100% Compliant with EFPIA & Sunshine Act

The landscape regarding the publication of transparency of transfers of value to Healthcare Professionals is constantly evolving, especially in Europe, where there is a drive for greater consistency between local regulations. Elsewhere too, however, the list of jurisdictions that require a specific type of management of the transparency of transfers of value continues to grow. Ontario, Canada, passed the extensive Healthcare Payment Transparency Act in 2017. In the Middle East, the Saudi Food and Drug Authority launched its initiative to disclose pharmaceutical company payments in 2018, and the Brazilian state of Minas Gerais now requires disclosure of any kind of donation or benefit to Healthcare Professionals.    

In addition, the process of collecting and communicating data on transfers of value to HCPs is changing as the introduction of increasingly sophisticated data collection and management tools improves the accuracy and efficiency of the published information. For example, in the first period of the Open Payments Usage Report, the U.S. government organization CMS (Center for Medicaid and Medicaid Services) retained 4.4 million records, or $514 million, from publication due to incomplete or inaccurate data. Today, end-to-end software-as-a-service (SaaS) solutions enable companies to automate the entire process, from qualifying Healthcare Professionals and Organizations (HCP and HCO) and establishing fair market value, to managing contracts and grants, generating activity reports and more. These systems generate data that enable pharmaceutical companies to better understand their operations and build efficacious partnerships with HCPs and HCOs.

Trueblue’s focus on customers and the evolution of transparency requirements have led the company to the development of a module aimed at ensuring total coverage of and compliance with aspects such as Transparency & Compliance in the management of promotional initiatives. Since 2006, Trueblue has concentrated its efforts in the creation of a specific solution dedicated to promotional activities (congresses, consulting, donations, etc.) capable of automating and optimising all processes relating to the management of pharmaceutical events in compliance with current transparency regulations. This is how Event Management was born, a solution that makes use of an integrated analytical model that allows customers to have complete, pre-configured and ready-to-use reports and analyses.

To date, the Event Management solution has been implemented in the major pharmaceutical multinationals. Our product is mainly composed of four modules that fully meet the specific needs of the Congress, Commercial, Compliance, Medical and Administrative Departments. The main modules that make up the solution are Budget & Planning, Operational Promotional Activities Management, Administration, and Transparency.

The EFPIA Code (European Federation of Pharmaceutical Associations and Industries) is a code of conduct that requires all companies members of EFPIA and companies members of associations that are part of EFPIA to publish all transfers of value to Health Professionals (HCPs) and Health Organisations (HCOs) on their corporate website.

The EFPIA Code constitutes the collection of ethical rules agreed by the members of the federation for the promotion of medical products to Healthcare Professionals and interactions with them and Healthcare Organisations, with the aim of ensuring that these activities are conducted in accordance with the strictest ethical principles of professionalism and responsibility. This Code applies to all types of communication and interaction (traditional and digital).

In 2019, EFPIA merged its three EFPIA codes (HCP – PO – Disclosure) into a single simplified code. The objectives of this consolidation were to simplify the concepts, eliminate repetitive provisions and clarify contents.

This review has been therefore undertaken to update the provisions of the Code to better align concepts and to better promote common understanding of the Code by stakeholders and the public in order to improve adherence to the Code.

The EFPIA Transparency Code therefore sets out guidelines for the disclosure of certain transfers of value (TOV) to HCPs and HCOs. Examples of transfers that must be disclosed include: contributions to health organisations and fees for scientific advice from HCPs as well as accommodation and travel costs incurred by the Pharmaceutical Company to invite physicians to Events.

This data is disclosed through specific reports developed by Trueblue, which the Pharmaceutical Company can publish on its website.

Data can be disclosed:

• In EXPLICITED form with the personal data (first name, last name, address, tax code/vat code) of the health care professional/organisation and the amounts incurred by the Pharmaceutical Company for the invitation and/or the amounts received by the subject (e.g. the fee for speakers)
• In AGGREGATED form, i.e. not detailing the details of HCPs/HCOs, nor the sums provided by the Pharmaceutical Company, but giving an overall total for all HCPs/HCOs

The explicited form takes place when HCP/HCOs give CONSENT to the disclosure of data, while data is published in aggregated form when they DENY consent

For US doctors, August 1, 2013 was a historic date, as on that day the Sunshine Act came into force. From that day on, any financial transaction, in cash or in kind, exceeding $10, between a physician or group of physicians and one or more manufacturers of drugs or other healthcare products must be notified and entered into a special public register that can be consulted by anyone from September 1, 2014. The register will also contain information on the properties and investments of each individual doctor and his or her immediate family members.

The Sunshine Act, full name Physician Payments Sunshine Act, is a law enacted on March 23, 2010 by the U.S. government as part of a package of laws on patient protection and access to care. The Sunshine Act is not intended to limit gifts and grants to doctors and health care institutions, but to make them transparent. The law was drafted after a group of journalists revealed that in 2009/10, the pharmaceutical industry had given more than 18,000 doctors a total of around $320 million, with payments of around $250,000 to the 10 leading doctors in the ranking.

Although the pharmaceutical industry could not have imagined it at the time, the passing of the US Physicians Payments Sunshine Act 2010 marked a turning point in global transparency regulation. Over the past decade since then, other countries have adopted similar requirements, building on and, in many cases, expanding US parameters for reporting interactions between manufacturers and HCPs and HCOs.

A 2018 research paper published in the International Journal of Health Policy and Management examined transparency protocols as issued and observed by nine different EU countries. Member States: Germany, Spain, France, Italy, Latvia, the Netherlands, Sweden, the United Kingdom and Portugal. In all but three (France, Latvia and Portugal), sector-led legislation regulates the supervision of pharmaceutical and other healthcare companies, but recent trends indicate that the flow is changing. Although the industry has paved the way for the development of transparency and reporting guidelines, regulators are showing a growing desire to integrate the process into ordinary government legislation.

The most recent example of this is occurring in Italy, and the result will be an important indication of current perceptions of American-style HCP and HCO regulation, and a look at the direction that such legislation could take in the future. Industry stakeholders on both sides of the Atlantic (Europe and America) should pay attention to this evolving process.

In Italy, with the result of 377 votes in favour and no votes against, the Chamber of Deputies approved the Sunshine Act – the bill that provides for the introduction of transparency obligations with regard to data of collective interest in relations between suppliers and health care workers. The bill has now passed to the Senate for final disclosure.

The aim is to prevent corruption involving the health sector and fully embrace the principle of Transparency, requiring mandatory disclosure of disbursements of money, goods, services and other benefits made by a supplier company to a person operating in the health sector with a unit value exceeding €50 or a total annual value exceeding €500.

In terms of compliance with the new regulations of the Italian Sunshine Act and based on previous experience in other countries where this publication is already present and active, Trueblue’s Event Management product has already integrated and configured a Sunshine Act management module (currently active in other countries, such as France) to adapt to Italian compliance.