400 DH staff moved to HK center for medical products as drug regulatory body takes shape, says health minister

Over 400 staff from the Department of Health will be assigned to work at the Hong Kong center that registers drugs and medical products, said Secretary for Health Lo Chung-mau.

Lo proposed creating four permanent or non-civil service positions at the Hong Kong Centre for Medical Products Regulation [CMPR] to provide leadership for its implementation of the “primary evaluation” approach in approving medical products.

The four suggested positions are: public health controller, assistant director of health, chief pharmacist (non-civil service) and chief electronics engineer.

At the Legislative Council meeting of the establishment subcommittee today, Lo noted that to move toward “primary evaluation,” the government must independently process medical product registration applications, which will increase the workload and require a continuous increase in staffing.

The “primary evaluation” involves assessing all primary data from preclinical and clinical studies, as well as manufacturing and quality control, to fully evaluate a medicine’s safety, efficacy and quality.

He indicated that the Drug Office and the Chinese Medicine Regulatory Office have already made personnel adjustments to align with the medical regulatory center’s work.

In addition to eliminating four permanent consultant positions and reallocating seven permanent directorate positions, Lo said at least 400 DH staff will be assigned to the center as needed.

“Therefore, our staffing proposal will not affect the civil service establishment, and the government is estimated to save about HK$2.4 million annually based on average employee expenditure,” he said.

On concerns about retaining talent after training director-level medical device professionals at the center, Lo said the center has both externally recruited and internally trained staff, with measures to ensure they serve for a period of time.

He noted that the center has a strong chance of becoming an independent third-party organization rather than a government entity and will adjust staff salaries according to global trends.

Deputy Secretary for Health Sam Hui Chark-shum explained that Hong Kong has limited experience in handling “primary evaluation" of medical products, necessitating the recruitment of external talent. 

Creating new positions will broaden possibilities and bring in more expertise to fulfill the functions of the regulation center, he said.

(Cheng Wong)