Healthcare Systems

EMA Welcomes Political Agreement on Critical Medicines Act

EU legislators have reached a provisional political agreement on the proposed Critical Medicines Act, and the European Medicines Agency is positioning its shortages, innovation and monitoring tools to support implementation and strengthen the resilience of EU medicine supply chains. This signals forthcoming EU-level measures for pharmaceutical manufacturers and health systems focused on vulnerability assessments, industrial and procurement interventions, and coordinated action to prevent shortages of critical medicines.

13 May 2026, 12:39ema.europa.euEuropean Union

EU Parliament and Council Reach Provisional Deal on Critical Medicines Act

EU legislators have reached a provisional political deal on the Critical Medicines Act, creating an EU framework to fund strategic manufacturing projects and reshape procurement rules to strengthen supply of critical medicines. This will tilt public funding and tenders towards resilient EU-based suppliers and joint procurement mechanisms, signalling future obligations for manufacturers and buyers to prioritise secure European supply once the regulation is formally adopted.

12 May 2026, 18:42europarl.europa.euEuropean Union

Italy Consiglio di Stato Refers Constitutional Challenge on 0.75% Medical Device Levy

In February 2026 Italy’s Consiglio di Stato referred to the Constitutional Court a constitutional challenge against the 0.75% turnover levy that funds the national medical device governance fund for supplies to the public health service. Medical device and in vitro diagnostic manufacturers subject to this Italian levy should monitor the case, as a future ruling could materially change the cost and design of market access obligations for devices sold to the national health service.

12 May 2026, 12:50gazzettaufficiale.itItaly

Croatia Adopts Ordinance on Medical Criteria for Determining Death for Organ Donation

Croatia has adopted a new ordinance under its Law on the Transplantation of Human Organs that updates medical criteria for determining death in the context of organ donation to include both neurological and circulatory criteria. This broadened framework is expected to expand the donor pool and align Croatia’s transplant system with international practice, reducing waiting times and mortality risks for patients needing organ transplants.

12 May 2026, 12:48zdravstvo.gov.hrCroatia

European Parliament Public Health Committee Endorses EU–Switzerland Health and Mutual Recognition Package

In May 2026 the European Parliament’s Public Health Committee endorsed the draft EU–Switzerland agreements on health security and mutual recognition of medical products, recommending consent for an Agreement on Health and a protocol updating conformity-assessment arrangements. If finalised, the package will integrate Switzerland into EU early-warning, joint-procurement and ECDC structures and streamline mutual recognition for medical devices and pharmaceuticals, reducing duplicative oversight while preserving EU control over core legislation.

9 May 2026, 19:03europarl.europa.euEuropean UnionSwitzerland

The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2026

UK Regulations 2026/495 remove previous exemptions so that temporary medical treatment provided at sports grounds, gymnasia and sporting or cultural events in England and Wales becomes a Care Quality Commission regulated activity from September 2026, with full effect from December 2027. Event and sports medicine providers operating on these sites will need to assess whether their services now require CQC registration and adjust governance, staffing and contractual arrangements ahead of the phased commencement dates.

9 May 2026, 14:17legislation.gov.ukUnited Kingdom

European Parliament Public Health Committee Backs EU–Switzerland Health and Conformity Assessment Agreements

In May 2026 the European Parliament’s Public Health Committee issued a draft opinion recommending consent to the Council decision concluding a broad package of EU–Switzerland agreements on health security and mutual recognition of product conformity assessment. While the package is still pending formal approval, this signals likely integration of Switzerland into EU health-crisis frameworks and medical-product governance, so companies active in both markets should prepare for closer alignment of surveillance, joint procurement, and conformity assessment processes.

9 May 2026, 13:28europarl.europa.euEuropean UnionSwitzerland

EMA Launches EU Pilot Programme for Breakthrough Medical Devices

In April 2026 the European Medicines Agency launched an EU pilot programme offering expert panel support for breakthrough medical devices, with an initial application window for high-risk cardiovascular and paediatric devices open until 22 May 2026. The pilot is an early step towards a permanent breakthrough pathway under MDR and IVDR, signalling faster and more predictable EU market access for truly innovative devices and shaping how regulators will handle high-risk technologies in future.

