have been contacted by the Commission about drug patent settlements. The investigation is part of an effort by the EU to fight anticompetitive actions by drugmakers that it says cost healthcare providers $4.4 billion between 2007 and 2008, according to Reuters. (...)

European Commission investigates drug companies
business.timesonline.co.uk 13.1.2010
Neelie Kroes, the European Competition Commissioner, says that big drug companies' patent settlements are a cause for concern

The European Commission is investigating big drug companies, including AstraZeneca and GlaxoSmithKline (GSK), over concerns that sweetheart deals are delaying the introduction of cheaper, generic medicines.

AstraZeneca confirmed yesterday that it had received a request for information from the Commission. GSK and Sanofi-Aventis, the French drugs group, are also believed to under investigation.

In July, the Commission published evidence that showed a sharp decline in the number of new medicines reaching the market, while consumers suffered delays of more than seven months after patent expiry for cheaper generic medicines. (...)

EU granskar danska Lundbeck
lakemedelsvarlden.se 8.1.2010
Den europeiska kommissionen kommer att inleda en närmare undersökning av det danska företaget Lundbeck. Anledningen är misstankar om att Lundbeck missbrukat sin dominanta ställning för att hämma konkurrensen för produkter med citalopram.

EU-kommissionen meddelade på torsdagen att de inleder en utredning mot Lundbeck efter misstankar om att de hindrar försäljning av generiskt citalopram. (...)

Abbott Labs pays $22.5 million to settle allegations it blocked generic drug competition
courant.com 7.1.2010
WASHINGTON (AP) — Drugmaker Abbott Laboratories has agreed to pay $22.5 million to settle allegations that it tried to block generic competition to a popular cholesterol medication, according to state officials.

The agreement was announced Thursday by attorneys general from 23 states and the District of Columbia, who sued Abbott to recover costs to state Medicaid plans.

The multistate lawsuit alleged that Abbott and a unit of Belgium drugmaker Solvay Pharmaceuticals made minor changes to the formulation of TriCor to prevent cheaper generic versions from launching. (...)

Thyroxine: anatomy of a health scare
BMJ 2009;339:b5613 (29 December)
(...) In 2007 and 2008 New Zealand pharmacies changed to the new formulation of Eltroxin. The old formulation had been used for more than 30 years without problems; but after the new tablets were introduced the rate of adverse event reporting rose nearly 2000-fold—from 14 reports in 30 years to more than 1400 in 18 months. What had happened? And does this incident provide important lessons for future formulation changes and migration to generic drugs? (...)

Årsaker til ulik generikaandel i nordiske land
legemiddelverket.no 7.12.2009
Legemiddelverket har analysert årsakene til at Norge har hatt et noe lavere salg av generika enn andre nordiske land. Ulikt regelverk for reservasjon mot generisk bytte i de ulike landene, lang behandlingstid for markedsføringstillatelser og forskjeller i refusjonsordningene og forskrivningspraksis kan forklare dette.

Generikas andel av markedet i Norge øker. I 2008 utgjorde generika knapt 40 prosent av volumet og vel 13 prosent av verdien av det totale salget. (...)

(Anm: Årsaker til ulik generikahandel i nordiske land (legemiddelverket.no 25.11.2009).)

Sen. Kohl To Propose Limit On Generic Drug Deals
online.wsj.com 3.12.2009
WASHINGTON (Dow Jones)--Sen. Herb Kohl (D., Wis.) on Thursday will propose an amendment to Senate health care legislation that would make it difficult for drug companies to enter into deals that critics say delay cheaper, generic drugs from reaching the market, according to a Congressional aide with the Senator.
Kohl, chair of the Senate Special Committee on Aging, has long been against the deals and has the support of the Federal Trade Commission, which says the deals violate anti-competition laws and banning them could save (...)

Why Biologics Remain Expensive
forbes.com 4.12.2009
Those generic drug companies lobby just like the rest of big pharma.

At a time when Americans are shopping for bargains and desperately learning how to live on a budget, it hardly seems appropriate for Congress to be keeping our health care costs high. But that's exactly what some congressional leaders are planning to do. (...)

How Drug-Industry Lobbyists Won on Health-Care
time.com 22.10.2009
(...) Waxman's loss that day was a big victory for drug companies, which have spent more than any other segment of the medical industry to make sure that they come out winners in the effort to overhaul the nation's health-care system. It's understandable the drugmakers would want a roll-call accounting of who their friends and enemies are, considering the size of the investment they are making on Capitol Hill: in the first six months of this year alone, drug and biotech companies and their trade associations spent more than $110 million — that's about $609,000 a day — to influence lawmakers, according to figures compiled by the nonpartisan watchdog group Center for Responsive Politics. The drug industry's legion of registered lobbyists numbers 1,228, or 2.3 for every member of Congress. And its campaign contributions to current members of Waxman's committee have totaled $2.6 million over the past three years. (...)

The Generic Nudge
The question before Waxman's committee last summer was this: How many years of monopoly protection should be afforded to biotechnology drugs, known as biologics, before cheaper alternatives are allowed on the market? These miraculous drugs — which differ from traditional, chemical-based pharmaceuticals because they are derived from living matter — are widely regarded as the future of the pharmaceutical industry and, indeed, of medicine itself. While only 20% of drugs on the market today are biologics, it is expected that, with 633 biotechnology medicines in development last year for more than 100 diseases, half the new drugs approved in 2015 will be. Biologics average more than 20 times the cost of traditional drugs: treating breast cancer with a year's worth of the biologic Herceptin can cost $48,000; Remicade, for rheumatoid arthritis, can cost $20,000 annually. For other, rarer diseases, the price of biologic treatments can be as high as $200,000 a year. (...)

EG-domstolen dömde fördel Gsk
lakemedelsvarlden.se 7.10.2009
EU-kommissionen måste göra om sin granskning av försäljningsvillkor som Glaxosmithkline använt i Spanien. Det är resultatet av en dom från EG-domstolen.

PRISSÄTTNING Ärendet gäller Gsk:s dubbla prissättning av sina produkter i Spanien. Redan 1998 meddelade Gsk EU-kommissionen att de avsåg använda sig av två priser, ett billigare för inrikes försäljning och ett dyrare för export via parallellhandel till andra EU-länder. EU-kommissionen har ansett att försäljningsvillkoren förhindrade parallellhandel med läkemedel. (...)

EU-raid mot farmasøytiske giganter
vg.no 6.10.2009
EU-etterforskere raidet tirsdag kontorene til noen av Europas største farmasøytiske

EU-etterforskere raidet tirsdag kontorene til noen av Europas største farmasøytiske selskaper, som er mistenkt for å ha brutt konkurransereglene.

I samarbeid med nasjonale myndigheter slo etterforskere fra EU-kommisjonen til, heter det i en uttalelse. (...)

