Malaysia’s drug market is growing at about 6% per year, but not easy to succeed in. First of all, registering foreign drugs in Malaysia takes a long time and is fairly demanding on the regulatory front. Second, generally, the existing IP protection framework in Malaysia is relatively weak. Malaysia’s patent protection is limited, and it is still on the Watch List of the Pharmaceutical Research and Manufacturers of America (PhRMA). Finally, Malaysia strongly favors domestic drug makers. However, if an international drug company that currently exports its drugs to Malaysia now moves production to Malaysia, it can be granted a 3-year procurement contract, which can be extended another 2 years if the same domestic/foreign enterprise also exports locally made drugs outside of Malaysia.
On a positive note, late last year the Malay Ministry of Health (MOH) reformed their procurement processes. Up until then, the MOH normally awarded one contract per drug maker for each drug. Unfortunately, this policy led to a shortage of human insulin last summer. As a result, the new procurement policy will allow multiple suppliers for the same drug going forward. This policy hopes to enable a more stable supply of drugs in Malaysia and open opportunities for more international drug companies with innovative products.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.