The fight for access to medicines in Thailand centers around the use of compulsory licensing on three drugs. The chronology on this page includes some of major moments towards bringing about the use of compulsory licensing in Thailand and globally.
- Medecins Sans Frontieres (MSF) starts a campaign to push drug company, Abbott to register the heat-stable lopinavir/ritonavir (a new formulation of key second AIDS drug Kaletra) in developing countries. The drug has been registered in the US since October 2005, but is not available in developing countries. Abbott has been selling the old formulation of the drug in African and Least Developed countries at US$500 since May 2002, but offers no differential prices in middle-income countries like Thailand.
“A second way for the government to limit its expenditures on second-line therapy is to grant compulsory licenses for the manufacture of patented second-line pharmaceutical products. Doing so will require high-level political resolve that is based on an accurate understanding of the costs to Thailand, the health benefits, the budgetary savings, and the trade repercussions of such action”. – The World Bank in a report (pdf) on Thailand.
In an open letter to the CEO of Abbott, Miles White, MSF and prominent doctors, researchers and people living with HIV/AIDS, express concerns about the lack of availability in developing countries of the new heat-stable formulation of lopinavir/ritonavir. The letter urges Abbott to immediately file for registration of the new formulation in all countries where the old formulation is registered, or pending, as well as in other developing countries. MSF also asks Abbott to publish a price for the new formulation for Least Developed countries, and middle-income countries and to communicate the list of countries eligible and the filing date for registration.
- Abbott responds to MSF, but fails to provide a price and timeline for registering the new formulation, stating that European approval was a prerequisite to registration.
- MSF places an order for the drug for 400 MSF patients in nine countries including Thailand. The order aims to put nearly 800 patients on the new formulation by the end of 2006.
- Abbott announces a price of US$500 per person per year (pppy) for the heat stable formulation of Kaletra in Africa and Least Developed Countries, but takes no step to make the drug available in any of these countries, except South Africa.
- After a cumbersome and time-consuming procedure, Abbott begins to ship the new formulation to a limited number of MSF projects in Africa for US$500 pppy. But the company still refuses to sell the drug to MSF’s programs in Thailand, where it still charges at least US$2,800 pppy for the old version of lopinavir/ritonavir. MSF urges Abbott to speed up its registration process, as the drug is still unavailable in most developing countries.
- Abbott announces a price of US$2,200 pppy for heat-stable Kaletra in low and low- middle income countries such as Thailand.
“WHO unequivocally supports the use by developing countries of the flexibilities within the TRIPS Agreement that ensure access to affordable high quality drugs.” – Margareth Chan, former Director of the World Health Organization.
Thailand issues a compulsory license for first-line AIDS drug efavirenz patented by Merck. Merck sells efavirenz for a non-profit price of 1,400 baht ($38.84) per month in Thailand. The Government Pharmaceutical Organisation (GPO) says it would import generic efavirenz, sold by Indian drug-maker Ranbaxy for 800 baht per month, until the GPO made its own version in June 2007. Thailand places an order for 66,000 bottles of efavirenz from Ranbaxy at 650 baht per bottle.
- Merck proposes a new price for efavirenz at US 72 cents per tablet, (around 780 baht per bottle) a price closer to what is proposed by generic competitors. The company also announces a global price reduction of efavirenz to 700 baht per month for countries whose prevalence rate of HIV/AIDS is 1% or higher.
“Can you tell me how much one human life is worth so I can compare it to the exports figures to the US.” – Doctor Mongkol Na Songkla, Minister of Health, Thailand.
The first batch of 16,000 bottles arrives in Thailand. The Ministry of Public Health says this price cut will allow them to provide efavirenz to an additional 20,000 patients.
- 22 US Congressmen write a letter to US Trade Representative Susan Schwab, to urge the US to respect Thailand’s decision to issue a compulsory license for efavirenz.
- Mrs Susan Schwab confirms the legal and social grounds for compulsory licensing saying, “We have not suggested that Thailand has failed to comply with particular national or international rules. We have taken care to respect fully the Thai government’s ability to issue compulsory licenses in accordance with its obligations as a member of the World Trade Organization.”
- Thailand issues two compulsory licenses, one for the key second-line AIDS drug lopinavir/ritonavir (Kaletra) patented by Abbott, as well as one for the heart medication clopidogrel bisulfate (Plavix) patented by Sanofi Aventis.
- World Health Organization’s (WHO) executive Director, Dr Margaret Chan sends a letter to the Public Health Minister of Thailand expressing WHO’s unequivocal support for the use of the “flexibilities” within the TRIPS Agreement, by developing countries, to ensure access to affordable high quality drugs.
“No company will live or die because of high price premiums for AIDS drugs in middle-income countries, but patients may.” – Bill Clinton, former US President.
Abbott responds to Thailand’s compulsory licensing by withdrawing registration applications for seven new drugs including the heat stable version of Kaletra, Kaletra/Aluvia, in the country.
- MSF denounces Abbott’s action and writes a response to the World Street Journal after the newspapers publishes a series of editorials calling Thailand’s compulsory licensing a “seizure of foreign drug patents” and accusing the government of trying to save money on medicines to increase the military budget.
- AIDS activists in Thailand and dozens of countries around the world call for a boycott of Abbott’s products, and demonstrate, send letters and speak out to condemn the company’s actions. MSF expresses its support to the activists but doesn’t call for a boycott. Instead MSF urges WHO, UNAIDS, and all relevant policy makers and governments to support countries wishing to use the flexibilities within the WTO’s TRIPS Agreement, to provide access to essential medicines.
