As of 1 January 2003 it has been possible to refer Danish patients, who have a life-threatening cancer disease or a similar life-threatening disease, to experimental treatment abroad. As of 1 June 2003 it has also been possible to offer experimental treatment with medicinal products in Denmark. The system concerns patients who can be offered experimental treatment abroad, i.e. patients with life-threatening diseases for which there are no well-documented treatment options.
The treating doctor must apply to the Danish Health and Medicines Authority for a compassionate use permit. It is only possible to apply for a compassionate use permit regarding a specific treatment for an individual patient. Thus, it is not possible to apply for a general compassionate use permit for a specified indication at a hospital ward or at a doctor's practice.
For the application the Danish Health and Medicines Authority's normal application form for human single compassionate use permit is used. The following information must be included in the application:
- Description of treatment including the expected duration of treatment.
- Product information, hereunder manufacturer, constituents, etc.
- Scientific literature or other information about effects, adverse reactions etc. to the widest extent possible.
- Copy of medical records.
- Information about planned monitoring of course of disease.
When deciding whether a compassionate use permit should be granted, the Danish Health and Medicines Authority may consult the national second opinion panel which gives advice about experimental treatment abroad. This panel may ad hoc include supplementing domestic and foreign expertise.
The Danish Health and Medicines Authority's decision about whether a compassionate use permit should be granted is made following an assessment based on the criteria mentioned in section 26 of the executive order on rights for hospital treatment and obstetric aid etc. The assessment includes an evaluation of:
- whether all other options of documented treatment or treatment offered as part of registered trials have been attempted, and
- whether it is possible that the treatment suggested could cure the disease or prolong the patient's life.
Experimental treatment of patients takes place at the risk of the treating doctor. The patients must be informed according to the executive order on information and consent and about disclosure of health information etc.
The Danish Health and Medicines Authority ensures that the requirements in the Medicines Act on quality and safety are fulfilled. Companies and laboratories producing or in other ways handling medicinal products must be authorised by the Danish Health and Medicines Authority according to section 8 of the Medicines Act and they are also submitted to the surveillance of the Medicines Act.
Adverse reactions related to the medicinal product or products must be reported to the Danish Health and Medicines Authority.