Schedule A Demo

Life Sciences Transparency & Sunshine Reporting Laws

A region-by-region and country-by-country reference to the disclosure obligations that govern transfers of value from pharmaceutical, biotech, and medical-device companies to HCPs and HCOs worldwide.

50+
Jurisdictions Covered

4
Global Regions

10+
Statutory Regimes

2026
Reference Year

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🔍

Informational reference only. This document is not legal advice. Reporting windows, thresholds, and platform mechanics change frequently. Always confirm current requirements with local counsel and the relevant competent authority before filing.

Cross-Regional Trends — April 2026

01 — Direction of Travel
Binding statutory regimes are replacing self-regulation. Italy’s Sanità Trasparente, Belgium, Portugal, Latvia, Romania and Slovakia have all moved to hybrid or full statutory models.
02 — Threshold Divergence
France captures benefits from €10. Italy uses €100 per item. The US threshold for CY2025 is USD 13.46 per instance. Saudi Arabia uses SAR 50. No single global threshold is possible.
03 — State-Run Platforms
France (Transparence Santé), Italy (Sanità Trasparente), Portugal (INFARMED), South Korea (KOPS), and the US (CMS Open Payments) all now operate government portals.
04 — Meaningful Penalties
Italy’s formula of €1,000 + 20× the unreported amount, French corporate fines of €225,000, and Colombia’s sanctions up to USD 1.5M mean financial risk is no longer purely reputational.
🌍
European Region
35 Countries
France
Statutory
🇫🇷
Law
Bertrand Act (2011) / Touraine Act (2016)
Authority
Ministère des Solidarités et de la Santé
Threshold
€10+ per benefit (incl. VAT)
Deadline
1 Sep (H1) / 1 Mar (H2)
Platform
Transparence Santé — fully public, searchable by HCP name, company, benefit type. Data retained 5 years.
Scope
Extremely broad — pharma, devices, cosmetics, tattoo products, software publishers for prescription tools, media covering health. Includes HCPs, HCOs, patient associations.
Penalties
Individuals: up to €45,000. Corporations: up to €225,000.
Note
Reporting is a statutory obligation — no HCP consent required. Only individual (not aggregate) disclosure permitted.
Italy
Statutory
🇮🇹
Law
Law No. 62 of 31 May 2022 (Sanità Trasparente)
Authority
Italian Ministry of Health / AgID / ANAC
Threshold (HCP)
>€100 single / >€1,000 annual
Deadline
31 Dec 2026 (H1 2026 data)
Platform
Sanità Trasparente public telematic register. Data searchable for 5 years. Submission via XML/XSD — manual entry not permitted.
Scope
ToVs, agreements, shareholdings, bond ownership, royalties/licences between companies and HCPs, HCOs, patient associations, scientific societies.
Penalties
€1,000 + 20× the value of each unreported ToV. For equity/IP: €5,000–€50,000 (up to €100,000 for false statements). Fines published on Sanità Trasparente for ≥90 days.
Status
Operationally dependent on register launch. Expected fully operative H1 2026 reporting cycle.
Belgium
Statutory
🇧🇪
Law
Belgian Sunshine Act — Law of 18 Dec 2016
Authority
FAMHP / AFMPS
Platform
betransparent.be
Deadline
Annual (EFPIA 6-month pattern)
Scope
Pecuniary advantages or benefits in kind granted directly or indirectly to HCPs, HCOs and patient associations whose principal activity is in Belgium.
