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Beginning of a new policy chapter The changes made by Parliament include:
• Requiring significant innovation as a prerequisite to the granting of a patent;
• Expressly limiting patentability of different forms of the same substance, absent a showing of a significant difference in efficacy;
• Maintaining a reasonably strong form of pre-grant opposition;
• Eliminating an unnecessary hurdle to the grant of compulsory licenses for export;
• Clarifying exports permitted under the general compulsory license provision, as well as establishing certain presumptive time frames used in such licensing;
• Improving a provision intended to permit parallel importation of patented products, and
• Allowing continued production in India of generic versions of medicines already on the market (if now patented by third parties under the so-called ‘mailbox’ system), with payment of a reasonable royalty—a form of “prior user right” adapted to India’s unique situation.
In considering this important new legislation, the government and Parliament were performing two roles. First, they were acting as intermediaries for the competing claims of various “stakeholders.” These stakeholders included domestic generic medicine producers, the domestic research and development community, foreign multinational pharmaceutical companies and their home country governments, domestic and foreign non-governmental organisations (NGOs) concerned with access to medicines, domestic clinical testing companies, domestic and foreign lawyers, accountants and business consultants, doctors, pharmacists and other healthcare providers. Of course, the ultimate “stakeholder” in this legislative debate is the patient or ultimate consumer of the medicine, both in India and around the world. Without doubt, it is no easy task for the government and Parliament to mediate the often competing claims of this disparate group of stakeholders and the amendments would not satisfy everyone.
The second role of the government and Parliament was to stand back from specific stakeholder claims and exercise their objective judgment regarding the best interests of India and its people. Here the government and Parliament needed to consider the short and long-term public health needs of India and the cost of satisfying those needs.
In India, as in most countries, there is a substantial disparity between the levels of income of the rich and poor. It is no real answer to India’s long-term public health needs to base a policy only on what the comparatively well-off segments of the population will be able to afford from their own resources. Ultimately, the government and Parliament must choose a policy that will allow them to address the country’s wider public health needs.
In light of India’s WTO commitment to initiate pharmaceutical product patent protection in 2005 — a bargain struck in 1994—the newly modified amendments to the Patents Act appear to strike a reasonable balance in India’s best interests. Its highly successful generic producers should be able to continue leading the world in the development and refinement of efficient production processes. Its local R&D community will be able to patent significant new medicinal innovations and seek higher returns in the Indian market. Indian inventors still may take advantage of looser patenting standards in the OECD countries and Indian companies will be able to sell their products in those foreign markets (at high prices!).
Foreign multinationals may be disappointed by India’s decision to limit their monopoly profits and may acquire fewer Indian companies. However, while this may be a short-term disappointment to the investing community, in the long run, India should be better off, as its own entrepreneurs maintain better control of their destiny. The major beneficiary is the Indian public which will not face such an immediate wrenching adjustment in terms of higher-priced medicines. People throughout the developing world will also continue to enjoy the benefits of India’s generics exports.
The new Indian legislation might still be improved, though I will not go into details here. In any case, it is not a panacea. Significant new medicinal advances will be patentable in India. If marketing patterns in the OECD countries hold, these new medicines will be sold in India at high prices. The government will, therefore, need to be vigilant in protecting the interests of the Indian public in affordable health care. It has already indicated that it is prepared to control prices. It may also need to grant compulsory licenses, a practice permitted under the WTO-Trips Agreement and reinforced in the Doha Declaration on the Trips Agreement and Public Health. No one should mistake the new legislation as an endpoint. It is only the beginning of a new chapter in addressing public health needs in India and around the world.
The writer is professor of international law, Florida State University College of Law, USA | ||
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