E-DRUG: Joint statement Indian NGOs and MSF on passage of Indian patent law
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The Affordable Medicines and Treatment Campaign
Medecins Sans Frontieres (MSF)
Lawyers Collective HIV/AIDS Unit
Alternative Law Forum
Delhi, India, 22nd March 2005, 8:45 p.m.
THE BEGINNING OF THE END OF GENERICS
Delhi, India, 22 March 2005 b Under a new Bill approved today, India will
start granting product patents for medicines - something they have not done
since 1970 - without the necessary procedures in place to safeguard against
increases in medicine prices. India amended its 1970 Patent Act in order to
be compliant with the requirements of the World Trade Organization (WTO).
A key safeguard to assuring availability of affordable medicines is the
procedure of compulsory licensing b the government grants patents, but
allows generic companies to make their versions of the patented medicines
against a payment of a royalty to the patent holder. However, in the Bill
that passed the Lower House (Lok Sabha) today, procedures are still
extremely complex and there is no control on levels of royalties to be
paid, which will lead to endless litigation and delays.
The new Bill "grandfathers" products that are already on the market by
allowing for the automatic right to produce. The generic companies in such
cases will pay royalties to be set by the government to the patent holder.
International norms for royalties are in the range of 3-4%. This new law,
however, does not set a fixed royalty rate. In South Africa,
GlaxoSmithKline attempted to charge 40% royalty until activists and the
courts intervened.
The worst-case scenario for people living with life-threatening diseases
has been averted, but only in the short-term.
People who rely on low-cost medicines will have to wait three years before
a generic company can even make an application for the right to produce a
drug. Whereas people in wealthy countries will have access to new medicines
immediately when they are proved safe and effective, people in poor
countries will have to wait years.
In addition, with this Bill, the government has crippled the critical right
of the public to oppose patent applications on medicines, through so-called
"pre-grant opposition." It is has been rendered ineffective because the
essential information on which to base the opposition will be withheld from
the public.
The Bill will go before the Upper House (Rajya Sabha) for a final vote. It
is expected that the Upper House will approve the Bill in its current form.
---
Rachel M. Cohen
U.S. Director, Campaign for Access to Essential Medicines
Doctors Without Borders/MC)decins Sans FrontiC(res (MSF)
333 Seventh Avenue, 2nd Floor * New York, NY * 10001-5004 * USA
Tel: +1-212-655-3762
Mobile: +1-917-331-9077
Fax: +1-212-679-7016
E-mail: rachel.cohen@newyork.msf.org
http://www.doctorswithoutborders.org/
http://www.accessmed-msf.org/