Pharma forum is back. Join us on Thursday 22 September, when Data Protection and Privacy Partner Victoria Hordern will be delving into the EU's digital strategy and the direction of the UK's data protection regime. The impact of data privacy regulations for pharmaceutical and biologics companies is just one of the topics to be discussed – see our full agenda here.
The EU announced its ambitious digital strategy in early 2020. Within this strategy lies two central themes – use of data and use of artificial intelligence (AI). Since then, draft laws have proliferated out of the European Commission to cover the digital space. There is a Digital Services Act and a Digital Markets Act. There is a Data Act and a Data Governance Act. And, of course, there is an AI Act. Regrettably, terminology and the sheer volume of regulation doesn't make the overall proposed legal landscape easy to digest. But for any business, and particularly businesses embracing digital technologies and whose lifeblood is data, getting a handle on the EU's new digital strategy will be essential.
For one thing, the EU is proposing a series of data spaces. These are designed 'to harness the value of data for the benefit of the European economy and society' and will lead to 'the development of common European data spaces in strategic economic sectors and domains of public interest'. The first one out of the blocks is the highly significant European Health Data Space (EHDS). The EHDS is truly ground-breaking in its proposal to create a system for the secondary use of health data for research and innovation. While the details are still being debated by the EU institutions, and concerns have been raised by EU data protection watchdogs, it promises to give individuals more control of their data in the primary care environment, while encouraging institutions (public and private) to make data available for purposes designed to benefit the public good. The EHDS offers an exciting opportunity for any European life sciences business and we'll be looking at the EHDS and its proposed stages for the secondary use of health data at the Pharma forum.
The other hugely significant development in the EU's digital strategy relates to the regulation of AI. AI is now used so widely across all sectors and contexts but one of the areas where it is already making a massive impact is in pharma and biotech. From disease detection to drug discovery as well as management of clinical resources, AI has enormous potential in the life sciences and healthcare sector. The AI Act proposed by the European Commission is designed to prevent the worst excesses that AI could be put to, ie invasive surveillance. But devices developed and used by pharma and biotech companies could also be classified as high-risk AI systems subject to additional restrictions under the proposed law.
And then there are the proposed EU laws dealing with data more specifically – the Data Governance Act and the Data Act. What do these laws mean for businesses given they both focus on encouraging the sharing of data?
And to what extent is the UK mirroring these EU initiatives? While the EU appears to have no immediate plans to update the GDPR, the UK is in the middle of reforming its data protection regime. What will the end result mean for UK businesses?
We'll discuss all this and more at the upcoming Pharma forum.
Exploring the legal and commercial issues that matter most to pharmaceutical and biologics companies across the UK and Europe.