The Association of the British Pharmaceutical Industry (ABPI) Public Consultation on New Draft Data Governance Principles
The Association of the British Pharmaceutical Industry (ABPI) has launched a public consultation on new draft Governance Principles that will set the terms for how Industry will use health data and help patients access potential medical advances.
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.
These principles aim to put trust, transparency, and public involvement at the heart of how the pharmaceutical industry uses health data – to accelerate our understanding of disease, and support the discovery, development, and evaluation of new medicines. They will also complement the governance processes established by data custodians. Further context and background are available in the online consultation form.
To inform the development of these principles, we are seeking input from the public, researchers, data custodians and patient representative groups. The online consultation page is available here and we would welcome feedback by 11th March.
We hope to reach a wide range of contributors and would welcome any support you can offer in cascading this to any relevant networks. Our tweet and press release are available via these links.