Intellectual Property and Access to Medicines – lessons from HIV EPIP, 5 September 2017, Bordeaux. Ellen ‘t Hoen, LLM University Medical Centre Groningen, Global Health Unit @ellenthoen www.medicineslawandpolicy.org

Brief history Late nineties, 40 mill people with HIV 8000 people a day died of AIDS in the developing world Effective antiretroviral medicines (ARVs) available @ $15,000 pppy No fixed dose combinations (FDCs) available from originators 2001 Indian generic companies offered the same ARVs (FDC) for $350 pppy National and international legal and political conflicts over patents were common -> 5 Sept ‘17 www.medicineslawandpolicy.org

IN THE HIGH COURT OF SOUTH AFICA (TRANSVAAL PROVINCIAL DIVISION) Case number: 4183/98 VS. 5 Sept ‘17 www.medicineslawandpolicy.org

Battle of Seattle ’99 WTO Ministerial Conference 5 Sept ‘17 www.medicineslawandpolicy.org

2001 WTO Doha Declaration on TRIPS and Public Health "the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health". … “we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all.” TRIPS Flexibilities Compulsory licensing/Government Use Parallel import Extension for LDCs (paragraph 7) Promised solution for CL for export (2017 TRIPS amended: 31bis) http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm 5 Sept ‘17 www.medicineslawandpolicy.org

Response to HIV Medicines Crisis Flexibility in implementation of WTO TRIPS WHO prequalification program to ensure medicines quality Global funding for HIV/AIDS Vibrant civil society Indian generics industry capacity Pre/post grant opposition Voluntary licensing/ Medicines Patent Pool Use of TRIPS flexibilities 5 Sept ‘17 www.medicineslawandpolicy.org

The use of TRIPS flexibilities 2011 - 2016 7/9 NCD 5 Sept ‘17 www.medicineslawandpolicy.org

2010 UNAID Establishes The Medicines Patent Pool

Results BUT … 2016 - 20 mill / 36.7 mill PLHIV have access to ARVS 48% decline in AIDS related deaths 2005 – 2016 WHO recommended triple ARV therapy available in FDCs for less than US $ 100 pppy. BUT … 5 Sept ‘17 www.medicineslawandpolicy.org

New WHO Essential Medicines Originator price intro US Cost of production1 Patent expiry Tuberculosis bedaquiline $ 30,000 ( 6 month) $ 48 -101 2023 Hepatitis C sofosbuvir (SOF) $ 84,000 (12 week) $68 -136 2014 (28 prodrug) SOF+ledipasvir $ 95,000 (12 weeks) $ 193 2030 (led) simeprevir $ 66,360 (12 weeks) $130 - 270 2026 daclatasvir $ 63,000 (12 weeks) $10 - 30 2027 Cancer imatinib $ 30.000 - >$100,000 (1y) $ 119-159 2014 (18 second) trastuzumab $54,000 (1 y) $ 242 2008 1. http://cid.oxfordjournals.org/content/early/2014/02/13/cid.ciu012.full (cost of production of HCV medicines) | Hill A. etal.,Target prices for mass production of Tyrosine Kinase Inhibitors (TKIs) for global cancer treatment access - Presented at 18th ECCO - 40th ESMO European Cancer Congress, 27th September 2015, Vienna, Austria [abstract number: 1203] | Dzintars Gotham, Joseph Fortunak, Anton Pozniak, Saye Khoo, Graham Cooke, Frederick E. Nytko, III, Andrew Hill; Estimated generic prices for novel treatments for drug-resistant tuberculosis. J Antimicrob Chemother 2017 dkw522. doi: 10.1093/jac/dkw522 5 Sept ‘17 www.medicineslawandpolicy.org Presented at 18th ECCO - 40th ESMO European Cancer Congress, 27th September 2015, Vienna, Austria [abstract number: 1203]

Prices of Hepatitis C meds US$74,000 to 147,000 5 Sept ‘17 www.medicineslawandpolicy.org

High Medicines Pricing a Global Issue Essential Medicines for Universal Health Coverage 5 Sept ‘17 www.medicineslawandpolicy.org

Dutch Ministers on Access to medicines: “We cannot achieve any real progress without acknowledging that the current patent-based business model and the way we apply international patent rules need to change. The system is broken.… Patent and intellectual property exclusivities are the only cornerstone of the current model. Companies can ask the price they like. This will no longer do. We need to develop alternative business models. And if public money is used for the development of new medicines, agreement upfront is needed about what this public investment will mean for the final price. We believe that companies must provide full transparency regarding the costs of research and development (R&D). “ NL Ministers E. Schippers (Health) and L. Ploumen (Foreign Trade and Development Cooperation) http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31905-5/fulltext 5 Sept ‘17 www.medicineslawandpolicy.org

Alternative financing models for innovation. The Lancet Commission: The concept of delinking costs from prices is based on the premise that costs and risks associated with R&D should be rewarded, and incentives for R&D provided by means other than through the price of the product. The Commission supports proposals to progressively delink the cost of R&D for priority medicines from the price of the products, and to develop new ways of sharing the cost burden of innovation internationally. 5 Sept ‘17 www.medicineslawandpolicy.org

The UN SG’s High Level Panel on Access to Medicines: Recommendation Building on current discussions at the WHO, the United Nations Secretary-General should initiate a process for governments to negotiate global agreements on the coordination, financing and development of health technologies. This includes negotiations for a binding R&D Convention that delinks the costs of research and development from end prices to promote access to good health for all. Such a Convention should focus on public health needs, including but not limited to, innovation for neglected tropical diseases and antimicrobial resistance and must complement existing mechanisms. 5 Sept ‘17 www.medicineslawandpolicy.org

Conclusions Use of TRIPS flexibilities and licensing work (if not constraint by TRIPS+ provisions e.g. DE) Medicines Patent Pool – expand licensing to all WHO essential medicines Award the innovation: alternative financing models for the development of new medicines based on ‘delinkage’ -> example prize fund, DNDi. 5 Sept ‘17 www.medicineslawandpolicy.org

Thank you! @ellenthoen For background sources please visit: www.medicineslawandpolicy.org 5 Sept ‘17 www.medicineslawandpolicy.org

Rest slides 5 Sept ‘17 www.medicineslawandpolicy.org

Prices of Tyrosine Kinase Inhibitors (cancer Rx) Thanks to A.Hill who Presented this data at 18th ECCO - 40th ESMO European Cancer Congress, 27th September 2015, Vienna, Austria [abstract number: 1203] Source UK Lapatinib: https://www.theguardian.com/business/2015/sep/23/uk-cancer-patients-being-denied-drugs-due-to-inflated-prices-say-experts