The MHRA has announced modifications to the Early Access to Medicines Scheme (EAMS) earlier this week.
The intention of EAMS is to reduce the regulatory burden and improve Real World Data collection for better safety monitoring.
This scheme has been in existence since 2014 and is the Group Access Program for patients within the UK.
The major characteristics of the EAMS programs have been that
- Group program for access to medicines before commercially launched
- The product must be provided free of charge
- Only accessible post-receipt of a Promising Initiative Medicine (PIM) classification
- An assessment of the current evidence will be undertaken by the MHRA and a Scientific Opinion published prior to the EAMS protocol being approved
The proposed changes are to
- Formalise the regulations and guidance for EAMS into UK law by use of a Statutory Instrument (a process which allows quick implementation without being passed by Parliament)
- Simplify the licenses needed to conduct an EAMS program
- This will be based on a risk assessment for each program
- Provide more support for the collection of Real -World Data
- Allows for collection without a clinical trial authorizsation (CTA)
- Research Authority & local Ethics Committee approval should be obtained
- Patients must give permission and collection cannot be a condition of supply
- Give more clarity on the liability for prescribers and patients
- Bringing into line with the existing General Medical Council (GMC) recommendations
- Formalise Pharmacovigilance regulations but to follow the existing regulations
- Ensure EAMS programs continue to be available in Northern Ireland
Implications for the Pharma Industry
- Overall, this is a positive step for the pharma industry and continues the UK Government policy objective of the MHRA and UK Government to ensuring that the UK continues to be an attractive country for the industry going forward
- The clarification on the legal status will give confidence to both the industry, physicians and patients
- The simplification of the licenses needed to run an EAMS will remove regulatory burden and complexity in setting these programs up
- The movements on Real World Data will make a real difference in these programs and allow this important data to be more widely collected
These modifications will be welcomed by both industry, physicians and patients. They will make a real difference in the initiation of EAMS in the UK. Our team will be monitoring the introduction of the Statutory Instrument into law to identify whether any further (intended or unintended) changes will be introduced.
Robert Donnell, EVP - Medicines Access
Smartway works with pharma and biotech companies from across the world, designing and implementing specialist, regulatory-compliant and effective access programs. Our team would be pleased to work with you to assess and develop your global access strategy. For more information see: https://www.smartwaypharma.co.uk/how-we-help/eap/consultancy
For more information and advice please contact [email protected]