[Ip-health] News: Express Pharma- Monopolising clinical trial data: implications for generic production

Terri - Louise Beswick Terri at haiweb.org
Mon Sep 6 07:23:50 PDT 2010


Monopolising clinical trial data: implications for generic production

 

In India, much of the debate on TRIPS, intellectual property (IP) and
generic production has focused on patents. Outside the limelight in
bilateral meetings and negotiations the notion of Data Exclusivity (DE)
for pharmaceuticals is quietly been introduced and promoted with Indian
policy makers.

 

DE refers to the granting of exclusive rights to pharma companies over
clinical and preclinical trial data required for registration of
pharmaceuticals. In practice, DE prevents the registration-and hence the
actual sale and use of low cost generics, jeopardising access to
medicines and negatively affecting public health programmes.

 

IFPMA, PhRMA and OPPI have argued that a clause in the TRIPS Agreement
on data protection-namely it's Article 39.3-requires countries to
implement DE. However, careful reading of the article and its
negotiating history do not support this conclusion. Article 39.3
essentially demands that undisclosed registration data about new
chemical entities (NCEs) be protected against unfair commercial use and
against disclosure. Thus, in line with standard drug regulatory
practice, authorities should not publish or share such data-but,
importantly, TRIPS does not prevent use of clinical trial data by drug
regulatory authorities (DRA) themselves to verify the quality, safety,
and efficacy of medicines including generics. Further disclosure is
allowed when it is necessary to protect the public.

 

"The real danger of India implementing a DE regime is that it will end
up granting exclusivity on not only new medicines but also minor
improvements of known medicines, based on submission of any clinical
trial data by multinational pharma companies. This will prevent
registration of generic versions even when a medicine has not been
patented in India, or when patents can be challenged or circumvented by
generic producers"

 

Although DE is not mandated by TRIPS, the European Union (EU), the US,
and a few other developed countries in bilateral trade negotiations are
pressuring developing country governments to adopt a DE regime that will
be implemented by their DRAs.

 

This has implications for India as on the trade front. India is
increasingly turning to bilateral and regional free trade agreements
(FTA). Already, at the instigation of its pharma industry, the European
Union is using these FTA negotiations with India to pursue intellectual
property provisions that goes significantly beyond the TRIPS standards
("TRIPS-plus"). DE therefore figures prominently in these negotiations.

 

The current text of the IP chapter in the EU India FTA as proposed by
the EU essentially requires that India introduce legislation that will
not permit the placing of a generic pharma product on the market if the
originator has submitted any clinical trial data relating to the
medicine to the Indian DRA (Drug Controller General of India).

 

By implication, the DCGI is prohibited from registering a generic
medicine as long as the exclusivity lasts over the trial data (usually
five to 10 years). Domestic producers will have to submit their own
safety and efficacy data to register the generic.

 

This will oblige them to repeat clinical and preclinical
trials-something that takes years and involves costs that the generic
companies usually cannot afford. But more importantly, the repetition of
clinical trials raises serious ethical concerns, since it would require
withholding medicines that are already known to be safe and effective
from some patients (the control group), solely for registering the
generic version. It is unlikely that this would pass the scrutiny of
ethical committees, making it impossible for generic companies to repeat
the clinical trials.

 

In reality, generic manufacturers would have to postpone the launch of
the generic version until the end of the exclusivity period. Thus, DE
can effectively delay generic competition and the ensuing price
reductions.

 

The real danger of India implementing a DE regime is that it will end up
granting exclusivity on not only new medicines but also minor
improvements of known medicines, based on submission of any clinical
trial data by multinational pharma companies. This will prevent
registration of generic versions even when a medicine has not been
patented in India, or when patents can be challenged or circumvented by
generic producers.

 

For example, when a new use or indication is found for an existing
medicine. By submitting, new clinical trial data for the new indication
to the regulatory authority, the originator company could trigger a
period of market exclusivity, despite the fact that the medicine is not
patentable under the Indian patent law.

 

Against the backdrop of disappointing levels of discovery and
development of new drugs and the Indian patent law that does not
encourage the patenting of minor improvements of known medicines, DE
provides a perfect opportunity to multinational drug companies to create
a new patent-like monopoly by blocking generic competition.

 

http://www.expresspharmaonline.com/20100915/management01.shtml




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