Global Transparency Reporting Laws & Deadlines

French Public Health Code, as amended by Law No. 2011-2012 of 29 December 2011 (the 'Bertrand Act') and reinforced by Law No. 2016-41 of 26 January 2016 (the 'Touraine Act'). Implemented by Decrees 2013-414 and the 2017 Decree establishing the Transparence Sante platform.

Ministere des Solidarites et de la Sante, via the Transparence Sante public portal.

Extremely broad - covers pharmaceuticals, medical devices, cosmetics, tattoo products, tissues/cells, software publishers for prescription or dispensing tools, and more. Covered recipients include HCPs (doctors, dentists, nurses, midwives, pharmacists, students), HCOs (hospitals, clinics, learned societies, professional associations), patient associations, and media that cover health.

Three categories of disclosure - Agreements ('Conventions'), Benefits/Advantages, and Remunerations.

Advantages and remunerations of EUR 10 or more (including VAT) must be declared. Agreements must be declared regardless of value.

Agreements, benefits and remunerations from 1 January to 30 June: declared by 1 September of the same year. From 1 July to 31 December: declared by 1 March of the following year (with publication cycles in October and April respectively).

Transparence Sante - fully public, searchable by HCP name, company, benefit type, date. Data remain published for 5 years.

Reporting is a statutory obligation and does not depend on HCP consent. Only individual (not aggregate) disclosure is allowed.

Individuals: fines up to EUR 45,000 (plus possible accessory penalties). Corporations: fines up to EUR 225,000. Reputational damage is often the greater concern because the data are public.

Law No. 62 of 31 May 2022 (the 'Italian Sunshine Act' / 'Sanita Trasparente'), in force since 26 June 2022 but operationally dependent on the launch of the Sanita Trasparente electronic register.

Italian Ministry of Health (in cooperation with AgID, ANAC and the Garante Privacy). Complementary industry codes are operated by Farmindustria (pharma) and Confindustria Dispositivi Medici (devices, 'CDM/MedTech').

Transfers of value (ToVs), agreements, shareholdings and bond ownership, and royalties/licences on intellectual property between manufacturing companies and HCPs, HCOs, patient associations and scientific societies.

For HCPs: any single ToV > EUR 100, or annual aggregate > EUR 1,000. For HCOs: any single ToV > EUR 1,000, or annual aggregate > EUR 2,500. Equity/IP royalties must be reported irrespective of value.

If the register becomes live by the end of 2025, data collection for H1 2026 runs January-June 2026, submission by 31 December 2026, and public release from early January 2027. H2 2026 data is due by 30 June 2027. Annual financial interests for 2026 are due by 31 January 2027.

Sanita Trasparente public telematic register, operated by the Ministry of Health. Data remain searchable for 5 years.

XML files using official XSD schemas - manual entry is not permitted. Two schemas: one for ToVs/agreements, one for equity interests and royalties. 'All-or-nothing' file validation.

For unreported ToVs: EUR 1,000 plus 20 times the value of each unreported item. For failure to report equity/IP: EUR 5,000 - EUR 50,000 (some sources cite up to EUR 100,000 for false statements or failure to correct). Company names and fines are published on Sanita Trasparente for at least 90 days.

Annually, within the first 6 months of the year after the expenses were incurred.

Members publish ToVs within the first 6 months of the following year.

For HCPs: any single ToV > EUR 100, or annual aggregate > EUR 1,000. For HCOs: any single ToV > EUR 1,000, or annual aggregate > EUR 2,500. Equity/IP royalties must be reported irrespective of value.

Belgian 'Sunshine Act' (Law of 18 December 2016), implemented by Royal Decrees in 2017. Reporting is mandatory since 2018.

Federal Agency for Medicines and Health Products (FAMHP / AFMPS).

Pecuniary advantages or benefits in kind granted, directly or indirectly, to HCPs, HCOs and patient associations (whose principal activity is in Belgium).

betransparent.be - a multi-stakeholder platform that integrates company disclosures with industry and professional-organisation input.

Annual, submissions due each year for data of the prior calendar year - publication follows the EFPIA six-month pattern.

Law No. 52/2015 of 9 June, as amended, which introduced legally binding transparency obligations for pharmaceutical and medical device companies.

INFARMED (National Authority of Medicines and Health Products).

All benefits granted, directly or indirectly, to HCPs, HCOs and patient organisations. Broad coverage of both financial and in-kind transfers.

Annual, within 6 months after the end of the reporting period.

INFARMED operates a central public portal. Disclosures must be made both to INFARMED and published there.

