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UN Panel asks countries to use TRIPS “flexibilities” and issue Compulsory Licenses to increase access to medicines


By Narayanan Suresh

A 15-member UN Secretary General’s High Level Panel on Access to Medicines has recommended that governments should be stringent with issuing of patents and use all flexibilities in international agreements to promote access to health technologies when necessary.

The report of the 15-member panel, co-chaired by Ms Ruth Dreifuss, ex-president of Switzerland and Mr Festus Gontebanye Mogae, former President of Botswana, will be discussed at length during the ongoing General Assembly Session of the United Nations attended by world leaders. The Panel was set up by Secretary-General, Mr Ban ki Moon in November 2015 to increase access to medicines by world’s poor people.

“Governments should adopt and implement legislation that facilitates the issuance of compulsory licenses. Such legislation must be designed to effectuate quick, fair, predictable and implementable compulsory licenses for legitimate public health needs, and particularly with regards to essential medicines,” the panel recommended.

Compulsory licensing is a provision given to governments to override patents of a particular medical product if it is not made available in adequate quantities or for emergencies in a country. Other manufacturers can seek a license from the government to make such a patented drug.

In March 2012, India issued its first-ever compulsory license to Natco Pharma to manufacture Bayer’s patented anti-cancer drug, Nexavar (sofrafenib tosylate). India’s Patent Office, while granting the compulsory license reasoned that “ Bayer took no adequate or reasonable steps to start the working of the invention in the territory of India on a commercial scale and to an adequate extent.”

According to the UN Panel, the use of compulsory licensing (CL) must be based on the provisions found in the Doha Declaration and the grounds for the issuance of CLs should be left to the discretion of governments.

The international law already allows the use of CL. The WTO ( World Trade Organization) declaration on TRIPS ( Trade Related Intellectual Property Services) Agreement and Public Health, 2001 affirms, inter alia, that the TRIPS Agreement “ can and should be interpreted and implemented in a public health, and in particular, to promote access to medicines for all.”

A key recommendation of the UN Panel is that WTO members should commit themselves at the highest political levels, to respect the letter and the spirit of the Doha Declaration on TRIPS and Public Health, refraining from any action that will limit their implementation and use in order to promote access to health technologies.

The reported added: “WTO members should make full use of the policy space available in Article 27 of the TRIPS Agreement by adopting and applying rigorous definitions of invention and patentability that are in the best interests of the public health of the country and its inhabitants.

“This includes amending laws to curtail the evergreening of patents and awarding patents only when genuine innovation has occurred.”

WTO members should revise Paragraph 6 decision in order to find a solution that enables a swift and expedient export of pharmaceutical products produced under compulsory license. WTO member should, as necessary, adopt a waiver and permanent revision of the TRIPS Agreement to enable this reform, the panel recommended.

The report recommended that the United Nations Conference on Trade and Development (UNCTAD), the UN Development Program (UNDP), the World Health Organization (WHO), the World Intellectual Property Organization (WIPO) and WTO should cooperate with one another and with other relevant bodies with the requisite expertise to support governments to apply public health-sensitive patentability criteria.

These multilateral organizations, the UN Panel recommended, should strengthen the capacity of patent examiners at both national and regional levels to apply rigorous public health-sensitive standards of patentability taking into account public health needs.

Issuing of CL is frowned upon by many developed countries and the global pharmaceutical industry.

The UN Panel has addressed this aspect also in its report by stating “Governments and the private sector must refrain from explicit or implicit threat, tactics or strategies that undermine the right of WTO members to use TRIPS flexibilities. Instances of undue political and commercial pressure should be reported to by the WTO Secretariat during the Trade Policy Review of Members. WTO members must register complaints against undue political and economic pressure which includes taking punitive measures against offending WTO members.

Another significant recommendation is that governments engaged in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfil the right to health.

As a first step, the report said, they must undertake public health impact assessments. These impact assessments should verify that that increased trade and economic benefits are not endangering or impeding the human rights and public health obligations of the nation and its people before entering into commitments. Such assessments should inform negotiations, be conducted transparently and made publicly available.

(The writer is COO of ABLE)