The Lok Raj Sangathan (LRS), Centre for Enquiry into Health and allied Themes (CEHAT) and the Indian Medical Association, Mumbai Branch, had jointly organized a seminar on “The Impact of the New Patent Law on People’s Health”, in Mumbai on Sunday, 3rd July 2005.

Dr. Gopal Dabde from Dharwad, Dr. Wishvas Rane from Pune and Dr. Arun Bal from Mumbai, all eminent doctors who have made ‘health for all’ their passion, were the invited speakers. Advocate Narendra Zaveri, who is an expert on Patent Law presented the draft of a petition to the parliament for the consideration of the eminent doctors who had gathered and for their association. After the welcome by Dr. Sunita Kshirsagar of the IMA, Mumbai and opening remarks by Dr. Prakash Kavli, President of IMA, Mumbai, the introductory speech was delivered by Dr. Sanjeewani Jain of the Lok Raj Sangathan. The closing remarks were by Girish Bhave, Convener of the LRS, Maharashtra. The presidium was graced by Dr. Bhujang and Dr. Joseph Daniel of the IMA.

All the speakers have made the material of their talks available to whoever wants to use it.

The passage of the new Patent Law – a violation of all democratic norms

Dr. Sanjeewani Jain pointed out that the British were the first to introduce patents into our country. They passed the product patent law in 1911. As a result the prices of the drugs were exorbitant, among the highest in the world. In 1970 there was an important change. A new patent law was enacted; products could not now be patented, only processes could. This meant that other manufacturers could produce the same product, as long as they did it by a process different from the one that was patented. This led to the growth of the generic drug industry. Due to competition, the prices reduced. Indian drugs became among the cheapest in the world (though they were still unaffordable to the majority of Indians).

The Indian drug industry has subsequently grown by leaps and bounds. Many companies have become multinational or are aspiring to become so.

In May 1994 India signed the WTO agreement that included Trade Related aspects of Intellectual Property Rights (TRIPS). The WTO agreement became effective for India from 1st January 1995. This had a clause requiring the country to change from process to product patents at least by 1st January 2005.

Moving in that direction, the Patents Act of 1970 and the Patent Rules of 1972 were amended. The mailbox for patent applications was introduced. This meant that the patent applications of those who wanted to file for product patents under the new law that would come in force would be collected together and processed after the new law came into effect. Exclusive marketing Rights (EMR) provisions were introduced. These changes were effective from 1.1.95. The effect of these changes was felt immediately, with prices of the drug for leukemia going beyond the reach of innumerable sufferers in the country.

Thereafter the Patents Second Amendment Bill was presented to the parliament; this included substantial changes in the Patents Act 1970. A Joint Parliamentary committee of 30 parliamentarians was set up to finalise draft proposals for the new Law. The JPC gave its draft proposals to the parliament after 2 years, in December 2001. The Amendment Bill amending 62 sections of the Act was passed by the parliament on 25th June 2002. Then followed a sordid drama that saw all democratic norms and procedures being violated by all the parties that came to power at the Centre during that period and their supporters.

To meet the TRIPS and WTO requirements, the only change further required was to remove the bar against grant of product patents for drugs, medicines, agro-chemicals and foods, which could have been easily introduced by a simple one clause amendment. However, in June 2003 the NDA government initiated discussions for major amendments. In 2003 the NDA government presented the Patent Amendment Bill in parliament proposing drastic amendments to the Patents Act of 1970. This was on the last day of the winter session of parliament!

This bill was immediately referred to the Parliamentary Committee. However the Bill lapsed because the Lok Sabha was dissolved in April 2004.

The Common Minimum Programme of the UPA promised, among many other things, “The UPA government will take all steps to ensure availability of life-savings drugs at reasonable prices. Special attention will be paid to the poorer sections in the matter of health care”.

Between January and December 2004, several representations were made by NGOs and concerned people, both to earlier the NDA and also to the UPA government, citing many objections to the proposed bill. However all this was to no avail.
After the UPA Government took over there were two sessions of Parliament. Several assurances were given in the Parliament, in different fora, and to the media that public interest will be protected and in particular that availability of life saving drugs at affordable prices would be taken care of. The winter session of parliament concluded on 22nd December 2004. The bill had not been discussed.

The patent ordinance was imposed in a very clandestine manner.

On 24th December, a Friday, the Cabinet meeting discussed the proposed Patent Act Amendments. At 8 p.m. on that day, the Commerce Minister informed the media in a televised briefing that no decision has been taken on the subject. Yet, on the evening of 26th December 2004, a Sunday, the Patents Amendment Ordinance 2004 was promulgated by the President of India. The Patents Rules 2003 were extensively amended by a notification on 28th December 2004. The ordinance promulgated was a more or less verbatim copy of the bill proposed by the NDA government in 2003.

