AFRO-NETS> MSF on Sydney WTO meeting

[Beverley Snell <bev@burnet.edu.au>]

MSF on Sydney WTO meeting
-------------------------

crossposted from e-drug

[This is important: WTO has not managed to solve the export problem 
for generics to countries that do not (yet) have the capacity to 
manufacture essential drugs locally. Wilbert Bannenberg]

Press release (briefing document below):

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.

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