Note
Mandatory since 2018. Multi-stakeholder platform integrates company disclosures with industry and professional-organisation input.
Portugal
Statutory
🇵🇹
Law
Law No. 52/2015 of 9 June
Authority
INFARMED
Scope
Financial and in-kind transfers to HCPs, HCOs, patient organisations
Deadline
Within 6 months of year-end
Platform
INFARMED central public portal — disclosures submitted to INFARMED and published there.
Greece
Statutory
🇬🇷
Law
Law 4316/2014 + implementing provisions
Authority
EOF (National Organisation for Medicines)
Also
SFEE (EFPIA) / SEIV (MedTech)
Deadline
Within 6 months of year-end
Scope
ToVs to HCPs, HCOs, patient organisations and medical scientific societies. Individual disclosure where law/consent allows; otherwise aggregate.
Latvia
Statutory
🇱🇻
Law
Cabinet Regulations (Pharmaceutical Law)
Authority
ZVA (Zāļu valsts aģentūra)
Platform
ZVA public portal + company websites
Deadline
Within 6 months of year-end
Note
Requires pharmaceutical companies to publish ToVs to HCPs and HCOs on the national competent authority's website.
Romania
Statutory
🇷🇴
Law
Law 95/2006 (Title XVIII) / MH Order 194/2015
Authority
ANMDMR
Platform
ANMDMR public portal
Deadline
By end of June
Note
Requires pharma and medical device companies to publish sponsorships and ToVs to HCPs/HCOs on the ANMDMR website.
Slovakia
Statutory
🇸🇰
Law
Act No. 362/2011 on Medicinal Products
Authority
ŠÚKL (State Institute for Drug Control)
Platform
ŠÚKL central portal
Deadline
Semi-annual; annual public within 6 months
Note
Pharmaceutical companies must disclose monetary and non-monetary benefits to HCPs/HCOs to ŠÚKL.
United Kingdom
Self-Regulatory
🇬🇧
Framework
ABPI Code (Pharma) / ABHI (Devices)
Platform
Disclosure UK (ABPI)
Pharma Deadline
Submit by last working day of March; published by end of June
Device Deadline
Within 6 months of year-end
Note
No statutory Sunshine Act. ABPI operates a central UK database. ABHI does not — device disclosures are typically made on individual company websites per MedTech Europe framework.
Germany
Self-Regulatory
🇩🇪
Framework
FSA Transparency Code (Pharma) / BVMed (Devices)
Platform
Company websites + FSA portal
Disclosure
Individual (with consent) or aggregate
Deadline
Within 6 months of year-end
Note
No statutory Sunshine Act. FSA and BVMed implement EFPIA and MedTech Europe principles respectively.
Spain
Self-Regulatory
🇪🇸
Framework
Farmaindustria (Pharma) / Fenin (Devices)
Platform
Farmaindustria central portal + company websites
GDPR Basis
Legitimate interest confirmed by AEPD
Deadline
Within 6 months of year-end
Note
Spanish DPA confirmed individual disclosure can proceed on legitimate interest basis without HCP consent where made under the Farmaindustria code.
Denmark
Statutory + Self-Reg
🇩🇰
Law
Danish Medicines Act + executive orders
Authority
Danish Medicines Agency (Lægemiddelstyrelsen)
Industry
LIF (Pharma) / Medicoindustrien (Devices)
Deadline
Within 6 months of year-end
Note
HCPs must obtain prior permission from the Danish Medicines Agency before working for pharma/device companies. Agency maintains a public register of permitted/notified HCPs.
Austria
Self-Regulatory
🇦🇹
Framework
PHARMIG (EFPIA) / AUSTROMED
Deadline
Within 6 months of year-end

