Artificial Intelligence
EU
Proposed new AI Act deal has been agreed upon by EU lawmakers – the text has yet to be published, but statements issued by The Parliament and Council provide some insight into agreed provisions.
Consultation on the reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle due to close on 31st December 2023 – please see the reflection paper and details for providing feedback here
Code of Practise
UK
The PMCPA has just launched its consultation on proposed changes to the 2021 Code of Practise. The consultation is now open for feedback and will run until 29 February 2024. The 2024 Code will be published in the second quarter of 2024. Please see information on the consultation and table of proposed changes for further information.
Data Privacy
EU
The Court of Justice of the European Union (CJEU) has reconfirmed the circumstances when businesses can be fined for breaching the General Data Protection Regulation (GDPR) – two judgements issued on 5th December confirmed that data controllers should not receive a fine unless an infringement was committed intentionally or negligently. The second judgement clarified the meaning of the term ‘undertaking’ when determining turnover and size of fines. See the Press Release of the CJEU and Ruling: Case C-683/21 and Ruling: Case C-807/21
UK
The Information Commissioner’s Office (ICO) recently launched a consultation on its draft guidance on transparency in the health and social care sector. The draft guidance is relevant to private sector organisations who deliver health and social care services, especially if using personal data for secondary purposes, research, sharing records and planning services. The guidance sets out expectations on transparency and emphasises the need to go beyond GDPR to build trust – see further details of the consultation, which is open until 7th January 2024
Health Data
EU
The European union and WHO have signed a €12 million agreement to strengthen health information systems and boost health data governance and interoperability in the WHO European region. The project aims to improve the use and reuse of health data and foster safe, reliable and resilient health information systems. See the European Commission press release here
EFPIA has responded to the text adopted by the European Parliament on the European Health Data Space (EHDS) and says more work is needed to ensure the right data is available and to protect stakeholder intellectual property and trade secrets – see statement. A stakeholder coalition has also called for refinement of the EHDS setting out its recommendations to address five key challenges – see statement and recommendations
Marketing Authorisations
UK
A reminder that the new International Recognition Procedure (IRP) will replace the EC Decision Reliance Procedure (ECDRP) on 1st January 2024. Information on the IRP is available here
Supply of Medicines
EU
The first version of the Union list of critical medicines has been published. The list specifies those medicines which are critical, cannot easily be replaced with other medicines and where prevention of shortages is particularly important. See EMA’s press release and the Union list of critical medicines here
For further information on these developments and how it could affect business, please contact us, we are always happy to provide our insights.
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