Phil Brown
Director, Regulatory & Compliance, ABHI
Leaving the European Union has created a need for health technology regulatory change and an opportunity to stimulate innovation and technology uptake for the benefit of UK patients.
Indeed, these precepts are enshrined in the Medicines and Medical Devices Act, which requires a regulatory environment that is favourable to research, manufacture and provide access to health technologies.
Becoming an investment hub for life sciences is therefore based on three premises.
Global regulation
New regulatory processes should be cognisant of global data requirements. This ensures that duplication of quality, safety and performance testing is reduced as far as is practicable, whilst maintaining the expected high levels of security demanded by UK patients. This can be achieved by:
- Adopting principles detailed by the International Medical Device Regulators Forum (IMDRF), including the application of the Medical Device Single Audit Programme (MDSAP). Such adoption will drive a consistency of technical data which can be applied across multiple jurisdictions.
- Consideration of regulatory requirements in other global jurisdictions, to streamline patient access for those products already approved to recognised high standards of safety.
Regulatory consistency and adaptability to new technologies will ensure the future proofing of the UK market.
Future proofing
Regulatory consistency and adaptability to new technologies will ensure the future proofing of the UK market. The MHRA must develop a regulatory system that can be equally applied to devices, IVDs, digital platforms and a combination thereof, whilst ensuring relevance for many years to come.
Lack of consistency within opinions proffered by European Notified Bodies has led to criticism of the CE mark. The MHRA can address this by providing a centralised expert opinion that can be unambiguously applied by UK Conformity Assessment Bodies. This will again add to an improved level and consistency of regulatory application, particularly with regards to innovation.
Access to innovation
Improved regulatory systems will be considered moot if they are not married to similarly improved procurement processes. The UK health system has to be understanding of the regulatory process, in order to be accepting of new products. This can be achieved by increasing stakeholder input to ensure it is truly holistic and representative of the full ecosystem – beyond simply the regulator and manufacturer – to include procurement agencies, governmental bodies, surgeons and end-users.