PHARMIG central platform or company websites. Partial statutory anti-corruption provisions also apply.

Switzerland
Self-Reg + Statutory
🇨🇭
Framework
scienceindustries PCC + Art. 55 HMG
Deadline
Within 6 months of year-end

Swissmedic supervises statutory integrity rules under the Therapeutic Products Act. PCC mirrors EFPIA principles. Disclosure on company websites.

Ireland
Self-Regulatory
🇮🇪
Framework
IPHA (EFPIA) / Irish Medtech / MedTech Europe
Deadline
Within 6 months of year-end

IPHA Transfers of Value database — publicly accessible. HPRA supervises promotional/transparency rules.

Sweden
Self-Regulatory
🇸🇪
Framework
LIF (EFPIA) / Swedish Medtech + Ethics Agreement
Deadline
Within 6 months of year-end

LIF central platform and company websites. Ethics Agreement with healthcare regions supplements transparency requirements.

Norway
Self-Regulatory
🇳🇴
Framework
LMI (EFPIA) / Melanor (MedTech)
Deadline
Within 6 months of year-end

Statutory promotional rules apply under the Medicines Act. Self-regulatory disclosure follows EFPIA/MedTech Europe principles.

Finland
Dual Framework
🇫🇮
Framework
Finnish Medicines Act + EFPIA via PIF
Deadline
Within 6 months of year-end

Statutory provisions require companies to keep a public list of payments to medical/healthcare associations. Additional disclosures follow EFPIA code via PIF / Lääkeyritykset. Company website publication.

Poland
Self-Regulatory
🇵🇱
Framework
INFARMA (EFPIA) / POLMED (MedTech)
Deadline
Within 6 months of year-end

Company websites and INFARMA central platform. PZPPF also applies for generics sector.

Czech Republic
Self-Regulatory
🇨🇿
Framework
AIFP (EFPIA) / CzechMed (MedTech)
Deadline
Within 6 months of year-end

AIFP's central 'Transparency' platform is one of the most mature in Central Europe.

Hungary
Self-Regulatory
🇭🇺
Framework
AIPM (EFPIA) + statutory gift/hospitality restrictions
Deadline
Within 6 months of year-end

Hungarian statutory law imposes restrictions on gifts and hospitality to HCPs. National MedTech Europe-aligned association for devices.

Turkey
Self-Regulatory
🇹🇷
Framework
AIFD (Pharma) / ARTED (Devices)
Authority
TITCK (regulatory oversight)
Deadline
Within 6 months of year-end
Platform
Company websites or AIFD platform

TITCK has regulatory oversight. ToV data gathered and shared with Ministry of Health on request.

