| |
|
|
"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." - World Bank’s report on Thailand (The Economics of Effective AIDS Treatment – Evaluating Policy Options for 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, Director of the World Health Organisation (WHO).
“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.
“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.
Chronology:
- March 2006: MSF starts a campaign to push 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$500 since May 2002, but offers no differential prices in middle-income countries like Thailand.
- 6 March 2006: In an open letter to the CEO of Abbott, Miles White, MSF and prominent doctors, researchers and People Living with HIV/AIDS express concerns about the lack of availability in developing countries of the new heat-stable formulation of lopinavir/ritonavir. The letter urges Abbott to immediately file for registration of the new formulation in all countries where the old formulation is registered or pending as well as in other developing countries. MSF also asks Abbott to publish a price for the new formulation for Least Developed countries and middle-income countries and to communicate the list of countries eligible and the filing date for registration.
- 13 March 2006: Abbott responds to MSF but fails to provide a price and timeline for registering the new formulation, stating that European approval was a prerequisite to registration.
- 15 March 2006: MSF places an order for the drug for 400 MSF patients in 9 countries including Thailand. The order aims to put nearly 800 patients on the new formulation by the end of 2006.
- March 2006: Abbott announces a price of US$ 500 pppy for 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.
- July 2006: 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 programmes in Thailand where it still charges at least US$2,800 pppy for the old version of lopinavir/ritonavir. MSF urges Abbott to speed up its registration process, as the drug is still unavailable in most developing countries.
- August 2006: Abbott announces a price of US$ 2200 pppy for heat-stable Kaletra in low and low- middle income countries such as Thailand
- November 2006: Thailand issues a compulsory license for first-line AIDS drug efavirenz patented by Merck. Merck sells efavirenz for a non-profit price of Bt 1,400 ($38.84) per month in Thailand. The Government Pharmaceutical Organisation (GPO) says it would import generic efavirenz, sold by Indian drug-maker Ranbaxy for Bt 800 per month, until the GPO made its own version in June 2007. Thailand places an order for 66 000 bottles of efavirenz from Ranbaxy at 650 baht per bottle.
- 6 February 2007: Merck proposes a new price for Efavirenz at US$ 72 cents per tablet, (around Bt 780 per bottle) a price closer to what is proposed by generic competitors. The company also announces a global price reduction of Efavirenz to Bt 700 per month for countries whose prevalence rate of HIV/AIDS is 1% or higher.
- January 2007: The first batch of 16,000 bottles arrives in Thailand. The MOPH says this price cut will allow to provide Efavirenz to an additional 20 000 AIDS patients.
- 10 January 2007: 22 US Congressmen wrote a letter to US Trade Representative Susan Schwab, to urge the US to respect Thailand’s decision to issue a compulsory license for Efavirenz.
- 17 January 2007: Mrs Susan Schwab confirms the legal and social ground of the CL: "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 CL (…) in accordance with his obligations as a member of WTO".
- 24 January 2007: 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.
- 7 February 2007:WHO’s executive Director, Dr Margaret Chan sends a letter to the Public Health Minister of Thailand expressing WHO’s unequivocally support for the use by developing countries of the flexibilities within the TRIPS Agreement to ensure access to affordable high quality drugs.
- 13 March: 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.
- 14 March 2007: 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.
- 20 March 2007: 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 condemns 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 vocally support countries wishing to use the flexibilities within the WTO’s TRIPS Agreement, to provide access to essential medicines.
- 26 March 2007: Abbott offers Kaletra to the MOPH for US$1700 pppy (Bt 5,938 pppy) excluding VAT.
- 27 March 2007: French minister for Foreign Affairs, Philippe Douste- Blazy gives public support for Thailand’s compulsory licenses. He is the only representative from the EU to take an official position. Stony silence from the other countries.
- 10 April 2007: After discussions with the WHO DG Chan, Abbott says it will more than halve the price of Kaletra/Aluvia in low and low and middle-income countries, bringing the cost of treatment to US$ 1000 pppy (Bt 34 500) from the original rate of US$ 2200 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.
- 23 April 2003: Abbott announces it will offer the new heat-stable version at the new US$ 1000 price to Thailand only if the country withdraws the compulsory license. The Thai MOPH strongly refuses.
- 26 April 2007: Global Action Day: 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.
- 26 April 2007: 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.
- 27 April 2007: Activists protest at the Abbott's Annual General Meeting for shareholders, held in Abbott Park, Illinois.
- 30 April 2007: 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”.
- 3 May 2007: AIDS activists protest outside the US embassy against the US Trade Representative's decision to put Thailand on the Priority Watch List.
- 4 May 2007: 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.
- 8 May 2007: Health Minister Mongkol Na Songkhla’ visit to 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 ARV 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 ARVs will be available to 66 developing countries in Africa, Asia, Latin America and the Caribbean through the Clinton Foundation's Procurement Consortium.
- 9 May 2007: 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 FTA. 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.
- 11 May 2007: The Thai ministry of Commerce rejects US “action plan”
- 9- 13 May 2007: 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 1st line Aids produced in Thailand, has world-record levels of resistance.
- 13 May 2007: MSF and other NGOs publish a counter add in the Bangkok Post and the Nation.
- 14 May 2007: Abbott offers the MOPH to sell Aluvia for about US$1,000 pppy (Bt 34,000) provided that Thailand doesn’t seek compulsory licensing for Aluvia and the price of Aluvia can’t be reduced any further in the future.
- 15 May 2007: 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 adds published were damaging to GPO and its product.
- 21 – 22 May 2007: 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.
- 28 June 2007: 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.
- 12 June 2007: Abbott decides to sue PLWAs group Act Up Paris in response to the April 27th, 2007 when Act up’s call on activists to visit Abbott’s website forced a slowing down of its service.
|
|