New Licensing Regime for Private Clinics in Hong Kong
A new licensing regime has been introduced in Hong Kong to regulate private clinics and beauty parlours that provide medical treatments, such as injections. The initiative aims to address changes in the way these facilities operate and ensure patient safety. Thousands of private clinics can now start applying for a new operating licence or a letter of exemption from Monday, under the tightened regulatory framework.
Dr Darwin Mak Wai-lai, head of the Department of Health’s Office for Regulation of Private Healthcare Facilities, explained that the new rules were implemented in response to evolving clinic operations. The focus is primarily on clinics that operate as chains, which may not be managed by healthcare professionals. “In the past, clinics were operated by doctors who ensured all rules were met,” he said. “Now, some clinics are no longer run by healthcare professionals, and they lack basic medical knowledge, while the doctors they hire have no control over the clinic’s management.”
The regulatory regime falls under the Private Healthcare Facilities Ordinance, passed in 2018. The requirements have already been applied to private hospitals and day procedure centres. The death of a 46-year-old woman in 2012 after high-risk experimental cell therapy injections at a beauty centre led to calls for stricter regulations.
According to Mak, approximately 1,500 out of the city’s 5,000 clinics will need to apply for a full licence, valid for five years. These clinics must appoint a chief medical executive—a doctor or dentist registered for at least four years—who will be responsible for day-to-day operations and ensuring compliance with a code of practice covering areas like infection control, governance, and safety incident reports.
Clinics operating before November 30, 2018, can apply for a provisional licence by April 13 next year. This will remain valid until they obtain a full licence, withdraw their application, or a date set by the health minister. The remaining 3,500 clinics are eligible for a letter of exemption, as they are operated exclusively by registered doctors or dentists.
Mak emphasized that beauty parlours providing injections also need to obtain a licence. “These premises must obtain a licence, and they could not simply hire a doctor to do injections; they must have a doctor to be in charge of the operation.” Doctors with a letter of exemption must still observe the code of practice and continue to be regulated by the Medical Council, which handles complaints.
Patients can later scan a QR code on the licence or exemption letter in clinics to verify the licensing status. While the government has not yet announced when penalties for unlicensed clinics will begin, operating one could result in a fine of up to HK$100,000 and three years of imprisonment.
Industry Reactions and Challenges
Dr Luk Che-chung, vice-chairman of Virtus Medical Group, described the licensing process as a “body check” to identify and address potential shortcomings. He noted that preparing applications would require comprehensive documentation, including protocols for handling dispensing errors.
Victor Yeung Hip-wo, vice-president of the Hong Kong Medical Association, mentioned that while doctors are largely aware of the new rules, some have technical questions, such as whether shareholders also need to be doctors. He added that older doctors might struggle with the online application process, requiring additional support.
Nelson Ip Sai-hung, chairman of the Federation of Beauty Industry, highlighted that fewer than 2,000 of the city’s 5,000 beauty parlours provide medical beauty services. However, he warned that some businesses may avoid applying for a licence due to concerns about the cost of making doctors legally liable as chief medical executives. Some are considering alternatives, such as opening small clinics or arranging for customers to receive injections elsewhere.
Key Requirements for Clinics
- Full Licence: Required for clinics operating as chains or those not exclusively run by doctors/dentists.
- Chief Medical Executive: Must be a registered doctor or dentist with at least four years of experience.
- Code of Practice: Covers infection control, governance, and safety incident reporting.
- Provisional Licence: Available for clinics operating before November 30, 2018.
- Exemption Letter: For clinics exclusively run by registered doctors or dentists.
The new regulations aim to enhance transparency and accountability in the healthcare sector, ensuring that all facilities meet minimum standards of safety and quality. As the implementation progresses, stakeholders are expected to navigate the challenges of compliance while maintaining high-quality care for patients.