- Abbott offers Kaletra to the Ministsry of Public Health for US$1700 pppy (Baht 5,938 pppy) excluding VAT.
- French minister for Foreign Affairs, Philippe Douste- Blazy gives public support for Thailand’s compulsory licenses. He is the only representative from the EU to take an official position. Stony silence from the other countries.
- After discussions with the WHO’s DG Chan, Abbott says it will more than halve the price of Kaletra/Aluvia in low and low and middle-income countries, bringing the cost of treatment to US$1,000 pppy from the original rate of US$2,200 pppy. The company says it would register the drug in 150 countries, but not in Thailand where it will continue to sell the old formulation.
- Abbott announces it will offer the new heat-stable version at the new US$1,000 price to Thailand only if the country withdraws the compulsory license. The Thai Ministry of Public Health refuses.
- One day before Abbott’s annual shareholder meeting in Chicago, AIDS activists and PLHA groups rally in front of Abbott’s office in Bangkok, and in other countries over Abbott’s decision to withdraw new medicines from Thailand. Several protests, press conferences are also organised around the world.
- USA for Innovation, a lobby group working for the US pharmaceutical industry and pretending to be a NGO publishes a full page add entitled “Slouching towards Burma – Thailand’s radical new regime” in the World Street Journal.
- Activists protest at the Abbott’s Annual General Meeting for shareholders, held in Abbott Park, Illinois.
- The US Trade Representative (USTR) includes Thailand on a Priority Watch List that singles out countries with poor record of intellectual property protection and exposes them to potential trade sanctions. Thailand’s compulsory licensing is one of the reasons invoked for the downgrade, among copyright violations on books and DVDs. The report says Thailand’s generic drug efforts are “further indications of a weakening of respect for patents”.
- AIDS activists protest outside the US embassy against the US Trade Representative’s decision to put Thailand on the Priority Watch List.
- Brazil issues a compulsory licence for governmental use, to allow the import of a generic version of efavirenz, after the drug’s patent holder Merck & Co failed to match the 60-per-cent price reduction requested.
- Health Minister Mongkol Na Songkhla visits Washington. Thailand joins the Clinton Foundation’s pool procurement. The Foundation announces it has negotiated with Indian generic producer Matrix for bulk purchases of Kaletra/Aluvia at US$695. The new agreements with generic drug manufacturers Cipla and Matrix not only significantly lower the price of AIDS treatment for second-line antiretroviral drugs but also for a new, once-a-day pill that is currently cost prohibitive in the developing world. Lower prices for 16 formulations of antiretroviral drugs will be available to 66 developing countries in Africa, Asia, Latin America and the Caribbean through the Clinton Foundation’s Procurement Consortium.
- According to the media (Prachachart), the US proposed an “action plan” to remove Thailand from its priority watch list. The demands are similar to those made by the US during talks with the Thai government about a Free Trade Agreement. They include an extension of drug patents from the normal 20 years, an expansion of drug patents to cover the diagnosis process and surgery; and restrictions on the right to issue compulsory licences.
- The Thai ministry of Commerce rejects the US “action plan”.
- USA for Innovation begins a series of attacks against Thailand’s compulsory licensing. They launch www.thailies.com to ”draw attention to the deceit in Thailand’s decision to steal American and European innovation” and claim in the national press that GPOvir, the first line regimen produced in Thailand, has world-record levels of resistance.
- MSF and other NGOs publish a counter attack in the Bangkok Post and the Nation.
- Abbott offers the Ministry of Public Health, the drug Aluvia for about US$1,000 pppy provided that Thailand doesn’t seek compulsory licensing for Aluvia, and that the price of Aluvia can’t be reduced any further in the future.
- Health Minister Mongkol Na Songkhla says that Thailand will not issue compulsory licenses to produce reduced-cost versions of patented drugs, if pharmaceutical companies offer prices lower than those charged by generic drug makers.
- GPO manufacturer of GPO-vir threatens to file a libel charge against USA for Innovation, on the ground that the firm’s ads were damaging to GPO and its product.
- Thai Minister of Health, Dr Mongkol, visits Washington on May 21-22 to meet congressmen and explain the government’s decision to issue compulsory licenses.
- GPO submits an application for the registration of the generic heat-stable formulation of Kaletra produced by Indian generic manufacturer Matrix. The Thai FDA promises to fast track the application which could pave the way for a compulsory license on Aluvia.
- Abbott decides to sue Act Up Paris (an activist group of people living with HIV) in response to when Act Up called on activists to visit Abbott’s website, forcing a slow down of its service.
- After an announcement to issue a Compulsory License, the National Health Security Scheme can save more money from HIV drugs, and decides to include chronic kidney treatment into the benefit package.
- The Thai Ministry of Public Health and the National Health Security Scheme announce they plan to extend the use of compulsory license for efavirenz and lopinavir/ritonavir until the patent expires.
- The Thai Ministry of Commerce and Department of Intellectual Property requested that the Cabinet reviews patent law, to include TRIPS Article 31(f). If agreed, this will enable Thailand to produce patented medicines for export under compulsory license. This will mean that countries that have no local pharmaceutical manufacturing capacity, will be able to access medicines at affordable prices from Thailand.