[Ip-health] WHO raps compulsory licensing plan Govt urged to seek talks with drug firms

[Kannikar KIJTIWATCHAKUL]

WHO raps compulsory licensing plan Govt urged to seek
talks with drug firms

By APIRADEE TREERUTKUARKUL
Bangkok Post Friday 2 Feb 2007

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 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.

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 monthly course.

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.
....................

Move to break drug patents lauded
Experts: WHO should back Thai intentions
Bangkok Post , Saturday February 03, 2007

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 drug patents
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 organisations
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 drug
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
and quantity.


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 uses.


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
compulsory licensing.

.................
HEALTH:
WHO Chief's Stand on Generic Drugs Slammed
Marwaan Macan-Markar

BANGKOK, Feb 2 (IPS) - 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).''

=91'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.
=91'This is a bad start. She needs to educate herself
about intellectual property rights.''

A Thai AIDS rights activist was as critical. =91'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 =91compulsory licencing' to
secure cheaper generic drugs.

=91'I'd like to underline that we have to find a right
balance for compulsory licencing. We can't be na=EFve
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
=91Bangkok 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 military-appointed
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 =91Bangkok Post' newspaper in January
2006, where he supported Thailand's move to secure
alternatives to expensive brand-name drugs.

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, =91'They
put him elsewhere =E0 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.

=91'(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. =91'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. =91'The WHO should be encouraging countries to
fully exploit TRIPS flexibility for the benefit of
public health.'' (END/2007)


...................

New WHO Chief Fails to Stand Up for People Living With
AIDS

Friday February 2, 5:45 pm ET

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 world.

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 that
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 naive
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
diseases.

In the Asia-Pacific region, AIDS Healthcare Foundation
currently provides free anti-retroviral treatment
through its clinics in India, China and Cambodia.

---------------------------------------------------------------------------=
-----
Source: AIDS Healthcare Foundation


Kannikar KIJTIWATCHAKUL (Kar)
Mobile 66-85-0708954
kakablue@yahoo.com



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