E-DRUG: Data exclusivity and trials data disclosure - collision?
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Dear E-Druggers,
In recent years activists have identified increased attention to the
issue of "data exclusivity" as a way in which generic medicine entry may
be delayed, even beyond the period of patent protection. For example,
TRIPS-plus provisions have been demanded in bilateral "free trade"
negotiations, potentially preventing regulators from relying on efficacy
and safety data submitted to them by innovator companies when
considering generic applications. Recent media coverage of GSK CEO
Jean-Pierre Garnier's statements ahead of Britain's presidency of the G7
has also emphasised this strategy -
* "India has made more progress by introducing a patent regime from the
start of this year. However, Garnier said Western drug companies wanted
more assurances concerning the exclusivity of data generated in
developing new drugs. "If India brings in data exclusivity provisions
and a world class regulatory environment, it has the potential to become
a major centre for pharmaceutical R&D," he said."
(http://in.news.yahoo.com/050204/137/2jeux.html).
* "He conceded that India, which pushed through temporary laws in order
to comply with the WTO treaty by the January 1, 2005, deadline, was
making a step in the right direction. But he cautioned that the real
test would rest with the way in which the legislation is enforced:
"There are thousands of people lodging patents in India and the
authorities have not yet allocated sufficient resources to process all
these filings. This will be a good test - are they going to process
these patents rapidly so that we can enforce them or is there going to
be such a bottleneck that it's going to be meaningless?"
(http://business.timesonline.co.uk/article/0,,8209-1469931,00.html).
Brook Baker recently pointed to the potential impact of US-style data
protection: "Because of data-protection rules in U.S. law, rules that
prohibit the FDA for five years from confirming the safety and efficacy
of bioequivalent generic products by even indirect reference against
marketing-approval dossiers submitted by originator companies, the U.S.
Fast Track process grinds to a halt for the newest medicines like
tenofovir."
However, there has a been a counter-trend, that of greater transparency
regarding clinical trials data. Although still voluntary, there seems to
be an emerging system for placing clinical trials data in the public
domain. My question, therefore, is whether or not such disclosure will
be sufficient to overcome data protection barriers. Will regulators be
able to rely on the fact that manufacturers have themselves revealed
enough of their efficacy and clinical phase safety data to argue that
they can use all available data when considering a generic application?
A minimal TRIPS-compliant interpretation might be based on protecting
company data that took considerable resources to generate from unfair
exploitation. Won't the most expensive data be that placed in the public
domain, if only in summary form?
regards
Andy
Andy Gray MSc(Pharm) FPS
* Senior Lecturer
Dept of Therapeutics and Medicines Management
* Study Pharmacist
Centre for the AIDS Programme of Research
in South Africa (CAPRISA)
Nelson R Mandela School of Medicine
University of KwaZulu-Natal
PBag 7 Congella 4013
South Africa
Tel: +27-31-2604334/4298 Fax: +27-31-2604338
email: graya1@ukzn.ac.za or andy@gray.za.net