New rules for persons collaborating with the industry

29 September 2014, Updated 07 October 2014

As of 1 November 2014, new rules governing healthcare professionals' collaboration with pharmaceutical and medical companies take effect. The rules governing association will be extended to include medical companies and nurses. Doctors' association with speciality stores trading in medical devices are also covered by the rules.

From 1 November 2014, the new rules governing healthcare professionals' collaboration with pharmaceutical and medical companies (association) will include:

  • Proprietary pharmacists' association with pharmaceutical and medical companies
  • Doctors' association with pharmaceutical and medical companies as well as speciality stores trading in medical devices
  • Nurses' association with medical companies
  • Dentists' association with pharmaceutical and medical companies

Notification before start of activity

The new rules also introduce changes for how to report an association to the Danish Health and Medicines Authority and for the types of collaboration requiring permission:

  • Participation in research projects (including clinical trials and investigations as well as non-interventional studies), presentations and training require prior notification to the Danish Health and Medicines Authority.
  • Possession of securities up to a value of DKK 200,000 (at the time of purchase) also requires prior notification.
  • Other associations, such as participation in advisory boards, consultancy support and possession of securities with a value of more than DKK 200,000 (at the time of purchase) require prior permission from the Danish Health and Medicines Authority.

Publication of information

From 1 November 2014, the Danish Health and Medicines Authority must publish information about healthcare professionals' remuneration from pharmaceutical and medical companies. If a proprietary pharmacist, doctor, nurse or dentist has several associations with the same company, the total remuneration from the company per calendar year will be published.

Notification of all existing associations

All healthcare professionals who have an association as of 1 November 2014 must submit a notification on the website of the Danish Health and Medicines Authority no later than 1 April 2015 if they want to continue the association. For example a doctor or a nurse with an association with a medical company.

The notification can be made from 1 November 2014 on the website of the Danish Health and Medicines Authority.

Financial support

The rules governing financial support will also be changed as of 1 November 2014.

From November, healthcare professionals and certain professionals engaging in the buying and selling of medicinal products and medical devices must notify the Danish Health and Medicines Authority if they receive financial support to participate in a professionally relevant activity abroad from a pharmaceutical or medical company.

Information about the person receiving support, the company granting the support and the relevant activity will be published on the website of the Danish Health and Medicines Authority.

Notification about financial support only applies to future activities taking place after the rules take effect on 1 November 2014.

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