Clinical trials of medicinal
products have to be notified to the Danish Medicines Agency (DMA)
in accordance with the Medicinal Products Act (§24). The responsible
investigator and the sponsor must submit the notification together
with the final version of the clinical trial protocol and other necessary
documentation; for a multicentre trial, co-notification from all centres
is required. The DMA will assess the quality of the clinical trial
and the safety of the patients. Clinical trials may not be initiated
before the DMA has granted permission.
In addition, the competent regional Scientific Ethics Committee must
be notified. This can be done at the same time as the DMA notification.
The Ethics Committee will forward its opinion directly to the DMA.
Before the clinical trial may commence, the approval of both the Scientific
Ethics Committee and the DMA must be obtained.
Great importance is attached to compliance with the ICH GCP guideline.
GCP compliance will be a requirement in Denmark as from May 2004,
although it is not a legal requirement at present.
 Health
Care System |
In Denmark, all residents
are entitled to access almost all health care services free
of charge. Most of the Danish health care services are run directly
by the public authorities and are financed by taxes. Within
the public health service, hospital treatment is free of charge
to residents. There are only very few private hospitals completely
outside the public health service.
General practitioners play a central role in the Danish health care system. The vast majority (98%) of Danish citizens belong to health insurance group 1 and choose to be registered with a general practitioner. These patients first consult their general practitioner, who decides whether referral to a specialist or hospital is necessary. The remaining 2% of the population have chosen health insurance group 2 and may consult any general practitioner or specialist directly, but they have to pay part of the costs themselves.
Within the Danish health service there are approximately 3,500 general practitioners, 1,000 specialists, 10,000 hospital doctors, and 23,000 hospital beds for the population of about 5,300,000. |
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DENMARK
