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.

Voir aussi : NautaDutilh ( Mrs. Florence Verhoestraete ,  Mrs. Sien Vandezande )

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


Click here to see the ad(s)
Tous les articles Droit Européen

Derniers articles Droit Européen

EU Omnibus Directive: what is the impact of the consumer protection reform for traders? Some take...
23/11/2020

Nearly one year ago, the EU Parliament adopted the directive No 2019/2161 (better known as the “Omnibus Di...

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

A European passport for crowdfunding
17/11/2020

At last, a European passport for crowdfunding! As from 10 November 2021, it will be possible for both new and existing cro...

A European passport for crowdfunding Read more

The EU digital finance package: unwrapping digitally fit rules for financial services
16/11/2020

The European Commission is eager to accelerate the EU’s digital transition and to ensure EU leadership in the realm ...

Read more

Derniers articles de Mrs. Florence Verhoestraete

Transparency in Belgian Healthcare Relationships
24/10/2019

Betransparent.be recently released its second Sunshine Act publication, based on information provided by 596 pharma and me...

Read more

Plain Cigarette Packaging in Belgium as from 1st January 2020
24/06/2019

Plain packaging is gaining ground in Europe and around the world. Following in the footsteps of France, the United Kingdom...

Read more

New Measures to Tackle the Unavailability of Medicinal Products
21/05/2019

The unavailability of certain medicines in Belgium is nothing new, and this situation is certainly not unique in Europe. H...

Read more

European SPC Waiver for Export and Stockpiling of Generics and Biosimilars
29/03/2019

On 14 February 2019, the Committee of the Permanent Representatives of the Governments of the Member States (Coreper) endo...

Read more

Derniers articles de Mrs. Sien Vandezande

New Belgian DPA decision: employee consent sometimes works
18/11/2020

Yes, employee consent is possible in certain circumstances – but do not assume old processing activities fully compl...

Read more

Are Saint Nick and Santa Infringers?
20/12/2019

With Christmas fast approaching, many of us have begun searching for the perfect presents. Recent figures from the Belgian...

Read more

LexGO Network