***Full-scale policy conference taking place online***
This conference will be a timely opportunity to discuss the future regulation of medicines, clinical trials and medical devices in the UK.
- Priorities for regulation and the role of the MHRA;
- Meeting the challenge of regulating and developing medicines during the Covid-19 Pandemic;
- Stakeholder priorities for medicine regulation - safety, research integrity and innovation:
- developing a regulatory ecosystem that supports innovation, provides regulatory certainty, and is transparent,
- research integrity, skills and international collaboration,
- key issues for patient care - research, communication and access to treatment,
- developing methods and technologies to ensure safe and effective medicines, and
- prioritising support for the uptake and adoption of innovations.
- The future for collaboration with the EU, and the UK’s relationship with the EMA ;
- Using technology to tackle irresponsible medical ads - partnership with online platforms and statutory enforcement partners; and
- Key issues for ensuring quality in clinical trials and the medicine approval process - research integrity, public trust and workforce development.
Developments that are relevant to the discussion:
- The Medicines and Medical Devices Bill, enabling the UK to take over regulation for medicines, clinical trials and medical devices after the UK leaves the EU - as well as the bill impact assessment;
- MHRA publication of updated guidance on medicine licensing post-Brexit, which aims to provide clarity on the UK’s status in the licensing process;
- The EMA updating their guidance following Brexit which provides information on the transition period, regulatory preparedness and preventing Brexit-related medicine shortages;
- Launch of the new research transparency strategy group by the Health Research Authority expected soon;
- Recent updates to the NHS patient safety strategy - including:
- a framework for involving patients in their own safety,
- appointing patient safety specialists, and
- publishing a national patient safety syllabus.
- The Life Sciences Sector Deal includes plans to accelerate developments in precision medicine by 2021
Areas for discussion at this conference:
- The Medicines and Medical Devices Bill - and its provisions for:
- ensuring the safety of human medicines and devices,
- access to and availability of human medicines and medical devices, and
- making the UK an attractive place in which to conduct clinical trials, supply human medicines or develop and supply devices.
- Healthcare regulation - the future landscape, and role of the UK in European regulatory procedures - including key issues for maintaining access, innovation and the supply of medicines to the UK;
- Clinical trials - looking at priorities for the research transparency group, and key issues including:
- priorities for research and funding in a changing landscape,
- what is needed from regulation to ensure the transparency of clinical trials - and how improvements in transparency will be measured,
- maintaining the trust of the public and clinicians, and encouraging engagement, and
- driving adoption and preventing variation.
- Safety of medicines and technologies - key issues for improvement, looking at:
- priorities for developing safe and effective treatments, and
- awareness raising and training in the administration of treatments for staff, patients and the general public and the developing role of patient safety specialists.
- Enforcement and sanctions - how non-compliance with regulations should be tackled, including:
- proposals in the Medicine and Medical devices Bill for a enforcement notices with criminal sanctions for breaches,
- how individuals affected by breaches to legislation will be able to bring civil proceedings forward, and
- what more can be done to deter the manufacture and supply of counterfeit products in the future.
- Innovation - ensuring the regulatory framework fosters development of new medicines and technology, including:
- priorities for meeting ambitions around scalability and adoption of new products and devices from successful clinical trials to rollout;
- progress of the Accelerated Access Collaborative (AAC) - set up to speed up the uptake of pioneering treatments,
- factors for effective adoption, looking at clinician trust, the role of AHSNs and limiting variation,
- improving the speed of the regulatory approval process, and
- further support could be provided to innovators, with the NHS Long Term Plan emphasising the importance of innovation and bringing the benefits to patients.