On the 6th August 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on the Early Access to Medicines Scheme (EAMS). The consultation will remain open until 17 September 2021, and submissions are being sought from stakeholders on a series of legislative proposals that are intended clarify the legal basis for EAMS.
EAMS is one of the ways through which a patient with a life threatening or seriously debilitating condition can gain access to a medicine before it has gained approval from the UK’s medicines regulatory authority. The MHRA hopes, through its legislative proposal, to ensure that EAMS remains an attractive option for patients, healthcare professionals and companies, so that cutting-edge therapies are available for patients where there is an unmet clinical need:
"We aim to make the legal basis for EAMS supply clear and minimise the burden on those supplying EAMS medicines and for those companies wishing to collect real-world data during the scheme. This will be delivered whilst continuing to ensure the safety of EAMS products through pharmacovigilance (safety monitoring), maximising patient access and benefit"
At present there is no UK legislation that specifically covers EAMS, with the scheme being entirely non-statutory. The consultation seeks views on proposals to add new provisions to the Human Medicines Regulations 2012 (SI 2012/1916). In particular, the MHRA believes that there are some aspects that would benefit from clarification in law and it is seeking to provide a specific statutory basis for EAMS, to improve regulatory certainty, patient access flexibility and reduce regulatory burden. In particular, through its legislative proposals the MHRA is hoping to:
- Simplify the supply of EAMS medicines: a new provision for EAMS medicines is proposed to simplify and harmonise expectations for their manufacture, assembly and importation;
- Provide a supportive framework the collection of real-world data (RWD): a key recommendation from the Government-commissioned independent review of the EAMS was that EAMS should become a vehicle to support the collection of real-world data;
- Clairfy the liability for prescribers and patients: at present, there is some perceived uncertainty about the use of medicines during the EAMS. The MHRA would like a provision in legislation to provide clarity around the use of EAMS medicines, in line with the General Medical Council (GMC) recommendations on prescribing unlicensed or off label medicines.
- Pharmacovigilance (safety monitoring) for EAMS medicines: In order to best support safe use and to reassure the individual patient and the healthcare professional when prescribing an EAMS medicine, the following pharmacovigilance requirements are being considered for inclusion in legislation:
- The requirement to operate a risk management system describing appropriate pharmacovigilance and risk minimisation activities
- The requirement to collate and maintain records of suspected adverse drug reactions and report to the MHRA
- The requirement to submit periodic reports summarising the suspected adverse drug reactions for the EAMS medicine
- The requirement to notify MHRA of new information that may impact the benefit/risk balance.
- Source: Consultation on proposed statutory instrument for the Early Access to Medicines Scheme
The MHRA proposes to make the legislative changes under Part 2 of the Medicines and Medical Devices Act, which provides powers to make regulations about human medicines.
Submissions to the public consultation should be made through the online survey which will be open until 11:45pm on 17 September 2021
(Co-authored by Lauren Neal)