OLG Frankfurt: Limits on the Production and Distribution of Unapproved Cancer Drugs by Pharmacists
Facts and Background of the Proceedings
The Higher Regional Court (OLG) of Frankfurt am Main, in a recent decision (Judgment of 11.04.2025, Ref. 6 U 225/23 – Source: urteile.news) had to decide on the scope of pharmacy law powers regarding the individual preparation and distribution of medicinal products. At the heart of the case was a pharmacist who had produced and distributed a preparation for the treatment of a serious cancer condition (glioblastoma multiforme) without a pharmaceutical law authorization. The product was based on a substance that was neither included in approved medications in Germany nor authorized for the treatment of the illness pursuant to § 21 para. 1 AMG.
The extent to which pharmacies are permitted to ensure the supply of severely ill patients with individually prepared medications is not only ethically and medically relevant, but also concerns key aspects of pharmaceutical and competition law.
Pharmaceutical Law Framework
Authorization Requirement under § 21 AMG
According to § 21 paragraph 1 of the Medicinal Products Act (AMG), drugs may in principle only be placed on the market if official authorization has been granted. This provision is especially intended to protect health and to monitor the quality, efficacy, and safety of medicinal products. There are exceptions to this, notably for medicinal products prepared in pharmacies for individual use based on special medical prescriptions (so-called magistral preparations), see § 21 para. 2 no. 1 AMG.
Limits of the Exemption Regulations
However, the OLG Frankfurt made it clear in its decision that the aforementioned exceptions must be interpreted narrowly. The prerequisite is that the preparation is actually based on a specific medical prescription for a particular person and is not intended to circumvent the authorization requirement. The judges emphasized that, especially when a product is manufactured and distributed on a larger scale and without sufficient medical individualization, it can no longer be privileged as a magistral preparation.
Furthermore, § 21 para. 2 no. 1 AMG explicitly excludes the production and distribution of finished medicinal products not intended for specific patients from the exception. These protective mechanisms are intended to prevent potentially unsafe or ineffective drugs from reaching the market without the required oversight authority.
Implications under Competition Law
Unfair Competition due to Violation of Mandatory Market Rules
In addition to the pharmaceutical law component, the judgment also highlights the significance of the competition law framework (§ 3a UWG). If an unapproved drug is offered or distributed in the course of business, this constitutes a violation of enforceable market conduct rules – as a result of which competitors may assert claims for injunctive relief.
The OLG found that the pharmacist not only violated pharmaceutical law provisions but also the competition law prohibition of unfair competition. According to the court, such practices disadvantage other market participants who comply with strict legal requirements.
Balancing Patient Interests and Health Protection
Supplying Severely Ill Patients
The court expressed understanding for the legitimate supply interests regarding severely ill individuals who rely on innovative or experimental therapies. However, protection of public health takes precedence. Approval procedures are intended to ensure that all medicinal products meet the highest standards of safety and efficacy – especially in the case of innovative therapeutic approaches.
No Individual Supply without a Specific Medical Prescription
The production of drugs by pharmacies for use in individuals remains possible, but requires a specific medical prescription. The OLG rejects any circumvention of this requirement by producing products for stock or for an unspecified group of people.
Significance of the Decision and Outlook
The judgment of the OLG Frankfurt makes clear that strict requirements must be observed regarding pharmaceutical and competition law regulations when producing and distributing unapproved medicinal products. Pharmacies – even in the interest of patient protection – are prohibited from exceeding the narrow limits of individual preparation. The decision is thus suitable for providing clarity and reducing uncertainties when dealing with innovative therapeutic options.
At the same time, the judgment is likely to affect (legal) practice for other market participants and the development of care concepts. It can be assumed that, particularly in the field of orphan drugs and experimental medicine, careful case-by-case examinations, oriented towards the legal regulations, will continue to be required. It remains to be seen how future courts will deal with comparable scenarios and to what extent lawmakers will respond to new developments in pharmaceutical law.
Notice of Ongoing Developments
Please note that despite the clarity of the OLG judgment regarding the manufacture and distribution of unapproved medicinal products, further court rulings or legislative amendments cannot be ruled out.
If you have any further questions regarding the legal framework surrounding the distribution, production, or approval of pharmaceuticals, or concerning a potential assessment under competition law, the team of MTR Legal Rechtsanwalt will be pleased to advise you.
