First published in our Biotech Review of the year – issue 8.
Introduced in March 2019, the Medicines and Medical Devices Bill affords the Secretary of State for Health the power to amend, by fiat, any regulation he or she might wish if it would thereby make the UK a more ‘attractive’ market for life sciences. Though near unprecedented in the extent to which the Bill transfers sweeping powers to the executive (which Lord Blencathra, Chair of the Delegated Powers and Regulatory Reform Committee, labelled an ‘inappropriate delegation of power’), the measures are not without their supporters. Indeed, in the words of former Health Minister Baroness Blackwood, the Bill “will slash red tape [and] support uptake of treatments for people with rare diseases”.
Whichever side proves to be correct, the Bill is hugely significant for the UK’s life sciences market and will set the tone for years to come. Aside from the constitutional wrangling, the Bill throws up one question of particular importance: will post-Brexit Britain emerge as a life sciences proving or dumping ground?
It was inevitable that action would be taken post-Brexit to safeguard Britain’s position as a premier life sciences hub. After all, a sudden secession or radical divergence from continental markets – home to almost half a billion consumers – risks seeing Britain drop precipitously down the life sciences pecking order. The UK could be left in the same position as Australia which, with its population of 25 million, rarely, if ever, sees new products launched until after the larger markets receive them.
The proving ground?
Though we cannot take it for granted that the Secretary of State will significantly alter the UK’s regulatory framework with these powers, the early indications suggest that in the coming years, laws could be amended to allow developers to bring medicines to market in the UK before concluding Phase 3 trials.
While consumers might express worry about skipping a phase of trials in this way, life sciences professionals will recognise that, broadly speaking, preliminary safety of a new medicine is established after Phase 2 trials. As a result, in certain circumstances there may be an ethical imperative to allow medicines to go to market before Phase 3 trials are concluded to determine their efficacy. This would not only mean that the UK could become a launching ground, but it is possible that pharmaceutical companies might also base their manufacturing operations in the UK, as close as possible to the initial market. If this occurs, the benefits for personalised medicine, cell & gene therapies, and medical device & diagnostic software in particular could be significant.
What’s more, whilst Parliament often provides valuable oversight, once the UK leaves the EU it will lose the ability to quickly alter legislation in emergency situations, as the EU can (and does). The Bill may go some way to restoring this streamlined system in emergencies and will mitigate the occasions where Parliament can act as a brake to new life sciences regulation. The minor amendments to the Human Fertilisation and Embryo Act, for example, took 18 months to clear both chambers.
Those debating the implications of the Bill frequently turn their eyes to Japan, which pioneered a similar ‘adaptive’ framework to encourage its stem cell sector. The Japanese stem cell market is widely touted as evidence that giving the executive the power to act swiftly does little to increase attractiveness or speed development. In truth, such a comparison is misleading: stem cell therapy remains a nascent sector because of current technological limitations that no amount of regulatory tweaking will overcome.
However, if the UK is breaking new ground, it may not be doing so alone. Not only does the European Commission possess significant powers to amend laws, but even Dr Jeffrey Shuren, a Director of the US’ Food & Drug Administration, has sought to streamline regulatory approval, despite famously declaring that the US does not “use our people as guinea pigs”. It would seem that the regulatory pendulum is pushing firmly in one direction: streamlining the regulatory approval process in the name of attractiveness.
The dumping ground?
Shuren’s comments are also indicative of concerns that sudden changes to regulatory frameworks can turn states into dumping grounds for hastily-rolled-out products. There are legitimate concerns that headline-grabbing products will be approved on a whim by election-minded officials. Senior voices from within the sector, meanwhile, have expressed serious concerns that the Bill could drive significant market instability.
The Government has attempted to assuage such concerns by assuring the sector that it will go beyond its statutory obligation and ensure that no changes to the regulatory regime are made without an industry consultation. As we enter 2021, assuming the Government keeps its word, this presents opportunities for companies within the sector to have their voice truly heard, to help shape the new framework. Whether Britain becomes a proving or dumping ground may yet be in the sector’s hands.