The new Patents Act was finally passed by the parliament in March 2005. There were a few amendments introduced, but the whole thing was done in a very rushed manner as well without proper discussion even in parliament. The Left parties in parliament claimed victory for this, but in actual fact the amendments are of benefit only to the Indian drug companies and not to the people of our country.

The story of the passage of the new Patent Law is a sordid tale of violation of all democratic rights and norms. However there is nothing unique or unusual about it, for the same thing has been repeatedly done in our country by all the different governments that have come to power in the Centre, e.g. in the case of joining of WTO, the New Economic Policy, the passage of black laws, etc.

Dr. Sanjeewani ended the first part of her talk by saying that the eminent audience of the day, consisting of a large number of doctors, scientists and engineers, should seriously consider the prime question, Who is in power in this “democracy”? How are decisions affecting the people of our country taken? How are the powers that be able to take anti-people decisions? Is there any mechanism by which the will of the people is ascertained and implemented? Are people really in power in our country? Are the “representatives” of people accountable to them?

In the second part of the talk, she pointed out the effects of monopolisation on research and raised questions about the rationale behind patents in general, and product patents in particular. Monopolies created by patent rights lead to enormous centralisation of R&D among a few global players. When a few MNCs in the US and Europe are going to determine the research priorities for the whole world, it is drugs like Viagra that will continue to be researched and propagated. The MNCs are not interested in producing drugs needed by poor people – like drugs for Malaria, T.B., Kala Azar, Cholera, Typhoid, etc.

New drugs and pesticides are constantly needed as the germs and pests rapidly develop immunity against the old ones. The new patent law will mean that new drugs and pesticides discovered will remain out of reach of the common people of our country due to their exorbitant prices. Indian people will be deprived of the benefits of advances as better drugs with fewer side effects will be out of their reach. The same will be true of other new chemicals. There is another danger that the multiplication of prices of drugs will create. When people find that the drug prices are beyond their reach, they will stop taking the medicines before the full course is over. This will lead to increasing drug resistance of the pathogens.

Why are pharma companies so keen on product patents? They claim that they require protection of product patent and high prices to support their large expenditure on R&D to invent new drugs. Actually the marketing and administration expenditure of pharma companies is many times more than what they spend on R&D. Added to this is the fact that the pharmaceutical industry is the most profitable in the world. Glaxo-Wellcome spent 14.6% of sales on R&D but its marketing expenditure was 35.2% of sales. Pfizer (one of the largest pharma companies worldwide) spent 17.1% of sales on R&D while its marketing expenditure was 39.2% of sales turnover. The pharma companies insist on product patents because they create monopoly, which leads to exorbitant prices.

Who pays for research on medicines? A World Bank study estimated that the total R&D expenditure of the drug industry at US $ 70-90 billion. Nearly half of the R&D expenditure is funded by taxpayers. This is true in India as well. Recently the Government of India announced a grant of Rs 18 crore to Indian drug companies for research. Research is done more in universities and national labs. However the benefit of the research is skimmed off by the pharmaceutical companies. In pharma companies, research is more to create monopoly to charge exorbitant prices.

Dr. Sanjeewani also pointed out that most patents are not genuine. There are 8926 applications pending for examination in the mailbox in India, the vast majority by U.S and E.U multinational pharmaceutical companies. However, only 274 new chemical entities received marketing approvals from the US FDA between 1995-2003. This is a clear indication that many of the applications in the mailbox are for patenting of products with frivolous or marginal changes and, therefore, fall outside of the requirement of protection required for patents by TRIPS.

One also is confronted by a broader question. Should scientific knowledge be private property? The idea of patenting is alien to the Indian culture. It is not only money that motivates scientists. Many scientists are motivated by higher ideals of working for the welfare of humanity. Scientists like Marie Curie, Alexander Fleming and Jonas Salk as well as Jagdishcahandra Bose bequeathed their inventions and discoveries to mankind, without any reward for themselves.

At the end of her talk, she raised several questions for the gathering: Can issues relating to life and death be patented? Should operating procedures be allowed patents (this is already being done elsewhere and may happen in our country in future)? What is society’s obligation to people? Should only those who can pay get health care? Should others be left to die? She pointed out that the IMA has unequivocally answered this in the negative – its mission is to make health care available to all, irrespective of the ability to pay.

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