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eAlerts Récentes

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  02/10/2024

  Hongrie

  Hungary begins implementation of EU AI Act with passage of Resolution

  The Hungarian government has issued Resolution 1301/2024. (IX. 30.), which establishes the foundation for creating the body responsible for implementing the tasks required by the EU AI Act. In issuing this resolution, Hungary has begun preparations for enforcing the regulation, which means that companies should now prepare for compliance by reviewing the AI systems they use, assessing these systems' alignment with the EU AI Act's requirements, and preparing the necessary risk management documentation to ensure transparency, accountability, and safety.Hungary’s new enforcement body will:Operate...

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  25/09/2024

  Belgique

  The Belgian Data Protection Authority publishes an informative brochure on artificial intelligence systems and the GDPR

  The Belgian Data Protection Authority has just published a brochure entitled “Artificial Intelligence Systems and the GDPR - A Data Protection Perspective” to explain the GDPR requirements specifically applicable to the development and deployment of AI systems. We have set out below a summary of this brochure and provided some key takeaways.The intersection of artificial intelligence (“AI”) and data protection law has become increasingly relevant in today’s digital landscape. As AI technologies evolve, they pose unique challenges that necessitate a thorough understanding...

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  25/09/2024

  Europe

  Priority entitlement: the EPO implements the new “rebuttable presumption” criteria of G 1/22 and G 2/22 (T 2360/19)

  In recent Technical Board of Appeal decision T 2360/19, the Board considered the validity of priority claims following the Enlarged Board of Appeal consolidated decision G 1/22 and G 2/22.The opposed patent EP2784162 in the name of The Broad Institute, Inc. relates to CRISPR gene editing technology and is a divisional of EP2771468. The parent patent EP2771468 was previously revoked as confirmed by the Board of Appeal decision in T 844/18 (discussed in our article here) following case law known as the “same applicant” or “all applicants approach”, which preceded G 1/22 and...

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  23/09/2024

  Pologne

  Polish Constitutional Court's position on restrictions on the pharmacy market - ‘Pharmacy for the Pharmacist 2.0’ law amendment unconstitutional

  GB PL

  In a judgment of 18 September 2024 (K 15/23), the Polish Constitutional Court found that the much-discussed amendment to the Pharmaceutical Law, widely known as Apteka dla Aptekarza 2.0 (Ada 2.0) or Pharmacy for the Pharmacist 2.0, contravenes the Polish Constitution in the way it was introduced.Ada 2.0 restricts the ability of entities or individuals who are not licensed pharmacists from taking control of pharmacies. Specifically, Ada 2.0 provides for the following:It prevents the acquisition of control, within the meaning of competition and consumer protection legislation, of an entity operating...

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  20/09/2024

  Hongrie

  CJEU ruling allows for VAT paid on subsidised pharma products to be partially reclaimed

  The Court of Justice of the European Union (CJEU) published a landmark ruling in a preliminary ruling procedure that will significantly benefit the Hungarian pharmaceutical industry.As a result of the decision, the sector’s VAT burden could be significantly reduced. In addition, distributors and market authorisation holders can request partial refunds on VAT payments on the sales of medicinal products and dietary supplements over the last five years if they were subject to a specific repayment obligation to Hungary’s National Health Insurance Fund (NEAK). These requests can be made...

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  19/09/2024

  Ukraine

  New Ukrainian law regulates off-label use of medicines

  On 21 August 2024, the Ukrainian parliament introduced new legislation that formalises the off-label use of registered medicinal products. This regulation establishes clear procedures for healthcare professionals (HCPs) to prescribe medicines for non-authorised indications, age groups, dosages, or methods of administration, which are commonly known as off-label use. The goal is to ensure patient safety, transparency, and accountability in off-label prescriptions by requiring informed consent, medical advisory board approval, and thorough documentation.The new mechanisms complement the existing...

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