[e-drug] Letter from 6 Latin American and Indian generics associations on paragraph 6

[James Love <james.love@cptech.org>]

E-drug: Letter from 6 Latin American and Indian generics associations on
  paragraph 6
---------------------------------------------

The following letter to WTO delegates was signed by six
developing country generic manufacturers associations

26 November 2002

Letter to WTO TRIPS Council on negotiations on Paragraph 6
of the Doha Declaration on TRIPS and Public Health

Dear Delegates:

We represent pharmaceutical manufacturers from the competitive 
sector, and are asking that trade negotiators agree upon a "solution" 
to paragraph 6 of the Doha Declaration on TRIPS that is consistent 
with the Amendment
196 to the EU Directive on Medicines Act that was recently approved 
by the European Parliament.  As noted by many public health groups, 
Amendment 196 would allow every country to deal effectively with 
abuses of patent rights for any health care product.  The text of 
Amendment 196 is as
follows:

        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 country.

Under this approach, any WTO member country would have the widest set 
of choices in finding suppliers in those cases where an abuse of 
patent rights is contrary to the public interest.

We note also that the World Health Organization, the UK Commission on 
Intellectual Property Rights, the Belgium Parliament and the French 
President have all supported an approach to the export issue that 
consistent with the European Parliament position set out in Amendment 
196.  We note also that the sale of medicines is regulated by 
governments in every significant pharmaceutical market, providing the 
patent owners with unique opportunities to safeguard their interests 
in the markets where the product are used by patients.

The European Parliament approach would have the decisions regarding 
the need to authorize non-voluntary use of a patent in the country 
where the medicines are used, which is appropriate.  Moreover, the 
European Parliament approach would rightfully have the compensation 
for patent owners be determined in the countries where the medicines 
are consumed.  This is the most rational way to ensure that 
compensation is related to the patient ability to pay, a fundamental 
principle also in various "differential pricing" schemes.

The positions advanced by the DG-Trade and USTR seek to undermine the 
value of the Doha Declaration on Health, first by creating the 
impression that each paragraph of the Declaration is limited in scope 
by Paragraph 1, secondly by creating a set of irrational and 
protectionist limitations on trade between countries of different 
incomes, and finally by imposing burdensome procedural requirements 
and safeguards on importing and exporting countries.

There is of course no evidence that compulsory licensing has been 
over-used by any country, and in those cases where governments 
determine the public interest is served by issuance of a compulsory 
license, they should have the practical ability to do so, not 
undermined by a deliberate and discriminatory regime of inefficiency 
that is masked as a free trade instrument.

Nor is there evidence that generic products have been inappropriately 
diverted to countries where patents are in place.

As the recent problems with Anthrax medications illustrated, both 
rich and poor countries may find themselves in need of supplies of 
imported generic products, for a wide range of illnesses.  The 
increasingly aggressive pricing of products such as Ceredase 
(alglucerase) and Glivec (imatinib) further
illustrate the importance of preserving effective public health 
safeguards for all national governments.

Sincerely,

Ruben Abete, General Secretary- ALIFAR
Latin American Association of Pharmaceutical Industries
(ALIFAR)

Maria Angelica Sanchez
Asociaci�n de Industriales de Laboratorios Farmac�uticos
(Asilfa)

Ho-Chi Vega
Industria Farmac�utica Dominicana, Rep�blica Dominicana
(INFADOMI)

Manuel Guillermo Yzaga Salazar
Asociacion de Industrias Farmaceuticas de Origen y Capital
Nacional  (ADIFAM)

D G Shah ,Secretary General
Indian Pharmaceutical Alliance

N.H. Israni, President
Indian Drug Manufacturers' Association

[Information supplied by James Love
James Love <james.love@cptech.org> BS]
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