Transparency in the Interactions between the Industry and Healthcare Professionals: Where Now ?

By Alexandre Regniault, Attorney at Court – Associate/Partner & Augustin Bricaire, Attorneys, Simmons & Simmons LLP

In the dynamic and complex world of healthcare & life sciences, ethics and compliance have been thought of as means to preserve the integrity of scientific research and findings, and ultimately, to ensure patient safety. A key element of compliance is the transparency imposed on (or sometimes self-imposed by) companies manufacturing or operating health products, particularly in their interactions with healthcare professionals (HCPs) or organisations (HCOs) in the context of their economic development. This article discusses global trends and challenges in transparency and explores how innovative technology could offer solutions to these challenges.

Transparency in the healthcare sector was first introduced in the USA in 2010 through the Physician Payments Sunshine Act (or “Sunshine Act”) whose main objective was to increase the transparency of financial relationships between healthcare professionals and pharmaceutical product manufacturers by requiring the latter to report payments made to doctors and hospitals. Since then, similar systems have gradually spread and developed worldwide, particularly elsewhere in America (Canada, Brazil, Colombia), in the EMEA region (with France leading in 2012, Belgium, Portugal, Romania, Israel, Saudi Arabia), and in other countries like Japan, Indonesia, South Korea or Australia. To date, transparency regulations and codes apply in more than 50 countries with about 120 reporting templates in use across pharma, medtech and generic sectors. More recently, this practice has gained legal ground in Italy, with the entry into force of the Italian Sunshine Act on June 2022;  this legislation imposes it on pharma and medical devices companies to disclose all payments and agreements with HCPs and HCOs. These regulations aim to shed light on potential conflicts of interest, thereby preserving patient car from any undue influence.

Transparency related to transfers of value operates at a national level, with local requirements varying whether in sources (mandatory law initiated by the government or practice voluntarily taken by industries), applicable thresholds above which interactions should be published (e.g., 10 euros in France, 500 euros in the Netherlands, no threshold in Germany), categories of beneficiaries concerned, timelines for reporting, platform displaying the available data (public platform or on the industry’s website), currency, language, etc.

It is important to note that these transparency initiatives are not only about complying with regulations or practice; they also concern the positive image that healthcare & life sciences l industries want to project in their economic development. Transparency thus strengthens the overall reputation of the healthcare industry, not only by meeting their legitimate business needs, but also by fostering trust and demonstrating a commitment to ethical practices.

However, transparency requirements continue to be more stringent and significantly growing, and their implementation is not without several challenges.

As mentioned earlier, the lack of harmonization and common rules between the jurisdictions concerned by this transparency reporting obligation requires navigating between the various regulations in place, both in terms of disclosure dates and categories of people concerned, etc. Organizations then need to adapt to this lack of uniformity by implementing scalable, robust, and flexible solutions to deal with these diverse requirements.

Another challenge is the disclosure of personal data of HCPs. Industries must continually ensure to closely monitor interactions between life science industries and HCP/HCO and manage their interaction in the best possible way, in order to minimize the risks of unethical behaviours, corruptions, bribery, or false claims. They must also reinforce the accuracy and completeness of the publication of transfers of value and ensure that all interactions with the relevant individuals are correctly published to ensure greater transparency.

Finally, the publication of data is not without risk with non-compliance with data protection law and in particular with the General Data Protection Regulation (GDPR) when personal data (name, first name, occupation, etc.) are collected in Europe. The GDPR, which has been fully in force since 2018, imposes strong sanctions and penalties in case of non-compliance (with a top fine up to 4% worldwide group turnover). Thus, a big task will be to reconcile data processing with the consent management provided for by personal data law, either by the GDPR or by local jurisdiction, as well as compliance with applicable data subject rights.

To meet these challenges, organizations will first need to plan for the time and effort required to fulfil their reporting obligations and involve dedicated staff. They will also need to ensure that they put in place sustainable solutions to establish, track, and maintain guidelines by unifying disparate processes and always ensuring that publications are made in compliance with the various regulations in place.

Technology could offer effective solutions to enable industries to fulfil their transparency obligations and face these challenges. Therefore, it is important for companies to equip themselves with efficient and secure tools to record, manage, and publish data from HCPs in a reasonable time, while ensuring that all data are accurate, complete and ready to be disclosed on the required platforms online. Artificial Intelligence (AI) and Machine Learning (ML) can automate the process of collecting, analysing, and reporting data, reducing the administrative burden on staff and also minimizing human errors. These tools can also offer a valuable means of navigating the complexity of different jurisdictions, managing large volumes of data, and ensuring accurate and timely reporting. Finally, innovative technologies can help life science companies to identify patterns and trends, providing them with valuable insights not only about their compliance with transparency rules, but also potentially benchmark against their competitors.

However, technology is not a panacea. It is a tool that, when used effectively, can greatly enhance transparency efforts. But it must be accompanied by a commitment to ethical practices and a willingness to engage in constructive dialogue with stakeholders, while always ensuring compliance with existing regulations that must be adapted to the current circumstances. Transparency is not just about disclosing information; it is about building trust, enhancing reputation, and ultimately improving patient care. Despite the many challenges, improving transparency remains a goal worth pursuing.

Alexandre Regniault – alexandre.regniault@simmons-simmons.com
Augustin Bricaire – augustin.bricaire@simmons-simmons.com

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