Overall, the Bill:
- Introduces powers in relation to medicines, clinical trials and medical devices, so existing regulatory frameworks can be updated after Brexit.
- Consolidates enforcement provisions for medical devices and introduces sanctions. This includes enabling civil sanctions as an alternative to criminal prosecution.
- Provides an information gateway to enable information to be shared about medical devices, for example to warn the public about safety concerns.
For medicines, the Government may:
- Amend the process for applying for or holding a marketing authorisation and exceptions for a marketing authorisation.
- Make provision for authorisations for manufacturing, importing, brokering and wholesale dealing of medicines - and manufacturing or supplying raw ingredients for medicines.
- Take steps to prevent falsified medicines.
- Make provisions for recording information about medicine supply; notifying and reporting adverse reactions; labelling and packaging; advertising medicines; increased registration requirements for businesses selling medicines online; requirements for a valid prescription; increased range of professionals who could supply medicines.
For clinical trials, the Government may:
- Update notification and reporting requirements, so that they become more proportionate, given the relative levels of risk. This could remove unnecessary bureaucracy for lowest risk clinical trials, encouraging the rapid introduction of new medicines.
- Amend or remove existing requirements for some or all trials before they start so they remain proportionate. Or having additional requirements to ensure trials continue to be conducted to high standards.
- Have provisions that correlate to the new EU Clinical Trial Regulations.
For medical devices, the Government intends to:
- Introduce requirements before a medical device can be put on the market. For example, the Government may require device manufacturers to have a quality management system.
- Make provisions for packaging, labelling, registration, safety and performance evaluation, and the monitoring of devices.
A Post-Brexit World
It is positive to see the Government's commitment to maintaining and growing the UK's life sciences industry and standards, especially in a post-Brexit world. This could see the UK continue to take the lead. What is particularly interesting is the desire to have proportionality in clinical trials according to the levels of risk, and increased requirements for devices.
VWV is holding a Conference in June 2020 through PING (Pharmaceutical Industry Network Group). There will be top speakers from areas such as where the UK is leading the way in a post-Brexit world - in life sciences - genomics, personalised medicine and AI.
If you are interested in being invited to attend the PING Conference, please contact Paul Gershlick in our Pharmaceuticals and Life Sciences team on 01923 919 320, or complete the form below.