[Ip-health] BMJ: Poor countries press for extension of exemption from drug patents

Thiru Balasubramaniam thiru at keionline.org
Wed Oct 21 23:59:33 PDT 2015

Poor countries press for extension of exemption from drug patents
BMJ 2015; 351 doi:
http://dx.doi.org/10.1136/bmj.h5605    (Published 20 October 2015)
Cite this as: BMJ 2015;351:h5605

Anne Gulland

Developing countries are still waiting to hear whether they will be granted
a permanent exemption from rules on intellectual property that enables them
to have access to generic drugs.

No agreement was reached after two days of talks at the World Trade
Organization on 15 and 16 October, and the decision on the exemption will
be deferred to next month.

Since the launch of the WTO's Trade-Related Aspects of Intellectual
Property Rights (TRIPS) agreement in 1995, low income countries have been
exempt from intellectual property rules on some items such as drugs. The
exemption, which enables poor countries to export and produce generic drugs
regardless of patent, has been granted on a time limited basis, and the
current waiver is due to expire in January 2016.

The 48 countries classed as the world's least developed have called for the
waiver to be extended as long as the countries still meet this
classification, as defined by the United Nations. The non-governmental aid
organisation Medecins Sans Frontieres has said that this would help
safeguard affordable access to drugs for millions of people in countries
such as Nepal, Bangladesh, Myanmar, Liberia, Haiti, and Lesotho.

MSF said that the ending of the waiver would discourage producers of
generic drugs from investing in developing countries. Rohit Malpani,
director of policy and analysis at MSF's access to medicines campaign,
said, 'It's becoming increasingly hard to convince companies to develop
drugs that are relevant to developing countries or even manufacture and
distribute drugs they are already making to developing countries.

'We spend a lot of time trying to persuade companies to focus on these
markets, and the possibility that intellectual property will come into play
is a big disincentive for them to invest.

He added that the axing of the exemption could mean that “some companies
may decide that these are markets they no longer want to invest in.”

The countries most against the exemption, the United States, Canada, and
Australia, did not publicly signal their intention over it before the
meeting, but Michael Punke, US ambassador to the World Trade Organization,
met ambassadors from 15 of the affected countries, where he said that the
US could not agree to an indefinite exemption, because of pressure from
some US stakeholders.

There is currently a fierce debate in the US about high drug prices,1 which
may be affecting the US position, said Malpani. But he added that the US's
main objection to the rules was 'ideological.'

He said,'It's based on a belief on the importance of having these rules in
place. It's a belief that it doesn't have an impact, when of course it
does. There's also a belief that having these rules will have some benefit
on research and development, but our experience shows that it doesn't.'

The end of the exemption would hamper poor countries' access to generic
versions of drugs such as antiretrovirals to treat HIV and sofosbuvir to
treat hepatitis C. Sofosbuvir can cost as much as $84,000 (£54000; ) for a
12 week course, but a company in Bangladesh has launched its own version
for $900. The United Nations Development Programme said that this price was
still out of the reach of many poor countries but that other manufacturers
may emerge, which would increase competition and lower the price further.

In September the European Commission did a U turn over its longstanding
opposition to a permanent extension of the exemption for low income
countries. Announcing the policy change, Cecilia Malmstrom, commissioner
for trade, said that intellectual property rules should be a 'non-issue'
when the world's poorest people were in need of treatment. The commission
believes that extending the exemption indefinitely would give certainty for
long term supply as well as enhance local production of drugs.

'This exemption will give the least developed countries the necessary legal
certainty to procure or to produce generic medicines,'  she said.

Cite this as: BMJ 2015;351:h5605

thebmj.com Feature: Patent wars ”affordable medicines versus intellectual
property rights (BMJ 2014;348:g1533, doi:10.1136/bmj.g1533)

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