PHA-Exchange> MSF on Sydney WTO meeting

[Aviva]

> crossposted from e-drug
>
> Ministers put lives at stake in trade-off
>
> Médecins Sans Frontières calls for Sydney trade ministers' meeting to
> ensure access to affordable generic medicines
>
> Sydney/Geneva, Wednesday 13 November 2002 -- The international medi-
> cal aid agency Médecins Sans Frontières (MSF, Doctors Without Bor-
> ders) warns that World Trade Organization delegates to the Informal
> Ministerial Meeting in Sydney must not compromise public health in
> pursuit of industrialised country priorities. In particular, MSF
> urges WTO Members to remove the restrictions on export of generic
> medicines.
> The Sydney meeting comes just one year after the WTO ministerial
> meeting in Doha, Qatar, where countries reinforced the priority of
> public health over patents.
> "On the anniversary of Doha, the trade ministers' meeting in Sydney
> is at risk of compromising these principles," says Ellen 't Hoen of
> the MSF Campaign for Access to Essential Medicines. "We fear that
> policy options which place significant barriers to access of generic
> medicines by developing countries will be promoted."
> Infectious diseases kill 15 million people each year. More than 36
> million people living with HIV/AIDS do not have access to the drugs
> they need, most of whom live in developing countries. One of the main
> barriers to access to medicines in these countries is price.
> Quality generic medicines generally cost less than brand-name equiva-
> lents, allowing more people to access treatment. Under the WTO's
> Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agree-
> ment, developing countries with no pharmaceutical manufacturing ca-
> pacity are allowed to import generic drugs to meet health needs.
> Paradoxically, generic producers are currently restricted in export-
> ing these drugs.
>
> Developing countries and international non-governmental organisations
> such as MSF believe that the removal of these export restrictions on
> generic producers is a simple, effective solution that balances pub-
> lic health demands and intellectual property protection in the spirit
> of the 2001 Doha meeting.
>
> "Delegates to the Informal Ministerial Meeting must support a perma-
> nent workable solution which removes restrictions on the export of
> generics, rather than pursue quick-fix policies that will put access
> to medicines at risk," says Ellen 't Hoen.
>
> Expedient trade deals must not come at the expense of human lives.
>
> For comment, call Ellen 't Hoen on +33-6-223-758-71.
>
> More information on Médecins Sans Frontières' Campaign for Access to
> Essential Medicines can be found at:
> http://www.accessmed-msf.org
>
> World Trade Organization Informal Ministerial Meeting 14-15 November >
2002, Sydney
>
> Action needed to ensure production and export of affordable generic
> medicines
> A briefing document by Médecins Sans Frontières
> 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 Decla-
> ration by working towards trade policies that contribute to providing
> access to existing medicines for all and encouraging research and de-
> velopment 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 li-
> cense, 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 predomi-
> nantly 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 Agree-
> ment. We instruct the Council for TRIPS to find an expeditious solu-
> tion 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 re-
> solved. TRIPS implementation deadlines for some important producer
> countries are quickly approaching, thus further limiting the possi-
> bilities of producing generic versions of medicines that are pro-
> tected 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 perma-
> nent. Solutions should not be limited to certain countries or dis-
> eases 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 insuffi-
> cient or no manufacturing capacity, including when there is no pat-
> ent. The UK Commission on Intellectual Property Rights pointed out it
> its recent report Integrating Intellectual Property Rights and Devel-
> opment 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 effec-
> tive solution to the 'paragraph 6 problem' is a limited exception un-
> der 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 Ar-
> ticle 30 is the most consistent with this public health principle.
> This solution will give WTO Members expeditious authorization, as re-
> quested 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 un-
> der 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 produc-
> tion. Such an exception is the most efficient as it would not require
> any extra procedural steps in the exporting country which might re-
> sult in the permission for export being denied or delayed. At the re-
> quest of an importing country, and after the granting of a compulsory
> license in that country if necessary, medicines could be automati-
> cally 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 specifi-
> cally 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 fo-
> cus on alternatives to promoting research and development and on de-
> signing 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 Pol-
> icy http://www.iprcommission.org 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, sub-
> paragraph 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 Dis-
> eases . Vol: 3: 61-63.