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.