3.04 Subscription of drugs
Substitution means that the pharmacy must inform the patient about the cheapest substitutable medicinal product which in terms of content is identical with the product prescribed by the doctor.
The current rules for substitution of medicinal products in Denmark have contributed to Denmark having one of the largest markets for generic medicines (me-too drugs) in Europe, which facilitates ongoing introduction of new therapies for the benefit of both patients and the Danish National Health Service.
On the other hand, general substitution schemes should not be introduced without discrimination. Each and every medicinal product needs a specific healthcare assessment based on stringent scientific documentation before it can be decided whether the product is substitutable. Such assessments must be taken a step further than the current bioequivalence evaluations which only concern the body's absorption of the medicine.
The aim of bioequivalence evaluations is to document that the medicine is absorbed to the same extent and at the same rate as both the original and the generic product and to document that generic products do not differ markedly from the original. The results of bioequivalence represent - like all other clinical documentation - an average for the population. Thus, some might experience differences between the generic product and the original product.
Lif believes:
- that generic substitution increases the risk of poor compliance due to frequent product switches and, therefore, the rules should be followed closely,
- that costs associated with the increased uncertainty due to extra consultations with the doctor and/or pharmacy staff should be further analysed,
- that the introduction of analogue substitution will diminish the doctor’s treatment options, and conflicts with patients’ interests.
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