The Court of Justice of the European Union (the “CJEU“) has issued a judgment clarifying the rights of parallel import licence holders. It ruled that the mere expiration of a marketing authorisation of reference does not affect the associated parallel import licence. The parallel importers rights may only be restricted if justified by specific circumstances relating to protecting public health.
Authorities refuse to adjust dosage instructions
Kohlpharma, a German pharmaceutical company, obtained a parallel import licence to import a medicinal product in tablet form from Italy. The parallel import licence was granted subject to it being adjusted to future amendments to the marketing authorisation of reference (the “MAR”) in Germany. The MAR also related to the medicine in tablet form.
The MAR holder was also allowed to market a variant of the same medicinal product in drop form, and to use a combined information leaflet. After the MAR expired and the medicinal product in tablet form was withdrawn from the German market, only the medicinal product in drop form remained on the market. Kohlpharma asked the competent authority in Germany for consent to amend the dosage instructions for its medicinal product in tablet form, so that they would align with the instructions for the medicinal product in drop form. This authority refused the application, because the MAR was no longer valid. The German authority argued that the treatment in drop form could be administered in 0.5ml or 1mg, while in tablet form, treatment could be administered in 5mg only. It held that the proposed amendments “created uncertainty and undermined the patient’s treatment compliance”, which was incompatible with the “requirement of safety of medicinal products”.
Kohlpharma appealed the decision to the Administrative Court of Cologne. The court asked the CJEU, through a preliminary ruling reference, whether the German authority’s refusal violated the rights of free movement of goods.
MAR expiration does not qualify as a circumstance justifying restricting free movement of goods
Menzis sought damages, alleging that AstraZeneca unlawfully delayed the generic’s market entry by enforcing the XR Patent rights and alleging that AstraZeneca benefited from the artificially high prices resulting from the delayed market entry of the generic at Menzis’ expense. Because of this, Menzis had to bear higher costs for reimbursements to patients. The District Court ruled in favour of Menzis, and held AstraZeneca liable to Menzis.
Liability for wrongfully enforcing patent rights
The CJEU held that the treaty provisions on free movement of goods imply that parallel importers do not have to satisfy the same requirements as undertakings applying for a marketing authorisation for a medicinal product for the first time. It points out that these provisions actually preclude national legislation pursuant to which the MAR withdrawal entails the end of validity of the associated parallel import licence. The rationale behind this is that the expiry of a MAR may not in itself call into question the quality, efficacy and safety of a medicinal product covered by a parallel import licence, in particular where the medicinal product in question continues to be lawfully marketed in the Member State from which the medicinal product is exported.
The CJEU underlined that it must, however, be assessed whether there are specific circumstances relating to protecting public health which could justify withdrawing the parallel import licence. The CJEU held that there were no such specific circumstances in this case. More specifically, the CJEU held that the following elements and circumstances cannot justify the refusal:
- The MAR’s expiration and the fact that the amendments are based on indications relating to another medicinal product – which uses the same active ingredient in a different pharmaceutical form and which is covered by a marketing authorisation in both the exporting Member State and the importing Member State.
- The fact that parallel importers are not subject to the obligation to regularly submit safety reports.
With respect to the second point above, the CJEU stressed that, in effect, the applicable pharmacovigilance of parallel imported medicinal products can be guaranteed through collaboration between the competent national authorities of the Member States. The exporting Member State must provide access to the relevant documents and data.
In conclusion, parallel import licence holders enjoy relatively strong rights. Medicinal products imported based on a parallel import licence are thus deemed to be safe for public health unless there are specific circumstances that suggest otherwise.
The News Update Life Sciences about the case Menzis v AstraZeneca be read here.
- Greetje van Heezik, Counsel
- Lorenzo Fiorilli, Associate
Compliments of Houthoff – a member of the EACCNY.