Info Service on Health Issues (February 07/02)
WHO DG's Shocking Views on Compulsory Licensing Criticised by Health
Movements and Experts
A controversy has emerged in the last few days on statements made by
the new WHO Director General Dr Margaret Chan on the compulsory licenses
issued by the Thai government for the production of three patented drugs.
Dr Chan was in Bangkok to attend the Prince Mahidol Award Conference
2007 held on 1-2 February 2007.
It started at the opening session on 1 February when she spoke on neglected
diseases and she praised the multinational drug companies, as well as
concluding that the solution to the neglected diseases problem was "drug
donation", i.e. that the industry should donate drugs.
On 2 February, the Bangkok Post carried the title on one of its articles:
"WHO raps compulsory license plan." The DG had waded into
one of the most publicized issues in Thailand today: The Thai government
has recently issued three compulsory licenses for 2 AIDs drugs and 1
heart drug. This had been warmly welcomed by patients' groups and health
NGOs, while criticised by the multinational drug industry as well as
the US and Swiss governments.
The WHO DG apparently gave warnings to Thailand during a visit to the
Office of Health Security, an agency that is responsible for ensuring
universal health care, and which played an important role in the compulsory
On 2 February the Thai NGOs organised a press conference during which
five experts and NGOs spoke, each one being very critical of the WHO
DG position. Those who spoke were Carlos Correa (professor in University
of Buenos Aires and expert on patent law and medicine), Dr. Ellen ’t
Hoen of MSF, James Love (CP Tech), Nimit Tienudom (the president of
Aids Access Foundation of Thailand) and Martin Khor (TWN).
Indeed, the Thai NGOs and organisations representing patients' rights,
as well as many NGOs, experts and individuals from outside Thailand,
were all outraged at what had transpired, and the criticisms against
the recent actions of the WHO leadership were also voiced inside the
We are attaching 4 documents below:
(1) a report by IPS press agency on the NGO criticism on WHO's DG and
recent actions by WHO leadership
(2) a report in Bangkok Post of 3 Feb on the press conference held by
Thai NGOs, at which the views of the DG on compulsory license were contradicted.
(3) AIDS Healthcare Foundation's criticism of the WHO DG's statements
(4) Bangkok Post article of 2 February on "WHO raps compulsory
With best wishes
Health: WHO Chief's Stand
on Generic Drugs Slammed
By Marwaan Macan-Markar, IPS, Bangkok, 2 February 2007
Civil society and humanitarian
groups slammed the new head of the World Health Organisation (WHO),
on the sidelines of a meeting here, after she appeared to favour the
interests of pharmaceutical giants over the plight of the sick and the
poor in the developing world.
''It is not the role of the WHO to protect the interests of the pharmaceutical
companies,'' Dr. Ellen Hoen of the international humanitarian agency
Doctors Without Borders (or MSF for Medecins Sans Frontieres) said at
a press conference, Friday. ''It is a reason
for concern that the WHO takes a more conservative role than the WTO
(World Trade Organisation).''
''The new DG (director general) of the WHO should have stood up for
the poor,'' added James Love, head of Knowledge Ecology International,
a Washington D.C.-based group lobbying for cheaper generic drugs. ''This
is a bad start. She needs to educate herself
about intellectual property rights.''
A Thai AIDS rights activist was as critical. ''The WHO has to look more
closely at its role in the global public health campaign. It must be
able to stand up to the threats of big pharmaceutical companies,'' said
Nimit Tienudom, director of AIDS Access Foundation, a Bangkok-based
non-governmental organisation (NGO) campaign for cheaper anti-AIDS drugs.
The rebukes were in response to comments made Thursday by Dr. Margaret
Chan who was appointed to head the global health agency in November
last year. On two occasions, say her critics, she failed to express
her support for developing countries fighting for cheaper alternatives
to expensive branded drugs. What she eventually said should embolden
the pharmaceutical industry, they add.
The most troubling for champions of cheaper alternative drugs were the
comments made by Chan when she visited Thailand's National Health Security
Office (NHSO), where she cautioned against hasty embrace of countries
resorting to 'compulsory licencing' to secure cheaper generic drugs.
