UK can learn from US to boost life sciences industry, say experts

Gareth Morgan and Catherine Drew of Pinsent Masons, specialists in advising life sciences companies, were commenting after research commissioned by the Association of the British Pharmaceutical Industry (ABPI) found that the Medicines and Healthcare Regulatory Authority (MHRA) has “gone through a period of strain regarding its operating and performance levels” and that “challenges” relating to the MHRA’s performance in some areas threatens the UK’s competitiveness, including around its regulation of clinical trials and the approval routes it offers for new medicines.

The ABPI has set out 12 recommendations to improve the way the MHRA functions that it says reflect industry views of the need for a “world-class regulator” to offer transparency, predictability, independence, adaptability and accountability. The recommendations are broadly aimed at making it easier for stakeholders to understand and engage with the MHRA’s structure and processes; improving the predictability and general delivery of the MHRA’s statutory functions for the provision of scientific advice, standard and expedited authorisation pathways and clinical trial approvals processes; strengthening the MHRA’s internal resourcing capabilities; and strengthening the regulator’s industry engagement.

Morgan said: “The report confirms several structural issues with the regulator that is harming growth, but importantly highlights that changes are needed to support innovation and bring more investment into UK life sciences.”

“Programmes like the Orphan Products Grants awarded by the US regulator, the Food and Drugs Administration (FDA), shows how in-tune the US is with incentivising in small areas of the life sciences market; in contrast, in the UK, whereas the UK doesn’t get sufficiently granular to really address the structural problems in its support of the life sciences sector,” he said.

“It is often when coming to expensive later stage clinical trials small UK companies are forced to partner, sale or out-license. Programmes to invest in selected UK companies in a similar manner to the US Orphan Products Grants could help retain much more value in the UK SME pharmaceutical and biotech sector,” Morgan said. “This may also make the MHRA a bit more commercially minded if it were given a key role in vetting the applications. We could even see joint MHRA/NICE scientific advice being combined with the grants to make sure companies were generating the right data, not just for the marketing authorisation application but also to achieve what they want in the technology appraisal that follows.”

Drew said the findings of the ABPI survey reflect the frustrations shared with Pinsent Masons by clients in the life sciences sector. She said the issues they experience with the MHRA’s performance has global, commercial, implications.

“For example, the lack of predictability and concerns about timelines for the MHRA to take actions – seemingly caused by a lack of capacity in the MHRA – has serious consequences in terms of planning for life sciences companies for multi-jurisdictional product launches, where the UK is one piece of a larger puzzle,” Drew said. “Concerns over transparency, both in terms of decision making and publication of information about what the MHRA has been up to and decisions they have taken, similarly present challenges for our clients.”

“If the MHRA is willing and able to implement the proposals set out in the reform then these could address industry concerns and help to ensure the UK is a market at the forefront of their product launch plans, rather than one considered to be a follow-on market,” she said.

Morgan said “broader structural issues with investment in the UK” also have to be addressed, to promote growth in life sciences and other industries.

“As a simple example, stamp duty on share purchases makes London a much less attractive place to list than the US,” Morgan said. “If the aim is to make the UK a hub of innovation, then barriers to entry into, cost of doing business on and, the liquidity of, the broader UK investment market need to be addressed. Current political and economic turmoil within many of the UK’s direct competitors for business investment into Europe presents an opportunity to establish that the UK is open for business to life sciences companies. It is an opportunity the UK government can ill afford to let pass.”