[Ip-health] Comment on CL by Thai CSOs

Kar K. kakablueblue at gmail.com
Sat Oct 2 13:15:26 PDT 2010


Mr. V. Bhaskar
Joint Secretary
Department of Industrial Policy and Promotion (DIPP)
Ministry of Commerce and Industry
Room No. 236, Udyog Bhavan
New Delhi - 110 011
Tel: 011-23063571
Fax: 23063017
Email: v.bhaskar at nic.in



28 September 2010



Dear Mr. Bhaskar,



We write today in support of India’s exploration of adopting policies for
the compulsory licensing of patents.  Thailand serves as an example that
India and other countries can follow when implementing policies for
compulsory licenses of patents to create a predictable policy environment
for the issuance of these licenses.  Thus far, the Thai government has
successfully issued compulsory licenses for HIV, cancer, and heart disease
medicines, at a savings of more than 1.5 billions of baht (US$ 50 million)
and doubled the number people having access to these medicines.  In this
letter, we briefly outline the history of one such compulsory license issued
for an HIV medicine and also attach further information about Thailand’s
history of issuing compulsory licenses.



In January 2007, following protracted negotiations with companies on price
that eventually failed, the Minister of Health of Thailand issued a
compulsory license for lopinavir/ritonavir which led to a significant
increase in access to this essential medicine in Thailand. It was
unfortunate that valuable time was lost in failed price negotiations that
were neither required by domestic nor international law, a fact pointed out
in the government’s white paper “Facts and evidences on the 10 burning
issues related to government use of patents in Thailand” (see annex 1).



It is of note that the Government of Thailand, and in particular the
Ministry of Public Health which played a key role in identifying the medical
needs, went on to issue government use licenses on drugs used to treat
cancer, a condition no less serious than HIV/AIDS, which leads to more than
30,000 deaths annually in Thailand, with more than 100,000 new cases
reported each year (see annex 2).



Your approval of compulsory licensing of patents in India also holds the
potential to lower the cost and improve access medicines for HIV/AIDS and
other chronic conditions. Many countries, including Thailand, have
successfully issued compulsory licenses for pharmaceutical products.  Not
only would lower prices provide more treatment and save lives, but it would
also save money that could be reinvested in scaling-up treatment and other
public health priorities, as it has in Thailand.



Lopinavir/ritonavir is an important product for treating HIV/AIDS, but
Abbott’s brand-name version is significantly more expensive than available
generics.  Prior to January 2007, a year’s supply of lopinavir/ritonavir
cost US$2,200 per person in Thailand.  However, after the Thai Minister of
Health approved the compulsory license for lopinavir/ritonavir, Thailand
began importing a generic version from India, significantly reducing the
cost of treatment to US$600 per person per year.  Furthermore, the price of
the original products also reduced to $US 1,000. Therefore, with this
drastic reduction in cost for lopinavir/ritonavir, use of this drug
increased in Thailand from almost zero bottles before the compulsory
license, to almost 5,000 bottles of lopinavir/ritonavir used in January
2009.



These savings not only increase access to second line ARVs, but can also be
channeled to deliver other essential health services. In Thailand, we used
the savings to start the Renal Replacement Therapy, including renal
transplant, peritoneal dialysis and hemodialysis. The same could be done in
India (for your reference we are enclosing presentations by the Thai
government documenting the savings, decrease in prices and increase in
availability of medicines as annex 3 and 4).



It is thanks to Indian generic producers that our efforts to enhance access
to essential medicine for Thai people were made possible as all the
medicines subject to compulsory license have been imported from India.
However we are extremely concerned that newer medicines, which are patented
in India, will no longer be available to us unless your government takes the
bold step of using compulsory licensing to open up generic production of
these medicines for both domestic use and for export.



International law and practice provides ample support for India to adopt
policies around compulsory licenses for patents. The World Trade
Organization guarantees its member states “the right to grant compulsory
licenses and the freedom to determine the grounds upon which such licenses
are granted.”[1] <#_ftn1> As members of the WTO, every country has the right
to use to the full extent its flexibilities for the benefits of its people.
Many countries have successfully issued compulsory licenses for
pharmaceutical products, including Thailand.  Furthermore, the proposed
license royalty rate of 5% represents quite a high contribution to the
research and development of new medicines and it should be  noted that the
Thai government fixed a royalty rate of 0.5% for the government use licenses
they issued.



