Kohlpharma: a parallel import cannot be refused solely because there is no common origin

What was decided

Chiesi made and sold Jumex in Italy under an Italian authorisation; Orion made and sold Movergan in Germany under a German one. Both are selegiline hydrochloride products, and both companies obtained the active ingredient from Chinoin in Hungary, Chiesi under a licensing agreement and Orion under a supply agreement with Orion’s Finnish parent. Kohlpharma applied to the German medicines institute to import Jumex, asking that Movergan’s authorisation be extended to it. The institute refused, citing Smith & Nephew: on its reading, a parallel import could only cross-refer to an authorised product if the two had a common origin, meaning manufacturers in the same group or licensed by the same licensor. Kohlpharma appealed, arguing that the Court of Justice had never made common origin a binding condition; it had simply been present on the facts of the earlier cases. The Higher Administrative Court of North Rhine-Westphalia referred the question.

The Court took as its premise, for the purpose of answering, that the two products did not differ significantly for the assessment of safety and efficacy; whether that was so on the facts was for the German court. On that footing it held that refusing an authorisation to a product already authorised in another member state restricts the free movement of goods, and can be justified only by what the protection of health requires. Once it is established that the assessment carried out for the authorised product can be applied to the imported one without risk to public health, a refusal “based solely on the fact that the two medicinal products do not have the same origin” cannot be justified. A common origin “may constitute an important element” in showing that the earlier assessment can be carried across; its absence “does not in itself constitute a ground for refusing”.

The Court then said how the question is to be decided where origin differs. The importer may show, from information that is available or accessible to it, that the imported product does not differ significantly from the authorised one. Where the importer cannot reach all the necessary information but provides data that make it “at least plausible” that the two do not differ significantly, the authority must decide on “the fullest information possible”, including what it holds already and what it could obtain through cooperation with the health authorities of other member states.

Timeline

Date	Event
12 November 1996	Smith & Nephew and Primecrown: products made under agreements with the same licensor have a common origin
14 March 2002	Higher Administrative Court of North Rhine-Westphalia refers the question (received 27 March 2002)
13 March 2003	Hearing
11 September 2003	Advocate General Tizzano delivers his opinion
1 April 2004	Judgment

What it means if you are…

A parallel trader. You can apply to import a product that has no corporate or licensing link to the UK reference product. The regulator cannot refuse just because the link is missing; it must look at whether the two products are similar enough for the reference product’s assessment to carry across. The burden is shared: you put forward what you can get, and if that makes similarity at least plausible, the regulator must use its own files and ask other regulators before deciding. In the UK this is why the standard and complex application categories exist, and why they cost more than a simple one: the regulator has to do the work that a common origin would otherwise have done for it. The explainer sets out the categories, fees and what each needs.

An originator or UK licence holder. A competitor’s product with the same active ingredient from a different source can be licensed as a parallel import against your product, provided the regulator is satisfied the two do not differ significantly for safety and efficacy. Your data stay yours, as Smith & Nephew held, but the regulator may use the assessment it made of your product, and information from other member states’ regulators, when it decides.

A wholesaler or buyer. A parallel-imported line under a standard or complex licence may come from a manufacturer unconnected with the UK brand owner. The regulator has found it similar enough to be licensed against the UK product, but it is not the UK brand made abroad; the licence and the leaflet will show who made it.

Status and what to watch

Good law and the foundation of every parallel import application that lacks a common origin. The Court did not say how much the two products may differ, only that the earlier assessment must be usable “without any risk to public health”; what that requires in a given case, and how far a regulator must go in seeking information from other authorities, remains for the national authority and courts. In the United Kingdom, where the MHRA’s cooperation with EEA regulators after Brexit is not published, that is the part of the judgment with the least settled practical content. The judgment is assimilated case law in the UK, open to departure by the Court of Appeal and the Supreme Court; neither has departed from it.

This note is a summary for commercial readers and is not legal advice.