A Common Understanding 2025

4.The NHS in Scotland working with the pharmaceutical industry and academia

Scotland’s ‘triple helix’ approach creates an end-to-end innovation pathway involving the NHS, industry and academia. This continuum of support for research and innovation in healthcare contributes to growing Scotland’s life sciences sector and ultimately delivers world-class care to the patients of Scotland.

All Scotland’s NHS Health Boards are committed to supporting research and innovation, with many having appointed a senior staff member to lead their board’s research and innovation programmes.

Health Boards publish Standards of Business Conduct policies setting out the expectations of staff as governed by legislation and Scottish Government circulars which should be maintained by all staff working in the NHS in Scotland. This includes independent contractors and locum healthcare professionals working under the NHS in Scotland terms and conditions. Healthcare professionals providing services to NHS patients are also bound by the codes and standards of their regulators and professional leadership organisations.

Most of the innovative pharmaceutical industry in the UK operates under self-regulation, which is set out in the Association of the British Pharmaceutical Industry (ABPI) Code of Practice. The Prescription Medicines Code of Practice Authority (PMCPA) is the self-regulatory body which administers the ABPI Code of Practice for the pharmaceutical industry, independently of the ABPI. Whenever a pharmaceutical company works alongside another organisation, it is usually governed by the ABPI Code.

Any collaborative working projects should be focused on delivering new initiatives that the NHS is not likely to be able to prioritise on its own. This work can encompass working in partnership with the NHS to explore service automation, redesign and transformation, however should not hinge upon these projects seeking to either deliver or replace an existing NHS service in its entirety.

There should be a pooling of resources, skills and expertise from all partners to a collaborative working project, with this resource and its outputs agreed prior to any work. It is accepted that the nature of the contribution of the distinct partners will differ, with each partner likely to be able to commit a different mix of resources (people, finance and equipment). There must be a shared commitment to successful delivery from all parties, and each party must make a significant contribution.

In addition, collaborative working projects as set out in Clause 20 of the ABPI Code of Practice, must:

• Enhance patient care or be for the benefit of patients, or alternatively benefit the NHS and, as a minimum, maintain patient care
• Not constitute an inducement to healthcare professionals or other relevant decision makers to prescribe, supply, recommend, buy or sell a medicine
• Be carried out in an open and transparent manner
• Be prospective in nature
• Be documented by a formal written agreement
• Have a summary of the agreement publicly available before arrangements are implemented
• Adhere to all relevant policies, including NHS policies
• In cases where treatment is mentioned, be in line with either nationally, regionally or locally agreed guidelines where such exist
• Ensure that the amount spent by pharmaceutical companies on collaborative working projects is publicly disclosed annually using established mechanisms.

The Chief Scientist Office

The Scottish Government’s Chief Scientist Office (CSO) oversees, manages and funds the research, development and innovation ecosystem in Scotland. CSO, and the networks and resource it funds through NHS Research Scotland (NRS) and the NHS Regional Innovation Hubs, prioritises working across and in partnership with the NHS, industry, third sector and Scottish universities. The CSO oversees pre-commercial procurements and the broader commercial/non-commercial clinical research and development across Scotland which remain outside the scope of this guide.

NRS is a collaboration between CSO and Scottish Health Boards to support and deliver clinical research. During 2023-24, NRS supported 1,568 studies (573 commercial and 995 non-commercial) recruiting 31,928 patients (8,146 commercial and 23,782 non-commercial) across the whole of Scotland.

CSO provides infrastructure support of c. £45 million to Scotland’s NHS Health Boards to support clinical research infrastructure. This includes the NRS Central Management Team, which provides a national single point of contact for advice and support; the Permissions Coordinating Centre which manages the multi-site approval system; NRS topic specific research networks and specialty groups which deliver national expertise and support; dedicated Clinical Research Facilities (CRFs) which provide research space and expertise. CSO also funds the NRS Biorepository network and Data Safe Havens which enable secure streamlined access to anonymised tissue and clinical data. The Scottish Health Research Register (SHARE) provides a growing research register of over 300,000 pre-consented patients. Locally, research is managed through dedicated research and development (R&D) offices embedded in NHS Health Boards.

This coordinated system is part of the integrated UK process delivering one submission of documents, one review of study contracts, using standard contract templates agreed UK wide, and one UK budget review using the agreed National Contract Value Review process. Scotland also supports a single Scottish pharmacy assurance within the UK Pharmacy Technical Assurance process.

