Issue brief |

WTO Informal Ministerial Meeting - Action needed to ensure production and export of affordable generic medicines

At the 2001 WTO Ministerial meeting in Doha, Members acknowledged that protecting public health, and in particular promoting access to medicines for all, has primacy over intellectual property protection. One year later, at the first anniversary of the Doha Declaration on TRIPS and Public Health, the significant progress made is at risk of being compromised in favor of the industrial interests of developed countries. Under pressure from the multinational drug industry, the EU and US are unwilling to support proposals that will lead to the availability of affordable generic medicines in countries that lack the ability to produce these medicines.

Médecins Sans Frontières (MSF) encourages delegates to the Informal Ministerial Meeting in Sydney to uphold the spirit of the Doha Declaration by working towards trade policies that contribute to providing access to existing medicines for all and encouraging research and development for new drugs to treat neglected diseases.

A key issue that remained unresolved in Doha is how to ensure that production for export to a country that has issued a compulsory license, but does not have manufacturing capacity, can take place within a country that provides pharmaceutical patents. Since Article 31(f) of the TRIPS Agreement limits compulsory licensing predominantly to supplying the domestic market, further clarification is necessary to ensure that countries without production capacity can make use of compulsory licensing provisions to the same extent that countries with manufacturing capacity can use these provisions. The Doha Declaration acknowledges the problem in Paragraph 6:

"We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002."

It is a matter of urgency that the production for export issue be resolved. TRIPS implementation deadlines for some important producer countries are quickly approaching, thus further limiting the possibilities of producing generic versions of medicines that are protected by a patent elsewhere.

We encourage the trade ministers to find a solution to the paragraph 6 problem that is workable, effective, economically viable and permanent. Solutions should not be limited to certain countries or diseases but offer a comprehensive solution to a flaw in the TRIPS Agreement.

Médecins Sans Frontières asks the Members of the WTO to consider the following:

1. Countries should be able to produce and export generic medicines in order to meet public health needs of other countries with insufficient or no manufacturing capacity, including when there is no patent. The UK Commission on Intellectual Property Rights pointed out it its recent report Integrating Intellectual Property Rights and Development Policy: "The crucial issue is that the economics of supply to one particular country with a limited market may be insufficient to attract potential generic suppliers."(1) Therefore, the most effective solution to the ‘paragraph 6 problem’ is a limited exception under Article 30 of the TRIPS Agreement. In its statement to the TRIPS Council on September 20, the World Health Organization acknowledges this solution as the most viable from a health point of view:

“Among the solutions being proposed, the limited exception under Article 30 is the most consistent with this public health principle. This solution will give WTO Members expeditious authorization, as requested by the Doha Declaration, to permit third parties to make, sell and export patented medicines and other health technologies to address public health needs.”(2)

This would allow “production for export” activities to be defined under national law as exceptions to the rights of patent holders. Since the production for export would not be an infringement, there would be no need to require a compulsory license for this kind of production. Such an exception is the most efficient as it would not require any extra procedural steps in the exporting country which might result in the permission for export being denied or delayed. At the request of an importing country, and after the granting of a compulsory license in that country if necessary, medicines could be automatically produced and exported – providing an efficient mechanism for meeting public health needs.

The European Parliament recently adopted the following amendment to the European medicines regulation that is based on the same principle(3):

“Manufacturing shall be allowed if the medicinal product is intended for export to a third country that has issued a compulsory license for that product, or where a patent is not in force and if there is a request to that effect of the competent public health authorities of that third country.”

2. Despite the enormous burden of disease in developing countries, drug research and development targeted at infectious and parasitic diseases has virtually ground to a standstill. Of the 1,223 new drugs approved between 1975 and 1997, only 13 (less than 1%) were specifically to treat tropical diseases.(4)

We encourage trade ministers to start discussion on the failure of the global trade and patent system to provide incentives for research and development for neglected diseases. These discussions should focus on alternatives to promoting research and development and on designing mechanisms to enhance the research capacity in developing countries through knowledge and technology transfer.

1. Report of the UK Commission on Intellectual Property Rights (2002) Integrating Intellectual Property Rights and Development Policy p.48.
2. See also WHO publication: Implications of the Doha Declaration on the TRIPS Agreement and Public Health, WHO/EDM/PAR/2002.3
3. Amendment 196, ARTICLE 1, POINT 7,Article 10, paragraph 4, subparagraph 1 a (new) (Directive 2001/83/EC)
4. Trouiller P, Olliaro P. (1999) Drug development output from 1975 to 1996: What proportion for tropical diseases? Int Journ Infect Diseases . Vol: 3: 61-63.