Case C-277/15, Servoprax – challenging language obstacles to parallel imported medical products [judgment 2016, ECLI:EU:C:2016:770]

Servoprax is wholesaler of medical products. Among the products it sells are blood glucose testing kits. Because those kits are imported into Germany, Servoprax gives them German labels and instructions. The question in this case is whether Servoprax’s labelling and instructions are clear enough to pass muster under the EU’s ‘in vitro diagnostic medical devices’ Directive 98/79.

Background
People with diabetes test their own blood glucose levels. One way they can do this is to use a glucose strip. A major manufacturer of these strips is Hoffmann-La Roche. In fact, this Swiss pharmaceuticals giant sells a couple of types of glucose strip, and it does so through its Germany subsidiary, Roche Diagnostics.

However, when Roche Diagnostics went through the necessary steps for obtaining the CE-mark of regulatory approval for its strips, it initially put those products on the EU market via an approved authority in the UK. Moreover, it did so on the basis of documentation that was written in English.

With the appropriate CE marks of UK-regulatory approval under its belt, Roche Diagnostics then decided to sell its glucose strips in Germany. This was not difficult. All it had to do was ensure that the instruction leaflet and the products’ packaging were printed in German.

Roche Diagnostic’s use of German, however, was a little odd. There was a gap between the English and the German-language versions of the labelling and the packaging, particularly when it came to the part of the pack that contained a ‘control’ solution. (Diabetics must use this liquid to check the accuracy of the glucose strip test.)

Comparing the two language versions reveals that when the glucose strips had undergone their CE-marking procedure, Roche had expressed the relevant chemical values in terms of mmol/l. Yet, when Roche made the German-language products and packaging, the relevant values were expressed either in terms of mmol/l, or mg/dl. And when it came to the control solution, the values were expressed in terms of both mmol/l, and mg/dl!

This translation gap caused a major headache to another German company, known as Servoprax. This company is a medical wholesaler whose product range includes Roche’s two glucose strips. (Servoprax makes its money from buying products elsewhere at lower prices and then parallel-importing those medical goods into Germany and selling them to its customers in Germany.)

However, before Servoprax can sell the imported-Roche products in Germany, it too must put labels on the outer packaging and use a German-language instruction leaflet. This was not a problem in so far as Roche had already written German-language packaging and labels so Servoprax could, and did, merely copy Roche’s words.

There was however one minute difference between Servoprax’s German, and Roche’s German. Namely, Servoprax’s labels only used values that were expressed in terms of mmol/l. This meant that if people wanted to arrive at a value that was expressed in terms of mg/dl, then people would need to do some careful calculations – if they got their maths wrong, then this could harm their health.

Keen to stop Servoprax’s parallel trade in Roche’s glucose strips, Roche emphasised that this difference between Roche’s labelling and Servoprax’s labelling which was capable of harming patients. Therefore, Roche forced Servoprax to undergo a new or a supplementary conformity assessment procedure before Servoprax would be allowed to market the glucose strips in Germany.

Servoprax duly obliged and it put the products through such a procedure. In December 2010, Servoprax obtained the relevant certificate from an approved body in Holland.

However, that was not the end of the matter. Roche then sued Servoprax in respect of the situation which had existed prior to the authorisation having been given by the Dutch authorities. And the scope of the litigation covered Roche gaining access to Servoprax corporate information, an award for damages, and legal costs. Roche’s attempts sparked litigation which ended up at the German Supreme Court.

At the German Supreme Court
The question before the German judges was whether the difference between Roche’s label and Servorpax’s label meant that Servoprax contravened the EU’s ‘in vitro diagnostic medical devices’ Directive 98/79 [OJ [1998] L331/1). The judges could not answer that question on the basis of existing EU law.

Namely, the Directive opens with the relevant definitions:

Article 1 Scope, definitions
1. This Directive shall apply to in vitro diagnostic medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. Both in vitro diagnostic medical devices and accessories shall hereinafter be termed devices.
2. For the purposes of this Directive, the following definitions shall apply:
…
(f) ‘manufacturer` means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
…

However, there were other planks of the EU legislation which needed to be taken into account, namely, Articles 2, 3, and 16 of the Directive, which provide:

Article 2 Placing on the market and putting into service
Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose. This involves the obligation of Member States to monitor the security and quality of these devices. This Article applies also to devices made available for performance evaluation.

Article 3 Essential requirements
Devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.
…
Article 16
CE marking
1.  Devices, other than devices for performance evaluation, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.
2.  The CE marking of conformity, as shown in Annex X, must appear in a visible, legible and indelible form on the device, where practicable and appropriate, and on the instructions for use. The CE marking of conformity must also appear on the sales packaging. The CE marking shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes III, IV, VI and VII.
3.  It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not thereby reduced.

And for ease, the relevant annexes deal with:
Annex i – essential requirements
Annex iv- EC declaration of conformity (full quality assurance system)
Annex v – EC type-examination
Annex vi – EC verification
Annex vii – EC declaration of conformity (production quality assurance)

The judges at the German Supreme Court noted that those Articles had been implemented into German law. However, those Articles in the Directive also needed to be read in light of Articles 4 and 9 of the Directive, which provide:

Article 4 Free movement
1. Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article 16 if these devices have undergone conformity assessment in accordance with Article 9.
…
Article 9 Conformity assessment procedures
…
3. For all devices referred to in List B in Annex II other than those intended for performance evaluation, the manufacturer shall for the purposes of affixing the CE marking, follow either:
(a) the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance) or
(b) the procedure relating to EC type-examination set out in Annex V couplet with:
(i) the procedure relating to EC verification set out in Annex VI, or
(ii) the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance).

With this web of legal provisions in mind, the legal issue before the German Supreme Court became a little more nuanced. Namely, on the one hand, Servoprax’s labels had copied the German-language wording on Roche’s glucose strips in all but one respect; on the other, there was also a translation gap between Roche’s German-language packaging and labelling, and the English-language documentation which Roche had used in support of its application for the relevant CE-marks from the regulatory authority in the UK.

The German judges wondered what to do in this situation but they doubted whether parallel-importers should be allowed to profit from it.

Questions Referred
The Curia website has yet to publish the official translation of the German Supreme Court’s questions.

Update – 21 August 2015
According to the Curia website, the German Supreme Court has asked:

1. In the case of an in vitro diagnostic medical device for self-testing blood sugar levels which has undergone a conformity assessment by the manufacturer in accordance with Article 9 of Directive 98/79/EC […] in Member State A (specifically: in the United Kingdom), which bears the CE marking of conformity in accordance with Article 16 of that directive and which meets the essential requirements set out in Article 3 of, and Annex I to, that directive, is a third party required to subject that device to a new or additional conformity assessment in accordance with Article 9 of Directive 98/79/EC before it places the device on the market in Member State B (specifically: in the Federal Republic of Germany) in packaging which contains instructions in the official language of Member State B, which differs from the official language of Member State A (specifically: German as opposed to English) and the instructions for the use of which are enclosed in the official language of Member State B rather than in that of Member State A?

2. Does it make any difference in this case whether the instructions for use enclosed by the third party correspond word-for-word to the information which the manufacturer of the device uses for the purpose of distribution in Member State B?