E-drug: Threat to drugs deal for poorer countries
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[Distributed as fair use. HH]
BMJ 2002;325:10 (6 July 2002)
"Foot dragging" by the West threatens drugs deal for poorer countries
Fiona Fleck Geneva
Campaigners fighting to give poorer countries facing health crises
access to affordable medicines have accused richer nations of back
pedalling and foot dragging on commitments made at last November�s
ministerial meeting of the World Trade Organisation (WTO) in Doha,
capital of the Gulf state of Qatar.
The United States and the European Union's 15 member states
pledged to ease the WTO's rules on patents, so that drugs such as
antiretrovirals for combatting HIV infection and AIDS could be
produced to meet urgent public health needs in the world�s poorer
countries.
Under the so called Doha Declaration, members of the WTO gave
themselves until the end of the year to come up with a solution.
But campaigners said that proposals made at a meeting of the
organisation's Trade Related Intellectual Property Rights (TRIPS)
council in Geneva last week were "temporary, unduly restricted, and
complex" with little chance of ensuring that people in poor importing
countries had access to more affordable medicines.
"For most people, the response from developed nations was
disappointing," said Cecilie Oh from Third World Network, a Geneva
based, non-governmental organisation, who followed the meeting.
Currently, a country that cannot afford to pay "market" prices for
drugs to treat HIV/AIDS (from manufacturers usually based in Europe
or the United States) does have some comeback under current WTO
rules. It may issue a compulsory licence compelling the patent owner
to license another producer to manufacture generic versions of the
patented product.
The Doha Declaration affirmed that a WTO member may give a
compulsory licence to either a domestic manufacturer or one in
another country to tackle a public health crisis. However, if the drug is
already under patent in that country, licensed production by a
manufacturer in a third country might be infringing that patent.
At the Geneva meeting, the United Kingdom and the European Union
proposed keeping the compulsory licensing system in place but adding
a waiver or moratorium to prevent infringement of patent rules. They
also wanted to find ways to prevent drugs produced under this special
arrangement being diverted to higher income, developed markets.
"This is not a permanent solution because we don't know how long
this moratorium would last," Ms Oh said, adding: "Also, why focus on
diversion of drugs . . . a problem that does not exist?"
Campaigners say the compulsory licence system is bureaucratic,
uncertain, and time consuming because both the importing country
and the company in the drug producing country must apply for the
licence and pay compensation to the patent holder.
"Which company would put itself in a position where it must apply for
a compulsory licence, hope that it gets it, and then have to pay
compensation to the patent holder? Then it's a question of how
much," said Ms Oh, adding: "It's risky. They'll probably think twice."
She said that developing countries proposed dropping the exporting
licence and replacing this with provisions in national legislation in the
producing country to simplify the procedure.
"For most people this seems a logical way to go because you don�t
have double compensation. Why should the patent holder be paid
twice when the drugs are going to be consumed in one country?" she
said.
Campaigners also raised concerns about restrictions on the quantity of
generic drugs that can be produced for export to poorer countries. Ms
Oh said that under existing agreements�for example, in India�such
drugs must be produced "predominantly" for the domestic market.
"It's not clear exactly how much it may produce, and, once we find
out how much, will this be enough for other countries wanting to
export these drugs?" she said.
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