Compulsory Licensing

Internet Workshop

Access and development: pharmaceuticals and the developing world
Developing PHM Oz analysis and action

Tuesday 1 May, 7:30pm

To be held using Paltalk internet software: see Internet Workshops for how to participate.

Program

The workshop will follow on from our first two workshops in February and March. Please prepare by reading the short powerpoint files from the previous workshops and the resources below.

Convenor: David Legge

Program of second compulsory licensing workshop Action: Where to from here?:

We discussed the development of our analysis, strategies to bring about action in Australia and the workshop we hope to hold at the Public Health Association conference in September.

Upendra's first presentation

Upendra's follow-up presentation

Gillian's presentation

Program of first compulsory licensing workshop Compulsory Licensing: current hot spots:

Compulsory licensing and where it stands now (Sharon)

Report of WHO Commission on IPRs and Health (David)

Current disputes over IPRs in India (Upendra)

Current disputes over IPRs in Thailand (Gillian).

For technical assistance in preparing to participate, please see the Internet Workshops page.

Resources

If you would like to add to this page, please see the Website Instructions for editing the Wiki.

Facts about compulsory licensing

WTO documents give a good overview of compulsory licensing and the key dates and documents: Fact Sheet Sept 2006 PDF file

Technical Note on pharmaceutical patents and the TRIPS agreement Web link

MSF documents are quite illuminating in how this fits into practical usage: PDF file, Web link

Report of WHO Commission on Intellectual Property Rights, Innovation and Public Health Web link
-- Chapter six: Towards a sustainable plan to promote innovation and access (concluding chapter) PDF file

Legal Framework for Compulsory License Drugs, Knowledge Ecology International, 16 March 2007 PDF file

News articles

Abbott to cut AIDS drug price in 40 poor countries
CHICAGO (Reuters) 11 April: Abbott Laboratories Inc., widely criticized for aggressive pricing of its AIDS medicines in developing countries, said on Tuesday it would slash the price of a key AIDS drug by more than half in more than 40 poor countries.
Read full article

Notes from March 16th 2007 U.S. Capitol Briefing on Thailand’s Compulsory Licenses
16 March 2007: On Friday, March 16, KEI organized a briefing in the U.S. Capitol on Thailand’s recent compulsory licenses on three drugs; two for HIV/AIDS (Merck’s efavirenz (Stocrin) and Abbott’s lopinavir + ritonavir (Kaletra)) and one for heart disease (Sanofi’s clopidogrel (Plavix)).
Read full article

MSF Denounces Abbott’s Move to Withhold Medicines From People in Thailand
15 March 2007: The international medical humanitarian organization Médecins Sans Frontières (MSF) today denounced Abbott Laboratories’ decision not to market its new medicines in Thailand.
Read full article

A New Low in the Pharma Drug Wars - Abbott Withdraws Seven Medicines in Thailand
14 March 2007: Brook K. Baker, Health GAP. How low will drug companies go to protect their intellectual property empire?
Read full article

Thailand stands up to Abbott
13 March 2007: When Thailand went ahead with a compulsory license on Kaletra, an AIDS drug, despite threats from Abbott the maker of the drug, the latter hit back by withdrawing the registration of a new heat stable form of Kaletra and six other drugs. The likely outcome will be more deaths of innocent patients.
Read full article

India: Former Swiss President joins chorus against Novartis' patent challenge
15 February 2007: More prominent figures have joined the chorus of over 300,000 people worldwide voicing concerns about Novartis’ legal challenge against the Indian government and its impact on access to essential medicines across the globe.
Read full article

WHO DG regrets her reported remarks on Thai compulsory licenses
15 February 2007: The WHO Director General Dr. Margaret Chan, has sent a letter to Thailand's Health Minister expressing regret for the embarrassment caused to his government by remarks she was reported to have made in Bangkok that were critical of the compulsory licenses granted by the government for three medicines.
Read full article

Thailand backs off threat to break drug patents
8 Feb 2007: [BANGKOK] Thailand has delayed breaking the patent of an AIDS drug and a heart medicine, and entered into negotiations with drug firms to lower the price so that more people can be treated.
Read full article

Stephen Lewis Criticises Margaret Chan
4 Feb 2007: Stephen Lewis, former UN Special Envoy for HIV/AIDS in Africa, calls for World Health Organization director Margaret Chan to reverse her support of drug companies over governments trying to provide medicines for their peoples. His remarks were recorded at the Global Justice student conference in Washington, DC, on February 4.
Video [1]
Fight AIDS [2]

WHO Chief's Stand on Generic Drugs Slammed
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.
Full article available from IPS: [3]