Governing Law: Greece has a statutory disclosure regime (Law 4316/2014 and subsequent implementing provisions) alongside the SFEE (Hellenic Association of Pharmaceutical Companies) code, which transposes the EFPIA Disclosure Code. For devices, the MedTech Europe Code applies via SEIV.

ToVs to HCPs, HCOs, patient organisations and medical scientific societies. Individual disclosure where the law/consent allows; otherwise aggregate.

Annual, within 6 months after the end of the reporting period.

Submissions are filed with the Greek National Organisation for Medicines (EOF), which publishes a central list.

Latvia has statutory transparency rules (Cabinet Regulations implementing the Pharmaceutical Law) requiring pharmaceutical companies to publish ToVs to HCPs and HCOs on the national competent authority's website.

State Agency of Medicines (Zalu valsts agentura, ZVA).

Annual, within 6 months after the end of the reporting period

ZVA public portal and company websites.

Romania has a statutory transparency obligation under Law 95/2006 (Title XVIII) and Ministry of Health Order 194/2015, requiring pharmaceutical and medical device companies to publish sponsorships and transfers of value to HCPs/HCOs on the National Agency for Medicines (ANMDMR) website.

ANMDMR (National Agency for Medicines and Medical Devices of Romania).

Annual, within 6 months after the end of the reporting period (publication by end of June).

ANMDMR public portal.

Slovakia has statutory transparency provisions under Act No. 362/2011 on Medicinal Products and Medical Devices, requiring pharmaceutical companies to disclose monetary and non-monetary benefits to HCPs/HCOs to the State Institute for Drug Control (SUKL).

SUKL.

Semi-annually in practice, with annual public reporting within 6 months after the end of the reporting period.

SUKL central portal.

Section 40A of the National Health Insurance Law (as amended in 2010), together with Section 40A(a) and guidance issued by the Ministry of Health.

Israeli Ministry of Health (MOH).

Donations in money or money's equivalent by an entity (including pharmaceutical and medical device companies) to a health establishment or HCP. Where the annual total provided by a donor to any single recipient exceeds approximately NIS 2,500, the donor must report each donation - identifying the recipient, the amount or value, and the purpose.

Annual - reports are submitted to the Minister of Health by 1 March each year for the preceding calendar year.

The Ministry of Health publishes the yearly list of reported donations on its website (health.gov.il Donations Report page).

The Joint Code of Ethics between the Israeli Medical Association and Pharma Israel (2014) supplements the statutory regime with industry-facing rules.

Saudi Food and Drug Authority (SFDA) Pharmaceutical Company Payments Disclosure Initiative, in effect since 2018 and operated through the SFDA Disclosure and Transparency Service.

Saudi Food and Drug Authority (SFDA).

All financial or in-kind transactions between pharmaceutical/medical-device companies and HCPs, healthcare institutions or charitable organisations in the Kingdom.

Reportable where the amount exceeds SAR 50 per individual transaction, or SAR 500 per covered recipient annually.

Quarterly submissions, due at the end of each quarter; annual disclosure exercise starts at the beginning of the calendar year. Webpage summary: 'Quarterly: due end of quarter.'

SFDA eServices portal / National Health Portal for Disclosure and Transparency (eservices.sfda.gov.sa).

Disclosed HCPs/institutions may review their own data and file an objection if they find discrepancies.

Korean 'Sunshine Act' - Article 47-2 of the Pharmaceutical Affairs Act and Article 13-2 of the Medical Devices Act, in force since 3 June 2017. Data collection began with fiscal year 2018. Public disclosure framework was formalised by the Ministry of Health and Welfare (MOHW) Guidelines of 21 March 2024.

Ministry of Health and Welfare (MOHW), through the Expenditure Report Management System (KOPS).

Economic benefits lawfully provided to medical personnel, pharmacists and medical institutions in seven categories: (i) samples; (ii) clinical trials; (iii) post-market surveillance; (iv) product presentations to multiple medical institutions; (v) product presentation to a single medical institution; (vi) academic conferences; (vii) price discounts tied to payment conditions.

Companies must prepare the expenditure report within three (3) months after the end of each fiscal year and retain supporting data for 5 years.

Within three months after the end of the company's fiscal year.

Data collection January-May each year; submission to MOHW June-July; de-identification and finalisation; public release in December; data remain publicly accessible for 5 years.

KOPS system, searchable by members of the public.

Administrative sanctions (including revocation of product approvals) and criminal penalties where economic benefits are provided outside the lawful exceptions. HCPs receiving illegal rebates also face criminal liability and disgorgement.

