Healthcare Systems

German Bundestag Holds First Reading of Bill to Strengthen Medical Registers

In May 2026 the German Bundestag held the first reading of a federal bill to create a Medical Registers Act and amend social security and implant register law, establishing a unified framework and new governance for more than 350 medical registries and their health data use. If adopted, this regime will formalise qualification and interoperability requirements, expand permitted reuse and linkage of registry data, and reshape compliance strategies for medical device and pharmaceutical firms that run or rely on clinical registries and real-world evidence.

24 May 2026, 21:17dserver.bundestag.deGermany

German Bundestag Adopts Pharmacy Reform Law (Apothekenversorgung-Weiterentwicklungsgesetz)

In May 2026 the German Bundestag adopted the Apothekenversorgung-Weiterentwicklungsgesetz, a far-reaching pharmacy reform that strengthens community pharmacies, expands their clinical and preventive tasks, and introduces tightly framed pharmacist prescribing powers for certain chronic and acute conditions. Once promulgated, the law will materially change how medicines, vaccinations and diagnostics are delivered through German pharmacies, while piloting PTA-led operations in rural areas and preparing a new remuneration framework that pharmacy operators and healthcare suppliers need to factor into medium-term planning.

24 May 2026, 21:17bundestag.deGermany

Germany: Bundestag Health Committee Backs Pharmacy Reform Bill (ApoVWG)

In May 2026, the Bundestag Health Committee backed Germany’s pharmacy reform bill (ApoVWG), including amendments on biosimilar rebate contracts, expanded pharmaceutical services and temporary PTA-led operations, and sent it to the plenary for adoption. The reform would broaden pharmacies’ role and tighten rules for mail-order and temperature-sensitive medicines, while leaving politically sensitive remuneration issues like the Packungsfixum increase to a separate pricing ordinance, with future cost and access impacts for insurers and operators still to be determined.

23 May 2026, 19:14dserver.bundestag.deGermany

EU Council Presidency Issues Cluster 4 Document on MDR/IVDR Simplification Proposal

The Council Presidency has tabled a non-public working document (ST 7254 2026 INIT) for cluster 4 examination of the EU proposal to simplify the MDR/IVDR framework and adjust related EMA and AI Act provisions, to be discussed at a 21 May 2026 Council meeting. This signals that negotiations on key elements of the medical devices simplification package are moving into detailed Council working-party scrutiny, but without yet creating new legal obligations or confirmed changes for manufacturers or healthcare providers.

23 May 2026, 09:10consilium.europa.euEuropean Union

Netherlands Proposes Amendments To Wkkgz Implementing Rules For Acute Care Closures

The Netherlands has tabled amendments to the Wkkgz implementing decree and regulation that would tighten early involvement rules when hospitals and other acute-care providers plan to suspend or close services, with application from 1 January 2027. These changes will force acute-care networks to engage municipalities, citizens and insurers earlier, obtain RIVM access analyses and continuity plans, and treat closures as regionally coordinated decisions, increasing governance and compliance workload for providers and local authorities.

22 May 2026, 19:01zoek.officielebekendmakingen.nlNetherlands

European Economic and Social Committee Opinion on Proposal to Simplify MDR/IVDR and EMA Support Rules

In late April 2026, the European Economic and Social Committee issued a detailed opinion on the EU proposal to simplify the MDR/IVDR and related EMA and AI Act provisions governing medical devices and in vitro diagnostics. Although non-binding, the opinion spotlights legal certainty, digitalisation, notified-body fees, reprocessing rules and EMA’s role as critical points that could shape the final legislation and future compliance expectations for device portfolios across the EU.

20 May 2026, 19:57eur-lex.europa.euEuropean Union

Hong Kong Announces Drug And Medical Device Regulatory Reforms And New Medical Products Regulator

Hong Kong’s Chief Executive has announced major reforms to drug and medical device oversight, including a “1+” registration pathway, phased primary evaluation starting in March 2026, and a new medical products regulator to be established by the end of 2026 on the way to a fully independent evaluation framework by 2030. These changes point to faster, more autonomous approval decisions and greater use of cross-boundary clinical and real-world data, so pharma and medtech companies should plan for a distinct Hong Kong regulatory regime when allocating trials, submissions, and investment over the rest of the decade.

20 May 2026, 17:57news.gov.hkHong Kong SAR ChinaChina

Netherlands Health Ministry Sets Applicability Date for New NEN 7510 Edition in Healthcare IT Systems

The Dutch Ministry of Health has formally set 1 June 2026 as the date when the latest NEN 7510 information security standard (parts 1 and 2) becomes applicable to electronic exchange systems and healthcare information systems. Healthcare providers and IT vendors operating these systems in the Netherlands must ensure their information security management aligns with NEN 7510-1:2024 and NEN 7510-2:2024+A1:2026 by that date, potentially requiring system, contract, and governance updates.

