[Ip-health] Frontline: Cleaning up after Mashelkar - Praful Bidwai

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COLUMN

Cleaning up after Mashelkar
PRAFUL BIDWAI

      A JPC to look into the patents law and a strong initiative to promote=
 innovation in pharmaceuticals through the non-patent route are needed.




FORMER Director-General of Council of Scientific and Industrial Research R.=
A. Mashelkar has brought disgrace upon India's scientific establishment by =
producing a tawdry, poorly argued, unbalanced and pro-big business report o=
n India's patents law, at the core of which lies rank plagiarism. Mashelkar=
 has withdrawn the discredited report of the "Technical Expert Group on Pat=
ent Law Issues", which he headed. He says he did this to uphold "scientific=
 ethics". But he continues to say: "I stand by the report and its findings,=
 100 per cent... ."

He claims that there was no "plagiarism" and that "it would be wrong to att=
ach motives" to the fact that a critical part of his committee's report was=
 bodily lifted from a previously published paper. He minimises and triviali=
ses this thoroughly deplorable and indefensible practice as consisting of m=
ere "technical inaccuracies" or a "copying error by the sub-committee" that=
 wrote the draft.

It is disingenuous to argue that only "eight to ten lines" were extracted v=
erbatim from the paper in question (by Shamnad Basheer), which was commissi=
oned and published by the United Kingdom-based pro-pharmaceutical industry =
Intellectual Property Institute. The paper's commissioning clearly points t=
o a conflict of interest.

What is crucial is that the plagiarised portion forms the heart of the Mash=
elkar Committee's recommendation that India should not limit the "granting =
of patents for pharmaceutical substances to new chemical entities only" as =
that would be incompatible with India's obligations under the TRIPS (Trade-=
Related Intellectual Property Rights) Agreement of the World Trade Organisa=
tion (WTO). The recommendation is backed by very little analysis. It cites =
Basheer, who wrote the paper as a doctoral student, as an authority.

Yet, Mashelkar has the gall to offer to "re-examine" the old report and "re=
submit" it.

This is not the only instance of plagiarism that Mashelkar stands accused o=
f. In 2004, he co-authored with Shahid Alikhan a book entitled Intellectual=
 Property and Competitive Strategies in the 21st Century (Kluwer Law Intern=
ational, 2004). The bulk of its section on traditional resource rights is l=
ifted from a paper by Graham Dutfield carried in the Bulletin of the Workin=
g Group of Traditional Resource Rights (TRR) Spring 1996, No. 2 (The Times =
of India, February 28). There are as many as five paragraphs in the Mashelk=
ar-Alikhan book that merely paraphrase, or repeat verbatim, sentences from =
Dutfield's paper, without attribution or acknowledgment.

This is not the place to discuss Mashelkar or any of the other members of h=
is committee, at least two of whom (Govardhan Mehta and N.R. Madhava Menon)=
 are distinguished and highly regarded individuals. What is material here i=
s not just the ethics of plagiarism but the policy bias of the Expert Group=
 towards Big Pharma and its view that "incremental innovation", and not jus=
t new chemical molecules/entities, should be patentable.

This is a prescription for "evergreening", or the virtually limitless paten=
ting of minor or marginal modifications to drugs in order to retain a monop=
oly over producing them for indefinite periods. As the "Glivec/Gleevec" cas=
e by Novartis now being heard by the Madras High Court demonstrates, this c=
an mean a 1,200 per cent difference in the price of medicines for leukaemia=
 and effective denial of patient access to cheaper drugs.

Big Pharma vigorously promotes and justifies "evergreening" because it is t=
he surest guarantee of monopoly-based superprofits. But "evergreening" is d=
emonstrably harmful to the goal of promoting public access to essential dru=
gs at reasonable or affordable prices.

Mashelkar has often unambiguously expressed his pro-industry bias by rootin=
g for monopolistic patents and by urging Indian scientists to file patent a=
pplications "before publishing their research". Mashelkar is all praise for=
 a highly questionable legislation being drafted by the Science and Technol=
ogy Ministry, which is modelled on the lines of the controversial Bayh-Dole=
 Act passed in the United States in 1980, which lifted a long-standing ban =
on the patenting of federally funded research and facilitated an unhealthy =
nexus between universities, laboratories and corporate interests.

The issue of granting stiff intellectual property rights (IPR) protection s=
uch as patents for innovation in pharmaceuticals is deeply fraught. As this=
 Column has argued earlier, the very concept of "intellectual property" is =
problematic: all individual innovations are based and built on the past ach=
ievements of others and the common pool of human knowledge. It is even hard=
er to argue that innovations in respect of health-related products should b=
e privileged for pecuniary reward. The ethics of granting patents for medic=
ines is extremely dubious given the life-and-death issues involved.

Philosophically, it makes little sense to "reward" any innovation through a=
 negative right - in reality, a monopolistic privilege to produce a particu=
lar product (or rather, to prevent others from making it). There are other,=
 perfectly viable, forms of recognising and appreciating innovation - for i=
nstance, through peer-group acknowledgement. In any case, most patents are =
held not by individual innovators but by corporations.

India capitulated to Western pressure to negotiate TRIPS in the Uruguay Rou=
nd and then found itself left with no choice but to sign the agreement in 1=
994 and allow the patenting of pharmaceutical products - as distinct from p=
atenting the processes of making them, which is what the Patents Act, 1970,=
 did.

