Self-regulation is an agile way to ensure high standards across the pharmaceutical industry. How does it work in Europe?  

Self-regulation plays a vital role in governing how pharmaceutical companies promote medicines, interact with health professionals and collaborate with patient community. By setting and enforcing rules and standards, industry organisations, such as a regional or national trade association, are at the heart of delivering on this commitment to 'self-regulating'. For their part, companies to adhere to and monitor their compliance with these standards.

Ethical interactions are at the heart of self-regulation. In fact, industry standards often go beyond what is required by law. That is because the aim of self-regulation in the pharmaceutical sector is to support the appropriate and legitimate use of medicines and the provision of high-quality patient care, while increasing trust and improving perceptions.

Self-regulation of Europe’s pharmaceutical industry  

The EFPIA Code underpins industry standards in Europe’s pharmaceutical sector, building on a long history of self-regulation in various European countries. Member associations in 37 European countries apply national codes encompassing the requirements of the EFPIA Code.

The Code sets out the minimal common values and principles, while allowing Member Associations to deliver effective self-regulation through country-level rules. This creates a level playing field where companies of all sizes and maturity operate under one set of agreed standards.

Member Associations are required by EFPIA to implement the EFPIA Code, which includes arrangements for dealing with complaints, and are required to have an independent Chair. For example, Member Associations must impose sanctions when companies violate the EFPIA Code. For instance, fines or public reprimands are common penalties for non-compliance.

Some Member Associations have set up self-regulatory bodies that are independent of the associations themselves to operate their local code. In addition to the activities of Member Associations, 40 pharmaceutical companies are members of EFPIA which requires their adherence to the EFPIA Code.

What are the benefits of self-regulation?

Europe’s pharmaceutical industry is governed by complex combination of laws and regulation. Self-regulation complements legal frameworks by raising and harmonizing industry standards. It helps to reduce the burden on government while providing industry with a means of enforcing Europe-wide rules to which companies must adhere. Transparency about national codes enforcement plays a crucial role, as it ensures that people see that actions are taken against non-compliant companies. For example, EFPIA requires the publication of annual code reports, detailing actions taken against violators.

Self-regulatory bodies use their knowledge of how the industry works to keep codes and governance standards up-to-date, adapting to reflect the ever‑changing interactions between the pharmaceutical industry and healthcare systems. It is also important to reflect the public expectations of how pharmaceutical companies should behave.

For example, EFPIA introduced requirements for disclosure of payments to health professionals to increase transparency as a response to criticism in this area. All EFPIA Member Associations applied these rules in the absence of local legal requirements.

The agility with which self-regulatory bodies respond to a changing environment has been illustrated through the move to digital platforms and new ways to ensure healthcare professionals receive information about treatments.

During the Covid-19 pandemic, EFPIA, IFPMA (International Federation of Pharmaceutical Manufacturers) and PhRMA (the US national association) collaborated to produce guidance on virtual interactions which showed how the self-regulatory process helped ensure interactions were conducted to high standards. As health professionals are receiving more information than ever from pharmaceutical companies outside of their home country, it is critical to ensure that global standards are aligned as far as possible to ensure there are consistent rules in place.

Another example of innovative self-regulation is the Europe-wide congress vetting system (known as e4ethics). This system reviews the compliance of large and multi-country third-party educational conferences and results in a binding decision on whether the event is compliant and appropriate for pharmaceutical companies to engage with the event. In 2021, the system merged with the equivalent system for the medical devices industry, improving consistency across the healthcare sector.

The future of self-regulation

The way self-regulation operates is vital to public confidence in self-regulation. As with any system, self-regulation needs to be open to scrutiny and oversight to remain effective. EU law permits self-regulation and close links with governments are critical to ensuring that it remains fit for purpose.

To be fit for purpose in the future, and to maintain and increase public confidence in the industry, self-regulatory systems must continue to respond to new challenges. There are several examples from the last decade of how ethical standards have been improved via the EFPIA Code. These include the improvements in transparency through disclosure, prohibition of branded promotional aids that were given to healthcare professionals in the past, as well as further restrictions over the provision of samples of medicines. As a self-regulated industry, we are never complacent and will continue to drive improvements.

Self-regulation is undoubtedly a privilege and one which requires accountability and commitment to high standards from the organisations and companies involved as well as significant investment. Through our proactive approach, we can continually improve and enforce standards and embed them throughout the sector, to deliver on our mission to help patients.