[Ip-health] In WHO, South defends use of TRIPS flexibilities for public health

Sangeeta Shashikant ssangeeta at myjaring.net
Fri Jan 31 07:34:02 PST 2014

TWN Info Service on Intellectual Property Issues (Jan14/06)
29 January 2014
Third World Network

Dear Colleagues,
Below is an updated news reports on the discussion on Intellectual
Property Flexibilities and Access to Medicines that took place at the WHO
Executive Board last week.
This report is also available at

Sangeeta Shashikant
Third World Network

In WHO, South defends use of TRIPS flexibilities for public health

Alexandra Bhattacharya* (Geneva): Developing countries defended their
right to use flexibilities allowed by the Agreement on Trade Related
Aspects of Intellectual Property (TRIPS) of the World Trade Organization
topromote access to affordable medicines as the WHO Executive Board
discussed a draft resolution on access to essential medicines.
The 134th session of the Executive Board met in Geneva from 20 to 25
January 2014.  The Executive Board is composed of 34 Member States and
meets twice a year to facilitate the work of the World Health Assembly.

The draft resolution titled ³Access to essential medicines² was proposed
by China, Libya, Republic of Korea and South Africa, and amongst one of
its elements, encouraged the use of TRIPS flexibilities by Member Sates
particularly with regard to the promotion to access to essential medicines.

The draft resolution was adopted by the EB and will be forwarded to the
next World Health Assembly in May.

Plenary discussion on the draft resolution triggered a number of
interventions by developing countries as the resolution comes at a time
when multinational pharmaceutical companies are orchestrating a challenge
to South Africa's legislative efforts to introduce IP policy reforms,
which will promote access for medicines.
Namibia, on behalf of the African Region called on the WHO to support its
member states in safeguarding the use of TRIPS flexibilities and stressed
on the need for strong technical support in this context at country level.
It also said that it ³fully supported South Africa in its fight to
increase access to medicines².
[Recently various documents revealed that the Innovative Pharmaceuticals
Association of SouthAfrica (IPASA) ­ a front organization of
multinationals in the pharmaceutical sector in South Africa ­ and the
US-based industry body PhRMA (the Pharmaceutical Researchers and
Manufacturers of America) have engaged a consultancy firm Public Affairs
Engagement (PAE) to subvert the South African intellectual property law
reform process.

In September 2013, South Africa issued its draft national IP policy which
proposes changing South Africa¹s IP law to include a number of health
safeguards including vigorous examination of patent applications, patent
oppositions, limiting patent term to 20 years only, and adopting easy to
use parallel importation and compulsory license mechanisms.
The PAE prepared a strategy for IPASA and PhRMA titled Campaign to Prevent
Damage to Innovation from the Proposed Draft National IP Policy in South
Africa. The Mail and Guardian reported this strategy on 17 January 2014.

In response to this revelation the South Africa Health Minister Aaron
Motsoaledi accused a group of multinational pharmaceutical companies
active in South Africa ³of conspiring against the state, the people of
South Africa and the populations of developing countries ­ and of planning
what amounts to mass murder², according to Mail and Guardian.]

At the Executive Board, South Africa in an emotional intervention called
the strategy written by the PAE to undermine South Africa¹s efforts to
reform its Intellectual Property policies ³unfortunate², adding that the
policy aimed at contributing ³towards the protection and promotion of
public health, and access to medicines in particular².
This is not the first time that South Africa has been under such an
attack, even in the face of the most devastating HIV/AIDS and TB
co-morbidities, South Africa added.

[In 1998, 39 pharmaceutical companies filed a suit against the South
African government over its Medicines and Related Substances Act. The main
issue was Amendment 15(c) which would allow TRIPS-compliant compulsory
licensing and parallel imports. In 2001 the pharmaceuticals companies,
under an extremely high amount of international pressure, dropped their

South Africa recalled that in 2000, the cost of combination antiretroviral
therapy per person per annum was US$10 000, but in 2010, ten years later
these costs had been reduced to USS$1 000 per person per annum, that is by
50%. This would not have been possible without generic competition, South
Africa said, adding that South Africa has been able to put 2.4 million
people on treatment.

Today around 4% of South Africans are on second line antiretroviral
therapy (ART) but this number must be increased to 14% for those who have
been on ART for more than 5 years, stressing that this will not be
possible at current costs which are 2.5 times the cost of 1st-line
therapy, emphasizing that  ³We have to put people on treatment that is

There are still other barriers to access, that requires attention in South
Africa, it further said, stressing that the new IP policy under discussion
will promote competition and ensure leveling of the playing field. Patent
examination isamongst these policy reforms, and has been an important
measure as reported in various reports by WIPO and WTO in partnership with
WHO, South Africa further said. It stressed that it was common practise in
Europe, US, India and Brazil to reject poor quality patents.
It also referred to WHO¹s comment to South Africa on its draft IP Policy
which said ³WHO encourages and supports IP policies that maximize
health-related innovations and promote access to medicines for all and
commit to provide assistance consistent with GSPOA².

Brazil said ³access to medicine was a key element in our country² and
stressed on the importance of the use of TRIPS flexibilities.