Etterforskerne var på jakt etter materiale som kan dokumentere at selskapene har misbrukt dominerende markedsposisjoner, eller benyttet uredelige forretningsmetoder i strid med EUs konkurranselover. (...)

EU har lenge holdt øye med legemiddelbransjen. Det er blitt hevdet at store bedrifter har inngått ulovlige avtaler med produsenter av billigere medisiner for at billigprodusentene skulle vente med å lansere sine medisiner. (...)

Leger uten grenser: - Karita kan forandre verden
vg.no 2.10.2009
(VG Nett) - Få legemiddelselskapene med på et frivillig patentsamarbeid som sikrer at færre dør, oppfordrer Leger uten grenser i en e-postkampanje rettet mot Karita Bekkemellem. (...)

- Av de viktigste medisinene, er 95 prosent gått av patent. Det forskes stadig på å finne medisiner mot HIV/Aids, og jeg regner med at Leger uten grenser vet hvor lang tid det tar å forske fram nye legemidler, sier Karita Bekkemellem og understreker at legemiddelindustrien er nødt til å tjene penger på å forske fram bedre medisiner.

- Hvis Leger uten grenser mener patenter er hovedproblemet, er det helt feil. De som står for utviklingen av viktige legemidler er en komersiell bransje som er nødt til å tjene penger, sier Bekkemellem til VG Nett. (...)

Hun frykter en nedtrapping av forskningen om ikke bransjen får ha visse rammebetingelser. (...)

Bedre patentbeskyttelse til medicin!
pharmadanmark.dk 28.9.2009
Patentsystemet stimulerer den innovative konkurrence, så virksomhederne konkurrerer om den bedste, hurtigste og mest effektive forskning, skriver Allan Skårup Kristensen fra Lif i Børsen i dag.

Det er uforståeligt, hvorfor patentbeskyttelsen på medicin kun er 20 år, når f.eks. design-lænestole er kopibeskyttet i 70 år, skriver chefkonsulent i Lægemiddelindustriforeningen (Lif) Allan Skårup Kristensen i en kommentar i Børsen i dag. (...)

Gir forskning og innovasjon økonomisk vekst?
forskningsradet.no 24.9.2009
Tre forskningsprosjekter legger grunnlaget for norsk forsknings- og innovasjonspolitikk ved å se på sammenhengen mellom økonomisk vekst, forskning og innovasjon. Nå foreligger foreløpige resultater. (...)

Patentsystemer som flaskehals for innovasjon
- Såkalte blokkerende patenter kan bremse utvikling og kommersialisering av teknologi, sa Christian Riis ved Handelshøgskolen BI i sin presentasjon. - Patenter sikrer aktører rettigheter til teknologi og ofte må man kjøpe rettighetene eller vente til perioden som rettighetene er bundet opp er over før man kan utvikle teknologien videre. (...)

Generics versus Brands: Are They Really Equivalent?
medpagetoday.com 25.8.2009
(...) "There will always be a slight, but not medically important, level of natural variability" in drug absorption, according to a review of concerns about generic drugs posted on the FDA's Web site. (See Facts and Myths about Generic Drugs)

"Much of the criticism we get really centers around anecdotes from patients," said Buehler in an interview. (...)

Our view on generic medications: Drugmakers seek excessive monopolies on ‘biologics’
blogs.usatoday.com 13.8.2009
Twelve years of exclusivity is too many for pricey pharmaceuticals. (...)

THE INFLUENCE GAME: Biotech drug lobbying war (Påvirkningsspillet: Lobbykrigen om biologiske legemidler)
forbes.com 3.8.2009 (Associated Press)
WASHINGTON -- With the nation's $46 billion biological drug market at stake, the war between makers of the pricey biotech medicines and their would-be generic competitors has involved millions of dollars in lobbying, thousands in campaign contributions and uncounted visits to members of Congress. And one noteworthy letter.

The note from the private National Health Council, sent to House leaders drafting health overhaul legislation, said the plea was on behalf of "the more than 133 million Americans living with chronic diseases and disabilities and their family caregivers." It urged lawmakers to protect the makers of high-technology biological medicines against early competition from lower-cost generic copycats. (...)

(Anm: Lobbyisme (lobbying - lobbyvirksomhet - lobbyregister - interessekonflikter - korrupsjon) (mintankesmie.no).)

Big pharma likely to push authorised generics more
pharmatimes.com 29.7.2009
Given the pressure being put upon pay-for-delay agreements, the number of authorised generics hitting the market is set to increase, claims a new study.

The analysis, from Datamonitor, says that the number of authorised generics agreements will grow, “in tandem with the increasing convergence” between branded and copycat companies. It adds that the growing trend for big pharma – notably GlaxoSmithKline, Sanofi-Aventis and Pfizer – to bolster their non-branded presence also means that “the strategy of fielding own-generics will gain traction”. (...)

Lobbyists battle over drug sales (Lobbyister kjemper om legemiddelsalg)
usatoday.com 28.7.2009
WASHINGTON — As Congress struggles with a massive health care overhaul, several lobbying powerhouses — including the pharmaceutical industry and the nation's largest advocacy group for retirees — are locked in a contentious fight over the future of biotechnology drugs.

Both sides have spent heavily to sway lawmakers in the debate over how long to keep the expensive drugs exempt from generic competition. President Obama is pushing for seven years of exclusivity as he looks to trim costs to help pay for his health care plan — five years less than what the industry wants. (...)

Industry donates to drug plan foes (Industrien donerer til fiender av legemiddelplan)
usatoday.com 28.7.2009
WASHINGTON — Lawmakers who count pharmaceutical companies among their biggest contributors lead the opposition to a health care proposal that would cut costs by allowing generic drugs to compete sooner with pricey biotechnology drugs, campaign-finance records show.

Sen. Orrin Hatch, R-Utah, has helped lead Senate efforts to give drug companies 12 years of exclusive rights to sell biotech drugs, rather than seven as proposed by President Obama. Hatch has received nearly $1.3 million from the employees and political action committees of drug and health products companies since 1989, making the industry his largest contributor, according to data compiled by the non-partisan Center for Responsive Politics.

HEALTH CARE OVERHAUL: Lobbyists battle over drug sales (Lobbyister kjemper om legemiddelsalg)

In the House, Rep. Anna Eshoo, D-Calif., whose district is home to dozens of biotech companies, is sponsoring a similar measure. Drug company employees and political action committees have donated $645,000 since 1992 to Eshoo — second only to the computer and Internet industry.

This year, she is the biggest recipient of pharmaceutical money in the House, the data show. (...)

Lobbyists battle over drug sales (Lobbyister kjemper om legemiddelsalg)
usatoday.com 28.7.2009
WASHINGTON — As Congress struggles with a massive health care overhaul, several lobbying powerhouses — including the pharmaceutical industry and the nation's largest advocacy group for retirees — are locked in a contentious fight over the future of biotechnology drugs.
Both sides have spent heavily to sway lawmakers in the debate over how long to keep the expensive drugs exempt from generic competition. President Obama is pushing for seven years of exclusivity as he looks to trim costs to help pay for his health care plan — five years less than what the industry wants.

