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’.
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
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
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
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.
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.
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).
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.