Ministry of Health (Kementerian Kesehatan) regulations, including Minister of Health Regulation No. 58/2016 and No. 14/2019 and related circulars that restrict and require reporting of industry support to HCPs and HCOs. Transfers of value require reporting to the Ministry of Health.

Ministry of Health (MOH) of the Republic of Indonesia.

Within 30 days after the HCP/HCO receives the support.

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

Physician Payments Sunshine Act (Section 6002 of the Patient Protection and Affordable Care Act of 2010), amended by the SUPPORT Act of 2018 to expand covered recipients. Implemented through CMS regulations as the Open Payments Program.

Centers for Medicare & Medicaid Services (CMS).

Applicable manufacturers of covered drugs, devices, biologicals and medical supplies reimbursable under Medicare, Medicaid or CHIP (requiring a prescription or FDA premarket approval/notification), plus applicable group purchasing organisations (GPOs) and physician-owned distributors.

Physicians (MDs/DOs, dentists, podiatrists, optometrists, chiropractors), teaching hospitals, and since 2021 reporting five further categories: physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists/anesthesiologist assistants, and certified nurse-midwives.

For calendar year 2025, payments or transfers of value below USD 13.46 per instance are excluded - unless the annual aggregate to any single covered recipient exceeds USD 134.54.

Annual - data covers a full calendar year.

Submission window: 1 February - 31 March of the following year. For CY2025 data, the deadline is 31 March 2026. Webpage summary: '31 March'.

Covered recipients have 45 days (1 April - 15 May) to review and dispute data before publication.

CMS Open Payments public database (openpaymentsdata.cms.gov) by 30 June each year.

Civil monetary penalties from USD 1,000 to USD 100,000 per violation (adjusted annually); aggregate cap exceeded USD 1.4 million as of 2024. CMS also began audits of applicable manufacturers in FY2023.

The federal Sunshine Act preempts identical state requirements, but many states impose additional or different obligations (Vermont, Minnesota, Massachusetts, West Virginia, Washington D.C., Nevada, California, Connecticut, Louisiana, and others). These often include compliance-program requirements, gift bans or additional reporting.

Resolution No. 2881 of 2014 (as amended) of the Ministry of Health and Social Protection establishing measures to ensure transparency in prescription and medical autonomy. Industry self-regulation via ANDI Chamber for Medical Devices (Code of Ethics and Transparency, 2015) also applies. Article 106 of Law 1438 of 2011 and Article 133 of Law 1474 of 2011 prohibit improper inducements and can carry fines up to USD 1.5 million.

Ministry of Health and Social Protection (Ministerio de Salud y Proteccion Social).

Transfers of value from pharmaceutical and medical-device companies to HCPs, healthcare organisations, learned societies, associations, NGOs, BPAEs (benefit plan administrators), health service providers and communication media covering health topics.

Transfers of value below half of one monthly legal minimum wage (1/2 SMLMV) are exempt from individual registration, unless aggregated annual value exceeds one SMLMV. Medical samples are exempt unless individual market value exceeds four SMLMVs.

Semi-annual. Webpage summary: 'Semi-annually: before September, and before April.'

Central portal managed by the Ministry of Health and Social Protection.

At national level, there is no federal Sunshine Act yet (bills such as PL 7,990/2017, PL 11,050/2018, PL 11,177/2018, PL 204/2019 and PL 1,041/2024 remain pending). At state level, the State of Minas Gerais has enacted: (i) State Law No. 22,440/2016 and Decree 47,334/2017, regulating disclosure of donations and transfers of value with potential conflict of interest (Resolution SES/MG No. 6368 of 10 August 2018); (ii) State Law No. 22,921/2018, regulating sponsorship of scientific exchange (Resolution SES/MG No. 6369 of 10 August 2018). At federal professional level, CFM Rule No. 2,386/2024 (in force from 1 March 2025) obliges physicians to declare industry ties to their Regional Medical Council (CRM).

State Secretary of Health of Minas Gerais (Secretaria de Estado de Saude de Minas Gerais). Publication is made through the Declara SUS platform.

Industries of medicines, orthoses, prostheses, equipment and implants must declare donations or benefits to HCPs - including gifts, event tickets, registration fees, accommodation, research financing, consulting and lecture fees - for HCPs registered with professional councils in Minas Gerais, plus sponsorships carried out by Minas Gerais-based companies in other states.

Annual report to the Minas Gerais State Health Department by the last business day of January for the previous calendar year's data.

Declara SUS - publicly accessible government portal.

Requires the physician - not the industry - to disclose relationships. Scope is limited to the names of companies and duration of the ties (no financial amounts) and disclosure is made on the CRM websites of the state where the physician is registered.