[Ip-health] CSO Letter to WIPO: Patents & Health (Opposing US proposal)

Sangeeta Shashikant ssangeeta at myjaring.net
Wed May 23 04:04:17 PDT 2012

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 requests the US to withdraw its proposal.
We are of the view that the US proposal fails to recognize the full impact
of patents on access to medicines. In addition, several of the US proposals
fall outside the mandate of the SCP.
The US argues that a number of factors affect the availability of medicines
in developing countries. While this may be the case, the ³price² factor can
singularly be determinative of life or death, where a deadly disease is
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. This has made
lifesaving drugs accessible to millions of people. By the end of 2010, 6.6
million people in low- and middle-income countries had access to ARV therapy
compared to 300 000 in 2002[1] <#_ftn1> .
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
allowed 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 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 access to medicines.[2] <#_ftn2>
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 worldwide. Use of
flexibilities such as pre-grant opposition and prohibition on patenting of
new uses of existing pharmaceuticals available in India¹s Patent Act has
also facilitated access. For instance, in 2006, public-interest groups filed
an opposition against GlaxoSmithKline (GSK)¹s application for a patent on a
fixed dose combination of two known ARV¹s for the treatment of HIV i.e.
zidovudine (AZT) and lamivudine (3TC) ­ Combivir (trade name given by GSK)
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.  The use of these flexibilities has also led to the
rejection of key patent applications on other vital HIV drugs for example
tenofovir, darunavir, and child friendly versions of  nevirapine in syrup
form allowing generic companies to continue to manufacture, supply and
export these medicines to the rest of the developing world.
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.[3]
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 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[4] <#_ftn4> , and yet the
US continues to insist otherwise in its proposal to the SCP.
To support its proposition, the US relies on WHO¹s 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.
The 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.[5]
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 IP system
is unable to address the R&D needs of many people living in developing
countries. Moreover just having a new drug available makes is meaningless if
it is unaffordable to the majority of the patients that need the drug.
We also stress that reliance solely on 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 them including
patent related flexibilities. In this regard it is worth recalling the Doha
Declaration on TRIPS and Public Health which states that the ³TRIPS
Agreement does not and should not prevent Members from taking measures to
protect public health². 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.
The issue of falsified and substandard medicines has NO connection with
patent issues. Thus the SCP 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.
Further the study on the relationship between intellectual property,
innovation and public health proposed by the US is one-sided as it focuses
only on the positive role of the patent system. 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.[6] <#_ftn6>   This report concluded that patents are not
a relevant factor or effective in stimulating R&D and bringing new products
where the market has very limited purchasing power as is the case for
diseases affecting people in developing countries. In fact the monopoly
costs associated with patents limit the affordability of patented
health-care products required in developing countries as well as could be a
barrier to further R&D efforts.
The report also 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 all WIPO 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 urgently enact and use patent
related flexibilities to further their public health objectives. LDCs's
should also seek further extensions of their transition periods, especially
with respect to pharmaceutical product patents and data protection.
1.     Access Campaign Médecins Sans Frontières  International (MSF)

2.     Africa Europe Faith and Justice Network (AEFJN), Belgium

3.     All India Drug Action Network, India

4.     Alternative Law Forum, India

5.     American Medical Student Association (AMSA)

6.     Asian Pacific Resource and Research Centre for Women (ARROW),

7.     Center for Health, Human Rights and Development, CEHURD), Uganda

8.     Centre for Internet and Society, India

9.     Center for Trade and Development, India

10.  Coalition for Health Promotion and Social Development, (HEPS Uganda)

11.  Doctors for Food Safety & Biosafety, India

12.  Egyptian Foundation for Health for All

13.  Egyptian Initiative for Personal Rights

14.    Gene Campaign, India

15.    Gonoshasthaya Kendra, Bangladesh

16.    Health GAP, US

17.    Health Poverty Action, UK

18.    HEPS, Uganda

19.    Initiative for Medicines, Access & Knowledge (I-MAK), US

20.    Initiative for Health & Equity in Society, India

21.    Knowledge Commons, India

22.    Labour, Health and Human Rights Development Centre, Nigeria

23.    National Working Group on Patent Law, India

24.    ONG Derechos Digitales, Chile

25.    Oxfam

26.    Peoples¹ Health Movement, Global

27.    Positive Malaysian Treatment Access & Advocacy Group (MTAAG+)

28.    Research Foundation for Science Technology & Ecology, India

29.    Third World Health Aid - Médecine pour le Tiers Monde (TWHA-M3M)

30.    Third World Network

31.    Universities Allied for Essential Medicines

32.    Wemos
33.    Dr. N. Raghuram, Ph.D. Associate Professor, Biotech Faculty, School
of Biotechnology,   GGS Indraprastha University

34.    T C James, Former Director (IPR) Department of Industrial Policy &
Promotion, India

[1] <#_ftnref1>  DOHA+ 10 TRIPS Flexibilities and Access to Antiretroviral
Therapy: Lessons from the Past, Opportunities for the Future; UNAIDS
Technical Brief 2011 available at
ion/2011/JC2260_DOHA+10TRI PS_en.pdf

[2] <#_ftnref2>  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 and Access to
Antiretroviral Therapy: Lessons from the Past, Opportunities for the Future;
UNAIDS Technical Brief 2011 available at
ion/2011/JC2260_DOHA+10TRI PS_en.pdf.

[3] <#_ftnref3>  See Country Experiences in Using TRIPS Safeguards, WHO,
2008 available at

[4] <#_ftnref4>  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: ³ 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.² See also the
UNGA Political Declaration on HIV/AIDs adopted in 2011.

[5] <#_ftnref5>  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.

[6] <#_ftnref6>  See

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