E-drug: Thai GPO requests compulsory license
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THAILAND A STEP CLOSER TO BECOME FIRST DEVELOPING COUNTRY TO USE COMPULSORY
LICENSE
Today, November 12, the Government Pharmaceutical Organization of Thailand
(GPO) delivered a letter to the Intellectual Property Department requesting
compulsory license (government use) for didanosine (ddI).
As a first step, GPO has now to try to come to an agreement with
Bristol-Myers Squibb (the patent holder) on a reasonable royalty fee. If no
agreement can be reached in the next 2-4 weeks the Intellectual Property
Department will examine if the full extent of section 51 of the patent law
can be applied. (In Thailand, only the BMS patent on the improved
formulation of ddI exists; there is no equivalent to the US patent from
1987 held by the US government because in Thailand process patents were
only introduced in 1992).
A group of 15 PHA and activists came to express their support to make ddI
available generically. Several press reporters and the European TV channel
CANAL+ were present. The event was already announced in an article in the
Bangkok Post this morning (see below and also watch for coverage in the
Bangkok Post and The Nation tomorrow).
This was an important day for all people living with HIV in Thailand and
for all who are working for improved access to medicines, both in the AIDS
activist movement and within GPO and the AIDS Division of the Ministry of
Public Health. Special thanks to the courageous action of Dr Krisana
Kraisintu and Khun Achara Eksaengsri from GPO's R&D Dept.
If this request will be successful it will be the first time that a
developing country will issue a compulsory license to protect public
health.
Tido von Schoen-Angerer, MD
Medecins sans frontieres
Bangkok, Thailand
MSFdrugs@asianet.co.th
BANKOK POST, FRIDAY, NOVEMBER 12, 1999, PAGE 4
MOVE TO LOWER DRUG COSTS
PATENT LAW ALLOWS AGENCY TO INTERVENE
By Anjira Assavanonda
The Government Pharmaceutical Organisation and non-governmental
organisations on HIV/Aids will ask the Intellectual Properties Department
to consider compulsory licensing for production of didanosine (ddl), an
important drug in the treatment of HIV patients. Compulsory licensing would
result in a lowering of the price of this expensive anti-retroviral drug.
The alliance is planning to meet with the department director-general today
to claim the right under article 51 of the patents law, which allows a
state agency to intervene in the manufacturing of the products if it deemed
in the public interest or to prevent or alleviate severe shortages of
medicines.
The alliance had consulted the Law Society of Thailand in a bid to end the
monopoly on highly priced drugs used for treatment of HIV/Aids. The
alliance comprises the Foundation for Consumers, the Public Health
Ministry's Aids Division, the Government Pharmaceutical Organisation (GPO),
Medicins Sans Frontieres (Belgium), Alden House, and the Access Aids
Foundation.
Saree Ongsomwang, of the Foundation for Consumers, said she also discussed
with the Law Society the possibility of revoking the patents of costly
drugs, particularly ddl. The patent for didanosine in Thailand is held by
Bristol-Myers Squibb (BMS), which markets it as videx. Ms Saree said the
patent should not be given to BMS since ddl was earlier
licensed by the US government's National Institute of Health. BMS made only
a little change in the formulation of the drug. She said it needed to be
interpreted whether the process of replacing non-active ingredients of ddl
is considered a new invention.
Ms Saree said the price of ddl is very high, making it unaffordable for
most HIV patients, and BMS has always refused to lower the price, claiming
the research and development cost is high.
A representative of the GPO said it has also developed its own process for
the production of ddl, but the project had been terminated after BMS
received the patent.
"We've done research on ddl since 1987. Every process has been completed
and we're even ready to produce the drug, but in 1992 BMS applied for the
patent and later received it, so we stopped our own project," said the
official.
It was not until early this year that the agency received advice from
experts from Medicins Sans Frontieres that it is possible for the Thai
government to consider compulsory licensing for the drug. If the GPO was
authorised to produce ddl, the price would be much cheaper, around 25 baht
a tablet compared to about 45 baht, he said.
Sak Korsaengrueng, chairman of the Law Society, said the law body will make
every effort to support the move. Mr Sak advised the GPO to immediately
submit its petition to the Intellectual Properties Court. Legally,
compulsory licensing could be applied in this case.
The issue of revocation of the patent given BMS would require much more
study, however.
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