TWN Info Service on Intellectual Property Issues (Feb08/03)

25 February 2008


COMPULSORY LICENSING OF CANCER DRUGS IN THAILAND

The former Health Minister of Health of Thailand, Dr Mongkol na Songkhla prior to leaving office signed (on 4 Jan) four ministerial announcements to compulsory license Letrozole, a breast cancer medicine produced by Novartis, the breast and lung cancer drug Docetaxel by Sanofi-Aventis and Roche's Erlotinib, which is used for treating lung, pancreatic and ovarian cancer.

[A white paper by the Thai Government on these licences is available at http://www.moph.go.th/hot/Second_white_paper_on_the_Thai_CL_[EN].pdf]

According to the former Minister there are about 15,000 people in Thailand with lung and liver cancer who are in need of the drugs.

Since the new government has taken over, the ministries of commerce, foreign affairs and health have been meeting to make a decision on the compulsory licensing (CL) of drugs i.e. whether it should be discontinued.

Bangkok Post recently reported (on 20th February) that the plan by Public Health Minister Chaiya Sasomsab to review the policy on compulsory licensing (CL) for four cancer drugs has hit a major obstacle after officials from the three ministries found that the CL cannot be revoked.

Bangkok Post reported Mr Chaiya as saying that the permanent secretaries of the commerce, foreign affairs and public health ministries had concluded that the ministerial announcements on four cancer drugs made by former public health minister Mongkol na Songkhla were legitimate and could not be lifted.

A recently completed WHO mission to Thailand has also added its support to the use of flexibilities in the Trade-Related Aspects of Intellectual Property Rights (Trips) agreement to improve access to essential medicines. In its 31-page report entitled ''Improving access to medicines in Thailand: The use of Trips flexibilities'', the WHO mission said the use of compulsory licences is one of several World Trade Organisation (WTO) mechanisms used for patented essential medicines not affordable to public health insurance schemes.

Please find below news stories on the Thai CLs as well as on WHO's support of the use of CL.

[Note: In 2006/2007, the Thai government issued 3 compulsory licenses: on 26 January for the heart disease drug clopidogrel (patent holder: Sanofi-Aventis’ Plavix) and the HIV/AIDS drug, lopinavir/ritonavir (patent holder: Abbott’s Kaletra), and on 29 November 2006 for the HIV/AIDS medicine, efavirenz (patent holder: Merck Sharp & Dohme’s Stocrin).

The experience is documented in a white paper titled "Facts and Evidences on the 10 Burning Issues Related to the Government Use of Patents on Three Patented Essential Drugs in Thailand" available at
http://www.moph.go.th/hot/White%20Paper%20CL-EN.pdf]


Best Wishes
Sangeeta Shashikant
Third World Network
email: ssangeeta@myjaring.net

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CHAIYA’S PLAN FOR CL POLICY REVIEW HITS MAJOR HURDLE

Bangkok Post, Feb. 20, 2008 (APIRADEE TREERUTKUARKUL)


A plan by Public Health Minister Chaiya Sasomsab to review the policy on compulsory licensing (CL) for four cancer drugs has hit a major obstacle after officials from three ministries found that it cannot be revoked.

Mr Chaiya said permanent secretaries of the commerce, foreign affairs and public health ministries had concluded that the ministerial announcements on four cancer drugs made by former public health minister Mongkol na Songkhla were legitimate and could not be lifted.

Although Mr Chaiya could not change the policy, a source said the government might take no further action under CL to bypass the patents of cancer drugs.

The meeting of the three ministries was ordered by Prime Minister Samak Sundaravej last week to decide if it should go ahead with the previous government's scheme to break the cancer drug patents.

Dr Mongkol signed four ministerial announcements on Jan 4 to individually license Letrozole, a breast cancer medicine produced by Novartis, breast and lung cancer drug Docetaxel made by Sanofi Aventis, Roche's Erlotinib, used for treating lung, pancreatic and ovarian cancer, and Imatinib of Novartis used on people with leukaemia.

