The bill would provide the Government with new delegated powers to update or amend the UK’s regulatory framework for medical devices and for human and veterinary medicines. Much of the current UK regulatory framework is based on EU regulations and directives. It would also allow a new information system to be introduced covering data on medical devices and would consolidate and expand enforcement provisions.
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The bill would provide new delegated powers to update or amend certain regulations governing the UK’s regulatory framework for medical devices and for human and veterinary medicines. Much of this regulatory framework has come from EU regulations and directives, which the UK has implemented through powers available under the European Communities Act 1972. These powers to update existing legislation will not be available after the end of the transition period. The Government has stated that without the changes brought in by the bill, the existing regulations could only be updated in future through primary legislation.
The bill would also make some additional changes to the regulatory framework for medical devices. These changes would include powers to establish a new system for recording data on such devices and the consolidation of enforcement provisions and new sanctions.
The bill received cross-party support in the House of Commons, with each party agreeing the bill was necessary in the circumstances. However, MPs raised concerns about matters including:
- the scope of the delegated powers available under the bill;
- whether it would lead to less regulatory alignment with the EU;
- why the wording of the bill’s regulation-making powers did not prioritise consideration of patient safety;
- tackling organ harvesting and other unethical practices; and
- the potential large policy changes it could lead to, including “hub-and-scope” dispensing.
The Government defended its position on these issues. It said the bill’s delegated powers were limited, and those powers would be subject to sufficient scrutiny. For example, the exercise of most of the delegated powers would require prior consultation with appropriate bodies and would be subject to the draft affirmative process. The Government also said it did not intend to make any bold policy changes without full consultation.
No opposition amendments were made to the bill during its House of Commons stages. However, MPs agreed some government amendments at committee stage. A new clause proposed by the Government was added at report stage. The House of Commons agreed each of these without a vote.