Distribution of Cough Syrup as a Medical Device: Judgment of the OLG Frankfurt and its Implications
The Higher Regional Court of Frankfurt am Main addressed the legal permissibility of the distribution of a product labeled as “cough syrup” in a recent ruling (Ref. 6 U 126/20; decision dated 08.07.2021), which, although presented in a form similar to pharmaceuticals, is actually marketed as a medical device based on a corresponding confirmation from the Federal Institute for Drugs and Medical Devices (BfArM). The decision not only sheds light on the distinction between pharmaceuticals (§ 2 AMG) and medical devices (§ 3 MPDG), but also raises significant questions regarding the prohibition of misleading advertising and labeling. The following explains the legal background, the court’s reasoning, and the consequences for companies in the healthcare sector in more detail.
Classification and Distinction: Pharmaceutical versus Medical Device
Background and Regulatory Environment
The focus of the proceedings was a product labeled as “cough syrup” featuring prints typically reserved for pharmaceuticals. Nevertheless, the distribution was expressly conducted as a medical device, supported by a certificate from the BfArM stating that the product does not meet the requirements of a pharmaceutical. Distinguishing between a medical device and a pharmaceutical is of great importance, not least due to the differing regulatory requirements regarding approval, labeling, and advertising.
Determining Legal Criteria
The criterion for legal classification is the specific purpose determination characteristic. While pharmaceuticals are characterized by pharmacological, immunological, or metabolic effects, medical devices are particularly defined by the fact that their primary effect in or on the body is not achieved pharmacologically. For providers, precise distinction is essential as it has significant impacts on approval procedures, advertising measures, and distribution channels.
Problem Outline: Risk of Misleading Presentation
Evaluation of Product Presentation
The claimant argued that the presentation of the product – particularly the designation as “cough syrup” and the visual proximity to pharmaceutical presentations – should be classified as misleading. From the claimant’s perspective, it suggests to the consumer that it is a tested and approved pharmaceutical within the meaning of the AMG, which constitutes an impermissible deception as per §§ 3, 5 UWG. The defendant company, however, pointed to the explicit release of the product as a medical device by the BfArM.
Principles of Jurisprudence on Misleading Advertising
Misleading within the meaning of competition law occurs, among other things, when essential information is withheld from the targeted public or when facts are claimed that are objectively incorrect. In assessing this, the specific form of presentation, external appearance, and accompanying advertisements must always be considered.
Judgment of the OLG Frankfurt am Main and Reasons
Key Reasons for the Decision
The OLG Frankfurt ruled that presenting the “cough syrup” as a medical device, despite its pharmaceutical-like design, does not constitute unlawful deception if essential requirements – particularly the BfArM’s permission – are met. According to the court, the official confirmation of classification as a medical device counteracts an assumption of deception. The product presentation was not deemed suitable to cause a misconception, provided the medical device regulations are adhered to and consumers are adequately informed about the status.
Significance of Regulatory Classification by the BfArM
The decision emphasizes the crucial role of regulatory classification. As long as the BfArM – as the competent German authority – expressly opposes classification under pharmaceutical law and classifies the product as a medical device, this official action provides sufficient legal certainty for manufacturers and distributors. A differing assessment by civil courts is only possible in exceptional cases, such as with subsequent findings or changed legal circumstances.
Impact and Advice for Companies in the Healthcare Sector
Relevance for Distribution and Advertising
The judgment highlights that companies in the medical product sector receive a solid basis for the distribution and advertising of their products, provided a careful and transparent regulatory classification has been made. The often challenging line between pharmaceutical and medical device requires continuous review of product claims and advertising efforts to avoid competitive violations and mitigate the risk of warnings or legal disputes.
Importance for Regulatory Compliance
The judgment further indicates that a purpose determination and product classification confirmed by the BfArM are crucial. Companies should maintain ongoing dialogue with the competent authorities and align their product presentation consistently with the current legal situation. It should be noted that regulatory classification not only impacts the marketability of the product but also affects liability potentials and advertising bans.
Summary Evaluation and Further Development
The OLG Frankfurt has set significant guidelines with its decision for dealing with medical devices designed similar to pharmaceuticals. Companies wishing to market products in the intersection between pharmaceuticals and medical devices are provided a legally secure framework, provided they strictly comply with relevant regulatory requirements and carefully document them. Nonetheless, the substantive distinction remains a complex field with practical challenges.
In a constantly changing regulatory environment, the current legal situation should be continuously reviewed. Ongoing proceedings – such as the present case before the OLG Frankfurt – are always individual decisions and may be influenced by new legal provisions or changing administrative practice (Source: OLG Frankfurt am Main, judgment dated 08.07.2021, Ref. 6 U 126/20; https://urteile.news/OLG-Frankfurt-am-Main_6-U-12620_Trotz-Praesentation-als-Arzneimittel-ist-Vertrieb-eines-Hustensafts-als-Medizinprodukt-bei-entsprechender-Erlaubnis-des-BfArM-keine-Irrefuehrung~N30581).
For companies, investors, and other stakeholders in the medical technology and pharmaceutical field, there is regularly a need to review their activities for regulatory risks and legal developments. For specific questions about product distribution, compliance with relevant regulations, or strategic alignment in the healthcare market, MTR Legal Attorneys is available as a nationwide and internationally active full-service business law firm.
