[Ip-health] Indian PLHA network appeals to the Prime Minister against Data exclusivity

Fri Jun 30 14:10:47 2006

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Dear Moderator,

Kindly post the  Indian PLHA network's appeals to the Prime Minister agains=
t Data exclusivity.

Leena Menghaney
Project Manager-India
Campaign for Access to Essential Medicines
Medecins Sans Frontieres - Holland (in India)
Tel: +91 11 24337225, + 91 1151552413
Fax:  +91 11 24336834
E-mail: msfh-india-medco-assist@field.amsterdam.msf.org

****************

Dr. Manmohan Singh                                                         =
      June 28, 2006
Hon'ble Prime Minister of India

The Prime Minister's Office
South Block, Raisina Hill,
New Delhi,
India-110 011.
Telephone: 91-11-23012312
Fax: 91-11-23019545 / 91-11-23016857

New Delhi

Dear Prime Minister,

I write to you on behalf of the Indian Network for People Living with HIV/A=
IDS (INP+). INP+ is a national network for, by and of people living with HI=
V/AIDS (PLHA) in India. We started in 1997 as a support group, and have now=
 grown into a national movement of 22 affiliated State Level Networks, 106 =
District Level Networks and more than 32,000 members across the country.

In the past few years' availability of affordable generic medicines manufac=
tured in India has changed the nature of HIV/AIDS in India and around the w=
orld - from a life threatening disease to a manageable chronic disease. How=
ever whether we have a life threatening disease or a chronic one is depende=
nt on one major factor - the continued availability of affordable generic a=
ntiretroviral medicines.

For a combination of three essential antiretroviral drugs from $ 10,439 per=
 patient per year, prices have fallen to $ 150 per patient per year in a ma=
tter of four years (2001 - 2005) because of generic production and competit=
ion from India.  The impact of price reduction on the availability of essen=
tial AIDS medicines is evident - the government of India is currently treat=
ing 20, 000 PLHAs and hopes to upscale to 100, 000 PLHAs in the coming year=
.

With the 2005 Patents (amendment) Act, which provides for granting patents =
on pharmaceuticals INP+ is being forced to take up prolonged and complicate=
d legal battles to prevent the patenting of antiretrovirals used in the tre=
atment of AIDS. Many of these applications are related to claims that are n=
ot related to 'new chemical entities' but are derivatives (salts, polymorph=
s) of older (pre-1995) drugs.

We have now come to know through media reports that the government is consi=
dering an amendment to the Drugs and Cosmetic Act. This move is apparently =
related to the Government of India's commitments under the TRIPS agreement;=
 specifically Article 39.3 of TRIPS. The clinical trial data that originato=
r companies submit to Regulatory Authorities (anywhere in the world) are at=
 the centre of the debate on Article 39.3.

Based on the briefing note published by the World Health Organisation, ther=
e are two legal options before the government of India:

a)     Data protection i.e. i.e. non - disclosure of clinical trial data to=
 third parties. This according to WHO will be TRIPS compliant and at the sa=
me time will not interfere with the work of a government body (the drug reg=
ulator) if he/she relies on clinical trial data to approve of affordable ge=
neric essential drugs.

b)      Data Exclusivity i.e. a certain length of time during which the Reg=
ulatory Authority is prohibited from relying on the available clinical tria=
l data in order to register a generic version of the same product.

However data exclusivity could prevent the registration of generic versions=
 of medicines even when there is no patent on a medicine, for example when =
a pharmaceutical does not meet the standards for patentability (e.g. becaus=
e it is not new).

A delay in registration i.e. marketing approval can seriously impact the li=
ves of people living with HIV/AIDS who face the threat of drug resistance e=
very four years and are therefore dependent on generic manufacture in India=
 to access newer drugs and treatment at affordable prices. We also remain h=
ighly susceptible to other infections; for instance as you may be aware HIV=
 and TB co-infection is of increasing concern for persons living with HIV/A=
IDS. Access to affordable essential drugs for opportunistic infections is a=
lso critical in ensuring long, healthy and productive lives for persons liv=
ing with HIV/AIDS.

The UPA in its Common Minimum Programme, had assured us that the government=
 will "take all steps to ensure availability of life saving drugs at afford=
able prices". More recently we have been heartened by the Government of Ind=
ia's commitment to ensuring access to healthcare for all as evidenced by it=
s role at the UNGASS review meeting in May 2006. The Indian delegation in t=
he face of stiff resistance succeeded in getting global political commitmen=
t reaffirming that TRIPS "can and should be interpreted and implemented in =
a manner supportive of the right to protect public health and, in particula=
r, to promote access to medicines for all including production of generic a=
ntiretroviral drugs and other essential drugs for AIDS- related infections.=
"

An inter-ministerial task force will meet on July 12, 06 to decide on the t=
wo
options - data protection or data exclusivity. We therefore strongly urge y=
ou to take into consideration public health needs of patients in India and =
other developing countries when implementing Article 39.3 of the TRIPS Agre=
ement. We request you to ensure that generic competition remains viable and=
 possible in India. So many of us are depending on it for access to afforda=
ble medicines worldwide. For us it is a matter of life and death.

Sincerely,

K.K. Abraham

President

Indian Network for People Living with HIV/AIDS

Tel: 09840066386

Flat No: 6, Kash Towers,
#93, South West Boag Road,
T. Nagar, Chennai -17

Cc.

Sri Ramvilas PaswanHon'ble Minister of Chemicals and FertilizersShastri Bha=
wan, Dr. Rajendra Prasad RoadNew Delhi 110 001Tel: 23386519, Fax: 23384020 =
Dr Anbumani RamadossHon'ble Minster of Health and Family WelfareNirman Bhav=
an, Maulana Azad RoadNew Delhi 110011Tel: 23061751, Fax: 23062358 Sri Kamal=
 NathHon'ble Minster of Commerce & IndustryRoom No. 45, Udyog BhavanNew Del=
hiTel: 23061008, Fax: 23012947 Mrs. Sonia GandhiPresidentIndian National Co=
ngress Party & Member of Parliament10, Janpath
New Delhi 110 001Tel: 23014161, 23012656

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