After eight long years of lobbying, the Thai government issued compulsory licenses for two antiretroviral drugs, Efavirenz and lopinavir/ritonavir (Kaletra) and for compulsory license opidogrel, an anti-clotting agent. The article below from the Thai Network of People Living with HIV documents the long running campaign.
The government announced its decision to issue a compulsory licence for Efavirenz in November 2006, and was immediately locked in talks with pharmaceutical company, Merck who held the patent on Efavirenz in Thailand.
Thai government came under pressure
The Thai Ministry of Foreign Affairs and the Ministry of Commerce were also under increasing pressure from the Thai Pharmaceutical Research and Manufacturers Association (PReMA), the US ambassador and the Swiss ambassador to try and stop the government from issuing these licenses. Compulsory licenses were issued for lopinavir/ritonavir and clopidogrel on 26 January 2007. Abbott Laboratories holds a patent for lopinavir/ritonavir which is sold under the brand name Kaletra. Sanofi- Aventis currently holds a patent for clopidogrel which is sold as Plavix.
Despite this pressure, the Thai Health Minister, Mongkol na Songkhla signed the licenses and imported a generic version of Efavirenz from Indian Pharmaceutical company, Rambaxy. The Government Pharmaceutical Organisation (GPO) has plans to manufacture generic Efavirenz but is still completing bio-equivalence studies. It is expected that production may be possible in six months time. The Thai government also has plans to import a generic version of Kaletra from Indian generic company, Matrix although it is yet to do so as it currently has a stockpile of Abbott manufactured Kaletra. The GPO is currently researching the possibility of manufacturing a generic version of Kaletra.
Groundbreaking decision to issue compulsory license
This was a ground breaking decision for Thailand’s military regime and came after years of lobbying previous governments by Thai Network of People Living with HIV/AIDS (TNP+), AIDS ACCESS Foundation, Medecins Sans Frontieres (MSF), academics and other HIV activists and organizations. A working group was set up by the National Health Security Office (NHSO) in 2004 to look into the possibility of issuing Compulsory Licenses and providing technical advice to the MoPH about this issue. Since its inception the working group has included representatives of NGOs.
Thailand amended its patent laws to be compliant with WTO regulations in 1992 and so the ability to issue compulsory licenses is a viable, legal option to ensure access to quality yet cheaper versions of patented ARV medication. In 2006, the World Bank identified the use of compulsory licenses by Thailand to procure less expensive generic medicines as a strategy to address excessive costs associated with providing second line treatment. The compulsory license for Kaletra alone is predicted to save Thailand as much as US$24 million a year.
Abbott Laboratories deny Thailand access to Aluvia
In defiance of the compulsory license, Abbott laboratories withdrew all their medications awaiting registration in addition to refusing to register any new pharmaceutical products in Thailand. This denied Thailand access to Aluvia, the new heat resistant formula Kaletra, as no generic equivalent was on the market at the time. Kaletra is WHO standard medication and is particularly pertinent for a tropical country such as Thailand. Abbott also refused to negotiate a numeration package with the Ministry of Public Health. Merck and Sanofi-Aventis rejected the 0.5% offered by the government.
Civil society fight back
TNP+, AIDS ACCESS Foundation and AIDS activists around the world rallied together to condemn Abbott’s actions and to denounce their intimidation campaign.
TNP+ called for a global boycott of Abbott products together with:
- AIDS ACCESS Foundation
- Thai Foundation for Consumers
- Thai Rural Doctors society
- Thai Chronic renal failure network
- Thai Alternative Agriculture network
- Thai Parents network
- Thai Rural Pharmacist society
- Thai NGOs Coalition on AIDS
- FTA Watch
The organizations held protests outside Abbott’s offices demanding that they register essential medicines in Thailand. A global day of action was organized 26 April 2007 to garner global support for the Thai government’s decision and to denounce Abbott’s bullying tactics. In Bangkok, TNP+, AIDS ACCESS Foundation and an alliance of supporting organizations and individuals marched to the Thai Ministry of Commerce’s Intellectual Property office to demand that the Thai Trade Competition Commission instigate criminal actions against Abbott in breach of Thai competition law 25(3) that prohibits a dominant firm from “suspending, reducing or restricting services, production, purchase, distribution, deliveries, or importation without justifiable reasons”. The demonstration then made its way to the business district to engage and educate the public about this issue
Activists around the world support Thai action
Actions against Abbott took place across the globe in solidarity with the Thai action including France, US, UK, Germany, India, China, Brazil, Argentina, Canada, Indonesia, South Korea, Nepal, Japan and Singapore to coincide with Abbott’s AGM held on the 27th April at Abbott’s headquarters in Chicago. TNP+ activist and chairperson, Wirat Purahong and long time HIV activist and former Thai Senator, Jon Ungpakorn flew to the US to participate in a speaking tour to highlight the importance of granting compulsory license as a legitimate way to increase access to essential medicines and to denounce Abbott’s unethical actions and attempts to intimidate other developing countries from utilising the flexibilities granted them in TRIPs. Jon and Wirat also attended the Abbott AGM at the invitation of a group of Abbott shareholders.
