European public assessment report (EPAR)

The European public assessment report is the document by which the European Medicines Agency makes public the scientific assessment of a medicinal product authorised under the centralised procedure. It is provided for by Regulation (EC) No 726/2004, which requires its publication after deletion of commercially confidential information. Known by its acronym EPAR, it includes a summary written in a manner understandable to the public.

Content of the report

The report sets out the reasoning of the Committee for Medicinal Products for Human Use on the quality, safety and efficacy of the medicinal product, the studies examined, the uncertainties identified and the grounds for the opinion. It also contains the annexes to the authorisation, including the summary of product characteristics, the labelling and the package leaflet, together with any conditions attached to the authorisation. It is updated to reflect variations, renewals and safety measures, and the Agency also publishes documents on withdrawn applications and negative opinions. National authorities publish comparable reports for the authorisations they grant.

The report as a source of strategic information

The report discloses the authority’s conclusions on points that determine regulatory protection. In particular, it indicates whether the Committee recognised new active substance status, and it sets out the assessment of significant clinical benefit on which the additional year of protection for a new indication depends. Competitors use it to establish the data protection timetable and to prepare their own dossier, in particular by identifying the expected bioequivalence studies.

The report in patent litigation

The public assessment report is frequently produced in pharmaceutical patent disputes. It sheds light on the exact composition of the product, its active substance and its indications, which are relevant to the assessment of infringement and to the examination of an application for a supplementary protection certificate. It may also be relied on to discuss the plausibility of the claimed technical effect or the difficulties encountered by the person skilled in the art. Its publication date, generally later than the priority date, limits its use as prior art against the basic patent, without excluding it for secondary patents filed later.

Key points

The European public assessment report reveals the scientific reasoning underlying the centralised authorisation of a medicinal product, redacted of confidential information. It provides information on new active substance status, on the indications and on the clinical benefit recognised, all of which are useful for calculating protection and as evidence in court. It should be consulted systematically, together with its successive versions, before establishing a protection timetable or commencing litigation, and its publication date should be checked whenever it is to be cited as prior art.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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