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Do discount campaigns on prescription-only medicines (POMs) run by mail order pharmacies lure patients into consuming medicinal products? The European Court of Justice (CJEU) in the case of Apothekerkammer Nordrhein (C-517/23) has held that they do not.

Following on from the AG Opinion of Advocate General Szpunar, which we provided an update on earlier in the year, this case is the latest in a stream of cases on advertising practices involving DocMorris, a Dutch mail-order pharmacy that supplies medicines to end customers in Germany. The CJEU concluded that the discount campaigns regarding unspecified POMs do not fall within the definition of “advertising of medicinal products” (Article 86(1) Directive 2001/83) as the discount is implemented at the point of purchase of the POM.  The decision of which product to prescribe has already been taken by a doctor and all the patient is left to do is choose the dispensing pharmacy. As such, the Court held that the purpose of the discount campaign is not to encourage patients to purchase medicinal products. Rather, it is simply to attract them to a specific pharmacy.

The facts of the case are set out in our previous blog available here.Continue Reading An update from the European Court of Justice on discount campaigns run by mail order pharmacies

In the last month, both the European Data Protection Board (“EDPB”) and the Court of Justice of the European Union (“CJEU”) provided their interpretation of key data protection concepts that are crucial for ensuring compliance with Regulation (EU) 2016/679 (“GDPR”).

In Opinion 22/2024, the EDPB provided guidance to data controllers on how to effectively oversee the activities of their (sub-)processors in a GDPR-compliant manner. The opinion was requested by the Danish data protection authority and likely related to the enforcement actions against Danish hospitals which allegedly failed to oversee processors (see our blog – https://www.biosliceblog.com/2024/02/proposed-fine-against-danish-hospital-for-failure-to-supervise-data-processors/).

In early October, the CJEU provided an answer to a key question raised by the courts in the Netherlands – can the legitimate interests legal basis be used for processing of personal data for commercial purposes (e.g., sharing with third parties for advertising and promotion) (Case C‑621/22).Continue Reading Notable developments in the interpretation of key GDPR concepts – why should Life Sciences companies care?

The Court of Justice of the EU (CJEU) has provided guidance on claims permitted to be made in the labelling and advertising for biocidal products under the Biocidal Products Regulation (Regulation (EU) No 528/2012 (BPR). 

The BPR aims to improve the free movement of biocidal products (substances intended to destroy, deter, render harmless, prevent the action of or otherwise control harmful organisms) while ensuring a high level of protection for human and animal health and the environment.Continue Reading CJEU rules on biocidal product advertising

In three separate preliminary rulings delivered by the Court of Justice of the European Union (CJEU) on 17 November 2022 (Novartis v Abacus Medicine, Bayer v kolpharma, and Merck Sharp & Dohme (MSD) v Abacus Medicine), the pharmaceutical industry received welcome guidance as to the extent to which brand owners may oppose the repackaging of medicinal products to comply with EU rules on tamperproof packaging.Continue Reading Tampering with the packaging? Further EU Court of Justice guidance for parallel traders

On 17 November 2022, the Court of Justice of the European Union (CJEU) delivered its preliminary ruling in joined cases C-253/20 Impexeco NV v Novartis (Impexeco), and C-254/20 PI Pharma v Novartis (PI Pharma), finding that where a parallel importer affixes the trade mark of a branded reference medicinal product onto the packaging of a generic product, the brand owner may oppose the placing of that generic product by the parallel importer on the market of a Member State. Though the CJEU provides an exception to this general rule, the authors query whether the exception will ever apply.

Importantly, this case compares: (i) the rules on when a parallel import licence can be obtained (which is a regulatory question), and (ii) when rebranding can legitimately take place for such products (which is an IP question). As set out below, the need for “identicality” is not the same for these two considerations.Continue Reading Parallel imports: identicality of products when repackaging

Today, the Court of Justice of the European Union delivered a landmark judgement with significant practical impact for companies transferring personal data outside the European Economic Area to the United States. The Court of Justice confirmed the validity of the Standard Contractual Clauses for transfer of personal data between a controller in the EU and a processor in a third country (e.g., the US) adopted by the European Commission in Decision 2010/87/EU. The Court has, however, invalidated European Commission Decision (EU) 2016/1250 on the adequacy of the protection provided by the EU-US Privacy Shield.
Continue Reading The CJEU confirms the validity of the Standard Contractual Clauses but invalidates the EU-US Privacy Shield

Advocate General Kokott issued her opinion last week in the preliminary ruling referral from the UK Competition Appeal Tribunal (CAT). The CAT proceeding is itself an appeal against an infringement finding against a number of companies (except one, IVAX, which is now part of TEVA, which received a ‘No Grounds for Action’ letter).

AG Kokott finds that an agreement to settle a patent dispute may constitute a restriction of competition by object or by effect and that entering into such an agreement may be an abuse of a dominant position. This is in line with the General Court’s recent judgments in Perindopril and Lundbeck, but her views diverge on market definition where she seems to side with the CAT on a narrow, molecule-level definition.Continue Reading Paroxetine: AG Rules on Reverse Payment Settlement Referral

EU law places strict controls on the use of nutrition and health claims on food labelling and in advertising. Under Regulation (EC) No 1924/2006 (the Regulation):

  • a nutrition claim is any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to the energy and/or nutrients or other substances it provides or contains (e.g., “low fat” or “source of fibre”); and
  • a health claim is one which states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health (e.g., “Calcium is needed for the maintenance of normal teeth”).

Under the Regulation, it is only possible to use nutrition claims that are listed in the Annex to the Regulation, and/or health claims that have been authorised by the European Commission following a European Food Safety Authority scientific review. The only exception to these requirements is in relation to claims that are trade marks (or brand or “fancy” names) and general, non-specific health claims (e.g., “Good for you” or “Healthy”). These claims may be used without prior approval, provided they are accompanied by an approved claim (which, in the case of a general health claim, must be an authorised specific health claim, such as the calcium example given above).Continue Reading Latest View on Health Claims on Foods in the EU

We recently published an Advisory on a decision of the CJEU earlier this month on parallel trade. Ordinarily, medicinal products can only be placed on the EU market if they have a valid marketing authorisation in the relevant Member State. However, within the EEA, the principle of free movement of goods applies, meaning that, subject to certain exceptions, Member States cannot prevent free movement of goods once they are lawfully on the market. Therefore, once a product has lawfully been placed on the market, it is possible for third parties to move that product between Member States, subject to certain requirements. This is known as parallel trade.

There have been many decisions in the CJEU considering when medicinal products can be parallel traded across the EU, and the limits on such trade. This recent decision from Poland (Case C-387/18, Delfarma), is the latest in this line of case law.Continue Reading Recent Important Decisions on Regulatory Requirements for Parallel Trade in the EU

On 14 February 2019, the Court of Justice of the EU (CJEU) delivered its judgment in Case C-423/17 Netherlands v Warner-Lambert Company, finding in line with the opinion of Advocate General Kokott issued on 4 October 2018, that “carving-out” indications or dosage forms covered by the patent right of a third party, leading to a skinny label for the product, is a request to limit the marketing authorisation for the generic medicinal product. In practice, this prevents the competent authorities from publishing a complete SmPC, showing all indications associated with the innovator product, on their website.

Today’s judgment will be welcomed by innovative companies seeking to ensure the effectiveness of their second medical use patents.Continue Reading CJEU decision on scope of skinny labels