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Policy

Primary care services

From
Director-General Health and Social Care
Directorate
Population Health Directorate, +1 more … Primary Care Directorate
Topic
Health and social care
Policy actions  6 of 7

Medicines

Medicines are the most frequent healthcare intervention and account for the second largest expenditure in the NHS in Scotland behind staff costs. They are crucial to helping people live longer, healthier lives. 

The UK Government regulates medicines safety, quality, efficacy, pricing and licencing. The Scottish Government and Health Boards are responsible for access to medicines, and we advise Ministers on these issues, led by the Chief Pharmaceutical Officer, Professor Alison Strath. 

We: 

More information about our work is provided below:

Access to new medicines

We are committed to increasing the availability of medicines that people in Scotland need.  

In Scotland, the SMC is our Health Technology Appraisal (HTA) body that appraises the clinical and cost-effectiveness of newly licensed medicines and provides recommendations on their routine use within the NHS. HTA examines the benefits, risks, and costs of new healthcare technologies. It helps decision-makers (like doctors and policymakers) decide if a new medicine is a good investment for the healthcare system and patients. 

The SMC comprises of clinicians, pharmacists, Health Board representatives, pharmaceutical industry representatives and members of the public. It operates independently of Scottish Ministers. 

Along with the Scottish Government’s Cancer Policy Unit, the Scottish Government’s Medicines Policy Unit co-funds the Cancer Medicines Outcomes Programme (CMOP) to assess the effectiveness and safety of cancer medicines in routine care in Scotland. This supplements clinical trial data and informs the SMC process, helping ensure medicines deliver expected benefits and value in the real world, beyond clinical trials. 

Ultra-Orphan Pathway 

The Ultra-Orphan Pathway (launched in 2018) provides those with the rarest diseases access to new and innovative medicines in the NHS in Scotland for up to three years, while outcome data is gathered. The current definition of 'ultra-orphan’ medicine applies to very rare conditions affecting fewer than 1 in 50,000 people - around 100 people or less in Scotland. 

The SMC can accept medicines on an interim basis, subject to ongoing evaluation and reassessment. CMOP supports this process for cancer medicines by providing real-world outcomes data. 

Health Boards have procedures for clinicians to request prescribed medicines not (or not yet) recommended for routine use in the NHS by the SMC, when they consider that there would be significant clinical benefit for that person. Under the Peer Approved Clinical System (PACS) Tier Two, cost is not a factor in decision making. 

Innovative Licensing and Access Pathway 

The aim of the Innovative Licensing and Access Pathway (ILAP) (launched on 1 January 2021) is to accelerate time to market and patient access for innovative medicines. These medicines include new chemical entities, biological medicines, new indications and repurposed medicines.  

The SMC is a key member of the ILAP partnership alongside the National Institute for Health and Care Excellence (NICE) and the MHRA. ILAP medicines are prioritised for scheduling as part of the SMC’s HTA process. 

The four UK nations have developed a pathway to support the pharmaceutical industry on introducing new medicines into the NHS. 

Regulation of medicines: licensing and safety 

Medicines safety, licensing and pharmacovigilance functions are reserved to the UK Government and are the responsibility of the MHRA. 

We work closely with the UK Government, the MHRA and other relevant bodies on: 

  • the regulation of medicines 
  • governance arrangements for the use and management of controlled drugs to minimise harm, misuse and criminality. A Post-Implementation Review of the regulations was undertaken by the Department of Health and Social Care (DHSC) at the end of 2024 and a report of the recommendations was published in 2025: The Controlled Drugs (Supervision of Management and Use) Regulations 2013 - Impact Assessment 
  • the implementation of the recommendations from the Independent Medicines and Medical Devices Safety Review (IMMDSR) ‘First Do No Harm’ (September 2020) - through our delivery plan (March 2021) 
  • considering the Hughes Report (February 2024) recommendations by the Patient Safety Commissioner for England - the Minister for Public Health and Women’s Health wrote a letter to the Health, Social Care and Sport committee to inform them of the Scottish Government work on these recommendations 
  • medicines safety issues, including those considered by the IMMDSR and the Hughes Report 
  • the MHRA’s Yellow Card Scheme, which safeguards medical products quality and efficacy in the United Kingdom, and we sponsor a Yellow Card Centre in Scotland 
  • monitoring outcomes from medicines in pregnancy - we commissioned Public Health Scotland (PHS) to establish a Medicines in Pregnancy surveillance asset which monitors the prescribing of anti-seizure medicines - PHS publishes a summary report and dashboard every six months  

