Affiliation with ENLI
Affiliation with ENLI
Members of the Danish Association of the Pharmaceutical Industry (Lif), the Danish Generic and Biosimilars Medicines Industry Association (IGL), the Danish Association for Parallel Importers of Medicines are automatically subject to the jurisdiction of the Ethical Committee for the Pharmaceutical Industry in Denmark (ENLI).
Who can join ENLI
In addition to the members of Lif, IGL and the Danish Association for Parallel Importers of Medicines, all pharmaceutical companies or organizations that have activities in Denmark can join ENLI.
What does the affiliation entails
As an affiliated company, you have to comply with the ethical rules that are governed by ENLI's control. The ethical rules state a number of minimum standards, which must be complied with, in addition to the applicable laws and ethical rules adopted by the industry itself, including the codes adopted in EFPIA.
ENLI has the competence to monitor/control and sanction the activities of affiliated companies, based on the rules set by the committee. The rules, including rules of procedure, sanctions etc., can be found at www.enli.dk.
Pharmaceutical companies are guaranteed a right to consultation before ENLI takes any action. In addition, pharmaceutical companies always have the opportunity to appeal a decision taken by ENLI's first instance (Investigator Panel) to the Appeals Board.
As far as the company's advertising activities towards healthcare professionals are concerned, most of these must be reported to ENLI, who will perform a random control. The companies have to pay a reporting fee of DKK 425 plus VAT per case. The reporting fee is billed quarterly.
As an affiliated company, you get the possibility of unlimited guidance by Investigators Panel's secretariat via phone and by e-mail. The secretariat has telephone hours every weekday between 9 am and 3 pm. Questions by mail can be sent to sekretariat@enli.dk.
As an affiliated company, you furthermore have the possibility - for a fee - to request for a pre-approval of a specific activity, whereby the company can be notified in advance whether their intended activity is in accordance with the rules set by the committee.
ENLI also publish guides and and informs via newsletters that are sent out approx. 5-8 times a year. Changes and updates of rules and guidelines are always announced via ENLI's newsletter. If you would like to receive ENLI's newsletter, simply send an email to sekretariat@enli.dk stating your request and your email address.
Fees
Pharmaceutical companies who have chosen to join ENLI, even though they are not members of the following associations: Lif, IGL or the Danish Association for Parallel Importers of Medicines, pays an annual affiliation fee of DKK 22,500 plus VAT.
Termination
Affiliated companies - though not members of Lif, IGL and the Danish Association for Parallel Importers of Medicines - can always terminate their affiliation with ENLI with 6 months notice to the end of a month.
Questions
If you have any other questions, you are always welcome to contact the ENLI secretariat on tel. +45 39 20 25 75 or by email sekretariat@enli.dk