Judgments provide clarity on free samples of medicines, on State aid to health insurance bodies, and on claims for damages against insurers.

RB – 06/2020

On June 11, 2020, the European Court of Justice (ECJ) issued three rulings regarding the provision of free samples by pharmaceutical companies to pharmacies, State aid for health insurance bodies, and claims for damages in the case of defective medical devices. The ECJ made the following judgments in the three cases.

Pharmaceutical companies may not distribute free samples of prescription-only medicinal products to pharmacists

In its judgment, the ECJ ruled that Section 47(3) of the German Law on medicinal products (AMG) must be interpreted in accordance with Article 96 of Directive 2001/83 (Community code relating to medicinal products for human use). In its press release, the ECJ stated that ‘…the Community code relating to medicinal products for human use does not authorise pharmaceutical companies to distribute to pharmacists free samples of medicinal products available only on prescription’. 

According to the ECJ, free samples of medicinal products may only be distributed to doctors because only they are entitled to prescribe them. This is to ensure there is medical supervision in view of the effects and risks associated with taking such drugs. However, providing non-prescription medicinal products to pharmacists is permitted.

The background to the decision was a legal dispute between Novartis and Ratiopharm. Novartis claimed that the distribution of free samples of the pain reliever Diclo-ratiopharm-Schmerzgel to German pharmacists was in violation of Section 47 (3) of the AMG. The Court of First Instance and the Court of Appeals upheld Novartis’ claim, and on appeal, the German Federal Court of Justice referred the matter to the ECJ.

The ECJ did not therefore rule on the dispute. The Federal Court of Justice must now issue a decision in accordance with the ECJ’s judgement.

State aid to health insurance bodies is not subject to EU State aid rules

This was confirmed by the ECJ in its judgment. This decision was preceded by a corresponding decision by the EU Commission in 2014, which stated that health insurance bodies operating under state control in Slovakia are not subject to EU State aid rules.

The ECJ upheld the decision that ‘the Slovak compulsory health insurance scheme pursues a social objective and applies the principle of solidarity under State supervision’. The Commission was also entitled to find the activity of the statutory health insurance scheme to be ‘not of an economic nature’ and as such ‘could not be classified as undertakings within the meaning of Article 107(1) TFEU’ (see ECJ press release).

The action for annulment that has now been decided was brought by the private Slovak health insurance institution Dôvera zdravotná poistʼovňa a.s., which considered State aid for two other institutions to be unlawful.

French breast implants: no obligation on insurance company to prohibition of discrimination

In its judgement, the ECJ ruled that EU law does not provide a basis for a German patient to claim damages from the insurance company of a French breast implant manufacturer.

A French manufacturer had filled breast implants with unauthorised industrial silicone. Due to the risk of implants rupturing, women were advised to have them removed. A German woman subsequently filed for damages, including against the manufacturer’s insurance company. The insurance company rejected the claim because coverage was limited to harm that occurred in France.

However, under EU law, EU citizens may not be discriminated against on the basis of their nationality. The ECJ has now decided that this prohibition of discrimination is not binding on the insurance company in this case. In secondary EU law, there is ‘no provision which imposes an obligation on the manufacturer of medical devices for civil liability insurance designed to cover risks linked to those devices, or which regulates such insurance’ (see ECJ press release).

The Higher Regional Court of Frankfurt am Main must now decide on the matter.

The case regarding defective breast implants had been the driver behind the adoption of the Medical Device Regulation (MDR) in 2017. However, the Regulation’s date of application has been postponed until 2021 due to the COVID-19 pandemic.