This work is linked to Medicines & Healthcare products Regulatory Agency (MHRA) work to scope a review of sanctions and penalties, for which MHRA has issued a statement.
The Chief Pharmaceutical Officers’ statement is as follows:
“Rebalancing” Medicines Legislation and Pharmacy Regulation
Recent discussions about the supervision of the sale and supply of medicines in registered pharmacies have taken place against a background of a wider, but associated, agenda. This includes the Medicines & Healthcare products Regulatory Agency’s (MHRA) work on the consolidation of medicines legislation and the planned review of penalties and sanctions, the recommendations from the Royal Pharmaceutical Society (RPS) & the Professional Forum of the Pharmaceutical Society of Northern Ireland (PFPSNI) review of the implementation of the Responsible Pharmacist (RP) Regulations and the General Pharmaceutical Council’s (GPhC) consultation on standards for registered pharmacies.
Developments in the broader context of legislation and regulation generally, including the Government’s initiatives to reduce regulatory burden, greater reliance on professional regulatory standards and, linked to that, the aim of avoiding use of detailed legislation to regulate professional activity except where this is unavoidable, suggest that now is the time to consider the interplay of the medicine supply components of medicines legislation and GPhC& PSNI regulation, and how they impact on patient and public safety and professional practice.
Professional practice in pharmacy has changed in recent years to become considerably more clinical in nature. This is set to expand further.
Although at a very early stage, the UK Health Departments’ Chief Pharmaceutical Officers, together with the MHRA, are considering exploring with professional and regulatory bodies in pharmacy the balance of medicines legislation and statutory independent professional regulation and consistency with other health professionals. The aim would be to examine the respective scope of legislation and regulation, and the interface between them, with a view to ensuring these are optimally designed to provide safety for users of pharmacy services, while facilitating and reducing the barriers to responsible development of practice, innovation and a systematic approach to quality in pharmacy.
Elements for discussion are likely to include the role of quality systems within the diversity of pharmacy practice in different service settings in providing robust, systematic assurance and protection of public and patients’ interests; roles and responsibilities; enhanced professionalism; governance and accountability; and links with wider work, such as the review of sanctions and penalties, being led by MHRA.
Ideas are at an early stage and any further work will depend on the outcome of these initial discussions. Updates will be shared as discussions move forward. Stakeholders will be involved when proposals are further developed.
 “Medicines legislation” here refers particularly to the medicine supply components of medicines legislation. “Pharmacy regulation” refers to the regulation of pharmacies, pharmacists and pharmacy technicians.