Seriously ill and terminal patients in Hong Kong could benefit from faster ‘1+’ drug approval system, health secretary says

Lo Chung-mau, also a doctor, on Sunday said the new system – dubbed “1+” and to be launched on Wednesday – would also allow foreign pharmaceutical and medical devices companies to bring their products to Hong Kong for trials and help present innovations from mainland China to the rest of the world.

“This [registration regime] holds great hope for those patients who have run out of treatment options,” Lo said in a radio interview. “Over the years, there were cancer patients I attended to asking us whether they could try out medications that were being tested in clinical trials.

“They would say ‘I will benefit if the medicine works. At least I have hope.’ Some other patients told me that even though the drug couldn’t help them, [their experience] would still help other patients in future.”

Lo said the “1+” mechanism could cut the time needed to approve new drugs from two years to seven months and would be “more self-driven and proactive, more speedy and efficient”.

“There is a drug that treats congenital obstruction of the bile ducts … If we use secondary evaluation, it will take more than two years to wait for approval by foreign review agencies before it is handed over to us,” he explained.

“However, if the ‘1+’ system was launched … a full 17 months could be cut, from 24 months to about seven months.

“For example, if someone is waiting for drugs for seriously ill or cancer patients, there will be new and more choices. If more drugs come, the prices will be much lower.”

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Lee earlier suggested the introduction of the “1+” system, where pharmaceutical products would only need a single registration and free sale certificate issued by any of the 36 existing reference drug regulatory authorities.

The process is called the “secondary evaluation” approach.

Lo added that the medical schools at the University of Hong Kong and Chinese University of Hong Kong, as well as the Department of Health, had considerable expertise to offer in drug approval.

Hong Kong may need 10 years to create drug regulation scheme with global status

He said that the 86 million population in the Greater Bay Area development zone, which includes Hong Kong, Macau, Guangzhou and eight other mainland cities, would provide enough market demand and clinical cases to support drug research and development, so there would not be a problem with getting international and mainland recognition.

Lee added the city also wanted to set up its own drug approval authority based on “primary evaluation” within eight to 10 years.

The authority could approve applications for registration of drugs and medical devices based on clinical information, rather than having to rely on regulatory authorities from other jurisdictions.