Healthy Skepticism Library item: 1401

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

US Seeks Further Restrictions on Generic Medicines for Developing Countries
MÈdecins Sans FrontiËres (MSF), Oxfam, Health Action International (HAI), Third World Network (TWN) and the Consumer Project on Technology (CPTech) 2003 Aug 25

Full text:

NGOs long involved in the process over “Paragraph 6” ? have acquired new information indicating that the US seeks further restrictions on exports of generic medicines to developing countries. They fear that the recent talks at the WTO TRIPS Council may result in further threats to access to medicines in poor countries.

The NGOs have learnt that, in a small group of five negotiating countries, the US has been seeking further provisions on a deal nearly agreed to in 2002, known as the “December 16” or “Motta text.”

Since 2001, the WTO TRIPS Council has been trying to find a solution to what is known as the Paragraph 6 problem: countries without drug production capacity will not be able to make meaningful use of compulsory licensing because of TRIPS restrictions on exports of generics.

According to Ellen ‘t Hoen, spokesperson for MÈdecins Sans FrontiËres (MSF), “The proposed deal poses so many hurdles and hoops to jump through, that we are really worried it may not work at all. By continually demanding more restrictions, the US seems to be pushing for a watertight system so that no generic drugs ever get through to the patients in developing countries who desperately need them.”

On top of the Motta text, US demands apparently include:

- Restricting the solution to “humanitarian use,” a vague clause that may disqualify normal generic production;

- An “opt-out” clause, that will further hinder the economic viability of the solution;

- Heavier burdens on suppliers to change the packaging of products made under this system; and

- A “review mechanism,” to monitor usage of the system and diversion of generics back into wealthy markets; this is a redundant layer of bureaucracy that can easily be manipulated to pressure countries out of the system.

Taken together, the effects of these provisions would be to discourage countries from using the system at all, and to heavily restrict generic production. The Motta text is already extremely cumbersome and does not provide an economic incentive to export generics. It seems that the US is pushing for additional limitations to the Motta text, which would be included in an accompanying “Chairman’s Text”.

Both the WHO and intellectual property experts have recommended a much simpler, workable, and economically viable solution: allowing generic production for export as a limited exception to a patent right. This is the solution the NGOs also favour.

“We recommend the WTO start with a clean slate,” said Michael Bailey of Oxfam. “WTO Members should take the time to find a real solution. Surely it is more important to get medicines to the most vulnerable populations, than simply to have a deal cut by Cancun.”

Current negotiations are occurring in talks between the TRIPS Council Chair and just five countries: the United States, Brazil, India, South Africa, and Kenya