Artificial Intelligence


  • On 13th March the European Parliament approved the text of the EU AI Act. Once the Council has signed off the text (expected later this month), it will be published in the Official Journal and will enter into force 20 days after publication. Please see adopted text of the AI Act here

Code of Practice

United Kingdom

  • On 27th March the PMCPA published rulings in three cases: i) Teva – Case AUTH/3656/6/22 concerning failure to include prescribing information, a black triangle and failure to include a prominent adverse event reporting statement. The PMCPA ruled breaches of clauses, 2, 3.2, 4.1, 4.9, 4.10, 7.11, 9.1 and 14.1; ii) Daiichi Sankyo – Case AUTH/3673/7/22 concerning provision of misleading information which could have prejudiced patient safety. The PMCPA ruled breaches of clauses 2, 5.1 and 6.1; and iii)  Daiichi Sankyo – Case AUTH/3677/7/22  concerning provision of misleading information and misleading impression incapable of substantiation, which was particularly serious and could have prejudiced patient safety. The PMCPA ruled breaches of clauses 2, 5.1, 6.1 and 6.2.

Competition Law


  • On 26th March the European Commission opened a formal antitrust investigation into possible anticompetitive conduct by Zoetis. The investigation will assess whether Zoetis may have breached EU competition law rules by preventing the market launch of a competing novel biologic medicine for treatment of chronic pain in dogs. See European Commission press release here

United Kingdom

  • The Competition and Markets Authority (CMA) has opened a consultation on whether to launch a Market Investigation Reference (MIR) into the veterinary services market for household pets. The consultation is open until 5pm on 11th April 2024 and follows the CMA’s review of veterinary services for household pets in the UK in September 2023. For further information see here

Clinical Trials


  • On 13th March the Malaysian Drug Control Authority agreed to update the Malaysian Guideline for Application of Clinical Trial Import License (CTlL) and Clinical Trial Exemption (CTX) Edition 8.0 which will published on 30 April 2024

Criminal Enforcement

United Kingdom

  • A company director and his pharmaceutical manufacturing company have been successfully prosecuted for knowingly providing falsified data to the MHRA in order to obtain a marketing authorisation. The MHRA Deputy Director (Criminal Enforcement) commented, “This is a shocking case of a pharmaceutical company that thought it was above the law and was not required to uphold our stringent standards for safety, quality and effectiveness.” For further information on the case see the MHRA press release

Data Privacy

United Kingdom

  • The Information Commissioner’s Office has published new data protection fining guidance, setting out how it decides to issue penalties and calculate fines. See here for further information.

Pharmaceutical Law Reforms


  • The European Parliament’s ENVI Committee met on 19th March to discuss the new pharmaceutical framework and vote on the compromise text regarding the draft Regulation and revised Directive. The final text will be voted on in the plenary scheduled for 10th April 2024. EFPIA expressed ongoing concerns with the proposed text in response to the ENVI Committee adoption of the amendments to the EU pharmaceutical legislation. The EFPIA response is available here

Health Data


  • A provisional agreement has been reached on the European Health Data Space (EHDS) after difficult negotiations. See the European Council press release here . Prior to the negotiations EFPIA had issued a press release setting out its concerns. See its 13th March press release here


  • The German Ministry of Health has announced that the German Health Data Use Act has been enacted on 25th March. The Act aims to advance health data research by allowing pharmaceutical companies to access health data for research purposes. See the text of the new law (in German) here

Health Technology Assessments


  • The EU public consultation on implementing the EU Health Technology Assessment Regulation closed on 2nd April. For more information on this initiative see here . EFPIA has separately commented that guidance is needed to ensure that EU Joint Clinical Assessments can improve patient access to innovative cancer treatments. See EFPIA press release

Intellectual Property


  • In a recent EPO Board of Appeal decision in  T 1437/21 about the validity of a patent, for the second medical use of a known drug in a sub-population of patients, The Board of Appeal held the claimed invention was novel and involved inventive step. The patent claims had been challenged on the basis of prior art in summaries and press releases about the success of earlier phase III clinical trials in the broader population. However, the patent was found novel and inventive on the grounds that the efficacy of the drug in the claimed subpopulation could not be derived, or be reasonably expected, in view of the press releases.
  • On 13th March MEPs voted to allow compulsory licensing of patented drugs in emergency situations. The Regulation on compulsory licensing for crisis management was proposed by the EU Commission in April 2023 (see proposal ). The proposal has met with considerable criticism, including from EFPIA , which previously stated that “the introduction of compulsory licensing at the EU level would promulgate the perception of companies and investors that Europe’s intellectual property framework is not predictable or stable.”

Marketing Authorisations


  • The CHMP recommended twelve medicines for approval at its March 2024 meeting. See here for further information.

Medical Devices

United Kingdom

  • On 11th March the UK government published its response to an independent review of equity in medical devices. See Government Response and MHRA Response to the independent review.

Pricing and Reimbursement

United Kingdom

  • The UK government has opened a consultation to seek views on a proposal to update the statutory scheme to control the cost of branded health service medicines. The government is proposing to update the statutory scheme to maintain broad commercial equivalence with VPAG, the voluntary scheme for branded medicines pricing. The consultation is open until 26th April 2024. For further information on the consultation and proposed updates to the statutory scheme, see here

For further information on these developments and how it could affect business, please contact us, we are always happy to provide our insights.

You can also stay informed and ahead of the curve by subscribing to our newsletter and following us on LinkedIn.