We recently published an Advisory on a decision of the CJEU earlier this month on parallel trade. Ordinarily, medicinal products can only be placed on the EU market if they have a valid marketing authorisation in the relevant Member State. However, within the EEA, the principle of free movement of goods applies, meaning that, subject to certain exceptions, Member States cannot prevent free movement of goods once they are lawfully on the market. Therefore, once a product has lawfully been placed on the market, it is possible for third parties to move that product between Member States, subject to certain requirements. This is known as parallel trade.
There have been many decisions in the CJEU considering when medicinal products can be parallel traded across the EU, and the limits on such trade. This recent decision from Poland (Case C-387/18, Delfarma), is the latest in this line of case law.
In this case, the CJEU re-affirmed its interpretation from previous cases that the Member State of import must ensure that the imported medicine and the domestic reference product, “without being totally identical“, have been manufactured with the same formulation and using the same active substance, and have the same therapeutic effects; and that the medicine to be imported does not raise concerns from a quality, efficacy and safety point of view. If the Member State of import confirms that these criteria are satisfied, the imported product should be granted a parallel import licence on the basis of the existing national marketing authorisation.
Importantly, and controversially, the CJEU stated that a parallel trader can import a generic product into a Member State in which that product does not have a marketing authorisation by relying on the existing authorisation for the reference product in the country of import. Companies could, in certain circumstances, therefore, treat the generic product as having been placed on the market in the country of import, despite the lack of an equivalent generic authorisation in that country. The view of the court that this does not have the potential to undermine the existing regulatory framework appears simplistic, and the decision could have wide-reaching implications for parallel imports across the EU. It remains to be seen how national competent authorities will apply this decision in practice.
Read our Advisory for more information.