LexGo

CJEU rules that free samples of OTC medicinal products can be provided to pharmacists
15/06/2020

 

On 11 June 2020, the Court of Justice of the European Union (CJEU) confirmed that it is prohibited to distribute free samples of prescription-only medicines to pharmacists but clarified – against the Advocate General's opinion of 20 January 2020 – that the prohibition does not extend to over-the-counter (OTC) products. 

Background

Before the German courts, Novartis successfully objected to the supply by Ratiopharm of free samples of a generic version of Novartis' Voltaren Schmerzgel (a pain relief gel with the active ingredient diclofenac) to pharmacists "for demonstration purposes". Ratiopharm appealed to the Bundesgerichtshof, which submitted a request for a preliminary ruling based on Article 96 of Directive (EU) No 2001/83/EC relating to medicinal products for human use (hereinafter the "Directive"). This provision permits, under strict conditions, the supply of free samples of medicinal products to persons qualified to prescribe them, i.e. physicians. In short, the Bundesgerichtshof asked the CJEU whether the supply of free samples under Article 96 of the Directive extends to pharmacists.

Distinction between prescription-only and OTC medicinal products 

Article 96(1) of the Directive sets out the conditions under which samples of medicinal products can be provided to "persons qualified to prescribe medicinal products" (limitation on the number of samples, only upon written request, subject to an adequate system of control and accountability and an obligatory summary of product characteristics). Article 96(2) authorises the Member States to adopt more restrictive measures in this regard.

The CJEU confirmed that Article 96 cannot be interpreted as authorising the supply of free samples of medicinal products to pharmacists, since they do not belong to the category of "persons qualified to prescribe medicinal products".

However, the CJEU went on to find that Article 96(1) applies to prescription-only medicinal products, which are potentially dangerous and whose use requires supervision by a physician, not to all medicinal products. Article 96(2) must be read in conjunction with Article 96(1) and has the same scope. Consequently, it relates only to medicinal products requiring a prescription.

In its interpretation, the CJEU relied on the Directive's distinction between OTC and prescription-only medicinal products, including the impact of this distinction on the possibility to advertise the products. Prescription-only medicines give rise to certain risks in relation to their use or effects and require supervision by persons qualified to prescribe them. Over-the-counter medicinal products, on the other hand, are not associated with the same risks. The CJEU mentioned Recital 51, which states that, under certain restrictive conditions, it should be possible to provide samples of medicinal products free of charge to persons qualified to prescribe (i.e. physicians) or supply (i.e. pharmacists) them, so that they can familiarize themselves with new products and acquire experience in dealing with them.

These considerations led to the conclusion that the Directive allows the supply of free samples of medicinal products to pharmacists under national law, subject to strict conditions in keeping with the Directive's purpose and provided the products concerned do not require a prescription.

Application to Belgium: Royal Decree of 11 January 1993

In Belgium, the Royal Decree of 11 January 1993 restricts the supply of free samples of medicinal products to persons qualified to prescribe them and hospital pharmacies (Article 1 in conjunction with Articles 2 and 5).

As the CJEU ruled that national law cannot prohibit the supply to pharmacists of free samples of OTC medicinal products, Belgian law will have to be amended to allow for this possibility.

Zie ook : Nautadutilh Avocats Luxembourg Sàrl ( Mr. Vincent Wellens )

[+ http://www.nautadutilh.com]


Click here to see the ad(s)
Alle artikels Europees recht

Laatste artikels Europees recht

CJEU: new developments in the realm of VAT recovery on dead deal costs
20/11/2020

In the context of a prospective acquisition of shares in a company in the telecommunications sector, and with the intentio...

Read more

CJEU clarifies legality of surveillance legislation for national security
20/11/2020

Recently, the Court of Justice of the European Union (“CJEU”) ruled on case C-623/171 and the joined case...

CJEU clarifies legality of surveillance legislation for national security Read more

EIOPA outlines approach on product oversight and governance
18/11/2020

EIOPA published a paper on its approach to product oversight and governance requirements for insurance distributors and ma...

EIOPA outlines approach on product oversight and governance Read more

The Court of Justice of the EU clarifies the assessment of position marks for services
15/10/2020

The Court of Justice of the EU recently clarified the criteria to take into account when assessing the distinctive charact...

Read more

Laatste artikels van Mr. Vincent Wellens

Finally some practical EDPB guidance on how to make international data transfers lawful
13/11/2020

After a long, four-month wait, we finally have recommendations from the European Data Protection Board (EDPB) on “su...

Read more

The Court of Justice of the EU clarifies the assessment of position marks for services
15/10/2020

The Court of Justice of the EU recently clarified the criteria to take into account when assessing the distinctive charact...

Read more

New controller-processor guidelines: beware of impact on data processing agreements
14/09/2020

Armed with useful flowcharts to help organisations determine their role, the European Data Protection Board (EDPB) has pub...

Read more

Benelux Regulators to Apply EIOPA Guidelines on Outsourcing to Cloud Service Providers by Insuran...
14/08/2020

On 24 April 2020, the European Insurance and Occupational Pensions Authority (EIOPA) issued new guidelines on outsourcing ...

Read more

LexGO Network