Content and Outcome

In the course, you will be updated on advertising regulations and the rules on transparency regarding collaboration between doctors, dentists, nurses, pharmacists, other healthcare professional groups, and the medical device industry. You will be equipped to handle the regulations and understand how to act as a stakeholder in this field going forward.

The course is based on the Danish advertising rules for medical devices and focuses on the regulations concerning financial benefits to healthcare professional groups. It also addresses the rules governing affiliations between the medical device industry and certain healthcare professional groups, as well as how these affiliations must be reported.

 
Parliament has adopted a law imposing the following obligations on companies:

• Registration of all Danish manufacturers and authorized representatives with products in Class IIa, IIb, and III, as well as active implants.
• Annual reporting to the Danish Health Authority of healthcare professionals affiliated with the company.
• Continuous information about the rules when entering into agreements on affiliation with doctors, dentists, pharmacists, or nurses, or agreements on financial support to a healthcare professional.

Obligations of healthcare professionals:

• Report collaboration with the pharmaceutical and medtech industries. Certain types of affiliation require approval from the Danish Health Authority, while others only require notification. Information about the affiliation, including cumulative amounts, will be published on the Health Authority’s website.

Affiliations subject to reporting include:

• Collaboration on education and research
• Shareholding and positions of trust in medtech companies
• Other collaborations, e.g., consultancy, participation in advisory boards, editorial work
• Receipt of financial benefits in connection with professional activities abroad

 
Target Group

The course is aimed at employees in the medtech industry, pharmacies, hospital management, as well as healthcare professionals in hospitals, etc. The target group also includes employees involved in designing advertisements or preparing documentation for advertising on the Danish market.

 
Instructors

Christian Vinding Thomsen, Partner, Attorney, Loeven
Lene Laursen, Deputy Director, Medicoindustrien

WHAT PREVIOUS PARTICIPANTS HAVE SAID ABOUT THE COURSE:

"It was interesting to hear about the legislation directly from the source. Overall, good and informative content, and great to have the opportunity to ask questions."

"It was a thorough review with case studies – that works well for me."

"We were able to have a dialogue with the presenter – so that we could relate a real-life example to what was being taught."

"Some highly competent instructors."

"They succeed in making it relevant and engaging, incorporating examples from our everyday work that are directly applicable."