PHM-Exch> Access to medicines resolution adopted by UN HR Council

[Claudio Schuftan]

From: shila kaur <kaur_shila at yahoo.com>  Health Action International Asia
Pacific (HAIAP)

Courtesy of TWN Info service.  Article written by K.M. Gopakumar of PHM.
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 Third World Network  www.twn.my <http://www.twn.my/>

*Access to medicines resolution adopted     excerpts
*
New Delhi, 15 Jul (K. M. Gopakumar) -- The United Nations Human Rights
Council has adopted a resolution on access to medicines despite opposition
from the United States and the European Union.

This was at the 23rd session of the Council held in Geneva on 27 May-14
June 2013. The resolution was sponsored by developing countries as a
follow-up to the Report of the UN Special Rapporteur on the right of
everyone to the enjoyment of the highest attainable standard of physical
and mental health, Anand Grover, on access to medicines.

Out of 47 members of the Human Rights Council, 31 voted for the resolution
while 16 abstained from voting.

[The following countries voted in favour of the resolution: Angola,
Argentina, Benin, Botswana, Brazil, Burkina Faso, Chile, Congo, Costa Rica,
Cote d'Ivoire, Ecuador, Ethiopia, Gabon, Guatemala, India, Indonesia,
Kenya, Kuwait, Libya, Malaysia, the Maldives, Mauritania, Pakistan, Peru,
the Philippines, Qatar, Sierra Leone, Thailand, Uganda, United Arab
Emirates, and Venezuela].

[The following countries abstained from voting: Austria, Czech Republic,
Estonia, Germany, Italy, Ireland, Japan, Kazakhstan, Montenegro, Poland,
Republic of Korea, Republic of Moldova, Romania, Spain, Switzerland, and
the United States of America.]

According to a developing country delegate, the EU and the US led the
abstention. It was learnt that the US proposed nearly five amendments to
the resolution with the objective of limiting the scope of the resolution
to essential medicines and also to dilute the wording on local
manufacturing.

Disagreement during the informal negotiations led to the decision of the
US, the EU, Japan, Republic of Korea, Switzerland and Kazakhstan to abstain
from voting.

Another developing country delegate termed the EU's abstention decision as
"backstabbing" because the EU had proposed a series of amendments during
the informal negotiations and consensus was reached on many issues raised
by the EU. However, the EU decided to back-track from the consensus and
joined with the US decision to abstain from voting.

According to an observer, the US might have purposefully proposed the
textual changes at the last minute to avoid consensus on a resolution
containing language to develop a policy framework on local production of
medicines.

It was also learnt that the EU, apart from suggesting more than 25 textual
amendments to the first version of the June 2013 resolution, also raised
three broad comments, which indirectly questioned the very idea of the
resolution.

It was learnt that even though some of the EU amendment proposals were
limited to language edit without altering the substance of the resolution,
many proposals for amendments were also aimed at diluting/limiting the
content of the resolution.


According to an observer, the resolution is a step forward in addressing
the issue of access to medicines within the right to health framework.

This is the first time a comprehensive resolution covering most of the
determinants of access to medicines within the human rights framework is
articulated in a stronger language than the earlier Human Right Council
Resolution 17/14 of 2011.

The Resolution 17/14 used the word "encourages States" and listed down 11
measures. This resolution is stronger than "urging". Further, the
resolution recognizes access to medicines as one of the fundamental
elements in the realization of the right to health in OP 2.

Secondly, unlike some earlier resolutions, the scope of the June 2013
resolution is not limited to essential medicines and covers all medicines.

Thirdly, the resolution clearly addresses the issue of prices of medicines
and urges States in the regulation of prices in OP 5(c), "To adopt
regulation measures with a view to providing access of the population, and
particularly individuals in vulnerable situations, to affordable
medicines". This clearly means the regulation of prices of medicines to
make them affordable for people. This is important in the context of
developing countries where people incur out-of-pocket expenditure to buy
medicines.

Fourthly, the resolution through OP 5(b) and OP 5(m), clearly establishes
the link between local production and the right to health framework.

Fifthly, OP 5(n) of the resolution also addresses the research and
development question within the right to health framework, especially
referring to a new R&D model based on de-linking of cost of R&D from the
price of health products.

Sixthly, the resolution also establishes the link between access to
medicines and universal health coverage in OP 5(p).

Seventhly, unlike the earlier resolution, this one reflects the conflict of
interest issue while referring to engagement with stakeholders. OP 5(e) and
OP 8 clearly state that the engagement with stakeholders is based on the
principle of safeguarding public health from undue influence by any form of
real, perceived or potential conflict of interest.

Another observer points out some of the shortcomings of the resolution.

First, the OP 5(a) language does not convey the message clearly because it
urges States to develop a national framework to ensure access to "medicines
that are affordable, safe, efficacious and of quality".

According to the observer, even though the intention is clear, it conveys a
meaning that the framework should ensure access to only those medicines
that are affordable, safe, efficacious and of quality. In other words, it
conveys a meaning that the framework need not address the medicines which
are not affordable but safe, efficacious and of quality.

Secondly, OP 5(h) dealing with the use of TRIPS flexibilities also states
that the protection of intellectual property is important for the
development of new medicines. This is a highly contested assertion. There
is enough evidence to show that the current IP framework, especially patent
protection, is not a necessity to develop new medicines, especially to
develop medicines to meet the needs of developing countries.

Thirdly, OP 5(j) on IP enforcement conveys a meaning that restrains the
application of IP enforcement only if the measures and procedures create a
barrier to the legitimate trade of affordable, safe, efficacious and
quality medicines. In other words, the resolution does not apply in the
context when the medicine is not affordable.

Fourthly, OP 9 urging states and international organizations to promote
innovative research and development to address health needs in developing
countries omitted the de-linkage of the costs of research and development
from the price of health products, mentioned in OP 5(n).

Fifthly, the resolution does not contain any mention of curbing the
unethical promotion of medicines. The Report of the Special Rapporteur
identified it as one of the important issues affecting access to medicines.
The Report recommended to "Prohibit unethical commercial marketing and
promotion of medicines by pharmaceutical companies through legal
accountability measures based on strict penalties and cancellation of
manufacturing licenses."

Similarly, the resolution is also silent on the transparency of clinical
trial data. The Special Rapporteur's Report recommended to "Ensure
transparency of data related to quality, safety and efficacy of medicines,
including the mandatory publication of adverse data." +
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