E-drug: More news coverage on ddI in Thailand
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More news coverage on the ddI issue in Thailand today:
DDI was in the headlines of "The Nation" while the "Bangkok Post" brought
its third article this week covering the events around compulsory license
and a possible court case contesting the patent on ddI in Thailand. There
was also good coverage in Thai-language newspapers and radio this week.
www.nationmultimedia.com/index/headline.html
www.bangkokpost.net
The newspaper reporting this week has been accurate except for a few
mistakes: South Africa has of course not yet issued compulsory license;
access to ARV is still around 5% and for the vast majority only includes
AZT/ddI. The CPTech website provides numerous examples of CL use in the US
but to my knowledge the US has not used CL for drugs, certainly not HIV
related drugs.
Tido von Schoen-Angerer, MD
Medecins sans frontieres
Bangkok, Thailand
[Perhaps reports of any further developments about this issue in Thailand
could be summarised rather than cirulating the whole articles. People who
would like access to complete articles could contact Tido. BS co-moderator]
Here are both of today's articles:
THE NATION, NOVEMBER 13, 1999, HEADLINES
BID TO HELP POOR FIGHT AIDS VIRUS
-DRUG AGENCY SEEKS TO CUT COSTS
By Mukdawan Sakboon
THE Government Pharmaceutical Organisation (GPO) will negotiate with
pharmaceuticals giant Bristol-Myers Squibb (BMS) to seek its approval to
manufacture the generic version of Aids drug didanosine (ddI) in a bid to
help poor patients gain access to cheaper Aids medicines.
If an agreement is reached with the company, which holds the patent to ddI,
the price of the drug would be drastically cut from the present Bt49 to
Bt25 or lower, said Krisana Kraisintu, head of Research and Development
Institute.
''We want to set an example in making essential drugs more affordable for
the people, especially the underprivileged segment,'' she said.
Krisana said Thailand would become the first developing country to seek a
compulsory licence for producing HIV/Aids drugs which already have a
patent.
In 1995, the GPO reduced the price of another Aids drug, AZT, from Bt40 per
capsule to Bt12, as a result of generic production.
Krisana and other GPO officials, representatives of non-government
organisations on HIV/Aids and consumers, and groups of people living with
HIV/Aids met the director general of the Department of Intellectual
Property (DIP) yesterday.
The drug agency and the NGOs have urged that a compulsory licence be sought
for the manufacture of ddI, as allowed under Article 51 of the 1979 Patent
Act, which was revised last year. Permitted by world trade rules governing
intellectual property, compulsory licensing allows companies/states to make
cheaper, generic versions of drugs, even while the drugs' makers hold
exclusive patent rights to the medications. However, it must be proved that
a licence would serve a public need and the patent holder receives
''adequate'' payment.
The GPO is yet to arrive at an amount to be paid to Bristol-Myers Squibb.
However, this cannot exceed 5 per cent of the company's sales of the drug,
said Krisana, adding the GPO will send a letter to the company on Monday
and give it two weeks to reply. If the GPO cannot reach an agreement on
payment, the DIP's director general would take a final decision. In case of
a dispute, it would be settled by the Intellectual Property Court,
according to provisions in the 1979 Patent Act.
Compulsory licensing was considered one of the means to narrow the gap
between those who can afford Aids treatments and those who cannot. The ddI
drug was developed and licensed by the US National Institute of Health.
However, BMS, after changing the formulation of the drug licensed by the US
authority, had sought and was granted a product licence in Thailand last
January, holding the drug's exclusive patent rights for 20 years.
The patent forbids the drug agency from producing the drug using similar
formulations, despite several years of development efforts and money,
Krisana said.
Compulsory licences have usually been issued in the US but US-based
pharmaceutical companies oppose the measure being used in other countries,
said Dr Tido Von Schoen-Angerer, drug project coordinator of the Medicins
Sans Frontieres (Belgium) aid group.
Drug makers, meanwhile, say losing some patent protection could discourage
new drug development by pharmaceutical companies, who have spent up to $1
billion developing a single Aids drug.
Law expert Chakkrit Kuanpot of Sukhothai Thammathirat University urged the
Department of Intellectual Property to act in the interest of the public
and fully cooperate with the GPO by issuing a compulsory licence. ''That
the GPO itself has to come out and acted for the patients, should serve as
a reminder to the DIP the problem of limited access to HIV/Aids medicines
in Thailand,'' he said.
Only 5 to 10 per cent of nearly 100,000 Aids patients in Thailand can
afford HIV/Aids drugs such as AZT and ddI, but most of them have to be
under research programmes conducted on a year-by-year basis.
BANGKOK POST, NOVEMBER 13, 1999, PAGE 4
PUSH FOR LICENSING OF HIV TREATMENT DRUG SUPPORTED
By Anjira Assavanonda
The Intellectual Property Department has promised to back the Government
Pharmaceutical Organisation (GPO) in pushing for compulsory licensing for
production of didanosine (ddl), a drug important in the treatment of HIV
patients.
Tablets produced by the GPO would be about half the current market price.
The GPO has claimed the right under article 51 of the patent law to
intervene in the manufacturing of the drug. The patent for didanosine in
Thailand has been held by Bristol-Myers Squibb (BMS) since January last
year. Article 51 allows the state agency to intervene in the manufacturing
of medicines if it is deemed in the public interest or to prevent or
alleviate severe shortages.
Santi Rattanasuwan, deputy director-general of the Intellectual Property
Department, said compulsory licensing of ddl is possible, but the process
could take a long time. The GPO must negotiate with BMS over the
percentage to be given to the company as required by the patent law.
Krisana Kraisintu, head of the GPO's Research and Development Institute,
said she will send a letter to BMS on Monday and ask the company to respond
within two weeks. If agreement could not be reached between the two
parties, the matter would be left to the department director-general to
intervene by calling a meeting of both parties within 90 days.
The director-general is authorised to make a decision over the percentage
to be given to BMS.
The firm is free to file complaints with the National Patent Committee and
the Intellectual Property Court.
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