De Peijper: the regulator may not make a parallel importer resupply a dossier it already holds

What was decided

Dutch law in the 1970s required anyone importing a medicine to hold a “file” for the product, giving its composition and method of preparation, signed off by the person responsible for manufacture abroad, and “records” for each batch showing it had been made and checked to that file. The file was produced to the authorities for certification, which doubled as the marketing permission. Only an importer who held the file could get it.

Adriaan de Peijper, managing director of Centrafarm, bought a medicine from a wholesaler in the United Kingdom and sold it to Dutch pharmacies. The product was made by a British manufacturer in a group run from Switzerland, and neither the manufacturer nor the group’s Dutch representative would give him the documents. He did not deny supplying the pharmacies without the file and records; he said he could not get them. The Rotterdam cantonal court asked the Court of Justice whether rules of that kind were a measure equivalent to a quantitative restriction, and whether they could be justified as protecting health.

The Court’s answer came in two parts. First, rules or practices that channel imports so that only certain traders can import are an obstacle to trade and are caught by the Treaty. Second, the health exception only covers what is necessary. Where the authorities already hold all the pharmaceutical particulars they need for a product, because the manufacturer or its appointed importer lodged them on an earlier occasion, it is “clearly unnecessary” for health purposes to make a second trader importing a product that is “in every respect the same” produce them again. For batch records, the authorities have a legitimate interest in checking that each batch matches the file, but they should ask whether that can be done without waiting passively for evidence in a form that favours the manufacturer: they can compel the manufacturer or its representative to supply particulars, they can cooperate with the authorities of other member states, and they can presume conformity and rebut it where necessary. A rule that lets the manufacturer and its representative enjoy a monopoly of importation simply by refusing to produce documents is unnecessarily restrictive, unless it is clearly proved that any other arrangement would be beyond the means of a normally functioning administration. The Court added that parallel importers are often able to sell at lower prices, and that the effective protection of health also demands that medicines be sold at reasonable prices.

The second question asked what happens where the imported product and the one on file differ slightly in composition or process, and the differences are so minor that the manufacturer appears to have introduced them to impede parallel imports. The Court said the same answer applies. The authorities may require the manufacturer to say whether it makes several variants of the product under the same name for different member states and to document the differences, but variants may be treated as different products only “if the documents produced in this way show that there are differences which have a therapeutic effect”.

Timeline

Date	Event
29 September 1975	Rotterdam cantonal court refers two questions to the Court of Justice in criminal proceedings against Mr de Peijper
2 October 1975	Reference received at the Court
20 May 1976	Judgment
6 May 1982	European Commission publishes its communication on parallel imports of proprietary medicinal products, built on this judgment
1984	The UK Medicines Control Agency issues its notes on parallel import licence applications, MAL 2 (PI), based on the 1982 communication

What it means if you are…

A parallel trader. This is the ruling that gives you a simplified route at all. A regulator that already holds the particulars of a product cannot insist you lodge a full dossier to import the same product, and cannot leave the manufacturer in control of whether you get the paperwork you need. The later cases, from Smith & Nephew in 1996 onwards, build out what “the same product” means; in the UK, the outcome is the parallel import licence and the simple, standard and complex application categories described in the explainer.

An originator. Refusing a parallel importer access to your documents does not stop the import; the regulator must find another way to check the product. Making small changes to a product’s composition from one country to another does not stop it either, unless the differences have a therapeutic effect, and the regulator may ask you to list the variants you make.

A wholesaler or buyer. The reason parallel-imported medicines reach your market at lower prices, and the reason the regulator is expected to make that possible rather than hinder it, both trace back to this judgment.

Status and what to watch

Good law. The judgment has been restated by the Court of Justice in every later parallel import case, including Smith & Nephew and Primecrown in 1996, Rhône-Poulenc Rorer in 1999, Kohlpharma in 2004 and Delfarma in 2021. In the United Kingdom it was given before the end of 2020 and so forms part of assimilated case law, which the Court of Appeal and the Supreme Court may depart from; neither has done so. The Treaty articles it applied were Articles 30 and 36 of the EEC Treaty, now Articles 34 and 36 TFEU.

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