Brussels, 29 September 2022
Today, the Commission decided to launch an infringement procedure against Poland ( INFR(2022)2098) for not complying with EU rules on the free movement of goods with regard to the parallel import of medicines. In particular, some provisions of the Polish Law on medicinal products related to the grant and the expiry of a parallel import licence do not comply with Articles 34 and 36 TFEU.
Ensuring the proper functioning of the Single Market is of particular importance and effective enforcement of the fundamental freedoms is essential for citizens and businesses. Parallel trade in medicines within the EU allows wholesalers to buy medicinal products in a Member State where the prices are lower and sell it in another Member States where the prices are higher. In Poland, the issuing of parallel import licences for a generic medicinal product is prohibited when the medicinal product previously authorised is a non –generic medicinal product. The issuing of these licenses is allowed only when both – the imported product and its authorised equivalent – are either both generic or both non-generic. This prohibition seems to be unjustified and disproportionate and thus contrary to Articles 34 and 36 TFEU.
Likewise, the Commission considers that the automatic expiration of a parallel import licence for a medicinal product after one year from the expiry of the marketing authorisation of reference, without carrying out an examination whether there is any risk to the health and life of humans, is also contrary to Articles 34 and 36 TFEU. Poland has now two months to address the concerns raised by the Commission. Otherwise, the Commission may decide to issue a reasoned opinion.