Anti-microbial Resistance

UK

  • The Association of the Bristish Pharmaceutical Industry (ABPI) has set out its response to the United Nations General Assembly political declaration on antimicrobial resistance. See ABPI response here

Artificial Intelligence

EU

  • The European Medicines Agency (EMA) has now adopted its reflection paper on artificial intelligence (AI) following its consultation and months of review and feedback. The final version of the reflection paper is available here
  • A kick-off plenary to help develop the general-purpose AI Code of Practice has taken place online. See European Commission press release for further information.
  • The EMA and Heads of Medicines Agencies have published a draft strategy to 2028 for public consultation. The draft strategy aims to prepare the European medicines regulatory network to handle changes in the field of medicines regulation, including how to leverage data, digitalisation and artificial intelligence. The consultation is open until 30 November 2024 and further information is available here

Brexit

UK

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the Windsor Framework which now includes a webinar in preparation for the Windsor Framework implementation date on 1 January 2025. See here for the updated guidance.
  • The ABPI has published an article ‘Getting ready for the Windsor Framework: ensuring continuity of UK medicines supply beyond 1 January 2025’. See here for the article. 

Codes of Practice

UK

  • The Prescription Medicines Code of Practice Authority (PMCPA) has released training webinars and an e-learning module on the updated Code of Practice for the pharmaceutical industry, explaining the changes in the 2024 ABPI Code. See here for the webinars and e-learning module.
  • The PMCPA has published updated Q & As for the 2024 Code of Practice, including updated Q & As to clause 12. See here for updated clause 12 Q & As.

Data Privacy

EU

  • Advocate General Medina has issued an opinion in Case C383/23 confirming that the General Data Protection Regulation (GDPR) fines for subsidiary infringement should reflect group turnover. See Opinion for further information.
  • On October 4th, 2024, the Court of Justice of the European Union (CJEU) published its decision in case C-507/23 regarding compensation for non-pecuniary damages under the GDPR. See Judgement for further information.
  • On 4 October 2024, the CJEU published its judgment in case Koninklijke Nederlandse Lawn Tennisbond v Autoriteit Persoonsgegevens (C-621/22). The CJEU clarified the meaning and conditions of legitimate interest as a legal basis for processing personal data under Art.6(1)(f) GDPR. See Judgement for further information.
  • The CJEU has published its decision in the Lindenapotheka case C-21/23, ruling that information entered by customers when ordering pharmacy-only medical products constitutes health data. It also concluded that the GDPR does not preclude national legislation which confers on competitors of a person allegedly infringing the GDPR, the right to bring an action against that person for such GDPR infringement on the basis of unfair commercial practices. See CJEU press release for further information.
  • The European Data Protection Board (EDPB) has adopted an Opinion on processors. The Opinion addresses eight questions on the interpretation of certain duties of controllers relying on processors and sub-processors, as well as the wording of controller-processor contracts, arising in particular from Art. 28 GDPR. See here for further information.
  • The EDPB has adopted Guidelines on the processing of personal data based on legitimate interest. The Guidelines will be subject to public consultation until 20 November 2024. See here for further information.
  • The European Commission has issued a first review of the functioning of the adequacy decision on the EU-US Data Privacy Framework. See Review Document for further information.

UK

  • The Information Commissioner’s Office (ICO) has launched a new audit framework to help organisations assess their own compliance. See ICO press release for further information.

Environmental Sustainability

EU

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a statement outlining how the EU can incentivise environmental sustainability of new medicines. See EFPIA statement here

Market Access

EU

  • The European Commission has launched a public consultation on the draft implementing act on joint scientific consultations on medicinal products for human use at Union level under the Health Technology Assessment (HTA) Regulation. The consultation is open until 29 October 2024. See here for further information.

UK

  • The ABPI has published an article outlining its review of the first six months of the UK’s voluntary pricing scheme, VPAG. See ABPI article here

Regulatory

EU

  • The EMA and the European medicines regulatory network have launched an initiative to further improve efficiency in the assessment and approval processes of new medicines in the European Union, including outlining measures to optimise use of the EU’s expert resources for faster assessments. See EMA press release for further information.

Tax

EU

  • The CJEU has ruled that payments made by pharmaceutical companies to state health insurers are rebates rather than taxes. The CJEU has looked at the rules around deduction of pharmaceutical subsidies from the VAT base previously, but this is the first case where the contributions being considered were mandatory payments in law rather than under contractual agreements. The CJEU ruled that these contributions qualified as rebates, which under VAT rules can be deducted from the VAT base. See Judgement in Case C-248/23 for further information.

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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