In a recent global compliance presentation at the Informaconnect Transparency, Aggregate Spend and HCP Engagement, Elon Shelf, Senior Compliance Advisor at MedPro, shared updates on transparency reporting regulations across various countries. The discussion covered the challenges in compliance, the evolving landscape of disclosure requirements, and the intricacies of conference guidelines, with specific attention to South Korea, Brazil, the UK, the Netherlands, and Italy.
South Korea: A New Era of Transparency
South Korea has been a focal point in the transparency arena, shifting from voluntary to mandatory disclosures in 2024. Companies now must submit reports directly to South Korea’s expenditure management system, KOPS (pronounced “cops”), with distinct submission windows for distributors, importers, CSOs, and manufacturers. The reports need to be prepared within three months after the fiscal year-end, and submission deadlines range from June 3 to July 20, depending on the type of entity.
A key development is that reported data will be de-identified for public access. Additionally, a new user guide for South Korea has been published, although it is only available in Korean, presenting a potential language barrier. The number of templates required for reporting has also increased from 14 to around 18, further expanding the reporting scope. There are also pending plans for a pre-disclosure and dispute timeline for companies, set to roll out by 2025.
Brazil: Movement Toward National Transparency
Brazil is actively considering three bills (7990/204, 1041) that, if passed, would create a nationwide transparency scheme. While currently only the state of Minas Gerais requires reporting, these bills propose extending this obligation across all of Brazil, aiming to increase transparency between the medical industry and healthcare professionals. This legislation was driven partly by findings from UOL, a Brazilian media company, which revealed significant industry spending on HCPs without oversight in most of the country.
The proposed regulations outline several reportable expenditures, such as travel expenses, gifts, and participation fees, all of which would be disclosed through a central reporting platform. The Ministry of Health would oversee this data, with submissions required within 90 days of the financial year-end.
UK: The Path Toward a National Disclosure Scheme
The UK is considering implementing a national Sunshine Act following a 2023 consultation on mandatory disclosure requirements. The proposal is based on the 2022 Health and Care Act, granting the Secretary of State the authority to mandate public disclosures of payments and benefits. The UK already has robust industry self-regulation via the ABPI (Association of the British Pharmaceutical Industry) and ABHI (Association of British HealthTech Industries). However, the proposed law would centralize these efforts and standardize reporting on the Disclosure UK platform, akin to the CMS platform in the U.S.
Key thresholds are set at £50 for individual transactions and £500 for aggregate payments per recipient. The results of the public comment period, which ended in October, are pending, leaving companies to anticipate further regulatory details.
The Netherlands: From Self-Regulation to National Law
A move toward greater transparency is also underway in the Netherlands. Historically, transparency has been regulated by industry associations via the TRZ platform, with participation limited to CGR and GHM members. A recent letter from Minister Dykstra to the Dutch House of Representatives called for a national law, aiming to overcome current shortcomings, such as the inability to search the database and lack of hospital oversight over HCP activities.
The decision to move to a national Sunshine Act is rooted in three main goals: establishing a centralized platform, enhancing hospital board oversight, and creating a clear framework for sponsorship regulation. While the timeline for implementation is uncertain, the Netherlands is expected to transition to this new framework over the next two to three years.
Italy: Stalled Progress on the Sunshine Act
Italy’s journey toward transparency has been a lengthy one. Though a Sunshine Act was passed several years ago, changes in government have delayed implementation. Technical specifications were released in October 2023, but further action has stalled, leaving companies in a state of uncertainty as they await the rollout of the online platform and enforcement deadlines.
Conference Guidelines: Navigating Global Standards
For companies hosting or sponsoring conferences abroad, adherence to international guidelines is crucial. Shelf emphasized the importance of pre-conference approval, particularly in Europe, where the EFPIA (European Federation of Pharmaceutical Industries and Associations) and MedTech Europe oversee compliance.
The EFPIA introduced an online platform, E4ethics, to assess and approve third-party events, mandating its use as of March 2020. MedTech Europe has a similar system called the Conference Vetting System (CVS), which also evaluates events for compliance. Both platforms are now unified under ethicalmedtech.eu, streamlining the approval process for pharmaceutical and device companies.
Six primary criteria are used to evaluate conference compliance: event program, geographic location, event venue, hospitality, participant registration, and communication support. Key restrictions include ensuring events are held in scientific or business centers, avoiding tourist or recreational destinations, and ensuring reasonable hospitality without lavish giveaways.
Interestingly, regional nuances play a role in compliance. For instance, in Nordic countries, rules explicitly restrict the distribution of chocolate and bonbons at conferences, given their cultural significance. Meanwhile, Germany’s strict guidelines allow only basic refreshments, and certain foods like schnitzels or ice cream are outright prohibited.
Enforcement Case Study: Germany’s Bavarian Medical Association
Shelf also highlighted a recent enforcement action in Germany, where the FSA (German industry association under EFPIA) overruled an approval granted by EFPIA for an event in the picturesque town of Lindau. Despite prior approval, the FSA deemed Lindau a recreational destination, posing a reputational risk. Interestingly, the FSA refrained from imposing penalties, recognizing the Bavarian Medical Association’s genuine effort to comply, though it typically channels fines to charities.
Conclusion
Transparency in global reporting is rapidly evolving, with numerous countries tightening their disclosure requirements and refining conference compliance guidelines. Companies operating internationally must stay informed of changing regulations, consult local legal counsel when necessary, and ensure adherence to both national laws and industry association codes. One company MedPro, through its Regulatory ID and other resources, provides ongoing updates and support to help navigate these complex compliance landscapes.