By Elizabeth Cheung,Emily Hung

Copyright scmp

Hong Kong health authorities aim to introduce a fast-track approval mechanism for life-saving drugs that can treat severe or rare diseases, a move that could reduce the current system’s processing time by one-third.
Secretary for Health Lo Chung-mau said on Thursday that the fast-track arrangement could help to respond to health emergencies such as a pandemic where infections spread quickly. The minister was elaborating on health measures outlined in the latest policy address a day earlier.
“The purpose of the fast-track drug approval mechanism is to address critical medical needs,” he said.
“When an outbreak of a novel infectious disease led to the Covid-19 pandemic, all countries adopted a fast-track approval mechanism for new vaccines and drugs … facing the tsunami of a new infectious disease, everyone was looking for the best way to cope.”
In his latest policy blueprint, Chief Executive John Lee Ka-chiu said on Wednesday that the government would expedite a “1+” mechanism for new drugs, piloting priority evaluation and approval for innovative drugs recommended by the Hospital Authority for the treatment of severe or rare diseases.
The 1+ mechanism is a streamlined approval process that only requires pharmaceutical products that have local clinical data to be certified by one of the 36 reference drug regulatory authorities before applicants can seek local registration.
Before the introduction of the 1+ mechanism, the certification of two reference authorities was needed to make an application for local registration.
Lo said authorities were aiming to build an even faster track within the 1+ mechanism, without compromising quality and safety.

Director of Health Ronald Lam Man-kin said that while the 1+ mechanism could currently approve drugs within 150 days, authorities hoped to further compress the duration to 100 days.
Lam said the 100-period could be potentially reduced further after a review of complexities and the volume of applicants under the coming arrangement.
Lo said that there was currently a Named Patient Programme, where doctors could make individual applications to use unregistered drugs if existing medications were insufficient, but added that it was not an ideal arrangement.
“It is not ideal for individual doctors to bear the professional responsibility; we wish to standardise the procedure, launching a fast track approval mechanism and gradually turn those individual applications into a formal system,” he said.
The Department of Health will also update guidelines on the use of social media among children and adolescents, as part of the measures mentioned in the policy address.
Lam said that it was time to review the guidelines given the availability of more data on the impact of screen time and social media on children and adolescents.
He said existing information already pointed out that prolonged screen time was linked to physical problems, such as becoming overweight, and mental health-related issues, such as online bullying.
A panel, composed of experts from the education, medical and other sectors, was likely to convene its first meeting by the end of the year to start looking into the matter, Lam said.