[Ip-health] News: Express Pharma- Fighting for flexbiblity

Marine Avrillon Marine at haieurope.org
Thu Oct 28 03:32:16 PDT 2010

Fighting for flexibility


After farming out manufacturing and clinical research and trials to
lower-cost destinations, pharma MNCs are today confident enough of the
outsourcing model to part with prized intellectual property (IP). GSK
continued on its R&D re-structuring strategy with yet another R&D
spin-off, this time transfering scientists working on experimental
candidates in the analgesics space into a new start-up company. In
exchange for rights to many patents on these leads, GSK took a minority
stake of 18 percent in the new startup company, Convergence


Just as outsourcing was never only about cutting cost but also freeing
up resources to focus on core expertise areas, R&D spin-offs are not
soley about reducing overheads and risks associated with the R&D
process. It is also about speeding up product development and discovery,
by cutting down hierarchies thereby introducing flexibility into the
decision making process. It is also about bringing the zest and
entrepreneurial spirit of a start-up into the drug discovery process.
The MNC has the option to license back successful leads so its a win-win
situation on both sides.


But on other fronts, IP protection measures are becoming more rigid and
insidious. Protests are mounting against the inclusion of IP provisions
in the European Union (EU)-India Free Trade Agreement (FTA) which is in
the final stages of negotiations in Delhi, as we go to press. Globally,
the recently released final draft of the Anti-Counterfeiting Trade
Agreement (ACTA) due to be signed by 40 countries, is also in the spirit
of EU regulations which pose barriers to the free trade in legitimate
medicines. In his post analysing the new ACTA text, Sean Flynn,
Associate Director, Programme on Information Justice and Intellectual
Property (PIJIP), at the Washington College of Law points out that the
definition of 'counterfeit' in ACTA, which countries are encouraged to
use when medicines are seized en route to other destinations, applies
"the law of the country in which the procedures . . . are invoked."
This, as Flynn says, is where ACTA conflicts with TRIPS Article 51 which
requires the use of the law of the importing country, not the in transit


The move to push ACTA through comes on the heels of two disturbing
events. The Indian government has done a U-turn and is set to withdraw
its complaint to the WTO regarding seizures of Indian drug consignments
at EU ports en route to countries in Africa and Latin America. The
second is the trend of decreasing fund allocation for developing world
diseases like AIDS, TB and malaria. The Global Fund to Fight AIDS, TB
and Malaria, which needs $13 billion just to keep existing programmes
running and and extra $7 billion to expand programmes, ended its recent
annual replenishment conference with pledges of just $11.7 billion,
fallling short of the basic funds required to keep the programmes going.
The US, which generally chipped in with one-third of the Fund's
finances, has pledged just $4 billion over three years, which is not
surprising, considering that funding for its own programmes like the
President's Emergency Plan for AIDS Relief (PEPFAR) has not shown an
increase as well. 


NGOs have long since dubbed India as the pharmacy of the developing
world, with more than 80 percent of MSF's AIDS medicines being
bought/sourced from generic producers in India. Any move that reduces
the already wafer-thin margins of these producers might see them
reducing or even shutting down production of these medicines. The
resulting scarcity of AIDS medicines could ironically see the
proliferation of spurious and counterfeit medicines, the very scenario
ACTA professes to guard against. The impact of the ACTA and EU-India FTA
negotiations could thus have tragic consequences unless the Indian
government fights for flexibility within these agreements. 


Viveka Roychowdhury




More information about the Ip-health mailing list