Skip to content

Non-EU consignment pharmacies' medicine prices remain unregulated

Mail-order pharmacies located in EU countries, other than Germany, are exempt from the former drug pricing regulations. The German Federal Court of Justice (BGH) found no violation in bonus payments offered by a Dutch pharmaceutical company on prescription medications.

Prices of medicines remain unregulated for pharmacies delivering consignments outside the European...
Prices of medicines remain unregulated for pharmacies delivering consignments outside the European Union

Non-EU consignment pharmacies' medicine prices remain unregulated

The evolving landscape of mail-order pharmacies in Germany and the Netherlands is shaped by a harmonious blend of EU-wide directives and national laws, ensuring safety, transparency, and consumer protection while maintaining control over drug pricing and competition.

### EU-Level Framework

The Directive 2011/62/EU lays the groundwork for common safety standards for online pharmacies, preventing the entry of falsified medicines into the supply chain. Member states can impose restrictions on the retail supply of medicines online, particularly prescription medicines, as long as these do not unduly restrict the internal market. All online pharmacies in member states must register publicly and display the EU logo, enhancing transparency and consumer protection.

Regulated professions such as pharmacists are permitted to promote their activities online within professional rules limits, as demonstrated by an EU Court judgment in 2025 that struck down Poland's general prohibition on pharmacy advertising as contrary to EU law. The European Shortages Monitoring Platform, mandatory since February 2025, requires marketing authorization holders to report medicine shortages, indirectly influencing pricing and supply dynamics.

### Germany

Mail-order pharmacies in Germany must adhere to national pharmaceutical laws consistent with EU directives. Pricing of medicines is generally regulated by reference pricing systems and pharmacy markups set by law to control costs in the healthcare system. Competition law allows mail-order pharmacies to compete, but within a framework that limits aggressive discounting to ensure pricing stability and quality assurance, respecting public health imperatives.

### Netherlands

The Dutch regulatory framework closely aligns with EU rules for online pharmacy sales. Mail-order pharmacies must comply with national medicine pricing policies and reimbursement rules that aim to balance cost containment with patient access. Advertising and promotion of pharmacy services are permitted, provided they adhere to professional and advertising standards that avoid misleading claims and ensure consumer protection.

### Summary Table

| Aspect | EU-Wide Regulations | Germany | Netherlands | |---------------------------|----------------------------------------------------|-----------------------------------------------|------------------------------------------------| | Online pharmacy registration | Mandatory public register and EU logo display | Registered and regulated with EU rules | Registered and regulated with EU rules | | Drug pricing | Member states impose controls to protect public health | Pricing controlled by national laws, price parity enforced | Pricing controlled by national policies aligned with EU | | Competition law | Advertising allowed within regulated limits; no general bans | Competition allowed with limits to ensure stability and safety | Competition permitted within professional and advertising standards | | Shortage reporting | Mandatory through European Shortages Monitoring Platform | Adheres to EU reporting requirements | Adheres to EU reporting requirements |

Notably, the Federal Court of Justice in Germany (BGH) has overturned the OLG Munich ruling regarding the applicability of drug price regulation to mail-order pharmacies in other EU countries. The E-prescription in Germany, introduced at the beginning of the year, has led to a boom in online trading of pharmaceuticals. The BGH referred to standards of the European Court of Justice (ECJ) in its decision, and the case pertains to bonus payments made by a mail-order pharmacy in the Netherlands in 2012. The E-prescription is mandatory from January 2024, and the case number for the decision made by the BGH is I ZR 74/24. The Bavarian Association of Pharmacists initially won the lawsuit in the lower courts in Munich, but the decision was overturned by the First Civil Senate of the BGH. It is crucial to emphasise that the new regulation in the Social Security Code is not a factor in the BGH's decision.

The purchase of pharmaceuticals in a pharmacy is confidential, but buying via platforms like Amazon Marketplace may reveal sensitive information. The sale of pharmaceuticals by mail was already allowed in the Netherlands prior to the E-prescription. The former drug price regulation in Germany does not apply to mail-order pharmacies in other EU countries. The presiding judge in the case is Thomas Koch.

Science and health-and-wellness sectors have significant intersections with the evolving mail-order pharmacies in both Germany and the Netherlands. For instance, the European Shortages Monitoring Platform, launched in 2025, not only requires reporting of medicine shortages but also indirectly influences pricing and supply dynamics in the pharmaceutical industry, contributing to overall health-and-wellness (Science). Moreover, the purchase of pharmaceuticals online raises concerns about the privacy and confidentiality of health information, as buying via platforms like Amazon Marketplace may reveal sensitive health data (Health-and-Wellness).

Read also:

    Latest