Thai generic drug programme argument heats up

Thailand's health minister, Mongkol Na Songkhla, has said he will expand the country's generic drug programme to include cancer and more HIV medications, if pharmaceutical companies do not cut their prices.

Mongkol, who was appointed as health minister after Thailand's September 2006 military coup, has continued to allow the production of generic versions of HIV treatments including, Abbott Laboratories' HIV drug Kaletra (lopinavir/ ritonavir), Bristol-Myers Squibb's Sustiva (efavirenz) and Novartis' heart disease treatment, Plavix (clopidogrel), which is the global number two best-selling heart drug.

In response to Thailand's continued defiance of international law concerning intellectual property rights, Abbott said it would stop selling new drugs there, including an improved version of Kaletra.

Mongkol remained unmoved by the claims of the pharmaceutical firms involved: "Our ministry has been negotiating with drug companies over the past two years to cut drug prices. But they did not cooperate with the ministry. They were never interested in negotiations. We've come to the point that we have to do something about it. We cannot wait and talk to them without any achievement."

The minister explained that HIV/AIDS is Thailand's top cause of death, followed by heart disease. Approximately half a million Thais are diagnosed with HIV, but less than 10 per cent can afford to buy Kaletra, while a similar proportion of the 300,000 heart disease patients in Thailand can afford Plavix.

Pharmaceutical companies have defended their actions by saying that they need to charge high prices for new medicines to recover R&D and marketing costs.

According to regulations formulated by the World Trade Organisation (WHO), countries are allowed to order compulsory licenses which temporarily suspend patents and clear the way for generic drugs to protect public health in emergencies only. In practice, few countries have used this provision and have accepted drug company access programmes for those patients who cannot afford the drugs in question.

Mongkol explained that the Thai government was forced to adopt a generic programme due to an increasing health care budget now valued at more than THB 250bn (EUR 5.9bn/ GBP 4bn/ USD 7bn), which is predicted to rise 10 per cent year on year. The current generic programme could reduce Kaletra monthly treatment prices from THB 11,580 (EUR 273/ GBP 185/ USD 330) to THB 4,000, according to French medical charity, Medicins Sans Frontiers (MSF). Also, daily treatment prices of Plavix could fall from THB 73 (EUR 1.70/ GBP 1.20/ USD 2.00) per day to less than THB 7.

Daniel Christman, senior vice-president of the US Chamber of Commerce, who previously met with Thai finance minister Chalongphob Sussangkarn and Commerce Minister Krirk-krai Jirapaet to discuss the government's capital controls and changes to foreign business law, has warned that Thailand risked losing investments from US companies.

Teera Chakajnardom, president of the Pharmaceutical Research and Manufacturer's Association of Thailand, added: "This is unprecedented in Thailand. If the government decides to allow more generic drugs, it will further damage the image of Thailand among international investors."

Dr David Wilson of MSF in Thailand said in a press statement: "Our patients in Thailand, who still use the old version of Kaletra, have been waiting for this new version for a very long time. The drug was registered in the US in October 2005, but still cannot be used in Thailand and many other countries where it is desperately needed. Refusing to sell the drug here is a major betrayal to patients."

Paul Cawthorne, head of the Thai MSF mission, supported the country's generic stance, suggesting that Minister Mongkol had complied with WTO rules, adding: "What the government has done so far is perfectly legal within Thai law and is also legal within WHO guidelines."

PMLive has already reported on a similar case in India, where Novartis is challenging Indian patent law following the domestic patent office's decision to decline protection for its cancer treatment Glivec (imatinib), as well as questioning the establishment of blocks to patent protection in the country. However, Indian generic firms, who wish to expand their existing pipelines, want the same protection afforded by international patent laws.

The situation in Thailand is different, however, in that the military-supported government remains unbowed by international pressure. Thailand's health ministry is next scheduled to hold talks with pharmaceutical companies on 26 March 2007.