PHARMACEUTICALS: Industry donates to drug plan foes (Industrien donerer til fiender av legemiddelplan)

"If you extend that 12 years, obviously it's better for (drugmakers') bottom line," Obama said Friday. "But it also means you're keeping important drugs off the market and driving up those costs further."

The pharmaceutical industry counters that a longer period of exclusivity is needed to recover its investments in "biologic drugs," which are made from living organisms and used to treat cancer, multiple sclerosis and other serious diseases. (...)

Danske nanoforskere vil muliggøre test af billig kopimedicin
ing.dk 22.6.2009
Dansk forskningskonsortium skal med et budget på 40 millioner kroner udvikle en test, der kan afgøre om kopimedicin har samme effekt som original produktet. Billigere udvikling og bedre medicin er også mål. (...)

Millionerne skal blandt andet bruges på at skaffe større viden om, hvordan aktivstofferne i lægemidler interagerer med hjælpestofferne. Hjælpestofferne sørger for eksempel for, at aktivstofferne i lægemidlet bliver frigivet på den rette måde og hjælper det frem til det rette sted i kroppen eller gennem tarmen, huden eller ud i blodet. (...)

Novo, KU og New Zealand er med
Konsortiet består af DTU Nanotech, Teknologisk Institut og KU Farma samt fem virksomheder: Novo Nordisk, Dako Denmark, Fef Chemicals, Gea Process Engineering og Egalet, der samlet spytter 21 millioner i projektet.

Herudover er der to internationale partnere i USA og New Zealand.

Arbejdet starter i september 2009 og løber frem til september 2012. (...)

Dangerous Side Effects
washingtonpost.com 16.7.2009
A law meant to spur prescription drug competition has instead delayed it. Congress could change that.

EVERY YEAR, American consumers pay an estimated $3.5 billion too much for health care because of a loophole in a law regarding the marketing of prescription drugs. (...)

Generics “save USA over $1 billion every three days”
pharmatimes.com 11.5.2009
Use of generic drugs saved the US health care system more than $734 billion from 1999 to 2008 and around $121 billion last year alone, says new research from IMS Health. (...)

Obama vill ha fler billiga mediciner
sydsvenskan.se 8.5.2009
President Barack Obama föreslog på torsdagen att anslaget till USA:s läkemedelsmyndighet FDA höjs med närmare 20 procent för att stärka inspektioner och öka antalet billiga läkemedelskopior, så kallade generika, på den amerikanska marknaden. (...)

Former Bristol exec pleads guilty in patent case
forbes.com 6.4.2009 (Associated Press)
The federal government said Monday a former executive for Bristol-Myers Squibb Co. has pleaded guilty to his role in a deal in which the drugmaker intended to pay a rival to keep a generic version of the anti-clotting drug Plavix off the market.

The Justice Department said Andrew Bodnar pleaded guilty to lying to the Federal Trade Commission about his discussions with Apotex, which made the generic. According to the agreement, Bodnar promised a rival, Apotex Inc., that Bristol-Myers would not launch its own generic version of Plavix if Apotex agreed to accept a $40 million payment in return for delaying its generic until 2011. (...)

Bristol-Myers pays $2.1 million in FTC settlement
forbes.com 27.3.2009 (Associated Press)
Bristol-Myers Squibb Co. said Friday it will pay the U.S. Federal Trade Commission $2.1 million to settle allegations that it attempted to pay off a generic drug developer to keep a competing version of the blockbuster drug Plavix off the market.

The company admits no wrongdoing as part of the settlement deal. (...)

Tar seg godt betalt for kopimedisin
aftenposten.no 12.3.2009
Apoteknæringen presser produsentene av kopimedisiner kraftig på pris, men tar seg svært godt betalt for distribusjonen. Kjedenes avanse ligger på 400–500 prosent. (...)

Experts Disagree on How Long Biologic Drugs Should Have Market Exclusivity
kaisernetwork.org 19.3.2009
Settling the "debate over how long biotechnology drugmakers should retain exclusive rights to their patents" if done right "will save patients' lives and cut costs; if done incorrectly, however, it could cripple investment in products that cost billions to develop," Roll Call reports. (...)

EU Patent Court drug rulings “must consider public interest”
pharmatimes.com 18.3.2009
The European Union Patent Court proposed by the European Commission must, crucially, take “due care of the public interest” in its considerations regarding pharmaceutical patents, say generic drugmakers.

Greg Perry, director-general of the European Generics Medicine Association (EGA), welcomed the proposal for a central EU Patent Court, put forward by the Commission’s DG Internal Market, as a “very positive initiative.” However, the Court should also take account of the interest of “other affected parties such as the public or the administration, not party in the litigation…when deciding on provisional measures,” he told the EGA’s legal affairs forum on March 13. (...)

Apoteknæringen har høy avanse på kopilegemidler - Dokument nr. 3:7 (2008-2009)
riksrevisjonen.no 12.3.2009
Legemiddelprisene i Norge er blant de laveste i Vest-Europa, samtidig som andelen kopilegemidler er lav. Apoteknæringen (apotek og grossister) har imidlertid høy avanse på kopilegemidler. Den gjennomsnittlige avansen er betydelig høyere enn for tilsvarende pakninger for originallegemidler. (...)

Ifølge Riksrevisjonens beregninger var apoteknæringens gjennomsnittlige avanse for kopilegemidler godt over 500 prosent i 2006 og over 400 prosent i 2007. Den gjennomsnittlige avansen i kroner per pakning for kopilegemidler ligger betydelig over den gjennomsnittlige avansen per pakning for de tilsvarende originallegemidlene. Avansen på kopilegemidler med trinnpris er, i motsetning til avansen på originallegemidler, ikke regulert. Trinnprisen er en fastsatt maksimalpris ut fra apotek, som gjelder for et utvalg kopilegemidler som er vurdert som likeverdige med originallegemidlet. (...)

Løy om kopimedisin
dinside.no 6.3.2009
Kopiprodusent tester ikke medikamenter ordentlig.

DinSide Ranbaxy, det største farmasøytselskapet i India, har løyet om testresultatene til over 20 kopimedikamenter, melder Yahoo!News.

Norske forbrukere har imidlertid ingen grunn til bekymring, ifølge Legemiddelverket. (...)

Generic Biologics Face 'Long, Tough Road to Realization,' Wall Street Journal Reports
kaisernetwork.org 4.3.2009
The development of new generic versions of expensive biologic drugs "faces a long, tough road to realization" because the complex generics "will likely face tough regulatory scrutiny, as well as high development and marketing costs," the Wall Street Journal reports. According to the Journal, President Obama's legislative agenda is expected to include a proposal to allow generic versions of biologic drugs, also known as "biosimilars." (...)

