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Medicines and Medical Devices Bill - Sitting 3

10 June 2020

Proposing MP
Philip Davies Con
Shipley
Type
Public Bill Committee

At a Glance

Issue Summary

The statement addresses an amendment proposing to add a prohibition on advertising medical devices under suspension and safety notices in the Medicines and Medical Devices Bill. The statement addresses amendments related to the defence of due diligence in medical device regulations and the publication timeframe for guidance on new civil sanctions. MP Alex Norris moves an amendment to require the Secretary of State to report back annually on their use of civil sanctions related to the Medicines and Healthcare products Regulatory Agency (MHRA). The statement addresses the proposal for civil sanctions in the Medicines and Medical Devices Bill and the requirement for a report on the use of recall powers within two years. MP Jo Churchill is discussing the new recall power introduced in the Medicines and Medical Devices Bill for higher-risk medical devices. The statement addresses the commencement of chapters 2 and 3 in part 3 of the Medicines and Medical Devices Bill, which relate to a new enforcement regime for medical devices and data disclosure provisions. The statement discusses the establishment of a registry for long-term implantable medical devices to improve patient safety and oversight. Philip Davies is thanking members for their contributions during the proceedings of the Medicines and Medical Devices Bill.

Action Requested

Alex Norris proposes amending clause 17 and 18 of the Bill to include a specific prohibition on advertising medical devices when served with a suspension or safety notice. Jo Churchill responds by confirming that the current legislation already includes this provision, thus Alex Norris withdraws his amendment.

Key Facts

  • Amendment 29 seeks to amend clause 17 of the Medicines and Medical Devices Bill.
  • The amendment aims to add advertising prohibition under suspension notices.
  • Jo Churchill confirms existing provisions cover the proposed amendment.
  • Amendments relate to clause 24 and schedule 2 in the Medicines and Medical Devices Bill.
  • The amendments aim to ensure defences of due diligence operate effectively across Scotland.
  • Jo Churchill states the new civil sanctions regime will require further provision through supplementary regulations made under paragraph 9 of schedule 1.
  • The amendment requires reports every 12 months instead of 'from time to time'.
  • Since 2008, the MHRA has brought only 3 prosecutions with 2 convictions.
  • In 2017-18, the MHRA seized 9.5 million falsified medical products.
  • The amendment aims to monitor and evaluate the effectiveness of civil powers and the capacity of the MHRA.
  • Civil sanctions will be an alternative to criminal prosecution for certain breaches.
  • Reports on civil sanctions are required under paragraph 15 of schedule 1 and will be published from time to time, likely annually.
  • Amendment 28 requires a report on the use of recall powers within two years after Royal Assent.
  • The Bill introduces a statutory power for the MHRA to conduct recalls on rare occasions when a manufacturer is unwilling or unable to carry out a recall.
  • Clause 34(2) allows the Secretary of State to disclose information about medical device safety concerns, including whether a device has been recalled.
  • Amendment 19 proposes that enforcement regime regulations come into force six months after Royal Assent.
  • Chapter 2 introduces civil sanctions under schedule 1.
  • Supplementary regulations must be made under paragraph 9 of schedule 1 before the new enforcement regime can be operational.
  • Clause 36 contains consequential provisions linked to disapplication of the previous enforcement regime in part 2 of the Consumer Protection Act 1987.
  • New clause 6 suggests establishing a registry for long-term implantable medical devices.
  • Clause 13(1)(h) provides for the creation of a register of medical devices available on the UK market.
  • Patient safety is the key priority in the regulation of medical devices as set out in clause 12(2).
  • The session was about the final stages of discussing and amending the Medicines and Medical Devices Bill.
  • Philip Davies praised all members for their conduct during the proceedings.
  • Clerks and Hansard reporters were thanked for their hard work.
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