Editor’s desk: A rocky road ahead

Rebekah Jordan shares her view from the seat at the Editor’s Desk on what impact the post-Brexit era might have on the UK process of medicine approvals and how external pharma manufacturers may respond.

The UK’s future role in R&D within the life sciences sector currently stands on unstable ground. On the back of the Brexit vote, the UK left the European Medicines Agency (EMA) – the EU drugs regulator – leaving all future medicine to be vetted and approved by the UK’s equivalent; Medicine and Healthcare products Regulatory Agency (MHRA).

Reflecting on the previous year – the first year following the Brexit transition period - the number of medicines approved in the UK was fewer than that of the EU and US combined.

What this means is a wake-up call for the UK and something to consider when the future regulation of medicinal products is firmed up, though if the MHRA’s published consultation on the regulation of medical devices is anything to go by, we can expect alignment with the EU in a lot of areas, with some room for manoeuvre on divergence.

For external drug manufacturers and developers, the UK’s current regulations could mean more paperwork, more time and at higher costs. The emphasis now also lies on the NHS and NICE to recommend which drugs should be made available in the NHS.

Consequently, the UK may not appear as an attractive option for international pharmaceutical manufacturers in the long term, compared to the EU and the US. A smaller market with even bigger barriers to entry.

However, it’s not all bad. The UK possesses a very strong life sciences innovation sector – a turnover of £80bn a year. To see less investments and support into its R&D from external manufacturers and investors would be a disaster to say the least. For instance, the AstraZeneca vaccine was originally developed here in the UK, not to mention, the UK was the first recorded country to approve the Omicron-specific vaccine – reflecting the country’s proactive approach for treatments. Teams at Oxford University also recently got behind a clinical study for Tecovirimat - a potential treatment for monkeypox – and is now recruiting its first round of patients.

It would be short sighted to say that less medicinal approvals means less access to effective treatments. What we may not be considering is the quality over quantity approach of medicines being approved, allowing for a more selective process. The prioritisation of treatments and vaccines for emerging epidemics or pandemics could mean patients receive life-saving treatments without delays.

All in all, current trends show that it’s too soon to tell whether the UK-EU break up will cause bumps in regulatory approval or affect the UK’s overall life science market. It’s also a question of whether this trend is going to impact in the long term.

So, amongst the majority of other things in the UK, we are again faced with uncertainty. In the meantime, I hope you enjoy this issue.