Relationships with and financial support from companies

Pharmaceutical companies:

A pharmaceutical company is defined as a company having obtained an authorisation under section 7(1) or section 39(1) of the Danish Medicines Act, or a representative in Denmark of a foreign company holding such an authorisation or authorised under Article 44, 47, 49, 52, 53 or 54 of regulation 2019/6 of 11 December 2018 on veterinary medicines, with the exception of public hospitals.

Link to list of pharmaceutical companies covered

Medical device companies:

With respect to medical device companies, it differs which companies are covered by the relationship rules and which are covered by the rules on financial support.

The following definition applies to professional relationships:

Medical device companies are defined as undertakings established in Denmark which manufacture, import or distribute medical devices in risk class IIa, IIb or III, or in vitro diagnostic medical devices, and representatives of such companies, except public hospitals.

The following definition applies to financial support:

Medical device companies are defined as manufacturers, distributors and importers of medical devices as well as representatives of manufacturers of this type of products and importers and distributors of this type of products, which are established in Denmark.

Link to list of medical device companies covered

Companies manufacturing, importing or distributing products without an intended medical purpose:

Companies manufacturing, importing or distributing products without an intended medical purpose are defined as Danish manufacturers, importers and distributors of products without an intended medical purpose listed in Annex XVI of the EU Regulation No. 2017/745 on medical devices, and which are in risk classes II a, II b and III, as well as EU representatives, established in Denmark, for a manufacturer of these types of products. In the following, this type of company is referred to as a company covered by section 5b(5) of the Danish Act on Medical Devices.

List of companies manufacturing, importing or distributing products without an intended medical purpose

Stores specialised in the sale of medical devices:

Stores specialised in the sale of medical devices are defined as stores established in Denmark and specialised in the sale of medical devices in risk class IIa, IIb or III, or in vitro diagnostic medical devices and representatives of such stores. A store is a specialised distributor if medical devices account for more than 50% of the store’s product range and turnover.

List of stores specialised in the sale of medical devices

To be covered by the rules on professional relationships, healthcare professionals must meet one of the criteria below:

• Treat patients in Denmark (also applies to cosmetic treatments, voluntary work and clinical trials or investigations)
• Have a managerial position, in which you have a significant influence on choices made by other doctors, nurses, midwives or dentists in relation to patient treatment
• Work in a prescription-handling unit (only applies to prescribing pharmacists)
• Be a pharmacist (upon appointment as a pharmacist, they become subject to the rules on professional relationships)

In terms of professional relationships, the following professions are covered by the companies below

Healthcare professionals covered by pharmaceutical companies:

• Doctors
• Nurses
• Pharmacists
• Dentists
• Midwives
• Prescribing pharmacists

Healthcare professionals covered by medical device companies:

• Doctors
• Nurses
• Pharmacists
• Dentists

Healthcare professionals covered by stores specialised in the sale of medical devices:

• Doctors

In terms of financial support, the following professions are covered by pharmaceutical and medical device companies

• Bioanalysts, incl. students
• Pharmacists, incl. pharmacist students
• Pharmacy technicians, incl. pharmacy technician students
• Midwives, incl. midwife students
• Clinical dieticians, incl. students
• Doctors, incl. medical students
• Radiographers, incl. radiography students
• Social and healthcare assistants, incl. students
• Nurses, incl. student nurses
• Dentists, incl. dental students

The following professions are only covered by pharmaceutical companies

• Veterinarians, incl. students 
• Veterinary nurses, incl. students

In terms of financial support, the following specialists engaged in buying and selling are also covered

Specialists engaging in the buying and selling of medicinal products and medical devices are also covered by the rules and must notify the Danish Medicines Agency if they receive payments to attend professionally relevant activities abroad or international, professionally relevant conventions and conferences in Denmark.

Pharmaceutical companies

In terms of pharmaceutical companies, the following specialists engaged in buying and selling are covered:

• Owners of and senior staff of stores authorised to sell OTC medicines permitted for sale outside pharmacies or medicinal products for production animals (see section 35 – link to section)
• Persons who offer commercial advice on and buy medicinal products outside pharmacies, including persons in the hospital sector (see section 36)

• Persons who offer commercial advice on medicinal products are defined as 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. The provision does not include employees at pharmacies or medical sales representatives employed by a pharmaceutical company. 

• Persons who purchase medicinal products are defined as persons who are employed to purchase medicinal products, i.e. purchasers employed at hospitals, in regions, municipalities or self-governing institutions. 

Medical device companies

In terms of medical device companies, the following specialists are covered:

• Owners of and senior staff of stores selling medical devices (see section 19)
• Medical technicians and other persons who, for business purposes, offer advice on medical devices and buy medical devices (see section 20)

• Persons who offer commercial advice on medical devices are defined as persons who, for business purposes, offer professional advice on medical devices to municipalities, regions, the state, hospitals and other healthcare institutions, including private clinics.
• For example, medical technicians, medical engineers, consultants and other persons offering professional advice on medical devices as part of their business. The provision does not include medical device consultants employed by a medical device company. 
• Persons who buy medical devices are defined as persons who are employed to buy medical devices. For example, purchasers employed at hospitals, in regions, municipalities, self-governing institutions or private clinics.