[Ip-health] USTR seeks to influence the position of the Indian Ministry of Health

Mon Apr 7 06:19:01 2008

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*INDIA'S MINISTRY OF HEALTH -- DATA EXCLUSIVITY NOT REQUIRED BY TRIPS &
WILL AFFECT ACCESS TO AFFORDABLE GENERIC MEDICINES *

*USTR seeks to influence the position of the Indian Ministry of Health *

*N*ew Delhi, 7 April '08: Representatives of the United States Trade
Representative (Ms. Tanuja Garde USTR, Washington D.C.) on behalf of
multinational pharmaceutical companies and the US government has already
met with the Indian Ministry of Health. This is to try and influence a
change in the Health Ministry's position that Data Exclusivity is not
required under Article 39.3 of the TRIPs Agreement and an amendment to
the Indian Drugs and Cosmetic Act can have a serious impact on the
approval and availability of affordable, low cost generic versions of
essential drugs.

Another meeting with USTR is slated to happen this month before
representatives of the Ministry leave for Geneva. The Indian Ministry of
Health is one of the key country delegations at the Intergovernmental
Working Group on Public Health, Innovation and Intellectual Property
(IGWG) established by WHO in 2006 and which meets in Geneva at the end
of this month to discuss and negotiate an action plan for research and
development that prioritizes the health needs of developing countries.

Developing countries feel that the draft action plan being negotiated in
Geneva should set out several underlying 'principles' for a global
strategy on health and innovation, among them the notions that the
"right to health" trumps commercial interests, and that intellectual
property rights should not become an obstacle to access low cost generic
medicines. One such specific principle is that Data Exclusivity is not
required under TRIPS and also from the perspective of public health and
access to medicines, it is preferable for developing countries not to
grant data exclusivity.

*India's Ministry of Health does not favour Data Exclusivity:*

As you may be aware the Indian Ministry of health till date has not been
in favour of data exclusivity as it feels that it will interfere with
the work of a government body (the drug regulator) that relies on
clinical trial data to approve of affordable generic essential drugs. It
favours the alternative i.e. 'data protection' or the non - disclosure
of clinical trial data to third parties. This according to the Ministry
of Health will be TRIPS compliant and will allow competition to take
place and thus avoid giving monopoly rights to the innovator drug
companies on the new drugs (not patented) and thus help keep a check on
their prices.

*However this can change if USTR is successful in influencing the
Ministry of Health to implement TRIPS PLUS provisions: *

In the past, USTR has on behalf of multinational pharmaceutical
companies successfully pressurised many developing countries to
implement Data Exclusivity, even though it is not required by the TRIPS
Agreement and can seriously affect access to low cost essential
medicines by delaying generic competition even in cases where the
medicines are not patent protected.

*WHO Report does not recommend Data Exclusivity:*

This position of the Ministry of Health is supported by the report of
the World Health Organization's Commission on Intellectual Property
Rights, Innovation and Public Health, which[1]
<mailbox:///D%7C/Thunderbird/Mail/Local%20Folders/Sent?number=105268806#_ftn1>,
states this very clearly:

Article 39.3, unlike the case of patents, does not require the provision
of specific forms of rights. [...] It does not create property rights,
nor a right to prevent others from relying on the data for the marketing
approval of the same product by a third party, or from using the data
except when unfair (dishonest) commercial practices are involved.[2]
<mailbox:///D%7C/Thunderbird/Mail/Local%20Folders/Sent?number=105268806#_ftn2>

*Data Exclusivity will further limit India's role in supplying essential
drugs to developing countries: *

In the last decade generic production in India has emerged as crucial
for the supply of quality affordable medicines to the developing world,
especially for newer drugs such as antiretrovirals (ARVs) for the
treatment of HIV.

Already in 2005, the Indian Parliament under obligation to implement
WTO's Agreement on Trade Related Aspects of Intellectual Property Rights
(TRIPS) amended its Patents Act to allow for the granting of
pharmaceutical product patents -- something India had not done since
1970. Patents being granted by the Indian Patent Office for
essential/life saving drugs, include newer antiretrovirals (such as
Etravirine) which could prove to be crucial in the treatment of AIDS.
This is already causing concern about the future of millions of people
living with HIV/AIDS dependent for treatment on affordable generic drugs
from India.

In addition to patents, data exclusivity will effectively prevent
marketing approval of essential drugs for several years even if patents
applications on these are rejected, for example when a pharmaceutical
does not meet the standards for patentability (e.g. because it is not new).

*Data Exclusivity* i.e. a certain length of time during which the
Regulatory Authority is prohibited from relying on the available
clinical trial data in order to register a generic version of the same
product.

As Indian generic manufacturers are directly involved in making
available affordable drugs in India and other developing countries,
patients and treatment advocacy groups are considerably concerned that a
delay in registration i.e. marketing approval of generic drugs can
seriously impact the lives of people living with HIV/AIDS who face the
threat of drug resistance every four years and are therefore dependent
on generic manufacture in India to access newer drugs and treatment at
affordable prices.

They also remain highly susceptible to other infections; for instance
HIV and TB co-infection is of increasing concern for persons living with
HIV/AIDS. Access to affordable essential drugs for opportunistic
infections is also critical in ensuring long, healthy and productive
lives for persons living with HIV/AIDS.

Experience shows Data Exclusivity in other countries has effectively
created a market barrier that is difficult for generic manufacturers to
overcome.

*Public Interest Groups oppose Data Exclusivity: *

In the last few years, several public interest groups including the
Indian Network for Persons living with HIV/AIDS (INP+), the Medico
Friends Circle, the Jan Swasthya Abhiyan (Peoples Health Movement), the
Global AIDS Alliance, Torchbearers (mental illness advocacy group),
MSF's Campaign for Access to Essential Medicines, the Bangalore HIV &
AIDS Forum and the Lawyers Collective HIV/AIDS Unit have also written to
the Prime Minister and the health ministry outlining their opposition to
Data Exclusivity for drugs as it can have a serious impact on the
approval and availability of generic versions of essential drugs in the
future.

*For more information contact:*

Leena Menghaney
Campaign for Access to Essential Medicines (MSF)
New Delhi, India
Tel: + 91 9811365412
Email: leena.menghaney@gmail.com

Gopa Kumar
Centre for Trade and Development
Email: gopa.kumar@centad.org
<http://us.f325.mail.yahoo.com/ym/Compose?To=gopa.kumar@centad.org>

------------------------------------------------------------------------

[1]
<mailbox:///D%7C/Thunderbird/Mail/Local%20Folders/Sent?number=105268806#_ftnref1>
The report is available at
http://www.who.int/intellectualproperty/documents/thereport/en/index.html

[2]
<mailbox:///D%7C/Thunderbird/Mail/Local%20Folders/Sent?number=105268806#_ftnref2>
Ibid. p.143.