PHM-Exch> Fwd: Sign-on Letter to WIPO: Patents & Public Health

Heba Wanis h.wanis at googlemail.com
Thu May 17 08:30:01 PDT 2012 

Dear All,

Please see this sign-on letter by Third World Network addressed to WIPO
regarding patents and public health. The Standing Committee on the Law of
Patents is meeting next week and will discuss proposals under this agenda
item; one by the Development Agenda Group and the African Group, and the
other by the USA.

You are invited to sign and to share this email with other interested gro
ups. Please send an email to sangeeta at twnetwork.org or
ssangeeta at myjaring.net by 21st May 2012.

Thanks very much.

Best wishes,
Heba

-------------------------------

** **

Dear All,


Next week the WIPO Committee on Patents will meet. On the agenda is a
proposal by the Development Agenda Group and the Africa Group on patents
and public health. See

*http://www.wipo.int/edocs/mdocs/scp/en/scp_18/scp_18_ref_scp_16_7.pdf *This
proposal was submitted on May 2011. But at a subsequent session, the US
submitted a proposal which makes outrageous statements on the issue of
patents and public health. Basically US is claiming that patents do not
adversely impact access to medicines; flexibilities particularly compulsory
license do not promote public health, endorses voluntary approaches, and
calls for a discussion on falsified and substandard medicines (an issue
totally unrelated to patents) in the SCP.

The US proposal is available at:
http://www.wipo.int/edocs/mdocs/scp/en/scp_18/scp_18_ref_scp_17_11.pdf


Thus some of us thought it would be a good idea to draft a letter in
support of the DAG and Africa Group proposal and to oppose the US proposal.
See the Open Letter below on this issue


*If you (as an individual) or your organisation would like to support this
letter, pls do send an email to sangeeta at twnetwork.org or
ssangeeta at myjaring.net by 21st May 2012. *


Regards

Sangeeta Shashikant

Third World Network

------------------------------------------------------------------------------------------

*
*

*OPEN LETTER TO WIPO MEMBER STATES ON PATENTS AND PUBLIC HEALTH*

* *

*The undersigned civil society organizations would like to express their
support for the proposal on patents and public health submitted to the
Standing Committee on Patents (SCP) by the Development Agenda Group (DAG)
and the Africa Group (SCP/16/7). *

* *

*The undersigned civil society organizations would also like to express
serious concerns with regard to the US proposal on patents and public
health contained in SCP/17/11 and request the US to withdraw its proposal
from the SCP. *

* *

We are of the view that the US proposal is frivolous and aimed at
trivialising the impact of patents on access to medicines. In addition,
several aspects of the US proposals fall outside the mandate of the SCP and
thus must not be accepted. ****

** **

The US argues that a number of factors affect the availability of medicines
in developing countries. While this may be the case, the “price” factor can
singularly can be determinative of life or death, where a deadly disease
istreatable.  ****

** **

In the past decade, ARV prices have dropped from more than US$10,000 per
person per year (pppy) in 2000 to less than US$65 pppy today – improved
first line regimens costing US$24,972 in the US cost as little as $219 from
generic producers. These 99%+ cost-savings have made lifesaving drugs
accessible tomillions of people, that by the end of 2010, 6.6 million
people in low- andmiddle-income countries had access to ARV therapy
compared to 300 000 in 2002. ****

** **

A twenty-two-fold increase in ARV coverage was only possible due to
competition from suppliers of generic drugs principally from India, where
the drugs were not patented as India used transitional period flexibility
under TRIPS. This single example shows how the removal of patent barriers
can have enormous positive impact for access to medicines throughout the
world.  ****

** **

The US SCP proposal undermines the role of patent flexibilities
particularly compulsory licensing in improving access to affordable
treatments. It is clear that the US has deliberately chosen to ignore
concrete evidence available today on the positive impact of the use of
public health relevant flexibilities on public
health.[1]<#1375b431f5cb5e11__ftn1>
****

