LCQ10: Using Hong Kong drugs and medical devices in Greater Bay Area
In November last year, the Central Government announced a measure of allowing designated Hong Kong-owned healthcare institutions in the Mainland cities of the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) to use, subject to approval, (i) Hong Kong-registered drugs and (ii) medical devices procured and used by Hong Kong public hospitals, with urgent need clinically (the Measure). The Measure was first implemented at the University of Hong Kong-Shenzhen Hospital (HKU-SZH) on a trial basis and the trial period ended on July 31 this year. After the trial work has achieved phased progress, the Mainland authorities will extend the relevant arrangement gradually to cover healthcare institutions in other cities of GBA that meet the requirements. In this connection, will the Government inform this Council:
(1) whether it knows the effectiveness of the Measure implemented in the trial period;
(2) whether it knows the timetable for the Mainland authorities to extend the relevant arrangement to cover healthcare institutions in other cities of GBA that meet the requirements, and whether they have plans to extend the Measure to cover (i) the first Hong Kong-owned private general hospital in Shenzhen (i.e. Shenzhen New Frontier United Family Hospital) soon to be commissioned, and (ii) the hospital which is being set up by The Chinese University of Hong Kong in Shenzhen and expected to be commissioned in 2026; if they do, of the details; if not, the reasons for that;
(3) given that under the existing arrangement, patients may make a request for a copy of their medical records in the Electronic Health Record Sharing System and give authorisation for the records to be passed to HKU-SZH for medical consultation purposes (medical record sharing arrangement), but it has been reported that such medical records cover only part of the information on medical history, whether the authorities will relax the restrictions on the request for and use of such medical records (e.g. extending the coverage to include patients' detailed surgical reports and images derived from radiological examinations such as nuclear magnetic resonance examinations), and extend the medical record sharing arrangement to cover other high-quality Mainland hospitals; if so, of the details; if not, the reasons for that;
(4) as it has been reported that the Measure currently focuses on western medicines, whether the authorities will extend the relevant arrangement to cover proprietary Chinese medicines, with a view to promoting the development of Chinese medicine in GBA; if so, of the details; if not, the reasons for that; and
(5) whether it will consider allowing the Hospital Authority to use, subject to approval, (i) Mainland-registered drugs and (ii) medical devices procured and used by designated healthcare institutions in GBA, with urgent need clinically; if so, of the details; if not, the reasons for that?
Having consulted the Department of Health (DH) and Hospital Authority (HA), my reply to the question raised by Dr the Hon Chiang Lai-wan is as follows:
(1) and (2) As a facilitation measure for Hong Kong residents working and living in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) to seek healthcare services, designated healthcare institutions operating in the GBA are allowed to use Hong Kong-registered drugs with urgent clinical use, and medical devices used in Hong Kong public hospitals with urgent clinical use, subject to the approval of Guangdong Province (the Measure). Guangdong Provincial Medical Products Administration (GDMPA) has completed the trial of the Measure at the University of Hong Kong-Shenzhen Hospital (HKU-SZH) on July 31, 2021. Currently, nine drugs and two medical devices are allowed to be used in the HKU-SZH through the Measure.
After the completion of trial, the Measure will be extended from Shenzhen to cover other cities and designated healthcare institutions meeting relevant requirements in the GBA. The first batch of five approved designated hospitals includes HKU-SZH, Modern Hospital Guangzhou, Guangzhou United Family Hospital, C-MER (Zhuhai) Dennis Lam Eye Hospital and Zhongshan Chenxinghai Hospital. The Government will continue to closely collaborate and communicate with the GDMPA on the Measure with a view to expanding the directory of drugs and medical devices as soon as possible, and extending the arrangement gradually to cover more healthcare institutions meeting relevant requirements in the cities in GBA.
