By Anthony Davies, Rob Allen, and Ian Pardo
We at Dark Horse are intrigued by the Medicines and Healthcare products Regulatory Agency (MHRA)’s latest: the advent of an “innovation passport” to create an accelerated route—or at the very least, clear the boulders from the path—to drug approval in highly specified situations. The concept of the ILAP (Innovative Licensing and Access Pathway) has the potential to cut both ways.
The European Medicines Agency (EMA) benefits from a single centralised evaluation and authorisation procedure for all ATMPs; see also the Voluntary Harmonisation Procedure as an option for simultaneous clinical trial application in more than one country. These would seem to put the MHRA and the United Kingdom at a competitive disadvantage; it may also remain overshadowed due to size, with the bigger player offering access to far more patients. In that case, over time the UK would become just another small outlier. However, we think it’s more likely that this incentivisation structure will help drive a change in perception and prove similar in progressive attitude (though not in execution) to MHRA’s leading of the pack in emergency-use authorisation for Pfizer/BioNTech’s COVID-19 vaccine.
If the MHRA continues to demonstrate a penchant for nimbleness in cell and gene—remember that back when the UK was in the EU* it acted as the primary lead for the vast majority of approvals—and if other countries want or need those products—keeping in mind here that cell and gene therapies often focus on markets where there is a truly urgent need—what happens?
We could anticipate a trend in which other regulatory agencies choose to acknowledge MHRA approval as an equivalent to their own. If that happens, the UK might well become an export hub for cell and gene products.
The scope of this theoretical export relationship would matter greatly, of course, as would the logistics of establishment of UK-MRAs (Mutual Recognition Agreements) beyond the current “MRA continuity” arrangements. The most logical first step in this direction would be to see MRAs between the UK and other, non-EU, countries emerge—and do so with ATMPs recognized. Considering the rapid growth and potential in the space, a trend such as this would position the UK in an advantageous and influential position.
* A refresher if needed: the UK joined the European Economic Community (the historical equivalent of the EU) in 1973, twelve years after the beginning of a process rife with applications, a veto, and years of talks. 47 years later, of course, we saw Brexit take place, as the UK left the EU on 31 December 2020. Instead of being bound by both the MHRA and the EMA, the UK now has the authority to unilaterally set the MHRA’s direction, from ILAP to EAMS (via PIM) to wherever else their innovations take them.