Compulsory Licensing

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''' Thailand approves copycat drugs '''
 
''' Thailand approves copycat drugs '''
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From correspondents in Bangkok
 
  
 
January 30, 2007 06:06am
 
January 30, 2007 06:06am
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Article from: Reuters
 
  
 
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.
 
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.
  
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As well as the "compulsory licence" of Plavix, made by US and European pharmaceutical giants Bristol-Myers Squibb and Sanofi-Aventis, Bangkok approved a generic version of Abbott Laboratories' Kaletra to treat HIV/AIDS.
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Full article available from The Australian: [http://www.theaustralian.news.com.au/story/0,20867,21140548-1702,00.html]
  
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The move, which Thai health officials said would save the country as much as 800 million baht ($31 million) a year, drew flak from the drug industry but praise from AIDS activists.
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''' Thailand throws down gauntlet to drug giants '''
  
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"We have to do this because we don't have enough money to buy safe and necessary drugs for the people under the government's universal health scheme," Health Minister Mongkol na Songkhla told reporters today.
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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.
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"The laws have been signed and became effective on Friday," said Mr Mongkol, who angered drugs companies in November by introducing Thailand's first such licence for Merck's Efavirenz anti-retroviral AIDS treatment.
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Under World Trade Organisation (WTO) rules, a government is allowed to declare a "national emergency" and licence the production or sale of a patented drug without the permission of the foreign patent owner.
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Teera Chakajnorodom, chairman of Bangkok-based pharmaceutical industry group PReMA, said he had not been told about the move in advance.
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Although the drug companies had not had time to coordinate a response, Mr Teera said they might launch a legal challenge.
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In Geneva, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) urged the Thai government to discuss the issue with drugs companies.
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Compulsory licences were open to abuse and could put the health of patients at risk, it said.
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The widening of compulsory licensing is another blow to foreign investors already reeling from capital controls imposed last month to stem a rise in the baht and a proposed tightening of laws governing overseas firms in Thailand.
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Foreign investors said it also appeared to be another case of the government, which assumed power after a September 19 coup against Prime Minister Thaksin Shinawatra, acting unilaterally and appearing indifferent to international reaction.
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Thawat Suntrajarn, head of the health ministry's disease control department, said the copycat drugs would initially be imported from India and then be produced by Thailand's state-owned drug maker.
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The price of Plavix would drop by more than 90 per cent to 6 baht (24 cents) per tablet, he said.
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Plavix is Bristol-Myers Squibb's biggest-selling medicine, which had annual sales of $US6 billion ($7.8 billion) before a copycat Canadian-made version hit the market briefly in August.
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Paul Cawthorne, local head of Doctors Without Borders, backed Mr Mongkol's stance, saying the government was spending 11,580 baht ($450) per patient per month for Kaletra and could cut that bill by two thirds if it switched to a generic make.
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"That's a perfectly legal method for them to ensure access to essential drugs for Thai people," he said.
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''' Thailand throws down gauntlet to drug giants '''
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Follow link to Sydney Morning Herald article. [http://www.smh.com.au/news/world/thailand-throws-down-gauntlet-to-drug-giants/2007/01/30/1169919338573.html]]  
 
Follow link to Sydney Morning Herald article. [http://www.smh.com.au/news/world/thailand-throws-down-gauntlet-to-drug-giants/2007/01/30/1169919338573.html]]  
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country.
 
country.
  