(3) In view of the impact of the COVID-19 epidemic, the Food and Health Bureau, with the support of HA, has set up a special support scheme under which HKU-SZH was appointed to provide follow-up consultation services for patients who had scheduled appointments with HA's specialist out-patient clinics and general out-patient clinics before the epidemic.
To ensure that patients under the special support scheme receive continuity of care, we have made special arrangements to enable the relevant patients to, via the HKU-SZH, make a data access request (DAR) to the Electronic Health Record Office (eHR Office) to obtain a copy of their medical records in the Electronic Health Record Sharing System (eHRSS). After obtaining the patients' authorisation, the eHR Office will facilitate to pass the relevant copies of the medical records to HKU-SZH.
For other healthcare providers in the Mainland, persons who have registered with the eHRSS can, in accordance with established procedures, make a DAR to the eHR Office to obtain a copy of their medical records and, as necessary, provide the relevant information to healthcare providers for reference. We will closely monitor the needs of Hong Kong citizens for obtaining their Hong Kong medical records when using healthcare services in the Mainland. We will make timely adjustments, including improving the eHRSS to facilitate members of the public to obtain copies of their medical records while outside of Hong Kong, and enhancing the transfer of copies of medical records to healthcare providers outside of Hong Kong.
With the broadening of the scope of sharable data to include radiological images (including magnetic resonance images) under Stage Two Development of the eHRSS, we will also study the feasibility of remotely transmitting high-resolution radiological images.
(4) The Government has been actively promoting the development of Chinese medicine drugs industry of Hong Kong. With the support from the Central Government, to implement the Construction Plan for the Chinese Medicine Highlands in the Guangdong-Hong Kong-Macao Greater Bay Area (2020-2025), GDMPA promulgated on August 27, 2021 a notice regarding the streamlining of approval procedures for Hong Kong registered traditional proprietary Chinese medicines (pCms) for external use. The holder of any traditional pCm for external use that has been registered with the Chinese Medicine Council of Hong Kong and in use in Hong Kong for more than five years may apply for registration with the GDMPA through the streamlined procedures. Such pCm, upon obtaining approval successfully, may be sold in the GBA.
The measure enables Hong Kong pCm manufacturers to expand their markets, as well as creates favourable conditions for Hong Kong pCm to "go global" in the long run. The Government will closely monitor the implementation of the aforementioned measure, with a view to further discussing with relevant Mainland authorities in a timely manner the introduction of new measures under different co-operation frameworks to further enhance co-operation in the area of Chinese medicine drugs between the two places.
(5) Regarding drug treatment, drugs listed on the HA Drug Formulary are intended for corporate-wide use by the HA benefiting the entire local population. In line with HA's procurement policy and procedures, all pharmaceutical products must comply with the requisite quality requirements, standards and regulations as well as pharmaceutical product registration with DH in order to ensure quality, safety and efficacy. Nevertheless, HA has put in place a mechanism to allow clinicians to provide non-Formulary drugs, registered and unregistered ones alike, in exceptional situations to ensure that patients are provided with appropriate clinical care. When the use of non-Formulary drugs is considered necessary for an individual patient, the HA clinician concerned should submit applications to DH and ensure compliance with all statutory requirements.
HA has an established mechanism for the use of medical equipment. When planning the adoption and procurement of medical equipment in public hospitals, HA will seek input from healthcare professional, make reference to the latest published literatures and clinical evidence, and consider local operational needs.
On the use of Mainland-registered and approved drugs with urgent clinical use and medical equipment used by designated healthcare institutions operating in GBA, the legal and healthcare systems, as well as import and export mechanisms of drugs are different in Hong Kong and the Mainland. HA and DH have to take into consideration various factors and would vet the applications in accordance with the relevant procedures in Hong Kong. To meet the needs of patients in Hong Kong, the HA maintains communications with different stakeholders, and will carefully consider various factors to explore the feasibility of the suggestion.
Ends/Wednesday, September 15, 2021
Issued at HKT 16:28
Issued at HKT 16:28