Doctors buying medicines for use in their own practices

23 June 2017

Doctors, veterinarians and dentists are only allowed to buy medicines for use in their own practices and dispense medicinal products to patients via Danish pharmacies. If, in exceptional cases, a medicinal product is not marketed in Denmark, the doctor can apply to the Danish Medicines Agency for a compassionate use permit. If the doctor is granted a compassionate use permit, the foreign medicinal product will be delivered to the patient via a Danish pharmacy.

Occasionally, doctors, veterinarians and dentists ask us if they can buy medicinal products to their patients at a lower price from a foreign pharmacy or wholesale distributor. 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 providing, splitting and dispensing 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 only perform the mentioned activities. The activities not mentioned in section 39(3)(ii), e.g. import, still require an authorisation under section 39(1).

Doctors, veterinarians and dentists cannot necessarily obtain an authorisation under section 39 to handle medicinal products, e.g. as a wholesale distributor of medicinal products. The reason is that doctors, veterinarians and dentists can prescribe medicinal products to patients and there must be no doubt that they choose the right medicinal product. This choice must be based on a professional assessment and not on any financial interests the doctor may have in the sale of a specific medicinal product. A relationship with a company with a section 39 authorisation as doctor, veterinarian or dentist requires a special authorisation that would hardly be granted if the relationship concerns the sale of medicinal products to be prescribed by the doctor.

In addition, medicinal products cannot be sold or dispensed in Denmark unless they comply with the Danish requirements for labelling, including Danish as language. Consequently, a doctor, veterinarian or dentist cannot buy a British medicinal product via a British pharmacy and dispense the product to a patient. In such case, the doctor should apply for a compassionate use permit from the Danish Medicines Agency subject to section 29 of the Danish Medicines Act. The compassionate use permit will stipulate that the product must be dispensed by a Danish pharmacy.

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