An appeal of Gandhi: The Patent Bill 2005

[Guest guest]

AIDS ACTIVISTS APPEAL TO SONIA GANDHI TO REVIEW THE PATENT BILL, 2005

Gandhi, Hon’ble Congress Party President

Cc: Manmohan Singh, Hon’ble Prime Minister

Abdul Kalam, Hon’ble President

Anbumani Ramadoss, Hon’ble Minister of Health

Kamal Nath, Hon’ble Minister of Commerce and Industry

Kapil Sibal, Hon’ble Minister of Science Technology and Oceans Development

Fernandes, Hon’ble MP, Chairperson on Parliamentary Forum on HIV/AIDS

Ram Vilas Paswan, Hon’ble Minister of Chemicals and Fertilisers

Date: 20/3/2005

Subject: Amendments to Proposed Patents Bill

Regarding: Implication for Survival of All Those Who Do and Could Benefit

from Affordable Indian Medicines

“My idea of a better world is one in which medical discoveries would be free

from patent and there will be no profiteering from life and death” Indira

Gandhi 6 May, 1981

This weekend in Mumbai, dozens of organizations from India,

Brazil, South Africa, Thailand, Nigeria, Nepal, Venezuela, Namibia,

Zimbabwe, Uganda, Costa Rica, Colombia, Pakistan, Malaysia, Sri Lanka,

U.S.A, France, Australia, U.K and Switzerland, have gathered for a global

south dialogue about the future of affordable and sustainable access to

HIV/AIDS treatment and health services generally. One issue critical to that

future is India’s Patent Bill.

We represent and support people living with and affected by HIV/AIDS from

five continents. We are grassroots and international organizations, human

rights advocates, lawyers, public health experts, and activists. We know

from experience that extending access to HIV/AIDS treatment and preventing

the deaths of millions more people living with HIV/AIDS in the global

south – including the 5.6 million people living with HIV/AIDS in India –

depends on access to a sustainable supply of affordable medicines, which

includes the production and distribution of generic antiretroviral

medicines. India has played a critical role in this regard, and has a legal

and constitutional obligation to protect, respect and guarantee access to

the highest attainable standard of health for its own people. It also has a

moral duty to all those around the world who have benefited from affordable

Indian medicines to continue providing such access, so that people do not

prematurely die without them.

If the Patent (Amendment) Bill, tabled on 18 March, in Parliament is passed

without substantial amendments, India will have failed these obligations.

People that are alive today because of access to affordable drugs and those

that have a hope of getting onto treatment will have been betrayed. The

Common Minimum Program made a commitment to ensure access to affordable

medicines and use all the flexibilities in TRIPS. Moreover, India’s leading

role in fighting the unequal trade regime imposed by the WTO will all be to

no avail if you insist on adopting a patent legislation that is more

restrictive than the WTO requires, thus causing harm to millions more in the

international world.

We are deeply disturbed and concerned that you are failing to listen to the

voices of your people who have entrusted you with their welfare, not to

mention the poor in the developing world who rely on affordable medicine

from India. As a democratically elected party, you have the strictest

obligation to ensure that the Patent Bill is debated thoroughly in a

transparent manner. This can only be done if it is referred to a

Parliamentary Select Committee, so that all of the communities affected can

participate and ensure that their voices are heard and represented. Losing

India’s enlightened leadership would set a bad precedent for other

developing countries who are also seeking to resist the pressure of the

multinational pharmaceutical industry. It will also undermine global

competition in the generics industry, and diminish pressure on generic

companies in other countries to keep prices down.

To prevent the above mentioned catastrophe occurring in India and other

developing countries, several aspects of the Bill require amendment. At a

minimum we implore that you make the following amendments to the Bill as it

stands:

1. Limit the scope of patentability: The Bill proposes to extend the

scope of patentability beyond the TRIPS requirements. TRIPS does not

require India to grant patents on new uses of known drugs, new dosages and

formulations, or combinations of known drugs. Earlier, the Mashelkar

Committee recommended limiting the patent protection only to new chemical

molecules. TRIPS requires no more, and the Bill should not provide for more.

2. Retain the pre-grant opposition: The Bill proposes to remove the

pre-grant opposition procedure. This is a vital right given to the public

to oppose the grant of patents. Currently, approximately 7,000 applications

are pending in the mailbox for the period from 1995-2004, although only 500

drugs were marketed in India during that time. Many of these applications

could be frivolous and legally invalid. Without a pre-grant opposition

procedure, generic companies could be forced to remove existing drugs from

the market, despite the fact that they could challenge these patents later.

All medicines will be affected by this problem, including existing drugs

such as the anti-cancer drugs Gefitiniv, Temozolomide, Zoledronic Acid Vail,

and Letrozole, and the anti-AIDS drugs Duovir, and Tenofovir.

