Britain’s medicines regulator is failing patients, innovators and the economy
3 min read
Anthony Harnden took up his new role as the chair of the Medicines and Healthcare products Regulatory Agency (MHRA) at the start of the year. It’s a good moment to assess how this most vital regulator is performing.
As the regulator for over 14,000 medicines and two million medical devices, the MHRA plays a key role in ensuring we remain a competitive market for global life science investment and that – above all else – the absolute highest levels of patient safety are maintained. Unfortunately, on both of these counts, the MHRA has proved severely lacking in recent years.
There have been no shortages of reports on the performance of the MHRA, not least by my fellow vice-chair on the Pharmacy APPG, Baroness Cumberlege, who in 2020 made clear the need for substantial reform to give patients a greater voice in its working. As a practising pharmacist I have seen first-hand the frustrations of patients who have discovered medicines and devices available elsewhere in the world only to find the UK inexplicably years behind our peers.
Following our withdrawal from the European Union in 2016, we were presented with an opportunity to diverge our regulatory system and reclaim our natural position as a global leader in pharmaceuticals and health technologies. Yet instead we have squandered this chance with years of regulatory uncertainty and ever-growing costs, making the UK an increasingly unattractive destination for global healthtech investment.
In the Spring Budget of 2023, then-chancellor Jeremy Hunt laid out ambitious and laudable plans to institute a near-automatic sign-off for medicines and technologies that have been approved by regulators in similar jurisdictions. While the MHRA has made slow progress towards this end, many in the sector continue to have strong misgivings about the pace of this change and the extent of its scope.
The MHRA must go further and faster in this space and seek global harmonisation to achieve the “near automatic sign-off” we were promised 18 months ago. When products can be backed up with years of data from Germany, America and other comparable jurisdictions, proving their safety and effectiveness, then there can be no justifiable reason to deny them immediate certification. The price of failure to push our regulator in this direction will not just be borne by disadvantaged UK life sciences companies, but ultimately our constituents who will miss out on treatments which in many cases might have been life-changing or indeed life-saving.
A change in leadership at the very top is an opportune moment to talk about what the goal of the regulator should be. The MHRA needs to take stock of reality; recognise its own limited capacity and prioritise its attention towards making the UK a premier destination for cutting-edge life science investment. Since departing from the EU, the MHRA has been working to introduce a UK certification mark (UKCA) similar to the previously used EU CE mark and comparable to the USA’s FDA 510(k) process. However, by introducing our own separate certification mark we have imposed similar costs on companies attempting to bring their products to market in the UK without providing anywhere near the market size that can be found in the US or EU.
Let us recognise our diminished capacity and attractiveness, accept international best practice, where years of strong evidence exists, and rethink the need for the UKCA mark. If, in the short-term, we must be a rule-taker instead of a rule-maker, let us use that space to instead focus our limited capacity on encouraging the very latest breakthroughs – instead of wasting time recertifying medicines and devices that have already proven themselves time and time again abroad.
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