Just prior to the AGM, Abbott agreed to register new formula Kaletra on the condition that the Thai government would not issue a compulsory license. TNP+ denounced their demands as blackmail, as they still failed to address Abbott’s decision to withdraw six other drugs that were awaiting registration. To date, the Thai government has not agreed to these demands.
The price reductions resulting from these actions
After the compulsory license was issued, Thai health authorities purchased a WHO pre-qualified generic form of Efavirenz from Ranbaxy. Ranbaxy’s generic price is 650 baht (US$20) per month compared with the Merck price of 1400 baht per patient per month (US $43). More than 66,000 bottles were imported on 5 January 2007, which lasted for three to four months and allowed health care providers to treat at the same cost an extra 20,000 patients with Efavirenz.
Subsequent to issuing the compulsory license, Merck and Abbott both offered significant price reductions proving that compulsory license can dramatically reduce the price of essential drugs. Merck offered to reduce the price of Efavirenz to $23 per bottle, however this offer was rejected as it was still more expensive than the Indian generic.
Encouraged by Thailand’s efforts, the Brazilian government announced that it had taken the first step towards issuing a compulsory license to import Indian generic Efavirenz. The decision came after Efavirenz’s manufacturer Merck refused to sell the drug to the Brazilian government at the same price that was offered to the Thai government. The Brazilian government was asking Merck to sell Efavirenz at US$0.65 a day, compared to the current price of around $1.60– a price reduction of almost 60%. Efavirenz is currently used by 75,000 patients in Brazil, and costs the Brazilian government $43.8 million a year.
On the eve of the Abbott AGM in a desperate bid to improve its tarnished public image, Abbott announced its plans to reduce the cost of Kaletra in Thailand and more than 40 low- and low-middle-income countries by more than half. The company said it will provide Kaletra in these countries for $1,000 per patient per year down from $2,200, which is less than the cost of generic versions of the drug.
Abbott provides the drug at a cost of $500 per patient per year in 69 of the poorest developing countries, including all of Africa however Kaletra is not registered in all countries where their price reductions are being offered, making their new deal meaningless. This price reduction did not affect the availability of the drug in Thailand as Abbott was still refusing to register it.
US Trade Representative downgrades Thailand
On 1 May the US Trade Representative Office (USTR) downgraded Thailand from “watch list” to “priority watch list”. US Ambassador to Thailand, Mr. Ralph Boyce, said that the Ministry of Health’s decision to issue the compulsory licenses was only one of the factors in the downgrade however it was one of the main reasons given in the USTR’s Special 301 report. Undue pressure from Abbott Laboratories and other pharmaceutical giants affected by the recent compulsory licenses has also been cited by many as another critical factor. US law enables the US to take trade action or seek dispute settlements with countries placed on these lists.
The downgrade has come despite the USA conceding that the Thai issued compulsory licenses were in complete compliance with World Trade Organization (WTO) rules and Thai law. Their concern, they claim was due to a “lack of transparency exhibited in Thailand”. TNP+ and AIDS ACCESS Foundation is not alone in viewing this decision as a total reflection of the unjust pressure and influence that drug companies have over the USTR and their desire to intimidate developing countries from utilising the flexibilities afforded them in WTO’s TRIPs agreement. The Doha agreement explicitly states that TRIPs can and should be interpreted in light of the goal “to promote access to medicines for all”. This hostile and aggressive retaliatory action by the USTR and drug companies is out of step with WTO rules and sets a dangerous precedent for other developing countries who wish to issue compulsory licences for essential medicines. TNP+ believes that the USTR and pharmaceutical companies must respect the laws of the WTO in the interests of public health.
Rights activists organize protests around the world
HIV treatment and rights activists again responded to this decision with a demonstration in front of the US embassy in Wireless rd, Bangkok. They draped a banner from the overpass that read “Evil USA: Stop threatening access to treatment in Thailand”. This received a lot of press both within Thailand and abroad.
In June 2007, ACT UP, a long time AIDS activist group based in Paris, informed TNP+ that they were being sued by US pharmaceutical giant, Abbott, for action taken whilst participating in the International Day of Action against Abbott on 26 April 2007.
Thousands of people around the world participated in an ACT UP lead “netstrike” that saw Abbott’s website bombarded with hits and forced a slowing of its server. Abbott decided to take legal action in what they ironically deem a “denial of service”. If successful, ACT UP could be fined more than $50,000 in addition to legal expenses. This was seen by ACT UP as a clear attempt by Abbott to silence them and deny them the right of free speech.
French law stipulates that it is forbidden to limit access to a website, unless the defendant had a “legitimate motive”. Holding companies accountable for unethical conduct and highlighting the denial of essential medicines in the name of greed and profit can surely be interpreted as a legitimate and honorable motive and welcome the opportunity to debate Abbott’ actions in a court of law. The court case took place in October 2007.
TNP+ united with ACT UP to demand that the petty lawsuit be dropped and that Abbott reverse their decision to withdraw life saving medicines from registration in Thailand.