''I'd like to underline that we have to find a right balance for compulsory
licencing. We can't be naïve about this. There is no perfect solution
for accessing drugs in both quality and quantity,'' Chan is quoted as
having said at the NHSO, according to Friday's 'Bangkok Post' newspaper.
Earlier in the day, Chan praised the pharmaceutical industry lavishly
during a keynote address delivered at the opening of a two-day international
conference that focused on ways to improve access to essential health
technologies for neglected diseases. The event,
hosted by a local university, attracted over 300 participants from the
developing and developed world.
The stance taken by Chan comes at a pivotal moment in Thailand's quest
to provide cheaper generic drugs to the country's poor. On Monday, the
government gave the nod to issue compulsory licences to secure two drugs,
one for HIV/AIDS, and the other for heart disease. That move triggered
a round of
protest from the pharmaceutical industry and from sections of the international
media more sympathetic to corporate financial agendas.
This was the third drug in as many months that Bangkok had felt a need
to break the patent held by a pharmaceutical company by issuing a compulsory
licence, which is a provision recognised at a WTO ministerial meeting
in 2001. Under this option that is
part of the trade related intellectual property rights (TRIPS), countries
can issue a compulsory licence to secure cheaper generic drugs to meet
a public health emergency.
Thai AIDS and public health activists had been hoping that Chan's presence
in Bangkok would boost the government's move to supply cheaper drugs
for the country's 80,000 people with HIV who need anti-AIDS medication
out of over 600,000 who have the killer disease.
Chan's comments have broader implications, too, since they come at a
time when the Geneva-based health agency is under increasing scrutiny
by NGOs and public health advocates. The latter fear that the WHO is
selling out to the pharmaceutical industry given the pressure imposed
on it by the U.S. government.
Few events illustrate this climate better than the way William Aldis,
the WHO representative in Thailand, was forced to quit his Bangkok mission
after writing a
commentary in the 'Bangkok Post' newspaper in January 2006, where he
supported Thailand's move to secure alternatives to expensive brand-name
It was an event not lost on U.S. Congressman Jim McDermott. In a speech
to the House of Representatives in June 2006, McDermott drew attention
to the U.S. government's role in Aldis' removal, saying, ''They put
him elsewhere à in a position where he would have no power similar to
what he had before.''
Washington also took the WHO to task last year for co-sponsoring a publication
that was critical of U.S. trade polices. The study looked at the options
available for developing countries to use the flexibility available
under the TRIPS agreement to gain access to cheaper medicines.
''(This publication) spuriously characterises the trade policy of the
United States as a threat to public health, and makes unnecessarily
inflammatory and prejudicial recommendations as to how the United States
can improve its trade policies,'' wrote William Steiger, a senior official
at the U.S. department of health and human services, in an August 2006
letter to the acting director general of the WHO.
What troubles civil society campaigners like Martin Khor, director of
Third World Network, a Penang-based think tank, is the reluctance of
the WHO to defend its position. ''It is not normal for the WHO to be
silent on this issue of developing countries using TRIPS flexibility
to get cheaper drugs,'' he told IPS.
The current tendency of the WHO to cave into such pressure goes against
the past record of the organisation as a leading advocate for developing
countries to tap the special provisions in TRIPS, he added. ''The WHO
should be encouraging countries to fully exploit TRIPS flexibility for
the benefit of public health.'' (END/2007)
Move to break drug patents
Experts: WHO should back
Bangkok Post, Saturday February 03, 2007
By PIYAPORN WONGRUANG
Thailand can go ahead with the compulsory licensing of anti-Aids and
heart disease drugs without having to negotiate with pharmaceutical
firms as suggested by the World Health Organisation (WHO), international
health policy and intellectual properties rights
experts said yesterday. The country's decision to break the patents
of the medicines was for government use; therefore, it could issue the
compulsory licences without giving prior notice to drug manufacturers,
said Carlos Correa, director of the University of
Buenos Aires' science and technology policy programme.
Under the World Trade Organisation's Agreement on Trade-Related Aspects
of Intellectual Property Rights (Trips), a member country can break
without letting the firms involved know if the move was to produce or
import the patented drugs for government use.
The compulsory licensing also covers non-Aids related drugs.
''Several developing countries have granted licensing, especially for
anti-Aids drugs. Even the US government has benefited from the mechanism.
