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TWN Info Service on Intellectual Property Issues (Dec06/01) 06 December 2006
In
the meantime, imports of the generic drug from See
below news stories and press release on Best
Wishes By Chee Yoke Ling, Third World Network (yokeling@myjaring.net) 1 December 2006 (Please note that this story is a modified version of what was first published in SUNS #6153 Friday 1 December 2006) Coming just before World AIDS Day on 1 December the move was a victory for people living with HIV/AIDS, health activists and governments trying to treat citizens in the face of astronomical drug prices. This
is the first time The antiretroviral drug, efavirenz, which is recommended by the World Health Organization (WHO) for HIV/AIDS treatment is commonly used and considered by doctors as one of the best components for first line therapy because it has less side effects and is more suitable for those co-infected with other diseases such as tuberculosis or liver infections. Although it has been in the market for many years, efavirenz remains very expensive around the world. Originally
developed by Dupont Pharma, the drug is now marketed by Bristol-Myers-Squibb.
Merck, another pharmaceutical giant, has marketing licence rights in
a number of countries including According
to The Nation, , “the so-called government compulsory licensing took
effect immediately following [the] announcement and the Government Pharmaceutical
Organisation (GPO) was expected to start mass production of a generic
version of the drug in six months”. In the meantime, imports of
the generic drug from Payment
equivalent to 0.5 per cent of the sales in Minister
of Public Health Dr. Mongkol na Songkhla told The Nation, a daily national
newspaper in Under the TRIPS Agreement, a compulsory licence can be issued to someone other than the patent holder to manufacture or import a product under patent. When used by a government (or a contractor of the government) for public non-commercial use there is no need for prior negotiations with the patent holder. In this kind of compulsory licensing, commonly called “Government Use”, it is sufficient for the government to inform the patent holder, and to pay an “adequate remuneration”. Compulsory licensing is an important legal tool to ensure access to affordable medicines and its importance and use were reaffirmed in the 2001 Doha Declaration on the TRIPS Agreement and Public Health. Thailand’s Patent Act 1999 in section 51 states that any ministry, bureau or department of the Government may, by themselves or through others, exercise the compulsory licensing right “in order to carry out any service for public consumption or which is of vital importance to the defense of the country or for the preservation or realization of natural resources or the environment or to prevent or relieve a severe shortage of food, drugs or other consumption items or for any other public service”. The Thai Network of People Living with HIV/AIDS (TNP+) and other HIV/AIDS activists hailed the Thai government’s decision. They have been at the forefront to advocate for the government to use the flexibilities in the TRIPS agreement. In a march that ended at the Ministry of Public Health on Wednesday when the announcement was made, TNP+ in a press statement said, “This ground breaking decision sets an important precedent for the issuing of CL for other desperately needed but costly medication for other chronic diseases such as kidney disease and cancer”. According to TNP+, the National Health Security Office formed a committee dedicated to investigating the possibility of issuing a compulsory license. “The compulsory licence will allow the Thai government to import a generic version of efavirenz from abroad until the GPO is able to produce its own generic version saving the Public Health System millions of baht a year,” the Network said. "Thank you for the courage of the Public Health Ministry. It's remarkably brave," said Nimitr Tienudom, the manager of AIDS ACCESS Foundation, in a report of The Nation newspaper. According to the international medical humanitarian organization, Médecins Sans Frontières (MSF), at least 12,000 people in the country are estimated to need efavirenz, but due to cost and supply difficulties, the number receiving the drug is significantly lower. “Merck’s
supply of efavirenz has not been reliable, and has resulted in treatment
interruptions, forcing several hospitals to supply sub-optimal dual
therapy,” said Dr. David Wilson of MSF in In welcoming this important move MSF also urged the government to issue such licenses for the production of other essential medicines. “Thailand is demonstrating that the lives of patients have to come before the patents of drug companies, and this policy needs to be expanded to essential drugs that are expensive and in short supply, such as the AIDS drug lopinavir/ritonavir, which currently costs over USD 194 and is far too expensive for Thailand,” said Dr. Wilson. Thomas
