TRIPS, IPR & procurement

Transcription

1 TRIPS, IPR & procurement = current issues and experiences = Karin Timmermans - WHO Indonesia Bi-regional Workshop on the management of anti-retroviral medicines Phnom Penh 15 Dec. 2004

2 Medicines are subject to two sets of rules: Intellectual property rights Registration requirements The right to exclude But not the right to market or to use Authorization to put a medicine on the market

3 Basic requirements for drug procurement: Patented? Registered? Originator drug -/ + + Generic version - + but

4 But there can be exemptions... Patented? Registered? Originator drug -/ + + Generic version - +

5 Possible exemptions for registration: Compassionate use exemptions Public sector procurement / tenders

6 Public health safeguards that can facilitate access to medicines: Parallel importation Compulsory licensing Government use Bolar provision

7 Public health safeguards that can facilitate access to medicines: Parallel importation Compulsory licensing Government use

8 TRIPS allows the use of these safeguard mechanisms. Moreover, the WTO s Declaration on the TRIPS Agreement and Public Health (Doha, 2001) reconfirms that countries are free to use these safeguard mechanisms to promote access to medicines for all ; However, these mechanisms can only be used when they are incorporated in the national law; Therefore it is important to have good laws.

9 Parallel importation: (international) exhaustion of rights One definition: Importation without the consent of the patent holder, of a patented product marketed in another country either by the patent holder or with the patent holder s consent.

10 Compulsory license: license granted without permission of the patent holder; TRIPS allows compulsory licenses, but imposes a number of conditions; many countries laws have CL provisions; a compulsory license can be issued for local production or for importation. However, TRIPS limits the capacity to export medicines produced under a compulsory license.

11 The Doha Declaration (paragraph 6) recognizes that it is not clear how countries with insufficient or no manufacturing capacity can make effective use of compulsory licensing, And instructs the WTO s TRIPS Council to find an expeditious solution to this problem. A solution was agreed in August 2003.

12 Key elements of the solution: countries should first notify WTO (except leastdeveloped countries); provide details of drugs to WTO; possibly 2 compulsory licenses (importing and exporting country); special labeling, packaging and/or coloring/shaping; notify WTO of the grant of compulsory license; prevent re-exportation; annual WTO review of the system; some countries have opted out/only for emergency.

13 Government use: A special case of compulsory license i.e. a compulsory license for the Government itself. Procedures for Government Use tend to be easier; But medicines produced under Government Use license cannot be sold commercially.

14 So if you want to procure generic medicines, what do you do? Where do you start?

15 Stepwise approach: 1. Are there patents in the country? If not, you can procure generics (provided they are registered) 2. Are there pharmaceutical patents? If not, you can procure generics (provided..

16 Stepwise approach: 3. Which ARVs are under patent in the country? And: how do we find out?

17 Stepwise approach: 3. Would a generic version of an ARV infringe any patent in the country? If not, generic procurement can proceed. If yes: - buy originator product, or - make use of safeguard mechanisms, if available under national law.

18 What are countries actually doing?

19 Some countries do not (yet) have a (functioning) patent law in place. => No problem, generic ARVs can be procured and used.

20 Cambodia: Patent law in place, but specifies that there will be no patents for pharmaceuticals until Note: - this is allowed for least-developed countries under the WTO s Declaration on the TRIPS Agreement and Public Health (Doha, 2001); - this is something other least-developed countries should also consider.

21 Thailand: Generic production of ARVs that are not patented in Thailand (incl. ddi powder); Challenging the ddi patent in court

22 Brazil: Generic production of ARVs that are not patented in Brazil; Negotiating price reductions of ARVs that are patented, using the threat of compulsory licensing

23 Malaysia & Indonesia: Government Use - Malaysia for importation, - Indonesia (mainly) for local production.

24 Malaysia Didanosine Zidovudine Didanosine+Zidovudine Valid for 2 years Indonesia Lamivudine Nevirapine Valid for 7-8 years Royalty to be determined Royalty 0.5 % Authorization by Minister of Domestic Trade Presidential Decree

25 Thank you