10th Report - Medicines and Medical Devices Bill

Summary written by Accountability Index from the government's response. It is not the government's own words.

The government says it has tabled amendments to respond to the Committee's concerns on the delegated powers, consultation, reporting, emergency regulations and criminal penalties, while setting out why it retains the option of protocols in emergencies.

• On the delegated powers at clauses 1, 9 and 14, amendments will make the "overarching objective" of regulations to "safeguard public health" for human medicines and medical devices, with a benefits-outweigh-risks test where safety is affected.
• A public consultation is required before regulations are made under any of the Bill's powers, and a reporting requirement on the operation of regulations under clauses 1, 9 and 14 is to be laid before Parliament.
• The government says it has "heard" the recommendation that emergency regulations carrying a declaration of urgency be subject to the made affirmative procedure, and that amendments to this effect were made at Lords Committee stage.
• It does not remove the option to set out conditions in a protocol, saying protocols are "essential" for a quick response, may only be used if provided for by secondary legislation, and would be time-limited.

Read the government's response ↗ Report an error