Cai of AIDS Care On
Tuesday, the China Treatment Advocacy Coalition comprising 27 independent
groups of persons living with HIV/AIDS in According
to the Coalition, among the approximately 30,000 people receiving free
anti-retroviral therapy from the government in However, the Coalition said that: “We have only seen delays and prevarications from [Merck], including in reply to our latest letter in October 2006. Therefore, we believe that it is our responsibility to report this situation to the press, and we hope that this media exposure will help to ensure that people with no access to medicine will all receive care and treatment”. In
the December 2006 AIDS Epidemic Update by UNAIDS/WHO, an estimated 8.6
million people were living with HIV in Only
With
this latest move using a compulsory licence to enable the GPO to first
import, and then locally manufacture, generic efavirenz Studies
by the WHO in 2005 and the World Bank last August have raised the alarm
bells on rising AIDS drugs costs in countries including ---------------------------------------------------------------------------- http://www.accessmed-msf.org/prod/publications.asp?scntid=30112006143362&contenttype=PARA& Senior
Advisor on Health Economics, Ministry of President of Intergovernmental Forum on Chemical Safety (IFCS) 30 November, 2006 What was the reason for issuing this compulsory license? We
have around 120 000 people on ARVs in But why issue the compulsory license now? For good reason, because after three years we have learnt a lot. At first we didn’t have much experience now we’ve done intense research and have found that the nevirapine-based formulation has about four times more serious side effects than the efavirenz one. And if possible, if we can afford it, we would hope that in the future we will be able to replace the nevirapine-based formulation with the efavirenz-based one. What will be the impact of this compulsory license on your national policy of universal access to ARVs? We will start by expanding the number of patients on the efavirenz-based ARV formulation and if we have a bigger budget and a further reduction in price, we should be able to cover all our patients. After the compulsory license, the price of efavirenz will be reduced by around half. Right now, it is only when patients can’t tolerate nevirapine that we switch them to efavirenz. But if the price of efavirenz goes down thanks to compulsory licensing, we will not have to subject these patients to the risk of nevirapine-based products in the near future. We will be able to start patients on the efavirenz-based formulation straight away. How many patients will benefit from this compulsory license? We have issued a compulsory license by the state which starts immediately and lasts for five years for up to 200 000 patients per year. Is
the compulsory license for both local production and import? At first,
we will import from What kind of price reduction do you foresee? The
Government Pharmaceutical Organisation estimates this will result in
a 50 % reduction in price. The current price from the originator company
is around 1400 ------------------------------------------------------------------------------------------- Price-Cut
Handcuffs: Brook K. Baker, Health GAP December 3, 2006 On
November 29, the Thailand Department of Disease Control, Ministry of
Health, announced that it had issued a compulsory license for Efavirenz
that would allow immediate importation at half the cost from Within two days, Merck leapt to the defense of its patent by offering to discuss discount prices or voluntary licenses with the Government Pharmaceuticals Organization. In doing so, Merck complained that it had received no prior warning's of the government's intention and further claimed that there had "been no process in terms of Thai law or international law, where the company has been consulted or where the company has been asked what they [sic] could do to assist." To the contrary, neither Thai law nor international law requires prior negotiation for a voluntary license or for price discounts before issuing a compulsory license for government, non-commercial use (commonly called government or crown use) or for a health emergency such as that presented by HIV/AIDS. Article 31 of the TRIPS Agreement specifically authorizes government use without negotiation, and the 2001 Doha Declaration on the TRIPS Agreement and Public Health confirms this procedure. There's no way that Merck officials don't understand the legality of Thailand's stated intentions, but that doesn't stop Merck's disinformation team from suggesting that Merck has been treated unfairly and perhaps even illegally. The
Well,
the Thailand
must resist Merck's price-cut/hands/cuff offer, an offer that might
