Letter to NHRC on Patent Amendment Bill

[Guest guest]

Please find a letter to the National Human Rights Commission ( India) on patent

amenmdment bill.

11th October

To

Justice A S Anand

The Chairperson

National Human Rights Commission ( NHRC)

Sardar Patel Bhavan, Sansad Marg

New Delhi 110001

Sub: (Third Amendment to Patents Act 2004)

Dear Justice Anand

I am writing this letter on behalf of Affordable Medicines and Treatment

Campaign (AMTC). The AMTC is a national campaign aimed at creating an

environment that will ensure sustained accessibility and affordability of

medicines and treatment for every individual in India, including access to

affordable Anti-Retroviral Therapy for persons living with HIV/AIDS. It consists

of civil society organisations, NGOs, patients groups, healthcare providers and

concerned individuals. The campaign was initiated in 2001 with the following

mission statement:

The right to life and health is a fundamental right guaranteed to every person

living in India and is non-negotiable. This campaign aims to demand and create

an environment that will ensure sustained accessibility and affordability of

medicines and treatment for every individual in India, including access to

affordable Anti-Retroviral Therapy for persons living with HIV/AIDS. This

campaign shall be democratic and participatory. It will seek the mobilization of

communities and civil society to make state, national and international agencies

and industry accountable for securing health for all.

AMTC attempts to encourage action on a wide spectrum of issues relating to the

right to treatment. These include WTO negotiations relating to the TRIPS

agreement (TRIPS), the impending amendment to Patents Act 1970, law and

regulation of drug pricing, national and state level governmental policies

relating to health including vertical disease programmes, health needs of the

population, transparency and accountability in the pharmaceutical sector,

treatment literacy and health care infrastructure etc.

As you are aware the Government of India has initiated to amend the Patents Act

1970 to introduce product patent protection to drug, medicine or food. A Patent

Amendment Bill (Bill) was introduced to this effect in the 13th Lok Sabha in

December 2003. The Bill lapsed due to the dissolution of Lok Sabha. In the last

week of August 2004 the Cabinet has decided to refer the Bill to a Group of

Ministers (GOM) to study the implications of contentious issues in the Bill. The

GOM consists of Minister of Defense, Minister of Health, Minister of Human

Resources Development and Minister of Commerce and Industry. We have learned

from news reports that provisions of the referred Bill are identical to the

lapsed Bill. This is a matter of concern because the Bill in its present form

seriously compromises the accessibility and availability of medicines, two

important components of right to health.

Introduction of product patent protection for medicines and agro-chemicals is

part of India's obligation under (TRIPS). TRIPS obligates member countries to

provide a universal minimum standard of protection for various types

intellectual property rights viz. trade mark, copyrights, geographical

indications, patents, industrial designs, plant varieties, topography of

integrated circuits and trade secrets. India has amended the Patents Act in 1999

and 2002 to comply with the obligations of TRIPS. The only pending obligation

with regard to TRIPS is the introduction of product patents to medicines and

agro-chemicals. India is to carry out this obligation by, before 1st January

2005.

As you know, the Patents Act 1970 does not provide product patent protection for

medicines and food. The Patents Act 1970 was enacted to scrap the Patents Act

1911, which provided product patent protection for medicines and food. The

Patents Act 1970 provides only process patent protection to medicines and food.

Process patent does not prevent others from making the product per se but

prevents others from using the patented process as well as using, offering for

sale, selling or importing the product obtained from the patented process. On

the other hand, product patent prohibits others from making, using, offering for

sale, selling or importing the patented product. As a result the product patent

gives a monopoly to the patent owner for the production of patented article

during the term of the patent (20 years). Therefore product patent protection

for medicines and agro-chemicals creates monopoly and eliminates competition in

the pharmaceutical market. Drug companies often abuse the patent monopoly and

fix exorbitant prices for the patented medicines. The introduction of product

patent thus reduces accessibility and affordability of drugs.

The impact of product patent on the accessibility and availability of drugs are

well documented. The most striking incident is the impact of product patent on

access to HIV/AIDS drugs. Till 2000, antiretroviral (ARV) drugs were not

accessible to the vast majority of people living with HIV/AIDS (PLHA) all over

the world because of the high price. Multinational drug companies priced ARV

drugs between US$12-13,000 annually per person. The price started falling in

2000 when manufacturers from India introduced generic versions of ARV drugs. Now

these generic drugs are given as low as US$ 140 annually per person to certain

international organisations like the Clinton Foundation. This is possible

because of the absence of a product patent regime in India. Further, the absence

of product patent protection has also facilitated the introduction of fixed dose

combination (FDC) of ARV drugs. A three-in-one cocktail pill introduced by the

generic manufacturers substituted two pills for six pills per day. Thus the FDCs

increased the accessibility as well as availability of ARV drugs. The

introduction of FDCs became possible only because of the absence of product

patent protection in India. The introduction of a product patent regime would

prevent generic companies in India from repeating this miracle.