Off-label and unlicensed medicines 

The term 'unlicensed medicine' is used to describe medicines that have no licence for use in the UK. ‘Off label’ prescribing is when a clinician prescribes a medicine where the product licence does not cover the indication or age for which the medicine is being prescribed. Clinicians can prescribe unlicensed medicines, or licensed medicines off label, where they consider there would be significant clinical benefit to the patient and in line with local health board protocols. Unlicensed or off-label prescribing is commonly used in some areas of medicine, such as in paediatrics, psychiatry and palliative care.  

The regulation, licensing and supply of unlicensed medicines is reserved to the UK Government, including the scheduling of cannabis-based medicines and we have no power to alter this. 

Medicines policy lead on issues around cannabis-based medicines safety, meeting regularly with DHSC to monitor policy changes and challenges. We work with Police Scotland and the Scottish Intercollegiate Guideline Network (SIGN) to ensure guidance aligns with UK Government policy. 

National Cancer Medicines Advisory Group (NCMAG) 

The NCMAG is delivered by Healthcare Improvement Scotland (HIS) and provides advice to Health Boards on the clinical and cost-effectiveness of repurposed cancer medicines where they may be used off-label or off-patent.  

National advice reduces the variation arising from local and/or regional consideration of these cancer medicine uses, minimises duplication of effort and supports equitable access to safe and effective treatments to improve outcomes for patients. The 2023-2026 Cancer Action Plan which is drawn from the 2023-2033 Cancer Strategy for Scotland commits to ensuring NCMAG advice is consistently implemented across the NHS in Scotland. 

Medicine pricing

The regulation of medicine pricing is a responsibility of the UK Government. There are two schemes which regulate the cost of branded medicines, a statutory one and a voluntary one. The current five-year Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG), launched in January 2024, is a UK wide voluntary agreement with the pharmaceutical industry which caps NHS spending on branded medicines. Under the new VPAG, the pharmaceutical industry will also invest an additional £400 million in a Life Sciences Investment Programme. This additional funding will support work in each of the four nations across three key areas: 

  • clinical trials 
  • manufacturing 
  • health technology assessment (HTA) 

The aim of the voluntary and statutory schemes is to safeguard the financial position of the NHS by limiting the cost of branded health service medicines. 

We have committed to investing VPAG rebates to fund the New Medicines Fund (NMF), providing additional funding to territorial health boards for new medicine costs. VPAG rebates are linked to medicine spend throughout the scheme duration. The NMF supports SMC-approved medicines and individual patient treatments for non-approved medicines, including orphan (rare), ultra-orphan (very rare) and end-of-life medicines for rare diseases. Since 2014-15, £906 million has been made available through this Fund. 

Regional medicine formularies 

Medicine formularies are widely used across the NHS in Scotland to provide prescribers with clinically effective, cost effective and safe prescribing recommendations. We support health boards to modernise formularies via a regional collaborative consensus model. 

This has seen the successful delivery of a regional formulary for the East of Scotland (NHS Borders, NHS Fife and NHS Lothian). Work is now ongoing to develop a second regional formulary for the West of Scotland (NHS Ayrshire & Arran, NHS Dumfries & Galloway, NHS Forth Valley, NHS Greater Glasgow & Clyde and NHS Lanarkshire). 

Covid-19

We continue to closely monitor all emerging evidence on the effectiveness of Covid-19 treatments. There are currently several treatments available, designed to treat the symptoms of the disease, for selected groups who remain at highest risk of becoming seriously ill with coronavirus. Further information is available on NHS Inform.  

Contact

Email: medicines.policy@gov.scot 

Telephone: 0300 244 4000 

Post: 

Pharmacy and Medicines Division 
Scottish Government 
1R, St Andrew’s House 
Regent Road 
Edinburgh 
EH1 3DG 

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