Drug trial hopes hit by tight regulations

Researchers say licensing rules mean city is losing out to rivals like Taiwan and South Korea. They hope a change in the law will help

PUBLISHED : Tuesday, 10 June, 2014, 4:21am
UPDATED : Tuesday, 10 June, 2014, 4:21am

A bureaucratic regulatory system is causing Hong Kong to fall behind regional rivals such as Taiwan and South Korea as a place to test the drugs of the future, a manager at the city's leading research centre says.

Under a system put in place a decade ago, a licence for a clinical trial lasts for only two years, despite the fact large-scale trials can take a decade or more. That means studies have to be put on hold while permission is sought.

The application process also requires researchers to submit a sample of the drug, which often means making complicated arrangements to have the sample imported.

The regulatory hurdles might only delay a trial by a month or two - but that is enough to drive sponsors to regional competitors with more flexible regulations, according to Henry Yau, managing director of the University of Hong Kong's clinical trials centre.

"A few months can make a big difference to a pharmaceutical research study, as drug patents only last 20 years," Yau said.

"Hong Kong has the talent, facilities and technology to develop itself into one of the leading hubs for clinical trials in the region. But it is sad to see it falling behind in recent years."

At the start of the last decade, the city was a leading research hub in the region, but while Taiwan and South Korea have risen to overtake Hong Kong, the number of trials locally has remained stagnant at about 360 per year since 2008, Department of Health figures show.

"The rising competitiveness of Taiwan and South Korea is at least partly a result of the improving regulatory environments in the two places over the last few years," Yau said.

Most other countries do not set a time limit on a licence for a particular trial nor require a sample of the drug, Yau said.

The regulations were first introduced to ensure tight monitoring of drug trials.

But the government is planning to relax the rules after the Department of Health decided that the city's regulations had fallen behind the international standard.

In March, it submitted amendments to the rules to the Legislative Council that would increase the length of licences to five years and remove the sample requirement. Lawmakers are expected to approve the changes later this year.

The Hong Kong Association of the Pharmaceutical Industry, which represents major drug companies that supply 70 per cent of the city's medicine, said more flexible regulations were needed to increase the competitiveness of the city as a venue for drug trials.

Chairwoman Sabrina Chan So-kuen said requiring researchers to submit a drug sample was particularly problematic as it often meant additional administrative work to acquire export and import certificates, which had nothing to do with proving the drug's safety.

"It usually takes 10 to 15 years for the industry to develop a new drug," Chan said.

"It is highly unlikely that large-scale trials can take place if they have to be terminated or halted for a new certificate in the middle of the research."

Chan took part in a review committee that advised the department on how the regulations could be relaxed.

Yau welcomed the plan to extend the validity of trial certificates, but said some large-scale trials would still be disrupted by the reapplication process.

Both Yau and Chan stressed that extending the certificate's validity period would not mean a relaxation of safety regulations.

Holders of trial licences would still be obliged to submit progress reports to the Department of Health every year and to report all serious adverse incidents that occur during the trial process.