LEGISLATION | Draft Royal Decree approving the State Plan for preparedness and response to serious health threats
On 15 September, the Ministry of Health opened a public hearing and information process for the draft Royal Decree approving the State Plan for preparedness and response to serious health threats.
The proposed new regulation aims to approve and develop the State Plan for Preparedness and Response to serious health threats. The content of this plan is as follows:
- Organisational structure for planning preparedness and response to serious health threats or other crises with a major impact on the healthcare system.
- Risk detection and assessment by the early warning and rapid response system.
- Risk levels of threats to public health.
- Declaration of a public health emergency of national importance.
- Preparedness and response capabilities for serious health threats or other crises with a major impact on the healthcare system.
- Assessment and reporting on the state of preparedness and response.
The deadline for submitting comments expires on 6 October 2025.
CASE LAW | Advertising in pharmacies
The Court of Justice of the European Union handed down its judgment on 19 June 2025 in case C-200/24, declaring that Polish national legislation violated EU law by imposing a general and absolute ban on advertising by pharmacies and pharmaceutical outlets through its Pharmaceutical Law.
The Court considers that the national rule is not justified and restricts the freedom of establishment and the freedom to provide services, and that it does not respect the principle of proportionality or adequately demonstrate that such a ban was necessary to protect public health or the professional independence of pharmacists.
CASE LAW | Online sale of medicines
In June, Madrid Central Administrative Court No. 3 handed down a ruling upholding the appeal filed by the plaintiff against the €27,000 fine imposed by the Spanish Agency for Medicines and Health Products (AEMPS). The AEMPS considered that, through its website, the plaintiff was acting as an intermediary in the online sale of medicines, but the court concluded that its activity did not constitute such intermediation, but rather an information society service that connected users with pharmacies and acted as an agent to collect medicines previously purchased by customers. The court considered that no infringement had been proven and annulled the penalty.
European Court of Auditors warns of critical shortage of medicines
Medicines shortages remain a critical issue for European Union countries. Although measures have been taken to address this problem, they do not appear to be effective, according to data provided by the EU Court of Auditors, whose analysis reveals that the European Union still lacks a framework for managing medicines shortages.