Following Brexit, regulatory oversight in the UK has switched from the European Medicines Agency (EMA) to the Medicines and Healthcare product Regulatory Agency (MHRA). Since becoming the sole decision maker regarding authorisations of medicines and medical devices in England, Scotland and Wales (Northern Ireland is still under EMA’s jurisdiction due to the Ireland/Northern Ireland protocol)1, the MHRA has stated that one of its main priorities is to accelerate access to medicines in the UK. However, with the work of one multinational agency (EMA) now falling to one national agency (MHRA) one would anticipate capacity issues and reports of potential staff cuts at MHRA do nothing to allay these concerns2. We look at some of the key initiatives launched by the MHRA and ask whether Brexit could, in fact, lead to faster access in the UK.
There is no disputing the MHRA has grand ambitions when it comes to increasing the speed at which patients can access new medicines. Both the new 150-day National Assessment and Rolling Review processes are testament to this. The first scheme aims to provide a decision on approvability within 150 days of submission, with the potential addition of a 60 day clock stop for companies to address any requests for information3. The second scheme encourages manufacturers to engage early with the MHRA to allow for the incremental assessment of regulatory modules with the ambition of completing the final phase of assessment within 100 days (again, with the potential addition of a 60-day clock stop)4. Contrast these timings with the current EMA average evaluation time of 333 days for all new active substances and the 257-day average for Priority Medicines (PRIME)5 and it’s clear that the MHRA are serious in their intent to speed up access for UK patients.
A further initiative taken up by the MHRA in the wake of Brexit is Project Orbis. This is a consortium coordinated by the Food and Drug Administration (FDA) involving Australia, Canada, Singapore, Switzerland, Brazil and the UK with the aim of delivering faster access to cancer treatments through either concurrent submission and review by the international partners or through the FDA sharing the outcome of completed reviews with partner agencies. Since joining the scheme in May 2021, the MHRA has approved nine products via the scheme6, the most recent of which, Exkivity (mobocertinib) received MHRA approval in March this year. Early approval from the MHRA was not proceeded by earlier advice from the National Institute for Health and Care Excellence (NICE) and so to prevent a delay between regulatory approval and reimbursement the manufacturer entered into an agreement with NHS England to supply the drug on a ‘budget-neutral basis’ while NICE completes its ongoing appraisal. This innovative funding arrangement ensured that patients in England were the first patients in Europe to have access to the treatment7,8.
Closer collaboration between regulatory and reimbursement agencies?
As seen in the example of Exkivity, faster regulatory approval alone does not guarantee faster access to medicines for patients. If the MHRA is to increase the speed at which it grants MAs, then NICE and the Scottish Medicines Consortium (SMC) must also provide earlier reimbursement decisions. One of the potential benefits of Brexit is that the MHRA can work seamlessly with NICE and the SMC in a way that EMA couldn’t, given the number of member countries, all with differing reimbursement agencies and processes. The Innovative Licensing and Access Pathway (ILAP) aims to capitalise on this opportunity by bringing together the MHRA, NICE, the SMC and other national partners such as NHS England to speed progression of medicines for life-threatening or seriously debilitating illnesses from clinical trials to access on the national health service (NHS)9. The initiative has echoes of the EMA’s Priority Medicines Scheme (PRIME), in that products meeting the inclusion criteria will receive advice on clinical trial designs and expedited licencing. The key difference in the MHRA’s scheme being the added involvement of UK reimbursement authorities to provide additional advice on access routes and commercial access issues.
For products not meeting the ILAP criteria, both the 150-day National Assessment and Rolling Review offer the opportunity to engage with NICE at the start of the regulatory process, however the extent of this interaction is yet to be defined.
What are the challenges?
Whilst Brexit has given the MHRA the flexibility to pursue its own work schedule it has also resulted in the loss of millions of pounds worth of funding. Reports last September suggested there would be job cuts of up to 20% of the MHRA’s workforce10. If this was to go ahead it is unlikely that the MHRA would have the capacity to do much more than ‘rubber-stamp’ approvals from the EMA or the FDA11.
In addition to having the capacity to carry out their ambitions, the MHRA is also reliant on the engagement of the pharmaceutical industry. Relative to the EU, the UK market is small, and manufacturers will now also need to find budget and resources to engage in an additional regulatory procedure. Will manufacturers see the benefit and if they do, will they want to engage early, or will the UK be an after-thought? The answer to these questions will likely depend on the size of the company in question and the nature of the product they are developing.
The MHRA has stepped up to the challenges of Brexit through launching a number of initiatives aimed at increasing the speed at which new medicines are available to patients. Early signs are that collaborations between the MHRA and other international agencies, particularly through Project Orbis, are already reaping benefits, and on paper both the 150-day National Assessment and Rolling Review should also lead to faster access to medicines in the UK. However, ensuring timely access to new medicines requires more than just regulatory approval; timely reimbursement approval and funding are also imperative. The ILAP programme demonstrates the commitment of all parties within the UK to achieving these goals and the recent approval of Exkivity is a success story for both international and national collaboration. Therefore, the initial signs are that Brexit could indeed increase the speed at which UK agencies are able to approve new medicines for patients. However, the big question remaining is whether the MHRA will receive the necessary funding to turn their ambitions into reality.