The Thai decision was also strongly supported by the WHO, UNAIDS, US
congressmen, and may NGOs. In addition the World Bank in its report “The
Economics of Effective AIDS Treatment: Evaluating Policy Options for
Thailand” includes a recommendation that “a second way for the government to
limit its expenditure on second-line therapy is to grant compulsory licenses
for the manufacture of patented second-line pharmaceutical
products”[2]<#_ftn2>(see annex 5 and 6).



We also found clear evidence that the threats from our trade partners,
especially the US, were false threats. Putting Thailand on the Priority
Watch List and cutting the GSP to three Thai products to the US did not
reduce overall Thai exports to the US or the export of the three products
(for this and more evidence of the impact of the Thai compulsory licenses
please see annex 7). However, the US and the EU are still trying to limit
Thailand’s ability to issue compulsory licenses through FTA negotiations,
the same tactic they are using in their negotiations with the Indian
government.



Compulsory licensing of patents is a valid and valuable means of improving
access to medicines, and India has our support as it explores this
possibility.  Moreover, we encourage the Indian government to work with us
and the Thai government to further the successful use of compulsory licenses
in the region to continue fighting HIV/AIDS, cancer, heart disease,
Hepatitis C and other chronic diseases.  If you need further information or
have questions about the enclosed information, please feel free to contact
us.



Sincerely,







Dr. Mongkol Na Songkhla,

Former Public Health Minister, Thailand



The Thai Network of People living with HIV/AIDS (TNP+)

 Alternative Agricultural Network



Rural Pharmacists Foundation



Rural Doctors Foundation



Drug Study Group



Health Consumers Protection Programme Chulalongkorn University



Social Pharmacy Action Research Unit, Chulalongkorn University



Thai NGO Coalition on AIDS



Foundation for AIDS Rights



AIDS ACCESS Foundation



Foundation for Consumers



Health and Development Foundation,



FTA Watch



Campaign for Alternative Industry Network (CAIN)



*Contact person: *

Kannikar KIJTIWATCHAKUL

Coordinator,

Co-Project between Campaign for Access to Essential Medicines, Médecins Sans
Frontières
and Health Consumer Protection Program Chulalongkorn University.

T (+66) 2 218 8445

F (+66) 2 251 3531

M (+66) 89 500 3217

kakablue at yahoo.com



Annexes:



   1. ‘*Facts & Evidence: the 10 burning issues related to the Government
   use of patents on three patented essential drugs in Thailand - **Document
   to Support Strengthening of Social Wisdom on the Issue of Drug Patent*’,
   The Ministry of Public Health and The National Health Security Office,
   Thailand, February 2007



   1. ‘*The 10 burning questions regarding the Government Use of Patents on
   the four anti-cancer drugs in Thailand,*’ The Ministry of Public Health
   and The National Health Security Office, Thailand, February 2008



   1. ‘*Thailand’s Experience with Government-Use Licenses*’, Presentation
   by Dr. Suwit Wibulpolprasert Senior Advisor on Disease Control, Ministry of
   Public Health, Thailand, Symposium on flexibilities in the International
   Intellectual Property Rules and the Local Production of Medicines for ASEAN
   Countries, 16-19 December 2008, Arnoma Hotel, Bangkok.



   1. ‘*Compulsory Licencing – Thailand Experiences*,’ Presentation by Dr
   Siriwat Tiptaradol, Deputy Permanent Secretary, Ex-SG-FDA, Ministry of
   Public Health



   1. *The Economics of Effective AIDS Treatment: Evaluating Policy Options
   for Thailand*.' The World Bank, Washington DC, USA, 2006



   1. *Improving Access To Medicines In Thailand: The use of TRIPS
   flexibilities*, Report of a WHO Mission, Bangkok, 31 January to 6
   February 2008



   1. *Assessing The Implications Of Thailand’s Government Use Licenses
   Issued In 2006-2008*, Health Intervention and Technology Assessment
   Program (HITAP), Ministry of Public Health, Thailand, July 2009





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

[1] <#_ftnref1> World Trade Organization, Declaration on the TRIPS Agreement
and Public Health, or “Doha Declaration,” Paragraph 5(b), 2001.

[2] <#_ftnref2> Revenga A, Over M, Masaki E, Peerapatanapokin W, Gold J,
Tangcharoensathien V, Thanprasertsuk S.

The Economics of Effective AIDS Treatment: Evaluating Policy Options for
Thailand.' The World Bank,

Washington DC, USA, 2006.



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