PHA-Exchange> Impasse on TRIPS talks and the Health permanent solution

[Claudio]

From: Third World Network 

www.twnside.org.sg

 

Impasse on TRIPS talks and the Health permanent solution

 

The World Trade Organisation was supposed to conclude a 'permanent solution' to the problem facing countries that have no or inadequate drug manufacturing capacity so that they can have access to affordable medicines.

 

The impasse that has taken place in the recent negotiations brings into focus the importance of the issue to the developing countries in the light of the global avian flu threat and the shortage of the anti viral drug to treat bird flu.

 

We include the background note by Sangeetha Shashikant and the report on the talks by Martin Khor.


Please find below the latest news on negotiations taking place in the World Trade Organization in Geneva on TRIPS (Trade Related Aspects of Intellectual Property Rights) and Public Health, in relation to supply of medicines to countries with insufficient or no manufacturing capacity.

 

Background Note: 

[For those not familiar with Paragraph 6 Negotiations (also known as the 30 August Decision)]

 

In November 2001, Trade Ministers in Doha agreed on a special declaration recognizing the right of countries to take measures to protect public health and promote access to medicines. This Declaration came to be known as the Doha Declaration on the TRIPS Agreement and Public Health (available at http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.doc .

 

The Doha Declaration as it is commonly known, confirmed among others the right of developing countries to use compulsory licenses (for purposes of import, manufacture and export of generic medicines without the consent of the patent holder but subject to certain conditions), parallel importation etc. 

 

It was expressly recognized by Paragraph 6 of the Doha Declaration that a solution has to be found about supplying essential medicines to countries with insufficient or no manufacturing capacity.

 

This concern arose largely from the fact that once countries that are major producers and exporters of generic products such as India put in place laws that grant patents on pharmaceutical products, these countries will face legal obstacles to produce and export cheap generic copies of patented medicines. This will be detrimental to the supply of medicines to countries with insufficient or no manufacturing capacity. 

 

India has beginning of this year allowed patents for pharmaceuticals products.

 

Essentially if there a patent on a pharmaceutical product, production for export can only take place under a compulsory license. However the TRIPS Agreement establishes that a compulsory license must be "predominantly for the supply of the domestic market". For more information on the procedures relating to compulsory license please refer to the TWN Manual at http://www.twnside.org.sg/title2/manual.htm 

 

Example:

If a pharmaceutical product is patented in India, it cannot simply manufacture and export.  The Indian government will have to issue a compulsory license to manufacture and the manufacturing must be "predominantly" to supply the Indian domestic market. Only the balance (the non-predominant portion) can be exported. 

 

In recognition of this problem paragraph 6 of the Doha Declaration directed that a solution be found. After months of debates, a temporary agreement to address the problem was finally reached on 30 August 2003 (the Decision). The Decision outlines various procedures that importing and exporting countries have to follow. Many have criticized this Decision as cumbersome and difficult to use. A Statement was also read by the Chair that presided over the meeting that came up with the Decision (Chairman's Statement). The Chairman's statement further requires more cumbersome procedures to be followed. Both the August Decision and the Chairman's statement came about following intense pressure from the multinational pharmaceutical companies in the developed countries particularly the US.

 

The 30 August Decision can be found at - http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm 

 

The Chairman's Statement can be found at - http://www.wto.org/english/news_e/news03_e/trips_stat_28aug03_e.htm 

 

The Africa Group submitted early this year a proposal to make the temporary agreement, permanent by amending the TRIPS Agreement as well as proposed the removal of the many procedures found in the August Decision. The Africa Group does not want to make any reference to the Chairman's statement. Brazil and India have found the Africa Group proposal to be a good basis for discussion on how to amend the TRIPS Agreement. Brazil and India are not happy with the way the consultations on this matter have taken place.

 

The US and European Community (EC) are not in agreement with the Africa Group proposal. They do not want to change any aspect of the August Decision and the Chairman's statement. Of particular concern is to the developed countries is the legal status of the Chairman's statement. 

 

For now (pending a permanent resolution of this matter), countries that wish to import a product that is patented in the manufacturing country (e.g. in India), there may be a need to use the 30 August Decision. To learn about when the 30 August Decision is triggered and the procedures that are required to be complied to produce, export and import generic medicines, please refer to the WHO publication to be found at 

http://www.who.int/medicines/areas/policy/WTO_DOHA_DecisionPara6final.pdf 

 

Further Resources:

For More information on the history and current Paragraph 6 Negotiations please click - http://www.cptech.org/ip/wto/p6/ 

 

Text of the TRIPS Agreement - http://www.wto.org/english/docs_e/legal_e/27-trips.doc 
 

Please do not hesitate to contact us should you wish to have further information.

 


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Impasse on talks on TRIPS and Health "permanent solution"


An impasse became evident on negotiations on the major remaining issue relating to the TRIPS Agreement and Public Health when some key WTO members appeared far apart on a solution, and disagreed even on how the process of consultations is going on, during a meeting of the TRIPS Council on 25 October.



Some developing countries, particularly Brazil and India, complained that they had been left out of consultations taking place between a few countries. They also reiterated their support for the proposal by the African Group as a good basis for negotiations towards a solution.



African countries indicated that they were prepared to engage with others, and quoted a declaration by the African Health Ministers for the need to find a permanent solution that removes all constraints and procedural requirements to the export and import of generic medicines.



The US was adamant that a solution must include the statement of the Chair of the General Council before the adoption of a decision on 30 August 2003. However, India, Brazil and other developing countries did not want a solution in which the Chairman's statement is upgraded to a higher legal status than what it now has.



The issue at hand is the TRIPS Council's search for a "permanent solution" to ensuring access to medicines for countries that have no or inadequate drug manufacturing capacity.



 

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