But he struck a deal with Novartis as the patent holder agreed to supply its medicine free to more than 900 patients under its philanthropic programme.

In a forum about Thai policy on CL yesterday, Foundation for Consumers manager Saree Ongsomwang said health activists and networks of cancer patients and people living with HIV/Aids were monitoring government actions on CL.

''We will definitely not agree with the government if the CL policy for cancer drugs has to be shelved or delayed until the US Trade Representative finishes reviewing the list of countries receiving export benefits from the US Generalised System of Preferences in April,'' she said.

Pongthep Wongwatcharapaiboon, a rural doctor at Na Noi hospital in Nan province, said the poor would be most affected if the government did not extend access to cancer drugs through CL.

Cancer drugs were very expensive and available only at private hospitals and large medical schools in urban areas.

The lack of financial support from the National Health Security Office, which runs the universal healthcare scheme, made it impossible for the 626 community hospitals across the country to treat cancer patients in remote areas.

Sarah Ireland, an Oxfam regional director for East Asia, urged the government to continue with CL for cancer drugs and other life-saving medicines so that poor people would have greater access to them. Thailand should be a leader for low and middle-income countries in exercising its flexibility within the Trade-Related Aspects of Intellectual Property Rights (Trips) to widen public access to these medicines, she added.

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MINISTER UNDER ATTACK FOR PLAN TO REVERSE CL

Bangkok Post, February 19, 2008 (PRADIT RUANGDIT and NAREERAT WIRIYAPONG)


Public Health Minister Chaiya Sasomsab's plan to cancel the compulsory licensing (CL) of patented medicines came under attack from the opposition Democrats and the National Legislative Assembly (NLA) on the first day of the government policy debate yesterday.

Democrat leader Abhisit Vejjajiva said Mr Chaiya's swift statement backing the reversal of the CL scheme was inappropriate.

It would weaken the country's negotiating power with giant pharmaceutical manufacturers and trade partners.

The government's policy on compulsory licensing should be based on three principles, he said.

''These are the patients' right of access to medicines; the country's right to apply measures in line with international trade laws and agreements to protect the public's health; and prompt negotiations with trade partners who have trouble with Thailand's bypassing of drug patents,'' said Mr Abhisit.

NLA member Amphon Jindawattana questioned Mr Chaiya's motivation in halting the policy to override drug patents and urged Prime Minister Samak Sundaravej to clarify the government's stance on the matter.

''Why did the minister come up with such an idea [to end compulsory licensing] despite the fact that it is beneficial to Thai citizens?'' he said.

Public Health Ministry spokesman Suphan Srithamma said the health minister's proposal to suspend licensing for life-saving drugs was restricted to four cancer drugs only.

He made the explanation after some health campaigners and patients expressed fears the Samak government would revoke compulsory licences for three Aids and heart drugs _ Efavirenz, Kaletra, and Plavix _ issued in November 2006 and January 2007.

''The ministry will go ahead with the issuance of CL on the three medicines. Aids and heart disease patients will be able to afford cheap drugs under the scheme,'' he said.

Dr Suphan said the revision of the previous government's bypassing of drug patents was aimed at making the scheme more transparent and the patients' benefits would be the centre of concerns.

The permanent secretaries for the Foreign, Commerce and Public Health ministries met last week to discuss whether the CL scheme should be continued after Mr Chaiya voiced his opposition to the decision to override the patents of four cancer drugs by former minister Mongkol na Songkhla on Jan 4.

The four drugs are the breast cancer drug letrozole produced by Novartis; leukaemia drug Imatinib also of Novartis; breast and lung cancer drug docetaxel of Sanofi-Aventis, and lung cancer drug erlotinib of Roche.

The officials are expected to come up with policy recommendations and submit them to the ministers next week, he said.

Kiatphong Noichaiboon, a director of the Federation of Thai Industries, urged the government to continue with the compulsory licensing of pharmaceuticals.