Scotland is also fully engaged with UK partners as part of the UK Clinical Research Delivery programme to ensure compatible and consistent ways of working across England, Scotland, Wales and Northern Ireland,¹ further developing the UK as a cohesive and streamlined place to undertake research within the global economy.

Scotland hosts four of the 20 recently announced UK Commercial Research Delivery Centres (CRDCs) funded through the Voluntary Scheme for Branded Medicine Pricing, Access and Growth (VPAG) Investment Programme.²

Examples of recent successes include:

Moderna

A cancer patient in Dundee became the first patient in Europe to be administered a personalised cancer therapy (Individualized Neoantigen Therapy - INT) for gastro-oesophageal cancer. The patient received this investigational mRNA therapy developed by Moderna and MSD, through the Phase 1 clinical trial (NCT03313778). Its components are designed to target each patient’s tumour by analysing its biological make-up to discover which potential targets for the immune system are present on the tumour. Then an individualised injectable mRNA therapy is specifically created to enable the patient’s own immune system to attack and destroy those tumour cells. Tayside Cancer Centre, a University of Dundee and NHS Tayside facility, is one of 38 cancer centres around the world running this trial of the mRNA therapy, which is also being investigated in people with non-small cell lung cancer, pancreatic cancer, gastric and gastro-oesophageal cancer.

BioNTech

Ninewells Hospital in Dundee became the first hospital site in Europe to open a trial of a new investigational immunotherapy for an aggressive form of lung cancer. The early-stage Phase 2 clinical trial (NCT06449209) is investigating a new dual targeting antibody treatment candidate in small cell lung cancer, co-developed by BioNTech SE and Biotheus Inc. The investigational therapy targets the tumour blood supply and aims to engage the patient’s own immune system to eliminate the cancer. To be the first site to open in Europe highlights Scotland’s leading role in advancing cancer treatment, offering new hope for patients fighting one of the most challenging cancers. Lung cancer is the most common cancer in Scotland with around 5,500 cases diagnosed each year. Bringing together expertise from the NHS, academia and industry is essential to increase and accelerate clinical trials and provide the latest treatment options for patients.

Clinical and Translational Research Infrastructure in Scotland

Strong infrastructure and world-class clinical and academic expertise create a vibrant research environment in Scotland with clinical research embedded within our NHS. As a location for research and clinical trials, Scotland has a number of advantages over many other countries, including:

• A single unified health system – the NHS in Scotland³
• A stable population of c. 5.4 million with a high incidence of complex disease⁴
• Nationwide clinical research infrastructure⁵
• Some of the best health data in the world with an informatics capability that exploits electronic patient records, linkable through a unique NHS patient identifier, enabling clinical trials, stratified medicine and genetic studies.⁶

Further to these strengths, a strong ethos of partnership working between NHS, Academia and Industry continually enhances research, clinical and commercial opportunities in Scotland and together we work to ensure that Scotland remains an excellent single research site, while also improving our global competitiveness and helping us face the challenges of chronic disease.

Investments in nationwide clinical research infrastructure also supports researchers, clinicians and industry, providing state of the art facilities to conduct clinical trials across all therapy areas. The NHS in Scotland and partner universities have worked together to deliver a framework for a fully connected network delivering Scotland as a single clinical research site and gaining recognition for a number of internationally recognised centres of excellence.

NHS Regional Innovation Hubs

The NHS Regional Innovation Hubs, the West of Scotland,⁷ the North of Scotland⁸ and Health Innovation South East Scotland,⁹ collectively cover all 14 territorial NHS Health Boards in Scotland. Their primary function is to bridge the gap between research and practical application, driving positive outcomes for healthcare, the economy and society at large. The Hubs consist of professionals from various fields, including eHealth, research and innovation, clinical leads and other specialised support staff. They work in partnership with industry, academia and the third sector to run clinical evaluations, run market access studies and research and conduct real-world impact evaluations.

Accelerated National Innovation Adoption (ANIA) pathway

The ANIA pathway is focused on using technology to fast-track proven technological innovations into the healthcare system across the NHS in Scotland. It is delivered in collaboration with a range of national organisations to combine the right skills and capabilities across Scotland to reduce the barriers to national innovation adoption. It does not replace existing procurement methods for medicines or pharmaceutical products which have a distinct pathway for adoption in Scotland, separate to ANIA.

High impact innovations that meet the ANIA criteria will progress along the ANIA pathway and ultimately move to the development of a value case, which will clearly articulate both the value proposition to the NHS in Scotland, including the associated benefits, and costs for national adoption. Following approval, the innovation will proceed to full-scale national adoption and eventual handover to ‘business as usual’ clinical services.