Therefore, the Thai
government's move is fully compatible with international law and practice,''
said Dr Correa.
He also played down concerns that compulsory licensing would discourage
medical firms from investing in new drug development, saying the scheme
would cause only a minor impact on the drug industry, which could still
make massive profits from selling new products.
The academic was one of the representatives from leading international
non-governmental organizations and academic institutes, which held a
joint press conference in Bangkok yesterday to voice their support for
the Public Health Ministry's decision to break the patents on the drugs.
The move came after the government's
endorsement of compulsory licensing to produce generic versions of the
anti-Aids drug Kaletra and the blood thinner Plavix came up against
fierce resistance from pharmaceutical firms, which threatened to put
investments in Thailand on hold.
WHO director-general Margaret Chan also cautioned Thailand over the
move and urged the government to begin negotiations with drug firms
to strike the right balance in accessing drugs both in terms of quality
Martin Khor, director of the Malaysia-based Third World Network, said
under Trips, a country is not required to negotiate with the patent
owners if the compulsory licensing is for government or non-commercial
Thailand's case was in accordance with this rule, he said.
The government should resist the pressure from the pharmaceutical industry
and stand firm on its decision to produce cheap drugs for patients in
need, said Mr Khor.
Health experts and activists taking part in the press conference also
expressed disappointment with the WHO's view on the patent breaking.
Instead of raising concerns about the move, they said, the WHO should
have praised Thailand for issuing the compulsory licences, which would
allow Thais greater access to affordable drugs.
The groups, including Medecins Sans Frontieres and the Bangkok-based
Aids Access Foundation, called on the world health body to revert to
its role of serving the public interest, and support the move to apply
New WHO Chief Fails to Stand Up for People Living With AIDS
Friday February 2, 5:45 pm
AIDS Healthcare Foundation Says WHO Chief's Lack of Support for Thai
Action on Compulsory AIDS Drug Licensing Makes it Clear That the 'Health
of People Living With HIV in Thailand Is Not Among Her Priorities'
LOS ANGELES, Feb. 2/PRNewswire/--
AIDS Healthcare Foundation (AHF), the US' largest HIV/AIDS healthcare
and prevention and education provider, which operates free AIDS treatment
clinics in the US, Africa, Latin America/Caribbean and Asia, today blasted
the World Health Organization's (WHO) newly-appointed Director General
Margaret Chan for statements she made in response to Thailand's action
on compulsory AIDS drug licensing which appear to favor pharmaceutical
companies' interests over people living with HIV/AIDS in the developing
The WHO leader's comments
-- made during a visit with Thailand's National Health Security Office
(NHSO) on Thursday -- comes on the heels of an announcement made
by the Government of Thailand regarding its intention to break a patent
on Abbott Laboratories' HIV/AIDS drug Kaletra by issuing a compulsory
license to produce a lower-cost version of the drug, in order to increase
access to the lifesaving medicine for its people. Under the World Trade
Organization's Trade-Related Aspects of Intellectual Property Rights
(TRIPS) Article 31, the Thai government has the authority to issue a
compulsory license in order to protect public health -- despite a misconception
a "national emergency" is required as a pre-condition to taking
such action. Approximately 108,000 of 500,000 people living with HIV/AIDS
in Thailand depend
on GPO-VIR, the generic version of the first-line anti-retroviral therapy
produced by the Government Pharmaceutical Organization. According to
the Thai government, an estimated 20,000 of these patients have developed
resistance to the drug, and are in need of Kaletra.
"AHF is alarmed by
Dr. Chan's comments regarding Thailand's move to increase access to
lifesaving AIDS medications for its citizens in need. It is clear that,
despite the WHO's mission to attain the highest possible level of health
for all people, the health of people living with HIV in Thailand is
not among Dr. Chan's priorities," said Michael Weinstein, AIDS
Healthcare Foundation's President. "Thailand's move to issue a
compulsory license for Kaletra will likely lower the price of this lifesaving
drug to nearly half of its current cost and will mean the difference
between life and death for thousands of Thai citizens in need. The comments
made by Dr. Chan serve only to undermine Thailand's efforts to protect
the health of its people and it is appalling that in her position
she would choose to advocate for multinational corporate interests over
the interests of people living with HIV/AIDS in the developing world.