Thailand approves copycat drugs
January 30, 2007: THAILAND'S army appointed government said today it had approved a cheap, copycat heart disease drug, the first time a developing country has ignored an international patent for such a treatment.
Full article available from The Australian: [4]

Thailand throws down gauntlet to drug giants
30 Jan 2007: IN A precedent-setting challenge to global drug companies, Thailand has become the first developing country to issue a compulsory licence to manufacture a generic drug that is not AIDS related.
Follow link to Sydney Morning Herald article. [5]]

Thailand Invokes WTO Rule To Sell Generics For HIV And Heart Disease Drugs
30 Jan 2007: Thailand has invoked a World Trade Organization (WTO) agreement on intellectual property rights to allow the manufacture, purchase and sale of generic versions of two drugs for heart disease and HIV/AIDS in the country.
Full article available online here

US activists try to deliver coffin to Novartis over Indian patent case
29 Jan: WASHINGTON (AFP) - Non-governmental groups tried to deliver a mini coffin to Swiss pharmaceuticals giant Novartis to protest legal action aiming to overturn a ban on a drug patent application in India.
http://news.yahoo.com/s/afp/20070129/hl_afp/usindiapharmacompany_070129215623

WHO’s mandate on IPRs under US attack
12 Dec 2006: At the recent meeting of WHO’s international working group on public health, innovation and intellectual property, the US challenged WHO’s work on the impact of Intellectual Property Rights (IPRs).
Read full article here

Other information

Rep Waxman letter to Novartis on Indian legal challenge
Read the letter here

Open Letter to WHO/UNAIDS India re Margaret Chan's comments on Thai Compulsory License
Read the letter here

WHO DG Chan Shocking Views Criticised by NGOs (Martin Khor, 5 Feb 07)
Read a Comment from PHM member on Chan's visit to Bangkok re Thai Compulsory License

MSF Petition regarding Novartis
http://www.msf.org/petition_india/can_eng.html

Patents versus Patients: Five years after the Doha Declaration
November 2006, Oxfam Briefing paper: Five years ago, members of the World Trade Organisation (WTO) signed a ministerial agreement to ensure that intellectual property rules would no longer obstruct developing countries’ efforts to protect public health. Since then, however, little has changed. Patented medicines continue to be priced out of reach for the world’s poorest people. Trade rules remain a major barrier to accessing affordable versions of patented medicines (generic medicines). The prevalence of debilitating and life-threatening diseases in poor countries is growing, but medicines are simply not available. Urgent action is needed.
http://www.oxfam.org.uk/what_we_do/issues/health/bp95_patents.htm

Public Health at Risk: A US Free Trade Agreement could threaten access to medicines in Thailand
April 2006, Oxfam Briefing paper: New stringent drug patent and marketing rules being negotiated in a Free Trade Agreement (FTA) between the US and Thailand would limit competition and reduce access to affordable medicines in Thailand. This would threaten the future of existing successful Thai HIV/AIDS treatment programmes, which rely on inexpensive generic drugs, and thus deprive thousands of people of effective treatment. Oxfam opposes an FTA with intellectual property rules that exceed the standards agreed at the World Trade Organization.
http://www.oxfam.org.uk/what_we_do/issues/health/bp86_thailand.htm

Journal articles

Please note, you will need access to the New England Journal of Medicine to read these articles. Most university libraries will provide access on site if you do not have online access.

Thailand and the Compulsory Licensing of Efavirenz' Robert Steinbrook NEJM Volume 356:544-546

Of the many medicines for human immunodeficiency virus (HIV) infection, efavirenz, a nonnucleoside reverse-transcriptase inhibitor that became available in the late 1990s, is one of the most important. For the initial treatment of adults, the combination of efavirenz and two nucleoside reverse-transcriptase inhibitors "has become a standard-of-care comparator in clinical trials," according to Hammer et al.1 Moreover, efavirenz is available in a fixed-dose combination tablet with the nucleoside analogues emtricitabine and tenofovir; this tablet is taken only once a day. Efavirenz can cause birth defects when taken during the first trimester of pregnancy, so its use is restricted in . . . .

Taking TRIPS to India — Novartis, Patent Law, and Access to Medicines Janice M. Mueller NEJM Volume 356:541-543

In August and September 2006, patients with cancer, lawyers for patient advocacy groups, and representatives of nongovernmental organizations (NGOs) converged on the offices of Novartis in Mumbai, India, to protest the company's efforts to obtain an Indian patent on Gleevec, the company's brand-name version of imatinib mesylate. Gleevec (spelled Glivec outside the United States) is used to treat chronic myeloid leukemia, and Novartis has patented the drug in 35 countries. The protesters also decried the drug's high price: Novartis sells it in India (where only 5% of people have private health insurance) for $26,000 per year; generic-drug manufacturers offer the drug at less than one tenth that price....