Drug price manipulation in mail-order pharmacies across various European Union nations rocks the sector - Medicines sold to dispensing pharmacies outside the European Union are experiencing price volatility
In a recent ruling, the Federal Court of Justice (BGH) in Germany has highlighted the complex interplay between national laws and European Union (EU) regulations regarding pharmaceutical pricing and discounts, particularly those offered by overseas mail-order pharmacies.
The BGH's ruling, which came into effect on December 15, 2020, repealed a provision in the German Pharmaceuticals Act that was found to violate EU law. According to the previous provision, pharmacies were not allowed to give "patients any benefits," a rule that was challenged by the European Court of Justice in Luxembourg in 2016.
The dispute in question was centered around the actions of Dutch mail-order pharmacy Tanimis Pharma. The company offered a direct discount of three euros per medication, up to a maximum of 15 euros per prescription, which was contested by the Bavarian Association of Pharmacists. However, the BGH's ruling did not directly address the legality of these discounts and bonuses offered by Tanimis Pharma, as the dispute was centered around the previous provision in the Pharmaceuticals Act.
The BGH stated that the pharmacists' chamber failed to provide such evidence to support the previous provision in the Pharmaceuticals Act that was found to violate EU law. The court also emphasized that it is still up to EU law to determine whether the new regulation in the Fifth Book of the Social Code, which replaced the contested provision, is necessary to ensure a safe, high-quality, and comprehensive supply of pharmaceuticals.
The current EU laws and regulations on pharmaceutical price discounts, particularly those offered by overseas mail-order pharmacies, are primarily focused on ensuring medicine availability, price transparency, and combatting shortages. While there are pricing rules within the EU, such as caps on distributor markups and new drug pricing rules, these pertain mainly to domestic distribution and sales rather than overseas mail-order pharmacies.
The EU has ongoing efforts to improve price transparency and align drug prices through mechanisms like international reference pricing, but these approaches focus on domestic pricing policies and authorized supply chains rather than discounts specifically from overseas mail-order pharmacies. There is no specific, direct EU legislation that explicitly regulates pharmaceutical price discounts offered by overseas mail-order pharmacies to EU consumers or that addresses their impact on the EU’s health system and pharmaceutical supply chain.
In conclusion, current EU regulations address pharmaceutical pricing and supply chain integrity primarily through controls on authorized suppliers and marketing authorization holders within the EU, emphasizing availability and shortage prevention. Regulations do not specifically govern discounts offered by overseas mail-order pharmacies. The impact of such overseas discounts on EU health systems and supply is indirectly addressed through broader policies on medicine supply security and pricing reforms, rather than distinct laws on international mail-order price discounts.
In light of the BGH's ruling, it is yet unclear how EU regulations will address vocational training opportunities for pharmacists, as they primarily focus on pharmaceutical pricing and supply chain integrity. However, understanding the complexities of medical-conditions related to health-and-wellness may benefit from vocational training programs that are consistent with science-based approaches, across EC countries.
