Abbott Pharmaceuticals in Thailand: Fact Sheet

Posted: 13 April 2007

Five years after the Doha Declaration, multinational pharmaceutical companies are on the offensive, seeking to undermine safeguards and eliminate generic competition to their patented medicines. If they are successful, it would set a worrisome precedent by encouraging companies to undermine developing countries’ efforts to implement pro-health policies within the legal boundaries of existing agreements. This will have devastating effects on poor people’s access to medicine.

Five years ago, all members of the World Trade Organization (WTO) signed the Doha Declaration, promising that intellectual property rules included in the TRIPS Agreement (Trade Related Aspects of Intellectual Property Rights) would no longer obstruct developing countries’ efforts to protect public health. They agreed that all countries can use various “public health safeguards” in WTO rules to promote access to affordable generic medicines. Five years on, multinational pharmaceutical companies are on the offensive, seeking to undermine these safeguards and eliminate generic competition to their patented medicines. If the companies are successful, it would set a worrisome precedent by encouraging companies to undermine developing countries’ efforts to implement pro-health policies within the legal boundaries of the TRIPS Agreement and Doha Declaration. This will have devastating effects on poor people’s access to medicines.

Abbott is challenging Thailand’s issuance of a government use license for Kaletra

More than 1 million women, men, and children have contracted HIV in Thailand and more than 500,000 people have died of AIDS since the outbreak of the epidemic. In order to tackle this national epidemic, the Ministry of Public Health recently issued a government use (compulsory) license for Kaletra, a 2nd line anti-retroviral (ARV) medicine urgently needed by an increasing number of AIDS patients. The Thai government’s action was legal, fully consistent with the TRIPS Agreement, and will drastically reduce HIV treatment costs. Yet in response to this decision, Abbott Laboratories protested, and subsequently withdrew registration of seven new medicines from the local market.

The Thai government is committed to provide universal access to ARVs for AIDS patients. HIV treatment in Thailand began in 1987. Since 2000, the National Access to Anti-retroviral Program for People Living with HIV/AIDS (NAPHA) has provided a wide range of triple-drug anti-retroviral (ARV) therapy. The program’s cost was dramatically reduced in 2002 when the Government Pharmaceutical Organization (GPO) introduced production of a generic ARV triple drug ‘cocktail’ called GPO-vir for 1,200 baht ($ 31) per patient per month, compared with 18,620 baht ($ 490) for imported, brand-name medicines. As a result, an unprecedented number of HIV positive individuals (80,000 people by the end of 2006) in Thailand have gained access to first line ARVs.

Despite its achievements, the program is facing new challenges. At least 8,000 Thais will soon develop drug resistance to 1st line ARVs, and will need to switch to 2nd line ARVs to survive. Because of the high cost of 2nd line treatment, the Thai government can only treat 2,000 drug resistant HIV patients. Abbott currently markets an important 2nd line ARV, Kaletra, at $2200 dollars per patient per year in Thailand. This makes 2nd line ARV treatment in Thailand unaffordable.

Thus, the Ministry of Public Health decided to issue a government use (compulsory) license for Kaletra, which empowers the government to manufacture or import generic versions of the medicine. According to Médecins Sans Frontières, switching to generic copies of Kaletra through use of a government use license will lower the price to only $1440 per patient per year. Issuing a government use license will drop the price of Kaletra sufficiently to allow the government to save an additional 8,000 lives.

Abbott’s decision to de-register seven medicines deprives patients of new therapies, and raises retaliatory, patent-protection tactics to a new level. It sends a powerful message to developing countries that they should not use lawful flexibilities to access affordable, generic versions of patented medicines, even if national and international law permits them to do so.

Oxfam calls on Abbott to re-register their new medicines onto the Thai market and to publicly recognize every country’s right to use legal safeguards included in the TRIPS Agreement to protect public health, including the use of government use licenses.

FACTS

The government has recently increased its commitment and spending on health care. According to the Ministry of Public Health (MoPH), spending on general health care has increased from 1,202 baht per head in 2003 to 1,899 baht per head in 2007, and spending on the National AIDS program has increased from 2.7 billion baht per year to 3.8 billion baht per year.
Government use licenses for AIDS medicines have been issued on numerous occasions before, although never for Kaletra. Other countries that have issued government use licenses for ARVs include Indonesia and Malaysia, and Brazil has threatened to issue compulsory licenses on multiple occasions.
Thailand has also issued government use licenses for two other medicines, efavirenz (Merck) and Plavix (Sanofi-Aventis). Merck’s response has been to lower the price of the medicine worldwide. Sanofi-Aventis had recently a meeting with the MoPH, offering to lower the price of Plavix and expanding collaboration with GPO in producing various vaccines.
Various civil society groups and medical organizations in Thailand and worldwide have pledged to boycott Abbott goods or products, insofar as it is practicable to do so. This has clearly demonstrated the reputation and business risk that pharmaceutical companies will face by challenging the right of developing countries to use TRIPS safeguards.
One of the new medicines withdrawn by Abbott, or the heat stable form of Kaletra (also called Aluvia) is one of the most important second-line anti-retroviral medicines. It combines ritonavir, a so-called booster, with a protease inhibitor in a single tablet. As opposed to the old form of Kaletra, Aluvia is heat-stable, which means that it does not require cold-supply chain management and refrigeration, thereby easing patient compliance, access and availability.
The other six medicines withdrawn by Abbott include: (1) painkiller Brufen, (2) antibiotic Abbotic, (3) blood clot drug Clivarine, (4) arthritis drug Humura, (5) high blood pressure medicine Tarka, and (6) kidney disease medicine Zemplar.