Key takeaways from our first breakfast briefing, February 2021 25 Feb 2021

We enjoyed welcoming delegates to our first virtual breakfast briefing earlier this month.  Our speakers, Dr Lucy Cook and Dr Zubair Hussain tackled the key trends shaping the medical and regulatory affairs landscape in 2021.  We enjoyed both their insightful presentations and the Q&A afterwards- the feedback was very encouraging, and we will be scheduling further breakfast briefings in the coming months.  Watch this space!

The future of the MHRA outside Europe is an area of great interest for many of you.  Moreover, participants were keen to learn more about the potential for the new Innovative Licensing and Access Pathway (ILAP) for medicines scheme to provide a more seamless approach for the development and reimbursement of medicines in the UK.  We will explore this and other topics further over the coming months.

Below, we summarise some of the event’s key questions.  Many thanks once again to our presenters and delegates for a fruitful first meeting!

Q&A Summary:

How does the location of a virtual event congress impact the applicable code?

Dr Lucy Cook noted that per the EFPIA guidance, we typically consider previous Congress attendance in applying the code.

However, Dr Malcolm Barratt-Johnson suggested a need for a global code beyond the national regulations to account for virtual congresses.

What are the issues with Product Licence numbers following Brexit?

Dr Zubair Hussain commented that as the UK becomes less aligned with European legislation, change is inevitable.  One of those areas is product license numbers which will need to change.  It’s important to note that the MHRA are relatively pragmatic, and you should discuss your specific requirements, but in the longer term, there will be a requirement to have a GB specific product license number.  The timing of adoption is an issue for sponsors to discuss with the MHRA.  Of course, if you are filing a variation that automatically triggers the need for GB stickers.

What is ILAP, and what are its implications?

ILAP is the MHRA Innovative Licensing and Access Pathway, which the UK introduced on the 1st of January.  The programme enables sponsors to work closely with the MHRA, National Health Service Executive, and NICE on a new medicine development and reimbursement pathway.  As stated in the government announcement, a successful Innovation Passport designation “triggers the MHRA and partners to create the “Target Development Profile” (TDP) document.  This ‘living document’ will set out a unique product-specific roadmap towards patient access in the UK healthcare system.”   This initiative’s introduction represents a significant step forward in the UK’s evolution as a leading authority in innovation.  A different scheme, Project Orbis, allows the MHRA to work with the FDA and other regulators to fast track the regulatory process across a global number of international co- regulators.

We look forward to seeing you at another PharmaMedic event soon.