Medicines and Medical Devices Bill progresses through Parliament
The House of Lords held its second reading of the Medicines and Medical Devices Bill last Thursday, with Innovation Minister Lord Bethell of Romford bringing the Bill before the House. The minister stated that the text is crucial to ‘the development of a modern, safe, medical regulation regime’ which will ensure patient safety is guaranteed and lives are saved into the future. Safety is the at the heart of the Bill’s mission, with medical devices tracking approaches and information sharing being proposed to bolster patient security. Part 3 of the Bill also protects patients by ensuring that the regulator has power to recall any device in the case of necessary steps not having been taken by the manufacturer. Lord Bethell recognised concerns from fellow MPs regarding the breadth of the bill, saying that its wide-reaching composition is due to primary legislation not being able to be relied upon to be passed quickly. He said that it is ‘essential’ that the Bill is passed before the end of 2020.
Responding for the Opposition, Shadow Health and Social Care Spokesperson Lord Hunt of Kings Heath voiced concern over the level of power being given to ministers in the Bill without the exceptional justification required. Consequently, the Lord called for the powers in the Bill to be subject to ‘sunset clauses’. An advantage of the Bill has been its speed, meaning UK companies can approve clinical trials faster than in the EU. However, the EU’s regulatory system risked UK companies moving to Europe to have their products or devices approved for use there. Baroness Thornton of the Opposition also made remarks on the Bill’s passing, saying that the Opposition would ‘look closely’ at the work of the proposed Patient Safety Commissioner, and any clarification needed on divergence regarding Northern Ireland. She echoed Lord Hunt of Kings Heath’s request for transparency over extra powers for ministers, as it appears that these have been introduced for ‘agility’ and without any specific policy reasoning behind their introduction.
Lord Bethell confirmed that the Bill would move to a Grand Committee in the House of Lords as part of its further progression through Government.