What is compliance?
Compliance can be defined as a set of processes designed to ensure that a company, its managers and employees respect the legal and ethical standards applicable to them.
For a long time, compliance was just about banking and financial security, but today it has come to the forefront thanks to anti-corruption laws in various countries, which have allowed this function to flourish within companies. Depending on how it is accepted and on the sector of activity, compliance can cover areas as varied as the prevention of corruption, economic and financial offences, or environmental and social risks.
In the healthcare sector, anti-corruption laws are complemented by legal provisions or professional codes, in order to ensure that interactions between healthcare companies and healthcare professionals and organizations meet the highest standards of integrity expected by all stakeholders (notably patients and governments).
Thus, compliance in these industries has a very strong focus on preventing conflicts of interest and, more generally, on monitoring the interactions that laboratories establish with healthcare professionals, healthcare organizations and patient associations.
Its corollary, the transparency of links of interest, is now one of the key elements on which compliance in the health industry is based. Its principle is based on making available to the public, free of charge, all the financial interactions that a laboratory enters into during the course of the year with these different actors.
The obligation to make transparent and public the links of interest between healthcare companies and healthcare professionals and organizations appeared simultaneously in the United States with the Sunshine Act and in Europe, particularly in France, with the Bertrand law in 2012, then at the level of the EFPIA zone, with the code of the same name, published in 2014, and now extends to many countries in the world, either within the framework of voluntary approaches promoted by the professional associations themselves, or by the implementation of national sectoral laws.
In practice, the role of compliance involves respecting, depending on the country, local regulations and/or professional codes and internal policies designed to govern the various modes of interaction with all stakeholders:
- Organization of promotional or scientific events
- Remuneration of healthcare professionals in the context of expertise contracts
- Donations to healthcare associations and organizations
- Relations with patients and patient organizations
- Control of the promotional message and materials used by the medical visit
Thus, the Compliance function is the guarantor of the ethics and deontology of all the company's employees with respect to all external parties called upon to interact with the company.
Comply with the regulations of the sector
Depending on the area, more or less severe penalties are provided for players whose activities do not comply with the established standards. In the healthcare industry, it is therefore essential to mobilize the resources necessary to achieve compliance: compliance teams, software, auditing, etc.
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