Treat the world: Working united across diseases for quality and affordable treatment for all – AIDS 2018 TRIPS Flexibilities 0.2 Across Diseases Ellen ‘t Hoen, LLM PhD Medicines Law & Policy University Medical Centre Groningen, Global Health Unit @ellenthoen www.medicineslawandpolicy.org

What is TRIPS? What is a patent? Flexibility of TRIPS: “…WTO members' right to protect public health and, in particular, to promote access to medicines for all.”

Public non-commercial use (Government Use) Government makes use of the patent without consent of the patent holder Payment of a reasonable royalty. No prior negotiations required. Does NOT require emergency situation. Can be part of routine procurement.

Least Developed Country? Medicine patented? No No Yes License agreement allows generic supply to a country with TRIPS flexibility? Least Developed Country? Medicine patented? Patent license agreement and your country is part of the territory? No Yes Yes No LDC pharma waiver Gov. non-commercial use Are there other sources of generic product? Yes Buy generic from licensee Yes No Buy generic from quality source Government non-commercial use TRIPS 31bis special CL for export Info on patent status: MEDSPAL.ORG Our work is licensed under Creative Commons. https://creativecommons.org/licenses/by-nc-nd/4.0/

Has this been used?

HIV NCDs/cancer FM‘t Hoen E, Veraldi J, Toebes B, Hogerzeil HV. Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001–2016. Bulletin of the World Health Organization. 2018 Mar 1;96(3):185. http://www.who.int/bulletin/volumes/96/3/17-199364.pdf

TRIPS Flexibilities Only applied for HIV?

Thailand - heart disease and cancer (’07-’08) Cost savings resulting from Thailand Government Use Licensing for NCD medicines (in $mill) Medicine Originator price After GU of patent Cost savings Clopidogrel 22.61 0.6 22 Letrozole 91.7 2.94 88.57 Docetaxel 48.34 2.1 46.1 Erlotinib 8.99 2.46 6.33 Total 447.34 87.84 358.41 Source: Mohara A, Yamabhai I, Chaisiri K, Tantivess S, Teerawattananon Y. Impact of the introduction of government use licenses on the drug expenditure on seven medicines in Thailand. Value in Health. 2012 Feb 29;15(1):S95-9. http://www.valueinhealthjournal.com/article/S1098-3015(11)03553-4/fulltext#tbl2

Malaysia - Government Use Licence for sofosbuvir (2017) www.medicineslawandpolicy.org

TRIPS-Flex developments in high income countries France -> Cancer researchers request GU for cancer drugs Germany -> Court ordered in patent dispute re HIV med Greece -> High cost of new meds/withdrawal of cancer med Ireland -> Resolution by the Irish Medical Association Italy -> Competition authority Romania -> Hepatitis C –request by civil society Russia -> court decision to grant CL for cancer drug Scotland -> Request by cancer patients Spain -> Hepatitis C The Netherlands -> MoH investigating the use of CL UK -> requests by cancer patients State of Louisiana (US) -> announced plans for CL for sofosbuvir https://khn.org/news/louisiana-proposes-tapping-a-federal-law-to-slash-hepatitis-c-drug-prices/

No use for patent related measures (CL/GU) if: There is no patent (anymore e.g. after patent opposition or expiry) Patent does not have to be enforced (LDCs) Price is affordable Patent holder is willing to license (e.g. to the Medicines Patent Pool)

20 years of Rx price development ARVs 15,000 $ www.medicineslawandpolicy.org

High medicines prices have their roots in the financing model of pharmaceutical research and development based on the granting of market exclusivities through patents or otherwise. This is not a situation we can “compulsory license” out off. New models of R&D financing that delink paying for the cost of R&D from price. (www.delinkage.org)

Dutch Ministers on Access to medicines in The Lancet: “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

Thank you! For background information please visit: www.medicineslawandpolicy.org www.accesstomedicines.org Follow me on Twitter: @ellenthoen