Free drug samples – new EU ruling restricts supply conditions

Under European law, the Community Code relating to medicinal productsⁱ provides for a number of conditions for the distribution of samples to healthcare professionals on a free-of-charge (FOC) basis.

Among these conditions, Article 96(1) of the Community Code requires that free drug samples be offered "only to persons qualified to prescribe them", on an exceptional basis.

However, Recital 51 of the Community Code provides that it should be possible, within certain restrictive conditions, to give free drug samples "to persons qualified to prescribe or supply them". This Recital suggests that not only physicians, but also (hospital) pharmacists could be offered free samples of medicinal products to familiarise themselves with new products and acquire experience in dealing with them.

Pursuant to Article 96(2) of the Community Code, Member States may also place further restrictions on the distribution of samples of certain medicinal products. In any event, distribution of samples free of charge to the general public for promotional ends must be prohibited, in accordance with Recital 46 of the Community Code.

On 11 June 2020, following a request for a preliminary ruling from the German Federal Court of Justice (Bundesgerichtshof), the Court of Justice of the European Union (CJEU) rendered a judgement in case C-786/18ⁱⁱ clarifying that:

• the Community Code does not authorise pharmaceutical companies to distribute to pharmacists free samples of medicinal products available only on prescription ;

• nevertheless, the Community Code does not prohibit the distribution to pharmacists of free samples of medicinal products for which a prescription is not required, ie over-the-counter (OTC) medicines.

This article outlines the background leading to the CJEU decision and the questions asked by the German referring court. It further addresses the outcome of the CJEU ruling and considers consequences of the decision for pharmaceutical companies doing business in the EU.

What is the background of case C-786/18?

In 2013, the German company ratiopharm GmbH distributed free samples of Diclo-ratiopharm-Schmerzgel to pharmacists within Germany.

Diclo-ratiopharm-Schmerzgel is the generic version of Novartis Consumer Health GmbH's Voltaren Schmerzgel, a pain reliever gel having diclofenac as an active substance.

According to Novartis, the distribution of samples carried out by ratiopharm would infringe the German Medicines Act (AMG) as this would amount to granting advertising gifts prohibited by national law.

Under Section 47(3) of the AMG, pharmacists are not listed among persons to whom samples of medicinal products may be offered for free.

After Novartis lodged an action before German courts, its case was upheld by a court of first instance, then by a court of appeal, and landed before the Federal Court of Justice (Bundesgerichtshof). In its judgement, the CJEU summarised the Bundesgerichtshof's position as followsⁱⁱⁱ:

• Although Recital 51 of the Community Code refers to both pharmacists and physicians, the wording of Article 96 - in the language version taken into account (ie German) - is ambiguous. It could be interpreted as referring only to the provision of free drug samples to physicians, without addressing such provision of samples to pharmacists.

• A difference in treatment between physicians and pharmacists would not be objectively justified and would be contrary to the freedom to pursue a profession. Both categories of healthcare professionals (physicians and pharmacists) would need to be informed, free of charge, about new medicinal products and to explain their use to patients or clients.

• On the question of whether Article 96(2) of the Community Code would give Member States a right to adopt rules which prohibits offering free drug samples to pharmacists, the referring court noted that both (a) the language of Article 96(2) - which allows Member States to place further restrictions on 'certain medicinal products' but not with regard to certain persons to whom samples are intended - and (b) Recital 51 of the Community Code, would not seem to support such an interpretation.

What were the questions referred to the CJEU?

Against this background, the referring court queried in essence:

1) whether Article 96(1) of the Community Code means that pharmaceutical companies may provide samples of medicinal products to pharmacies free of charge if such samples comply with the requirements laid down in paragraphs (a) to (g) of Article 96(1); and

2) if the answer to the first question is affirmative, whether Article 92(2) of the Community Code allows for a national provision such as  Section 47(3) of the AMG, if such national provision would prohibit pharmaceutical companies from providing samples of medicinal products to pharmacists free of charge.

How did the CJEU reach its decision?

According to the CJEU, the prohibition laid down in Recital 46 of the Community Code does not encompass a general prohibition directed at healthcare professionals, nor does it contain a specific prohibition towards persons entitled to deliver medicinal products^iv.

The CJEU supports this approach with the three following arguments^v:

• The prohibition laid down in Recital 46 of the Community Code does not include any prohibition, generally towards healthcare professionals or specifically towards persons who are entitled to deliver medicinal products. Therefore, in the context of promoting the sale of medicinal products, it cannot be held that there is a prohibition on the supply of free samples to pharmacists under EU law.

• Recital 51 of the Community Code underlines the possibility to distribute free samples of medicinal products to persons authorised to supply medicines, albeit under certain restrictive conditions. According to the EU legislature, this activity is justified where the provision of such samples enables these persons to become familiar with new medicines and to gain experience in their use.

• Where medicinal products are being promoted to persons qualified to prescribe or supply them, Article 94(1) of the Community Code read in connection with Recitals 46 and 51, is likely to cover - even if it does not explicitly mention it - the provision of such samples among other forms of advertising, as long as the benefit derived from it by these persons is inexpensive.

It follows that the Community Code accepts that national laws provide for a possibility to offer FOC drug samples to pharmacists, subject to restrictive conditions, while respecting the objectives pursued by the Code^vi.

However, such national laws should not allow the distribution to pharmacists of free samples of medicinal products captured by Article 96(1) of the Community Code, ie free samples of medicinal products subject to prescription^vii.

What are the consequences of the CJEU decision?

Pharmaceutical companies distributing FOC drug samples to pharmacies, including hospital pharmacies, will have to consider whether they are acting in compliance with the new CJEU ruling. They may have to review internal standard operating procedures on samples distribution in light of the new requirements, including by separating prescription-only medicines from OTC drugs and closely considering the professional qualifications of samples' beneficiaries on a case-by-case basis. Challenges await as Article 96(2) of the Community Code allows for divergent national implementations across the EU and Member States legislation may differ from one country to another.

Please contact us if you are interested in assessing the impact of the CJEU decision on your activities in the EU.

ⁱ Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use, as amended.

ⁱⁱCJEU, C‑786/18, ratiopharm GmbH v. Novartis Consumer Health GmbH, 11 June 2020 (Judgement), ECLI:EU:C:2020:459 (the Decision).

ⁱⁱⁱ Paragraphs 24 and 25 of the Decision.

^iv Paragraph 47 of the Decision.

^v Paragraphs 48 to 50 of the Decision.

^vi Paragraph 51 of the Decision.

^vii Paragraph 52 of the Decision.