With the Medicines and Medical Devices Bill heading through Parliament, Claudia Rubin asks what is required to get this legislation right?
The Government would like us to view the Medicines and Medical Devices Bill, which had its second reading in Parliament in March, through the lens of boosting Britain’s long-term prospects outside the EU.
While Brexit has made some new legislation in this area essential, this Bill is also a much-needed opportunity to shape the access environment for healthcare innovation.
Broadly welcomed by industry and by members across the House of Commons, the intentions behind the Bill are good. It is in how it will be applied and whether it is bold enough, that we are most interested.
What exactly does it mean when it aims to maintain alignment with EU marketing authorisations, for example? How will it prevent rare disease patients in this country from being excluded from participating in pan-European clinical trials? How comprehensive will the data stored in the proposed new medical devices registry be?
“The intention is that the Bill enables the Government to legislate to create a comprehensive statutory register of medical devices in the UK”
MPs recognise the Bill’s importance, not least as a requirement of Brexit, but also because they are keen to protect the pharmaceutical industry. As the single largest private sector investor in UK research and development and a provider of many jobs across the country, it is good to see politicians acknowledging what is at stake.
So, despite broad cross-party support for the Bill, it will attract detailed interest, particularly from those MPs who, judging by their informed contribution to the second reading debate, have a strong sense of the opportunities and pitfalls ahead. This in turn makes it particularly worthwhile for industry to delve carefully into the detail and assist in the Bill’s scrutiny to ensure optimum legislation emerges.
Politicians are concerned to see a robust regulatory framework for medical devices. MPs know all too well the NHS’s uncomfortable history of poor regard for patient safety. If publication hadn’t been delayed due to the COVID-19 outbreak, they would have been keenly reading the report from the Independent Medicines and Medical Devices Safety Review (the ‘Cumberlege Review’) which was due to be published in March, and no doubt ensuring the Bill encapsulates the lessons learned from it.
Indeed, better capturing the benefits of innovation without compromising patient safety is one of the four key aims of the Bill, according to the Secretary of State for Health and Social Care. This is certainly a fine line to tread.
There are some welcome examples of where the Bill helps to bring us up to date with innovation, such as in the law relating to manufacturing processes. In the era of personalised medicines, this Bill recognises that hospitals must be able to assemble treatments like gene therapies or 3D printed tablets at the bedside of a named patient.
The Bill also grapples with patient safety. One of the most interesting exchanges so far is around the requirement that the Secretary of State must have regard to the i) safety of medicines and medical devices, ii) availability of medicines and medical devices and iii) attractiveness of the UK as a market for them. However, as shadow health secretary Jon Ashworth pointed out, will these criteria be of equal value? Given that the Bill confers an extensive range of powers on the Government, enabling it to enact significant change through secondary legislation, further clarity on this aspect is essential.
Giving the Government power to make regulatory changes when necessary, without the need for primary legislation, will allow the UK regulatory environment to be more conducive to rapidly evolving healthcare technology. But it is clear that if the regard for safety is over-emphasised, it will be to the detriment of the second and third priorities. Getting the balance right will be essential and further definitions are required.
In devices, the right balance is most keenly going to be needed in the proposed new devices register. The intention is that the Bill enables the Government to legislate to create a comprehensive statutory register of medical devices in the UK. It is suggested that such a register could be held by the MHRA, and that it would be compulsory to register a device with them.
Registries are generally welcomed by industry, who have long argued for better use of the data they generate. Further clarification on the MHRA’s role in the registry, what additional funding will be in place for MHRA’s extra workload, and crucially what the scope of the registry will be, is needed.
With an eye on safety, the Chair of the Access to Medicines and Medical Devices All Party Parliamentary Group, Anne Marie Morris MP, has called for the registry to facilitate following the journey of a device after it is implanted in a patient, in order, for example, to be able to recall faulty units or to evaluate longer-term benefits.
The potential scope and function of a registry is fundamental, given that medical devices do not lend themselves well to randomised controlled trials enabling them to demonstrate in-year savings. Devices’ value instead often lies in longer term health outcomes and data registry could be pivotal for NICE approval. Seizing the opportunity that a well thought-through registry offers the MedTech landscape is indicative of the need for industry to help ensure we get this piece of legislation just right.
Claudia Rubin is a Director at Decideum. Go to www.decideum.com