The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have published a guidance on their guiding principles on the transparency of machine learning medical devices. The transparency principles provide good practice guidelines on transparency for all medical devices.

This Practice Note provides an overview of the Medicines and Medical Devices Act 2021 (MMDA 2021) which, in summary, makes provision about a Commissioner for Patient Safety in relation to human medicines and medical devices, enables the existing UK regulatory frameworks for medicines and medical devices to be updated following the end of the implementation period, consolidates the enforcement provisions on medical devices and allows the sharing of information on medical devices. The Practice Note outlines the legal context and the purposes of MMDA 2021, tracks the steps of its legislative procedure and examines the key provisions on human medicines, clinical trials and medical devices: • Background and purposes of the Medicines and Medical Devices Act 2021 • Overview of the Medicines and Medical Devices Act 2021 • Part 2—Human medicines • Part 4—Medical devices • Timeline of legislative procedure and commencement This Practice Note does not track the steps of secondary legislations made under MMDA 2021. For further discussion, see News Analysis: Analysing the Medicines and Medical Devices Act 2021. For key secondary

Medicines for Europe has issued a press release highlighting the need for substantial reforms in EU pharmaceutical regulation. The organisation has emphasised that the current review of EU pharmaceutical legislation presents a crucial opportunity to modernise regulatory frameworks, particularly for generic medicines which constitute 70% of prescriptions. The proposed changes include digitalising regulatory processes, simplifying administrative procedures, and implementing the European Medicines Agencies Network Strategy 2028 Strategic Plan to enhance access to generic and biosimilar medicines. The organisation specifically advocates for connecting European Medicines Verification System and  substances, products, organisations and referentials systems to monitor medicine shortages, introducing electronic patient information, and gradually eliminating paper leaflets. These reforms aim to create a more agile, efficient, and digitally-advanced regulatory network while maintaining scientific rigour.

Medicines for Europe has reported sustained shortages of essential medicines, including critical antibiotics such as amoxicillin, indicating a structural market failure rather than isolated disruptions. Analysis presented by Director General,  Adrian van den Hoven, shows that manufacturers face sharply rising production, labour and energy costs while national pricing systems continue to suppress the prices of off-patent antibiotics. A study across sixteen European countries found that antibiotic prices have declined by around 10% since 2020, despite production and raw material costs increasing by more than 30%, contributing to product withdrawals and hundreds of shortages. These pressures have weakened supply chains, reduced market participation by manufacturers and forced clinicians to rely on alternative treatments, with consequences for infection control and antibiotic resistance.

Medicines for Europe has issued an open letter to the European Commission, Ministers of Health, Industry and Environment across the EU, urging coordinated legislative action to protect patient access and strengthen the supply of critical medicines. The letter proposes a Pharmaceutical Action Plan comprising three key measures. First, it calls for the expedited adoption of EU pharmaceutical legislation, cautioning against extending intellectual property (IP) exclusivities, which could cost healthcare systems up to €100 billion, while delaying generic and biosimilar market entry and inflating public spending. Second, it urges amendments to environmental laws, notably the Urban Wastewater Treatment Directive, which may impose unaffordable levies on essential medicines, jeopardising supply and access—especially for diabetes and antibiotic treatments. Third, it recommends boosting domestic production of critical medicines through EU funding, revised state aid rules, and health security provisions in trade agreements. The signatories include CEOs and senior executives from major pharmaceutical companies across Europe.

Medicines for Europe has applied to intervene in legal proceedings before the EU General Court challenging the EPR scheme in the recast Directive 91/271/EEC (Urban Wastewater Treatment Directive (UWWTD)) . The group argues the scheme imposes disproportionate costs on the generic medicines sector based on flawed toxicity data and threatens patient access and supply. The case questions the legality and scientific basis of EU environmental regulation impacting pharmaceuticals.

