Poland breaking EU law by allowing unauthorized cheaper drugs

Polish legislation authorizing the placing on the market of foreign medicinal products lacking authorization by the European Medicines Agency which are cheaper than, but similar to, those already authorized is contrary to European Union law, according to the European Court of Justice.

The European Commission brought the present action for failure to fulfil obligations before the Court of Justice as it considers that the Polish legislation is contrary to the directive in that it provides for a derogation from the requirement for marketing authorization in the case of medicinal products from abroad which have the same active substances, the same dosage and the same form as the l products which have obtained marketing authorization in Poland, on condition, in particular, that the price of those imported medicinal products is competitive in relation to the price of the products which have obtained such an authorisation.

The Court points out, first, that the harmonized marketing authorization procedure enables cost-efficient and non-discriminatory market access, whilst ensuring that the requirements of safeguarding public health are achieved.