Glenys Thornton considers what’s really at play in the government’s latest health-related legislation
The Medicines and Medical Devices Bill has its second reading in the Lords today and although a mere 46 clauses long, it is a cornucopia of proposals that clearly form part of a wider strategy to use Brexit as cover for an unaccountable power grab.
The bill follows a pattern set by others – with sweeping powers for the government to do pretty much what it wants when it wants. And in this case, that means updates or changes to the UK’s existing laws on human and veterinary medicines, clinical trials, and medical devices at the end of the Brexit transition period next January.
Until now, such changes have flowed from updates at EU level, but this legislation will put structures and powers in place for the UK Government and the Department of Health in Northern Ireland. And it seems that most Brexit-related bills due between now and Christmas contain similar constitutional challenges.
It remains unclear if this latest health-related bill is a Trojan Horse – with a seemingly innocent and benign exterior that hides huge and serious dangers within. Or just another example of the current Prime Minister’s cavalier disregard for both timeliness and accountability, combined with the Lords health minister Lord Bethell’s self-confessed aptitude for hustling. Perhaps it’s a combination of all of these things?
Experienced ministers know when the Lords respective – and highly respected – committees on Delegated Powers and the Constitution jointly criticise a bill then troubled times lie ahead. Committees that have said they are “deeply concerned not only by the Government’s failure to provide sufficient justification for the adoption of a ‘skeleton bill’ … but also by their failure to acknowledge to the breadth of powers the Bill would confer”; and “If the Government is unable to specify the principles according to which it intends to amend and supplement the existing law, the delegated powers in the Bill should be subject to sunset clauses”. In short, putting powers in a bill because they might come in useful is not regarded as sufficient justification.
A great deal is at stake – substantially so when it comes to life sciences and clinical research, and divergence from existing standards on medical devices.
Leaving the EU medicines regulatory regime is a significant risk. The government seeks to maintain the attractiveness of the UK life sciences sector and ensure patients continue to benefit from the excellent clinical research that takes place here. So, it is vital that we fully understand what will constitute the “attractiveness” mentioned in the bill and how it will be communicated globally. And how that will be reconciled with patient safety.
On the concerns over potential divergence in standard, the BMA has suggested that this must be kept under constant evaluation to ensure such changes do not negatively impact upon the timely supply of safe medicines to UK patients.
The new EU regulation on medical devices is an example of a change coming through that the UK should seek to capture in any future regulatory framework. Expected to be force in 2021, the revised rules were drafted in the aftermath of the metal-on-metal hip and PIP implant scandals and will introduce stricter requirements on the authorizing bodies and ensure greater post-market surveillance. One question, therefore, is how UK patients will benefit from such changes when we are no longer part of the EU’s processes?
Of course, our approach to scrutinising this bill won’t stop there. We will also seek to implement some of the Cumberlege Report conclusions; support extending prescribing rights to additional healthcare professionals (including radiographers); and get clarification on Northern Ireland and regulatory divergence, changes to the hub and spoke proposals, the proposed Patient Safety Commissioner, the Medical Devices Register, and the impact on animal medicine and veterinary regulation. Last but not least, we will be looking for serious debate on amendments supported by Philip Hunt and Ray Collins on organ and tissue harvesting.
Baroness Glenys Thornton is Shadow Health Minister in the House of Lords. She tweets @GlenysThornton
Published 2nd September 2020