The licence (or marketing authorisation) for a new drug for multiple sclerosis is granted by a regulatory authority. The regulatory authority reviews the clinical research to check that the drug is effective, safe and meets manufacturing quality standards. If they are satisfied, a marketing authorisation or licence is issued. This allows the product to be sold by the licence holder in the regions covered by the regulatory authority.
From January 1st, 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) carries out licensing for new medicines in England, Scotland and Wales.
In Northern Ireland, new medicines are licensed by the European Commission following recommendations from the European Medicines Agency (EMA).
Once a new medicine has been licensed, it needs to be appraised by the bodies that decide whether it is a cost effective treatment to provide on the NHS. The NHS is legally obliged to fund medicines recommended by these bodies. The reverse also holds true - if a new drug is not approved, then local health authorities are not required to provide funding for it.
The bodies that appraise new drugs are:
- England - National Institute for Health & Care Excellence (NICE)
- Wales - NICE / All Wales Medicines Strategy Group (AWMSG)
- Scotland - Scottish Medicines Consortium (SMC)
- Northern Ireland - Department of Health (DoH)
NICE was established in 1999 to reduce variation in access to care and treatment across the NHS in England and Wales. Its role has since been expanded to include the promotion of good health and ill health prevention and social care services.
NICE has three main roles:
- Technology appraisals - guidance on the use of new and existing medicines and treatments. These appraisals decide whether it is cost effective for the NHS to make licensed treatments available. The MS Trust takes an active role in NICE consultations.
- Clinical guidelines - guidance on treatment and care of people with specific diseases and conditions. The most recent version of the guidelines for MS were published in October 2014.
- Interventional procedures - guidance on whether procedures used for diagnosis or treatment, such as surgery or x-rays, are safe enough and work well enough for routine use.
- NICE website
- National Clinical Guidelines For the Management of Multiple Sclerosis in Primary and Secondary Care
AWMSG advises the Welsh Government to ensure that effective treatments are available to people in Wales. Guidance from NICE usually applies to Wales. If NICE are not due to assess a medication within 12 months of it getting a licence, AWMSG may run their own appraisal.
AWMSG can recommend to the Welsh Government that the NHS in Wales takes an alternative approach to NICE guidance. This occurred with their decision about Sativex, a drug used to treat spasticity in MS but not approved by NICE. In 2014 AWMSG approved Sativex for use by the NHS in Wales.
SMC issues guidance on treatments for use by the NHS in Scotland. A separate body, the Scottish Intercollegiate Guidelines Network (SIGN), produces clinical guidelines on areas of healthcare. Both bodies fall under Healthcare Improvement Scotland. Under its pervious name (NHS Quality Improvement Scotland) this organisation published national standards of care for neurological conditions in Scotland in October 2009.
- Scottish Medicines Consortium (SMC) website
- Scottish Intercollegiate Guidelines Network (SIGN) website
NICE guidance is generally accepted in the NHS in Northern Ireland once it has been checked by the DoH for any policy and financial consequences.