Rules set for stem cell industry


KUALA LUMPUR: Guidelines for cell and gene therapy products (CGTPs) issued by the Health Ministry will be enforced from 2021, says Dr Lee Boon Chye.

The Deputy Health Minister said it was to give stem cell industry players time to adopt the guidelines as the ministry did not want to hamper the growth of the industry.

“We view this industry as important even in its infancy stages,” he said at the Malaysian Association for Cell Therapy (MACT) annual symposium at TPC Kuala Lumpur yesterday.

He also said the National Blood Centre was involved in facilitating the industry’s growth through its cord blood bank and the National Stem Cell Coordinating Centre, set up in 2014.

“These are some of our efforts in developing the industry,” he said.

MACT president Dr Lim Teck Onn said the effective use of stem cell for medical purposes was evidence-backed, but cell therapy might be controversial for aesthetic applications.

“The use of stem cell for genuine medical therapy has never really been an issue.

“There are data and proven trials and even US Food and Drug Administration-approved indications.

“The big problem however is its use in wellness, anti-aging and some beauty products.

“As an industry association, we have an obligation to make sure that companies involved in these activities do so responsibly and not take patients and consumers for a ride,” he said.

On a separate matter, Dr Lee said they were also looking into the appeals by healthcare industry players, lobbying for patients’ right to import medication for personal consumption and experimental treatment.

The import of medication for personal use, he said, was largely unregulated as it was “virtually impossible” to monitor thoroughly.

But he added that such imported medications should not exceed a month’s supply.

“On experimental treatment, patients may seek such treatments so long as the practising doctor has been subject to vigorous medical ethics assessment,” he said.

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