Boo Su-Lyn | CodeBlue

Ex-PM Dr Mahathir Mohamad, who is also a patient at IJN, criticises a government mandate for IJN to switch public patients from original to generic meds, citing the importance of maintaining IJN’s good reputation. IJN was founded in 1992 under his tenure.

KUALA LUMPUR, Nov 20 — Dr Mahathir Mohamad has expressed concern over the impact of the National Heart Institute (IJN)’s compelled shift to generic drugs on the top cardiac centre’s long-established reputation.

CodeBlue asked the former prime minister, who is also IJN’s most high-profile patient aged 99, if he was concerned about the impact of the new policy decision on IJN’s ability to provide the best care to patients – as it saw fit – without being hamstrung by the payer’s dictate. The Ministry of Health (MOH) pays for the care of government patients, including pensioners and civil servants, at IJN.

“IJN has established a good reputation. It is important that the reputation is sustained,” Dr Mahathir, who is Malaysia’s fourth and seventh prime minister, told CodeBlue in a brief statement.

IJN, a cardiovascular and thoracic care hospital owned by the Minister of Finance Incorporated (MOF Inc.), was founded in 1992 during Dr Mahathir’s first stint as prime minister when he served for 22 years from 1981 to 2003. IJN operates as a private hospital; it is not a government hospital under the MOH.

When asked if he would push the government for a slower transition for IJN to generics, instead of a seemingly blanket policy starting 2025, Dr Mahathir said: “The generic drugs should be observed as they begin to be used, especially in India. As the results come in and they are effective, they should be used in stages while observations are made.”

Dr Mahathir, who has a history of heart problems, was hospitalised in IJN three times this year. He was discharged last month after admission on October 15 for a lower respiratory tract infection.

The medically trained former PM – who has not practised medicine for decades – expressed his personal belief that “as far as possible, original drugs should be used for everyone.”

Dr Mahathir made disproven, untrue claims that “generic drugs are often ineffective. This is especially so for old people, such as pensioners.” He also wrongly compared generics to local herbal medication; traditional and complementary medicines are completely different from highly regulated generic drugs.

“In the case of local herbal medicine, no clinical tests have been scientifically carried. In the case of generics, there have also been no clinical trials. The generics simply follow the familiar and assume the need for trials is not necessary,” said Dr Mahathir in his exclusive statement to CodeBlue.

The National Pharmaceutical Regulatory Agency (NPRA) requires bioequivalence studies for the registration of generic medicines in Malaysia, but clinical trials are required if the generic product is re-purposed or for new indication. Clinical trials are also mandated for the approval of biosimilars.

Generic drugs are usually synthesised from chemicals, whereas biosimilars, like their reference biological products, are typically manufactured from living systems (for example, micro-organisms like yeast, bacteria, and animal cells).

For approval to market a generic drug, the United States’ Food and Drug Administration (FDA) does not require a repeat of costly clinical trials on ingredients or dosage forms already approved for safety and effectiveness. This allows generic medicines to be brought to market more quickly and at lower cost, allowing for increased access to medications by the public.

The Galen Centre for Health and Social Policy previously said Malaysia has one of the highest and most rigorous pharmaceutical regulatory standards in the region.

A 2020 study published in top scientific journal Nature concluded that generic medications were at least similar, and in some cases even superior, to their branded counterparts regarding death and major cardiovascular events. The researchers had conducted a population-wide cohort study among 9.4 million people in Austria, from 2007 to 2012, on 17 branded drugs versus generic versions for the treatment of hypertension or heart failure, hyperlipidemia (high cholesterol), and diabetes mellitus.

“We conclude from this comprehensive study of almost all insured individuals in Austria that use of generic medications associated with similar or even slightly lower rates of mortality or non-fatal cardiovascular events,” researchers wrote.

Contrary to Dr Mahathir’s claims, generic medications are effective and safe for everyone, regardless of age. In a November 8 statement, the MOH stressed that generics approved by the NPRA have equivalent safety and effectiveness to brand-name drugs.

NPRA requires bioequivalence studies for the registration of generic medicines to prove that generics have the same active ingredients, rate of absorption by one’s body, and level of content in the blood for the same period as innovator drugs taken with the same dosage.

“MOH guarantees that the use of generic medicines is safe, effective, and produces the best effects based on careful evaluation by registered medical practitioners of patients’ clinical needs.”

The Malaysian Organisation of Pharmaceutical Industries (MOPI) – which represents 51 local pharmaceutical manufacturers of generics and biosimilars in the country – pointed out that by volume, generics have a market share of 91 per cent in the United States, 77.5 per cent in Canada, and 70 per cent in European Union (EU) countries.

“Generics and biosimilars are not ‘cheap alternatives’ – they are therapeutically equivalent to their originator counterparts,” MOPI said in a statement last November 6.

Over the past decade, the MOH’s payments to Institut Jantung Negara Sdn Bhd (IJNSB) for government-dependent patients jumped 68 per cent from RM361.8 million in 2013 to RM606.5 million in 2023.

A 2023 analysis sighted by CodeBlue found extremely high drug prices charged by IJNSB to the MOH. These prices range from 42 per cent to a whopping 4,323 per cent higher than the MOH’s procurement for IJN’s 10 most prescribed medications, including common statins, that are all innovators.

Besides Dr Mahathir, a few other ordinary patients at IJN previously said they preferred the original medications that they had been prescribed at IJN, either due to drug allergies to other medicines or because they had gotten used to their existing treatment regimens. These pensioners were discharged from IJN to MOH hospitals earlier this year.

During the tabling of Budget 2025 last month, Prime Minister Anwar Ibrahim announced that pensioners would be allowed to continue their care at IJN. Three days after Anwar’s announcement, the MOH and the Ministry of Finance (MOF) made the decision to substitute originator medications with generic equivalents for government patients to reduce the MOH’s cost burden. Public patients comprise about 85 per cent of IJN’s patient load.

Health Minister Dzulkefly Ahmad told Parliament last week that the MOH has a generic-first policy, adding that IJN’s management has agreed to shift to generics.