India referred to The Doha Declaration on TRIPS and Public Health which it
said was  ³very clear and unambiguous² in the right of member states to
use, to the full, the provisions in the TRIPS Agreement, which provide
flexibilities for public health, adding that the Declaration also
reaffirms that the Agreement can and should be interpreted and implemented
in a manner supportive of WTO members' right to protect public health and,
in particular, to promote access to medicines for all."
India also noted that the declaration referred to all medicines and not
just essential medicines and therefore it stronglysupported S. Africa ³in
its efforts to defend the spirit of Doha Declaration on TRIPS and Public
Health so that it can provide access to medicines at an affordable cost."

Cuba, Argentina, Nigeria, Zimbabwe and Bolivia also expressed support for
South Africa.

WHO's Director General, Margaret Chan said ³I have been following the
event in South Africa and I was very struck by what is happening and I
have said so in other contexts and I will repeat again: no government
should be intimidated by interested parties for doing the right thing in
public health². Chan thanked governments for their solidarity with South
Africa, stressing that ³nobody should be denied access to life-saving
intervention or medical products.²

South Centre, and intergovernmental think tank for developing countries,
expressed strong support to South Africa¹s efforts ³to improve access to
medicines, particularly to the ongoing work undertaken to review its
intellectual property legislation in order to integrate public health
concerns into pharmaceutical patent examination.²

South Centre also recalled that history was repeating itself as 14 years
ago, in the Executive Board developing countries and some developed
countries supported the Government of
South Africa when 39 pharmaceutical companies brought a court case against
the South African Government over the terms of its Medicines Act.  It
welcomed a message of support from the Executive Board to the Government
of South Africa on its ongoing reform to their Patents Act.

South Centre added that it supports developing countries making use of
their right to incorporate all the flexibilities contained in the WTO
TRIPS Agreement in their intellectual property legislation and implement
them in order to ensure theaccess of all peoples to necessary medicines.

M?decins Sans Fronti?res (MSF) said that the intersection between
intellectual property, innovation and public health is recognized in a
number of WHO resolutions and in the TRIPSAgreement and yet it remained
achallenge for WHO member states, especially developing countries, to use
these flexibilities when drafting intellectual property policies that aim
to promote access to affordable essential medicines. It added that the
events in SouthAfrica last week illustrated that multinational
pharmaceutical companies will go to great lengths to protect profit
margins, even when it comes at the expense of people¹s lives, and involves
the covert derailing of government policies aiming to balance intellectual
property, public health and access to medicines.  It underlined that such
attacks on urgently needed reform are unacceptable in a country facing one
of the world¹s most acute HIV and TB epidemics, with medicine prices up to
35 times higher than countries with more robust generic competition.

No developed country made an intervention in defense of South Africa's

Adoption of Draft Resolution on Access to Essential Medicines

After numerous informal meetings among Member states, the draft resolution
came up for consideration at the final plenary session of the Executive

In contention was operative Paragraph 11 of the draft resolution which
urged Member States ³to consider, as appropriate, adapting national
legislation in order to make full use of the provisions contained in the
TRIPS agreement, including the flexibilities recognized by the Doha
Ministerial Declaration on the TRIPS agreement and Public Health and other
WTO instruments related to TRIPS agreement, in order to promote access to
essential medicines, as stated in the Global Strategy and Plan of Action
on Public Health, Innovation and Intellectual Property².

US, a non-EB members objected to the use of the words ³as stated in²,
adding that it preferred the use of the term ³ in accordance² which in its
opinion, ³frames proceeding language in full context of the Global

Egypt stated that the use of ³ in accordance with² placed limitations on
the member states with regard to the interpretation of TRIPS Agreement

Brazil, proposed ³ in line with² as alternative wording. This was accepted
by the EB Members with  Australia  commenting that as it was  under ³some
attack with regard to TRIPS flexibilities²( in reference to the on going
challenges to its tobacco plain packaging legislation) and it preferred
the use of ³in line with².

A NGO observer noted that operative paragraph 11 has limited utility as
the scope of the resolution is limited to essential medicines and most of
the medicines on WHO's Essential Medicines List (EML) are off patents. The
observer also noted that several critical patented medical treatments do
not make it to the EML due to the criteria of selection which includes
"costs-effectiveness" . Consequently  since cost continues to be a key
criteria for the selection of essential medicines, patented medicines with
a high price tag tend not to be included to the EML. Recently, civil
society organisations criticized WHO for the exclusionof two critical
cancer medications I.e.  Trastuzumab for the treatment of breast cancer
and Imatinib Meslate for the treatment Chronic Myeloid Leukemia (CML) from
WHO Œs 18th edition of essential medicine list.

Further, the resolution is silent on the provision of adequate resource
allocation to WHO¹s essential medicine program. WHO¹s medicine program is
under funded and under staffed. Oxfam in a letter to Lancet dated January
2013 urged member states ³(1) prioritise and restore the full range of
activities that are needed to support Member States to manage medical
products; (2) support, with adequate finance from the central WHO budget,
medicines-related functions that require independence from the interests
of individual donors; and (3) maintain and increase technical expertise in
countries through the National Pharmaceutical Officers scheme to build
national pharmaceutical capacity for universal health coverage².

The Resolution on ³Access to essential medicines² will now be discussed
during the World Health Assembly which is expected to be held 19­24 May

[*With inputs from Alice Fabbri and Chiara Di Girolamo, WHO Watchers]

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