[Ip-health] WTO - LDC request for extension of transition period on pharmaceuticals

K.M. Gopakumar kumargopakm at gmail.com
Thu Feb 26 01:52:54 PST 2015


*Title :* UPDATED TWN IP/Health Info: WTO - LDC request for extension of
transition period on pharmaceuticals
*Date :* 26 February 2015

*Contents:*

Dear friends colleagues,

We are pleased to provide you with an updated version of our earlier report
on the formal request by the Least Developed Countries Group to extend the
period of exemption from intellectual property rights for pharmaceutical
products.

A strong statement was made by Bangladesh on behalf of the LDC Group at the
WTO TRIPS Council that met on 24-25 February 2015 in Geneva. Highlights of
this statement are included below.

The updated version was first published in SUNS #7970 Thursday 26 February
2015.

With best wishes,
Third World Network
------------------------------

*UPDATED TWN IP/Health Info: WTO - LDC request for extension of transition
period on pharmaceuticals*

New Delhi, 25 February (K. M. Gopakumar) – Least developed countries 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 Organization Member remains a least developed
country (LDC). 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 2015 by Bangladesh on behalf of the LDC Group, and
posted officially by the WTO Secretariat on 23 February (IP/C/W/605).  It
will kick start a series of negotiations this year for the extension of the
transition period.
[Under Article 65.1 of the TRIPS Agreement 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 Art. 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 (24 – 25 February 2015) on this request. Several
developing countries subsequently took the floor to support the LDC request.
Bangladesh said that, “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, 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 (Article70.9) 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 the light of 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 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 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 2021 is enough to take care
of health needs. According to these experts the extension of 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 5of 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 the upcoming meeting
of the TRIPS Council in June.

A delegate from the Indian mission in Geneva who participated in the TRIPS
Council meeting informed Third World Network 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.

M้decins Sans Fronti่res (MSF) also 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 Policy and Analysis of the MSF Access
Campaign said that, “Any flexibility which can safeguard access to low cost
generic medicines and vaccines is welcomed by MSF.”

(Edited by Chee Yoke Ling)





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