On September 9, 2025, the Joint Committee of the three European supervisory authorities—EBA, EIOPA, and ESMA, collectively known as the ESAs—published its fourth annual report on the scope of voluntary disclosure of Principal Adverse Impacts (PAI) under the Sustainable Finance Disclosure Regulation (SFDR). This latest report, released just a day before the annual deadline set out in Article 18 of the SFDR, marks a significant step in Europe’s ongoing effort to foster greater transparency and responsibility in the financial sector, particularly when it comes to the environmental and social impacts of investments.
Principal Adverse Impacts, or PAIs, refer to the most significant negative effects that investments can have on the environment and people. The SFDR requires financial market operators to consider these impacts and, crucially, to take steps to reduce them. The annual report offers a snapshot of how well these operators are meeting the expectations set out by the regulation, both at the level of individual entities and specific financial products.
According to the ESAs, this year’s analysis involved surveys with national competent authorities and a close review of publicly available PAI statements across asset management, insurance, and occupational pensions, as well as a sample of financial product disclosures. The findings? There’s clear evidence that financial market operators are making a concerted effort to publish more comprehensive information in line with SFDR disclosure requirements. The overall quality of these disclosures has improved, a trend that’s been building over the past several years.
But the report doesn’t just highlight progress—it also shines a light on persistent gaps. Large multinational financial market operators generally provide more detailed and robust information, setting a high bar for transparency. Smaller entities, on the other hand, often blend general ESG (environmental, social, and governance) or marketing content with their SFDR disclosures, sometimes making it harder for stakeholders to distinguish between regulatory compliance and promotional messaging. According to the ESAs, this discrepancy underscores the need for more targeted guidance and support, especially for smaller players who may lack the resources of their multinational counterparts.
National competent authorities who participated in the survey noted that some operators have taken good practices from previous reports to heart, leading to tangible improvements in the quality and clarity of their disclosures. The ESAs’ 2025 report includes a series of recommendations aimed at helping these authorities strengthen their oversight of PAI information. It also offers advice for the European Commission, which is preparing for the next review of the SFDR. The message is clear: while progress has been made, there’s still work to do to ensure that all market participants are providing the kind of transparent, actionable information that regulators—and the public—expect.
Meanwhile, in Italy, a parallel push for better transparency and communication is unfolding in the pharmaceutical sector. On July 16, 2025, the project “Rethink Safety Communication,” promoted by the Pharmaceutical Industry Association (AFI) in collaboration with Federfarma, officially concluded. The initiative, which began in December 2024, aimed to revolutionize how drug safety information is communicated across the country. The result was the publication of an official Position paper containing concrete recommendations designed to improve access to information, ultimately enhancing protection for both healthcare professionals and patients.
At the heart of “Rethink Safety Communication” was a recognition that the current system for managing additional risk minimization measures (aRMM) and communication to healthcare professionals (DHPC) needed a serious overhaul to keep pace with new challenges in the sector. The project team conducted an in-depth analysis of European regulations and developed a series of action proposals, which will now be shared with public regulatory authorities. Their goal? To offer constructive input to both the European Medicines Agency (EMA) and the Italian Medicines Agency (AIFA), supporting the development of a system that provides clearer and more timely information—a change that could make a real difference in safety outcomes.
The Position paper identifies three key areas of intervention, each of particular interest to pharmacists and pharmacies. First, it stresses the importance of recognizability and comprehension of safety materials. Uniformity in the structure and format of aRMM and DHPC content is seen as essential, as is the inclusion of a concise summary document to accompany aRMM materials. This, the authors argue, would help ensure that crucial safety information is both accessible and understandable to those who need it most.
Second, the Position paper highlights the urgent need for new digital tools. Specifically, it calls for the creation of an institutionalized digital repository—linked to the regulatory authority—that would collect all DHPC and aRMM materials in a comprehensive, up-to-date manner. Such a repository would make it far easier for healthcare professionals to access the information they need, when they need it, reducing the risk of errors or omissions in patient care.
Third, the document underscores the importance of training and awareness. It recommends implementing targeted information campaigns to raise awareness among healthcare professionals about the existence and function of aRMM and DHPC materials. The hope is that by increasing familiarity with these resources, professionals will be better equipped to use them effectively in their daily work.
Another key recommendation is to integrate DHPC and aRMM materials directly into prescription and dispensing databases. This would ensure that doctors and pharmacists have immediate access to the latest safety information at the point of care, supporting more informed decision-making and ultimately improving patient outcomes.
Both the ESAs’ annual report and the conclusions of the “Rethink Safety Communication” project point to a broader trend across Europe: a growing recognition that transparency, clarity, and timely access to information are essential for protecting both people and the environment. Whether in finance or pharmaceuticals, the message is the same—regulatory compliance is just the starting point. The real goal is to create systems that empower professionals, safeguard the public, and foster trust.
As Europe looks ahead to the next review of the SFDR and Italy moves to implement the recommendations from “Rethink Safety Communication,” one thing is certain—the drive for better, clearer, and more effective information is not slowing down. If anything, it’s picking up speed, with regulators, industry groups, and professionals all pushing for change that will benefit everyone involved.
The coming months will reveal how these recommendations are put into practice and whether the momentum for greater transparency can be sustained. For now, both reports serve as a reminder that while progress is being made, the journey toward truly effective communication—and the safer, more sustainable systems it supports—is far from over.
