E-drug: Exclusive marketing rights in Thailand
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Exlusive marketing rights for pharmaceutical are getting under media attack
in Thailand: read todays headlines in the Bangkok Post, again featuring
Khun Saree (what would Thailand be without her?) and reference to the
WHO/MSF report from August.
This is a well written, accurate explanation of the situation and is well
worth reading. (This problem is different from the patent issues around
ddI !!)
www.bangkokpost.net/today/151199_News01.html
There is a lesson to learn for other countries: even if a public
institution like the NIH does not pursue patenting of its inventions in
developing countries, generic production might still be delayed if there is
strong exclusive marketing right protection that a licensee might use.
Exclusive marketing rights exist in Thailand under the cover of Safety
Monitoring and were introduced thanks to pressure from the US Trade
Representative. The US Trade Representative even seeks further extension
beyond the current 5-6 years (www.ustr.gov/reports/nte/1999/contents.html
and www.ustr.gov/reports/nte/1995/contents.html)
Similar problems mightexist in other countries.
Please send me an e-mail if you would like to have the MSF report: "Access
to HIV/AIDS Medicines in Thailand", that is mentioned in the article.
Tido von Schoen-Angerer,
Medecins sans frontieres
Bangkok, Thailand
MSFdrugs@asianet.co.th
BANGKOK POST, NOVEMBER 15, 1999, HEADLINES
HIV-AIDS: PUSH TO GET DRUGS ON SALE SOONER �
REDUCED TEST PERIOD WOULD LOWER PRICE
By Anjira Assavanonda
Non-governmental organisations want the length of the safety monitoring
programme (SMP) for drugs used in the treatment of HIV/Aids in Thailand cut
by half, so people will have access to treatment sooner.
The SMP usually takes up to four years and is carried out by the Food and
Drug Administration (FDA). Mandatory registration of a drug can take up to
two years before it is allowed on the market.
The long wait involved is viewed as a barrier to the use of the drugs in
treatment programmes.
Saree Ongsomwang, of the Foundation for Consumers, said the many
HIV-infected people in Thailand are also left untreated because of the
prohibitive prices charged by the original manufacturers of drugs.
The joint report by a World Health Organisation (WHO) and Medicins Sans
Frontieres (MSF)) fact-finding mission in Thailand in August concluded the
high cost in Thailand is linked directly to the monopoly derived from the
exclusive rights held by the original drug manufacturers, either from the
patent or during the safety monitoring programme.
Ms Saree said the alliance of NGOs on Aids is looking into the Patent Act,
which does provide flexibility to ensure access to essential drugs, such as
through the issuing of a compulsory licence for public non-commercial use
to prevent or alleviate a severe shortage of a medicine.
Patent protection is effective only for a product invented after 1992.
However, all new drugs introduced to the Thai market must pass through the
FDA's registration procedure, whether the patent application has been filed
in Thailand or not.
The FDA puts these new drugs in the SMP for at least two years to assess
their safety, efficacy and quality before allowing them on the market.
During this period, the drug is only available in public or private
hospitals where adverse drug reaction is monitored.
No generic equivalent can be registered until the drug is demonstrated to
be safe for use and released from the SMP. This means the manufacturers of
these new drugs do not face any competition
while the drug is in the SMP stage.
The WHO/MSF report said manufacturers of most HIV/Aids drugs still enjoy
exclusive marketing rights in Thailand during the SMP period, although they
do not have patent rights if the drugs were developed before 1992. The
report said the situation is further compounded because patent holders are
allowed an extension up to four years to proceed with the SMP, which
eventually means five to six years taking into account the year or two
needed to complete the registration process. The report recommended that
the SMP process should be speeded up to allow
generic competition from non-patented drugs as soon as possible, yet
without impeding the safety assessment.
Ms Saree said 11 types of HIV/Aids drugs are on the SMP list, nine
anti-retroviral drugs and two drugs for opportunistic infections.
Among them is stavudine, which will be released from SMP next year. Dr
Krisana Kraisintu, head of the Research and Development Institute of the
Government Pharmaceutical Organisation, said her agency has already
prepared to produce stavudine once the drug is released. She said the long
SMP process had caused the suspension of several of the GPO's drug
development projects.
"If the GPO itself could produce stavudine, the cost would be cut to half
the current price," she said.
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