UK Law and Practice Contributed by: Adela Williams, Ewan Townsend, Libby Amos-Stone and Eleri Abreo, Arnold & Porter
2.5 Use of Data From Clinical Trials Data resulting from clinical trials is likely to be consid- ered as special category (sensitive) personal health data for the purposes of the data protection legisla- tion, even if it is in coded/pseudonymised form, and will be afforded greater protection than non-special category personal data. The Data Protection Act 2018 and the UK GDPR provide that pseudonymisation is a security measure that can be used to protect personal data, but it does not mean that the data is beyond the scope of the UK GDPR. The resulting data can be transferred to a third party or affiliate, provided that any UK GDPR provisions gov- erning such a transfer are complied with. The Data (Use and Access) Act came into effect on 5 February 2026, amending the UK GDPR and Data Protection Act 2018 including by allowing patients to provide “broad consent” to use of their personal data for an “area of scientific research” rather than for spe- cific, narrowly defined studies. 2.6 Personal or Sensitive Data Any database containing personal data, including special category (sensitive) personal health data, must comply with the UK GDPR, which requires that: • the data are processed lawfully; • the data are relevant, up to date and limited to what is required; • sufficient security measures are put in place; • the data are not stored for longer than is neces- sary; and • the relevant individuals have been informed of the use and storage of their data. The person managing the database would also need to comply with the requirements of the UK GDPR.
• any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or • any substance or combination of substances that may be used by or administered to human beings with a view to: (a) restoring, correcting or modifying a physiologi- cal function by exerting a pharmacological, immunological or metabolic action; or (b) making a medical diagnosis. The UK Medical Devices Regulations define a medi- cal device as any instrument, apparatus, appliance, software, material or other article, used alone or com- bined, for humans to: • diagnose, prevent, monitor, treat or alleviate dis- ease; • diagnose, monitor, treat, alleviate or compensate for an injury or handicap; • investigate, replace or modify the anatomy or a physiological process; or • control conception. To distinguish between medical devices and medicinal products, it is necessary to consider: • the intended purpose of the product, taking into account the way the product is presented; and • the method by which the principal intended action is achieved. Where the assessment is not straightforward, or where disagreement arises, the MHRA’s Medicines Border- line Section is able to issue determinations. Where a product falls into more than one category, a product will be classified as a medicinal product. 3.2 Marketing Authorisation for Biologic Medicinal Products A medicinal product may only be placed on the UK market if it has been granted a marketing authorisa- tion (MA). Biological medicinal products must meet the same quality, safety and efficacy criteria to obtain an MA as those for non-biological medicinal prod- ucts. However, since biological medicinal products are especially sensitive to a change in starting materials or manufacturing conditions, they are subject to specific
3. Marketing Authorisations 3.1 Product Classification The HMRs define a medicinal product as:
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