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The increasing pressure on the public health budgets is in the spotlight these days and raises a number of different issues. The need for identifying potential savings has, among other things, entailed that legislation on off-label use of cheaper medicinal products has been implemented in some countries and that public authorities have issued recommendations in relation hereto. In this article, we will explain what the legal position is in Denmark in relation to off-label use and recommendations for off-label use of medicinal products. A particular problem in this regard is the interaction with patent rights which is also accounted for in this article.

Is Off-Label Use and Recommendations for Off-Label Use of Medicinal Products Legal? Regulatory and Patent Implications from a Danish Perspective