20 May 2026, 06:19zoek.officielebekendmakingen.nlNetherlands

Australia TGA Issues Weekly Medicine Shortages Report for Week Commencing 11 May 2026

Australia’s medicines regulator has issued its weekly report summarising new, updated, discontinued, and resolved medicine shortages for the week commencing 11 May 2026. This bulletin highlights changing availability across many prescription medicines, supporting healthcare providers and supply teams in managing stock, planning therapy alternatives, and monitoring supply risk in the Australian market.

20 May 2026, 05:58tgacomms.health.gov.auAustralia

Washington PQAC Proposes Clarifying Amendment on Ancillary Utilization Plans (WAC 246-945-410)

In April 2026 Washington’s Pharmacy Quality Assurance Commission proposed a clarifying amendment to WAC 246-945-410 so that only pharmacies, consistent with underlying statutes, may submit Ancillary Utilization Plans for approval, with a public hearing scheduled for 28 May 2026. This fine-tunes governance around pharmacy ancillary personnel rather than expanding scope, but pharmacies that rely on AUPs should confirm that submission and approval responsibilities sit with the licensed pharmacy entity ahead of final adoption.

18 May 2026, 17:20content.govdelivery.comUnited States

Oklahoma Legislature Approves Permanent Rules for Health-Related Agencies (HJR 1093)

Joint Resolution HJR 1093, passed by the Oklahoma Legislature in May 2026, approves permanent rules filed by a broad set of state health-related agencies (including the Health Care Authority and State Board of Pharmacy) for the 2026 rulemaking cycle, while explicitly excluding a defined subset of Medicaid rules. This consolidates the year’s regulatory changes for key health, Medicaid and pharmacy regulators, signalling that any previously proposed requirements for providers, payers and pharmacies are moving toward implementation and should be reviewed against existing compliance plans.

16 May 2026, 08:54oklegislature.govUnited States

German Government Submits Draft Medical Registers Act to Strengthen Registries and Data Use

In May 2026 the German government submitted a draft Medical Registers Act that would create a central registry framework, new quality criteria and data-sharing rules for medical registries, and align Social Code Book V and implant registry law around use of the health insurance number for pseudonymised data linkage. If enacted, medtech, pharma and health-data stakeholders running or relying on registries in Germany will face stricter qualification and governance requirements but also easier, more legally secure access to high-quality real-world data for safety, reimbursement and innovation decisions.

15 May 2026, 16:12dserver.bundestag.deGermany

Ohio HB 892 Would Establish Ohio-Made Medicine Manufacturing Program

Ohio legislators have introduced HB 892, the Ohio-Made Prescription Drug Act, to establish a state-run programme that partners with manufacturers and payers to improve the affordability and availability of generically equivalent medicines. If enacted, this could reshape how generic drugs are sourced, priced, and prioritised for Ohio public and private purchasers, creating new opportunities and expectations for manufacturers and healthcare payers involved in essential medicines.

15 May 2026, 15:09search-prod.lis.state.oh.usUnited States

France IGAS–IGF Report Recommends Reforms to Generic Drug Distribution Rebates and Pharmacy Remuneration

France’s inspection bodies IGAS and IGF have published a January 2026 report on the pharmaceutical distribution chain that quantifies the scale of rebates and commercial payments on generics and biosimilars and recommends far‑reaching reforms to CEPS pricing, rebate transparency, and pharmacy remuneration. If taken up by government and legislators, these proposals would shift France’s retail medicines market away from opaque rebate‑driven contracts towards lower list prices, centralised purchasing, and stricter reporting, reshaping margins, business models, and compliance obligations for manufacturers, wholesalers, buying groups, and pharmacies.

15 May 2026, 09:01vie-publique.frFrance

European Commission Sets Out Strategy to Reinforce Global Health Resilience Amid Geopolitical Change

In May 2026 the European Commission issued a non-binding global health resilience strategy (COM(2026)197), setting out five priority areas and nine flagship initiatives to strengthen health systems, preparedness and governance in a more geopolitical world. For life-science, healthcare and pharmaceutical stakeholders this signals sustained EU focus on pandemic preparedness, antimicrobial resistance, diversified supply chains and support for manufacturing and clinical research in partner countries, shaping future funding priorities and potential regulatory reforms rather than creating immediate new obligations.

14 May 2026, 18:36international-partnerships.ec.europa.euEuropean Union

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