Sunshine Reporting in Europe: Who’s Leading the Way in Transparency?

by | Sep 2, 2025 | Compliance

Author


May Khan

May Khan
Director
Vector Health Compliance

May Khan leads the Compliance Services team at Vector Health, a SaaS company focused on life sciences compliance. Her experience includes global transparency reporting, Sunshine Act strategy, and HCP risk monitoring. At Vector, she coordinates cross-functional teams focused on data integrity, customer service, and regulatory alignment.

 

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After years of being a purely voluntary exercise, transparency reporting in healthcare is gradually becoming mandatory by law in many parts of Europe. Inspired by the US Physician Payments Sunshine Act (2010), a growing number of EU countries have introduced legally binding rules requiring pharmaceutical and medical device companies to disclose their financial relationships with healthcare professionals (HCPs) and organizations (HCOs). While France paved the way, others including Italy and Belgium have since followed, each with its own scope, thresholds, and reporting systems.

France — The First Mover in Europe

France became the first European country to adopt a Sunshine-style law with the Loi Bertrand in 2011, implemented in 2013 and reinforced by the Loi Touraine in 2016. The French framework applies to both pharmaceutical and medical device industries, requiring detailed reporting of transfers of value—cash or in kind—to HCPs, HCOs, and certain other stakeholders. Disclosures are made on the public Transparence Santé platform, with few exemptions (e.g., benefits under €10).

Italy — New Law, Implementation Underway

Italy’s Sunshine Act (Law No. 62/2022) entered into force in June 2022, introducing mandatory reporting for a wide range of transfers of value, including consultancy fees, sponsorships, agreements, and intellectual property rights for pharmaceutical, medical device, and other life sciences companies. A central public portal—Sanità Trasparente—is planned, but technical implementation is still in progress and expected to go live by late 2025.

Since the implementation is not far away, the Italian Sunshine Reporting community has been actively gathering with life science company representatives in Italy for workshops and expert-led discussions to provide practical insight into the Sanità Trasparente register from both compliance and legal perspectives. If your life science company has a presence in Italy and is looking to prepare processes and structure for successful submission, stay tuned for our upcoming events in September 2025 which will help you become fully ready before the Telematic Register goes live.

Belgium — Comprehensive Transparency Rules Since 2017

Belgium joined the limited group of EU countries with full statutory transparency through its Sunshine Act (Belgian Law of 18 December 2016), implemented via Royal Decrees in 2017. Since 2018, companies must disclose to the Federal Agency for Medicines and Health Products (FAMHP) any pecuniary advantage or benefit in kind granted, directly or indirectly, to HCPs, HCOs, and patient associations with a principal activity or registered office in Belgium.

Notably, Belgium exempts certain items such as meals and drinks offered during exclusively scientific events, benefits of negligible value, price discounts, and free samples. Disclosures are published on the public Betransparent.be portal.

Portugal — Comprehensive Statutory Transparency Law

Portugal has implemented legally binding transparency obligations through Law No. 52/2015, which requires pharmaceutical and medical device companies to report all benefits granted to HCPs, HCOs, and patient organisations. Disclosures must be made to the Portuguese National Authority of Medicines and Health Products (INFARMED) and are published on its public portal. Portugal’s system is notable for its broad scope, covering both direct and indirect transfers of value, and for making data available in a central, government-operated online database.

United Kingdom — Limited Voluntary Disclosure

The United Kingdom does not have a legally binding Sunshine Act that covers all healthcare professionals. Instead, transparency in interactions between industry and healthcare is governed primarily by self-regulatory frameworks.

For the pharmaceutical sector, the Association of the British Pharmaceutical Industry (ABPI) operates Disclosure UK, a publicly accessible database that publishes annual data on transfers of value from member companies to healthcare professionals (HCPs) and healthcare organisations (HCOs). While participation is mandatory for ABPI members, it remains a voluntary initiative for non-member companies.

For the medical technology and diagnostics sector, the Association of British HealthTech Industries (ABHI) aligns with the MedTech Europe Code of Ethical Business Practice, which requires members to disclose educational grants and certain types of collaborations with HCPs and HCOs. Unlike the ABPI, the ABHI does not operate a centralised UK disclosure database; reporting is typically done via company websites or upon request, in line with the MedTech Europe framework.
This dual framework means that while the UK maintains a degree of transparency in industry–HCP interactions, coverage and accessibility vary significantly between the pharmaceutical and medtech sectors, and there is no unified national Sunshine reporting portal.

Germany — Self-Regulation Only

Germany does not have a statutory Sunshine law for healthcare transparency. Instead, the Association of Voluntary Self-Regulation for the Pharmaceutical Industry (Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V. – FSA) provides voluntary guidelines that apply to member companies. These rules cover transfers of value to healthcare professionals and organisations, but disclosure is optional and dependent on recipient consent. The lack of a binding legal framework means transparency levels can vary significantly across the sector, especially in the medical device field, which is not covered by the FSA code.

The Netherlands — Hybrid Self-Regulation

The Netherlands has implemented partial statutory transparency requirements through the Healthcare Transparency Register (Transparantieregister Zorg), in place since 2013. It requires pharmaceutical companies, medical device manufacturers, and certain healthcare providers to disclose financial relationships exceeding €500 annually. While more comprehensive than purely voluntary models, the system does not capture all forms of transfers of value and has a narrower scope than France or Belgium.

Spain — Industry Code Only

Spain has no national Sunshine law, but the Farmaindustria Code of Practice requires member pharmaceutical companies to disclose transfers of value to healthcare professionals and organisations. The disclosure covers categories such as travel, accommodation, consultancy, and research funding. However, as with Germany, the rules are binding only on member companies and rely on voluntary adherence by non-members, resulting in uneven transparency.

Looking Ahead

As the country examples above show, the European transparency and Sunshine reporting framework remains far from unified. France, Italy, and Belgium stand out as leading examples of mandatory disclosure regimes designed to prevent corruption and promote transparency, with comprehensive laws and centralised public registers. Portugal and Denmark follow a similar statutory model, while others like Germany, the Netherlands, the UK, and Spain rely on partial laws or voluntary industry-led codes. The result is a patchwork of approaches with significant differences in scope, thresholds, and reporting mechanisms.

For multinational life sciences companies, this lack of harmonisation creates both practical and compliance challenges. In practice, it is crucial to determine whether the rules in force in the country where the physician or organisation is located apply to the interaction in question. For foreign companies, this assessment — combined with the differences between national laws — can make the exact regime and formalities difficult to anticipate.

As a result, obtaining specialised legal advice is highly recommended to ensure cross-border engagements are compliant and to navigate divergent definitions, inconsistent timelines, and varying enforcement standards. As the EU moves toward greater regulatory alignment in other areas of healthcare, stakeholders will be watching closely to see if transparency reporting follows the same path.