[Ip-health] Pharmabiz- EU's latest moves on counterfeit drugs cause fresh concerns to Indian pharma

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EU's latest moves on counterfeit drugs cause fresh concerns to Indian
pharma

Thursday, October 15, 2009 08:00 IST
Joseph Alexander, New Delhi

The recent moves by the developed countries, especially the European
Union, on the counterfeit medicines issue have caused fresh worries
among the Indian generic exporters, prompting them to take recourse with
the authorities for renewed efforts including international intervention
along with other developing countries.

While the European Commission is proposing a new directive against
counterfeit medicines, the Council of Europe has prepared a convention
on counterfeiting of medical products and similar crimes involving
threats to the public health. Both the moves have caused ample worries
for the Indian industries as they feel that it was in the same line of
the IMPACT attempt in the WHO some time back.

The industry associations back home have called upon the government to
take up the matter and at all possible levels to protect the interest of
the domestic industry. "We have urged the government to take it up at
political, diplomatic and bureaucratic levels to drive the point and
ensure the availability of quality medicines at affordable price by
developing countries," according to SME Pharma Industries Confederation
vice-chairman Lalit Jain.

According to the draft convention being finalized by the Council of
Europe this week, the manufacturing of counterfeit medicine has to be
sanctioned. According to Article 6, 'Each party shall take the necessary
legislative and other measures to establish as offences under its
domestic law when committed intentionally, the supplying or the offering
to supply including brokering, the trafficking, including keeping in
stock, import and export of counterfeit medical products, active
substances, excipients, parts, materials and accessories'. And a
counterfeit medical product is defined as 'a product with a false
representation of its identity and/or source'.

However, the Indian industry has slammed it as another tactic to assault
the generic industry. "These are moves to promote IMPACT type
legislation and EU is already doing this through their falsified
medicines directive. Then what will be given to developing countries is
legislation similar to that of EU i.e. on falsified medicines. This new
EU -Directive has coined term falsified medical products instead of
counterfeit, which developing countries have opposed successfully in
WHO," Jain said in a letter sent to the Pharma secretary listing the
harmful clauses in the proposed legislations by the European countries.

At its second and final meeting on September 1 to 4, 2009, an ad hoc
committee on counterfeiting of medical products and similar crimes has
agreed on a draft text of the Convention. This text has been transmitted
to the European Committee on Crime Problems (CDPC) for finalisation at
the Committee's plenary meeting being held this week, it is learnt.



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