Patently unfair: Patent (Amendment) Bill, 2004

[Guest guest]

Patently unfair

New year resolutions may have to include " I will stay healthy, " backed up with

crossed fingers and touched wood, if the Patent (Amendment) Bill, 2004 becomes

law in its current form. According to public interest groups working on health

issues, the prices of drugs required for the treatment of many common diseases

could shoot up if the Government goes ahead with pushing the Bill through

Parliament during the winter session or even, as some reports suggest, issuing

an ordinance that will render the amendment a reality without the inconvenience

of a legislative debate, let alone a public one.

Unlike most year-end resolutions, which generally depend on individual will,

good health clearly cannot be guaranteed through personal endeavour. Among those

likely to be affected by the proposed amendment are the large numbers of people

suffering from a wide range of illnesses - including life-threatening and

chronic conditions-such as diabetes, asthma, hypertension, coronary heart

disease, schizophrenia, depression, cancer, HIV/AIDS, arthritis, spondylitis,

and respiratory and urinary tract infections. This is because the relatively

low-cost, locally manufactured generic drugs that are currently available to

patients here may have to be withdrawn from the market when the patent

applications pending for several medicines used in the treatment of these and

other ailments are granted, as they are likely to be, under the proposed

legislation.

Health advocates suggest that it is time citizens became aware of the sword of

Damocles hanging over their heads and got involved in protecting the public's

right to health and healthcare, which is critically dependent upon access to

affordable medicines. It is significant that the October 2004 report of the

Fourth People's Commission on Review of Legislations Amending Patents Act 1970,

chaired by former Prime Minister I.K. Gujral, with a number of eminent persons

as members, reflects the concerns of health activists.

Obligation under TRIPS

The controversial third amendment to the Indian Patents Act, 1970 relates to

India's obligations under the global agreement on Trade Related Aspects of

Intellectual Property Rights (TRIPS), adopted in 1994 as one of a package of

agreements that member states of the World Trade Organisation (WTO) must adhere

to. Under the agreement, developing countries like India have to introduce

patent protection for pharmaceutical and agro-chemical products by January 1,

2005.

The Indian patent law has already been amended twice-in 1999 and 2002 - to

comply with TRIPS. Thanks to earlier amendments, the term of patent protection

has been extended from seven to 20 years, and Exclusive Marketing Rights (EMR)

are available for drugs and agro-chemicals, allowing manufacturers a monopoly

over products even before their patent applications are approved.

The primary purpose of the present Bill is to introduce product patents, as

required by TRIPS. At present Indian law provides patent protection for

processes - not products - in the pharmaceutical and food sectors. Since a

process patent gives the owner exclusive right only over the manufacturing

process, anyone can make and sell a particular product as long as they use a

different process to produce it. On the other hand, a product patent prevents

others from manufacturing, selling, distributing or importing the patented

product-even versions produced through different processes - without

authorisation.

The process patent regime that has prevailed so far, and the competition that it

has allowed, has kept the prices of medicines in the country amongst the lowest

in the world (even though certain recent developments in drug policy have

already driven the cost of several drugs up to unprecedented levels). With the

introduction of a product patent regime, patent owners will be able to

monopolise the market for 20 years and, in the absence of competition, get away

with exorbitant prices that could put many essential medicines out of the reach

of the majority of Indians.

Likely impact of monopolies

The case of a drug used in the treatment of patients suffering from Chronic

Myeloid Leukaemia (CML) illustrates the likely impact of monopolies in the

pharmaceutical sector. The generic version of the drug, produced in India, costs

Rs.9,000 to Rs.12,000 per month. The government has now granted EMR to Novartis

AG for their version of the drug, Gleevec. If it is enforced, generic versions

of the drug will have to be withdrawn from the market, forcing most Indians

suffering from CML to do without the life-saving medicine because Gleevec is

priced at an astronomical Rs.1,20,000 per month. Their fate now hangs in the

balance, with both the pharmaceutical industry and civil society groups having

challenged the grant of EMR for this product before the Supreme Court.

Health activists allege that the Bill in its present form does not use the

limited flexibility available within TRIPS, expecially in the context of the

2001 Doha Declaration on Public Health. Despite several ambiguities and

deficiencies, the latter does state that the agreement should be interpreted and

implemented in the light of WTO member countries' right to protect public health

and promote access to medicines for all.

