Chief Executive John Lee today announced that the Government will develop Hong Kong into a Health & Medical Innovation Hub by establishing a Drug Approval Authority based on “Primary Evaluation” in the long run.

In his Policy Address, Mr Lee said the Government is determined to leverage Hong Kong’s medical strengths with the long-term objective of establishing an authority that registers drugs and medical devices under the “primary evaluation” approach, ie to directly approve applications for registration of drugs and medical devices based on clinical data, without relying on other drug regulatory authorities.

“We will endeavour to attract more pharmaceutical and medical device enterprises, both locally and from around the world, to conduct research & development (R&D) and clinical trials in Hong Kong, and build up the capacity, recognition and status to ensure that the eventual approval mechanism of drugs and medical devices of Hong Kong would be widely recognised internationally and by the Mainland.”

The Government will set up a preparatory office to study the potential restructuring and strengthening of the current regulatory and approval regimes for medicine, medical devices and medical technology.

The office will also put forward proposals and steps for the establishment of the Hong Kong Centre for Medical Products Regulation (CMPR), moving towards the transition to the “primary evaluation” approach in approving applications for registration of pharmaceutical products, and explore the upgrading of the CMPR as a standalone statutory body in the long run.

Mr Lee said this will help accelerate the launch of new drugs and medical devices to the market as well as foster the development of R&D and testing of medical products and related industries.

Meanwhile, the Government will pursue Hong Kong’s accession to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use as an observer to familiarise with and promote the latest development of drug regulation.

It will also establish the Greater Bay Area International Clinical Trial Institute in the Hetao Shenzhen Hong Kong Science & Technology Innovation Co-operation Zone next year to provide a one stop clinical trial support platform for medical research institutions.

The Hospital Authority will also establish the Cluster Clinical Research Support Office in 2024-25 to provide advisory and support services for frontline staff, introduce additional measures to encourage medical teams to participate in clinical research and trials, expedite the process of ethics review of clinical research, and strengthen the systems and mechanisms for supporting clinical research and data sharing.

To accelerate patients’ access to new chemical or biological entities (NCEs) and promote the development of clinical trials and R&D of drugs in Hong Kong, the Government will enhance the existing drug regulatory regime by establishing the new “1+” mechanism this year.

Under the mechanism, pharmaceutical products containing NCEs for life threatening or severely debilitating diseases with local clinical data will be allowed to register conditionally with only one certificate of pharmaceutical product issued by reference drug regulatory authorities instead of two under the prevailing arrangement.

Digital healthcare record

With an aim to develop a personalised eHealth account for every resident, Mr Lee proposed to roll out the eHealth+ to build a comprehensive healthcare information infrastructure over the next five years.

It will allow users to check and carry electronic health records as well as scheduled appointments through mobile phones anytime.

Enhancing public healthcare services

To further enhance public healthcare services, the Hospital Authority (HA) aims to reduce the waiting time of stable new case bookings for the specialties of Ear, Nose & Throat as well as Orthopaedics & Traumatology by 10% in 2024-25.

It will set up Hong Kong’s first Chest Pain Centre in Queen Mary Hospital in 2025 in accordance with national accreditation standards, with a view to optimising the patient journey for those suffering from cardiovascular diseases, improving treatment outcome and increasing the survival rate.

The HA will also establish a breastmilk bank and formulate the related mechanism for breastmilk donation in 2025 to provide breastmilk for infants and young children who cannot be breastfed by their biological mothers, and especially to minimise the chance of serious illness in premature or severely ill babies.

To enhance the community’s oral health, the Government will launch the Primary Dental Co-care Pilot Scheme for Adolescents to provide those aged between 13 and 17 with partial subsidies for private dental check-up services.

Mental health

Mr Lee also noted that the Government attaches great importance to mental health. To expedite case management, the HA will optimise the ratio of case manager to patients with severe mental illness to no higher than 1:40 under the Case Management Programme.

For new cases triaged as urgent and semi-urgent at psychiatric specialist outpatient clinics, the median waiting time will be maintained at no longer than one week and four weeks respectively.

Meanwhile, a pilot scheme will be launched in three District Health Centres next year in collaboration with community organisations to provide mental health assessment for those in need, and to provide early follow‑up and referral for high‑risk cases.

District Services & Community Care Team members will also be provided with mental health support training to assist in the early referral of people in need in the local communities for support.

Healthcare manpower supply

To alleviate the shortage of dentists and nurses, Mr Lee proposed to update the registration regimes to provide new pathways for admission of qualified non-locally trained dentists and nurses for serving in specified institutions under the premise that the professional standards and patients’ welfare are maintained.

The Government will introduce amendment bills to relevant ordinances by mid-2024.

Chinese medicine development

Mr Lee added that the Government will actively promote the development of Chinese medicine in Hong Kong.

A digitalised Chinese medicines information platform will be launched early next year for Chinese medicine identification and educational purposes.

The Government will also formulate the Chinese Medicine Development Blueprint for release in 2025.

Cross-boundary medical collaboration

Additionally, the Government will strengthen medical collaboration with the Mainland. The HA will resume the hospital accreditation programme to ensure its management and services attaining international standards.

The HA will also support the Shenzhen Hospital Accreditation Research Centre to set up an office in Hong Kong in the future with a view to contributing to the internationalisation of the national hospital accreditation standards and improving the overall healthcare quality of the Guangdong-Hong Kong-Macao Greater Bay Area.

The Government will roll out the Elderly Health Care Voucher Greater Bay Area Pilot Scheme by extending the coverage of the elderly health care vouchers initially to about five suitable medical institutions in the Greater Bay Area as trial service points for providing primary healthcare services.

It will also cover individual designated medical institutions providing dental services at places near Hong Kong such as Shenzhen.