TWN Info Service on Health Issues (February 07/02)

5 February 2007

WHO DG's Shocking Views on Compulsory Licensing Criticised by Health Movements and Experts

Dear friends

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 licensing.

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 conference.

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 license plan"

With best wishes
Evelyne Hong

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 nave 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 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 'Bangkok 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, ''They put him elsewhere 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 lauded

Experts: WHO should back Thai intentions

Bangkok Post, Saturday February 03, 2007


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 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 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.


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 nave 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.


WHO raps compulsory licensing plan

Govt urged to seek talks with drug firms

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.