The Government published the Pharmacy and Poisons (Amendment) Bill 2019 (the bill) in the Gazette today (October 18). The bill seeks to update the existing legislation to regulate advanced therapy products (ATPs) with an aim to safeguarding public health.
 
     A spokesman for the Food and Health Bureau said, "ATPs are innovative medical products based on genes, cells and tissues. There is at present no dedicated regulatory framework for ATPs. In view of the high risks associated with the rapid scientific advancement, the Government considers it necessary to introduce a clear and dedicated regulatory framework on the research and therapeutic use of ATPs in order to safeguard public health and facilitate their development."
 
     The bill sets out that ATPs should form a specific subset of pharmaceutical products under the Pharmacy and Poisons Ordinance. As such, regulatory requirements for pharmaceutical products under the Ordinance and other relevant ordinances will apply to ATPs. Due to the high-risk and complex nature of ATPs, it is proposed under the bill that all facilities which manufacture ATPs should obtain a licence in accordance with the Ordinance.
 
     In addition, considering the special nature of ATPs, special requirements on licensed manufacturers of ATPs concerning labelling, record keeping and etc. will be included in the bill to ensure the safety, quality and efficacy of their products. The requirements are modelled on the regulatory regime of the European Union, which is internationally recognised.
 
     A public consultation on the proposed regulatory framework was conducted from April to June 2018. Respondents generally supported the proposal, which could provide a clear regulatory framework for development of ATPs. The legislative proposal was subsequently announced in the 2018 Policy Address. The Government consulted the Legislative Council Panel on Health Services on the legislative proposal in April this year. Members generally supported the proposal and urged the Government to introduce the bill as soon as possible to safeguard public health.
 
     The bill will be introduced into the Legislative Council for scrutiny on October 30, 2019.

Ends/Friday, October 18, 2019
Issued at HKT 11:00

NNNN