Inter Press Service - June 26, 2000
Kelvin Ng

Public Health Minster Korn Dabbaransi announced on Jun 19 that the ministry would buy the cheaper generic drugs for the human immunodeficiency virus (HIV) manufactured by the Government Pharmaceutical Organisation (GPO) -- and encourage local companies to produce them.

Local anti-HIV drug manufacturers are also in the midst of negotiations that promise price cuts of up to 87 percent, Dr Somsong Rukphao, director of the Communicable Diseases Control (CDC) department, was quoted as saying in local media reports.

When contacted, Dr Somsong said all the manufacturers had agreed to price reductions. He did not give any details, but estimated that the cheaper drugs will be available within two months.

Although non-government organisations representing Thailand's 800,000 HIV-positive people welcomed the recent developments, they said more needs to be done.

Only an estimated one percent of HIV-positive Thais can afford a three-drug combination anti-HIV therapy which doctors recommend, said Saree Aongsomwang of the Coordinating Committee for Primary Health Care of Thai NGOs (CCPN).

This raises the issue of access to affordable medical care in a developing country like Thailand, whose efforts to curb the HIV/AIDS pandemic have resulted in lower new rates of infection.

Thailand has also had to cut down on medical aid to people with HIV due to hard economic times. The country's HIV prevalence rate stands at 2.23 percent of people aged 15 to 49, which amounts to 800,000 people.

At the same time, Thailand's efforts may well hold lessons for other developing countries that are trying to make HIV drugs more accessible to their people and find ways to get beyond the high prices at which they are sold by big pharmaceutical firms.

For instance, stavudine (d4T) manufactured by U.S. company Bristol-Myers Squibb (BMS) costs 104 baht (2.7 U.S. dollars) per 40 milligramme tablet. By contrast, the same GPO-produced d4T tablet costs only 15 baht (38.6 U.S. cents).

The difference in the monthly bill for a twice-daily dose would reach 5,340 baht (137 dollars), or more than 40 percent of the 12,729- baht monthly income of an average household in Thailand.

"People have the right to access medication, even the poor," said Saree. However, relying more on locally-produced drugs for HIV is complicated by government bureaucracy in drug procurement and a fear of reprisals from politically-powerful pharmaceutical firms, said Dr Tido von Schoen- Angerer of international medical aid agency M decins Sans Fronti res (MSF or Doctors Without Borders).

"Even though it has been announced, there has been no commitment by the public health ministry or the CDC to actually buy the GPO drugs," Dr Schoen-Angerer said in an interview.

GPO started manufacturing d4T in June, and according to various sources, bulk purchases like those by public agencies are needed to continue production of the drug.

CDC has not bought any d4T because it is still "waiting" for GPO submission of test results. "It is not my responsibility to ask them for it," said the center's Dr Somsong.

External tests on d4T, didanosine (ddI) and zidovudine (AZT) -- the other two anti-HIV drugs that GPO makes -- have already been done, said the director of its research and development department, Dr Krissana Kraisintu. They meet the stringent criteria that the Thai Food and Drug Administration sets. "It is very easy to make a generic drug, I can do it in just one week," she said.

However, GPO complies with international intellectual property laws and will not manufacture Thailand-patented drugs, said Dr Krissana. "We could already manufacture ddI tablets two years ago. But then we found out that Bristol-Myers Squibb had a patent for it (in Thailand)," she added.

Besides securing patents in Thailand to ensure marketing exclusivity, pharmaceutical firms can also apply for a safety monitoring period with the local Food and Drug Administration.

Pressure built up last year when GPO started manufacturing generic ddI powder, offering it at 26 baht per 100 milligrammes (67 cents) compared to BMS' 49 baht (1.26 dollars) for a 100 milligramme tablet.

An official from the US Trade Representative's Office sent two letters regarding the issue, said Dr Schoen-Angerer. The director of GPO's research and development department, Dr Krissana confirmed this, although she could not remember the official's name.

"Yes, there is pressure. But which job doesn't have its pressures?" said the director, refusing to comment further.

According to British medical journal The Lancet, trade pressure hurts developing countries' efforts to put HIV drugs within reach. It says the threat of US trade restrictions forced the Thai government to introduce a product patent law in 1992 and dissolve its Pharmaceutical Patent Review Board in 1998.

However, CDC director Somsong said there has never been any form of pressure to either discourage local production or government purchase of generic drugs. "With CDC's budget, we have to buy several kinds of antiretrovirals. We have to consider other priorities. Of course we wish we could give antiretrovirals to any HIV-infected person," he said.

Indeed, as the World Health Organisation (WHO) says, providing access to life-sustaining treatment for the poor and also safeguarding the intellectual property rights of patent holders are complex issues.

At an NGO roundtable meeting in Geneva on May 1, WHO director- general Gro Harlem Brundtland said: "One assumption in strengthening intellectual property rights was that more research, development and production would take place in developing countries and that prices would come down. We have to ask: is this happening?"

Pharmaceutical companies say that exclusive marketing rights help channel more money back to researching new treatments. But statistics from the annual survey of the Pharmaceutical Research and Manufacturers of America (PhRMA) seem to paint a different picture.

Global sales by these pharmaceutical research and manufacturing firms have increased by more than 32 percent, from 101 billion U.S. dollars in 1996 to 134 billion dollars in 1999. In the same period, research and development consistently accounted for 16 to 17 percent of total sales.

After a year of intense pressure from the WHO and NGOs, five major pharmaceutical companies signed an agreement on May 11 to discuss improving access to HIV/AIDS treatment and care. The five are Germany's Boehringen Ingelheim, U.S. companies Bristol-Myers Squibb and Merck & Company, Glaxo Wellcome of U.K., and Hoffmann-La Roche of Switzerland.

MSF's Dr Schoen-Angerer remained skeptical of the deal, saying "they are just trying to maintain a monopoly".

Producing generic drugs is more sustainable for a country, making it less dependent on foreign aid, various NGOs say. Many believe that even with the May 11 agreement, patented drugs manufactured by multinational pharmaceutical firms will always be more expensive.

GPO's Dr Krissana said: "Even if they reduce (prices), it can't be the same price (as GPO's). It won't be more than 10 times. If they can, I'll be very happy, because I can stop manufacturing." (END/IPS/ap-he- hd/kn/js/00).
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