1. 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

2. Brief history Late nineties, 40 mill people with HIV
8000 people a day died of AIDS in the developing world
Effective antiretroviral medicines (ARVs) $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

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

4. Battle of Seattle ’99 WTO Ministerial Conference
5 Sept ‘17

5. 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)
5 Sept ‘17

6. 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

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

8. 2010 UNAID Establishes The Medicines Patent Pool

9. 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

10. New WHO Essential Medicines
Originator price intro US
Cost of production1
Patent expiry
Tuberculosis
bedaquiline
$ 30,000 ( 6 month) $
2023
Hepatitis C
sofosbuvir (SOF)
$ 84,000 (12 week) $
2014 (28 prodrug)
SOF+ledipasvir
$ 95,000 (12 weeks)
$ 193
2030 (led)
simeprevir
$ 66,360 (12 weeks) $
2026
daclatasvir
$ 63,000 (12 weeks) $
2027
Cancer
imatinib
$ >$100,000 (1y) $
2014 (18 second)
trastuzumab
$54,000 (1 y)
$ 242
2008
1. (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: /jac/dkw522
5 Sept ‘17
Presented at 18th ECCO - 40th ESMO European Cancer Congress, 27th September 2015, Vienna, Austria [abstract number: 1203]

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

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

13. 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)
5 Sept ‘17

14. 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

15. 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

16. 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

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

18. Rest slides
5 Sept ‘17

19. 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: