[Ip-health] SUNS : Thailand issues compulsory licence for cheaper AIDS drug

[Sangeeta]

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SUNS #6153 Friday 1 December 2006

Thailand issues compulsory licence for cheaper AIDS drug

Beijing, 30 Nov (Chee Yoke Ling) -- Thailand's Ministry of Public Health
announced on Wednesday that the government will use a 5-year compulsory
licence for domestic manufacture of a much cheaper generic AIDS drug just
before World AIDS Day on 1 December.

 This is the first time that Thailand is using a legal tool under its patent
law and which is allowed by the Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS) of the World Trade Organisation.



The anti-retroviral drug, efavirenz, which is recommended by the World
Health Organization (WHO) for HIV/AIDS treatment, is commonly used and
considered by doctors as one of the best components for first-line therapy
because it has less side effects and is more suitable for those co-infected
with other diseases such as tuberculosis or liver infections. Although it
has been in the market for many years, efavirenz remains very expensive
around the world.



Originally developed by Dupont Pharma, the drug is now marketed by
Bristol-Myers-Squibb. Merck, another pharmaceutical giant, has marketing
licence rights in a number of countries including Thailand and China.



According to The Nation, the Thai daily newspaper, "The so-called government
compulsory licensing took effect immediately following [the] announcement
and the Government Pharmaceutical Organisation was expected to start mass
production of a generic version of the drug in six months".



In the meantime, imports of the generic drug from India under the same
compulsory licence will start. The cost of the drug for treatment will be
$22 per month using the Indian generic version compared to the Merck price
in Thailand which is $41 per month. The cost of the locally produced drug is
expected to be around half of Merck's.



Payment equivalent to 0.5% of the sales in Thailand for the generic version
of efavirenz will be made to Merck.



Minister of Public Health Dr. Mongkol na Songkhla told The Nation that there
were about 500,000 HIV-infected people who needed to use anti-retroviral
treatments, yet only about 100,000 had access to the drugs because of the
high prices - as well as insufficient budgets. "Of course, the company
[patent holder/licensee] will do something to oppose this but we're doing
everything according to not only the country's law, but also international
law," said Mongkol.



Under the TRIPS Agreement, a compulsory licence can be issued to someone
other than the patent holder to manufacture or import a product under
patent. When used by a government (or a contractor of the government) for
public non-commercial use, there is no need for prior negotiations with the
patent holder. In this kind of compulsory licensing, commonly called
"Government Use", it is sufficient for the government to inform the patent
holder, and to pay an "adequate remuneration".



Compulsory licensing is an important legal tool to ensure access to
affordable medicines and its importance and use were reaffirmed in the 2001
Doha Declaration on the TRIPS Agreement and Public Health. Thailand's Patent
Act 1999 in section 51 states that any ministry, bureau or department of the
Government may, by themselves or through others, exercise the compulsory
licensing right "in order to carry out any service for public consumption or
which is of vital importance to the defense of the country or for the
preservation or realization of natural resources or the environment or to
prevent or relieve a severe shortage of food, drugs or other consumption
items or for any other public service".



The Thai Network of People Living with HIV/AIDS (TNP+) and other HIV/AIDS
activists hailed the Thai government's decision. They have been at the
forefront to advocate for the government to use the flexibilities in the
TRIPS agreement.



In a march that ended at the Ministry of Public Health on Wednesday when the
announcement was made, TNP+ in a press statement said, "This ground breaking
decision sets an important precedent for the issuing of CL for other
desperately needed but costly medication for other chronic diseases such as
kidney disease and cancer".



"Thank you for the courage of the Public Health Ministry. It's remarkably
brave," said Nimitr Tienudom, the manager of AIDS ACCESS Foundation, in a
report of The Nation newspaper.



According to the international medical humanitarian organization, Medecins
Sans Frontieres (MSF), at least 12,000 people in the country are estimated
to need efavirenz, but due to cost and supply difficulties, the number
receiving the drug is significantly lower.



"Merck's supply of efavirenz has not been reliable, and has resulted in
treatment interruptions, forcing several hospitals to supply sub-optimal
dual therapy," said Dr. David Wilson of MSF in Thailand.



In welcoming this important move, MSF also urged the government to issue
such licenses for the production of other essential medicines. "Thailand is
demonstrating that the lives of patients have to come before the patents of
drug companies, and this policy needs to be expanded to essential drugs that
are expensive and in short supply, such as the AIDS drug
lopinavir/ritonavir, which currently costs over $194 and is far too
expensive for Thailand," said Dr. Wilson.



Thomas Cai of AIDS Care China, an HIV/AIDS community group based in the
southern city of Guangzhou, also joined the support for the Thai
Government's move.



On Tuesday, the China Treatment Advocacy Coalition comprising 27 independent
groups of persons living with HIV/AIDS in China, issued a press statement as
part of their continuous efforts which started 2 years ago to get Merck to
reduce the price of efavirenz.



According to the Coalition, among the approximately 30,000 people receiving
free anti-retroviral therapy from the government in China, fewer than 3,000
are able to receive efavirenz due to high costs. Efavirenz is much more
suitable for those who have liver infections, and a large number of HIV/AIDS
patients in China have such co-infections, the statement explained.



However, the Coalition said that: "We have only seen delays and
prevarications from [Merck], including in reply to our latest letter in
October 2006. Therefore, we believe that it is our responsibility to report
this situation to the press, and we hope that this media exposure will help
to ensure that people with no access to medicine will all receive care and
treatment".



According to the December 2006 AIDS Epidemic Update by UNAIDS/WHO, an
estimated 8.6 million people were living with HIV in Asia in 2006, including
the 960,000 people who became newly infected in the past year.



Approximately 630,000 died from AIDS-related illnesses in 2006. The number
of people receiving anti-retroviral treatment has increased more than
threefold since 2003, and reached an estimated 235,000 by June 2006. This
represents about 16% of the total number of people in need of
anti-retroviral treatment in Asia.



Only Thailand has succeeded in providing treatment to at least 50% of people
needing it, according to the Update.



Thailand's achievement is possible because of generic drug production that
underlies the country's universal HIV/AIDS treatment programme. According to
MSF, before generic production by the Government Pharmaceutical Organisation
(GPO), the public drug manufacturer, the cost of HIV/AIDS treatment was more
than $924 per patient per month, and only 3,000 people were getting
treatment.



Since GPO's generic version of HIV/AIDS triple therapy was available from
2002, the cost of treatment has fallen by 18 times. More than 85,000 people
with HIV/AIDS are currently receiving treatment.



With this latest move using a compulsory licence to enable the GPO to first
import, and then locally manufacture, generic versions of efavirenz,
Thailand has further strengthened its policy to ensure access to affordable
AIDS drugs.



Thailand is the third country in the region to use compulsory licensing for
cheaper anti-retroviral drugs after Malaysia and Indonesia. In 2003, the
Malaysian Government issued a 2-year government use order for imports of
generic drugs from India. As a result, treatment cost at government
hospitals dropped by an average of 81% per patient per month.



Indonesia issued a government use order in 2004 to manufacture two generic
versions and this will run until the end of the patent term in 2011 and 2012
respectively. The Indonesia Government, as in the Thai case, awarded 0.5% of
the net selling value to the companies concerned.



The price of one of the drugs (lamivudine) fell from a retail average of
$225 in 2000 to $28 under the government scheme that is supplied by domestic
production. The cheaper drugs are used to treat almost 50% of those in need
of AIDS treatment in 2006 compared to 3.5% in 2003.



Studies by the WHO in 2005 and the World Bank last August have raised the
alarm bells on rising AIDS drugs costs in countries including Thailand. Both
the WHO and World Bank recommended that countries use the public health
safeguards in TRIPS and the Doha Declaration. +




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