Genomics in Scotland strategy: business and regulatory impact assessment

Business and regulatory impact assessment (BRIA) for the Genomics in Scotland: Building our Future five-year national strategy (2024 to 2029).


5. Regulatory and EU Alignment Impacts

Intra-UK Trade

The strategy, which aims to improve the accessibility and availability of genomic medicine services for people in Scotland, may have an impact on intra-UK trade. A significant amount of genomic testing is carried out by providers, commercial or NHS operating commercial services, elsewhere in the UK. In some cases, this is the most cost-effective option (i.e. highly specialised services, ultra-rare indications) but there are tests that may be supported more cost-effectively in Scotland. It is possible that, in the future, laboratories may offer testing services externally if capacity is increased.

International Trade

It is possible that transforming services to use modern equipment and methods may facilitate more international trade. Developing the genomics medicine infrastructure in Scotland may support further inward investment. The Scottish Science Advisory Council report in 2019 concluded that, in relation to clinical cancer genomics, “the biggest opportunity is the potential to attract clinical trials to Scotland, which would maximise patient benefit in the shortest timeframe whilst bringing investment into Scotland.” Potential investment along these lines is also relevant for research into rare and inherited conditions and precision therapy trials which also rely on the provision of comprehensive genomic information and the infrastructure to support equitable access to genomically-driven platform trials.

EU alignment

This strategy should have no impact on the Scottish Government’s policy to maintain alignment with the EU. It is important that we ensure that genomic information generated in Scotland can be integrated with information from elsewhere in the UK but it is also important that it is compatible with both EU and international data standards to maximise insights and generate opportunities for collaboration.

Contact

Email: holly.ennis@gov.scot

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