Exclusive | Hong Kong can attract pharmaceutical giants by having own drug regulatory system, health chief says while citing need for R&D in Covid aftermath

Health secretary Lo Chung-mau says firms are often spurred to carry out research where a regulator is based
Looking back at first year as health minister, he defends fine-tuning pandemic controls, saying ‘small steps are in fact the safest way of walking’

Hong Kong healthcare and hospitals

Elizabeth Cheung

Published: 9:00am, 30 Jun 2023

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A key lesson Hong Kong should learn from the Covid-19 pandemic is the need to radically boost its research and development capabilities and consider setting up its own drug regulatory approval system, the health minister said, as he outlined his plans to transform the city into a biomedical innovation hub.

Giving the city a powerful body that could approve products for the market would also attract pharmaceutical firms that often carried out research where the regulator was based, Lo Chung-mau told the Post on Wednesday.

Looking back over his first year as health secretary, the veteran surgeon also said he had reached some targets, including devising measures to tackle the pandemic that were firmly rooted in evidence.

Hong Kong must learn from the Covid-19 pandemic and boost its research and development capabilities, the health minister has said. Photo: Xiaomei Chen

While that approach led to incremental changes, steady transitions were crucial to ensure the city emerged from the pandemic, he argued.

“Some people said Hong Kong walked out of the pandemic with tiny steps. But small steps are in fact the safest way of walking,” Lo said. “Do you run on slippery floors? No. Fighting the pandemic is like walking on a slippery floor where you can fall down anytime.”

When severe acute respiratory syndrome, or Sars, hit Hong Kong in 2003, authorities responded by placing residents in isolation and quarantine, Lo noted. But the virus behind Covid-19 mutated quickly, so additional measures such as early genome sequencing and the timely development of vaccines and antivirals were helpful in returning the city to normality, he said.

The three-year battle underscored the need for the city to ramp up research and development (R&D), Lo argued. Under Beijing’s latest blueprint for national development, Hong Kong should establish itself as a hub for innovation and technology.

“The biggest lesson we have learned this time is we must raise our R&D capacity,” the secretary said.

Lo noted that local universities had outstanding basic research, but there were often gaps in clinical trials and approvals.

Lo also revealed health authorities were also considering whether the city should eventually set up an operation similar to the Food and Drug Administration in the United States, which is responsible for certifying new products before they enter the market.

Hong Kong currently runs a “secondary evaluation” system for drug approvals. Local authorities rely on registration approvals given by the 36 regulatory bodies in mainland China and overseas which conduct their own assessments based on primary data and information.

A pharmaceutical firm can apply to register a drug in Hong Kong provided it has obtained approval from two or more of the 36 bodies.

Calling the existing system “relatively passive”, Lo said the practice did not provide enough incentives to attract pharmaceutical companies to carry out R&D developments in Hong Kong.

“If [a pharmaceutical product] is approved as long as it has obtained registrations from the United States or Europe, it doesn’t have to carry out R&D in the city,” Lo said, noting that research was usually closely linked to where the approval process took place.

Lo added that given the huge market on the mainland, a faster drug approval process in the city and a policy that allowed some drugs registered in Hong Kong to be used over the border could attract more research and clinical trials to the city, boosting its status as the region’s biomedical hub.

Launched in 2021, the policy allows specified mainland healthcare institutions to use Hong Kong-registered drugs and medical devices for urgent clinical uses, subject to the approval of the Guangdong provincial authorities.

So far, 23 Hong Kong-registered drugs and 13 medical devices have been permitted for use in 19 mainland institutions participating in the scheme.

Shenzhen is one of 11 cities involved in China’s bay area plan. Photo: Martin Chan

“If we can speed up the clinical trials, approvals and use of new drugs in Hong Kong … there will be major incentives for pharmaceutical firms to come to Hong Kong for product development and approval,” Lo said. “New drugs from overseas and the most advanced medical products could also be used in the Greater Bay Area through the policy.”

Beijing’s bay area plan calls for linking Hong Kong, Macau and nine other southern Chinese cities into an economic powerhouse.

Authorities are already taking steps to move towards establishing Hong Kong’s own drug evaluation mechanism. They are considering having the city join the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), a global organisation that brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug developments and registration.

Members would be recognised by the World Health Organization as stringent regulatory authorities in drug approvals.

But Lo predicted membership would take time.

“Joining the ICH is not the only key to attracting more R&D activities to Hong Kong,” he said. “We will press ahead in the right direction.”

Additional reporting by Sammy Heung