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How can Seychelles in future obtain affordable, good quality medicines for HIV/AIDS, Hepatitis C, cancer
and other non-communicable diseases? Medical View
Wilbert [email protected] Seychelles TRIPS workshop 18 Sep 2014
Main death causes in Seychelles
• Cardiovascular (32%)• Cancer (20%)• Diabetes and other NCDs (22%)• Communicable diseases (19%)– HIV/AIDS– Hepatitis-C– Respiratory infections
• Injuries (7%)
We all know what to do...
• NCDs– Healthy life style, exercise, salads, vegetables– Stop smoking, drink less, lose weight
• HIV/AIDS, Hepatitis-C– Educate population– Safe sex, condoms– Needle exchange programmes
• Safer roads, control cars, don’t drink & drive...
Needed but medicinesNew medicines may be patented
• Non-communicable diseases:– Cancer medicines– Diabetes (leading to kidney failure)– High blood pressure– Stroke (new expensive heparins)
• 2nd and 3rd line antiretrovirals • New DAA treatments for hepatitis-C• Can the government afford them?
Remember the South Africa case?
• Antiretrovirals were unaffordable– $7000-12000 pp/year due to the patents of big pharma– Brazilian/Indian generics cheaper ($900, then $360, now $62)– But generics could not be bought due to patents
• SA govt made a law to make patented medicines cheaper; – 39 drug companies vs. Nelson Mandela
• South Africa eventually won the case in 2001– Not with lawyers! But with AIDS activists (TAC) testifying in court, press
releases, TV interviews, public pressure (MSF) etc• SA govt first did not want to make ARVs available
– No trust in ARVs or multinational drug companies– Finally accepted ARVs using economic arguments– Now has the biggest ARV program in the world (>2.5m on ART)
Anti-retrovirals and patents
• First fixed-dose combinations by generic co’s • Generic competition (India <2005) ↓ prices• Old 1st line access after SA court case• New 1st line (tenofovir, $500 to $26) due to
voluntary licences by Gilead to 8 generic co’s• 2nd and 3rd line ARVs patented and expensive but
licenses available in Medicines Patent Pool• Future? India > 2005 no generics unless voluntary
licenses or compulsory license for export
Hepatitis-C in Seychelles
• 440 HCV cases diagnosed so far• 360(82%) males and 80(18%) females– IV drug users (needle exchange = cost effective!)
• 36 (9%) had HIV + HCV co-infection• 13 HCV related deaths• Peg-Interferon expensive, injectable, serious
side-effects (depression) and not very effective
DAAs: new hope for hepatitis-c
• Hepatitis-c can now be cured by taking 2 new directly acting antiretrovirals (DAA) for 12-24 weeks– Stops progression to liver failure and liver cancer
• Example: Sofosbuvir by Gilead– 1 tablet costs $1000; a cure (to survive) > $84,000– Difficult discussions in USA, Europe: can we afford?– Seychelles: 440 HCV cases x $84,000 = $37 million...
• Egypt, Mongolia got 99% discount: $900 per course• Raw material cost only $68 - $136 per course• New voluntary licenses announced by Gilead this week
– Awaiting lower price generic DAAs in coming years
Cancer medicines
• 14m new cancers discovered globally (8.2m deaths)– Fastest growing market for big farma
• Seychelles: cancer 20% of all deaths• Government spends SR 4.5m on cancer medicines
– 30% on Herceptin (trastuzumab, for breast cancer)– Many patient-specific medicines
• Older anti-cancer medicines are available as generics in India• Newer anti-cancer medicines patents granted or pending, but:
– Patent not accepted (2nd use), application withdrawn or compulsory license
– Check patent status of cancer medicines in Seychelles!
Conclusions
• Many diseases are preventable.– Sometimes treatment is prevention
• Treatments are expensive (often because of patents), but thanks to the large numbers of PLWHIV in low income countries we may get cheaper generics
• Non-communicable diseases often need chronic and new medications
• Such medicines may be patented and expensive• Lower prices generics nevertheless possible if there is
demand and use of patent law flexibilities• Seychelles use TRIPS flexibilities in procurement practices
