In the process of passing its first patent law, Cambodia has disregarded a World

Trade Organization declaration that would ensure it access to new, cheap generic

drugs for the next 14 years.

The Declaration on the TRIPS Agreement and Public Health, signed at the WTO's Ministerial

Conference in Doha, November 14, allows least-developed countries (LDCs) such as

Cambodia to exclude pharmaceuticals from local patent laws until 2016.

This means that - unlike other WTO member countries - LDCs in the organization

may use new copy-cat drugs created by coun-tries that do not protect patents.

Generic drugs are already widely used in Cambodia and have proved invaluable in treating

AIDS patients. In a new pilot project, Médecins Sans Frontieres (MSF) is treating

HIV/AIDs patients with generic antiretroviral (ARV) drugs for $350 per patient per

year. By comparison the cost of a brand-name ARV cocktail in May, 2000 was $10,400.

MSF's legal consultant seconded to the Ministry of Health, Victor van Spengler, worked

on the draft of Cambodia's first patent law. He said it was approved by the Council

of Ministers prior to the WTO declaration and therefore did include pharmaceuticals.

To ensure the country gained the benefit from the WTO's ruling, said van Spengler,

the government simply needed to send an amendment to the National Assembly.

However, the deputy director of the intellectual property department at the Ministry

of Commerce, Var Rothsan, said the draft patent law had already been sent to the

National Assembly and there was no need to make an amendment.

"We hope the patent law will be passed by the National Assembly within the first

quarter of this year," he said. "The draft law is sufficient for Cambodia.

There's no need to exclude pharmaceuticals."

He said it was important that the patent law complied with the TRIPS agreement (trade-related

aspects of intellectual property rights), which sets out minimum standards for all

WTO members. While TRIPS includes pharmaceuticals, the recent declaration specifically

released LDC countries from some obligations.

"We recognize the gravity of the public health problems afflicting many developing

and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis

and other epidemics," the declaration stated.

Cham Prasidh, Minister of Commerce and the man in charge of Cambodia's bid to join

the WTO, said he was unaware of the declaration made at Doha. However, he emphasized

the importance that the country's laws were consistent with WTO standards.

"There is time to make changes but it needs to come from the Ministry of Industry

[which drafted the patent law]," he said.

However sources in the Ministry of Industry said that as the patent law was awaiting

approval from the government, making changes was out of their hands.

MSF's van Spengler said that the draft patent law had public health safeguards, which

meant the government could over-ride patent protection under certain circumstances.

"Governments can make medicine when it's in the public interest - it is one

of the so-called safeguards, to make patented medicines or give the license [to a

third party]," he said. "They can decide if the public health interest

is more important than the interests of the patent owner."

However, van Spengler said, having the provision was one thing, but actually being

able to navigate the legal minefield was another.

"This facility in law is very nice, but how can they use it?" he asked,

referring to the overstretched resources of the Ministry of Health (MoH). Given the

public health problems in the country, said van Spengler, the WTO declaration was

"a blessing for Cambodia," as it would considerably simplify matters.

"This will give Cambodia 15 years to fine tune their patent law while the MoH

will have time to build its capacity and infrastructure so it can successfully exploit

future ministerial regulations pertaining to the patent law," he said.

MSF country head, Catherine Quillet, said generic production had been helpful in

lowering prices of ARVs, but she was concerned that Cambodia could legislate itself

out of access to these cheaper generic drugs.