Doctors buying medicines for use in their own practices
Storage and dispensing
An exemption in the Danish Medicines Act allows doctors, veterinarians and dentists to buy medicines for use in their own practices with the intention of using them in direct relation to treatment. Doctors may also dispense medicines to a patient in quantities corresponding to the patient’s need until the medicine becomes available in a pharmacy.
The medicines are intended for use in the doctor’s practice, including home visits when medicines are carried in a doctor's bag. The doctor's possibility to carry medicines cannot be delegated to others. In other words, a doctor may not allow an assistant to carry and use medicines for treatment outside the doctor's practice.
We are sometimes asked if medicines purchased for use in the practice can be stored somewhere else, e.g. in a medicine depot in a local healthcare centre or an asylum centre. Medicines purchased for use in the practice cannot be stored in depots, medicine cupboards or doctor's bags in various places outside the premises of the medical practice – not even if geographical circumstances, etc. would make it more practical to have a medicine depot where an assistant could dispense medicines to patients according to the doctor's prescription. A doctor’s bag can only be carried by the doctor.
Via a Danish pharmacy
Doctors, veterinarians and dentists must buy medicines for use in their own practices from Danish pharmacies, and special vaccines, sera, and the like from Statens Serum Institut (SSI) or DTU Vet, the National Veterinary Institute. In the rare event that a medicine is not marketed in Denmark, the doctor may apply for a compassionate use permit from the Danish Medicines Agency for. If the permit is granted, the foreign medicine will be dispensed to the patient via a Danish pharmacy that will arrange for its purchase.
Doctors, veterinarians and dentists are not permitted to buy medicines for use in their own practices from or in a foreign country, not even if the medicine is cheaper, there are supply difficulties in Denmark or if the product is sold over the counter abroad. Patients can ask a pharmacy abroad to accept a prescription, but a Danish doctor cannot buy medicines abroad and dispense the medicines to a patient or use it in his or her own practice.
Reasons and legal basis
Pursuant to section 39(1) of the Danish Medicines Act, any manufacture, import, export, storage, resale, distribution, dispensing, splitting and packaging of medicinal products is subject to authorisation from the Danish Medicines Agency.
According to section 39(3)(ii), an exception applies to doctors, veterinarians and dentists as regards providing, splitting and dispensing of medicinal products for use in their own practice.
This means that doctors, veterinarians and dentists do not need an authorisation under section 39(1) if they perform the mentioned activities only, i.e. providing, splitting and dispensing. The activities not mentioned in section 39(3)(ii), such as import and resale therefore still require an authorisation under section 39(1).
Doctors, veterinarians and dentists cannot easily obtain an authorisation under section 39 to handle medicines, e.g. as a wholesaler of medicinal products. This is because doctors, veterinarians and dentists prescribe medicines to patients, and there must be no doubt that they only select the right medicine based on a professional assessment and not because they have financial interests in the sale of a specific medicine. If a doctor, veterinarian or dentist was to have a relationship with a company with a section 39 authorisation, a special authorisation is required, which is unlikely to be granted if the relationship concerns the sale of prescription-only medicines. However, it is not uncommon for veterinarians to hold an authorisation to sell veterinary over-the-counter medicines (HV marked medicines). The Danish Veterinary and Food Administration has stated that it is not required for veterinarians to have their relationship with such a company assessed because it concerns over-the-counter products.
If a medicine is not available in Denmark, the doctor will need to apply for a compassionate use permit from the Danish Medicines Agency according to section 29 of the Danish Medicines Act. The compassionate use permit will stipulate that the product must be dispensed by a Danish pharmacy.
Doctors cannot establish medicine cupboards at the institutions they are linked to. This follows from the executive order on the handling of medicines in hospital departments and other healthcare institutions. Medicine cupboards may only be established in hospital departments or other healthcare institutions, cf. 39(3)(i) of the Danish Medicines Act. A healthcare institution is an institution whose primary purpose is to treat patients, and therefore, medicine cupboards cannot be established in nursing homes, care centres and residential centres, etc.