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

2. 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.”

3. 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.

4. 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.

5. Has this been used?

6. 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 Mar 1;96(3):185.

7. TRIPS Flexibilities
Only applied for HIV?

8. 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 Feb 29;15(1):S

9. Malaysia - Government Use Licence for sofosbuvir (2017)

10. 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

11. 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)

12. 20 years of Rx price development
ARVs 15,000 $

13. 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. (

14. 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)

15. Thank you!
For background information please visit: Follow me on