Issue brief |

Recommendations to the European Commission for discussions at the June 2001 TRIPS Council on Health and Access to Medicines

MSF briefing to the European Parliament. Includes A closer look at price (do patents affect price of drugs?), discussion of the TRIPS agreement (does it work for the poor?), equitable pricing, investment in R&D, and international funding.

Médecins Sans Frontières (MSF) asks the European Commission to support an interpretation of the TRIPS Agreement that favours public health needs. The main objective of the deliberations at the TRIPS Council should be to encourage a more equitable sharing of the benefits of medical technological development and advances between the populations of developed and developing countries and to seek ways to correct the present imbalance between the unbridled exercise of private property rights and public interest. The discussions should also address the failures of the present intellectual property system (IPR) system to provide incentives for research and development (R&D) for neglected diseases.

Discussions in the TRIPS Council should not take place in isolation from debates elsewhere such as at the UN Commission on Human Rights, the World Health Assembly and multiple regional fora.

Specific recommendations:

1. The European Commission should go beyond general statements and give the widely acknowledged "flexibility" of the TRIPS Agreement "hands and feet" by supporting practical implementation options. The European Commission should:

a. Allow for and advocate a wide scope of interpretation of Article 31 and support fast track administrative compulsory licensing procedures, especially when they relate to public health.
b. Support compulsory licensing for export to address public health needs.
c. Advocate humanitarian and health exceptions to patent rights under article 30 for:
i. globally procured goods or goods purchased with financing of a global health fund;
ii. to allow developing countries to ensure that the poor obtain access to essential medicines.
d. Support the principle of international exhaustion of rights (parallel import).
e. Support "Bolar exemptions" to avoid delays in the introduction of generic products.
f. Avoid restrictive and anti-competitive interpretations of country obligations under article 39 of the TRIPS, concerning health registration data.

2. The European Commission should seek alterative ways to increase R&D financing for neglected diseases. Replace the current emphasis on private commercial rights with a system obligating countries to support essential medical research and development that addresses public health needs. Public sector commitment to R&D for neglected diseases when the market fails to address those needs should be increased.

3. The European Commission should enhance measures to encourage and improve pharmaceutical technology transfer with the aim to build or strengthen infrastructure and encourage local and regional production of essential medicines. Encouraging technology transfer to the least developing countries is an obligation under the TRIPS Agreement (see article 66.1), however pharmaceutical technology transfer should be specifically targeted to developing countries with production capacity or potential production capacity that would allow a regional function.

4. The European Commission should support an extension of the implementation deadlines for the least developed countries until mechanisms to remedy the effects on access to essential health technologies are in place.

5. The European Commission should declare that bilateral pressure to prevent countries from making maximum use of the TRIPS flexibility should not be exercised and is counter to the nature of the multilateral trade system.

6. The European Commission should support a moratorium on dispute settlement procedures that may affect access to health care products.

7. The European Commission should encourage full and active involvement of the WHO in the discussions and preparations of discussions related to health and medicines at the TRIPS Council and encourage WHO's involvement in any dispute settlement procedures that affect health.

8. The European Commission should encourage ongoing assessment of the effects of TRIPS on access to essential health commodities and R&D for neglected diseases.

9. The Assessment of the TRIPS Agreement should take place in cooperation with the WHO and WIPO. The European Commission could:

a. Ask that WIPO or WHO examine the costs and capacity of maintaining a patent system on medicines, in terms of (a) examining patents and (b) litigating claims.
b. Ask that WHO or WIPO address the consequences of poor countries not having the capacity to avoid overly broad, non-novel or anticompetitive patents.
c. Ask that WIPO address the issue of administrative models for examining the validity of patents and for compulsory licensing that would be workable in poor country settings.