# \[e-drug\] US Seeks Further Restrictions on Generic Medicines for

**URL:** <https://talk.edrugplus.org/t/e-drug-us-seeks-further-restrictions-on-generic-medicines-for/17489>\
**Category:** e-drug\
**Created:** [August 26, 2003, 3:52am UTC](https://talk.edrugplus.org/t/e-drug-us-seeks-further-restrictions-on-generic-medicines-for/17489 "2003-08-26T03:52:21Z")\
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**Author:** ![ingrid.cox](https://avatars.discourse-cdn.com/v4/letter/i/ecae2f/32.png) [@ingrid.cox](https://talk.edrugplus.org/u/ingrid.cox)\
**Post date:** [August 26, 2003, 3:52am UTC](https://talk.edrugplus.org/t/e-drug-us-seeks-further-restrictions-on-generic-medicines-for/17489/1 "2003-08-26T03:52:21Z")

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Developing Countries  
Sender: owner-e-drug@usa.healthnet.org  
Precedence: bulk

E-drug: US Seeks Further Restrictions on Generic Medicines for  
Developing Countries  
---------------------------------------------

&nbsp;&nbsp;Press release: 25 August 2003, Geneva

&nbsp;&nbsp;M�decins Sans Fronti�res (MSF), Oxfam, Health Action International  
(HAI), Third World Network (TWN) and the Consumer Project on  
Technology (CPTech)

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."

&nbsp;&nbsp;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 M�decins Sans Fronti�res  
(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.

For further information, please contact:

- Ellen 't Hoen, M�decins Sans Fronti�res, tel. +33 6 223 758 71  
- C�line Charveriat, Oxfam, tel. +41 22 321 2371  
- Spring Gombe, Health Action International (HAI Europe), tel. +31 20 683  
3684  
- C�cilia Oh, Third World Network, tel. +41 76 523 1233  
- James Love, Consumer Project on Technology, tel. +1 202 387 8030

ingrid.cox@geneva.msf.org

Access Essential Drugs Monitor #32 at [http://www.who.int/medicines/mon/mon32.shtml](http://www.who.int/medicines/mon/mon32.shtml)

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