** **

The case of India provides solid evidence on how the use of the
transitional period facilitated the availability of generic medicines,
which in turn enabled massive scaling up of HIV/AIDS treatment. Use of
flexibilities such as pre-grant opposition and prohibition on patenting of
new uses of existing pharmaceuticals available in India’s Patent Act has
also facilitated access. For instance, in 2006, public-interest groups
filed an opposition against GlaxoSmithKline (GSK)’s application for a
patent on Combivir arguing that the product is a combination of two drugs
in one pill and thus not deserving of a patent under the Indian patent law.
Following filing of the pre-grant opposition, GSK withdrew its pending
patent applications in India as well as in other countries enabling
improved access to generic versions of Combivir.   ****

** **

A number of countries have also used compulsory licensing to overcome the
patent barrier and improve access to medicines. This includes Malaysia,
Zimbabwe, Brazil, Thailand, and Indonesia and evidence available suggests
that overall the compulsory licenses led to availability of more affordable
generic versions of medicines in the country issuing the
license.[2]<#1375b431f5cb5e11__ftn2>
****

** **

Most recently the Indian patent office granted a compulsory license to a
local manufacturer on Bayer's anti-cancer medicine sorafenib on the ground
that the patented drug was not available to the public at a reasonably
affordable price. The patented version costs US$5600 per month while the
generic version produced under the compulsory license would only costs
US176, i.e. at a price reduced by nearly 97%. As a result of the compulsory
license other generic producers have also slashed prices of other key
cancer drugs by more than 50%. The compulsory license clearly will improve
access to affordable medicines for cancer patients in India. ****

** **

In view of this concrete evidence that is publicly known, it is indeed
shameful that the US government continues to question the role of patent
flexibilities to improve access to medicines. The importance of using
flexibilities to improve public health is recognized in various
international instruments, to which US is a party[3]<#1375b431f5cb5e11__ftn3>,
and yet the US continues to insist otherwise in its proposal to the SCP. ***
*

** **

To support its proposition, the US relies on WHO’s List of Essential
Medicines noting that patents presently protect only about 4% of the
medicines. It is a well-known fact that drugs for HIV/AIDS were only added
to the EML after extensive campaigning by AIDS activists and that the WHO
Model List is under-inclusive because it excludes many newer and more
expensive treatments that remain covered by patents, such as in the case of
cancer treatments. In addition, just because other factors, including
health system weaknesses, may affect access, this does not preclude the
need to also address patent barriers. ****

** **

In fact, WHO itself has recognized that patents can impact access to
medicines and has issued/commissioned various publications on the matter
that encourage the use of TRIPS flexibilities to overcome the patent
barrier.[4] <#1375b431f5cb5e11__ftn4> ****

** **

The US also asserts that using flexibilities weakens patent rights and that
more medicines are made available if patent protection is strong. We find
this argument to be baseless particularly as no data has been presented to
support the co-relation between the use of flexibilities by low- and
middle-income countries and reduced incentive for development of new
products. Further it is now widely acknowledged that the existing
incentivesystem is unable to address the R&D needs of many people living in
developing countries. Moreover just having a new drug available makes is of
no help if it is unaffordable to the majority of the patients that need the
drug. ****

We also stress that sporadic voluntary approaches are simply inadequate to
address the access to medicines challenge facing developing countries as
these approaches depend on the willingness of the patent holder.****

We are of the view that governments have a responsibility to ensure that
the access to medicines needs of its people is satisfied. Toward this end
governments should use the full range of options available to themincluding
patent related flexibilities. In this regard it is worth recalling the Doha
Declaration on TRIPS and Public Health which states that the “TRIPS
Agreement does not and should not prevent Members from taking measures to
protect public health”. It also reaffirms the right of WTO member states to
grant compulsory licenses and the freedom to determine the grounds upon
which such licenses are granted, the right to determine what constitutes a
national emergency or other circumstances of extreme urgency (mentioned in
Article 31 of the TRIPS Agreement) and the freedom to determine its own
regime of exhaustion of rights.****

In its proposal the US also calls for the SCP to address issues of
falsified and substandard medicines, in particular the extent to which such
medicines hinder the availability of genuine medicines, both generic and
patented. ****