But this was seen and acknowledged as a compromise driven by compulsions - =
not the ideal state of affairs as India would like them to be, nor one to b=
e desired. Thus, India amended its Patents Act in 2005 only under explicit =
pressure from the WTO, which demanded that a mere notification in respect o=
f product patenting would not be enough.

Policy drift


However, the Mashelkar Committee report and the new Bill on "rewarding" sci=
entists all point to a major shift in thinking among some of our policymake=
rs. Product patenting - and in general, a stiff, highly monopolistic IPR re=
gime strongly biased in industry's favour - is now seen as acceptable, desi=
rable and worthy in and of itself.

This is a dangerous sign. It also tells us that policy on important issues =
such as IPR in respect of medicines or computer software cannot be left in =
the hands of "eminent" scientists and "experts", many of whom have fallen p=
rey to corporate ways of looking at the world - in which private greed beco=
mes the motive force of innovation, growth and development.

We need to take remedial measures - urgently and without hesitation. To sta=
rt with, the Mashelkar Committee has completely lost its credibility. It wo=
uld be pointless to replace it with yet another "expert" committee. As the =
unhappy experience with the Knowledge Commission shows, what we need is les=
s technical expertise and more political clarity and a vision rooted in the=
 public interest.

It would be best to set up a Joint Parliamentary Committee (JPC), which can=
 summon experts whenever necessary but which will be guided by the spirit o=
f the debate on the patents issue in Parliament in April 2005. The JPC shou=
ld subject experts' views to the scrutiny of the public interest.

We need to do much more. There is no reason why we should not explore the l=
imits of TRIPS to the fullest extent (including its public interest-related=
 Articles 7 and 8) and do whatever is possible within its framework, as ela=
borated by the Doha Declaration on Public Health.

Equally, we must draw a clear line of distinction between the interests of =
the pharmaceuticals industry, including its wholly indigenous sector, and t=
he larger social good. The two were closely related (yet conceptually separ=
ate) during the TRIPS debate but have become increasingly divergent. Many I=
ndian drug manufacturers support patents for incremental innovations but wi=
th a raised bar.

Three Initiatives


At least three important initiatives are in order (the last two of which I =
am indebted to my scientist friend Satyajit Rath of the National Institute =
of Immunology). First, we must make the granting of patents an adversarial =
process. Put simply, this means that as in criminal law, which treats an ac=
cused as innocent unless proved guilty beyond reasonable doubt, access to k=
nowledge or innovation must be treated as unrestricted unless proved patent=
able on the strict criteria of novelty, original invention, utility, indust=
rial application, and so on.

A patent applicant would have to submit extensive data to back his/her clai=
m and allow it to be scrutinised in an adversarial fashion (akin to cross-e=
xamination in a criminal trial). This will hopefully limit the number of pa=
tents and toughen the criteria for granting them so that the larger public =
interest of establishing access to affordable medicines prevails over paroc=
hial considerations of profit.

Equally important in such an amended law would be an emphasis on compulsory=
 licensing, or the grant of a licence to a non-patent holder to manufacture=
 a product considered essential in the larger national interest or in a med=
ical emergency (a situation that is near-perennial in Indian society where =
half the population lacks access to modern medicines).

Second, we must use public instruments to establish access to essential med=
icines and to make them affordable. We have a number of pharmaceuticals pub=
lic sector undertakings (PSUs) that, despite official neglect, lack of supp=
ort for innovations, and the depredations of the private sector, possess a =
fair amount of research and development (R&D) capability, good-quality spec=
ial materials such as yeasts for fermentation, and a proven capacity to mak=
e low-cost products.

The PSUs must be revitalised. They deserve strong R&D support. They should =
be mandated to produce "social good"-related drugs for national health prog=
rammes in large quantities. The government should procure drugs directly fr=
om them rather than buy them from the open market.

In any compulsory licensing regime, PSUs will have a special, probably irre=
placeable, role. Many Indian private manufacturers might hesitate to work w=
ith compulsory licences for fear of an adverse reaction from the original p=
atent-holder. PSUs would have fewer constraints.

Third, we must set up a programme to encourage non-patent-based innovation =
in every sphere. For instance, we must participate in and encourage open so=
urce initiatives like Bios (Biological Innovation for Open Society, www.bio=
s.net) , which create a domain of non-patentable but "protected commons". B=
ios supports innovation in ways that overcome inequities and benefit the di=
sadvantaged and marginalised.

Equally important is a policy declaration by the government that the fruits=
 of publicly funded research cannot be and will not be patented. Instead, t=
hey would be placed in protected commons and made accessible to all institu=
tions and companies that agree not to patent them even though they may use =
them to generate profits.

No less significant, we must institute "patent-busting" - just the way many=
 multinational corporations do. This is a perfectly legal operation to brea=
k into the patent "thicket" or "hedge" that companies build around a single=
 innovation so that it can be shielded and its patent monopoly preserved. T=
his is perfectly compatible with TRIPS, indeed even with restrictive patent=
s laws in Western Europe and the U.S. It must be put to full use.

This is the only way India can still fulfil the worthy objective of medicin=
es and health for all while remaining TRIPS-compatible and yet not caving i=
n to market fundamentalism.
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