Medicines for Europe has announced that its member companies, including Adamed, Fresenius Kabi, InsudPharma, Polpharma, Sandoz, Stada, Zentiva and Teva, have appealed to the European Court of Justice (ECJ) against the General Court’s decision rejecting their standing to challenge cost allocations under the Urban Wastewater Treatment Directive (UWWTD). The appeal seeks review of the Extended Producer Responsibility (EPR) scheme, arguing that it imposes disproportionate and discriminatory financial burdens on pharmaceutical manufacturers, underestimates total costs, and overstates the contribution of medicines to wastewater pollution. The document states that the scheme could make the supply of essential medicines economically unviable, leading to shortages and increased healthcare costs, while offering limited environmental benefit due to constraints on modifying active ingredients. It further contends that the timing of implementation may prompt early market withdrawals and that the scheme conflicts with the ‘polluter pays’ principle by assigning costs beyond the sector’s actual contribution, with the appeal framed as necessary to protect medicine availability, public health and pharmaceutical manufacturing in the EU.

Medicines for Europe, representing manufacturers supplying 70% of EU dispensed medicines, presented five trade policy recommendations to the European Commission on 17 June 2025. The proposals, based on the organisation's 2024 Market Access Barriers Report, focus on removing trade barriers, supporting off-patent manufacturing, ensuring fair market access, balancing intellectual property frameworks, and advancing regulatory convergence. The recommendations aim to address challenges identified across 11 key markets while strengthening EU pharmaceutical manufacturing competitiveness and global medicine access.

Medicines for Europe has published a fact sheet on the proposed EU Biotech Act, outlining its assessment of the initiative and its implications for the European biosimilar medicines sector. The fact sheet situates the Biotech Act in the context of growing global competition in biotechnology, highlighting that Europe is falling behind other biotech hubs due to unbalanced investment across the value chain, fragmented biotech clusters and skills, slow regulatory evolution, vulnerabilities in supply chain security and the absence of a coordinated EU biotech strategy and funding framework. It sets out the four pillars of the EU Biotech Act—manufacturing, regulatory, intellectual property and trade, and skills—and emphasises the need for a sustainable, innovation-ready biosimilar manufacturing and research and development (R&D) footprint to strengthen Europe’s competitiveness, resilience and market attractiveness.

Medicines for Europe has responded to the European Parliament’s draft report on the Critical Medicines Act, presented to the Committee on Public Health. The organisation supports the draft report’s aim to improve the Critical Medicines Act but believes the proposed regulation should be further strengthened to ensure security of supply for all medicines on the list. It notes that only 40% of medicines in the general pharmaceutical market and approximately 50% of critical medicines undergo procurement. Medicines for Europe argues that, by not mandating pricing and reimbursement policies in national plans supporting security of supply, the Act fails to address half of the listed medicines. The organisation calls for security of supply criteria to be included in both public procurement and pricing and reimbursement policies.

Medicines for Europe has published a letter urging EU co-legislators to ensure that the proposed Critical Medicines Act (CMA) delivers meaningful demand-side measures to address structural causes of medicines shortages. The letter calls for alignment on a compromise reflecting the CMA’s original objectives of strengthening EU strategic autonomy, supply diversification and solidarity. Medicines for Europe argues that economic root causes contribute to approximately 50% of shortages and links price-driven procurement practices, including widespread use of single-winner tenders and lowest-price awards, to market fragility and supplier consolidation. It states that 74% of countries use single-winner tenders and that up to 84% of procedures are awarded solely on the basis of lowest price. It supports mandatory security-of-supply award criteria for hospital medicines procured through tenders, representing 52% of critical medicines, and calls for pricing and reimbursement measures to be included in national security-of-supply plans for retail medicines, representing 48%. Medicines for Europe warns that, without meaningful demand-side provisions in Articles 18 and 19, the CMA will fall short of its objective to improve the availability, supply and production of critical medicines in the EU.

Medicines for Europe has issued an open letter to the Committee of Permanent Representatives (COREPER). In the open letter Medicines for Europe expresses concern over the Council’s dilution of the Critical Medicines Act, warning that such actions threaten the EU’s health security. The Act, originally intended to address medicine shortages and bolster strategic autonomy, included reforms to support manufacturing, diversify supply chains and promote solidarity across Member States. However, some larger nations are resisting these measures under the guise of national competence, prioritising cost-containment over supply security. This has led to market consolidation, price deflation and increased reliance on non-EU production, particularly in China. The letter highlights that the Act does not infringe on national sovereignty but merely enforces existing EU obligations, with examples from Greece, Sweden and Portugal demonstrating successful implementation of supply security criteria.