UK Introduces Medicines, Medical Devices Bill in Post-Brexit Overhaul

Regulatory NewsRegulatory News | 13 February 2020 |  By 

Just two weeks after Brexit, the UK government has introduced a bill to update its regulatory framework for human and veterinary medicines, clinical trials and medical devices, while ensuring the UK remains an attractive market for the life sciences industry.
The bill was read for the first time in the House of Commons on Thursday and is scheduled for a second reading on 2 March.
The UK is currently in the midst of an 11-month transition period ending 31 December 2020, during which it will continue to follow EU law. Once the transition period ends, the UK will no longer be able to update its regulatory schemes for healthcare products and clinical trials through secondary legislation under section 2(2) of the European Communities Act (ECA) or via section 11 of the Consumer Protection Act (CPA) for certain aspects of medical device regulation.
As such, the newly introduced Medicines and Medical Device 2019-20 delegates powers to update the existing regulatory frameworks for human and veterinary medicines, medical devices and clinical trials after the transition period.
“Delegated powers may only be exercised in relation to a finite list of matters specified on the face of the bill and only after consideration has been given to the safety and the availability of human or veterinary medicines or device … and the attractiveness of the UK as a place to develop and supply these products,” the Department of Health and Social Care writes in an explanatory note accompanying the bill.
For medical devices, the bill would also consolidate and expand the government’s enforcement authority by disapplying the CPA and the amendments to the Medical Devices Regulations 2002 so that the power to issue enforcement notices for devices is contained solely within the new bill.
Additionally, the bill would grant the Secretary of State for Health and Social Care the power to impose civil sanctions in the form of monetary penalties in response to breaches of the Medical Devices Regulations 2002, “as an alternative to criminal prosecution” and grants the Secretary new powers to share information about medical devices in response to safety issues.
The bill also allows for broader prescribing of low-risk medicines by healthcare professionals and includes provisions to allow hospitals to develop and provide personalized medicines.
“The new bill means hospitals can use patient tissue and DNA samples to tailor treatments to individual patients when other medicines have failed, or to develop drugs that have a shelf-life of minutes and would otherwise be unavailable to them. This has the potential to streamline access to treatments for patients with rare cancers and brain tumors,” the Department of Health and Social Care writes.
UK Parliament, Bill, Explanatory Note, Statement


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