New Development in Public Procurement of Medicines
New Development in Public Procurement of Medicines
July 2025
Miha Stravs, Partner
Selih & partnerji
In June 2025, the European Commission initiated infringement proceedings against Slovenia (INFR(2025)4011) for alleged non-compliance with Directive 2014/24/EU on public procurement. The trigger? An amendment to the Pharmaceutical Activities Act (“ZLD-1“), which permits public pharmacy institutions to procure medicines without resorting to standard public procurement procedures.
The Commission asserts that the new regulation does not meet the conditions for exceptions allowed by the European directive, thereby violating fundamental EU law principles such as transparency, competition and equal treatment of tenderers.
Key Provisions of Article 14.a of ZLD-1:
As of December 28, 2024, public pharmacy institutions procure medicines under specific ZLD-1 rules, which include:
- Procurement exclusively from wholesalers with a valid permit.
- Mandatory procurement from at least three wholesalers annually.
- A limit of 70% of annual medicine turnover with a single wholesaler.
- The goal of ensuring quality and timely supply while economically using public funds.
- Maintenance of special records on medicine stock provision.
The pharmaceutical inspection is responsible for oversight, while legal protection procedures under the Public Procurement Legal Protection Act are no longer applicable to these types of procurements.
What’s Next? Slovenia has two months to respond to the formal notice. Otherwise, the Commission may issue a reasoned opinion, which marks the next step in the infringement procedure. This case raises critical questions about the relationship between public service, safeguarding public health and adherence to EU internal market rules.
Read the full Commission press release here: https://ec.europa.eu/commission/presscorner/detail/sl/inf_25_1241
July 2025
Miha Stravs, Partner
Selih & partnerji
In June 2025, the European Commission initiated infringement proceedings against Slovenia (INFR(2025)4011) for alleged non-compliance with Directive 2014/24/EU on public procurement. The trigger? An amendment to the Pharmaceutical Activities Act (“ZLD-1“), which permits public pharmacy institutions to procure medicines without resorting to standard public procurement procedures.
The Commission asserts that the new regulation does not meet the conditions for exceptions allowed by the European directive, thereby violating fundamental EU law principles such as transparency, competition and equal treatment of tenderers.
Key Provisions of Article 14.a of ZLD-1:
As of December 28, 2024, public pharmacy institutions procure medicines under specific ZLD-1 rules, which include:
- Procurement exclusively from wholesalers with a valid permit.
- Mandatory procurement from at least three wholesalers annually.
- A limit of 70% of annual medicine turnover with a single wholesaler.
- The goal of ensuring quality and timely supply while economically using public funds.
- Maintenance of special records on medicine stock provision.
The pharmaceutical inspection is responsible for oversight, while legal protection procedures under the Public Procurement Legal Protection Act are no longer applicable to these types of procurements.
What’s Next? Slovenia has two months to respond to the formal notice. Otherwise, the Commission may issue a reasoned opinion, which marks the next step in the infringement procedure. This case raises critical questions about the relationship between public service, safeguarding public health and adherence to EU internal market rules.
Read the full Commission press release here: https://ec.europa.eu/commission/presscorner/detail/sl/inf_25_1241