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The WTO agreement, which was negotiated as the Doha Declaration in 2001,
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Full article available online [http://www.medicalnewstoday.com/healthnews.php?newsid=61863 here]
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allows governments to circumvent patent licences in the event of national
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health emergencies and to issue generic licences for the manufacture and
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sale of cheaper versions of essential drugs.
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The two drugs in question are Plavix and Kaletra. Plavix (chemical name
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clopidogrel) is made by the US pharmaceutical company Bristol-Myers Squibb
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and the French pharmaceutical company Sanofi-Aventis, while Kaletra
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(chemical name lopinavir) is made by the US company Abbott Laboratories.
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Plavix (clopidogrel) is an oral antiplatelet drug used to treat a range of
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heart and cardiovascular diseases. In 2006, Apotex, a Canadian generic
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drug manufacturer started selling clopidogrel but was stopped last month
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when a Canadian court rejected its right to do so. In 2005, Plavix was the
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world's second biggest selling pharmaceutical product with annual sales
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approaching 6 billion US dollars.
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Kaletra (lopinavir) is a protease inhibitor antiretroviral drug and is
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given in combination with ritonavir as a multi-drug capsule to treat
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HIV/AIDS. Kaletra (lopinavir) was developed to enhance the HIV resistance
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of ritonavir, and when given alone it does not have enough
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bioavailability. The patent for the drug lapses in the US in 2016.
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Other countries such as Brazil and India have already used the WTO
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national emergency exception rule to circumvent patent licences to make
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HIV drugs more accessible.
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Thailand's Public Health Minister, Mongkol na Songkhla, said the decision
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is justified because the high cost of the patented versions of the drugs
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has made the health crisis worse in his country.
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Human rights agencies and aid organizations such as Medecins Sans
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Frontieres are said to have applauded Thailand's actions.
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This is the second move by Thailand to issue compulsory generic licences for patented drugs under the WTO regulation. Last November it issued
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generic licences for the anti-AIDS drug efavirenz.
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The Thai government will first import some of the generic drugs from India
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while it sets up its own production. They estimate that by using generics
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treatment costs will reduce by up to 90 per cent, making it possible to
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treat the 500,000 people with HIV/AIDS and 200,000 people with heart
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disease in the country.
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The pharmaceutical companies are said to be displeased with the move as
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they were not expecting it and are "concerned about continuing to invest
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in a country where the government cannot provide a basic guarantee for the
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safety of their assets," according to the Pharmaceutical Research and
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Manufacturers' Association.
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The Thai Health Ministry said it would be willing to discuss imports at
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cheaper prices with the pharmaceutical companies, but felt this was the
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only way they would be able to deal with their public health crisis.
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==== Journal articles ====
 
==== Journal articles ====

Revision as of 01:12, 15 February 2007

Contents

Compulsory Licensing, Intellectual Property Rights and Pharmaceuticals

Back to PHM Vic homepage

Internet Workshop

Compulsory Licensing: current hot spots

Tuesday 20 Feb, 7:30pm

To be held using Paltalk internet software: see the Paltalk website to download.

Program

The workshop will provide an opportunity to hear about and discuss:

· compulsory licensing and where it stands now (Sharon)

· report of WHO Commission on IPRs and Health (David)

· current disputes over IPRs in India (Upendra) and Thailand (Gillian).

Convenor: David Legge

The presentations will be brief and there will be adequate time for discussion. The workshop will not go on for more than one hour.

Technical

This workshop will be conducted via the internet in real time voice. The platform is PalTalk (download at [ttp://www.paltalk.com/en/start_chatting.shtml]).

You will need a headset with earphones plus boom microphone (less than $30 at any electronics computer stuff shop). You need a computer (PC) with Win 2000 or higher and 128 MB RAM and a sound card.

We ask those who are thinking of coming to let me as convenor know what their PT ID is so that they can be invited into the room.

For more information email david[at]phmoz.org

Resources

Facts about compulsory licensing

WTO documents give a good overview of compulsory licensing and the key dates and documents: Fact Sheet Sept 2006 [1] (note PDF file)

Technical Note on pharmaceutical patents and the TRIPS agreement [2]

MSF documents are quite illuminating in how this fits into practical usage: [3] (note PDF file), [4]

News articles

Thailand approves copycat drugs

January 30, 2007 06:06am

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: [5]

Thailand throws down gauntlet to drug giants

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. [6]]

Thailand Invokes WTO Rule To Sell Generics For HIV And Heart Disease Drugs

Article Date: 30 Jan 2007 - 0:00 PST

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

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....


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