The MHRA have been undertaking work to scope a review of sanctions and penalties. The aim of this review will be to ensure that we have a proportionate and appropriate range of sanctions and penalties that support us in delivering our public health responsibilities. It will:
- cover all the sanctions and penalties in legislation for which the MHRA is responsible – including legislation relating to medicines, devices, blood and Good Laboratory Practice
- consider whether the MHRA’s legislation contains the right suite of offences and penalties. This will include exploring whether existing offences and penalties are necessary, proportionate and accompanied by the right penalties; and whether any new offences should be introduced to ensure the protection of public health
- consider whether it might be appropriate to introduce non-criminal sanctions (for example, civil sanctions) to supplement or replace criminal offences; and the relationship of sanctions with alternatives to regulation, such as self-regulation
- take account of developments in the broader context of legislation and regulation generally. This includes Government initiatives to reduce regulatory burdens, greater reliance on professional regulatory standards, and the aim of avoiding use of detailed legislation to regulate professional activity except where this is unavoidable. In relation to medicines, it will build on our recent consolidation of UK medicines legislation, which greatly simplified how offences and penalties are set out in medicines law.
It will also be linked to work by the UK Health Department’s Chief Pharmaceutical Officers, together with the MHRA, to explore the balance of medicines legislation and pharmacy premises and professional regulation as they relate to the supply of medicines. This work is at a very early stage, but the aim would be to examine the respective scope of legislation and regulation, and the interface between them. This would be 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. Consideration of medicines legislation as it relates to the supply of medicines would encompass specific issues that have arisen to date – for example, addressing pharmacy interests’ concerns over prosecution of pharmacists for dispensing errors. The link of this work with a sanction and penalties review is significant, as it will influence analysis of the appropriateness and proportionality of existing offences. More information is available on the Department of Health website.
The sanctions and penalties review will be taken forward as part of our regulatory programme. This programme will capture the key pieces of regulatory work that we intend to undertake. It will aim to ensure that we deliver our remit to safeguard public health proportionately and efficiently, and that interested parties can understand and engage with our key initiatives. We will be consulting with interested parties in the coming months on the content of the programme and how we can measure and assess its impact.
We will be developing the timetable for the sanctions and penalties review in the coming months, taking account of the differing timescales needed to deliver the various elements of the regulatory reform programme and the work to rebalance medicines legislation (in relation to the medicines supply aspects) and pharmacy premises and professional regulation. We will keep interested parties in close touch with our emerging thinking and wish to work collaboratively with them on how best we can achieve reforms – including the scope to convene an independently-chaired reference group in order to fully test proposals for change.