Companies' duty to inform in the case of financial support to specialists and healthcare professionals

If a specialist or healthcare professional receives payments from a pharmaceutical or medical device company to attend professionally relevant activities abroad, the person must notify the Danish Medicines Agency. In this connection, your company must inform the specialist or healthcare professional about this notification duty.

Inform specialists and healthcare professionals about their notification duty

Companies’ duty to inform implies that pharmaceutical and medical device companies must inform specialists and healthcare professionals of sections 202(b) and 202(c) of the Danish Health Act, including the duty to notify the Danish Medicines Agency and the Danish Medicines Agency’s publication of information that specialists and healthcare professionals have received financial support to attend professionally relevant activities abroad.

Your company must provide this information when you accept to pay for expenses in connection with a professionally relevant activity abroad. This information may be given orally or in writing.

Companies covered by the rules

The rules apply to the following companies:

Pharmaceutical companies

Pharmaceutical companies mean companies with an authorisation under section 7(1) or 39(1) of the Danish Medicines Act.

The duty to inform does not apply to public hospitals.

Medical device companies

Medical device companies mean manufacturers, distributors and importers of medical devices as well as their representatives.

Inform the following healthcare professionals

Companies covered by the rules must inform the following healthcare professionals when they accept to give financial support: bioanalysts, veterinarians, pharmacists, pharmacy technicians, midwives, clinical dieticians, doctors, radiographers, nurses, social and healthcare assistants, dentists, veterinary nurses and students within these professions.

Veterinarians, veterinary nurses and students within these professions are only covered by the rules if they receive financial support from a pharmaceutical company.

Inform the following specialists

Companies covered by the rules must inform the following specialists engaging in the buying and selling of medicinal products and medical devices when they accept to give financial support:

Pharmaceutical companies

Pursuant to the Danish executive order no. 1153 of 22 October 2014 on advertising etc. for medicinal products (in Danish only), pharmaceutical companies must inform:

• owners of and senior staff of stores authorised to sell OTC medicines or medicinal products for production animals (see section 34)
• persons who offer commercial advice on and buy medicinal products outside pharmacies, including persons in the hospital sector (see section 35)

Persons who offer commercial advice on medicinal products mean persons who, for business purposes, offer professional advice on medicinal products to municipalities, regions, the state, hospitals and other healthcare institutions. For example, consultants and other persons offering professional advice on medicinal products as part of their business operations. The provision does not include employees at pharmacies or medical sales representatives employed by a pharmaceutical company.

Persons who buy medicinal products mean persons who are employed to buy medicinal products. For example, purchasers employed at hospitals, in regions, municipalities or self-governing institutions.

Medical device companies

Pursuant to the Danish executive order no. 1155 of 22 October 2014 on advertising etc. for medical devices (in Danish only), medical device companies must inform:

• owners of and senior staff of stores selling medical devices (see section 18)
• medical technicians and other persons who, for business purposes, offer advice on medical devices and buy medical devices (see section 19)

Persons who offer commercial advice on medical devices mean persons who, for business purposes, offer professional advice on medical devices to municipalities, regions, the state, hospitals and other healthcare institutions.  For example, medical technicians, medical engineers, consultants and other persons offering professional advice on medical devices as part of their business operations. The provision does not include medical device consultants employed by a medical device company.

Persons who buy medical devices mean persons who are employed to buy medical devices. For example, purchasers employed at hospitals, in regions, municipalities or self-governing institutions.

Legislation

Pharmaceutical companies 

The Danish Health Act, Part 61 a: Industrial collaboration and the Danish Medicines Act provide the legal framework for financial support from pharmaceutical companies.

The duty to inform of pharmaceutical companies giving financial support to participation in professionally relevant activities abroad is laid down in section 28 of the Danish executive order no. 1153 of 22 October 2014 on advertising etc. for medicinal products (in Danish only).

Medical device companies

The Danish Health Act, Part 61 a: Industrial collaboration and the Danish act on medical devices provide the legal framework for financial support from medical device companies.

The duty to inform of medical device companies giving financial support to participation in professionally relevant activities abroad is laid down in section 15 of the Danish executive order no. 1155 of 22 October 2014 on advertising etc. for medicinal devices (in Danish only).