Delfarma: a parallel import licence cannot die automatically when the reference licence lapses

What was decided

Delfarma, a Polish parallel importer, held a licence granted in January 2011 to bring Ribomunyl granules into Poland from the Czech Republic, resting on the Polish marketing authorisation for Ribomunyl as its reference. That reference authorisation ceased to be valid on 25 September 2018. Polish law says a marketing authorisation expires if the product is not placed on the market within three years of grant or is absent for three consecutive years, the Directive’s sunset clause, and it also says that a parallel import licence expires automatically one year after the reference authorisation does. On 24 September 2019 the registration office declared Delfarma’s licence expired from the following day. Delfarma appealed to the Warsaw administrative court, which asked the Court of Justice whether an automatic rule of that kind squares with the free movement of goods.

The Court answered that it does not. A parallel import of a medicine already authorised in the importing state is outside the Directive and governed by Articles 34 and 36 of the Treaty, and a rule that cancels a parallel import licence automatically because the reference authorisation has gone is a restriction on imports. It can be justified by the protection of health, and the Court accepted that losing the reference authorisation deprives the authority of a source of safety information. But the Polish rule went further than that purpose required. The reference authorisation had lapsed under the sunset clause, which turns on whether the product is sold, not on whether it is safe; the parallel import licence then fell with it a year later with no examination of any actual risk, and the authority had not considered whether the information it needed could be obtained another way, from the exporting state’s authority or from the importer. Nor could the gap be filled by pointing out that parallel importers do not file periodic safety reports: that exemption exists because the reference holder files them, and it is not in itself a health reason for cancelling the licence.

The ruling follows a line that runs from Ferring in 2002 and the two Paranova cases of 2003 through kohlpharma in 2020: a parallel import licence may be linked to a reference authorisation, and the reference’s withdrawal may justify withdrawing the licence, but only after an individual examination of the health consequences, and withdrawal of the reference for commercial reasons is not enough on its own.

Timeline

Date	Event
10 September 2002	Ferring (C-172/00): automatic lapse of a parallel import licence on withdrawal of the reference authorisation is contrary to the Treaty
8 May 2003	Paranova Läkemedel (C-15/01) and Paranova (C-113/01): the reasons for the reference’s withdrawal must be examined
27 January 2011	Poland grants Delfarma a parallel import licence for Ribomunyl from the Czech Republic
15 January 2016	Licence extended
25 September 2018	Polish reference authorisation for Ribomunyl ceases to be valid
24 September 2019	Registration office declares the parallel import licence expired from 25 September 2019; confirmed 18 November 2019
9 September 2020	Warsaw administrative court refers three questions to the Court of Justice
7 July 2021	Hearing; the Court proceeds without an Advocate General’s opinion
25 November 2021	Judgment

What it means if you are…

A parallel trader. Your licence is tied to a reference authorisation, but it is not the reference authorisation’s shadow. If the reference lapses under the sunset clause, is withdrawn for commercial reasons or is simply not renewed, the importing authority must look at whether continuing your imports actually endangers patients before cancelling your licence, and must consider whether the safety information it wants can come from the exporting country or from you. A blanket rule, or a decision that cites only the missing reference, can be challenged on this judgment.

A generics or launch planner. The case is about parallel imports, not generics, and it does not touch the sunset clause as applied to your own authorisation. Its interest is indirect: a reference product that an originator lets lapse in one market may go on being supplied there by parallel importers for some time, which affects the market a generic walks into.

A wholesaler or buyer. A parallel-imported line can survive the disappearance of the domestic original. Where the reference has lapsed, ask the importer whether its licence has been reviewed rather than assuming the line is gone.

Status and what to watch

Good law and unappealed, as a preliminary ruling. It binds every member state’s authorities, and the same case law was retained in the UK, where a parallel import licence likewise depends on a UK reference authorisation; the MHRA’s practice when a reference licence lapses is a point to check in its parallel-import guidance rather than assume. The pharmaceutical package replaces the sunset clause with a different mechanism from around the end of 2028, which will change how reference authorisations come to lapse but not the Treaty rule applied here. This note is a summary for commercial readers and is not legal advice.