Extension of ENLI’s authority

Life Sciences and Health Care  Written on 09.03.2016

As of 1 February 2016, the Danish Ethical Committee for the Pharmaceutical Industry (ENLI) has been given authority to control and impose sanctions on pharmaceutical companies that do not comply with the regulations pertaining to the clinical testing of pharmaceuticals and non-interventional studies.

The extension of ENLI’s authority is a consequence of the guidelines recently approved by The Danish Association of the Pharmaceutical Industry (Lif) for ENLI’s control of and authority to impose sanctions on pharmaceutical companies’ actions that are in violation of the so-called joint declaration on clinical testing of pharmaceuticals and non-interventional studies drawn up by Lif, the Danish Medical Association and the Organization of Danish Medical Societies.

Hence, ENLI may now control and impose sanctions on those companies, which do not comply with the aspects of the joint declaration mentioned above, and which are not otherwise controlled nor sanctioned. The extension of ENLI’s authority specifically relates to controlling and imposing sanctions in relation to any of the following:

  • Whether or not the research protocol has been sent to the Danish Multi-Practice Committee (a committee under the Danish College of General Practitioners), in the event that the research includes general practice areas;
  • Whether or not the research schedule should be sent to the Danish Multi-Practice Committee for comments, in the event that the research includes general practice areas;
  • Whether or not the relevant EFPIA guidelines on transparency and access on the part of qualified researchers to data and results from commercially initiated clinical studies have been or are being implemented;
  • Whether or not a company has made payments into a hospital-managed research account;
  • Whether or not a company has made payments into a company account linked to a general medical practice;
  • Whether or not the company has acknowledged the authority of the Danish Committees on Scientific Dishonesty (DCSD): and
  • Whether or not the company has acted on reasonable suspicions of scientific dishonesty and reported this to the DCSD.

Source: Guidelines for ENLI’s control of and authority to impose sanctions on actions on the part of pharmaceutical companies, which contravene the Joint Statement of The Danish Association of the Pharmaceutical Industry, the Organization of Danish Medical Societies and the Danish Medical Association on clinical testing of pharmaceuticals and non-interventional studies.

Only pharmaceutical companies, which are members of Lif, are subject to ENLI’s authority and sanctions, and only ENLI has the authority to decide to adopt a case for review.

ENLI’s options of imposing a sanction in cases of contravention of the joint declaration mentioned above comprise a public reprimand, fine (in the sum of between DKK 30,000 and DKK 150,000), ordering that activities are rectified (in order to bring them in line with the joint declaration) and publication of the reprimand for contravening the joint declaration.

DELACOUR follows ENLI’s practice in this area, and you are welcome to contact the DELACOUR team of life sciences experts if you wish to receive further information on the extension of ENLI’s authority and the consequences for your company.