On 31 May 2017, the delegations of Brazil, China, Fiji, India, and South Africa tabled a paper to the World Trade Organization’s (WTO) TRIPS Council entitled “Intellectual Property and the Public Interest.” In their communication (IP/C/W/630), the proponents called for a series of discussions at the WTO TRIPS Council on Intellectual Property and the Public Interest. Brazil, China, Fiji, India, and South Africa proposed compulsory licensing as the first theme of IP and the Public Interest discussions at the TRIPS Council meeting in June 2017.
In relation to TRIPS flexibilities, the proponents of public interest discussions at the WTO highlight the political and economic pressures faced by WTO members when endeavoring to use TRIPS flexibilities.
6. Many governments have not used the flexibilities available under the TRIPS Agreement for various reasons, such as capacity constraints or political pressure from states and corporations mentioned in the UN Secretary-General’s High Level Panel Report on Access to Medicines. Moreover, even where some developing countries used the flexibilities available to them under the TRIPS Agreement to address public interest objectives through measures which are fully consistent with the TRIPS Agreement, these attempts have been challenged legally as well as politically. Political and economic pressure placed on governments to forgo the use of TRIPS flexibilities violates the integrity and legitimacy of the system of legal duties and rights created by the TRIPS Agreement, as reaffirmed by the Doha Declaration.
The public interest coalition of WTO members underscored the upsurge of regional free trade agreements that vitiate countries’ room to maneuver.
7. A slew of regional trade agreements containing “TRIPS plus” standards of IP protection and enforcement have the potential to significantly affect the policy space available for effective and full use of the TRIPS flexibilities. The most common “TRIPS plus” provisions in free trade agreements (FTA) that affect the pharmaceutical sector are: the definition of patentability criteria; patent term extensions; test data protection; the linkage of regulatory approval with patents and enforcement of IPRs, including border measures. Such provisions can delay market entry of generics and increase prices of medicines. Investor-State disputes under regional or bilateral investment protection agreements are also emerging as significant threats to the use of TRIPS flexibilities in the public interest.
In addition to addressing the challenges imposed by trade rules on access to health technologies, Brazil, China, Fiji, India, and South Africa highlighted how increased “copyright protections create similar problems of access to knowledge goods, limiting the ability of many people around the world to access print, audio, or visual works of education or entertainment that we take for granted.”
9. There is a growing concern about an imbalance between intellectual property and the public interest. With regard to health technologies, for example, patents and related monopoly rights in test data, without sufficient use of balancing exceptions and limitations to protect the public interest, permit companies to maintain high prices and exacerbate crises of access around the world, where many patients cannot afford medicines, and force governments with finite health budgets to ration care. Increased copyright protections create similar problems of access to knowledge goods, limiting the ability of many people around the world to access print, audio, or visual works of education or entertainment that we take for granted. These are only a few examples of the problem. There is a need to pursue a development-oriented approach towards formulating IP laws and policies rather than pursue an iconoclastic approach of IP for development.
For the discussion on compulsory licensing scheduled for the 13-14 June 2017 meeting of the TRIPS Council, the proponents have proposed the following points for consideration, including an exchange of state practice.
11. Compulsory licensing occurs when a government allows someone else to produce the patented product or process without the consent of the patent owner.9 Article 31 TRIPS lays down a set of conditions for issuing compulsory licenses of patents. The Doha Declaration on the TRIPS Agreement and Public Health states that, “Each Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted”. In spite of the clarity of this language, WTO Members around the world seeking to make use of compulsory licences as a tool to increase access to affordable medicines have faced various challenges/barriers.
12. Some possible grounds for compulsory licensing are suggested in Article 5A of the Paris Convention (e.g. abuse of patent rights, including failure of the patent holder to work the invention) and in Article 31 of the TRIPS Agreement (e.g. national emergency and public non-commercial use) . However, this list is not exhaustive. The Doha Declaration on the TRIPS Agreement and Public Health confirmed what was already implicit in the TRIPS Agreement – that WTO Members have the freedom to determine the grounds upon which compulsory licenses are granted. They are thus not limited to emergencies or other urgent situations, as is sometimes mistakenly believed. A range of grounds have been set out in national laws like (i) non-working or insufficient working, (ii) anti-competitive practices, (iii) public interest, (iv) dependant and blocking patents, (v) Government use.
13. The sponsors of this communication invite Members to share their national experiences and examples of using compulsory licenses. The information exchange could serve to enhance understanding of Members on various grounds available for issue of compulsory licenses and problems faced by Members while using them.
• What grounds are available in their national laws to issue compulsory licenses?
• What are the difficulties faced by WTO Members in using compulsory licenses, including constraints, such as insufficient or no manufacturing capacities?
• How the measure of compulsory licence was used by governments to obtain price reduction from patent holders?
• What was the result of using compulsory licenses in terms of price and access to affordable products and technologies?