GSK promises to cap price of its drugs in poorest countries
BMJ 2009;338:b686 (18 February)
GlaxoSmithKline, the United Kingdom based pharmaceutical group, has unveiled a series of policies to boost access to its drugs in poorer and richer countries alike (www.gsk.com/media/Witty-Harvard-Speech-Summary.pdf).

In a speech at Harvard Medical School last week, Andrew Witty laid out his approach for the first time since taking over as the company’s chief executive last spring, saying: "Society expects us to do more . . . To be frank, I agree. We have the capacity to do more and we can do more." (...)

Billigere medicin er politik
business.dk 17.2.2009
Den britiske medicinalkoncern Glaxo Smith Kline har vakt opsigt med et løfte om at skære medicinpriserne ned med 75 pct. i de fattigste lande i verden. Men det er mere end en politisk udmelding end en reel hjælp til de fattigste, lyder kritikken. (...)

»Der er positive signaler i udmeldingerne fra Glaxo Smith Kline, men langt hen ad vejen er der tale om politik. Skal adgangen til medicin i de fattige lande virkelig udvides, må medicinalindustrien tage et meget større skridt,« siger Michelle Childs, leder for Læger Uden Grænsers internationale kampagne for øget adgang til medicin, til Berlingske Business.

Samme holdning har Mikkel Wakefield, der er salgsdirektør i danske MissionPharma, som specialiserer sig i at sælge kopimedicin til de fattigste lande.

»Det lyder flot, men er ren politik. For dem handler det om deres offentlige image. De store medicinalkoncerner er ikke særlig velsete i de fattige lande på grund af patenter og høje priser,« siger Mikkel Wakefield. (...)

Billig fornøjelse
Prisnedsættelserne og investeringerne i infrastruktur kommer da heller ikke til at koste Glaxo Smith Kline de store beløb. Det erkender Andrew Witty selv ifølge Wall Street Journal. I dag omsætter Glaxo Smith Kline for i cirka 250 millioner kr. i de 50 fattigste lande i verden. 20 pct. af overskuddet på salget i disse lande vil udgøre et sted mellem otte og 16 millioner kr. (...)

Metaanalyse – Ingen klinisk forskel på kopipræparater og originalpræparater
irf.dk 5.2.2009 (INSTITUT FOR RATIONEL FARMAKOTERAPI (IRF)
(...) Det kan opfattes som indlysende, at der må være samme kliniske effekt af to præparater, som indeholder samme mængde virksomt stof, og for hvilke samme mængde af det virksomme stof bliver optaget i blodbanen. Denne meta-analyse fastslår, at al klinisk evidens på det kardiovaskulære område også peger i den retning. I stort set alle undersøgelser og for hvert eneste lægemiddel blev der fundet klinisk ækvivalens mellem kopipræparater og originalpræparater.

Med den baggrund kan det virke paradoksalt, at der i mere end halvdelen af de ledende artikler blev udtrykt en negativ holdning til generisk substitution. Forfatterne til disse editorials må simpelthen have baseret deres holdninger til generisk substitution på noget andet end evidens. (...)

US accuses firms of delaying generic drug launch
Forbes.com 2.2.2009 (Associated Press)
Federal regulators accused Solvay Pharmaceuticals and three generic drugmakers on Monday of illegally agreeing to keep cheaper versions of a lucrative hormone-boosting drug off the market.

The lawsuit from the Federal Trade Commission alleges that Brussels, Belgium-based Solvay agreed to share its profits with the generic firms provided they did not launch their low-cost versions until 2015. Androgel, a gel-based testosterone drug, is Solvay's best-selling product with U.S. sales over $300 million. (...)

Copycats Force Glaxo To Downsize
forbes.com 2.2.2009
The drugmaker is reportedly poised to cut up to 10,000 jobs amid competition from generics.

While pharmaceutical companies have largely escaped the economic slump that has beset many of their blue chip counterparts, they haven't escaped the problem of competition from cheaper, generic drugmakers. GlaxoSmithKline, the British pharmaceutical firm, is poised to cut between 6,000 and 10,000 jobs as cheaper generics threaten to further dent its profits, according to separate reports in the Daily Telegraph and Daily Mail newspapers on Monday. (...)

Copycats Push Glaxo To Streamline
forbes.com 2.2.2009
Pharmaceutical stocks have shown defensive qualities in the last tumultuous months, but they haven't escaped the problem of competition from cheaper, generic drugmakers. GlaxoSmithKline, the British pharmaceutical firm, is poised to reduce its headcount as cheaper generics threaten to further dent its profits. The company refused to deny it would announce job cuts on Thursday, when it reveals its fiscal 2008 results, though some reports point to a reduction of between 6,000 and 10,000 jobs . (...)

Forecast Insight: Depression - Generic induced brand erosion leads to market decline
datamonitor.com 19.1.2009
Introduction
The depression market was valued at around $11.04 billion in 2007 across the seven major markets. Following marginal growth to 2011 ($12.01 billion), the market is forecast to decline in value through to 2017 ($9.81 billion) when brand erosion due to generic incursion affecting all major drug classes used to treat depression finally outweighs the success of reformulations and follow-on products. (...)

2 milliarder kroner spares årlig gjennom ordningen med trinnpris og generisk bytte
legemiddelverket.no 13.1.2009
Trinnprissystemet er myndighetenes virkemiddel for å sikre at samfunnet kan nyte godt av lavere priser når det er blitt generisk konkurranse på medisiner. (...)

Hvorfor trinnpris?
Når patentet løper ut og originallegemidlene får konkurranse av generiske preparater, forhandler grossistene om lavere priser fra legemiddelfirmaene. Grossistene får ofte senket prisen på originallegemidlet, i tillegg til at generika introduseres til en lavere pris.

Trinnprissystemet er en enkel måte myndighetene kan sikre at også folketrygd og pasient kan nyte godt av lavere legemiddelpriser. (...)

- Er pillene mine trygge, statsråd?
aftenposten.no 29.12.2008
(...) Så er det kvinnen med den rødbrune hatten, Bjørg Margrethe Sauge, sin tur. Hun tar mikrofonen hun får tildelt og overbringer klart og tydelig sine spørsmål til statsråden om øremerkede midler til kommunene og kvaliteten på tilbudet til pasienter i hjemmet, som hun mener er altfor dårlig. Avslutningsvis vil hun vite:

–Det er fremkommet i mediene at enkelte erstatningsmedisiner ikke holder mål. Noen medisiner er basert på nanoteknologi, særlig de som har langtidsvirkning. Undersøkelser har vist at celler i kroppen ikke klarer å bryte ned rester av nano. Jeg bruker erstatningsmedisinen Alendronate Arrow. Er den farlig? Til slutt, takk for at du inviterte til dette møte. (...)

