Tag Archives: China

The following is issued on behalf of the Council on Human Reproductive Technology:
 
     The Council on Human Reproductive Technology (Council) today (March 13) launched a consultation with stakeholders, including licensed centres and relevant organisations, on the proposed amendments to the Code of Practice on Reproductive Technology and Embryo Research (Code). The consultation period is until April 13. Details of the proposed amendments to the Code have been uploaded to the Council’s website (https://www.chrt.org.hk).
      
     Currently, under section 15(2) of the Human Reproductive Technology (Licensing) Regulation (Cap. 561A), gametes or embryos for own use can be stored for at most 10 years. For cancer patients or any other patients who may be rendered infertile as a result of chemotherapy, radiotherapy, surgery, or other medical treatments, the maximum storage period for embryos is 10 years, and that for gametes is 10 years or until the patient reaches 55 years of age, whichever is the longer.
      
     Pursuant to section 45(2)(f) of the Human Reproductive Technology Ordinance (Cap. 561), the Council may make regulations on the maximum period of storage of embryos and gametes. Based on the feedback from stakeholders during the consultation of the last review of the Code in 2023, and referencing the practices in other jurisdictions, the Council conducted a comprehensive review of the legal limits on the storage of gametes (including sperms and eggs) or embryos from medical, ethical, social and legal perspectives. The relevant work has recently been completed and the Council preliminarily proposes to amend the Code based on the following major principles:
      
(i) lifting the legal restrictions on the storage period of gametes or embryos for own use, irrespective of the gender, age, or medical conditions of the patient;

(ii) the Council will amend the operational measures in the Code accordingly to ensure that the public is fully aware of the associated medical risks before engaging in unnecessary and prolonged storage of gametes or embryos without medical reasons;

(iii) the amended Code will require licensed centres to provide patients with relevant information, such as the risks of egg-retrieval procedures, the rapid decline in fertility or pregnancy rate associated with ageing of women, the risks of advanced maternal age, as well as the social impacts of delayed childbearing. Patients must sign a consent form to acknowledge the receipt of such information. After storing the gametes or embryos for a certain period, licensed centres are required to provide counselling tailored to the individual circumstances of the patients, and the storage of their gametes or embryos may only be extended with the written consent of the patients; and

(iv) the amended Code will request licensed centres to provide additional statistical data for regulatory purposes.
 
     Members of the public are also welcome to submit their comments on the above recommendations to the Council by post (The Secretariat, the Council on Human Reproductive Technology, Boards and Councils Office, Department of Health, Room 58, 17/F, Wu Chung House, 213 Queen’s Road East, Wan Chai) or by email (hrtc@dh.gov.hk) before the end of the consultation period. The Council will consider the views received before making the official final recommendation to the Government. read more

     The 2025 Award Scheme for Learning Experiences under the Qualifications Framework (QF) will open for applications from tomorrow (March 14) until May 31. Practitioners from 23 industries implementing the QF (see Annex) are welcome to apply.
      
     A spokesman for the Education Bureau said that “Together, go further” continues to be the theme for this year’s Award Scheme, which not only enables awardees’ participation in learning activities outside Hong Kong but also promotes their professional growth and development in the workplace. The Award Scheme aims to encourage practitioners who have excelled in continuous learning to broaden their horizons through engaging in learning activities held locally or around the world, enabling them to keep abreast of the latest developments of the industry and extend their exposure and networks, thereby realising their personal and career goals.
      
     Since its inception in 2013, the Award Scheme has attracted over 2 600 applications from practitioners of various industries, over 700 of whom were awarded. Over half of the awardees participated in learning activities outside Hong Kong, while approximately 40 per cent engaged in local learning activities. The Award Scheme provides financial support for practitioners to engage in learning activities, and strengthens their commitment to lifelong learning. By pursuing continuous education, they are able to enhance their knowledge and skills, serve as role models for lifelong learning within their respective industries, and contribute to the promotion of the QF.
      
     The spokesman added that industry practitioners can participate in a variety of learning activities under the Award Scheme, including competitions, seminars, sharing sessions, exhibitions and study tours. Awardees participating in local learning activities will receive an award of $10,000, while those engaging in learning activities outside Hong Kong will receive an award of $30,000. Practitioners of various industries are encouraged to seize the opportunity to apply for the Award Scheme and go further in their careers.
      
     For details, please visit the website (www.hkqf.gov.hk/AwardScheme) or the Facebook page (www.facebook.com/QFAwardScheme) of the Award Scheme. read more

The following is issued on behalf of the Office of The Ombudsman:
 
     The Ombudsman, Mr Jack Chan, today (March 13) announced the completion of a direct investigation operation into the Housing Department (HD)’s handling of illegal parking in public housing estates, and made 12 recommendations for improvement to the HD.
 
