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[e-drug] UNITAID NGO Delegation Expresses Strong Support for LDC Extension Request

E-DRUG: UNITAID NGO Delegation Expresses Strong Support for LDC Extension 

10 March 2015

The NGO delegation to the Board of UNITAID offers its strong support for the 
proposal of WTO least developed country Members to extend the transition period 
for enforcing protections for pharmaceutical related patents and clinical data 
"for as long as the WTO member remains a least developed country."  

The proposal, IP/C/W/605, was offered by Bangladesh on behalf of LDCs at the 
24-25 February 2015 meeting of the WTO TRIPS Council and will be taken forward 
at its next 1 June 2015 meeting.  In addition to seeking an unconditional 
extension of the current pharmaceutical transition period set to expire on 1 
January 2016, the LDCs also seek a waiver from the General Council with respect 
to two additional transition measures, namely mailbox and exclusive marketing 
rights provisions under Articles 70(8) and 70(9) of the TRIPS Agreement.

LDC Members are unequivocally entitled to the requested extension and waiver 
under paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public 
Health, under the text of the original 2002-2016 pharmaceutical transition 
decision, and under Article 66.1 of the TRIPS Agreement which states that LDC 
Members "shall" be granted extension upon properly motivated request.

Although LDC Members already have some degree of assurance with respect to not 
having to grant patent rights on pharmaceutical products or to protect 
pharmaceutical data under the 2013 TRIPS Council Decision extending the general 
TRIPS transition period until 1 July 2016, the proposed pharmaceutical 
extension is clearer, stronger, and longer and thus will help guarantee 
continuing access to affordable medicines in the poorest and most 
capacity-constrained countries in the world.

The benefit of the proposed extension is that it will guarantee freedom from 
pharmaceutical patents and data protections (and mailbox and exclusive 
marketing rights) for as long as a country remains so technologically and 
developmentally constrained that it is an LDC.  There will also be no ambiguity 
whatsoever in the likely text of the eventual decision - it will allow LDCs not 
only to deny patents on pharmaceutical products but to not enforce any existing 
pharmaceutical patents as well.  This level of assurance has been used by 
dozens of LDCs over the past 13 years, especially with respect to 
antiretroviral medicines.  LDCs' rejection  of pharmaceutical patents under the 
extension in turn allows donors and countries to lawfully procure generic ARVs 
at the lowest possible price and gives assurance to generic producers that they 
will not be sued by Big Pharma companies.

The granting of this requested extension should be non-controversial.  Its 
passage will further UNITAID's ability to support market entry of affordable 
new medicines, diagnostics, and prevention technologies to address the 
HIV/AIDS, tuberculosis, malaria, and hepatitis C pandemics in LDCs.  In an era 
of constrained resources but dramatically unmet need, it is crucial that LDCs 
have the policy space to be free of monopoly protections on medicines so that 
they can fulfill their human rights duty to ensure access to medicines for all.

Brook K. Baker, NGO Board Member
Diarmaid McDonald, NGO Alternate Board Member

Professor Brook K. Baker
Northeastern U. School of Law
Affiliate, Program on Human Rights and the Global Economy
416 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
Senior Policy Analyst Health GAP (Global Access Project)
NGOs Board Member UNITAID

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