The third amendment to the Indian Patents Act, due to be passed in the winter session of Parliament, threatens to compromise the public's access to essential medicines and, thereby, people's right to health. AMMU JOSEPH explores the implications of the proposed legislation for citizens in the context of the passage of Human Rights Day December 10 which looks at among other things, the right to health and healthcare.
TANNEN MAURY/BLOOMBERG NEWS
Life-saving medicines could become extremely unaffordable.
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relatively low-cost, locally manufactured generic drugs that are currently available to patients here may have to be withdrawn from the market when the patent applications pending for several medicines used in the treatment of these and other ailments are granted, as they are likely to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, especially 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.
For example, the Bill appears to provide a loophole for pharmaceutical companies to keep products patented in perpetuity 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 year that patents should be given only to new chemical molecules or 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 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 Joseph 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.
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