HIV generics at risk from patenting rules
Tighter intellectual property rights rules are making production of
generics medicine for HIV more difficult thus depriving many poor people
access to life-saving drugs.
PlusNews
Most of the estimated 5.2 million people worldwide on antiretroviral
(ARV) treatment are taking generic versions manufactured primarily in
India, but tighter global intellectual property rights and trade rules
could shut down ‘the pharmacy of the developing world’.
Symbol of HIV/AIDS |
While the patents on many older, first-line ARVs have expired,
leaving generic manufacturers free to produce them, newer, less toxic
and more effective drugs are patented and priced out of reach of less
developed nations.
The main way generics manufacturers can produce newer drugs is to
obtain a ‘voluntary licence’ from the patent holder. This usually sets
quality requirements and defines the markets in which the licensee can
sell the product.
For example, pharmaceutical giant Gilead has allowed the South
African firm, Aspen Pharmacare, to manufacture and distribute branded
and generic versions of tenofovir, one of the newer first-line ARV
drugs.
However, civil society activists say voluntary licences skew the
balance of power too far in favour of patent-holders. “This is a way to
control generic competition by creating dependency on the innovator
companies,” from the HIV/AIDS unit of India’s Lawyers Collective
Manmohan Amonkar, said at the recent International AIDS Conference in
Vienna.
The US and the European Union have been accused of pressuring
countries to implement stricter intellectual property regulations.
Special 301
“The United States is using trade threats to coerce countries into
adopting intellectual property laws that will increase the cost of
medicines,” Director of US advocacy at the NGO, Health Global Access
Project (GAP) Matthew Kavanagh, told IRIN/PlusNews.
“By jeopardizing generics, especially those from India, they are
effectively putting millions of lives at risk.”
‘Special 301’, an annual review process led by the Office of the US
Trade Representative, has placed several countries, including India, on
a ‘priority watch list’ for failure to properly enforce intellectual
property rights. According to Kavanagh, this is “a warning of imminent
trade sanctions” against a country, which could affect its exports to
the US.
Health GAP recently joined several other NGOs in putting an official
complaint on the use of Special 301 to the UN Special Rapporteur on the
Right to Health, stating that it is “in violation of the international
right to health”.
The HIV virus |
TRIPS-plus
The Trade-Related aspects of Intellectual Property (TRIPS) laid out
by the World Trade Organization contain minimum standards of protection
for pharmaceutical intellectual property, but also accommodate
developing countries.
For example, it gives countries the right, under specific situations
such as public health emergencies, to issue compulsory licences – an
authorization given by a government to a third party to produce a
patented invention without the permission of the patent-holder.
Through Free Trade Agreements (FTAs) and Economic Partnership
Agreements, the US and European Union (EU) may circumvent the TRIPS
agreement by making provisions that, for instance, limit the
circumstances under which compulsory licences may be issued or extend
the life of patents beyond 20 years - a practice known as TRIPS-plus.
Of particular concern are negotiations around a ‘Broad-based Trade
and Investment Agreement’ between India and the EU, due to be completed
by December 2010. Activists fear such an agreement may impose
TRIPS-plus-type conditions on India’s manufacture and export of generic
medicines.
“Shifting away from generic competition would put the power of
price-fixing back into the hands of ‘big pharma’ and make ARVs
unaffordable again,” project coordinator for Médecins Sans Frontières in
the South African township of Khayelitsha Matthew Kavanagh said.
Efforts to reduce the impact of TRIPS-plus have mainly involved
negotiating with big pharmaceutical companies, many of which are
prepared to make special provisions allowing for generic versions of
their drugs to be produced in poor countries.
Patent pool
A new patent pool, in which it is hoped patent holders will place
their patents for use by generic companies in exchange for royalties, is
expected to help lower the prices for life-saving medicines. UNITAID,
the funding mechanism that runs the patent pool, has already negotiated
a two-thirds cut in the price of paediatric ARV formulations.
“If we manage to get this (patent pool) off the ground, we will be
able to solve many, many problems,” UNITAID’s senior adviser for
intellectual property and medicines patent pool Ellen ‘t Hoen, said in
Vienna.
However, she warned that it meant financing for HIV had to remain
strong, as even the lowest-cost drugs needed an assured market. While
the pool remains empty for the moment, she said UNITAID had held talks
with several drug developers, including the US’s National Institutes for
Health, Tibotec, Gilead and Merck, all of whom had shown ‘considerable
interest’.
“Access to treatment is a fundamental human right; this puts the
obligation on all of us to do all we can to make sure that it happens
right here, right now,” she said.
Third World Network Features |