[Ip-health] OSI blog post: India and Europe Trading Away Access to Medicines

Els Torreele etorreele at sorosny.org
Sat Feb 5 10:55:19 PST 2011


India and Europe Trading Away Access to Medicines

Recent news reports
<http://www.indianexpress.com/news/dont-swallow-this-pill/742546/0>  on
negotiations between India and the European Union on a proposed free
trade agreement (FTA) have many health and human rights experts worried
that millions of people may be left without access to life-saving
medicines. Indeed people in low-resource countries are critically
dependent on affordable medicines produced by India, which for that
reason has been dubbed the "pharmacy of the developing world." If, as
reports indicate, EU negotiators succeed in pressuring India to beef up
intellectual property protection at the expense of public access rights
for life-saving drugs, the FTA would seriously undercut India's ability
to produce generic, low-cost drugs, with detrimental effects on access
to medicines for the developing world.

Some will remember the news headlines of ten years ago when people
living with AIDS in South Africa, Brazil, Thailand and other countries
gained the world's attention by protesting against international
pharmaceutical companies. The medicines that could save their lives were
then priced at over US$10,000 per year, and were simply unaffordable.
Many people were dying. 

Backed by global indignation at this injustice, treatment activists
denounced the excessive pricing policies of the large pharmaceutical
companies and demanded solutions. In response, government companies in
Brazil and Thailand, and private companies in India started to produce
generic copies of these medicines, which led to robust competition and a
dramatic drop in prices. In a matter of months, the price of the first
line AIDS drugs dropped by 99 percent - to under US$100 per patient per
year. This price drop was the single most important factor that allowed
the scaling-up of AIDS treatment, to the point where more than five
million people are now on treatment. Ninety-two percent of people living
with HIV in low- and middle-income countries are using generic
antiretrovirals manufactured in India.

Unfortunately, the mechanisms available to us ten years ago for
achieving such a price drop have been under sustained threat. Hidden in
the fine print of bilateral free trade agreements, such as the proposed
EU-India FTA, are clauses that enforce even stronger intellectual
property protections than those required under the World Trade
Organization's TRIPS agreement (which enforces 20-year patents on
pharmaceuticals). India is under great pressure to accept these
co-called "TRIPS-plus" provisions as part of a package of market access,
trade, and investments. While they come in different shapes and forms,
the most critical TRIPS-plus measure on the table in the EU-India trade
deal is called "data exclusivity" -- which essentially is another means,
aside from patents, for blocking off generic competition. With data
exclusivity, generic companies are blocked from using the existing
clinical data on a medicine to register it, regardless of whether a
patent exists or not. 

During a period of data exclusivity (which can be up to 12 years
depending on the negotiation outcome), no generic medicine can be
registered. This is a backdoor to patent protection, and risks
undermining the fine balance between safeguarding access on the one
hand, and stimulating innovation and business on the other. This balance
was deliberately worked out by India's parliamentarians when they
revised their Patent Act in 2005. The FTA would make redundant one of
the core provisions of the Act -- section 3d -- which precludes patents
on minor modifications of existing drugs, which do not add therapeutic
benefit. This provision is intended to avoid "evergreening" of patents
as a strategy to delay generic entry. With data exclusivity, the
extension of the monopoly would be achieved independent of whether a
product deserves patent protection (more on data exclusivity in the
video below).

As European and Indian negotiators continue their talks behind closed
doors, people living with AIDS are mounting public protests - joined by
other access to medicines activists, including many organizations
supported by the Open Society Foundations. Thousands of people have
marched in the streets of New Delhi, Bangkok, Phnom Penh, Jakarta,
Nairobi, Rio de Janeiro, Geneva, and Brussels to focus attention on this
very real threat posed to access to affordable medicines, across the
developing world.

Europe is usually keen to profile itself as concerned about global
health and access to medicines for people living in developing
countries, as evidenced by this European Parliament resolution
TA-2007-0353+0+DOC+XML+V0//EN>  as well as commitments from
commissioners responsible for health and international development.
However, the sad reality is that trade and commercial interests in the
end overrule good intentions -- certainly when it comes down to poor
people's health. 

Let us hope Indian negotiators will draw strength and courage from the
many activists out there who are fighting for their lives (join them on
4687138908841> ) - and withstand the pressures to agree to these
TRIPS-plus provisions. 

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