Medicines and Medical Devices Bill — House of Lords, 2021-01-14
Topic: Health
James Bethell (Conservative, Centre-right): My Lords, in moving Amendment 50, I shall speak also to Amendments 64 and 96. We have spoken extensively about the critical importance of patient safety and the need to improve medical device safety in bold new regulations going forwards. The need for medical device scrutiny to the highest standards was expressed by noble Lords throughout Grand Committee and, of course, in the report of my noble friend Lady Cumberlege. We recognise that improved and strengthened post-market surveillance and vigilance is essential. Equally, it is critical that we take further steps to strengthen oversight and increase transparency behind regulatory decision-making. Amendment 50 would support those efforts This new clause provides the Government with the power to create a statutory committee for independent expert advice on matters relating to medical devices. Historically, systems for post-market surveillance for medicines and medical devices have evolved differently. However, given scientific and technological advances and the kinds of innovative products and treatments becoming available, whether classed as medicines or medical devices, there is now need for greater assurance of equally high standards of surveillance, to ensure the upmost protection of patients The Commission on Human Medicines, which has a statutory basis in the human medicines regulations, provides an expert independent view to the MHRA on human medicines. It is visible and is underpinned by a statutory footing in the Human Medicines Regulations 2012. There is a parallel set of experts for medical devices. The Devices Expert Advisory Committee, or DEAC, advises the MHRA on medical devices but does not have an equivalent statutory footing. Amendment 50 would change this. Subsection (1) provides a delegated power to establish a committee to advise on matters relating to medical devices. The aim is to strengthen the vigilance system for medical devices. A statutory committee for medical devices will support structured decision-making and formal accountability, allowing for clear roles and responsibilities for independent expert advice. This will strengthen the MHRA’s ability to manage safety issues which are identified in clinical use even more effectively, ensuring that timely decisions are made and appropriate action taken to protect patients Proposed new subsection (2) provides that regulations may include, among other things, provision about membership, matters which the committee may or must consider, and establishment of sub-committees. This subsection also allows for provision to be made regarding co-operation with other bodies with medical devices expertise and the Commission on Human Medicines, allowing for join-up and best use of our experts Proposed new subsection (3) lists matters that regulations under proposed new subsection (2)(a) in relation to membership may cover. This includes the number of members, their appointment, the circumstances in which they cease to be members, and requirements as to independence from the Secretary of State. Proposed new subsection 3(c) allows for provisions to be made about payment of remuneration and allowances to committee members The amendment also amends Clause 41, enabling regulations relating to the advisory committee to make consequential provisions. Pursuant to Clause 45, regulations are to be made by statutory instrument and subject to the affirmative procedure. We consider it appropriate that Parliament has the opportunity to scrutinise regulations made under this power, given that the placing of this committee on a statutory footing will be a key element of enhancing the safety of medical devices. These regulations will be subject to all the requirements in Clause 45: public consultation and use of the affirmative procedure; and allowing patients, and other stakeholders, to comment before regulations are made to establish the Committee Those regulations will set out clearly, and transparently, how the statutory committee would provide advice where the regulator identifies that there is a need for scientific, technical or clinical advice. They will set out requirements to engage patients in the advisory system; for timeframes for advice on safety concerns to be issued; and requirements to communicate publicly about new and emerging risks. Rightly, the public want more transparency and accountability in regulatory decision-making. They want clearer, greater communication and explanation relating to the performance of healthcare products in clinical use. Patients deserve clear and up-to-date information on the safety of healthcare products from credible and authoritative sources. This statutory committee will meet that need. A statutory devices advisory committee will give confidence to patients, as well as clinicians and the public, that the regulator will take account of expert views on medical devices in a fast-moving area of life sciences. It will create an equilibrium in the level of external advice informing regulatory decisions across all healthcare products. There are two other amendments in my name in this group and I do not intend to dwell on them, as they are only minor and technical. Amendment 96 provides for consequential changes to allow the DEAC to be commenced. Amendment 64 makes a technical amendment in relation to the time limits for bringing prosecutions for an offence. Time limits already exist but, as part of the clarification of the enforcement regime in Part 3, changes were made to break the link between consumer protection legislation and medical devices, and to streamline the enforcement regime. Due to an oversight, the current time limit was removed but not then reinstated by the Bill into the medical device regulations. Without this change, the system would not function correctly. I beg to move Amendment 51 (to Amendment 50)