Merck satsar på biologiska kopior
lakemedelsvarlden.se 10.12.2008
Amerikanska Merck ska grunda en ny avdelning som ska ta fram biologiska kopior. Målet är att företaget ska ha sex kopior av biologiska läkemedel på den amerikanska marknaden år 2017. Merck är det första amerikanska företag som uttalat planerar sin verksamhet utifrån en förmodad lagändring som gör biologiska kopior tillåtna även i USA.

BIOSIMILARS Den nya avdelningen ska heta Merck Bioventures och företaget planerar att satsa 1,5 miljarder dollar på avdelningen fram till år 2015. Den första projektet, som går under arbetsnamnet MK-2578, är en kopia på Amgens erytropoetin Aranesp. Förhoppningen är att Mercks kopia ska bli godkänt och finnas på marknaden 2012. (...)

European Regulators Widen Inquiry Into Drug Makers
nytimes.com 26.11.2008
BRUSSELS — European Union regulators led a second round of raids on pharmaceutical companies this week, just days before the release of the findings of an earlier antitrust investigation.

The competition commissioner, Neelie Kroes, began the initial investigation in January with a series of raids on major drug companies, including GlaxoSmithKline, Pfizer and Sanofi-Aventis, searching for evidence that they were slowing the release of generic drugs and new medicines. (...)

Obamas vinst påverkar läkemedelsindustrin
lakemedelsvarlden.se 5.11.2008
Den amerikanska läkemedelsindustrin har varit relativt kyligt inställd till presidentvalet. Men några förändringar kommer sannolikt ske som påverkar läkemedelspolitiken när Barack Obama tar över som president.

I flera av de stora medicinpolitiska frågorna har Barack Obama och John McCain haft samma inställning under valkampanjen. Båda har förespråkat återimport av läkemedel från billigare länder, ökad användning av generika och en mer tillåtande inställning till biosimilars. Båda kandidaterna har också uttryckt att de vill häva förbudet på federal finansiering av embryonal stamcellsforskning. Förändringar som kan komma att ske efter presidentskiftet. (...)

Nearly Two-Thirds of Prescriptions Initially Filled by Medicare Beneficiaries Were for Brand-Name Drugs, Study Finds
kaisernetwork.org 25.9.2008
Medicare beneficiaries enrolled in the prescription drug benefit are more likely to ask pharmacists for generic medications when they pay for them and for more expensive brand-name treatments when the program provides coverage, according to a study released on Thursday by Medco Health Solutions, the AP/San Francisco Chronicle reports. (...)

Study: Seniors not quite embracing generic drugs
sfgate.com 25.9.2008
(09-25) 02:24 PDT WASHINGTON, (AP) -- Seniors who switch between low-cost generic drugs and the original products based on who's footing the bill are likely driving up the cost of the government's Medicare drug plan, according to a new study.(...)

The study was published by Medco Health Solutions Inc., a drug benefit manager that handles prescriptions for about 20 percent of Americans. Prescription benefit managers earn more money when patients choose cheaper medications. (...)

- Kan bli sykere av kopimedisiner
nrk.no 31.7.2008
Bruken av kopimedisiner kan føre til feilmedisinering som gjør folk sykere. Det mener Allmennlegeforeningen. (...)

Leder i Allmennlegeforeningen Jan Emil Kristoffersen mener at bytte av navn og utseende fører til feilmedisinering.

- Pasientene slutter å ta et viktig legemiddel fordi de får en pille med nytt navn. Eller så tar de begge deler og får dobbel dose fordi de ikke forstod at de fikk en ny versjon av det samme, sier Kristoffersen. (...)

Kristoffersen mener at problemene rundt nye navn og nytt utseende på medisiner har vært kjent lenge.

- Stortinget har med helt åpne øyne vedtatt en ordning som sparer penger, men som har en risiko ved seg for enkelte pasienter, sier han. (...)

Prosecution over drug price fixing collapses
BMJ 2008;337:a814 (14 July)
Five drug companies and nine directors accused of a multimillion pound conspiracy to swindle the NHS by fixing the prices of generic drugs are poised to escape criminal charges after a judge threw out the case against them, subject to appeal. (...)

Operation Holbein, the largest prosecution ever handled by the Serious Fraud Office (SFO), accused the five companies—Goldshield Group, Kent Pharmaceuticals, Norton Healthcare, Generics UK, and Ranbaxy UK—of fixing the supply and prices of penicillin based antibiotics and the anticoagulant warfarin in the 1990s. (...)

The five companies have paid sums totalling an estimated £38m in civil settlements with the NHS, without admitting liability. (...)

Drug Makers Lobbying States To Restrict Use of Lower-Cost Generic Alternatives
kaisernetwork.org 17.6.2008
Pharmaceutical companies, which "have been waging war against inexpensive generic drugs for years at the national level," are now "taking their fights to the states, promoting proposals that would" bar pharmacists from automatically replacing prescriptions for brand-name drugs with generics, the Baltimore Sun reports. Measures that would prohibit pharmacists from automatically replacing certain brand-name drugs with generic counterparts have been considered in 27 states and have been adopted by two states over the last two years, according to the National Association of Chain Drug Stores. (...)

Drugs giant settles £800K claim
bbc.co.uk 1.5.2008
Norton has agreed similar deals with other health boards
A US healthcare giant has agreed a £800,000 settlement with the health service in Northern Ireland over the alleged price-fixing of generic drugs.

Norton was among a number of companies named in court papers over the alleged formation of price-fixing cartels.

The drugs company agreed to the payment on a "full and final basis" but did not admit liability. (...)

Norge svartelistet av USA
nrk.no 26.4.2008
Norges bruk av kopimedisiner har sikret landet en plass på USAs liste over land som overvåkes for brudd på patentrettigheter.

Fredag offentliggjorde USAs kontor for handelspolitikk (US Trade Representatives) listen over land de vil overvåke i 2008 for brudd på patentreglene. (...)

Iceland's hi-tech future under threat
bbc.co.uk 13.4.2008
(...) Generic drugs
The landscape of Iceland is the black and white of snow and lava, but it's dotted with swish offices for software companies and pharmaceutical research firms.

One of the world's biggest makers of generic drugs, Actavis, has a sparkling new office overlooking the Atlantic.

From here, it directs its research labs in Malta, the United States and India.

As patents on pharmaceutical products expire, it is ready, literally at midnight, to fly great cargo planes of its products into the air-space of markets with drugs at a fraction of the cost of the original product. (...)

(Anm: Actavis (actavis.no).)

Avslutter særskilt overvåkning av generiske legemidler
helserevyen.no 4.4.2008
Statens legemiddelverk har nå avsluttet den særskilte overvåkningen av generiske (likeverdige) legemidler. (...)

Generics: Just as good?
latimes.com 17.3.2008
(...) Officials of the Food and Drug Administration insist this feat of economics comes without any compromise to a medicine's effectiveness. To be marketed in the United States, these low-cost medicines must be approved by the FDA, which ensures they are "bioequivalent" to their brand-name counterparts -- the same dose of the same active ingredient, delivered in the same way, and manufactured according to the same standards of quality. (...)