bring temporary price discounts, but at the cost of yet again disincentivizing
generic production and yet again demotivating developing country utilization
of a key TRIPS flexibility. In fact, It
is no secret to Merck that its supply chain in ------------------------------------------------------------------------------------------------------------ http://www.salon.com/tech/htww/2006/11/29/thailand_pharma/ Why
Free trade and AIDS in a post-coup, post-midterm election world Andrew Leonard (How the World Works) Nov. 29, 2006 | Thailand's Ministry of Public Health indicated today that it would grant the application of the Government Pharmaceutical Organization for a compulsory license to manufacture a generic version of the AIDS retroviral drug Efavirenz. (Thanks to the Consumer Project on Technology for the link.) The
reason: AIDS sufferers in Bristol-Myers
Squibb and the rest of Big Pharma would rather How,
specifically, would this happen? If you look at other FTA agreements
that the 1) TRIPs allows any nation to declare a compulsory license without declaring a reason. The Singaporean and Australian agreements limit the use of such licenses to antitrust remedies, public non-commercial use, or national emergencies. 2)
For a generic drug manufacturer to enter a given market with a particular
drug, it must receive regulatory approval to market that drug. Recent
bilateral FTAs negotiated by the 3) In order to get marketing approval a generic manufacturer must also present test data proving its safety and effectiveness. Typically this is done by using the test data already amassed for the original patented drug. TRIPs forbids this only in cases of "unfair commercial use." Bilateral FTAs require varying periods of test data exclusivity, no matter what the circumstances. Taken
together, these provisions are carefully designed to hamper a country
like Compulsory
licenses, Big Pharma and TRIPs frequently pop up in the pages of How
the World Works. But in the context of post-coup In
the But
a close look at what really goes in the bilateral FTA sausage factory
makes the name-calling a little suspect. One way to look at these FTAs
is to see them as devices by which the Is
it really protectionist for Democrats to say, let's reexamine this equation,
and reevaluate the question of which sector of the Should,
for example, the pharmaceutical industry be gaining a global advantage
at the expense of concessions that may make life for manufacturing workers
in the U.S. more difficult? Isn't what the Unfortunately, Democrats bashing globalization on the campaign trail rarely delve into the nitty-gritty details of FTA agreements in order to make a case for their opposition to how trade is currently practiced. If they did, and laid out carefully how the tradeoffs benefit some American industries while hurting others, while simultaneously having a negative impact on public health in the developing world, it might get a little more difficult to bash them as protectionist. ------------------------------------------------------------------------------------------------------------ MSF Press Release MSF Welcomes Move to Overcome Patent on AIDS Drug in Thailand Thailand today for the first time announced it will issue a compulsory licence for use by the government to improve access to a key HIV/AIDS medicine, efavirenz. The international medical humanitarian organization Médecins Sans Frontières (MSF) welcomes this important move and urges the government to issue such licenses for the production of other essential medicines. The
drug efavirenz, which is recommended by WHO for HIV/AIDS treatment,
is currently patent protected in “Merck’s
supply of efavirenz has not been reliable, and has resulted in treatment
interruptions, forcing several hospitals to supply suboptimal dual therapy,”
said Dr. David Wilson of MSF in The
compulsory license will apply both to import and local production of
the drug. It
is estimated that at least 12,000 people in Generic
production is the cornerstone of Both the World Health Organization (in August, 2005) and the World Bank (in August, 2006) have predicted dramatically rising drug costs in Thailand due to the fact that patients need to switch to newer and more expensive drugs in cases of resistance and toxicity. Both organisations recommend the use of public health safeguards enshrined in the Doha Declaration on TRIPS* and Public Health. “Thailand is demonstrating that the lives of patients have to come before the patents of drug companies, and this policy needs to be expanded to essential drugs that are expensive and in short supply, such as the AIDS drug lopinavir/ritonavir, which currently costs over 7,000 baht a month (US $194) and is far too expensive for Thailand,” said Dr. Wilson. *World Trade Organization Agreement on Trade-related Aspects of Intellectual Property Rights
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