[Ip-health] Financial TImes: Concern over drugs to dominate WTO

[Thiru Balasubramaniam]

October 24, 2005 Monday
London Edition


HEADLINE:  Concern over drugs to dominate WTO

BYLINE: By KATHRIN HILLE and ANDREW JACK

DATELINE: LONDON and TAIPEI



Growing international concern over the cost and availability of antiviral
drugs to treat bird flu is likely to overshadow a World Trade Organisation
meeting tomorrow.

African countries and non-governmental organisations are calling for easier
guidelines by which patents for pharmaceutical products can be overturned,
allowing them to import medicine more cheaply from generic drug manufacturers.

The move comes as Roche, the Swiss pharmaceutical group that controls the
manufacture of Tamiflu, the leading antiviral drug for flu, has given growing
indications that it may issue licences to some leading generic drugs companies
to speed up production.

Representatives at tomorrow's trade-related aspects of intellectual property
(Trips) council meeting in Geneva will discuss an August 2003 agreement that set
the rules by which countries can override drug patents.

The US and a number of European countries have led efforts to restrict use of
the agreement, by both voluntarily opting out of the right to import such drugs
themselves and by lobbying developing countries that have threatened to do so.

However, European Commission concern over inadequate EU stockpiles and
pressure from US politicians to push Roche into talks with generic manufacturers
have highlighted tensions.

African health ministers meeting in Gabarone this month called for the "full
use" of the current options to produce generic medicines and the removal of
existing constraints in negotiating "a more appropriate permanent solution" for
the import and export of generics.

Responding in part to international concern about the high costs and limited
short-term availability of Tamiflu as fear grows about a potential flu pandemic,
the WTO last week released guidelines stressing that countries were entitled to
issue "compulsory licences" allowing generic manufacturers to override patents.

To save time in cases of emergency, this action could be taken even without
attempting to agree a voluntary licence with the patent holder, it said. Patent
holders would then be paid a fee.

However, Ellen 't Hoen from Medecins sans Frontie`res said the August 2003
agreement had never been used, and was all but unworkable because of political
pressure, bureaucratic hurdles and the opt-out of developed countries that
limited the incentive for generic companies to produce drugs.

Roche is shortly to meet the generics companies Teva, Barr, Mylan and
Ranbaxy. It said on Friday it acknowledged "some ... might be in a position to
realistically produce substantial amounts of (Tamiflu) . . . in accordance with
appropriate quality specifications, safety and regulatory guidelines". It would
not disclose the financial terms on which any such agreement would be concluded.

Meanwhile, Taiwan at the weekend reiterated its demand for negotiations with
Roche over licences for Tamiflu production. Additional reporting by Kathrin
Hille in Taipei {i)www.ft.com/birdflu