9 May 2026, 07:20ema.europa.euEuropean Union

EMA Reports NexoBrid Supply Shortage In Selected EU/EEA Member States

EMA has announced an ongoing shortage of the burn debridement medicine NexoBrid in 12 EU/EEA countries after a sterility-test issue with the 5 g presentation and commercial withdrawal of the 2 g pack, with supply expected to remain constrained until at least June 2026. Hospitals and burn units in affected markets should plan alternative wound-debridement pathways, adjust stock strategies, and follow national guidance while regulators and the manufacturer work to restore availability.

8 May 2026, 18:02ema.europa.euEuropean UnionEuropean Economic AreaAustriaBelgiumDenmarkFinlandGermanyItalyNorwayNetherlandsPolandRomaniaSpainSweden

Switzerland Opens Consultation On Extending Therapeutic Products Integrity Rules To Medical Devices

Switzerland has launched a consultation to amend the Ordinance on Integrity and Transparency in the Therapeutic Products Sector so that existing bans on financial incentives for prescription medicines are extended to medical devices. If adopted, the reform will tighten compliance expectations for hospitals, physicians, pharmacies and device manufacturers, requiring marketing and purchasing practices to align with stricter anti-kickback standards in the Swiss therapeutic products market.

8 May 2026, 08:55fedlex.admin.chSwitzerland

Oklahoma Legislature Sends HB 3644 (Blake Burgess Act) on Venous Thromboembolism Registry and Hospital Requirements to Governor

Oklahoma has passed HB 3644 (the Blake Burgess Act), a venous thromboembolism bill that would require hospitals and ambulatory surgical centres to implement VTE risk protocols and staff training, establish a statewide VTE registry with annual hospital reporting, and tighten VTE screening and information duties for assisted living centres, and it is now awaiting the Governor’s signature. If approved, healthcare operators in Oklahoma will need to update clinical policies, training and data systems ahead of the Act’s 1 July 2026 start date and prepare for VTE registry reporting and departmental analytics obligations from mid-2027, with increased oversight of VTE outcomes and assisted living practices.

8 May 2026, 07:28oklegislature.govUnited States

US Senate Introduces Ensuring Access to Lower-Cost Medicines for Seniors Act (S. 4323)

A new US Senate bill would require Medicare Part D plans and Medicare Advantage drug plans to favour lower-cost generic drugs and biosimilars on formularies and in cost-sharing from plan year 2028, limiting barriers that keep reference brands in preferred positions. If enacted, this would structurally boost market access and utilisation for generics and biosimilars while increasing pricing and access pressure on higher-cost reference medicines, shaping manufacturers’ contracting, portfolio, and pricing strategies.

4 May 2026, 20:05govinfo.govUnited States

Italy Council of State Refers 0.75% Medical-Device Turnover Levy to Constitutional Court

On 28 February 2026 the Italian Council of State referred to the Constitutional Court multiple appeals by Roche Diagnostics and other medical-device and IVD suppliers challenging the 0.75% turnover levy that finances Italy’s medical-devices fund. If the Court annuls or reshapes this funding mechanism, medical-device manufacturers could see the parafiscal contribution reduced, removed or redesigned, altering cost structures and how device-governance activities are financed in the Italian market.

4 May 2026, 18:26gazzettaufficiale.itItaly

EU Council Circulates Four-Column Table For Critical Medicines Act Proposal (Amending Regulation (EU) 2024/795)

In April 2026, the Council of the EU circulated a four-column negotiating table for the proposed Critical Medicines Act, which would create an EU framework to secure the availability and supply of critical medicinal products and amend Regulation (EU) 2024/795. This signals that the file has moved into detailed interinstitutional negotiations, so pharmaceutical manufacturers and supply-chain actors should anticipate forthcoming binding EU requirements on supply resilience and begin assessing potential impacts on their portfolios, inventories and reporting.

