In an age where rising healthcare costs are a pressing concern, generic medicines represent one of the most powerful tools we have for ensuring affordable access to treatment. Yet, despite their proven effectiveness, questions and doubts still surround them.

What are generic medicines?

Generic medicines are not second-rate versions of original or “originator” drugs. They are scientifically developed to contain the same active ingredients, in the same quantity, and to deliver the same therapeutic effects.

When a pharmaceutical company discovers a new drug, they are granted a patent, giving them exclusive rights to manufacture and sell the drug for a set period – usually 20 years. This exclusivity allows them to recover the substantial investment made in research, clinical trials, and regulatory approvals. However, once the patent expires, other companies are allowed to produce the same drug.

As generic manufacturers do not bear the initial costs of drug development, they can offer clinically equivalent treatments at significantly lower prices, easing the financial burden on patients and healthcare systems alike.

In Malaysia, as in many countries, every drug – whether generic or originator – must undergo strict regulatory controls. The Drug Control Authority, through the National Pharmaceutical Regulatory Agency (NPRA), evaluates and registers all medicines before they can be marketed and sold in Malaysia.

For generics, the process often includes bioequivalence testing, where the generic drug must demonstrate that it behaves similarly in the body to the originator drug. This is done using plasma concentration curves in healthy human volunteers, generally showing the drug falls within 80-125 per cent of the originator’s performance.[1] Far from being a loophole, this threshold is an internationally recognised scientific standard that ensures both safety and efficacy.

Dispelling myths: Generics are “less effective”

The idea that generic drugs are “less effective” is not only misleading but also harmful. Generics are subject to rigorous testing and must meet the same safety, quality, and efficacy standards as their originator counterparts.

Differences in appearance such as colour, shape, or packaging are superficial. The active ingredient, the one that actually works in your body, is the same in both the originator drug and the generic drug. Patients may sometimes react differently to any drug, whether generic or originator, because individual responses vary. This is not a sign of inferiority but of multifactorial variations from one person to another in how their body responds to a drug.

The role of trust and education

There is a well-documented placebo effect in healthcare, where beliefs can influence how we feel after taking a medication. If someone believes a branded drug “must be better”, they may perceive improved results – even if the science says otherwise. This makes patient education crucial in shifting perceptions and building trust in generics.

Ultimately, patients have the right to choose between originator and generic options, but informed patients make better decisions. Healthcare providers play a vital role by confidently prescribing generics when appropriate and explaining their effectiveness. It is not just about offering cheaper options, it is also about ensuring access to safe, proven treatment for everyone.

Governments cannot sustainably afford to buy originator drugs indefinitely, especially for chronic diseases or large populations. Generics help stretch healthcare budgets without compromising on quality.

At times, governments may invoke compulsory licensing, provided for under the agreement on Trade-Related Aspects of Intellectual Property Rights, to allow the production of a patented drug without the consent of the patent holder. This has happened in Malaysia for Hepatitis C and certain Human Immunodeficiency Virus (HIV) treatments, when public health need outweighed patent rights. Such measures ensure critical drugs reach those who need them most, especially when pricing becomes a barrier to treatment.

Generic medicines are not second-best. They are essential, effective, and safe tools in the healthcare arsenal. As healthcare costs rise, embracing generics is not just a personal choice, it is a collective responsibility.

Let us build confidence through education, advocacy, and evidence. When we trust the science behind generics, we ensure that quality care is within reach for all.

-- BERNAMA

Prof Dr P.T. Thomas is the Executive Dean at the Faculty of Health and Medical Sciences, Taylor’s University.

[1] https://www.sciencedirect.com/topics/immunology-and-microbiology/bioequivalence