Science and sustainability in generic medicines

WE wish to express our support for the recent statements made by Health Minister Datuk Seri Dr Dzulkefly Ahmad regarding the National Generic Medicines Framework. The announcement that Malaysia has achieved over RM900mil in savings through the “generic first policy” over the past two years is significant for our national healthcare sustainability.

As pharmacy educators, we must emphasise that the cornerstone of this framework is scientific parity, where all medicines are evaluated based on scientific evidence from regulatory approval, bioequivalence (BE) studies and ongoing monitoring.

In Malaysia and across the world, generic medicines are not merely cheaper alternatives to innovator medicines; they are products that have undergone rigorous bioequivalence studies to ensure they match the safety, quality and efficacy of their innovator counterparts.

For a generic medicine to be registered by the National Pharmaceutical Regulatory Agency (NPRA) and for it to be sold or used in Malaysia, it must demonstrate that its therapeutic delivery, quality and safety is essentially as good as the innovator version.

Economically, the RM900mil saved through the use of generic medicines will be essential for the upgrading of ageing healthcare infrastructure and the critical task of training and retaining our healthcare personnel.

Investing in the career development pathways and permanent positions for healthcare employees is of paramount importance, particularly as the public healthcare system struggles with workforce shortage and staff burnout.

We must also consider this framework through the lens of current geopolitical realities. The global pharmaceutical market is increasingly volatile, particularly with the uncertainties surrounding potential tariff changes in the United States.

Malaysia cannot remain overly dependent on a narrow corridor of expensive innovator medicines from North America and Europe. By prioritising generic medicines, we protect our national health security from external price shocks and trade tensions that could otherwise compromise our access to life-saving treatments.

To achieve this, the diversification of our supply chains is required. The Health Ministry’s exploration of alternative sources for active pharmaceutical ingredients (APIs) and finished products from countries like China, India, Turkey and Brazil is pragmatic and will strengthen our domestic manufacturing capacity while ensuring our supply remains resilient even when global trade routes are disrupted.

The successful implementation of the National Generic Medicines Framework will also rely on the clinicians who make the everyday decisions of what medicines to prescribe to their patients.

The choice of medicines is deeply rooted in the trust between a clinician and their patient. While the science of bioequivalence is sound, we must ensure that our prescribers are fully integrated into this transition.

We acknowledge the concerns of colleagues regarding clinical autonomy, and it is important that this framework is implemented as a collaborative shift in prescribing practices rather than a rigid mandate.

When clinicians are confident in the regulatory rigour behind generics, they can effectively bridge the price-quality perception gap for their patients.

However, a word of caution is necessary. While the drive for cost-containment is commendable, the government must ensure that these savings are used in the right places.

Fiscal efficiency should not lead to a compromise in complex care for high-risk patients who may still require specific innovator formulations for clinical reasons.

The goal must remain value-based healthcare, which prioritises saving where the science permits so that we can afford to invest where the patient’s need is greatest.

DR WONG YEN JUN

Lecturer

and DR MARK CHEONG WING LOONG

Deputy head of School (Education)

School of Pharmacy

Monash University Malaysia