041105 Patent and Public Health

Trade Agreements and Health

Patent and Public Health:

Addressing the Future Imperatives of Health Security in the Post-TRIPS Era

11 April 2005, New Delhi

As per obligations under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organisation (WTO), from 1^st January 2005 onwards the product patent regime has been introduced in India vide the Patent (Amendment) Act, 2005. Now product patent is enforced in all sectors, including the pharmaceutical and agro-chemical sectors, which so far had been out of such provisions. From the perspective of access to health, the questions that arise are: Is India prepared to deal with the changed situation? What should be the future course of action with respect to manufacture, trade and procurement of generic drugs?

There are law and policy tools that are available with the Government to deal with adverse situation vis-à-vis access to medicines, which may arise due to the introduction of product patent regime. These include, among other things, built-in safeguards in the Patents Act using the TRIPS flexibilities, competition law and policy and drug price control regime. The questions that need to be looked into are: How to implement these built-in safeguards; How India should use competition law and policy to tackle adverse conditions with respect to access to drugs which may arise due to introduction of product patent regime? Does the new competition regime have such a scope? Is the present drug price control regime effective and sufficient in controlling the prices of patented drugs? etc.

The Workshop aims to discuss the above-said issues amongst the stakeholders and come out with suggestions that can shape an action plan to address future challenges with respect to access to health, in the post-TRIPS era

Agenda

09.30 – 10.00 hrs	Registration
	Inaugural Session
10.00 – 10.05 hrs	Welcome address by Shri B. P. Sharma, Joint Secretary, Department of Health, Ministry of Health & Family Welfare
10.05 – 10.20 hrs	Inaugural Address by Shri P. Hota, Secretary, Department of Health, Ministry of Health & Family Welfare
10.20 – 10.30 hrs	Address by Dr. S. J. Habayeb, WHO Representative to IndiaAddress by Dr. S. J. Habayeb, WHO Representative to India
10.30 – 10.35 hrs	Vote of thanks by Shri Rajesh Bhushan, Director (IH), Department of Health, Ministry of Health & Family Welfare

	Introductory Session An overview of recent law/policy developments on patents & public health WTO Cell, Ministry of Health & Family Welfare
11.00 – 11.30 hrs	Tea Break
	Technical Session I
11.30 – 11.45 hrs	Manufacture of ‘quality’ generic drugs – options available with Indian pharmaceutical sector and the preparedness of the Indian pharmaceutical industry to deal with the changed scenario	Shri Gajanan Wakankar, Executive Director, Indian Drug Manufacturers Association, Mumbai
11.45 – 12.00 hrs	Para 6 of Doha Declaration and India’s response	Shri Narendra B. Zaveri, Advocate, Mumbai
12.00 – 13.00 hrs	Open Discussion

13.00 – 14.00 hrs	Lunch Break

	Technical Session II
14.00 – 14.15 hrs	How far the TRIPS-Flexibilities are being addressed in the Patent (Amendment) Act, 2005?	Shri B. K. Keayla, Centre for Study of Global Trade System and Development, New Delhi
14.15 – 14.30 hrs	Anti-competitive practices in Patent Licensing Arrangements and the scope of competition law/policy in dealing with them	Shri Anand Grover, AMTC, Mumbai
14.30 – 14.45 hrs	WHO perspective on Patents and Public Health	Dr. Weerasuriya, Regional Adviser, EDM, WHO-SEARO
14.45 – 15.30 hrs	Open Discussion

15.30 – 16.00 hrs	Tea Break

	Concluding Session - The Way Forward
16.00 – 16.45 hrs	Post-TRIPS scenario and Access to Medicines: the way forward for India · Shri Z.H. Charna, Director, Organisation of Pharmaceutical Producers of India · Shri Ashwini Kumar, Drug Controller General of India, New Delhi · Shri Gurdeep Singh, Director, Department of Chemicals and Petrochemicals, New Delhi · Shri Sunil Nandraj, WRI Office
16.45 – 17.15 hrs	Open Discussions
17.15 – 17.30 hrs	Valedictory & vote of thanks