** **

We are of the view that the issue of falsified and substandard medicines
has absolutely NO connection whatsoever with patent issues and thus WIPO
does not have the mandate to discuss this issue. A pharmaceutical product
is granted a patent on the basis whether it fulfills the patentability
criteria applied nationally and not on the basis of quality and safety of
medicines.  Further the issue of availability of quality, safe and
effective medicines is the mandate of the WHO, wherein there are on-going
intergovernmental discussions on the issue of quality and safety of
medicines. ****

** **

We reiterate that the US proposal is frivolous and aimed at trivialising
the issue of the impact of patents on access to medicines. ****

** **

More specifically we urge that Member States do not accept the specific
proposals made by the US, particularly proposals that invite WHO to make a
presentation in the SCP on non-patent barriers and on the effect of
falsified medicines and to study the issue of availability of unpatented
medicines and factors (unrelated to the patent system) that affect
availability of medicines, including the effect of falsified medicines.
These proposals fall outside the mandate of the SCP and thus should not be
accepted. The appropriate forum for these issues is the WHO and not WIPO. **
**

** **

Further the study on the relationship between intellectual property,
innovation andpublic health proposed by the US is one-sided as it focuses
only on the positive role of the patent systems. It should be noted that
the WHO Commission on Intellectual Property, Innovation and Public Health
released a detailed report in 2006 on the linkages between IP, innovation
and public health.[5] <#1375b431f5cb5e11__ftn5> This report led to the
adoption of the Global Strategy and Plan of Action on IP, Public Health,
and Innovation in 2008. Thus any further work in this area must build on
the WHO outcomes. ****

** **

*For the reasons mentioned above, the undersigned organizations would like
to call upon the US to withdraw its proposal on patents and public health
contained in SCP/17/11. *

*The undersigned organizations would also like to express their support for
the DAG and the African Group proposal on patents and public health and
call on allWIPO Member states including the US to support that proposal.
Further WIPO member states must  make all efforts at this SCP to agree to a
work-plan as outlined in the DAG and African Group proposal.  *

*We also encourage and call on all countries to enact and use patent
related flexibilities to support their public health objectives. LDCs's
should also seek further extensions of their transition periods, especially
with respect to pharmaceutical product patents and dataprotection. *

*Signatories*

** **

Health GAP****

Oxfam****

Third World Network****

* *

* *

* *

** **

** **

** **

** **

** **

------------------------------

[1] <#1375b431f5cb5e11__ftnref1> See for e.g. South Centre/WHO. The use of
flexibilities in TRIPS by developing countries: can they promote access to
medicines? Geneva: South Centre/WHO, 2006; DOHA+ 10 TRIPS Flexibilities
andAccess to Antiretroviral Therapy: Lessons from the Past, Opportunities
for the Future; UNAIDS Technical Brief 2011 available at
http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2011/JC2260_DOHA+10TRI
PS_en.pdf<http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2011/JC2260_DOHA+10TRIPS_en.pdf>
.****

[2] <#1375b431f5cb5e11__ftnref2> Country Experiences in Using TRIPS
Safeguards, WHO, 2008 available at****

http://www.searo.who.int/LinkFiles/IPT_Briefing_note_4_country_experiences.pdf
****

[3] <#1375b431f5cb5e11__ftnref3> See for instance the WHO Global Strategy
and Plan of Action on public health, innovation and intellectual property
(GSPOA) adopted by all WHO member states including the US in 2008 through
resolution WHA 61.21 states in para 12 that: “ International intellectual
property agreements contain flexibilities that could facilitate increased
access to pharmaceutical products by developing countries. However,
developing countries may face obstacles in the use of these flexibilities.
These countries may benefit, inter alia, from technical assistance.” See
also the UNGA Political Declaration on HIV/AIDs adopted in 2011[3]****

[4] <#1375b431f5cb5e11__ftnref4> See
http://www.who.int/phi/publications/category_ip_trade/en/index.html for a
full list of WHO publications on intellectual property and health.****

[5] <#1375b431f5cb5e11__ftnref5> See
http://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf
 ****
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