The European Medicines Agency (EMA) has revised its policy on access to EudraVigilance data for medicinal products for human use, issuing a comprehensive framework that delineates how various stakeholders may obtain and utilise information contained within the EudraVigilance database. The policy, adopted by the EMA Management Board in December 2015 with a minor technical update to Annex B in September 2016 and entering into force on 22 November 2017 following the launch of the new EudraVigilance system, establishes a proactive approach to data disclosure. It aims to support enhanced safety monitoring of authorised medicines, improve signal detection and evaluation of potential safety issues, bolster research activities and provide clearer information on suspected adverse reactions to healthcare professionals, patients and the public, all whilst ensuring strict compliance with European Union data protection legislation. Specific access rights are attributed to different user groups, including marketing authorisation holders, national medicines regulatory authorities in the European Economic Area, academic institutions, international bodies such as the World Health Organization and regulatory authorities outside the EU, with detailed requirements regarding access tools, data elements available and confidentiality undertakings. The revisions, which incorporate a summary of changes under Revision five as set out on page three of the document and further detail access to EudraVigilance data, underline the EMA's commitment to transparency, data security and the continuous improvement of pharmacovigilance practices within a robust regulatory framework.

The European Commission has confirmed that Directive (EU) 2024/2853 (the revised Product Liability Directive) entered into force on 8 December 2024. The new rules seek to establish an up-to-date framework for victims seeking compensation for damage, such as personal injury, property damage and damage to data, caused by defective products, and provide greater legal certainty for economic operators. It applies to all products, including household items as well as artificial intelligence, software and product-related digital services, and to products sold online. Under the revised Product Liability Directive, the Commission will also develop a publicly accessible EU database of court judgments on product liability cases, with a view to better explain the application of the rules.

Employment analysis: A revised Employment Rights Bill (ERB), as brought from the House of Commons to the House of Lords was published on 14 March 2025. The second reading in the House of Lords is scheduled for 27 March 2025. The latest amendments proposed by the government are wide-ranging and include: (1) an extension of the right to be offered a guaranteed hours contract to agency workers, (2) the setting of statutory sick pay (SSP) at the lower of £118.75 or 80% of the employee’s normal weekly earnings, (3) the introduction of two alternative thresholds for determining whether the collective redundancy consultation obligation applies, (4) changes to the protected period for collective redundancy consultation, (5) a duty to keep records relating to annual leave, (6) an extension of the regulation of employment businesses, (7) changes to trade union legislation and (8) powers for the Secretary of State to issue notices of underpayments, to bring employment tribunal proceedings and to recover enforcement costs.

The Finland Arbitration Institute (FAI) has announced that the revised Arbitration Rules and Expedited Arbitration Rules came into force on 1 January 2024. The revised Rules contain updates in terminology including gender-neutral terminology.

Banking & Finance analysis: On 25 January 2024 the Loan Market Association (LMA) published an updated version of their Guidance for Green, Social, and Sustainability-Linked Loans External Reviews. This News Analysis looks at what has changed and key aspects of the updated guidance.

Local Government analysis: The Home Office issued the latest version of the Revised Guidance issued under section 182 of the Licensing Act 2003 (LA 2003) on 20 December 2022. David Wilson of a2z Licensing considers the changes.

Employment analysis: An updated version of the HR1 form, for use by employers to notify BEIS of a proposal to dismiss as redundant 20 or more employees, has been published by the Insolvency Service, as well as a new accompanying employer guidance document, on 3 August 2020.

The European Securities and Markets Authority (ESMA) and the European Commission have published guidance on the revised Markets in Financial Instruments Regulation (MiFIR). The revised MiFIR will apply from 28 March 2024, other than some parts of the regulation which will be phased in over the coming years. Further Commission delegated regulations are in the process of being developed, including on the single volume cap.

The Department for Transport (DfT) has laid the revised National Networks National Policy Statement (NPS) before Parliament.

Planning analysis: The government has published a revised version of the National Planning Policy Framework (NPPF). Key changes from the previous version, published in December 2023, impact green belt policy and policy on establishing housing need and housing land supply. There is also greater policy support for infrastructure and community facilities, among other changes. A consultation response, published on the same day, sets out the government’s commitments to wider changes to the planning system, including changes to the regime under the Planning Act 2008 (PA 2008) for nationally significant infrastructure projects (NSIPs), and changes to planning fees. This is a brief summary of the key changes; further analysis on the implications will follow.

Planning analysis: This analysis sets out comments from Jennifer Eng, Principal Associate at Capsticks on the National Planning Policy Framework (NPPF).

Judge Brian Doyle, President of the Employment Tribunals (England and Wales), has amended and reissued the Presidential Guidance on general case management. The guidance was revised to remove all references to and relating to employment tribunal fees, following the Supreme Court’s decision in R (on the application of UNISON) v Lord Chancellor [2017] UKSC 51 that fees were unlawful. Editorial revisions have also been made.