The main role of the Bill is to replace regulations on medicines and medical devices safety arising from EU Directives, which will expire in 2021 at the end of the transition period agreed between the UK and EU.
The Bill collates existing regulatory powers for medicines, medical devices, and clinical trials exercised by the European Medicines Agency (EMA) and those which currently exist at national level via the Medicines and Healthcare products Regulatory Agency (MHRA) into a new regulatory framework for the UK.
The Bill also delegates powers to the Secretary of State to allow updates to the regulations, and provides additional tools (including a range of civil rather than criminal penalties) to prosecute breaches of the UK’s regulatory frameworks. This includes powers over important aspects of medical care such as who has the authority to prescribe medicines and implementation of rules around falsified medicines, as well as giving the Secretary of State
As the EU begins the implementation of the Medical Devices Regulation (MDR) and In Vitro Medical Devices Regulation (IVDR), it is notable that the Bill does not define a specific direction on whether the UK will align with these, however it does provide the frameworks and powers that will be required to implement any resulting policy.