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EU Judgment in Case C-488/20 Delfarma (Free Movement of Goods)
25 November 2021
Thursday 25 November
The reference for a preliminary ruling was made in a dispute between Delfarma Sp. z o.o., a company incorporated under Polish law (‘the applicant’), against Prezes Urzędu Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (President of the Office for Pharmaceutical and Medical Products, Medical Devices and Biocidal Products) (‘the respondent’) concerning the decision of the Respondent of 24 September 2019 on the expiry, with effect from 25 September 2019, of a parallel import authorisation granted to the pharmaceutical product Ribomunyl (hereinafter ‘the contested decision’).
In the present case, on 27 January 2011, the applicant obtained a parallel import authorisation for the pharmaceutical product Ribomunyl on the basis of a marketing authorisation for a reference medicinal product on the territory of Poland, granted to the pharmaceutical company Pierre Fabre Medicament Polska Sp. z o.o., which expired on 25 September 2018.
In the contested decision, the defendant found that, according to the relevant provisions of the Polish Law on Medicinal Products, the mere fact of the expiry of the marketing authorisation for a reference medicinal product would have led to the expiry of the parallel import authorisation in question after one year.
In this decision, the defendant pointed out that, while it follows from the case-law of the Court that the expiry of a marketing authorisation for a reference medicinal product cannot imply the withdrawal of the parallel import authorisation granted for the medicinal product in question, the parallel import authorisation should nevertheless be withdrawn in the event that the reference marketing authorisation has been withdrawn for reasons relating to a risk to the life or health of humans, pursuant to Article 36 TFEU.
In this respect, the defendant argued that, in the event of the withdrawal of the reference marketing authorisation, there would be no medicinal product to which the parallel imported proprietary medicinal product could “refer” if it were necessary to make changes or updates to the data required for the exercise of proper pharmacovigilance.
Furthermore, it added that parallel importers are exempted from the obligation to submit periodic safety reports on the medicinal product and thus, in the absence of a marketing authorisation for the reference medicinal product, the competent authority does not have current data on the risk-benefit balance of the drug therapy. According to the applicant, the contested decision is manifestly contrary to the principles underlying the functioning of the European Union and to the case-law of the Court of Justice in relation to parallel trade