Future of UK Regulation Conference 2023: International recognition
This is the third of four blogs reporting from the BIA conference, ‘The Future of UK Regulation: Driving innovation in the life sciences’, which looks at how the UK’s new international recognition route to market will work and compares and contrasts it with the national marketing authorisation procedure.
International recognition: enabling access to innovation and supporting a UK USP
In one of the most notable moves made since becoming a sovereign regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) is creating a new international recognition route via which it will grant UK marketing authorisations to medicines approved by other trusted regulators.
The International Recognition Procedure (IRP) will come into effect in January 2024. Building on the recognition procedures currently used, the IRP will replace the European Commission Decision Reliance Procedure that was brought in to fill the regulatory gap after the UK left the EU in 2021, to ensure patients were not denied access to new, innovative medicines because of separate authorisation from the MHRA.
The IRP will sit alongside the national marketing authorisation procedure as well as Project Orbis, which is coordinated by the US Food and Drug Administration (FDA) for approving innovative oncology products, and the Access Consortium.
The IRP raises questions for companies over which route to choose, what flexibility it will offer in practice and how it will contribute to making the UK regulatory system globally competitive, proportionate and committed to ensuring patient safety, while also attracting inward investment and commercial clinical trials. “The MHRA is looking to ensure resources are targeted to support innovation, through using our regulatory partners decisions. How this translates to what companies feel appropriate for their product, we can help with clear guidance and advice,” said Julian Beach, Interim Executive Director, Healthcare Quality and Access, MHRA, at the conference.
The IRP is open to applicants who have already received an authorisation from a ‘Reference Regulator’. These are the FDA, the European Medicines Agency (EMA), Swissmedic, Australia’s Therapeutic Goods Administration, Japan’s Pharmaceutical and Medical Devices Agency, the Health Science Authority of Singapore, and Health Canada. In addition, approvals by the Access Consortium that did not include MHRA as part of the work-sharing procedure can be used for the IRP.
A key issue, both in terms of the practicalities and the support for innovation, is that there are two recognition routes – A, which can lead to a decision in 60 days, and B, for which the timeline is 110 days plus a potential clock stop. Most innovative medicines such as advanced therapy medicinal products, products that contain first-in-class new active substances or incorporate novel or cutting-edge technologies will fall within Recognition B, which may mean it is not much faster than the 150-day national approval route.
There may be uncertainties, but these should be seen from the perspective of the underlying objective of providing additional choice for access to the UK market. “We can have more collaboration; we can discuss which pathway might be best for your potential applications. And that way, we can be resourced appropriately to ensure we can deliver the capability and service that is expected,” Mr Beach concluded.
International recognition routes: implications for NICE
Marketing approval does not equal market access. As the gatekeeper, the National Institute for Health and Care Excellence (NICE) is also thinking about how it needs to change its processes to ensure that the MHRA’s new regulatory flexibility and the introduction of the IRP will speed up patient access to innovative products, Dr Nick Crabb, Interim Director, Science, Evidence and Analytics, NICE, told the conference.
Currently NICE starts gathering data for its cost-effectiveness assessments six months before a product is licensed, so that appraisal meetings can be scheduled around the time of authorisation. If a company applies for recognition based on an FDA approval, that will inevitably mean NICE is not able to meet this timeline.
In addition, there will be less clarity on what is coming down the pipeline and is likely to mean there is less mature evidence that is relevant to the UK context. “That could negate the purpose of granting an earlier licence and / or increase the need for a managed access agreement,” Dr Crabb said.
NICE foresees three categories of potential outcomes for products approved via the IRP. For medicines with an evidence base that is sufficient for NICE evaluation, little or no change is required; for medicines with an uncertain evidence base, there is likely to be a managed access programme; in cases where the evidence is uncertain and not suitable for managed access, there will be more negative recommendations and long delays between marketing authorisation and NICE guidance.
Dr Crabb added that NICE is thinking hard about mitigation measures for this third category. These include ensuring companies can notify NICE of their intentions at the earliest opportunity; introducing new fields to UK Pharmascan database to enable companies to notify an intention to use the IRP; improving information sharing between MHRA and NICE, and within NHS England; improving IT systems to support monitoring of industry pipelines and information sharing.
Perspectives from international regulators
Swissmedic has operated as a sovereign regulator since it was established in 2002, giving it significant experience of treading the line between relying on the assessments of trusted counterparts and carrying out the most complex reviews of newest technologies itself to maintain and advance its in house expertise.
Alongside its membership of the Access Consortium, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and other international multilateral collaborations, Swissmedic has a worldwide network of bilateral collaborations, including with the MHRA.
Dr Jörg Schläpfer, Head of Management Services and International Affairs, Swissmedic, told delegates that reliance on the evaluation results of their regulatory partners across a product’s life cycle, mutual recognition – for example of GMP inspections, and work sharing, are extensively used by Swissmedic in managing the growing variety and complexity of products.
For Dr Schläpfer, the MHRA’s decision to join the Access Consortium has given the partnership a significant boost. “We can actually position ourselves behind the FDA and EMA, as a third really important consortium of regulators with a strong direction,” he said. Work sharing within the Access Consortium cuts resource and time overheads, but marketing authorisations remain sovereign decisions.
“If you have an innovation, the Access Consortium is the way to go if you want to get into a market that has approximately 150 million inhabitants,” Dr Schläpfer said.
Shannon Thor, Deputy Director of the Europe Office, Office of Global Policy and Strategy, FDA, outlined opportunities for fostering collaboration and sharing knowledge and information with other regulators. “We promote high FDA safety and efficacy standards and advance FDA’s international objectives. We facilitate regulatory dialogue, and we share data, information and technical expertise and conduct policy analysis, and develop strategic engagements,” she said.
At a bilateral level the FDA and MHRA work together through a confidentiality agreement to share non-public information, including pre- and post-marketing information. A mutual recognition agreement allows the two agencies to rely on each other’s drug inspections. “It can yield efficiencies for us and foreign regulatory systems by avoiding duplication and we can reallocate resources towards more potentially higher public risk inspections across the globe,” Ms Thor said.
For more information, please contact Dr Christiane Abouzeid, BIA’s Head of Regulatory Affairs