The impact of monopoly on access to medicines is already felt in India. The

Controller of Patents has granted an Exclusive Marketing Right (EMR) to Novartis

AG, for the drug called Gleevec used for the treatment of patients suffering

from Chronic Myeloid Leukaemia (CML), a life threatening form of cancer. EMR is

granted as a transitional arrangement before providing product patent

protection. Gleevec is sold by Novartis AG at Rs. 1,20,000 per month.. The

generic version of the drug was otherwise available to CML patients at Rs

9,000-12,000 per month. The EMR, if enforced will result in the withdrawal of

generic version of Gleevec from the market. Consequently, the overwhelming

majority of patients that suffer from CML every year in India will be denied

access to this life saving drug. Both the industry and the civil society have

approached the Supreme Court of India to challenge the decision of granting EMR

on Gleevec.

Thus it shows that introduction of product patent in India will reduce the

accessibility and availability of medicines. Therefore, we feel that utmost care

is required to introduce the product patent regime. Certain flexibility

available under the TRIPS should be used to its full extent to safeguard

accessibility and availability of drugs and medicines. The Bill however, fails

to make use of this flexibility at its optimum level. Main criticisms against

the bill are as follows.

a.. Firstly, the Bill proposes to extend the scope of patentability beyond the

TRIPS requirements by amending Section 3 (d) to allow patent protection for new

use of known drugs. Patent for new use would help pharmaceutical companies to

extend the monopoly over the drug even after the expiry of original patent.

There is no obligation under TRIPS to provide patent protection to new use of

known drugs. Earlier, the Mashelkar Committee recommended to limit the patent

protection only to new chemical molecules.

a.. Secondly, the Bill proposes to do away with the pre-grant opposition

procedure. Currently, there are approximately 6,000 applications pending in the

mailbox. In the absence of pre-grant opposition, these 6,000 applications would

escape much needed public scrutiny. Public scrutiny is crucial in light of the

fact that less than 500 drugs have been granted marketing approvals in India

between 1995-2004.

a.. Thirdly, the Bill has not properly incorporated the " August 30th Decision " ,

which permits the grant of compulsory licence for export purposes. The Bill

proposes to permit compulsory licensing for export purpose if there is a

compulsory license in the importing country having no or insufficient

manufacturing capacity in the pharmaceutical sector. This ignores the fact that

Least Developing Countries (LDCs) need not provide product patent till 2016. In

the absence of patent protection, issuance of compulsory license is impossible.

In that event, the Indian drug companies would not be able to export to LDCs.

a.. Lastly, the Bill fails to revamp the compulsory licensing mechanism. Even

though the Chapter on compulsory licenses in the Patents Act 1970 states the

need for protecting the public interest, the same spirit is not reflected in the

substantial provisions. Cumbersome procedures without any time line for the

final disposal of application makes the compulsory license mechanism an

impractical option to curb abuse of patent monopoly.

India as a party to the International Covenant on Economic Social and Cultural

Rights (ICESCR) has an international obligation to protect peoples' right to

health. According to Article 12 of ICESCR " The States Parties to the present

Covenant recognize the right of everyone to the enjoyment of the highest

attainable standard of physical and mental health " . As you know, accessibility

to and availability of drugs are recognized as important components of right to

health. The introduction of product patent in the current form will further

reduce the access to drugs. The Supreme Court of India recognized the

enforceability of right to health within the scope of Article 21 of the Indian

Constitution ( Panikurlangara v Union of India 1987 (2) SCC 165).

Further, Article 15(1)( of the ICESCR recognises " right of everyone to enjoy

the benefits of scientific progress and its applications " . The Supreme Court

often interpreted fundamental rights in consonance with international treaties.

Hence, the implementation of product patent should not result in the denial of

rights guaranteed under the Constitution of India and the ICESCR. According to

Section 2 (d) & (f) of Protection of Human Rights Act, 1993 rights under the

ICESCR are the rights that the National Human Rights Commission (NHRC) has to

protect.

We therefore request your urgent intervention to safeguard peoples' right to

health guaranteed under the Constitution of India and ICESCR by using the

mandate under Section 12 (d), (f) and (j) of the Protection of Human Rights Act,

1993. In the context, we request NHRC.

a.. To seek information from the Government of India regarding the steps which

are already taken or under consideration to safeguard the right to health under

the product patent regime.

a.. To study and recommend to the Government of India on the steps to be taken

to ensure the enjoyment of benefits of scientific progress and its application,

an obligation under Article 15(1) ( of ICESCR.

a.. To study and recommend to the Government of India on the options available

within the TRIPS Agreement to safeguard right to health.

a.. To hold a national level consultation with concerned individuals and groups

on the implications of intellectual property rights on peoples' right to health.

With warm regards

For AMTC

Anand Grover

Project Director,Lawyers collective HIV/AIDS Unit

E-mail: <aidslaw@...>

CC

1.. Justice Y. Bhaskar Rao , Member, NHRC

2.. Mr. R.S. Kalha, Member, NHRC

3.. Mr. P.C.Sharma, Member, NHRC

4.. Mr. Tarlochan Singh, Member, NHRC