     Currently, there are 195 public housing estates in Hong Kong, with more than 780 000 households and about 2 million residents (not including residents of Tenants Purchase Scheme and Buy-or-Rent Option). The HD is responsible for the day-to-day management of estates and handling a wide range of issues. As proper management of public housing is a vital livelihood issue, this Office has decided to conduct detailed studies on it. Given the broad scope, the Office will initiate direct investigation operations into various aspects of public housing management in phases. This direct investigation operation focuses on illegal parking.
 
     From time to time, the Office takes note of public complaints and media reports about illegal parking in public housing estates. Particularly, the Office is concerned about the obstruction of emergency vehicular access by illegally parked vehicles, which may hinder the rescue operations of emergency vehicles in the event of contingencies and lead to serious consequences. In this connection, the Office probed the HD’s enforcement mechanism against illegal parking in public housing estates, with site inspections conducted in four selected estates, namely Yau Oi Estate, Cheung Hong Estate, Lai Yiu Estate and Queens Hill Estate, where the installation of vehicle barrier gates in all vehicular access is infeasible due to geographical constraints.
 
     To tackle illegal parking in Yau Oi Estate, the Office learned that the HD has specifically strengthened road controls outside office hours. Apart from enforcement in collaboration with the HD’s Mobile Operations Unit, the Estate Office has also enlisted the support of the Hong Kong Police Force (HKPF) on a case-by-case basis. The Estate Office has acquired more immobilisation devices and instructed the security service contractor to deploy more staff dedicated to patrolling. An additional closed-circuit television (CCTV) system has been installed in the estate, and the Internet of Things (IoT) sensors are piloted on specific road sections to facilitate the staff’s remote real-time surveillance of traffic. As a result of the HD’s commitment to improvement, the situation of illegal parking has been alleviated.
 
     As regards the other three public housing estates, the Office’s investigators found illegal parking during site inspections. In Lai Yiu Estate, illegal parking was even found along the emergency vehicular access.
 
     Mr Chan said, “In certain public housing estates, the installation of vehicle barrier gates is infeasible due to geographical and environmental constraints, resulting in practical enforcement challenges against illegal parking, particularly outside office hours. Our site inspections revealed prolonged illegal parking of many vehicles in public housing estates at night; some of these vehicles may even obstruct emergency vehicles. The situation is unsatisfactory. Nevertheless, as the case of Yau Oi Estate has shown, strengthening enforcement is indeed conducive to alleviating illegal parking. Overall, we urge the HD to improve its handling of parking violations, especially to step up combating illegal parking along emergency vehicular access to minimise potential safety hazards.”
 
     The Ombudsman’s recommendations for improvement to the HD are:
 

• continue to closely monitor the situation of illegal parking in public housing estates, especially on roads where the installation of vehicle barrier gates is infeasible, and formulate enforcement strategies;
• step up enforcement against blackspots of illegal parking;
• take enforcement action against illegal parking along emergency vehicular access immediately without warning, including impounding or towing away the vehicles;
• strengthen collaboration with the HKPF to arrange joint operations for greater deterrence and increasing the non-compliance costs of offenders if necessary;
• step up monitoring the follow-up actions taken by security service contractors, consider stipulating key performance indicators for contractors under their service contracts and requiring them to report enforcement results regularly;
• consider compiling statistics and analysing the records of written warnings against illegal parking issued by the Estate Offices to facilitate their monitoring of illegal parking by frontline staff, with a view to supervising staff and reallocating resources where necessary;
• conduct timely review on the effectiveness and results of the pilot use of CCTV surveillance and IoT sensors;
• if the results of pilot arrangement are positive, proactively explore expanding the pilot arrangement to more public housing estates to facilitate effective detection by frontline staff of illegal parking;
• organise sharing sessions and training for the Estate Offices and security service contractors regarding enforcement against illegal parking from time to time;
• review existing manpower and, according to actual circumstances, explore any need to internally redeploy or obtain additional resources for enforcement;
• step up publicity and education for motorists, stressing the importance of refraining from illegal parking on emergency vehicular access; and
• draw up an implementation timetable for the above recommendations and conduct regular reviews.

 
     The Office is pleased to note that the HD has accepted all of its improvement recommendations.
 
     The full investigation report is available on the website of the Office of The Ombudsman at www.ombudsman.hk for public information. read more

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     In view of media enquiries on the donation of histotripsy medical devices to local healthcare institutions, the Health Bureau, the Department of Health (DH) and the Hospital Authority (HA) provide a consolidated response today (March 12) as follows:

     The Government of the Hong Kong Special Administrative Region is committed to complementing technological innovation with institutional innovation. Through a series of measures such as the establishment of the Greater Bay Area Clinical Trial Collaboration Platform and the setting up of the Hong Kong Centre for Medical Products Regulation for the purpose of establishing the “primary evaluation”, the Government has been enhancing Hong Kong’s drug and medical device approval and clinical trial capabilities on all fronts, so as to facilitate the translation of innovative biomedical research results into clinical applications, expedite patients’ access to advanced diagnostic and treatment services, and foster new quality productive forces in biomedical technology.

