- The EU-Thai FTA could include five years of data exclusivity for new drugs
Thai-EU FTA raises alarm for people with AIDS
By Marwaan Macan-Markar
BANGKOK, Dec 29 2012 (IPS) — Days before leaders of the European Union (EU) arrived in Norway to collect this year’s Nobel Peace prize, Thai public health activists sent a letter to the northern powerhouse, warning that the EU’s 2012 accolades face a credibility test in this Southeast Asian country.
They had in mind the fate of Thailand’s generic drugs supply-line when Bangkok and the EU begin talks in early 2013 for a free trade agreement (FTA). The letter to Joao Aguiar Machado, deputy director general for trade at the European Commission, called for the bloc to respect global trade rules’ special provisions for developing countries.
The EU’s history of pressuring various developing countries around the world to comply with its conditions and requirements in free trade negotiations – which seek to remove all barriers to EU firms wishing to do business abroad – run “contrary to the expectations” of a Nobel Peace laureate, added the letter sent days before the Dec. 10 awards ceremony in Oslo.
“We are worried that the EU negotiators will force Thailand to accept new conditions on patents that would make access to new generic drugs more difficult,” says Chalermsak Kittitrakul, campaign officer at the AIDS Access Foundation. “People with HIV and patients needing medicines for cancer, heart disease and diabetes will have to pay more.”
“These clauses in a Thai-EU FTA would make it difficult for Thailand to produce or import generic drugs,” he told IPS. “It will pave the way for big pharmaceutical companies to monopolise the market and undermine generic competition.”
The EU is Thailand’s second largest trading partner after the ten-member Association of Southeast Asian Nations (ASEAN). According to Thai officials, bilateral trade between the two partners stood at 35 billion dollars in 2010.
Thai activists want the negotiating text for the bilateral trade deal to stay within the bounds of the World Trade Organisation (WTO) law on Trade-Related aspects of Intellectual Property Rights (TRIPS), which was adopted during the groundbreaking international trade talks in Doha in 2001.
This provision permits developing countries with health emergencies to break the drug patents of pharmaceutical giants to either produce or import generic drugs.
But the FTA negotiations the EU has pursued with Thailand’s southern neighbours, Malaysia and Singapore, have raised concerns about what could lie in wait when the EU begins its bilateral trade talks with Bangkok next year.
“They (the Brussels negotiators) are pushing for TRIP-Plus demands such as data exclusivity,” says Paul Cawthorne, an officer with the Access to Essential Medicines Campaign launched by the global humanitarian agency Doctors Without Borders (known by its French acronym MSF).
According to a leaked document from a Thai trade negotiating team seen by activists here, there is a chance that the EU-Thai FTA could include five years of data exclusivity for new drugs, a clause designed to stop safety-related clinical test or trial data submitted to regulatory authorities from being used by the manufacturers of generic drugs.
“This will slow down the process to produce and supply new drugs to the generic market,” Cawthorne told IPS. “This blocking tactic using data exclusivity will have a broader impact because Thailand has been a producer of generic drugs for years.”
Data exclusivity is not currently required by international law, argues Cawthorne. “The TRIPS agreements require (WTO) member-states to protect clinical data, but there is no obligation to grant any period of monopoly or exclusivity in the use of these data.”
Thai health activists are hoping that their record of mounting successful campaigns against pharmaceutical giants – even from the United States – to ensure a thriving generic drugs market for patients in the country and across the region remains intact.
The last showdown was in mid-2007, when activists threw their weight behind the then Thai government to invoke a WTO rule to secure generic drugs.
In January that year, Bangkok issued a ‘compulsory licence’ (CL) to buy cheaper alternative antiretroviral drugs (ARVs) from India, bringing the country a reputation as another battleground for pharmaceutical giants determined to protect their intellectual property rights and profits from the generic drugs lobby.
Thailand, once one of the region’s countries worst hit by AIDS, is currently home to about 600,000 people with HIV, of which 200,000 people have access to first- and second-line ARVs from government hospitals.
Such ARV coverage has earned the country praise in the region, adding to a long list of achievements to contain the spread of the killer disease and care for those infected.
Issuing CLs has meant Thais with lung and breast cancer and heart disease have had access to cheaper generic drugs since 2007, the year that even saw the Thai push for generics being endorsed by the World Bank.
The Washington-based financial institution revealed in a report that the use of CLs in Thailand’s AIDS treatment programme would slash the cost of second-line drug treatments by 90 percent, helping the country to save an estimated 3.2 billion dollars over 20 years.
Such details are expected to fortify the current campaign. “It makes economic and public health sense for Thailand to strengthen its generic drugs supply and not expose it to TRIPS-plus measures,” says Jacques-chai Chomthongdi, research associate at Focus on the Global South, a Bangkok-based think tank.
“Activists want the process to include public participation to protect the interests of people who need generic drugs,” he told IPS. “They have received word that the EU is insisting that TRIPS-plus provisions be included as a prerequisite to the FTA talks.”