[e-drug] Malaysian compulsory licensing law

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E-DRUG: Malaysian compulsory licensing law
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[Any E-drugger in Malaysia who can comment on this article?
http://thestar.com.my/news/story.asp?file=/2001/4/29/nation/2906crpa&newspage=Search
Crossposted from Pharm-Policy with thanks. NN]

Sunday, April 29, 2001
Move to produce drugs locally welcomed

By C. Celestine 

KUALA LUMPUR: The Malaysian Medical Association (MMA) has welcomed the
amendment which allows drugs to be locally manufactured even though the
patent has not expired. 

Its president Dr P. Krishnan expressed concern that there could be a
proliferation of counterfeits in the market with parallel imports of the
same drugs. 

Dr Krishnan, who said that "a manufacturer must have the GMP (good
manufacturing practice) approval from the Health Ministry before he can
market his products,'' added that there must be a control mechanism in
place to oversee parallel import of drugs. 

On Friday, Domestic Trade and Consumer Affairs Minister Tan Sri
Muhyiddin Yassin said local manufacturers can produce generic drugs
without fear of being taken to court following the recent amendments to
the Patents Act 1983. 

He said that "the law complied with international treaties like the
Trade Related Intellectual Property Rights (Trips) Agreement, to which
Malaysia was a signatory.'' 

The Trips Agreement requires countries to grant patent protection to
pharmaceutical products for a minimum period of 20 years, from the date
of application. 

But there was also a provision under it that allowed a country to
legislate in favour of compulsory licensing and parallel importing of
drugs for life-threatening situations. 

Malaysian Organisation of Pharmaceutical Industries (Mopi) president
John Lee said the move to allow locally manufactured drugs to be sold
would help erase the perception that they were not on par with imported
drugs. 

With the increasing costs of medical care it would enable
pharmaceuticals to contribute meaningfully to the national healthcare
system, he said. 

"We have a responsibility to make sure that drugs are accessible and
affordable besides maintaining the standard and quality at all times.'' 

Lee agreed there was a need for a mechanism to monitor the parallel
import of drugs. 

"A good control system is needed to not only control the proliferation
of drugs but one that is also a data base for distribution and compiling
statistics,'' he said.
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