He said the CL issue was unrelated to international trade or favourable tariffs received by Thai exporters from foreign countries.

''CL is the right measure and there is no need to reverse what has been implemented,'' said Mr Kiatphong.

The network of nongovernmental organisations working on HIV/Aids said the committee and consumer groups would file administrative charges against the Public Health Ministry for dereliction of duty if the ministry refuses to proceed with the compulsory licensing scheme.

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WHO BACKS USE OF TRIPS FLEXIBILITIES IN NEW REPORT

Bangkok Post, Monday February 18, 2008 (ACHARA ASHAYAGACHAT)


The World Health Organisation (WHO) mission to Thailand has added its support to the use of flexibilities in the Trade-Related Aspects of Intellectual Property Rights (Trips) agreement to improve access to essential medicines. In its 31-page report entitled ''Improving access to medicines in Thailand: The use of Trips flexibilities'', the WHO mission said the use of compulsory licences is one of several World Trade Organisation (WTO) mechanisms used for patented essential medicines not affordable to public health insurance schemes.

The seven-member team _ which comprises experts from the WHO, WTO, the United Nations Development Programme and law experts _ met representatives of Thai health authorities, drug firms, patient networks and civil groups on compulsory licensing from Jan 31 to Feb 6. The report has been released amid debate on whether overriding drug patents, approved by the coup-appointed government, should be continued.

New Public Health Minister Chaiya Sasomsab stated clearly on his first day in office that he wanted the scheme to be reversed. His stance drew harsh criticism from civil groups and health experts.

The report provides technical information and policyoptions on the general rules and mechanisms available to countries for use of the flexibilities contained in the Trips and other international agreements, in order to promote greater access to pharmaceutical products. The WHO mission, led by German Velasquez from its headquarters in Geneva, said its report is not intended to make any evaluation or assessment of the use of Trips flexibilities in Thailand.

Kannikar Kijtiwatchakul, a campaigner for Medecins Sans Frontieres, said the report implied that Thailand's past acts regarding the issuing of compulsory licences were legal and transparent as far as public health matters were concerned.

The mission said in its report that the Trips agreement contains a range of mechanisms and options to protect public health that countries can consider when formulating intellectual property laws and public health policies.

''The use of compulsory licences and government-use provisions to improve access to medicines is one of several cost-containment mechanisms that may be used for patented essential medicines not affordable to the people or to public health insurance schemes,'' the report says.

It is acknowledged that the decision to grant compulsory licences and use other Trips flexibilities is often complicated and involves different stakeholders. ''It is therefore important to establish clear decision-making processes, including the determination or designation of the authorities or bodies charged with responsibility for the various stages of decision-making,'' the report said.

The Trips does not specify the nature of the authority or the process that is mandated to grant compulsory licences or determine the level of compensation. However, WTO members may designate authorities and a system to proceed with the granting of compulsory licences.

''It is noted that the systems vary in different countries, with some adopting administrative procedures and others a mixed system, where initial decisions relating to the granting of compulsory licences and compensation are made administratively and appeals are made to the judicial system,'' the report said

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COMMERCE MINISTER CALLS FOR REVIEW OF CL

Bangkok Post -- Feb. 14, 2008 -- Commerce Minister Calls for Review of CL


(BangkokPost.com) - Deputy Prime Minister and Commerce Minster Mingkwan Sangsuwan on Thursday asked the Intellectual Property Department to study the pros and cons of compulsory licensing (CL) of cancer drugs before deciding whether it should be discontinued.

Mr Mingkwan demanded that the study be completed within this week.

CL of the key drugs by the former government raised concerns that the US may downgrade Thailand from the Priority Watch List to the Priority Foreign Country list, which is the last and most severe US copyright protection category.

The possible ending of CL by the current government raises concern among health activists and cancer patients who cannot afford the patented drugs.

According to former Public Health Minister Mongkol na Songkhla, there are about 15,000 people with lung and liver cancer who are in need of the drugs.