Date: 4 February 2011
Source: Open Society Foundation
Link: http://www.indianexpress.com/news/dont-swallow-this-pill/742546/0
Recent news reports 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
<http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P6-
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.
Keywords: FTA / Free Trade Agreement / HIV /
AIDS / World Trade Orgnization
|