4 May 2026, 09:19consilium.europa.euEuropean Union

Washington DOH Launches Vaccine Recommendations and Immunisation Schedules Under HB 2242

Washington has enacted HB 2242 and, from March 2026, empowered its Department of Health to publish independent vaccine recommendations and immunisation schedules via a new public webpage, with current child and adult schedules now available. This non-mandatory state schedule nonetheless drives no-cost coverage obligations for nongrandfathered health plans and funding responsibilities for carriers, governments, and school districts, so Washington-regulated insurers and plan sponsors need to align benefits design and vaccine budgeting with DOH updates.

3 May 2026, 11:49doh.wa.govUnited States

Taiwan TFDA Amends Remote-Area List Under Pharmaceutical Affairs Act Article 102 for Tainan City

On 23 April 2026, Taiwan’s TFDA amended Annex 13 under the Pharmaceutical Affairs Act to update the list of Tainan City clinics classified as remote areas without practising pharmaceutical personnel, with immediate effect. This changes where exemptions from normal pharmacy staffing and prescribing–dispensing separation rules apply, so clinic and pharmacy operators in Tainan must confirm whether their sites now fall inside or outside the revised remote-area designations.

3 May 2026, 09:10fda.gov.twTaiwan

EMA Updates ESMP User Guide for Marketing Authorisation Holders (Version 1.4)

The European Medicines Agency has issued version 1.4 of its ESMP user guide, updating how marketing authorisation holders must report medicine shortages and crisis-related supply data via the European Shortages Monitoring Platform in line with Regulation (EU) 2022/123. The guide tightens expectations on master data completeness, routine and crisis reporting workflows, and responsiveness to automated shortage reminders, so MAHs should review ESMP/IRIS/PMS access, data quality and internal shortage management processes to ensure continued compliance.

1 May 2026, 18:37ema.europa.euEuropean UnionEuropean Economic Area

EMA Updates ESMP Implementation Guide for Marketing Authorisation Holders (Version 1.5)

EMA has updated its ESMP Implementation Guide for marketing authorisation holders to Version 1.5, refining the technical data structures and validation rules for reporting medicine shortages and availability under Regulation (EU) 2022/123 across the EU and EEA. This update tightens expectations on master-data completeness, use of RMS identifiers and shortage-history reporting in both normal and crisis or MSSG-led scenarios, so MAHs should review ESMP interfaces, SPOR mappings and PMS/IRIS governance to avoid rejected submissions and meet the two-week PMS data readiness expectation during monitoring actions.

1 May 2026, 18:34ema.europa.euEuropean UnionEuropean Economic Area

EMA Updates ESMP Implementation Guide For National Competent Authorities (Version 1.5)

EMA has issued Version 1.5 of its ESMP implementation guide for national regulators, adding critical-shortage and Voluntary Solidarity Mechanism reporting requirements and clarifying how authorities must structure ESMP data under Regulation (EU) 2022/123. This entrenches a more granular, standardised data model for EU and EEA medicines-shortage monitoring, meaning NCAs—and indirectly MAHs and wholesalers—need robust inventory, demand-forecasting and crisis-reporting capabilities aligned with ESMP templates.

1 May 2026, 18:34ema.europa.euEuropean UnionEuropean Economic Area

UK DHSC Adds Atriance (Nelarabine) to Northern Ireland MHRA Authorised Route List

On 27 April 2026 the UK Department of Health and Social Care updated the Northern Ireland MHRA Authorised Route (NIMAR) list to include Atriance (Nelarabine) 250mg/50ml solution for infusion vials. This expansion of the NIMAR list gives companies and health services more flexibility to meet patient need in Northern Ireland by moving authorised stock from Great Britain under an established regulatory route.

30 Apr 2026, 10:48gov.ukUnited Kingdom