The Collaboration Agreement terminated and the Danish Legal Board of Self-Regulation concerning Pharmaceuticals will be dissolved

The collaboration agreement concerning conditions for collaboration between doctors, pharmacists and pharmaceutical companies has been terminated and the Danish Legal Board of Self-Regulation will be dissolved and replaced by a new industry self regulation system.

The Danish Association of the Pharmaceutical In­dustry (Lif), the Danish Medical Association (LF), the Danish Pharmaceutical Association (DA), the Danish Generic Medicines Industry Association (IGL) and the Parallel Importers of Pharmaceuticals (PFL) have decided to terminate the Heads of Agreement for Terms and conditions for collaboration between doctors and phar­macists and pharmaceutical companies (the "Collabora­tion Agreement"). The Collaboration Agreement is ter­minated with effect from the end of March 2011. The Danish Legal Board of Self-Regulation concerning Phar­maceuticals ("NSL") will be dissolved simultaneously. From 1 April 2011 a new industry self-regulation system is to replace the current system under the aegis of the NSL.

The reason for the termination is that Lif since the estab­lishment of NSL has adopted a wide range of ethical codes that complements the legislation and by which the industry itself has decided should be complied with by the companies. Many of these additional ethical rules and regulations are not part of the Collaboration Agreement or subject to NSL's control today. The ethical rules and regulation that Lif needs to comply with - be­sides the Collaboration Agreement - are the Danish Medicines Act, the Danish Order and Guidance on Adver­tising, the European regulation adopted by Lif's European sister organisation the European Federation of Pharma­ceutical Industries and Associations (EFPIA) as well as specific ethical guidelines issued by Lif, e.g. Lif’s ethical rules for dialogue and negotiations with decision-mak­ers, Lif's ethical rules for collaboration between patient groups etc. and the pharmaceutical industry and Lif's ethical rules for pharmaceutical companies' relations with the Danish hospital sector.

In order to ensure compliance with and control of these ethical rules and regulations by only one ethical board - a "one stop shop"-principle - as well as a uniform application of the rules and regulations, Lif therefore wishes to withdraw from the Collaboration Agreement and to establish a new ethical enforcement board. In addition to this Lif wishes to establish a more up-to-date system that conforms to fundamental princi­ples of law – e.g. introduction of hearings for parties and an appeals body, end of administrative fines, better guid­ance, higher quality grounds etc.

Lif, IGL and PFL are currently in dialogue on a possible collaboration about the future ethical board.

Until the end of March 2011 NSL will fulfil its duties as before with unchanged competencies and authority. The partners' (companies and health professionals) obligation will also remain in force in the period.

If you have any questions regarding the termination of the Collaboration Agreement and the consequences thereof, please contact Mikkel Vittrup, Attorney-at-Law, or Annika Valla Broman, Attorney-at-Law,