Data protection and life sciences

Personal data is at the very core of every life science business. Life sciences companies handle significant amounts of personal data and are reliant upon the collection and use of personal data, which often includes sensitive health-related data, in order to carry out key business functions. For example, conducting clinical trials on patients, collecting data on drug safety and adverse reactions in order to comply with pharmacovigilance requirements, and collecting genetic information for the development of personalised medicines all rely on the collection and processing of data relating to individual data subjects. Consequently, it is vitally important that life sciences companies understand, and are in compliance with, the strict rules that apply to the processing of personal data.

This Overview provides an introduction to the application of the data protection regimes to key areas of the life sciences under the EU General Data Protection Regulation, Regulation (EU) 2016/679 (EU GDPR) and the United Kingdom General Data Protection Regulation, Assimilated Regulation (EU) 2016/679 (UK GDPR) (together the ‘GDPR regimes’).

Assimilated law is the name given to retained EU law (‘REUL’) which remains in force after

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Latest Life Sciences News

Life Sciences weekly highlights—16 January 2025

This week's edition of Life Sciences weekly highlights includes news analysis on the Court of Justice’s decision to introduce an invention test for combination products to be eligible for supplementary protection certificates. Also included, is news that the MHRA published a collection of post-market surveillance guidance to support the new PMS regulation adopted 16 December 2024, EMA announced its readiness to support the implementation of the new regulation on health technology assessment effective on 12 January 2025, the ICH has adopted a new version of its Guideline for Good Clinical Practice E6(R3), the European pharmaceutical industry proposed a phased implementation of electronic product information for medicinal products, the European Commission has unveiled an action plan aimed at strengthening cybersecurity measures in the healthcare sector and it launched the COMBINE programme aimed at harmonising drug-device studies, among other stories.

MHRA releases guidance on new Medical Devices Post-Market Surveillance requirements

The MHRA has released a collection of guidance documents to support medical device manufacturers implement the new Post-market surveillance (PMS) regulation SI for medical devices in Great Britain (GB) which will come into force on the 16th June 2025.

What is an ‘active ingredient’ for an SPC?—the UK IPO rules out excipients but on what basis? (Halozyme v The Comptroller-General of Patents)

Life Sciences analysis: The Patents Court has confirmed the UK IPO Hearing Officer’s decision to refuse to grant two SPCs for combination products in circumstances where both products in each combination are not ‘active ingredients’ within the meaning of Article 1(b) of the SPC Regulation. The products were combinations of Trastuzumab with recombinant human hyaluronidase, and Rituximab with recombinant human hyaluronidase. The judge agreed with the lower tribunal that recombinant human hyaluronidase was not an active ingredient within the SPC Regulation, which requires that ‘a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation’. The judge held that the UK IPO Hearing Officer was entitled to make the findings he did about recombinant human hyaluronidase and that, therefore, it can be appropriate to refer primarily to the regulatory documentation that accompanies a drug (the SmPC and EPAR). Particularly, in situations where additional documentation adds nothing. He would, however, not be drawn into finding that those should be the only documents referred to (as the UK IPO was urging for simplicity). Of interest is that this judgment was made while the same question was pending before the Court of Justice from a referral by the Czech Supreme Administrative Court, which the judge indicated could be persuasive. Written by Daniel Byrne, partner at Venner Shipley LLP.

NICE consultation open about proposed changes to routing criteria for highly specialised technologies

The Highly Specialised Technologies (HST) Programme evaluates technologies for ultra-rare diseases (defined in NICE strategic principles, and previously referred to as ‘very rare’). The HST Programme is designed to be used in exceptional circumstances. It can be challenging to identify the exceptional circumstances when the HST methods and processes should be used. This is because of the difficulty in getting the information needed at the point of a routing decision. Proxy information is often relied on and used to make judgements. The consultation opened on 19 December 2024 and will run until Thursday, 30 January 2025, with a closing time of 5 pm for comments.