The Malaysian Insider

JAN 19 – Mr Ganesh, a 57-year-old retiree, suffers from diabetes and hypertension. He spends about RM500 per month on medication to control his condition.

Many Malaysians are in the same boat as Ganesh. The question remains – how many Malaysians can afford RM500 per month on medication after retirement?  Undoubtedly, their burden would be lightened with affordable quality alternative generic drugs.

The Malaysian obsession with anything and everything imported and branded has been a bane for many local manufacturers. It does not matter how many “Buy Malaysian” campaigns the government can launch, Malaysians will always cast their eyes West-ward and East-ward but never In-ward.

The tendency to equate all things imported (and expensive) with being of high quality and better is not confined to the fashion industry. It has, in fact, permeated a cross section of industries, including the highly-regulated domestic pharmaceutical industry.

Despite the achievements made by the Ministry of Health and Malaysian pharmaceutical manufacturers, awareness and acceptance of generic drugs in Malaysia has yet to reach its optimum potential and recognition.

Jimmy Piong, President of the Malaysian Organisation of Pharmaceutical Industries (MOPI) said: “It is imperative that consumers understand and accept the fact that locally-manufactured generics are of equal, if not higher, quality as innovator drugs and other imported generic drugs.

“We must get rid of our obsession with all things foreign and the mentality that expensive is better.  We end up paying a premium on them. If we look at ‘Buy Malaysian’ from a practical rather than from a status perspective, we can do away with or have less unnecessary wastage of resources.”

A recent study conducted by a group at Universiti Sains Malaysia found that most innovator drugs are 27 per cent to 90 per cent more expensive than generic drugs.

Below is a chart showing the percentage range of price difference between innovator drugs and their generic drug equivalent.

The study showed that consumers can save up to 90 per cent of the cost of if they switch to generic products.

For the Government, a cost comparison study conducted in 2006 showed that by prescribing generic drugs for only nine medicines, it can save up to RM17million per year in pharmaceutical drugs expenditure.

A growing population together with an increasingly ageing population will spur demand for pharmaceuticals and medical care. With healthcare spending of Malaysians projected to grow at about 13 per cent a year, the need for affordable and quality medicine becomes even more urgent.

Dr Mohamed Azmi Hassali of Universiti Sains Malaysia commented: “A major component of direct healthcare cost is medications. In most countries, including Malaysia, governments are relying more on generics to save on healthcare costs. In the private healthcare sector, where the use of innovator medications is high, patients have to bear the high cost of medication. One solution is to give patients a choice – innovator or generic drugs.

“In Malaysia, the drug control authorities are very strict when it comes to drug registration. There is no double standard for either generics or innovator medicines.

“Generic medicines, therefore, are as safe and as good as innovator drugs. They play a key role in the affordability of pharmaceuticals. Consumers need to be well informed of the options, and it is the role of healthcare professionals and government agencies to raise awareness and promote the use of generics among consumers and healthcare providers.”

Drug regulations in Malaysia

Contrary to common misconceptions relating to local generic drugs, Malaysian pharmaceutical manufacturers are required to comply with the Code of Good Manufacturing Practices as laid out by the Malaysian Drug Control Authority (DCA), the national body that regulates the production, import, marketing authorisation (registration) and sale of all pharmaceuticals.

Furthermore, Malaysia, being a member of the International Pharmaceutical Inspection Cooperation/Scheme (PIC/S) since 2002, has helped to improve further the standard and quality of local generic drugs, over-the-counter and health supplements industries.

Malaysian generic drugs manufacturers must adhere to the strict European Union regulations and registration processes laid down by the PIC/S that require generic drugs produced to be thoroughly tested for safety and efficacy before they can be sold domestically and overseas.

In 1985, the National Pharmaceutical Control Bureau (Ministry of Health) was tasked with ensuring the quality, efficacy and safety of all pharmaceuticals (including generics) in the country through a national registration and licensing scheme. This scheme is being evaluated against international standards

Quality, safety and efficacy of the drugs were determined through evaluation of scientific data and laboratory tests before they are accorded marketing authorisation. A system to monitor products in the market was set-up while information on drugs was made available to medical professionals and consumers through a national drug information service.

To maintain the high quality and safety standards of generic drugs, periodic on-site inspections are carried out by auditors from the National Pharmaceutical Control Bureau. Local manufacturers that export to other international markets are also subject to audits by auditors from drug regulatory authorities of the countries to which the generic drugs are being exported.

Additionally, domestic pharmaceutical manufacturers carry out bio-equivalence (BE) tests on generic drugs based on a list prescribed by the Malaysian Drug Control Authority. The list of drugs requiring BE studies grows by a substantial number every year. To date, a total of 96 drugs are required to be BE compliant before they can secure market authorization for sale domestically.

A BE test involves comparing a generic drug and its innovator counterpart using the same dosage, under the same conditions on a number of healthy human volunteers to prove that the generic drug releases its active ingredient into the bloodstream at virtually the same speed and in the same amounts as the innovator drug.

In short, the efficacy of the generic drug must be the same (within established tolerances) as the innovator counterpart before it is given marketing approval.

Piong explained : “Discovery costs and manufacturing costs are the two major factors that determine the eventual price of a drug. Generic drug manufacturers do not incur any aspects of discovery costs. Their main cost is in the manufacturing process (which includes product quality, safety and efficacy). The benefits in savings are passed on to consumers resulting in lower pricing which, unfortunately, are taken by some as reflective of the quality of the drugs.

“For Malaysians to truly reap the benefits of the local pharmaceutical industry, this mentality of foreign and expensive being better has to change soon if Malaysians from all strata are to enjoy equitable access to essential medicines that are safe, effective and affordable.” – Malaysian Organisation of Pharmaceutical Industries