Originally announced in the Queen’s Speech with grand ambition, the Medicines and Medical Devices Bill seeks to ensure the United Kingdom remains a global leader in life sciences post-Brexit and that patients across the country can access pioneering treatment on the NHS. Its less inspiring but more fundamental purpose is legal necessity, bridging existing EU Directives into a compatible UK statute post-Brexit.
The government is hailing this Bill as a new dawn for the life sciences sector post-Brexit. True to form, Matt Hancock, Health and Social Care Secretary, took to Twitter, lauding the Bill as the mechanism to provide ‘patients access to the most cutting-edge treatments and boosting Britain’s
position as a world-leader in life sciences’.
The Bill has brought to the surface a new wave of ‘access activism’ as parliamentarians have taken the opportunity to call for more transparency, and parliamentary scrutiny, of how medicines are approved. Through amendments and online activity, parliamentarians have not been shy about wading into access debates, a reaction to inboxes full of emails from constituents and patient groups demanding access to treatments not yet available on the NHS.
The end of ‘Medicines for the Many’?
The Bill is making its way through Parliament at pace, with Labour opposition being largely constructive in its passage. Proceedings thus far have also featured a notable lack of criticism the pharmaceutical industry. This is surprising when you consider that it is less than a year since Labour’s Medicines for the Many manifesto was published under Jeremy Corbyn, promising wide-ranging reform to effectively nationalise medicines manufacturing and circumvent patent law if pharmaceutical companies were deemed to be charging too high a price for their products.
Alex Norris, appointed Shadow Public Health Minister following Sir Keir Starmer’s election as leader of the party, has led the Labour front-bench response to the Bill. Notwithstanding the public caveat that “we have no choice but to pass the Bill”, he has remained positive about the benefits the new measures could have for the UK’s life sciences industry. Indeed, through amendments he has tabled, Norris has sought to put the onus on the Secretary of State to report to Parliament when a ‘medicine which is clinically beneficial has not been made available on the NHS.’ Though unsuccessful, this amendment has intensified a new tendency to place scrutiny on government rather than just the manufacturer when a treatment is rejected for use by the NHS.
What does this mean for NICE?
This new wave of ‘access activism’ will likely frustrate those tasked with approving medicines. The independent National Institute for Health and Care Excellence (NICE) was set up just over 20 years ago precisely to take the politics out of deciding which treatments the NHS should pay for, instead applying strict economic modelling criteria to every assessment of a new treatment. Though the industry has called for reform and flexibility in NICE’s methods for many years, the rapid rise of precision treatments being developed, that can significantly help patients who previously had no options left, has enfranchised MPs to engage in similar debates. The cost-effectiveness of these new treatments is not straight forward for NICE to assess and MPs are increasingly being lobbied by constituents and their families to intervene on their behalf. This re-introduction of politics into the medicines access debate has precipitated the central argument of ‘access activists’ in Parliament during the Bill: parliamentarians must take responsibility for making medicines available to their constituents through the NHS.
A change in government thinking?
For MPs, an expansion of parliamentary oversight provides a route to pressure the government on medicines access issues, ensuring the government find it increasingly difficult to stay passive, leaving NHS England and industry to go back and forth.
Whether reinvigorated ‘access activism’ will fundamentally change the landscape will be largely down to whether there is cross-party support to further increase parliamentary scrutiny of medicines access issues. Regardless of the Bill’s outcome, its passage has illustrated that medicines access issues are not as politically ambivalent as the independent NICE might like. No matter what happens next, it’s clear that the strength and determination of patient communities and charitable advocacy groups – though stalled by the significant financial turmoil COVID-19 has wrought – has had a significant impact by making sure Parliament and government know that they cannot be the cheerleaders of a post-Brexit renaissance for UK life sciences, without getting to grips with individual medicines access issues.