On 26 June 2023, the Spanish National Court annulled the evaluation system of newly approved medicinal products based on Therapeutic Positioning Reports (“ITPs”) set up by the Spanish Ministry of Health in 2020 (“Plan”).
The Court based its decision on the grounds that (1) the system was created without following the legal procedure, and (2) was approved by a body that did not have the authority to do so.
The Court concludes that Therapeutic Positioning Reports (ITPs) cannot be considered a mandatory instrument for the evaluation of medicines prior to the financing decision and clarifies that the Spanish Agency of Medicines and Medical Devices (AEMPS) has the exclusive competence to issue such reports.
The annulment of the Plan is expected to shorten the timeframe for financing new medicinal products going forward (by ‘financing’ we refer to the pricing and reimbursement procedure that the medicinal products approved in Spain have to undergo before they can be commercialised).
In more detail
Nature of the Plan
The Court concluded that the Plan was not an organisational document, instead, it was an agreed document between different independent bodies. In this regard, the judgment recalls that the competent body to draft and approve the ITPs is the Spanish Agency of Medicines and Medical Devices (“AEMPS”), excluding other administrative bodies from performing this task.
Content of the Plan
The Court noted that the Plan sought to make changes to the regulatory framework for ITPs set out in the legislation. For instance, the ITPs included a new economic assessment, whereas the applicable regulations on pharmacovigilance and prevention of the entry of counterfeit medicinal products, only provide for its scientific foundation. In addition, the Plan established a hearing procedure for third parties, as well as the creation of a new unit to track ITPs, which is more typical of the process of creating regulatory provisions. Therefore, it is clear that the Plan was not merely an organisational instrument for the administration.
Preparation of the Plan
The Court explained that the Plan was approved by the Permanent Pharmacy Commission, which did not have the necessary powers to undertake this task, as this should be carried out by the Ministry of Health. Furthermore, the Plan did not comply with the procedural requirements set out in the applicable regulations, on governance and common administrative procedure for public administrations. The following steps were missing:
- No public consultation of stakeholders was carried out at any moment.
- There was no Regulatory Impact Assessment Report.
- There were no reports from the General Technical Secretariat of the Ministry of Health, the Ministry of Finance and Public Function and the Council of State.
- There was no submission of the proposal to the General Commission of Secretaries of State and Undersecretaries.
- There was no approval of the proposal by the Council of Ministers.
- There was no publication of the proposal in the Official State Gazette.
The annulment of the Plan is expected to shorten medicine products financing timelines approximately 90 days (although in practice it could be even longer), as the Plan required the preparation of an ITP as a prerequisite for the financing of medicinal products, thus delaying timelines that are generally already long. In this way, it is hoped that the delay in the financing of medicinal products in Spain can meet the legal deadline of 180 days, as there are currently delays exceeding this deadline by more than 400 days.
More information on this regulatory development can be found in our Insight Plus publication which can be accessed via this link.