[Ip-health] The Hindu: Dilip Shah of IPA on Mashelkar Report

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http://www.hinduonnet.com/thehindu/thscrip/print.pl?file=3D2007030802721100=
.htm&date=3D2007/03/08/&prd=3Dth&

Dilip G. Shah, Secretary-General of the Indian Pharmaceutical Alliance who =
has had 40 years of experience in the pharmaceutical industry, answers ques=
tions on what type of pharmaceutical products should be eligible for patent=
s in India; innovation in the Indian industry; and issues raised by the Mas=
helkar report, which has been withdrawn on account of `technical inaccuraci=
es and plagiarism.' Excerpts from the interview conducted in Mumbai:


                                            How do we define new chemical e=
ntity?


New Chemical Entity is not defined either in TRIPS or in Indian law, not ev=
en in United States patent law. Only the U.S. Food and Drug Association has=
 defined NCE. Nowhere else is there a definition. This makes it clear that =
each country has the freedom to define in its own law what it considers to =
be a new chemical entity. This FDA definition is a good definition, which v=
ery clearly says that for any new inventive drugs you can submit a patent a=
nd any derivatives [small changes in form, usage] are not eligible.


The Mashelkar report concludes that India cannot limit patents to NCEs beca=
use that would contravene Article 27 of the TRIPS agreement. What is IPA's =
view?


The technical expert group has taken an interpretation of Article 27 withou=
t examining its nuances or considering practices followed by other WTO memb=
ers such as Canada, or even taking note of the judgment of the WTO dispute =
settlement panel and appellate body [India-Patent Protection for Pharmaceut=
icals and Agricultural Chemical Products AB-1997-5, WT/DS50/AB/R, December =
19, 1997]. Extensive volumes have been written on interpretations of Articl=
e 27, 7, and 8 and the Doha Declaration on public health.


 Two commissions have also examined this. First, the United Kingdom Commiss=
ion on Intellectual Property Rights (CIPR). Dr. Mashelkar was a member. Sec=
ondly, the WHO set up a commission on the same subject. Dr. Mashelkar was a=
 member of this also. The commissions came to the same conclusion: defining=
 patentability is a flexibility provided in the TRIPS agreement.


 The absence of international patent law has led some countries to seek har=
monisation in terminology of patent law at WIPO [World Intellectual Propert=
y Organisation] since the conclusion of TRIPS. Had TRIPS provided uniform p=
atentability, there should be no need for the United States, European Union=
, and Japan to demand harmonisation.


 Instead of examining the technical and legal issues of Article 27 and maki=
ng use of available evidence, the Mashelkar group developed another set of =
criteria, which is purely political. This committee wasn't set up for that.


What were these criteria?


First, the report says they [the technical experts] want access to affordab=
le medicines. But all it says is that every effort must be made to provide =
drugs at affordable prices to the people of India. But on how and who will =
make the drugs, there is nothing. You don't need an expert group to make th=
is statement. This is a political statement.


Secondly, the report implies that not limiting patents to NCEs would encour=
age innovation by Indian industry. But in this you encourage only tweaking =
of molecules [manufacturing derivatives] instead of real innovation.


 Thirdly, the report claims that Indian industry is capable of only increme=
ntal innovation. And as evidence for that, the Mashelkar group cites in Ann=
exure IV of the report, 215 (not 339 as it would appear at first glance) pa=
tent applications for incremental innovations. But why are Indian companies=
 doing this? If the U.S. permits incremental innovation and I am going to s=
ell my product in the U.S., I will go by U.S. rules. So I will file applica=
tions for the U.S. market for incremental innovation. Concluding from this =
that incremental innovation is the only capability of the Indian industry i=
s not true. It's not true for the simple reason that companies do not want =
to make any claims today on where they stand on the development of a new mo=
lecule. They treat it as a trade secret. But we have enough evidence that t=
he Indian industry has the capability for original research. Between 1998 a=
nd 2004 there were 60 molecules in the pipeline. Only if you ignore this da=
ta will you
 come to the conclusion that we can only do tweaking of molecules! And by u=
sing that argument you will only perpetuate tweaking of molecules. If you b=
lock that route, you push companies to go for high-end research.


Fourthly, Dr. Mashelkar says he wants to balance India's obligations under =
international agreements with the wider public interest. But he is a scient=
ist =97 that is not his term of reference. He was asked merely to say wheth=
er this was TRIPS-compliant or not. Balancing obligations is a political de=
cision.


What is your take on the fact that the Mashelkar group's conclusions are "b=
orrowed without acknowledgement" from a paper funded by an association of m=
ultinationals?


That is not the issue. The issue is intellectual honesty. If Dr. Mashelkar =
did not agree with what was written in the WHO report or the U.K. CIPR repo=
rt, which stated that "developing countries should not be deprived of the f=
lexibility of defining their own patent systems," then why did he not recor=
d his dissent? Whether he quotes Shamnad Basheer or Frederick Abbot, that i=
s not the issue.


What action should the government take?


Since Dr. Mashelkar has withdrawn the report on his own, we have to see wha=
t new evidence and analysis he produces. This will create a credibility gap=
. How is he going to substantiate any changes? Anything that he writes in t=
he second report will be compared with the first. He gave explanations to j=
ournalists when they asked him why submissions like Frederick Abbott's were=
 not included; he said that only documents with the secretariat were used. =
But all these documents were available with the secretariat. We submitted s=
ome of them. If evidence was available with him earlier, why did he not exa=
mine that, analyse it and put it in the report? He has created a very diffi=
cult situation for himself and other members of the committee. The Governme=
nt should not let him withdraw this report. Leave it and close this chapter=
.


Do you think a new committee should be put together?


At this moment I think we need to give the present intellectual property ri=
ghts regime a chance to work. Let it be implemented and we can take at leas=
t five years to assess, one its impact on public health, specifically the a=
vailability and prices of medicines; two whether patented medicines are bro=
ught into this country by the innovators; three, the impact on domestic ind=
ustry and its ability to export; and four, what sort of R&D is taking place=
 and whether Indian industry has moved to high-end research or not. Then ev=
aluate which direction to take. Until that time there is no need to keep de=
stabilising or creating uncertainty on the IPR regime.


 This will not be acceptable to multinationals. So the government has to ma=
ke a clear statement that we in India are taking a calibrated approach to I=
PR.



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