Fikk mindre smerter av narrepiller
dagbladet.no 5.3.2008
Og de dyre virket best, sa forsøkskaninene. (...)

«Kopi er dårligere»
Forskeren Dan Ariely ved Duke University skriver i en kommentar at resulatatene kan forklare hvorfor pasienter ofte opplever at kopier av legemidler har dårligere effekt enn originalen - tross identisk innhold.

- Placeboeffekten er en av de mest fascinerende, minst utnyttede kreftene i universet, sier atferdsøkonomen Dan Ariely ifølge forskning.no, som har omtalt undersøkelsen.

Og som minner om at dette er en ganske liten studie som man ikke kan dra bastante konklusjoner av. (...)

(Anm: Dyr placebo virker best. (forskning.no 5.3.2008).)

A bitter pill for Big Pharma
latimes.com 27.1.2008
Overdependence on 'blockbuster' drugs is taking a toll on the industry.

The strategy that has made the pharmaceutical industry one of the wealthiest and most powerful on Earth is finally starting to betray it. (...)

Damning new report says branded medicines are overprescribed
pharmatimes.com 17.1.2008
Branded medicines are overprescribed, according to a damning new report from the Committee of Public Accounts, which says the pharmaceutical industry spends more than £850 million annually on marketing its products to GPs. (...)

EU misstänker konkurrensbrott inom läkemedelsindustrin
lakemedelsvarlden.se 16.1.2008
Eu-kommissionen har påbörjat en granskning av hela läkemedelssektorn för att undersöka om konkurrensen fungerar som den ska. Det minskade antalet nya substanser på marknaden kan bero på att stora företag missbrukar sin ställning menar kommissionen. (...)

Kommissionen påpekar också att undersökningen inte främst kommer att leta efter särskilda kartellbildningar, utan de är istället intresserade av att se vilka överenskommelser som kan finnas mellan företagen som har patent och generikaproducenterna. Här refererar kommissionen till Astrazeneca som för två år sedan dömdes till böter på 60 miljoner euro för att de missbrukat patentsystemet och på så sätt försenade införandet av generiska kopior av Losec (omeprazol). (...)

EU Probes Drugmakers (EU gransker legemiddelprodusenter)
forbes.com 16.1.2008
BRUSSELS, BELGIUM - European Union antitrust regulators said Wednesday they were raiding pharmaceutical companies - including Pfizer Inc., AstraZeneca PLC, Sanofi-Aventis SA and GlaxoSmithKline PLC - in a probe into why so few new medicines and drug makers are emerging.

EU antitrust chief Neelie Kroes said she was looking at the entire pharmaceutical industry and wanted to know why generic drugs were so slow to hit the market in Europe. Generic medicines are made by other companies after the original developer of the drug loses its exclusive patent rights. (...)

It said the probe was partly triggered by its 2005 case against AstraZeneca in which the company was fined 60 million euros ($73 million) for filing misleading information to patent offices to delay generic versions of its ulcer drug Losec for most of the 1990s. (...)

Europe spends 200 billion euros ($298 billion) on medicines every year, or 400 euros ($595) per person. Most of that cost is carried by state health insurance programs. (...)

Oxfam calls for drug firm action
bbc.co.uk 27.11.2007
Many Africans do not get Aids treatment because of lack of funds
Drug firms are missing out on a huge potential market by failing to make drugs affordable for the world's poor, a report by charity Oxfam suggests. (...)

The Ongoing Regulation of Generic Drugs
NEJM 357:1993-1996 (November 15)
Today, generic drugs account for 63% of all U.S. prescriptions for drugs (see Figure 1). Since generic drugs sell at substantially lower prices than their brand-name counterparts, they save consumers and purchasers of prescription drugs tens of billions of dollars per year. Moreover, their expanded role has been linked to an attenuation of overall price increases for prescription drugs. Between 2007 and 2010, roughly 110 drugs will lose their patent protection — including well-known products such as Norvasc (amlodipine), Imitrex (sumatriptan), Fosamax (alendronate), and Risperdal (risperidone). Estimates suggest that these 110 drugs are currently responsible for $50 billion a year in sales1— so competition from generic drugs could generate large additional savings. (...)

Innovasjon, men uten respekt for patenter
Andreas Moan, forsknings- og utdanningsdirektør ved Ullevål Universitetssykehus
dagensmedisin.no 30.8.2007
- Det er forstemmende at norske myndigheter benytter et hull i patentlovgivingen til å hente ut kortsiktig fortjeneste. Det har klar negativ konsekvens for innovativ industri i Norge, og er et alvorlig signal fra en nasjon som vil bli ledende innen medisinsk nyskaping og bioteknologi, skriver Andreas Moan. (...)

Dette skjedde første gang for om lag to år siden. Da fikk ett av Norges største legemidler, alendronate, sin patenttid avkortet med fire-fem år - og med et beregnet tap for legemiddelprodusenten på over 100 millioner kroner pr. år. (...)

Likevel innsyn i dokumentasjon av generika?
Tidsskr Nor Lægeforen 2007; 127: 1669 (14.6.2007)
Sivilombudsmannen støtter kravet om innsyn i dokumentasjon for generiske legemidler og ber departementet vurdere vedtaket om alendronatgenerika på ny. (...)

Generisk bytte av legemidler i sykehus
Tidsskr Nor Lægeforen 2007; 127: 1232-3 (3.5.2007)
Generisk bytte av legemidler i sykehus medfører mange risikomomenter og praktiske problemer. Hvis leger delegerer denne oppgaven til sykepleiere, må rutinene kvalitetssikres og formaliseres. Legemidler med samme virkestoff og ATC-nummer trenger slett ikke være bioekvivalente og byttbare. Journalplikten tilsier dessuten at alle bytter må dokumenteres. En nasjonal standard for god praksis på området er ønskelig. (...)

DOJ, FTC Disagree Over Drug Co. Payments
forbes.com 18.4.2007
A senior Department of Justice official Wednesday publicly disagreed with recent statements by Federal Trade Commissioner J. Thomas Rosch that payments by pharmaceutical companies to generic drug makers should be illegal. (...)

Stikker av med prisgevinst
e24.no 20.3.2007
Et nytt prissystem skulle sikre forbrukerne billigere medisiner. Men store deler av gevinsten fra legemiddelprodusentenes priskutt havner i grossistenes lommer. (...)

French regulators fine GlaxoSmithKline 13.2 million for 'predatory' policy
signonsandiego.com 14.3.2007
LONDON – GlaxoSmithKline's French unit was fined $13.2 million for hindering the use of generic drugs in hospitals through “predatory” pricing policy on an injectable antibiotic, French regulators said Wednesday.

The Conseil de la Concurrence ruled that in1999 and 2000 the Glaxo laboratory sold injectable Zinnat below cost to freeze generic drug manufacturers out of the hospital market.

GlaxoSmithKline spokesman Phil Thomson said the company would appeal. (...)

