Health Ministry views seriously claims by pharmaceutical association on potential harm of generic medicines

PUTRAJAYA: The Health Ministry views the baseless and irresponsible statements seriously and will not hesitate to take action against certain parties claiming that generic medicines could harm patients.

In a statement on Friday (Nov 8), the ministry said such statements raise concerns among patients-whether in the ministry’s facilities or private healthcare-encouraging them to reject treatment regimens.

“The Health Ministry will not hesitate to take firm action, including legal measures, against those responsible,” it said.

It was responding to a report of an online portal on Nov 5, which quoted a statement from a pharmaceutical association claiming that the use of generic medicines can be harmful to patients.

The ministry has emphasised that generic drugs are safe for use, effective, and have optimal results based on thorough assessments by qualified healthcare practitioners regarding the clinical needs of patients.

It further said that it would never compromise the quality, safety, and health of patients to reduce treatment costs, including medications.

The ministry said that the National Medicines Policy developed in 2006 is part of the government’s efforts to ensure that Malaysians have access to essential medicines.

“One of the key strategies under this policy is the Generic Medicines Policy, which encourages the use of generic drugs in both the public and private healthcare sectors. The aim is to strengthen access to affordable medications while maintaining their quality, safety, and efficacy,” read the statement.

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On Oct 28, sources cited by the portal alleged that the government had instructed the National Heart Institute (IJN) to replace innovator drugs with generic medicines for public patients to reduce costs borne by the ministry.

Generic drugs refer to medicines that contain the same active ingredients as innovator drugs and are produced after the patent for the innovator drug expires.

Innovator drugs are new medicines first introduced and patented by the company that developed or discovered them after conducting clinical trials and research.

According to the ministry, all medicines, including generic drugs, must undergo strict requirements and evaluations before being registered with the Drug Control Authority (DCA) in Malaysia to ensure their quality, safety, and efficacy.

It said that generic medicines are cheaper than innovator drugs as they do not incur the initial research and development costs, marketing expenses, and promotional costs associated with innovator drugs, although there are costs for conducting bioequivalence assessment.

“A large-scale study conducted in Austria, involving over nine million people, found that the use of generic medicines helps reduce healthcare costs without compromising patient health in the treatment of chronic diseases such as hypertension, hypercholesterolemia (high cholesterol), and diabetes.”

“The study also noted that generic medicines are as effective as innovator drugs in preventing serious heart problems and death,” it added. – Bernama