Welcome to ENLI´s website

On the website you can read more about ENLI, including the purpose, the functions that ENLI carries out, the parties behind ENLI, which rules ENLI monitors etc.

Pharmaceutical companies must use the reporting site on ENLI´s website when they report one of their activities to ENLI, file a complaint about another company, request for a pre-approval, or appeal a decision from the Investigator´s Panel.

The Ethical Committee for the Pharmaceutical Industry (ENLI) was established on 1 April 2011 and monitors the pharmaceutical industry. With the establishment of ENLI, the pharmaceutical industry is implementing a further strengthening of the pharmaceutical industry's already extensive ethical self-regulation.

Purpose

New knowledge about medicines and treatment is a necessary prerequisite for healthcare professionals performing their daily work. For example, a patient who goes to the doctor should be confident that the doctor is so well-informed and has such up-to-date knowledge about medicines that the doctor can prescribe exactly the medicine that best suits the patient.

In addition, healthcare professionals and the pharmaceutical industry each possess valuable knowledge about medicines and their use. Knowledge sharing is therefore crucial for the development of new medicine and benefits all stakeholders. However, it is clear that the collaboration between the pharmaceutical industry and the health sector's stakeholders must take place in an ethically sound manner with the professionalism and patient safety as the focal point.

The Ethical Committee for the Pharmaceutical Industry, ENLI is established to ensure self-regulation with these ethical frameworks for the companies that are affiliated with ENLI. ENLI thus acts as a voluntary supplement to the control that the Danish Medicines Agency carries out, just as ENLI's regulatory basis in a number of areas contains rules that go further than what Danish law requires. The purpose of ENLI is to ensure a professional, factual and independent collaboration between the affiliated pharmaceutical companies and the healthcare sector's other parties, and to ensure openness about the affiliated companies' cooperation with their stakeholders.

Function

ENLI controls and sanctions that the pharmaceutical companies affiliated with ENLI comply with the Danish legislation and industry ethics. That is, rules that regulate the pharmaceutical companies' collaboration with and information for healthcare professionals, decision makers, patient associations and hospitals. You can find the rules subject to ENLIS’s jurisdiction under the section “Rules”.

If ENLI´s rules are violated, ENLI may impose fines on companies and a number of other strict sanctions such as correction of incorrect information, revocation of illegal material, cancelling a scheduled event or the like. You can read more about ENLI's sanctions under the section “Rules”.

The parties behind

ENLI is established by the Danish Association of the Pharmaceutical Industry (Lif), the Danish Generic and Biosimilars Medicines Industry Association (IGL), and the Danish Association for Parallel Importers of Medicines. In addition, a number of associations and companies outside the above-mentioned associations have the opportunity to join ENLI for an annual affiliation fee.

Affiliated companies

Here you can see which companies are subject to the ethical rules under ENLI's jurisdiction.

Independence

ENLI is a self-regulatory committee established by the pharmaceutical industry. In order to ensure that ENLI's assessments are taken independently of the pharmaceutical industry, no ENLI employee must be associated with the pharmaceutical industry at the same time. In addition, ENLI follows an arm's length principle, which means that the pharmaceutical industry can in no way affect the decisions made by ENLI. The above-mentioned independence includes both the Investigation Panel in the 1st instance and the Appeals Board of the 2nd instance.

External parties

ENLI has made a guide for use by e.g. medical societies and others who cooperate with the pharmaceutical companies affiliated to ENLI. You can read more about ENLI's guides under the section “Rules”.