The early access to medicines scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.
The scheme was launched in April 2014 and demonstrates a joint commitment from government and industry in the UK to pharmaceutical innovation, providing a platform for medicines to be brought to patients at a much faster rate than ever before.
The scheme is voluntary and operates within the current regulatory structure. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the scientific aspects of the scheme and will give a scientific opinion on the benefit/risk balance of the medicine. Read further information on the scheme, including the number of applications made.
Once licensed, medicines which have been developed through the EAMS will be appraised for routine use by the National Institute for Health and Care Excellence (NICE) (and equivalent bodies in the devolved administrations). Companies will be able to use the evidence collected in the earlier stages of the scheme. This can only happen if companies join the scheme early and are members for a sufficient period of time. Read about procedures at NICE to support EAMS.
If an EAMS medicine is subsequently recommended through a technology appraisal, it will then be commissioned by the NHS.
Government - industry stakeholder task group
A government - industry stakeholder task group has been established to bring together key stakeholders from the bio-pharmaceutical industry, government and arms’ length bodies. They inform the development of EAMS procedures, establish consistent lines of communication between stakeholders and clarify, address and accelerate the resolution of issues.
Membership of the group includes:
- Medicines and Healthcare products Regulatory Agency (MHRA)
- National Institute for Health and Care Excellence (NICE)
- NHS England
- Office for Life Sciences (OLS)
- Department of Health
- devolved administrations (Scottish Government, Directorate General Health and Social Care; Welsh Government, Department of Health and Social Services; Department of Health, Social Services and Public Safety, Northern Ireland; NHS Scotland and NHS Wales)
- Scottish Medicines Consortium
- All Wales Therapeutics and Toxicology Centre
- Association of the British Pharmaceutical Industry (ABPI)
- Bio-industry Association (BIA)
- Ethical Medicines Industry Group (EMIG)
- invited representative companies
- other stakeholders including the Centre for the Advancement of Sustainable Medical Innovation (CASMI)
The stakeholder task group has produced and agreed supporting material to help explain the scheme and how it operates in practice:
The guidance will be updated in the light of experience and future developments. Information on processes in Scotland, Wales and Northern Ireland will be added.
Core principles of EAMS
EAMS aims to balance the interests of the full range of stakeholders, including patients, industry, clinicians and the NHS.
EAMS operates within the current regulatory structure and is voluntary and non-statutory.
The information provided by the company as part of an EAMS application is treated as commercial in confidence and all stakeholders (Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE), NHS England (NHSE), devolved administrations, the Scottish Medicines Consortium (SMC) and the All Wales Therapeutics and Toxicology Centre (AWTTC)) will ensure the confidentiality of commercially sensitive information.
Companies making an EAMS application should engage early with relevant bodies in the UK to facilitate the timely uptake of the medicine in the NHS.
The manufacturer retains control over the public release of information on the award of a promising innovative medicines (PIM) designation. Industry have confirmed their agreement for MHRA to advise nominated contacts in NICE, NHSE, DAs, SMC and AWTTC of the award of a PIM designation and the notification of a preliminary positive scientific opinion at Day 45 of step II, by copying them into the letter on the date of issue subject to this information being treated as commercial in confidence, unless and until this information is made public or otherwise disclosed by the company.
A company provides the medicine free of charge to the NHS during the EAMS period which is defined as after the award of an EAMS positive scientific opinion and up to the granting of the marketing authorisation. Those patients receiving a free of charge medicine during this EAMS period will continue to do so up to the point of a positive funding policy (eg Health Technology Assessment (HTA) guidance, national funding policy, local funding arrangements etc).
Ideally, all relevant EAMS medicines will start the relevant national Health Technology Assessment during the EAMS period to support timely coordination with regulatory processes.
Patients across the NHS should have equity of access to EAMS medicines during the EAMS period within the arrangements agreed between a company and each country in the UK.
EAMS, and arrangements for usage of EAMS products, should not be burdensome for the NHS and NHS organisations should not duplicate the provision of an EAMS Scientific Opinion at local level in NHS governance and clinical decision making.
EAMS can provide an opportunity to generate real world patient data in the NHS – the expectation is that medicines with a positive scientific opinion could be made available to patients up to 12 to 18 months ahead of formal marketing authorisation.
The requirement to collect additional data and the nature and level of data to be collected will be agreed by all parties including clinicians and patients on a case by case basis.
Companies will agree clear exit strategies with relevant bodies for the following situations:
- if no marketing authorisation is granted
- if HTA guidance/commissioning decision is negative
Review of EAMS
When EAMS was launched in April 2014, it was agreed that there would be a review of the scheme within 2 years. OLS commissioned PWC Strategy to conduct an independent review of EAMS. The PWC review of EAMS was published on 22 March 2015.
The review of EAMS will feed into developing policy thinking for the Accelerated Access Review (AAR), announced by the Minister for Life Sciences on 20 November 2014. The AAR will help to ensure that NHS patients benefit from earlier access to innovative medicines, diagnostics and devices, and help government lead the global race for life sciences investment by making the UK the best place for 21st century medical innovation and product development.
There are direct links to the Department of Health (DH) departmental priority to raise standards in health and care through the use of technology and the review will support NHS England’s Five Year Forward View commitment to accelerating the quicker adoption of cost-effective medicines, diagnostics and devices.