AHF seeks immediate clarification from the Director General on her position
regarding Thailand's efforts
to protect the health of its citizens."
According to Thursday's
Bangkok Post article, "WHO Raps Compulsory Licensing Plan"
by Apiradee Treerutkuarkul (February 2, 2007): "The World Health
Organization yesterday cautioned Thailand over its move to adopt compulsory
licensing for producing
generic versions of heart disease and anti-Aids drugs. "I'd like
to underline that we have to find a right balance for compulsory licensing.
We can't be naïve about this. There is no perfect solution for accessing
drugs in both quality and quantity," said WHO director-general
Margaret Chan. Speaking during a visit to the National Health Security
Office, Dr Chan said she truly felt that the pharmaceutical industry
was part of the solution to better drug access and that the government
should open negotiations with drug
firms over the issue."
Last week, AIDS Healthcare
Foundation praised the Government of Thailand for its plan to break
the patents on the lifesaving HIV/AIDS drug Kaletra, and hailed its
efforts to step up the availability and use of generic lifesaving drugs
for the Thai people. The
group called Thailand "a leader in scaling up AIDS treatment for
its populace" and applauded the government's commitment to treat
and save Thai people living with HIV/AIDS and other life-threatening
In the Asia-Pacific region,
AIDS Healthcare Foundation currently provides free anti-retroviral treatment
through its clinics in India, China and Cambodia.
WHO raps compulsory licensing plan
Govt urged to seek talks
with drug firms
Bangkok Post Friday 2 Feb 2007
By APIRADEE TREERUTKUARKUL
The World Health Organisation
yesterday cautioned Thailand over its move to adopt compulsory licensing
for producing generic versions of heart disease and anti-Aids drugs.
''I'd like to underline that we have to find a right balance for compulsory
licensing. We can't be naive about this. There is no perfect solution
for accessing drugs in both quality and quantity,'' said WHO director-general
Speaking during a visit
to the National Health Security Office, Dr Chan said she truly felt
that the pharmaceutical industry was part of the solution to better
drug access and that the government should open negotiations with drug
firms over the issue.
She encouraged the Public
Health Ministry to improve the public-private partnership in order to
give the public better access to drugs. Public Health Minister Mongkol
na Songkhla declined to comment on the issue.
The president of Aids Access
Foundation, Nimit Tienudom, dismissed the WHO director-general's standpoint.
''It's disappointing. The organisation should have supported drug access
and promoted the study of quality and inexpensive drugs for the sake
of the global population rather than supporting pharmaceutical giants.''
The ministry last week endorsed
a policy for the compulsory licensing of two drugs _ Kaletra, an advanced
anti-Aids drug, and Plavix, a treatment for heart disease by invoking
Article 51 of the 1992 Patent Law to import or produce a generic version
of the two drugs.
In November, the ministry
issued the same law to import and produce the anti-Aids drug Efavirenz,
resulting in a reduction in the price from 1,400 baht to 700 baht per
Plavix will cost just six baht per tablet under compulsory licensing,
while the original price was 70 baht. The patented regimen of the second-line
anti-retroviral drug costs 11,580 baht a month per patient and this
could be cut to a third under compulsory licensing.
Thailand is the first developing country to invoke compulsory licensing
under the World Trade Organisation's rules for a non-Aids related drug.
The WTO allows a government to declare a ''national emergency'' and
license the production or sale of a patented drug for state use. The
patent holder would receive royalties equal to 0.5% of the annual sales,
according to the ministerial plan.
About 108,000 of 500,000
people living with HIV/Aids depend on GPO-VIR, the generic version of
the first-line anti-retroviral therapy produced by the Government Pharmaceutical
Organisation. An estimated 20,000 HIV-positive people have developed
resistance to the drug, and need a combination of lopinavir and ritonavir,
which is marketed as Kaletra.
However the country's Pharmaceutical
Research and Manufacturers Association disapproves of the decision,
claiming that compulsory licensing could result in more companies relinquishing
patents for heart and anti-Aids drugs and that it could lead to the
isolation of Thailand from the global biotechnology investment community.
Kaletra is manufactured by Abbott Laboratories, and Plavix by Sanofi-Aventis
and Bristol-Myers Squib.
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