Legislation calls for cheaper biotech drugs
usatoday.com 14.2.2007
Congressional support is building to bring generic competition to life-saving biotech drugs that can cost thousands of dollars a year.

Legislation introduced Wednesday in the House and Senate would give the Food and Drug Administration the ability to approve cheaper copies of biotech drugs. Biologics, such as insulin and cancer drug Herceptin, are based on living cells, while traditional drugs are made from chemicals.

The FDA approves generic versions of traditional drugs once they lose patent protection.(...)

The legislation says the FDA could approve "comparable" copies without rigorous testing if the FDA is satisfied that they would produce the same effects in patients. (...)

100 employees at HQ in Kirkland lose jobs
canada.com 31.1.2007
10,000 globally Drugmaker slashes 285 in Canada

Pfizer Canada Inc. announced yesterday it's cutting almost one- fifth of its Canadian workforce as part of a larger initiative to slash 10,000 jobs worldwide. (...)

"If there was no generic (drugs) in the world, all these people would probably keep their jobs," said Claude Camire of Paradigm Capital in Toronto. (...)

Lobbyists focus on safety in debate over generic drugs
boston.com 18.12.2006
Critics say profits are the real issue
By Diedtra Henderson, Globe Staff | December 18, 2006
WASHINGTON -- Biotechnology lobbyists attempting to slow the development of cheap generic versions of the world's most expensive drugs have been emphasizing questions about their safety in an effort to win support among the new Democratic leaders of Congress. (...)

Biotech Industry Lobbyists Seek Support for Tough Generic Prescription Drug Standards
kaisernetwork.org 18.12.2006
In an effort to slow the market arrival of generic competitors, lobbyists for the biotechnology industry have been raising questions about the safety of generic biotech drugs "in an effort to win support among the new Democratic leaders of Congress," the Boston Globe reports. James Greenwood, a former member of Congress who now is president of the Biotechnology Industry Organization, has encouraged federal regulators to require that generic biotech drug manufacturers be required to meet the same standards of research and testing as brand-name manufacturers. (...)

Generika - udokumentert virkning?
Tidsskr Nor Lægeforen 2006; 126:2548 (5.10.2006)
De av oss som så Dagsrevyen 2.8. 2006, ble der opplyst om at «norske leger er i harnisk … nektes innsyn i viktig dokumentasjon. Leger vet ikke hvordan den medisinen de skriver ut til pasienter med benskjørhet virker. Myndighetene tvinger legene til å skrive ut den billigste medisinen, men helsemyndighetene nekter dem å se dokumentasjon av virkningen.» Videre ble det sagt at pasienter med osteoporose inntil nylig fikk veldokumentert originalpreparat til behandling av sin beinskjørhet. En pasient ble intervjuet og uttrykte bekymring over effekten til det «udokumenterte kopipreparatet hun nå påtvinges» på apoteket. Likeså fremsto en representant for Osteoporoseforeningen med samme tvil om den generiske kopiens virkning og trygghet. (...)

Det er uforståelig for meg at en nestor innen osteoporosebehandling i Norge, Jan Falch, står frem i et slikt innslag på Dagsrevyen, og er med på å øke kollegers og pasienters skepsis til generiske kopipreparater. Mener Falch at virkningen av to identiske molekyler natriumalendronat (trihydrat) er avhengig av hvem som produserer dem? Er det større grunn til å stole på pakningsvedlegget til originalpreparatet enn det til kopipreparatet når begge er godkjent av Statens Legemiddelverk og tilsvarende fagmiljøer i en rekke andre europeiske land? Denne type TV-innslag fremmer en ubegrunnet skepsis blant både leger, pasienter og befolkningen generelt og tjener kun originalpreparatets produsent, som «tilfeldigvis» også fikk meget god eksponering i innslaget. (...)

Approval of generic drugs creates headache for the FDA
bizjournals.com 12.6.2006
The U.S. Food and Drug Admin­istration's recent approval of a generic biotechnology product is anything but a generic OK. (...)

Dose of relief
boston.com 30.4.2006
Are generic drugs just what the cost-cutters ordered? As healthcare prices spiral upward, some are encouraged by an emerging trend: Key drugs are losing patent protection. Now they look to the FDA to unclog the approval pipeline for generics. (...)

Drugs companies accused of £150 million NHS fraud
timesonline.co.uk 5.4.2006
The Serious Fraud Office today began criminal proceedings against five pharmaceutical companies after a four-year investigation into alleged price-fixing of generic drugs sold to the NHS. (...)

The companies named are responsible for more than 50 per cent of NHS supplies of generic medicines - drugs that are out of patent and therefore available for any manufacturer to produce without having to pay royalties. All deny the charge. (...)

Krever billige kopimedisiner
aftenposten.no 26.4.2006
Statens legemiddelverk mener at prisene på kopilegemidler for høye, og krever nå billigere medisin. (...)

U.S. pushes to limit generic drug rights
iht.com 18.4.2006 (International Herald Tribune)
NEW DELHI -- Under global trading rules, the inventors of medicines ordinarily enjoy the right to a 20-year monopoly on their inventions. But five years ago, the United States joined 141 other countries to sign the Doha Declaration, confirming the right of poor countries to break drug patents and produce cheap generic drugs in the event of contagions like HIV.

At the time, Thailand was heartened. It had been trying everything in its fight against AIDS. It coined a jingle to promote safe sex. It placed condoms in massage parlors. Most important, it curbed deaths among the poor by giving them generic versions of medicines invented by multinational drug makers.

So it came as a jolt in January when the United States asked Thailand to sign a free trade agreement that would, on paper, dilute its right to break patents and use generics.

Washington said the agreement would save lives by spurring innovation and by making multinationals more confident to sell drugs in the country. But Thai officials saw the proposal as a morbid bargain: either refuse the U.S. offer, and thereby scuttle a trade deal with the United States worth billions of dollars, or accept it and lift the price of AIDS drugs beyond the reach of the poor.

"Those who require the essential drugs but cannot afford it, they will have to die," said Dr. Suwit Wibulpolprasert, the Thai official who is coordinating the Public Health Ministry's response to the U.S. proposal.

Thailand is not alone. It is merely the latest target of a quiet worldwide campaign by the administration of President George W. Bush to coax developing nations to barter away their patent- breaking rights in exchange for lucrative trade benefits, according to public- health experts and government officials from Thailand to Brazil.

Specifically, Washington is pushing bilateral and regional trade agreements in which countries enact "superpatents" that prolong U.S. drug makers' monopolies and limit the conditions under which their patents can be broken. These new rules, once they are adopted by developing countries, roll back the patent-breaking rights that were confirmed by the 2001 declaration at World Trade Organization talks in Doha, Qatar.

In effect, Washington is stitching together its own parallel global patents system. The trade deals, negotiated in secret, attract little notice. But they have already been signed with developing countries battling AIDS, including six in Central America. And negotiations are beginning with several nations pivotal to the fight against the virus, from Thailand to five southern African countries, including South Africa and Botswana.

