Constitutional Concerns Raised Over Planned PTA Substitution in Pharmacies

Recent proposals to allow pharmaceutical technical assistants (PTAs) to temporarily replace licensed pharmacists in German pharmacies have sparked significant debate, with legal and professional organizations voicing constitutional concerns. The proposed reforms, aimed at addressing staffing shortages and improving service flexibility in pharmacies, have been met with critical responses from key industry associations.

One of the central issues highlighted by professional associations is the ongoing stagnation of the fixed dispensing fee for pharmacies. According to a detailed statement, it is considered essential that the fixed fee be raised to at least EUR9.50 per prescription, reflecting the inflation and cost increases experienced over the past twelve years. Expert analyses indicate that, adjusting for inflation alone, the fee should have reached EUR11.78 by 2023. Over the past two decades, pharmacies have saved health insurance providers an estimated EUR29 billion, yet the lack of fee adjustment has resulted in what is described as an unjustified EUR21 billion in savings for insurers during this period.

The associations advocate for an annual adjustment of this fixed fee, to be determined each June, taking into account metrics such as the nominal wage index, consumer price index, gross domestic product growth, inflation rates, and negotiated wage increases within the sector. While the reform proposal's suggestion to introduce a negotiated solution for fee adjustments has been positively received, there remains skepticism about other aspects of the plan.

The introduction of additional compensation for rural pharmacies has also been criticized. Associations argue that this measure would undermine the principle of a uniform pharmacy dispensing price and could create new challenges regarding the definition and classification of 'rural pharmacies.' Instead, they recommend a structural increase in the emergency service allowance to better support pharmacies in less populated regions.

A major point of contention is the plan to ease the requirement for the continual presence of a licensed pharmacist in pharmacies by permitting PTAs to act as substitutes under certain conditions. Professional organizations emphasize that the presence of a qualified pharmacist is not merely a formality but is integral to ensuring compliance with numerous legal and regulatory obligations. They argue that current exceptions to this rule are intentionally narrow, and expanding them would represent a fundamental shift in pharmacy practice that could conflict with constitutional principles. Specifically, the organizations refer to legal opinions suggesting that such a policy change could only be enacted through explicit legislative action due to its potential impact on the established legal framework governing pharmacies.

Further concerns have been raised regarding the risk of weakening the prohibition on non-pharmacist ownership of pharmacies. It is feared that loosening the requirements for pharmacist presence could inadvertently erode existing safeguards against third-party ownership, which are designed to ensure independence and professional standards within the sector.

Instead of broadening substitution rules, the associations propose that pathways for PTAs to pursue a full pharmacy degree should be improved. They also advocate for expanded opportunities for continuing education, which could lead to an evolved professional role for PTAs. Upon completion of advanced training, these professionals could be authorized to provide additional pharmaceutical services and possibly administer vaccinations, thereby enhancing their contribution to the healthcare system without undermining essential regulatory safeguards.

The ongoing debate underscores the complex balance between maintaining high standards in pharmaceutical care and adapting to evolving workforce and healthcare needs. As the government considers these reforms, professional and legal input will play a critical role in shaping policies that uphold both patient safety and the sustainability of pharmacy operations across Germany.