[Ip-health] Centad letter to Indian Government to disengage from IMPACT process

[Kajal Bhardwaj]

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[ Picked text/plain from multipart/alternative ]

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Below is the text of the letter sent by the Center for Trade and Developmen=
t (Centad), Delhi to the Indian Government regarding IMPACT.
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New Delhi
Dated: 13-01-2009
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Secretary,
Ministry of Health and Family Welfare
Government of India=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=
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Sub: Request for urgent discontinuance from engaging in WHO-IMPACT process =
by rejecting WHO document EB/124/14 along with the appended draft resolutio=
n.
Sir,
The undersigned represent a not-for-profit research and advocacy think-tank=
 based in New Delhi, actively engaged in Trade and Public Health research w=
ith an access to medicines approach. We understand that the World Health Or=
ganisation secretariat has called for a meeting of the Executive Board to d=
iscuss the counterfeit medical products issue and to endorse a resolution b=
ased on report of the secretariat (EB124/14). The report outlines the defin=
ition of =93counterfeit=94 in the context of drug regulation to serve as a =
model text for national legislations. It has been brought to our notice tha=
t the working definition agreed by the International Medical Products Anti-=
Counterfeit Taskforce (IMPACT) at its third General Meeting (December 2008)=
 has many ambiguities.
The word =93counterfeit=94 used in the definition has specific connotation =
in the context of Intellectual Property Rights i.e. the trademark law. The =
present definition to be adopted can conflate issues of intellectual proper=
ty rights enforcement with that of drug safety and regulation. There are se=
rious concerns presented by the use of drug regulatory forum as an IPR enfo=
rcement forum. The consequences that flow from the IMPACT counterfeit defin=
ition may have serious legal and economic implications and could undermine =
flexibilities prevailing in current international IPR agreements. Hence the=
 ministry must evaluate all options by consulting industry and legal expert=
s before endorsing the IMPACT definition.
Moreover, there are grave concerns presented by conflict of interests in th=
e constitution and process of IMPACT. Many pharmaceutical industry organiza=
tions based in developed countries have actively participated in formulatin=
g the definition. They also engage in various others forums in promoting an=
 extremely stringent intellectual property enforcement agenda to circumvent=
 fair competition in generic trade in pharmaceuticals in and from developin=
g countries. We are of the opinion that endorsing IMPACT initiative may not=
 be in line with Ministry=92s much appreciated efforts to promote generic d=
rugs and further the access to medicines agenda.
The concern regarding falsifying medicinal products is limited to the issue=
 of spurious and sub-standard drugs. We therefore request your good office =
to instruct the Indian delegation to oppose the report (EB124/14) and the a=
ppended draft resolution along with process ab-initio.
Alternatively, concerned about the real issues that affect safety and effic=
acy of medicines and to further the agenda for containing spurious and sub-=
standard drugs, the WHO secretariat should be requested to start the proces=
s afresh by adopting a legitimate member country driven agenda.
Yours truly,
Santhosh M. R. =A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=
=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0 =A0=A0=A0=A0=A0Yogesh Pai=A0=A0=A0=
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=A0=A0=A0=A0=A0=A0=A0=A0=A0 Abhilash Gopinath
(Associate Fellow)=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0=A0 =A0=
=A0 =A0=A0=A0=A0=A0=A0=A0=A0 =A0(Associate Fellow)=A0=A0=A0=A0=A0=A0=A0=A0=
=A0=A0=A0=A0=A0=A0=A0=A0 =A0 =A0=A0=A0=A0=A0=A0=A0=A0(Research Consultant)
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CENTRE FOR TRADE AND DEVELOPMENT (CENTAD)