National Generic Medicines Framework

The Malaysian healthcare system runs as a two-tiered system consisting of public and private healthcare sectors. In the public sector, healthcare costs are subsidised by the government through general taxation, whereas in the private sector, these costs are paid for by patient’s out-of-pocket funds, private insurance or their employers.

The principal objective of the Malaysian National Medicines Policy (MNMP) is to improve health outcomes of Malaysians by promoting equitable access to essential medicines, promoting rational use of medicines and ensuring quality, safety, effectiveness and affordability of medicines. The policy includes a range of measures, including procurement policies and price transparency mechanism, information and education, quality assurance, and monitoring and evaluation.

Part of the MNMP is the development of a National Generic Medicines Framework which aims to foster healthy competition in medicines pricing and achieve generic prescribing in both public and private healthcare institutions.

Generic Medicine is defined as a product that is essentially similar to a currently registered product in Malaysia. Generic medicines may be further classified into two groups; Scheduled Poisons and Non-Scheduled Poisons. However, the term generic is not applicable to Biologics (including biosimilars). Therefore, the scope of this framework focuses on generic medicines and does not include biosimilars.

The Director General of Health has issued a directive on generic medicines labelling (Surat Pekeliling KPK Bil 17/1986) to call for all medicines dispensed in public healthcare facilities to be labelled by their generic names. Such practice has been implemented in all public healthcare facilities where generic medicines are widely used.