- September 2020
OHE publishes a report on the legal barriers to the better use of health data to deliver pharmaceutical innovation. As a society, we place a huge value on data: from supermarkets using our previous shopping habits to help us effortlessly…
OHE publishes a report on the legal barriers to the better use of health data to deliver pharmaceutical innovation.
As a society, we place a huge value on data: from supermarkets using our previous shopping habits to help us effortlessly select our preferred tea bags, to insurance companies tailoring their offerings to our specific motoring needs. With the proliferation of digital technology, we are collecting more and more data in real-time, through which we can discern patterns in behaviour and begin to predict events. The health care market is no exception.
Despite the exciting new opportunities that the expansion of health data creates, these opportunities are necessarily bounded by the legal framework which governs how data can be collected, accessed, and used. In an OHE Consulting Report, recently published, we outline the main legal barriers to the better use of health data to deliver pharmaceutical innovation. To identify tangible and specific legal barriers, we investigated the legal issues arising from six key activities along the pharmaceutical lifecycle:
A key development in this space was the introduction of the General Data Protection Regulation (GDPR) earlier this year. For most, mention of the GDPR seems to conjure feelings of uneasiness (what does this mean for me?), confusion (is this personal data, and do I need consent/re-consent to use it?), or exasperation (dealing with the flood of new privacy notices filling up your email inbox from other companies grappling with the same issues). The Regulation, which became law across all European countries in May 2018, intends to harmonise data protection practices across Europe. However, considerable ambiguity remains. This ambiguity – which arose in consideration of all six activities considered in our report – is principally around the appropriate legal basis for data processing in the absence of consent. Under the GDPR, pharmaceutical companies should be considered to have “legitimate interests” in processing data (Article 6), which due to its sensitive nature must and does undergo rigorous safeguarding activities, and must meet one of the additional legal bases for processing health data outlined in Article 9: (h) provision of health or social care, (i) public interest in the area of public health, or (j) scientific research. In our report we speculate which legal bases may be most appropriately applied to the six pharmaceutical activities studied, but clear guidance and consensus is required.
The legal barriers that arise in the utilisation of data by pharmaceutical companies vary across a product’s lifecycle. However, the main issues can be described under eight main themes.
The GDPR was not designed to hamper important scientific research, and we propose that it does not create new legal barriers. In assessing the legal barriers to the better use of data, many of the issues we identified were uncertainties rather than barriers per se. Therefore, there is a strong case for industry to deal proactively with the uncertainties, sharing good practice and engendering trust by co-creating a code of conduct, outlining principles of responsible use.
We all have a stake in how our health data are collected and used to drive innovation and improvements in health care delivery. A shared understanding of the value to society of pharmaceutical research is therefore necessary and underpins our legal frameworks.
Cole, A. and Towse, A., 2018. Legal Barriers to Better the Better Use of Health Data to Deliver Pharmaceutical Innovation. OHE Consulting Report, London: Office of Health Economics.
Cole, A., Garrison, L., Mestre-Ferrandiz, J. & Towse, A., 2015. Data Governance Arrangements for Real-World Evidence. OHE Consulting Report, London: Office of Health Economics. RePEc.
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