the pharmaceutical industry's
self-regulation body


April 2023

Avoid the two misconceptions most frequently
encountered by ENLI

The pharmaceutical industry’s internal watchdog, ENLI, warrants a high ethical level in marketing matters. In general, self-discipline of the attached businesses is fine. There are, however, areas in which they can do even better. Here’s an insight into ENLI’s work and suggestions for the pharmaceutical industry’s continued strengthening of its credibility.

Unethical behaviour and poor publicity create anxiety among patients and healthcare professionals which, for years, will affect the entire pharmaceutical industry. Just a single slip affects everybody. Fortunately, cases that may tarnish the industry’s reputation are few and far between. The high degree of self-regulation and preventive measures means that most businesses know how to comply with rules and regulations.

Last year, 29 fines were imposed out of a total of about 5,000 reported activities. The cooperation between the affiliated businesses and ENLI is excellent and intentions to comply with rules and regulation are considerable. This enhances the industry’s credibility. If you are a newcomer to the industry, the following is a brief account of what ENLI is all about.

Quite briefly: What is ENLI?

The Ethical Committee for the Pharmaceutical Industry, ENLI (in Danish, ENLI is short for Etisk Nævn for Lægemiddelindustrien), is the pharmaceutical industry’s own self-regulation body, established to ensure that advertising targeted at healthcare professionals and other interested stakeholders takes place in such ways as are legally and ethically sound.

ENLI operates as a voluntary supplement to such monitoring as is performed by the Danish Medicines Agency, and within a number of areas, ENLI’s rules go considerably beyond Danish legislation. For this reason, the pharmaceutical industry is one of the most regulated industries in Denmark.

Severe self-regulation means safety within the industry

Confidence in the pharmaceutical industry and safety for patients and decision-makers constitute the decisive cause for self-regulation and the legitimacy of ENLI. Also, the knowledge that all are working in accordance with the same principles provides considerable security among the businesses.

Each year, the ENLI members submit about 5,000 descriptions of their marketing activities to ENLI. Approximately 38% comprehensive random sampling takes place on the basis of these descriptions. For comparison, certain countries only consider cases upon the reception of complaints.

”We are probably considered to be quite strict as compared with other countries. This should however be ascribed to the fact that, on an ongoing basis, we carry out spot checks and develop practice rather than simply taking action on the basis of complaints. This ’strictness ’ is to the benefit of the industry as, this way, they need not observe each others’ moves to such a great extent. There is a certain safety in the knowledge that everyone plays according to the same set of rules and in the relatively high degree of probability that ENLI will, itself, detect any breach of the rules,” ENLI head of secretariat, Rikke Bækgaard Thomassen, explains.

Two misconceptions most frequently encountered by ENLI

In general, the industry is good at prudent action and compliance with the rules. In two areas, however, ENLI at times experience the businesses to be challenged. Hence, a good piece of advice to the businesses would be to remember the following in respect of marketing compliance:

1: Not a function, rather a mindset

Certain businesses tend to reduce compliance to a function pertaining to an individual employee.

This employee becomes an internal policeman – the nay-sayer. Though this may well be a fine service to the remainder of the business, it also signifies a vulnerability when an experienced and knowledgeable compliance-person resigns. It is therefore a good idea to incorporate compliance as a natural element of the employees’ mindset.

”To certain businesses, a high level of compliance is directly bound up with the person having held the position. We discover this from the increasing number of inquiries in the event of one important employee’s resignation,” Rikke Bækgaard Thomassen continues.

2: Not limited to marketing

It is moreover important to remember that the rules apply to EVERY EMPLOYEE of the business. There is no distinction between medical and marketing. The very moment you communicate to the world outside the business, you are the business – regardless of your title and role – and then the rules apply.

”Some will then, mistakenly, believe themselves to be on the safe side. Even though, for instance, most businesses have internal rules relative to who shall be permitted to respond to which inquiries. Even if a medical person considers him- or herself to be a researcher performing scientific work, the very same rules shall apply for this person as the rules applying to his/her colleagues in marketing,” Rikke Bækgaard Thomassen further explains.

Absolutely necessary to keep updated

The banning of gifts and strict rules as to when, and at what level, the provision of meals shall be acceptable are examples that illustrate how public opinions of what is acceptable with respect to dealings with doctors and public authorities will constantly undergo changes. Nothing is carved in stone, and what was acceptable at an earlier point in time may now be a no-go. In matters of ethics it is important to be attentive to changes.

Regardless whether you are a newcomer to the pharmaceutical industry or belong among the more experienced, you will have excellent opportunities for keeping updated. All our courses within Marketing Compliance provide rich opportunities for the discussion of details and concrete cases. Here, your will also go deeply into some of the areas that give rise to the most questions.

See our collective selection of Marketing Compliance courses.

In addition, we also provide consultancy adapted to the individual business as well as networking for marketing compliance-professionals.