Other European Countries
Self-Regulatory (EFPIA)
🇪🇺
Countries
Ukraine, Bulgaria, Croatia, Bosnia, Serbia, Slovenia, Estonia, Lithuania, Luxembourg, Malta, Iceland
Deadline
All: Within 6 months of year-end
Ukraine
AIPM-Ukraine EFPIA-aligned code. Legislative reform ongoing — statutory requirements may be introduced.
Bulgaria
ARPharm (EFPIA) / BASMED (MedTech). Certain provisions of Medicinal Products Act also apply.
Croatia
iF! / EFPIA. HALMED sets certain promotional/transparency requirements.
Serbia
INGRB (EFPIA). Not an EU member but EFPIA Code applies via member association.
Slovenia
MSIF (EFPIA) / MedTech Europe-aligned. JAZMP has oversight.
Estonia / Lithuania / Luxembourg / Malta / Iceland
All follow EFPIA self-regulatory framework. Estonia, Luxembourg, Malta, Iceland are EEA countries without dedicated national MedTech associations — MedTech Europe rules nonetheless apply to devices.
Russian Federation
Self-Regulatory
🇷🇺
Framework
AIPM (Pharma) / IMEDA (Devices)
Deadline
By 30 June of the following year
Important Note
Engagement with the Russian market is subject to international sanctions regimes that should be reviewed separately. Disclosure is generally made on company websites.
🌏
Middle East & Africa Region
GCC + Wider MEA
Israel
Statutory
🇮🇱
Law
Section 40A — National Health Insurance Law (2010)
Authority
Israeli Ministry of Health (MOH)
Threshold
~NIS 2,500 aggregate per recipient per donor
Deadline
1 March each year (prior calendar year)
Platform
MOH publishes yearly list of reported donations on health.gov.il (Donations Report page).
Also
Joint Code of Ethics between the Israeli Medical Association and Pharma Israel (2014) supplements the statutory regime.
Saudi Arabia
Statutory
🇸🇦
Framework
SFDA Disclosure and Transparency Initiative (since 2018)
Authority
Saudi Food and Drug Authority (SFDA)
Threshold
>SAR 50 per transaction / SAR 500 annual aggregate
Deadline
Quarterly — due end of each quarter
Platform
SFDA eServices portal / National Health Portal (eservices.sfda.gov.sa).
Note
Disclosed HCPs/institutions may review their own data and file an objection if they find discrepancies.
Mecomed (GCC excl. KSA + MEA)
Industry Framework
🌍
Framework
Mecomed Code of Ethical Business Practice (2007, rev. 2017)
GCC Coverage
UAE, Kuwait, Qatar, Bahrain, Oman
Wider Coverage
Lebanon, Jordan, Egypt, Iraq, Morocco, Tunisia + others
Deadline
Annually — not later than 6 months after year-end
Scope
Educational Grants: Type A (third-party organised educational events including attendance, faculty, event running); Type B (scholarships, fellowships, public awareness campaigns).
Platform
Transparent Mecomed (disclosure.mecomed.com) — data published for access by Mecomed members, with a view to broader public access over time.
🌐
Asia-Pacific Region
6 Countries
South Korea
Statutory
🇰🇷
Law
Korean Sunshine Act — Art. 47-2 PAA / Art. 13-2 MDA (in force Jun 2017)
Authority
Ministry of Health and Welfare (MOHW) / KOPS
Deadline
Within 3 months after end of company fiscal year
Public Disclosure
December each year (MOHW guidelines, 2024)
Scope — 7 Categories
Samples; clinical trials; post-market surveillance; product presentations (multiple institutions); product presentations (single institution); academic conferences; price discounts tied to payment conditions.
Penalties
Administrative sanctions including revocation of product approvals and criminal penalties. HCPs receiving illegal rebates also face criminal liability and disgorgement.
Data Retention
Supporting data must be retained for 5 years. Public data remain accessible for 5 years.
Australia
Self-Regulatory
🇦🇺
Framework
Medicines Australia Code — Edition 20 (from 30 Mar 2025) / MTAA (Devices)
Reporting
Two periods per year
Deadlines
31 August and 28 February
Platform
Medicines Australia website — public reports
Edition 20 Change
Expanded transparency reporting to include grants and donations to healthcare organisations, aligning Australia more closely with international norms.
Penalties
Code breaches can lead to fines up to AUD 300,000 (adjudicated by independent Code of Conduct Committee) and mandated remedial action.
Japan
Voluntary + Statutory
🇯🇵
Framework
JPMA Transparency Guidelines (pharma) / JFMDA (devices) + Clinical Research Act Art. 33
Deadline
No statutory deadline — disclosure during following fiscal year after financial close
Platform
Each member company's website
JPMA Updated
March 2025, applied from FY2025 payments
Categories
R&D expenses, academic research support (donations), manuscript/writing fees, lecture fees, consulting fees, information-provision-related expenses.
Statutory Obligation
Clinical Research Act (in force 1 Apr 2018) imposes disclosure obligation for Specified Clinical Research under Art. 33.
New Zealand
Self-Regulatory
🇳🇿
Framework
Medicines New Zealand Code of Practice
Deadline
30 June each year (prior period)

Supplemented by general medicines regulation under Medsafe. Individual company disclosures and Medicines New Zealand central resources.

Indonesia
Statutory
🇮🇩
Framework
MoH Regulation 58/2016 and 14/2019 + IPMG / GP Farmasi codes
Authority
Ministry of Health (Kementerian Kesehatan)
Deadline
Within 30 days after the HCP/HCO receives support
Scope
Sponsorships for scientific events, educational/research support

Reporting covers sponsorships for scientific events, educational support, research support and similar benefits. Company codes of IPMG and GP Farmasi supplement the regulatory regime.

