As Free Trade talks with the US continue, Malaysia is clearly taking a cue from Thailand and insisting on reserving the right to import any patented drug, and to compulsory licensing. The country wants to be able to produce a med locally if official believe doing so would be in the national interest, or to use a drug for natural disasters or non-profit purposes.

“We want to exercise our rights if a certain drug is important to us,” says health minister Datuk Seri Dr Chua Soi Lek, adding that drug prices wouldn’t be affected if Malaysia ‘exercises its rights,’ but would give intellectual property protection to the local industry.

As an example, he cited AIDS drugs, which Malaysia began importing from India in 2004 and are now manufactured locally. As a result, prices have been slashed by about 80 percent.

Chua says Malaysia would allow data exclusivity for five years from the same date as in the country of origin and that the decision to give data exclusivity was under the purview of the Drug Regulatory Authority. Data exclusivity would be given for a new indication of a known med, but not to drugmakers that simply change dosage strength or based on how a med is presented.

For those not familiar with the term, data exclusivity is what happens when a company creates a new product and has to submit all information to the ministry’s Drug Regulatory Authority in order to market it. The data then becomes exclusive rights of that company.

Further reading…
The Star.

[tags]AIDS, Compulsory Licensing, Generics, Malaysia, Thailand[/tags]