We have previously noted that 2023 may be a blockbuster year for European biotech deal making. A recent article in the Financial Times examines the UK Government’s attempts to build on this, and turn the UK into a ‘science superpower’.
This has been the express strategy of a number of different Governments, as previously discussed. While the UK remains a leader in Europe, there is more that the Government can do to help the UK compete with US hubs like Boston and San Francisco.
- Changing the route to an exit: The ‘Golden Triangle’ of Oxford, Cambridge and London continues to be the investment destination of choice in Europe, particularly for life sciences. While the article praises the UK’s ability to foster start-ups and encourage early-stage venture financing, it raises questions about whether the Government could do more to encourage significant “scale-up capital”. The article notes that early-stage UK companies are often attractive targets for overseas investors.
The article also quotes the chief executive of the London Stock Exchange, who highlights the spare capacity in the UK. As part of this, the Government could consider reforms to make it easier for UK start-ups to access public markets in the UK, rather than pursuing a listing on Nasdaq. It may also mean encouraging a more significant domestic venture capital market, fuelled by British pension funds.
- Infrastructure: There are some logistical issues that the UK needs to overcome, such as greater investment in lab space in the Golden Triangle (as noted previously). This may be one area where private investors and landlords can come to the Government’s rescue. However, again, the Government should be investing in this infrastructure itself, and seeking to crowd-in private capital. There is a political balancing act here, as the Government wants to be seen to be levelling-up the regions, but actually greater capacity in the Golden Triangle is potentially what is needed to create a US-style hub.
- Clinical trials and patient data: As noted in a number of recent posts (here and here), the interaction between the UK GDPR (and privacy issues) and clinical research remains a block on innovation – particularly in competition to the US. In addition, the UK has a unique resource in the form of the NHS, which is currently under-utilised in the context of R&D. This is an area in which the Government could significantly help the sector, without the need for increased Government spending, by liberalising the ability for private companies to share data for research and collaborate with the NHS.
The Government’s proposed reforms of the UK’s data protection laws regularly refer to its intention to fuel innovation in clinical and scientific research by simplifying the rules around data collection, sharing and use. To help meet those aims, the Data Protection and Digital Information Bill, which was laid before Parliament in July 2022 and forms part of the far-reaching National Data Strategy, (1) extends the ability for researchers to obtain consent for projects that aren’t known at the time of consent, (2) broadens the scope of “scientific research” to include certain commercial R&D activities, and (3) applies the exemption to providing a privacy notice if doing so would be impossible or involve disproportionate effort to scenarios where the data are collected directly from individuals (currently, the exemption applies only to data that have not been obtained from the individual).
It must be said that these developments have not been uniformly welcomed, so it remains to be seen whether they will remain in their current form when the Bill is finalised. However, the National Data Strategy gives the UK a unique opportunity to learn from and improve on the fragmented approach to clinical research that has developed across the EU under the GDPR. For that reason, the Government should continue to explore how it can support the country’s life sciences industry while ensuring that its data protection laws retain the trust of patients and the wider public alike.
- Regulatory Reforms: As the article mentions, the UK has long been known for its strong academic science base, but more could be done from a regulatory perspective to support the transition from university spin-out to fully-fledged life sciences company. As mentioned above, this sentiment is not entirely new; during his time as prime minister, Boris Johnson set out his Government’s Life Sciences Vision which detailed plans to make the UK “the leading global hub for Life Sciences” and to “utilise the full breadth of our regulatory freedoms from Brexit to make the UK the best place in Europe to invest in a life-science business”.
Since the expiry of the Brexit transition period, efforts have been made towards the realisation of this objective. For example, the Medicines and Medical Devices Act 2021 was passed to facilitate the introduction of changes to the UK’s regulatory regime, such as those contemplated in public consultations on clinical trials and medical devices. Notably, these consultations were partly prompted by the entry into application in the EU, of significant rafts of legislation concerning both clinical trials and medical devices, after Brexit. However, not all post-Brexit regulatory initiatives have been prompted by developments in the EU. For example, the novel Innovative Licensing and Access Pathway has recently been implemented in the UK to support innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Looking to the year ahead, significant regulatory reforms are currently in the EU pipeline. These include the revision of the general pharmaceutical legislation, the establishment of a European Health Data Space and the regulation of AI and its associated liability. Typically, law-making in the EU is slow. A ‘recent’ example being Regulation (EU) No 536/2014 on clinical trials which, despite being passed in 2014, only entered into application in 2022. Against this background, now is the time for the UK to exercise its newly acquired agility and promote its life sciences industry by introducing innovation-friendly regulatory reform.
In conclusion, the UK looks set to remain the destination of choice in Europe for both entrepreneurs and US investors/buyers. However, there is more that the Government needs to do to foster the sector, including the physical infrastructure, regulatory reform and promoting domestic champions.
...the government’s “entire mission” is to shift the UK from being an “academic powerhouse to a science superpower”.