ABPI Consultation on industry principles for use of health data

Trust, transparency, and public involvement are at the heart of how we should use health data.

That’s why we’re consulting on new principles for the pharmaceutical industry that do just that.

Health and genomic data can accelerate our understanding of disease, improve healthcare services, and support the discovery, development, and evaluation of new medicines.

The NHS routinely collects and stores data on everything from health services to treatments and outcomes across the country. There’s enormous potential to unlock this data and help push back the frontiers of research and medicine.

We are seeking input from the public, researchers, data custodians and patient representative groups on a set of draft governance principles that the biopharmaceutical industry will adhere to when analysing and using UK health data. These will complement the governance processes established by the data custodians and help build trust and transparency into the system.

What are the draft principles?

Principle 1: Transparency of purpose

Industry will be clear and open about what company researchers aim to do with health data; how the data will be analysed, what the expected benefits are and how risk will be managed.

Principle 2: Clarity of arrangements

Contractual arrangements with data custodians will be designed to return ‘fair value’ as agreed by both parties, with the goal of contributing to the sustainability of the system (recognising the costs associated with collecting, validating, curating, storing, and analysing the data), regardless of whether the outcomes of individual projects are positive or negative.

Principle 3: Patient and Public Involvement and Engagement (PPIE)

Industry will support the trend towards efficient involvement of patient/public representatives in the design and approval of health data projects, whether within their organisations or when projects are reviewed by data custodians.   

Principle 4: Non-exclusivity of arrangements

Benefits accruing will be applied across the UK health service, for the benefit of all appropriate patients, hence supporting the principle that any dataset should be available for analysis by any bona fide researchers at any time.

Principle 5: Compliance with prevailing laws and regulations

All projects and arrangements will adhere to national level legal, regulatory, privacy and security obligations.

Thank you for taking part in the survey

These principles – and our members’ commitment to them – will underpin our work to generate and maintain public trust in the research-based biopharmaceutical industry and its use of health data in the long term.

The consultation closed on 11 March 2022 and now the ABPI will review the submissions.