25 August 2020
On 3 July 2019, the Court of Justice of the European Union (CJEU) handed down a preliminary ruling that liberalises the parallel import of medicines in Poland.
The Court ruled that Polish pharmaceutical authorities were not able to oppose parallel import of a medicine, when this medicine was registered in another EU state as a generic medicine, whereas it was registered in the full procedure in Poland as a reference medicinal product (directive no. 2001/83).
Therefore, the provision of the Polish Pharmaceutical Law, which states that one may be granted with authorisation for parallel import only for the same category of products (generic or original medicines), is contrary to Article 36 of the Treaty on the Functioning of the European Union (TFEU).
The CJEU ruled that the provision at stake restricts parallel import of medicines and thereby constitutes a measure which has an effect equivalent to a quantitative restriction prohibited by Article 34 TFEU.
Delpharma is a leading parallel import company located in Poland. Delpharma was interested in parallel import of reference medicine branded locally Sumamed, which was registered in the UK under the brand name Azithromycin.
The national pharmaceutical authorities refused to grant Delpharma authorisation for parallel import. The national authority pointed out that the medicine imported into Poland from the UK was in fact Azithromycin which is registered in the abbreviated procedure and hence it was a generic medicinal product and not its local original (reference) version which was registered in the full procedure under the local brand Sumamed.
In order to demonstrate the identity of the two medicines at stake, the parallel importer should have submitted with the national authorities full documentation as to the registration of Azithromycin in the UK. This condition could not have been satisfied since Azithromycin was registered in the UK in the abbreviated procedure.
Consequently, the Voiveoship Court in Warsaw, which heard the case, followed Delpharma’s request, submitted the CJEU with the motion for preliminary ruling in this regard.
The CJEU reasoned that the requirement to identify the registration category of medicinal products in the exporting and importing countries could not specify the condition to obtain authorisation for parallel import because this infringed freedom of trade within the EU.
The CJEU underlined that, based on previous judicial decisions, the EU pharmaceutical authorities were authorised to exchange information in order to verify the registration and category status of the given medicines.
It is adequate that the parallel importer submits evidence as to the medicines’ characteristics, safety and efficacy. Should the national authorities have doubts as to the identity of the medicines at stake, they should have rather contacted the parallel importer and asked them to submit additional documents.
Therefore, the provision of Polish Pharmaceutical Law which automatically allows the national authority not to grant authorisation for parallel import, when the parallel importer does not submit documentation allowing it to verify the identify of the imported medicinal product with its local version (registered in different procedures), appears disproportionate with the main aim of protecting public health and human life.
Since the CJEU preliminary judgements generally have a binding effect for Polish judicial bodies, it is now clear that the controversial provision of Polish Pharmaceutical Law is void (pursuant to Article 267 of the TFEU).
The ruling in the Delpharma case indirectly verified the incompatibility of the Polish provision with EU law and thereby this ruling liberalises rules for the parallel import for local distributors. This judgment is also a signal for foreign pharmaceutical companies to revise their IP strategy in Poland as to parallel import.
The intense parallel import in Poland of medicines appears a likely scenario since Poland currently faces a shortage of almost 500 medicines, pharmacists warn. Pharmacies are starting to have a lack of medicines for diabetes, hypertension, thyroid diseases, asthma, pulmonary diseases, and allergy.
There is also a shortage of oncological and neurological drugs. Poland is the 5th biggest EU life sciences market with almost 40 million consumers.
It appears that liberalisation of parallel import regulations in Poland may in fact fit the purpose of protecting public health and human life, as declared in the directive 2001/83/EU.
by multiple authors
by multiple authors
by multiple authors