The RCP and colleagues from the Faculty of Pharmaceutical Medicine and the British Association of Dermatologists, sent a briefing to MPs ahead of the Second Reading of the Medicines and Medical Devices Bill (2 March 2020).
A large proportion of the legal framework for medicines and medical devices in the UK derives from EU Directives and has been implemented into domestic legislation. The bill seeks to address this regulatory gap through introducing regulation-making, delegated powers covering the fields of human medicines, clinical trials of human medicines, and medical devices. Its purpose is to enable the existing regulatory frameworks to be updated at the end of the Brexit Transition Period.
- The Bill presents an opportunity to streamline access to treatments for patients with chronic conditions such as rare cancers, is welcome. However, it is crucial that strong safeguards regarding quality and safety of such treatments are established. We understand that the European Union Tissue and Cells Directive (EUTCD) is currently being reviewed but would like to seek reassurance from the Government that they will ensure that the UK continues to align UK regulations after the transition period with this directive.
- Granting additional healthcare professionals restricted prescribing rights for ‘low-risk’ medicines is welcome and can help address the pressures facing the healthcare system. It is crucial that doctors are involved with the decision-making process and closely consulted with on what medicines qualify as ‘low-risk’.
- To ensure that the UK remains as one of the best places in the world for science and innovation, the government must commit to aligning guidelines for clinical trials with existing EU legislation.
- It is vital that the practical considerations relating to the powers given to the Secretary of State in this act regarding medical devices are advanced in partnership with clinicians. It would also be timely for DHSC to review how the CAS alerts system works in relation to medical devices.
- To help rapidly expand the field of medicine and surgery, the Bill should include provisions for the UK to seek a new role for the CHM or another body to be established that would have the competence to include provision of expert advice on medical devices. The Bill should also clarify the role of the MHRA in the qualification of the efficacy and safety of medical devices and in vitro diagnostics. This includes the role they may play in constructing and maintaining a register of products approved for use.