Because of these agreements, India's generics industry, the world's largest, is reining in plans to supply poor countries and refocusing on richer ones, said Dilip Shah, head of the Indian Pharmaceutical Alliance, which represents generic makers.

"For the Indian pharma industry," he said, "it's not doomed; it will find a way out. But for the patients in the third world, it's bad."

Public health officials warn of catastrophic consequences if the bilateral deals are applied to AIDS drugs.

"If you prevent countries from using generic drugs," said Pedro Chequer, the head of Brazil's national AIDS program, "you are creating a concrete obstacle to providing access to drugs. You are promoting genocide, because you're killing people."

First-generation AIDS drugs reached the world's poorest people only when the use of generics cut their cost to $140 a year from more than $10,000. As new drugs emerge to treat patients resistant to first-line medicines, the trade agreements make a similar drop "extremely difficult to ensure," according to Médecins Sans Frontières, or Doctors Without Borders.

Washington maintains that the trade deals are directed toward diseases other than AIDS.

And Richard Feachem, executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, based in Geneva, acknowledged that it was too early to tell whether the bilateral agreements would be used to block access to AIDS drugs.

"If we do see this in practice," he said, "we should condemn it. But it really is in the interpretation of these agreements in very particular circumstances."

Yet, in defending the bilateral agreements, Bush administration officials often cite the AIDS example to make their case.

Stronger patents save lives, the argument goes, by keeping companies confident enough in profit to keep discovering new drugs.

Dr. Mark Dybul, the second-ranking official in the White House program to fight AIDS, said that because AIDS patients constantly grow resistant to medicines, it is disastrous to widen access today and have no drugs tomorrow.

"As an individual physician sitting in front of an individual patient, you will do whatever you need to for that patient now," said Dybul, a physician by training. "When you're a public-health physician, you're not a physician for one person but for millions of people. And you need to be thinking about whether the action in that single setting, repeated hundreds of thousands of times, will cause a problem for the millions."

Spreading the new patents system are U.S. trade negotiators, who some experts believe are assuming the influence that public health experts once had over the Bush administration's AIDS policy.

Victoria Espinel, an assistant U.S. trade representative, strongly defended the use of trade agreements to promote patents that "have more in place" than the patents agreed upon at the WTO talks in Doha, which she described as merely "harmonizing minimum standards."

"It is crucial to public health," she said, "to promote the innovation of drugs and to make sure that research and development of drugs continues."

As for exempting AIDS drugs from the new accords on patent-breaking, she said, "I want to emphasize that there is enough flexibility in our free- trade agreements to allow our partners to do what they need to do."

An explicit promise to exempt AIDS drugs, however, is not in the agreements, said Wibulpolprasert, the Thai official. And that, experts say, is at the heart of the problem: Nations must take Washington's word for it.

An examination by the International Herald Tribune of several free-trade accords reveals provisions that appear, on paper, to limit the freedom to use generics.

Several agreements, for example, prolong a patent monopoly beyond 20 years if the developing country's regulators show "unreasonable delays" in approving a patent. This provision, absent from World Trade Organization rules, sustains higher prices.

Many agreements also serve to prolong patents by requiring generics to be retested as if they were new inventions. Retesting a drug biologically equivalent to one already approved takes time and may be unethical, since infected patients must be given placebos. The WTO rejected this five-year ban on the use by generic makers of the safety data submitted for the original branded drug.

And while the WTO lets countries decide when to break patents, the new U.S. agreements limit this action to special cases - to enforce antitrust law, for example, or during emergencies. Experts say the most important use of generics is excluded: to reduce costs by making branded products compete with generics.

Last year, when Brazil was faced with upgrading tens of thousands from $140- a-year generics to Kaletra, a patented drug costing more than $3,000 a year, it threatened to break the patent unless given a discount by the U.S. company Abbott Laboratories, Kaletra's inventor. Members of Congress in the United States threatened import tariffs in retaliation. Although the Bush administration says it was not involved, Espinel, the assistant U.S. trade representative, hinted at how Washington's tacit desires can be enough to make countries fall into line.

"Do I think that that would be the best way for a country to go about promoting itself as an innovation player and a destination for foreign investment?" Espinel said. "Probably not."

Bill Clinton, the former American president, came to Brazil's rescue. His foundation tapped overseas contacts to find a generic drug for about $900 a year - a price Brazil used to negotiate with Abbott, which spent $1.8 billion on research in 2005 and reported a profit of $3.4 billion.

Finally, Brazil backed down from its threat to break the patent, and Abbott gave it a discount of about 50 percent.

Abbott is "gratified to get support" from "people in and outside of government," said a company spokesman, Brian Kyhos.

"Actions that undermine intellectual property do create a risk to continued innovation," he said.

FDA backlog = Billions for Big Pharma?
money.cnn 10.4.2006
A bottleneck of generic drug applications may give branded drugs more time on the market without generic competition.

- Big Pharma could land billions of dollars in annual sales that it would have lost to generic competitors thanks to a Food and Drug Administration backlog of applications for generic drugs.

Some $100 billion worth of branded drugs are expected to go off patent over the next five years. In theory, this should translate into lost revenue for branded drug companies because they would face a plunge in sales as they compete with low-cost generic versions of their drugs.

But the FDA's Office of Generic Drugs, which reviews applications for generic drugs, faces a bottleneck of some 800 applications. This is the result of a 36 percent surge in applications last year, according to the Generic Pharmaceutical Association, citing statements made by Gary Buehler, director of the Office of Generic Drugs, at a GPhA conference in February.

Nye EU-regler for generiske legemidler
helserevyen.no 30.22.2005
EU har nå vedtatt nye regler for utstedelse av markedsføringstillatelser for generiske legemidler, som er medisiner med samme virkestoff, men produsert av ulike firma.

Ordningen som er innført kalles «europeisk referanselegemiddel» og innebærer at en produsent av et generisk legemiddel (generikaprodusent) kan søke om markedsføringstillatelse for legemidlet selv om referanselegemidlet ikke har vært godkjent i Norge, eller i det landet der det skal markedsføres.
Statens legemiddelverk antar at den nye ordningen med europeisk referanselegemiddel vil tre i kraft i Norge i løpet av 2006. Men inntil videre er ikke endringene i EUs legemiddelregelverk en del av EØS-avtalen.

Glaxo, Pfizer Copy Own Drugs in Effort to Fight Generic Rivals
bloomberg.com 10.11.2005
-- The day after a copy of GlaxoSmithKline Plc's Paxil hit stores in 2003, the company introduced its own cheaper version of the $3 billion-a-year depression drug.

In doing so, Glaxo deprived Apotex Inc. of six months of market exclusivity it had expected under a U.S. law designed to nurture the generic drug industry. Weston, Ontario-based Apotex says the competition cost it as much as $400 million in sales.

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