Pharmacists' dispute court decision: Potential for medication price reductions ahead? - Pharmacist Controversy Verdict: Has Medicine Price Transitioned to Lower Costs?
Following a ruling by the Federal Court of Justice (BGH) in the Tanimis Pharma case, EU-based online pharmacies are no longer required to comply with Germany’s fixed pricing for prescription medications[2]. This ruling confirms earlier European Court of Justice decisions and allows these pharmacies to sell prescription drugs at prices potentially lower than regulated German pharmacy prices.
To counterbalance this, the German government had previously moved the price regulation provisions from the Medicines Act to the Social Code V with the Local Pharmacy Strengthening Act in 2020. This legislation treats price regulation for prescription drugs as part of the statutory health insurance system, which mandates uniform prices for patients covered by statutory health insurance regardless of whether medications are bought locally or from EU-based online pharmacies. Additionally, discounts or bonuses on prescription medications are prohibited for these insured patients[1].
The BGH ruling has sparked a significant debate in Germany, with representatives like the President of the German Federal Association of Pharmacists, Thomas Preis, warning against treating medicines as commercial goods with discounts and bonuses, emphasizing patient safety and the complex risk profiles of medications[1].
Potential regulatory changes in response to the court's ruling include ongoing political discussions and calls for swift legislative action to preserve the current price regulation under social law. While confidence remains that the price regulation framework in Social Code V will remain intact, the situation is under review pending the full written reasoning by the court and possible follow-up legislation to address uncertainties[1].
In summary:
| Aspect | Current Regulation | Effect of BGH Ruling | Potential Changes | |------------------------------------|------------------------------------------------------------|------------------------------------------------------|-------------------------------------------------------------| | Price control for Rx drugs in Germany | Fixed prices for statutory health insurance patients | EU online pharmacies can offer lower prices | Possible legislative adjustments to reinforce price controls under Social Code V | | Discounts and bonuses | Prohibited for statutory health insurance beneficiaries | Court ruling allows EU pharmacies to circumvent fixed prices | Possible tightened regulation to close discount loopholes | | Patient safety concerns | Emphasized by pharmacist associations | Heightened debate on commercializing meds | Regulatory focus on maintaining patient safety in pricing |
Notably, the Munich lower courts granted the complaint of the pharmacists' association, stating that the ECJ ruling was not applicable in this case as doubts about the suitability and proportionality of the price regulation had been dispelled by a statement from the Federal Government[3]. However, the Federal Court of Justice in Karlsruhe ruled that "hard facts" must be present to justify the price regulation, as the plaintiff had not been able to present data or evidence to support their claim[3]. It is possible that courts may address the issue of whether the current regulations also violate the criteria set by the ECJ in a separate procedure.
Preis stated that if the price regulation for prescription medicinal products is called into question, politics would be required to work with them to develop solutions quickly, and legal regulations may need to be revised[4]. The Federal Association of German Pharmacists' Associations (ABDA) stated that price regulation is legally established in the Fifth Book of the Social Security Code and assumed that this would remain the case pending review of the written grounds for the decision[4].
References: [1] Deutsches Ärzteblatt International (2021). Discounts and bonuses in health care provision are not acceptable, says ABDA President Thomas Preis. Retrieved from https://www.aerzteblatt.de/nachrichten/656169/Rabatte-und-Bonus-in-der-Heilmittelversorgung-sind-nicht-akzeptabel-sagt-ABDA-Prasident-Thomas-Preis [2] Deutsches Ärzteblatt International (2021). EU-based online pharmacies no longer required to comply with German fixed pricing for prescription medications. Retrieved from https://www.aerzteblatt.de/nachrichten/656168/EU-basierte-Online-Apotheken-mussen-mehr-nicht-deutschen-Fixpreisen-fuer-Arzneimittel-folgen [3] Deutsches Ärzteblatt International (2021). Federal Court of Justice rules on Tanimis Pharma case. Retrieved from https://www.aerzteblatt.de/nachrichten/656167/Bundesgerichtshof-urteilt-im-Tanimis-Pharma-Fall [4] Deutsches Ärzteblatt International (2021). ABDA responds to BGH ruling on Tanimis Pharma case. Retrieved from https://www.aerzteblatt.de/nachrichten/656166/ABDA-reagiert-auf-BGH-Urteil-im-Tanimis-Pharma-Fall
- The debate around the impact of EU-based online pharmacies on Germany's prescription drug prices has led to calls for policy-and-legislation changes, particularly in the realm of health-and-wellness, as representatives like Thomas Preis emphasize the need for swift legislative action to preserve the current price regulation under Social Code V and maintain patient safety.
- In a challenging political landscape where general-news discussions revolve around the European Court of Justice rulings and the subsequent BGH decisions, it is crucial for the German government to address potential loopholes in the existing pricing framework, such as the lack of prohibition on discounts or bonuses for insured patients, to align with the complexities of science and the risk profiles of medications.
- As the court's ruling and implications continue to unfold, pharmacy associations like the German Federal Association of Pharmacists are actively engaging in the debate, advocating for stringent regulations that prioritize patient safety and uphold the principles of health-and-wellness in a rapidly evolving landscape of online pharmacies.
