Guideline no. 9010 of 13 January 2010
- Introduction
- Which companies are subject to the obligation to report?
- Which types of collaboration must companies report?
- Time of notification
- Penalties for failure to report
- The Danish Medicines Agency's use of information
- How do companies make a notification?
- Questions
1. Introduction
This guideline concerns pharmaceutical companies' obligation to notify the Danish Medicines Agency of any doctors, dentists or pharmacists associated with the companies. The rules on pharmaceutical companies' obligation to report is stipulated by Danish executive order no. 794 of 15 July 2008 on notification of information on doctors, dentists and pharmacists associated with pharmaceutical companies etc., which came into force on 1 August 2008.
Pharmaceutical companies' obligation to report supplements doctors, dentists and pharmacists' obligation to report concerning their association with pharmaceutical companies, cf. section 3(2) and (3) of the Danish Pharmacy Act.
2. Which companies are subject to the obligation to report?
The following companies are subject to the executive order and the obligation to report:
- companies holding a marketing authorisation for a medicinal product that may be sold or dispensed legally in Denmark, cf. section 7 of the Danish Medicines Act.
- companies authorised by the Danish Medicines Agency to manufacture, import, export, store, sell, distribute, dispense, split and package medicinal products, cf. section 39(1) of the Danish Medicines Act.
3. Which types of collaboration must companies report?
Companies are obligated to notify the Danish Medicines Agency about:
- doctors or dentists associated with the company who prescribe or dispense medicine to patients in Denmark.
- pharmacists associated with the company who distribute medicine in connection with patient treatment in Denmark.
Companies' obligation to report encompasses associations such as full-time and part-time employment, consultancy support, participation in clinical trials, research projects, presentations, training, writing of articles and scientific advice, including advisory boards and seats on the board of directors, etc.
In general, the obligation to report only concerns doctors, dentists or pharmacists who are paid by a pharmaceutical company for their services. The payment comprises taxable personal income.
The obligation to report also includes the situation where a pharmaceutical company pays an amount to a health centre. If a pharmaceutical company makes a payment to a health centre, it must state which doctor or doctors that are associated with the company.
The obligation to report does not include the situation where a pharmaceutical company has deposited an amount in a research account managed by a hospital. However, if the pharmaceutical company is sponsor of a clinical trial with medicinal products, the company must always report information about the doctor or dentist acting as investigator for the trial, cf. section 2(6) of executive order no. 744 of 29 June 2006 on good clinical practice in clinical trials of medicinal products in humans. This applies regardless if the doctor or dentist is paid by the company (sponsor), as the relationship between sponsor and investigator is close and long-term.
Associations where the doctor, dentist or pharmacist is not personally remunerated for his/her work, but where an especially close relationship is formed with the company, are subject to the obligation to report. For example, it may include being an unpaid member of the board of directors or a doctor with comprehensive unpaid involvement in the company. A comprehensive unpaid involvement may be the situation where a doctor performs tasks of a duration of more than 4 weeks of full-time work for the pharmaceutical company within one calendar year.
The companies' obligation to report only concerns doctors, dentists and pharmacists' shareholding, shares, share options and similar interests in the company, if the company is aware of this relation.
If the payment concerned is for a single service provided, e.g. a single course or presentation of insignificant implications within one calendar year for a pharmaceutical company, and the remuneration is fair relative to the service provided, it is not necessary to report the association, cf. section 1(3)(i).
Being member of an advisory board or a board of directors is always subject to the obligation to report.
4. Time of notification
Once a year – no later than 31 January of the following calendar year – companies must notify the Danish Medicines Agency of all doctors, dentists or pharmacists associated with the company.
Simultaneously with the notification to the Danish Medicines Agency, the company must inform each individual doctor, dentist or pharmacist of the content of the notification, cf. section 3(2) of the executive order.
5. Penalties for failure to report
Pharmaceutical companies are obligated to make an annual electronic notification to the Danish Medicines Agency about any doctors, dentists or pharmacists who have been associated with the company during the past calendar year.
Violation of the obligation to report and the information to be notified is punishable by fine, cf. section 4(1) of the executive order.
6. The Danish Medicines Agency's use of information
The Danish Medicines Agency uses company notifications for spot checking doctors, dentists and pharmacists' applications for association with companies pursuant to section 3(2) and (3) of the Danish Pharmacy Act. Moreover, the notifications are used for controlling if any doctors, dentists or pharmacists have failed to apply for their association with a company.
7. How do companies make a notification?
Companies must notify the Danish Medicines Agency electronically once a year no later than 31 January via a notification form available at the Danish Medicines Agency's website www.dkma.dk.
On the application form, the company must state the company's name and CVR no. (Danish Central Business Register no.), cf. section 2(1)(i) of the executive order.
In connection with its completion of the notification form, the pharmaceutical company must submit the name, address and CPR no. (Danish civil registration number) of all persons associated with the company as well as the period of the association, cf. section 2(1)(ii)-(iii).
Both home and work address can be used, as long as the address can be used for identifying the person reported.
The Danish Medicines Agency's website contains an Excel template that can be used for filling in this information.
8. Questions
If you have any questions about the rules on pharmaceutical companies' obligation to report, please send them by mail to the Danish Medicines Agency, Axel Heides Gade 1, DK-2300 Copenhagen S or by e-mail to dkma@dkma.dk. You may also call the Danish Medicines Agency's service hotline on +45 4488 9515.
Danish Medicines Agency, 14 January 2010
