1. Access to medicines and medical technologies
Concerns for patients after Brexit
Heather Clarke for
Cathalijne van Doorne
Vice President, European Federation of Neurological Associations
Member of the Patient and Consumer Working Party at the EMA

2. Issues of concern – all potentially impacting access!
Relocation of EMA: loss of expertise and delays
Continuity of supply of medicines and medical devices
Reduction in standards of safety

3. Relocation of EMA EMA de-prioritising activities?
!! Relocation at time when more new medicines than ever coming to market…
Could this mean issues in accessing these new medicines due to delays in the approval pipeline because of:
EMA de-prioritising activities?
e.g. paediatric medicines and public health issues
EMA losing experienced personnel?
Relocation of EMA

4. Loss of the UK’s national competent authority
In 2016, UK’s MHRA carried out, on behalf of EMA:
20% of the scientific evaluations of new medicines
50% of the scientific evaluations of medical devices
How do we redistribute and rebalance this workload?
Will the loss of the UK’s national competent authority to the joint pool of expertise of the EMA be detrimental to the scientific approval of medicines & create delays in access?
Loss of the UK’s national competent authority

5. Delays in Approval?
Shared Regulatory Framework vs separate national systems of regulation
Particular concern for smaller patient groups e.g. paediatrics and rare diseases.
2006 EU Paediatric Regulation
2000 EU Regulation on Orphan Medicines
Will these groups be unfairly impacted?

6. Delays in Access
For UK patients: Despite bilateral trade agreements with the EU, in Switzerland, access takes an average 157 days longer than the EU.
Some products may never be marketed in the UK , 45% of applications have not been submitted to Australia, Canada and Switzerland.
37m packs supplied from EU27 to the UK each month
For patients across the EU: On medicines, over 2,600 final products have some stage of manufacture based in the UK
45m medicines packs supplied from UK to the EU27

7. Reduction in Safety Standards?
UK is a significant partner in pharmacovigilance work.
The MHRA contributes to 30% of EU’s pharmacovigilance
UK’s participation in EU systems is essential:
Data sharing networks
Pharmacovigilance infrastructure

8. What If? …example Medicines for rare disease patients (Duchenne)
patients in the EU, in the UK.
Promising treatment will slow down the progression.
In case of no Brexit deal:
- No link to the EMA’s medicines approval process
- Small population size and market opportunity
- Patients in UK could face lengthy delays in accessing the medicine

9. UNCERTAINTY In Conclusion
BUT NUMBER ONE CONCERN FOR PATIENT ORGANISATIONS IS:
UNCERTAINTY
Our three key unanswered questions:
What areas will be deprioritised by the EMA and how can we compensate for this? No patient group should be left behind!
How will the MRHA’s workload be redistributed to avoid undue delay?
Will safety standards be guaranteed?
In Conclusion

10. Thank you for listening!
@EUneurology