Medicines

Medicines play a crucial role in the NHS and to our commitment to supporting people to live longer, healthier lives. Medicines represent the most frequent healthcare intervention and are the second largest item of expenditure for NHSScotland.

The Scottish Government and health boards are responsible for making sure there is a supply of medicines in the NHS. But the regulation of medicines, and in particular their licensing, safety and pricing, are the responsibility of the UK Government. We advise Ministers about these issues, led by the Chief Pharmaceutical Officer (CPO), Professor Alison Strath.

We:

More information about our work is provided below:

Access to medicines

We are committed to increasing patients’ access to safe and effective new medicines.  

In 2013, we reported on the role of SMC and Review of Individual Patient Treatment Request (IPTR) and Area Drug and Therapeutics Committee (ADTC).

We also continue to implement the recommendations of the 2016 independent review of access to new medicines, which was led by Dr Brian Montgomery.

The SMC has introduced a new decision making process for 'ultra-orphan' medicines for very rare conditions that allows medicines to be available on the NHS for a period of up to three years while information about the outcomes they achieve is gathered. It has also introduced a new process for the interim acceptance of new medicines. We produced guidance for health boards, clinicians, pharmacists, patient groups and pharmaceutical companies on the new approach to the assessment of ultra-orphan medicines (May 2019). Work is also underway to drive forward a financial risk share agreement for NHS boards.

We have introduced a new system for clinicians to apply for their patients to be prescribed medicines not recommended for routine availability by the SMC. This new system is called the Peer Approved Clinical System (PACS) Tier Two, and has been operating in each health board area since 1 June 2018. A six and 12 month review of PACS Tier 2 has been completed and we will include our response on next steps as part of a refresh of CEL 17 (2010), which will take place during 2021.

We are working with NHS Scotland and other key stakeholders on a Digital Health & Care Strategy for the development of NHS Scotland’s capabilities on medicines data. This follows the 2018 medicines use and digital capabilities report.

Regulation of medicines: licensing, safety and supply

The regulation of medicines is a responsibility of the UK Government, and in particular the Medicines and Healthcare products Regulatory Agency (MHRA).

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

Pricing of medicines

The regulation of medicine pricing is a responsibility of the UK Government, but we are involved in a UK-wide voluntary agreement between the four UK countries and the pharmaceutical industry that caps NHS spending on new branded medicines. This is the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS).

Where companies’ revenue exceeds the cap agreed as part of the VPAS scheme, the Scottish Government and the three other UK Administrations receive rebates from companies that are signatories to the voluntary agreement. There is also a statutory scheme - more information in the Branded Health Service Medicines (Costs) (Amendment) Regulations 2018.

We use receipts from VPAS to provide a specific fund, the New Medicines Fund, to health boards to help with the costs of introducing new medicines.

Single National Formulary

We are working to develop a Single National Formulary (SNF). The SNF will reduce unwarranted variation in the medicines prescribed in different parts of the country.

There is already a high degree of commonality in prescribing practice across the 11 formularies (prioritised lists of recommended medicines) used by the 14 health boards, but some variability remains in prescribing across some therapeutic areas. Under the SNF, clinicians will continue to have discretion to prescribe for individual patients as they consider appropriate.

UK exit from the EU

The UK Government is responsible for the UK Border; this means that many of the practical issues connected to medicine supply such as entry and customs are outside the Scottish Government’s control. However, we are working closely with the UK Department of Health and Social Care (DHSC) and the other Devolved Administrations to plan for any potential disruption now that the EU Transition Period has ended, including doing all we can to ensure that patients in Scotland will still have access to the medicines they need.

In addition to UK-led arrangements and in response to lessons learnt from the first wave of COVID-19, we have built a national Scottish stockpile of critical care and end of life medicines, as well as supplies of COVID-19 treatments. NHS National Services Scotland National Procurement (NP) is working on behalf of the Scottish Government to purchase the majority of NHS Scotland’s share of the identified stocks of COVID-19, critical care and end of life medicines for the national stockpile and this has been fully procured. The NP team are working closely with Scottish Government officials to ensure, where necessary, additional stock is sourced to meet NHS Scotland’s requirements via the UK-led sourcing work streams.

We are continuing to work closely with the Department of Health and Social Care and the other Devolved Administrations to manage the consequences of the end of the EU Transition Period, including doing all we can to ensure that we will still have access to medicines in the event of border disruption as border and custom controls are phased in, in January and July 2022.

More information

To report any safety concerns with any medicines, find out more about the yellow card scheme.

Contact

Email: medicines.policy@gov.scot

Telephone: 0300 244 4000

Post:

Pharmacy and Medicines Division
Scottish Government
1ER, St Andrews House
Regent Road
Edinburgh
EH1 3DG