     Innovative research and development of the most advanced, effective and up-to-date medical products can benefit the public. However, innovative medical products must be scientifically proven, including proven by clinical trials that they are safe and effective before they can be translated to clinical applications and at the same time form the basis for industrial development.

Regulation of medical devices
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     At present, the DH provides support to the Pharmacy and Poisons Board of Hong Kong in assessing applications for registration of pharmaceutical products (including advanced therapy products) and approving applications for registration of pharmaceutical products after proving the relevant safety, efficacy and quality requirements have been met. In addition, the Board also approves applications for clinical trials / medicinal tests in relation to pharmaceutical products.

     Unlike pharmaceutical products of which registration and clinical trials are governed by legislation, there is no specific legislation to regulate medical devices in Hong Kong, including the clinical trials and use. Making reference to the recommendation of the Global Harmonization Task Force (now known as the International Medical Device Regulators Forum), the DH has introduced a voluntary Medical Device Administrative Control System (MDACS), under which a listing system for medical devices and traders as well as a post-market monitoring system are in place to ensure that medical devices supplied in Hong Kong meet the requirements on safety, quality and performance. Information of listed medical devices is uploaded to the website of the DH’s Medical Device Division (www.mdd.gov.hk/en/mdacs/search-database/list-md/index.html). The HA has also implemented the priority procurement strategy since 2024, giving preference in considering the procurement of medical devices listed under the MDACS.

     The medical devices donated to the local healthcare institutions have not been listed under the MDACS. The DH has recently received an application for listing a histotripsy medical device, and the application is being processed.

Trial of medical devices
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     Clinical trials carry a certain degree of risk to the participants and should be conducted by registered healthcare professionals after informing the participants of the associated risks and obtaining their explicit informed consent. At present, even though there is no statutory provision prohibiting healthcare professionals from using new medical devices on patients, healthcare professionals have the professional responsibility to act in the best interests of patients and ensure that all trials are conducted with the explicit informed consent of patients.

     It is understood that the LKS Faculty of Medicine of the University of Hong Kong, the Faculty of Medicine of the Chinese University of Hong Kong and the Hong Kong Sanatorium & Hospital are using the donated histotripsy medical devices for clinical trials on liver cancer treatment. These clinical trials can effectively assess the safety and efficacy of the devices for the Asian population, in particular patients in Hong Kong. The Government and the HA are paying attention to the results of these clinical studies, and expect that the data will provide a scientific basis for wider application in the future.

Application of medical devices
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     Regarding the application of new drugs and medical devices in the public healthcare system, the HA has established robust mechanisms for evaluating and deciding on the introduction of new drugs, devices and other innovative treatments for public healthcare services. The safety of the treatment methods, whether there is sufficient evidence supporting their therapeutic effectiveness, the cost-effectiveness of such introduction, as well as comprehensive comparisons with existing treatment services have to be considered. When making consideration according to these mechanisms, the HA must ensure fairness and objectivity as well as prudent use of public resources. Also, the consideration process will not and should not be influenced by whether the treatment method is provided or sponsored by individual pharmaceutical or device manufacturers.

     The application in the public healthcare system of new drugs and medical devices, and methods for treatment that are still in the clinical trial phase without sufficient clinical data should be handled in a very careful and prudent manner. The HA will closely monitor medical technology developments, with experts regularly studying and reviewing treatment options for patients and the latest developments in clinical and scientific evidence of related technologies, while considering healthcare professionals’ opinions and overseas developments to plan for the introduction of medical technologies. Meanwhile, the availability of relevant expertise, manpower and facilities, as well as complementarity with government policy directions, will also be taken into account.

     Concerning the research and development (R&D) of medical devices and drugs, clinical trials should be distinguished from clinical services. No clinical service may be provided when clinical trial is still unfinished. Citizens who need to seek medical services due to illnesses should consult professionals including medical practitioners, and should not be influenced by other online advertisements or publicity through endorsements.

     As announced in the Chief Executive’s 2024 Policy Address, the Government is expediting the reform of the approval mechanism for drugs and medical devices, including devising the timetable for the establishment of the Hong Kong Centre for Medical Products Regulation and the roadmap towards adoption of “primary evaluation”, formulating strategies and measures to facilitate R&D of drugs and medical devices, and taking forward the preparatory work for legislating for the statutory regulation of medical devices, so as to further enhance the overall regulatory regime of medical products in Hong Kong, thereby facilitating Hong Kong’s development into an international health and medical innovation hub, and at the same time benefitting local patients. read more