LDCs seek indefinite extension of transition period for TRIPS compliance


East African countries and other least developed countries (LDCs) are lobbying for an extension of transition period beyond the current date of July 1, 2013 to become TRIPS compliant. The LDC groups’ request for extension of transition period will be discussed in the WTO council meet scheduled to be held next week. This proposal for extension has garnered support from more than 300 civil society organizations. 

The WTO recognizes least developed countries as those comprising more than 880 million people (approximately 12% of the world population) but accounting for less than 2 % of world GDP and about 1 % of global trade in goods. The LDCs are a particularly vulnerable group and face a host of problems stemming from extreme poverty. A complete list of LDCs can be found here. Patent protection increases costs and renders many essential medicines inaccessible to the LDCs. 


Brief history 
The WTO agreement on Trade related aspects of intellectual property rights (TRIPS) was signed in 1995 and set global minimum protection standards for almost all forms of Intellectual Property (IP) including patents. The member countries were required to implement TRIPS provisions before prescribed dates depending upon their developmental status. Developed countries had to become TRIPS compliant by Jan 1, 1996. Developing countries which did not have product patent regime were given 10 years’ time until Jan 1, 2005 to implement TRIPS provisions. While the initial time frame given to LDCs for TRIPS compliance was until 1st January 2006, Article 66 provides that “Council for TRIPS shall, upon duly motivated request by a least-developed country member, accord extensions of this period.” Subsequently, two extensions have been granted to LDCs. 
The DOHA declaration extended the transition period for LDCs up to January 1, 2016 but only for TRIPS obligations related to pharmaceutical product patents and test data. 
The second extension granted by TRIPS council in 2005 provided that LDCs could take time until 1st July 2013 to implement TRIPS provisions (all provisions in general not just pharmaceutical obligations). The second extension was subject to the clause that once LDCs have implemented laws as a part of TRIPS compliance, they cannot retract those laws (“no-roll back” clause).

Image from here

Proposal by LDCs 
Recently, Haiti on behalf of other LDCs submitted a proposal to extend this the transition period for implementing all TRIPS provisions. This proposal would not be subject to any clause requiring the LDCs to preserve their existing IP laws (“no-roll back” clause). Also, this time the LDCs seek an indefinite transition period. Given that developing a viable technological base is a long term process and it is impossible to determine when the individual members will overcome constraints and achieve that goal, the LDCs have requested that the transition period should remain in force until the member is “no longer considered a LDC.” 
This proposal was met with reluctance by developed countries who believe that a blanket extension for all LDCs might not be appropriate. Also they are not in favor of an infinite extension period. 
In spite of being a developing country with reasonable infrastructure and technological base, India was grappling with the product patent regime enforced by TRIPS so one can imagine the problems these LDCs would face!! 
Also it is extremely important that LDCs have the flexibility to independently manufacture affordable essential medicines (without IP hindrance) or able to import medicines without requiring to apply for a compulsory license every time. Extending the transition period will make the LDCs (especially East Africa) particularly attractive to generic drug makers from India and this will facilitate adequate supply of affordable medicare. In fact generics like Cipla have set up their plants in Africa and extending the transition period would attract investments from even more generic companies. 
Fire in the blood, writer-director Dylan Mohan Gray’s touching documentary shows how millions of people die in AIDS afflicted-Africa because they lack access to essential anti-retro-viral therapy. Swaraj is going to post on this topic shortly. 
LDCs represent weakest and poorest segment of the international community and considering the huge disease burden (HIV, Hepatitis) on LDCs, adequate measures should be adopted for protecting health of people in the LDC community.

Madhulika Vishwanathan

Madhulika is a registered Indian patent agent and has completed her Master’s in Pharmacology from the Institute of Chemical Technology (ICT), Mumbai. Her interests include issues involving pharmaceutical and biotechnology patent law, regulatory aspects like Hatch Waxman litigation and antitrust law.She is currently working at law firm based out of Memphis, TN.

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