Philippines
Regulatory (Event-Centred)
🇵🇭
Framework
DOH Administrative Orders / FDA regulations + PHAP Code
Authority
Department of Health / FDA
Deadline
Notice of Meetings: one month prior to event
Status
Event-centred; wider Sunshine-style disclosure pending

Current regime requires sponsors to provide notice of meetings and disclose sponsorships. Pending developments on wider annual aggregate Sunshine-style disclosure are ongoing.

🌎
Americas Region
4 Jurisdictions
United States
Statutory
🇺🇸
Law
Physician Payments Sunshine Act (ACA 2010) + SUPPORT Act 2018
Authority
CMS — Open Payments Program
Threshold (CY2025)
USD 13.46 per instance / USD 134.54 annual aggregate
Deadline
31 March (for prior calendar year data)
Covered Recipients
Physicians (MDs/DOs, dentists, podiatrists, optometrists, chiropractors), teaching hospitals, and since 2021 reporting: physician assistants, NPs, clinical nurse specialists, CRNAs/AAs, certified nurse-midwives.
Publication
CMS Open Payments public database (openpaymentsdata.cms.gov) by 30 June. 45-day physician review/dispute window (1 Apr – 15 May).
Penalties
Civil monetary penalties from USD 1,000 to USD 100,000 per violation. Annual aggregate cap exceeded USD 1.4 million as of 2024. CMS audits began FY2023.
State Overlay
Many states impose additional obligations: Vermont, Minnesota, Massachusetts, West Virginia, Washington D.C., Nevada, California, Connecticut, Louisiana and others. Often include compliance-program requirements, gift bans or additional reporting.
Colombia
Statutory
🇨🇴
Framework
Resolution 2881/2014 + Law 1438/2011 Art. 106 + Law 1474/2011 Art. 133
Authority
Ministry of Health and Social Protection
Threshold
<½ SMLMV exempt (unless annual aggregate >1 SMLMV)
Deadline
Semi-annually: before September and before April
Scope
ToVs from pharma and device companies to HCPs, HCOs, learned societies, associations, NGOs, BPAEs, health service providers and communication media covering health topics.
Penalties
Improper inducements can carry fines up to USD 1.5 million under anti-corruption provisions.
Brazil
State-Level Statutory
🇧🇷
Law
Minas Gerais: State Law 22,440/2016 + 22,921/2018; CFM Rule 2,386/2024 (from 1 Mar 2025)
Authority
State Secretary of Health of Minas Gerais / Declara SUS
National Status
No federal Sunshine Act — multiple bills pending
Deadline
Last business day of January (prior calendar year)
Scope
Medicines, orthoses, prostheses, equipment and implants — donations/benefits to HCPs registered in Minas Gerais plus sponsorships by Minas Gerais-based companies in other states.
CFM Rule 2,386/2024
Requires the physician (not industry) to disclose relationships — company names and duration only (no financial amounts) — on CRM state websites. In force from 1 March 2025.
Canada
Statutory (Pending) + Voluntary
🇨🇦
Ontario Law
HSPTA 2017 — law enacted, not yet operative (as at Apr 2026)
National
IMC Voluntary Framework on Disclosure of Payments (2017)
Ontario Deadline
End of June (planned — not currently enforced)
National Deadline
Voluntary — typically on participating company websites
Ontario HSPTA Status
Statute is law but implementation repeatedly delayed since 2018. Draft regulations consulted on but not finalised or enforced. Companies should monitor Ontario Ministry of Health publications.
Ontario Penalties (if enacted)
Up to CAD 10,000/day for individuals; up to CAD 100,000/day for corporations.
National IMC Framework
Participating pharma companies voluntarily report aggregated payment amounts to Canadian HCPs and HCOs. No central government database at national level.

Managing multi-country transparency reporting?

Vector Health’s end-to-end managed service handles requirements across 60+ countries — from data collection to submission.

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