Info Service on WTO and Trade Issues (Feb15/06)
New Delhi, 25 Feb (K. M. Gopakumar) - The Least Developed Countries (LDCs) have submitted a request for the extension of the transition period with regard to intellectual property protection of pharmaceutical products.
The request seeks an extension of the transition period from 1 January 2016 to as long as the World Trade Organisation Member remains a least developed country.
The transition period exempts LDCs from most obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
The current transition period on pharmaceutical products, granted in 2002 in pursuant to Paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health, will end on 1 January 2016.
The formal request was submitted on 20 February by Bangladesh on behalf of the LDC Group, and posted officially by the WTO Secretariat on 23 February (IP/C/W/605).
The request was introduced at the TRIPS Council on 24 February under ‘other business' and a brief discussion continued on it on 25 February.
The request is expected to kick-start a series of negotiations this year for the extension of the transition period.
[Under Article 65.1 of the TRIPS Agreement, the LDCs obtained 10 years of a transition period for the implementation of the Agreement including on product patent protection of pharmaceutical inventions.
[However, in 2001, trade ministers, through the Doha Declaration on the TRIPS Agreement and Public Health, instructed the TRIPS Council to extend the transition period related to pharmaceutical products up to 1 January 2016.
[This extension was done without prejudice to the possibility of further extension of the transition period with regard to the implementation of the TRIPS Agreement (general exemption) under Article 66.1 of the TRIPS Agreement wherein the TRIPS Council "shall, upon duly motivated request by a least developed country Member, accord extensions of this period".
[Under this provision LDCs obtained two extensions of the transition period with regard to the implementation of the TRIPS Agreement in 2005 to 2013, and in 2013 to 2021. Thus, the extension of the transitional period on pharmaceutical products is additional to the general exemption granted in 2013 and expected to go beyond 2021.]
Bangladesh made an impassioned statement on behalf of the LDC Group at the TRIPS Council meeting on 24 February on this request. Several developing countries subsequently took the floor to support the LDC request.
Bangladesh said that the "LDCs represent the weakest and most vulnerable group of the community of nations. With deficiency and hardship touching all aspects of life, the population have been suffering from, and are highly susceptible to different forms of diseases. As a result, there are many other associated risks and impediments such as access to medicine and health services".
Bangladesh stressed that: "Though we have a general TRIPS waiver up to 2021, considering the gravity of the situation of lack of access to medicine and proper health care, LDCs require time to reasonably overcome their public health problem."
Key parts of the request were highlighted in the statement (see below for details).
If the current request is approved, the LDCs need not implement product patent protection in relation to pharmaceutical inventions even beyond the current 2021 timeline for the implementation of the TRIPS Agreement, as the pharmaceutical exemption is sought for a Member that remains an LDC.
The request for the extension of the transitional period also covers test data protection under Article 30.3 of the TRIPS Agreement.
The request also seeks exemption from the ‘mailbox' (Article 70.8) and exclusive marketing rights (Article 70.9) of the TRIPS Agreement.
[Under Article 70.8, during the transition period on pharmaceutical patents a WTO Member is to receive patent applications and examine those applications and apply to these applications, as of the date of application of this Agreement, the criteria for patentability as laid down in the Agreement as if those criteria were being applied on the date of filing in that Member or, where priority is available and claimed, the priority date of the application. The duration of the patent would be counted from the date of filing.
[Under Article 70.9, a WTO Member who is availing of the transition period with regard to patent protection of pharmaceutical patents shall give exclusive marketing rights for a period of five years after marketing approval is obtained in that Member or until a product patent is granted or rejected in that Member, whichever period is shorter, provided that, subsequent to the entry into force of the WTO Agreement, a patent application has been filed and a patent granted for that product in another Member and marketing approval obtained in such other Member.]
The LDC request clearly spells out the need for the extension of the transition period in light of the current health situation of LDCs.
It states that: "In 2011, some 9.7 million of the 34 million people living with HIV worldwide, live in LDCs. Of the people living with HIV in LDCs, 4.6 million were eligible for antiretroviral (ARV) treatment in accordance with the 2010 World Health Organization HIV treatment guidelines, however, only 2.5 million were receiving it. While the ARV treatment situation may have somewhat improved since the 2001 Declaration on TRIPS and Public Health (WT/MIN(01)/DEC/2), the need remains significantly great. There are particularly complex challenges for LDCs with respect to second line HIV treatment which is more than double the price of the first line regime, and third line HIV treatment which could be as much as 15 times the price of first line treatment".
The request cites concerns expressed by the Joint United Nations Programme on HIV/AIDS (UNAIDS) that "without extension of the transition period, access to antiretroviral therapy and other key medicines in LDCs will face real challenges" an with "a real danger ... progress that has been made to improve access to HIV-related medicines in these countries will be reversed".
It also cites cancer incidence in LDCs, "which is expected to rise 82% from 2008 to 2030 in low-income countries (compared to 58% in upper-middle and 40% in high-income countries)".
Reference is also made to Resolution A/HRC/23/L.10/Rev.1 of 11 June 2013 adopted by the UN Human Rights Council on access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health which urges States to promote access to medicines for all, including through the use, to the full, of the provisions of the TRIPS Agreement which provide flexibility for that purpose.
The request further notes that the extension of the transition period on pharmaceutical products in 2002 "has facilitated access to affordable medicines in LDCs. However, LDC Members of the WTO continue to face massive health challenges from communicable and non-communicable diseases".
In addition, the request also seeks extension on other grounds contained in Article 66 such as lack of technological base and local manufacturing ability as well as the special needs of LDCs.
The request states: "In addition to the socio-economic and financial constraints, LDCs also lack adequate technological base and local pharmaceutical manufacturing capacity. These special needs and circumstances of LDCs, and the vulnerability of LDCs confirm the need for a renewed transition period for as long as these constraints remain".
Health experts point out that the extension of the transition period is crucial for LDCs irrespective of the general exception granted until 2021, and reject the view that the general exemption until 2021 is enough to take care of health needs.
According to these experts, the extension of the transitional period on pharmaceutical products is unconditional and allows LDCs to suspend any TRIPS provisions related to pharmaceutical products.
However, the general exemption granted in 2013 has certain conditions that may be subject to interpretation and may be used against full suspension of existing provisions in some of the LDC intellectual property laws, which already provides some protection to pharmaceuticals.
[The 2013 general exemption extension states: "Recognizing the progress that least developed country Members have already made towards implementing the TRIPS Agreement, including in accordance with paragraph 5 of IP/C/40, least developed country Members express their determination to preserve and continue the progress towards implementation of the TRIPS Agreement. Nothing in this decision shall prevent least developed country Members from making full use of the flexibilities provided by the Agreement to address their needs, including to create a sound and viable technological base and to overcome their capacity constraints supported by, among other steps, implementation of Article 66.2 by developed country Members".]
The request is expected to be discussed at length in an upcoming meeting of the TRIPS Council in June.
A delegate from the Indian mission participating in the TRIPS Council meeting informed TWN that "India supports all initiatives to promote access to medicines at affordable cost in poor countries".
Meanwhile, the LDC request has been widely welcomed by health experts and activists.
Medecins Sans Frontieres (MSF) welcomed the request to extend the pharmaceutical transition period until LDCs are no longer classified as such.
Referring to their work in many LDC countries and their reliance on low-cost affordable generic medicines to provide affordable access to treatment, Rohit Malpani, Director of Policy and Analysis of the MSF Access Campaign, said: "Any flexibility which can safeguard access to low-cost generic medicines and vaccines is welcomed by MSF."