In a recent decision the Council of State once again addresses several issues concerning the application of the principle of equivalence in technical specifications in public tenders for the supply of drug products with the same active ingredient. In general, according to the principle of equivalence in public tenders, each bidder may offer any solutions or products that have technical characteristics equivalent to those specified in the tender.

The Council of State highlights the importance of this principle in public tenders for the supply of drug products with the same active ingredient.

What role is played by the ATC classification in assessing equivalence between drug products? And what conditions must be met for scientific studies concerning the non-equivalence of drug products to be considered reliable?

Our Healthcare and Life Sciences Focus Team breaks down the Council of State’s decision here.