A loophole

For example, the Bill appears to provide a loophole for pharmaceutical companies

to keep products patented in perpetutity by proposing grant of patents for

existing drugs for which a " new use " has been found - even though there is no

obligation under TRIPS to issue patents for different uses and/or dosages of

known medicines. Even the official committee that looked into the regulation of

the pharmaceutical sector, headed by Dr. R.A. Mashelkar, had recommended just

last y ear that patents should be given only to new chemical molecules or

entities, so as to limit the number of entities, so as to limit the number of

patent protected drugs. Health activists believe that this provision will extend

patent protection to medicines even after the 20 year period, for less than

valid reasons.

This provision also nullifies the common assertion that product patents will not

push the cost of medicines up because most drugs used for common ailments are

already in the generic category. This argument is misleading because new and

better drugs required for the effective treatment of many illnesses are

constantly being produced and patented. At present, locally manufactured

versions of many new drugs are available in the country for a fraction of their

cost in most other parts of the world. The situation is expected to change once

product patents come into force.

Take the example of " atypical anti-psychotic " drugs, used in the treatment of

schizophrenia, a common and life-long mental illness. There is currently little

price difference between old and new drugs in this category here, and the prices

of locally produced brands are far lower than those of multinational companies.

As a result even public hospitals such as the National Institute for Mental

Health and Neurosciences (NIMHANS) in Bangalore are increasingly prescribing the

latter, which have fewer side-effects and ensure better quality of life. If the

patent application pending for one of these drugs - Olanzapine - is successful,

cheaper local versions of it will no longer be available to patients here. No

doubt more drugs in this category - and others - will soon follow suit.

The implications

The financial implications of sharp increases in the cost of medicines are

particularly serious in the Indian context. In the absence of an effective

public health system and universal - let alone public - health insurance,

patients here, and their families, typically shoulder the entire burden of

medical expenses, including purchase of drugs.

Another worrying aspect of the Bill is that it apparently proposes to do away

with the " pre-grant opposition procedure, " an important mechanism that enables

civil society to block frivolous patents. According to health activists, with

nearly 5,000 patent applications for pharmaceutical products currently pending

in the mailbox (a majority filed by foreign corporations and individuals),

public scrutiny is essential to ensure that only necessary, useful drugs are

granted patents.

The Bill's provisions relating to compulsory licenses - an important mechanism

within TRIPS that allows countries to get around patent monopolies under

certain, specified circumstances - are also being opposed by health activists,

who believe that a complete revamp of the compulsory license system is called

for in the interest of public health. The significance of compulsory license

becomes clear in the context of treatment for people living with HIV/AIDS

(PLHA).

As recently as four years ago, millions of PLHA across the world, and in India,

could not afford the cost of treatment with antiretroviral (ARV) drugs, known to

prolong the lives of HIV+ people. At that time prices ranged between US$ 10,000

and 12,000 (approximately Rs.4,50,000 to Rs.5,40,000) per person per annum.

Prices began falling when Indian manufacturers introduced generic versions of

ARV drugs until, by 2003, the annual cost per person had come down to US$ 140

(about Rs.6,300)

Such a dramatic decrease was possible because of India's process patent regime,

which is about to pass into history. The introduction of a product patent regime

will make compulsory licenses all the more important for the promotion of public

health. Yet the Bill reportedly does little to strengthen this mechanism and

ensure that it can be used at least to the extent envisaged in the Doha

Declaration.

Health activists point to a number of legal documents, both international and

national, including the International Covenant on Economic Social and Cultural

Rights and India's Protection of Human Rights Act, 1993 to argue that the

country must not trade away its right, and duty, to protect and promote public

health. A number of other landmark documents relating to health, including

international ones such as the 1978 Alma Ata Declaration and the 2000 People's

Charter for Health, as well as domestic ones like the 1946 report of the Health

Survey and Development Committee headed by Sir ph Bhore and the 1983

National Health Policy recognise the provision of essential drugs at affordable

costs as a key ingredient of a humane and just health policy.

Speaking at the World Health Assembly in Geneva in 1981, Indira Gandhi said, " My

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

of patents and there would be no profiteering from life or death. " It would be

ironical if, by passing this Bill in its present form, those who claim to

represent her legacy foist a very different world on the people of this country.

Source: The Hindu, December 12, 2004.

Forwarded by :

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

A. SANKAR

Executive Director

EMPOWER

E-mail: <ttn_empower@...>