On 22 December 2010, the Court of Justice of the European Union issued a decision in case C – 385/08 regarding the granting of marketing authorisations for several generic medicinal products immediately prior to the date of accession of Poland to the EU (1 May 2004).
The CJEU ruled that:
- by enforcing marketing authorisations for generic versions of the reference product Plavix (Zyllt, Areplex, Klopidogrel, Clopidix); and
- by placing and keeping on the market medicinal products for which the marketing authorisation was not issued in accordance with Directive 2001/83/EC after 1 May 2004;
the Republic of Poland failed to fulfil its obligations under Article 6(1) of Directive 2001/83/EC, in conjunction with Article 13(4) of Regulation (EEC) No 2309/93, and Articles 89 and 90 of Regulation (EC) No 726/2004.
The CJEU’s decision provides grounds for several innovative companies to demand compensation from the Polish state for loss of profit suffered as a result of the generics registered in breach of EU law being kept on the market during the period 1 May 2004 to 31 December 2008.
Background of the case
During Polish accession negotiations, the parties agreed to the wording of the transition provisions contained in Annex XII of the Treaty of Accession. Paragraph 1.5 of Annex XII states: “By way of derogation from the requirements of quality, safety and efficacy laid down in Directive 2001/83/EC, marketing authorisations for the pharmaceutical products on the list (in Appendix A to this Annex) issued under Polish law prior to the date of accession, shall remain valid until they are renewed in compliance with the acquis and in accordance with the timeframe set out in the abovementioned list, or until 31 December 2008, whichever is the earlier”.
As a result of paragraph 1.5, several marketing authorisation proceedings concerning products listed in Appendix A to Annex XII were completed in a much shorter timescale than the average of two years for the national registration procedure leading to the grant of national MAs immediately prior to 1 May 2004. The MAs were granted despite the fact that many documents required under Polish law were missing.
The innovative companies strongly opposed this practice. In response to the alleged illegality of this practice, the Polish authorities stated that the MAs were conditional MAs containing additional recommendations and requiring additional investigation, and had been granted in conformity with Polish pharmaceutical regulations.
The innovative companies decided to notify the Commission about this controversial practice. The case of Plavix (Sanofi Aventis) was chosen as an example. The Commission shared the innovators’ view and, after it had formally exchanged submissions with the Republic of Poland, requested that the necessary actions be taken by the Polish authorities to comply with EU law.
The Polish authorities refused to take action claiming that the legality of Polish administrative decisions granting MAs issued before the accession to the EU should be assessed solely on the grounds of Polish law. As a result, the Commission decided to file a complaint against the Republic of Poland at the CJEU.
In the Commission’s view, the transitional period set out in paragraph 1.5 of Annex XII did not apply to the marketing authorisations containing additional recommendations and requiring investigation granted by the Polish Minister for Health between January and April 2004. Those decisions did not constitute marketing authorisations prior to 1 May 2004 for the purposes of paragraph 1.5 of Annex XII.
Furthermore, the Commission claimed that the marketing of generic versions of the reference product Plavix could not be covered by the transitional period laid down in paragraph 1.5 of Annex XII because the derogations provided therein related exclusively to the requirements of safety, quality and efficacy prescribed in Directive 2001/83/EC, and not to the 10-year period of data protection laid down in Article 13(4) of Regulation (EEC) No 2309/93 and Articles 89 and 90 of Regulation (EC) No 726/2004.
The CJEU shared the Commission’s view and ruled that the Republic of Poland failed to fulfil its obligations under Article 6(1) of Directive 2001/83/EC, in conjunction with Article 13(4) of Regulation (EEC) No 2309/93, and Articles 89 and 90 of Regulation (EC) No 726/2004.
From a Polish law perspective, the decision of CJEU is potentially controversial because, notwithstanding the CJEU’s justification, it seems that Directive 2001/83/EC, Regulation (EEC) No 2309/93 and Regulation (EC)No 726/2004 were applied retrospectively. It should be noted that prior to 1 May 2004 Plavix had been registered by means of a national procedure and the data exclusivity period (which at that time under Polish regulations was three years) had already lapsed.
It should also be noted that the practice of granting conditional MAs immediately prior to 1 May 2004 despite necessary documents being missing was perceived as contrary to Polish regulations in force at that time by many experts and by the Polish Supreme Audit Office (the state administrative audit body). The Ministry of Health did however oppose such views and will now have to accept the ruling of CJEU in Case C– 385/08.
As mentioned above, the decision of the CJEU provides grounds for several innovative companies to demand compensation from the Polish state. Traditionally pharmaceutical companies in Poland were rather reluctant or even afraid to sue the State. This attitude is slowly changing and it seems likely that they will at least now consider taking action in court.