3. Streamline compulsory licensing procedures: The Bill fails to revamp

the compulsory licensing mechanism. This mechanism must be swift and

simple, and provide certainty about timelines, procedures, and royalties, to

overcome abuse by patent holders. Cumbersome procedures will make

compulsory licensing an impractical option, and invite vexatious litigation

and other obstruction by patent monopolists.

4. Facilitate export under compulsory license: The Bill has not properly

incorporated the waiver to Articles 31 (f) and (h) of TRIPS adopted on

August 30, 2003 by the WTO General Council. It imposes an unnecessary

hurdle on many developing countries without their own manufacturing capacity

who might want to buy low-cost drugs from India, by requiring them to issue

a compulsory license whether or not the drug they want to purchase is

patented in their country. This is illogical, unnecessary, and an

imposition on other countries’ ability to respond to domestic public health

needs. It will also prevent Indian companies from exporting to many

countries that are in desperate need of affordable, quality medications.

5. Keep generic drugs on the market: Lastly, the Bill does nothing to

prevent medicines currently being produced in India from being removed from

the market when mailbox patent applications are granted. The Bill must be

amended to ensure immunity for any producers currently making, distributing,

and exporting any medicine that may later come under patent, subject only to

the payment of a reasonable royalty from the date of the grant of the

patent.

The choices that are made regarding the Bill have serious life

and death consequences for millions of Indians and people around the world.

In fact, there have already been protests in several countries against the

Ordinance, to support efforts to ensure affordable and sustainable access to

medicines. Letters from the United Nations, the World Health Organisation,

and Médecins Sans Frontières have also been sent to members of the

Government. If you trade away our rights to life and health today by

accepting ill-considered provisions and/or excessive TRIPS amendments, it

will seriously undermine affordable access to all medicines for all people

and the peoples trust in you.

Sincerely,

One World, One Fight, Brazil

Pan African Treatment Access Movement, Africa

Aids Law Project, South Africa

Aids Law Unit Legal Assistance Centre, Namibia

Treatment Action Campaign, South Africa

Agua Buena Human Rights Association, Costa Rica

GESTOS-Soropositividade, Comunicacao e Genero, Brazil

Marhalem Mansor - Positive Malaysian Treatment Access Advocacy Group,

Malaysia

Act Up-Paris, France

Gay Men’s Health Crisis, U.S.A

Amy Kapczynski, U.S.A

Consumer Project on Technology (CPTech), U.S.A

Ellen ’t Hoen - Médecins sans Frontières, Access to Essential Medicines

Campaign

Thabo Cele - Treatment Action Campaign, South Africa

Open Kumar - Care Foundation, India

Low – PT Foundation, Malaysia

Gaelle Krikorian, France

Lawyers Collective HIV/AIDS Unit, India

Affordable Medicines Treatment Campaign, India

Nava Kiran - Plus, Nepal

German Humberto Rincon Perfetti – Lawyers and Human Rights, Colombia

Lawan Sarovat, Thailand

Thai Network of People Living with HIV/AIDS, Thailand

Médecins sans Frontières – Belgium, Thailand

Dr Prakash C Rao – Peoples Health Movement, India

Solidarity and Action Against the HIV Infection in India, India

Dr Alpana Sagar – Centre of Social Medicine and Community Health, India

Peoples Health Movement (Jan Swasthaya Abhiyan), India

Positive Action for Treatment Access, Nigeria

Dr. Tokugha – YRG Care, India

Delhi Network of Positive People (DNP+)

Andy Quan, Australia

Bhavani Fonseka, Sri Lanka

Ng. Ratan Singh, Manipur Network of Possitive People, India

Sharan Society for Serving Urban Poverty, India

Health Gap (Global Access Project), U.S.A

Megharaj Pokharel – Nepal Environmental Lawyers Association, Nepal

Mr. Bajendra A Shioke – Network of Maharashtra by People Living with HIV &

AIDS (NMP+), India

Grupo Pela Vidda –RJ, Brazil

Ezio T Santos-Filho, Brazil

Zimbabwe Activists on HIV and Aids, Zimbabwe

Pan-African Treatment Access Movement, Africa

Tendayi Kureya – Southern Africa HIV/AIDS Information, Zimbabwe

Group for Rehabilitation, Awareness, Care & Empowerment, India

Essential Inventions, U.S.A

Olayi Mafu, Treatment Action Campaign, South Africa

___________________________________

Lawyers Collective HIV/AIDS Unit

63/2, 1st Floor, Masjid Road

Jangpura

New Delhi 110 014

Phone - 2432 1101, 2432 1102, 2432 2237

Fax - 2432 2236

e-mail - aidslaw1@...