Life after TRIPS

The pharmaceutical industry must invest in research and development

 
By Angela Saini
Last Updated: Sunday 07 June 2015

Life after TRIPS

-- India currently ranks amongst the top five manufacturers of bulk drugs in the world. Having muscled out hefty competition from foreign multinationals, the country is almost self-sufficient in drugs. This is largely because Indian drug manufacturers circumvent patent rules by slightly altering their production processes. But they will not be able to do so from 2005. From that year the country will have to comply with the Trade-Related Intellectual Property Rights (trips) provision, that vests patent holder with sole rights over manufacturing of a product for the duration of the patent.

The only long-term solution to sustain the pharmaceutical industry is to invest heavily in research and development (r&d). But developing new drugs is risky business. Crores can be invested and years can be spent in isolating and developing a molecule only for it to fail at the final trial stage. Estimates suggest that for every 5000 new compounds that undergo development and testing, only one reaches the marketplace.

With this in mind, the department of science and technology sought to rejuvenate the sluggish research record of pharmaceutical companies by introducing the Drugs and Pharmaceutical Research Programme in 1995. This programme supports collaborations between publicly funded research institutions and the pharmaceutical industry, with each party holding patent rights to subsequent discoveries in proportion to the ratio of their investments. To date 35 collaborations have taken place, yielding 3 product patent applications and 12 process patent applications. The programme has also created a number of national facilities to provide systems for research, which may be beyond the means of industry and institutions. Such facilities include a large throughput drug screening centre in Lucknow, and a transgenic mice facility for clinical testing in Hyderabad. Such efforts notwithstanding, the r&d scenario pertaining to drugs is bad.

In such times, India's wealth of natural resources and biodiversity offer great potential. There are in excess of 80,000 medicinal plants in India; but so far only 120 plant derived chemical compounds have been developed into modern drugs. This is a bandwagon onto which some firms have already jumped, mostly foreign multinationals. The global herbal industry is worth about us $50 billion, to which the Indian contribution is only 10 per cent.

The government has a number of initiatives to investigate this potential, including setting up the Board of Medicinal Plants and the Biodiversity Board. Among the on-going collaborative projects of the Drugs and Pharmaceuticals Research Programme includes investigation into herbal drugs with respect to particular diseases such as rheumatism.

Of course, drug development has to be balanced with the needs and rights of the public. Legislation governing intellectual property rights has created a minefield over the past decade, with wealthy companies struggling against ngos, farmers and indigenous peoples for control over natural resources. Among the most painful battles recently has been the effort to patent products derived from neem, a plant that has been used for centuries as an antiseptic and general cure-all. Both neem farmers and the poor, who could no longer have access to or afford neem, have fought hard against us companies to maintain rights to their sacred plant. Their rights were eventually secured because of world agreement that what is in the public domain cannot be patented. Therefore, if a plant has been published in a text as having certain curative properties, this information cannot be patented. While this is good news for some, it also means that there are no commercial interests in researching Ayurvedic drugs, whose properties are given comprehensively in Hindu texts.

The one way of making such research commercially viable is in the case of 'novel human intervention'. If specificity is created (for example if it is ascertained that a plant can cure a symptom of a particular disease such as arthritis), then this knowledge can be patented. This, like for every drug discovery in the world, is also a risky venture with dubious chances of success. But if Indian consumers are ever to have access to affordable medicines then it is a route that has to be taken.

Angela Saini is a reporter with Frontline

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