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Product Regulation & Liability

Spain: Evaluation system of newly approved medicinal products based on Therapeutic Positioning Reports annulled

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In brief

The Spanish National Court annulled the evaluation system of newly approved medicinal products set up in 2020 by the Spanish Ministry of Health because the system was created without following the legally established procedure and was approved by a body that did not have the authority to do so. The court states that the Therapeutic Positioning Reports cannot be considered as a mandatory instrument for the evaluation of medicines prior to the financing decision and clarifies that the Spanish Agency of Medicines and Medical Devices has the exclusive competence to issue such reports. The annulment of the Plan is expected to shorten the timeframe for financing new medicinal products.

In more detail

On 26 June 2023, the Spanish National Court (Audiencia Nacional, in Spanish), upholding in full the appeal filed by Farmaindustria, annulled the evaluation system of newly approved medicinal products based on Therapeutic Positioning Reports (ITPs) concerning medicines in the National Health System (“Plan”). Consequently, all the structures covered by the Plan have also been annulled.

In the judgment, the court examined the Plan and concluded that it was not merely an organizational document in which specific criteria were established internally by administrative bodies but that it was a document that had been agreed between several independent administrative bodies, each of which had its own competencies. In this regard, the judgment recalls that the only body legally competent to draft and approve the ITPs is the Spanish Agency of Medicines and Medical Devices (AEMPS), excluding other administrative bodies such as the Directorate General for the Basic Portfolio of Services of the National Health System or the representatives of the different Autonomous Communities.

The court also noted that the Plan sought to make changes to the current regulatory framework for ITPs, modifying the methodology used to establish their scope. In this regard, the new ITPs included both a scientific and economic assessment, whereas Law 10/2013, which established the ITPs, indicates that they should only have a scientific approach. The Plan also established a hearing procedure for third parties potentially affected by its content, as well as the creation of a new unit to monitor the ITPs.

With regard to the procedure followed for the preparation of the Plan, the court emphasized that regulations and ministerial orders on health matters are the responsibility of the Ministry of Health. The Plan was approved by the Permanent Pharmacy Commission, which is part of the Interterritorial Council and only performs advisory functions. Therefore, it did not have the necessary powers for such approval. Furthermore, the Plan did not comply with the procedural requirements set out in Law 50/1997, about the Government and in Law 39/2015 about the Common Administrative Procedure. The following steps were missing:

  • No public consultation of stakeholders was carried out, which allows at least 15 days to discuss, among other things, the needs, objectives, and intended solutions of the new regulations.
  • A Regulatory Impact Assessment Report was not prepared, and its specific mention was omitted from the Plan.
  • The General Technical Secretariat of the Ministry of Health, the Ministry of Finance and Public Function, and the Council of State did not issue the necessary reports.
  • The proposal was not submitted to the General Commission of Secretaries of State and Undersecretaries, nor was it submitted to the Council of Ministers for approval, nor was it published in the Official State Gazette.

The annulment of the Plan is expected to fulfill the first step of Farmaindustria’s objective of shortening medicine product financing timelines, as the Plan required the preparation of an ITP as a prerequisite for the financing of new medicinal products, with no exceptions, thus delaying timelines that are generally already long.

For more information, please click on this link to read the full ruling of the Spanish National Court. In case you need individual advice for your company, please contact our team of experts.

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Author

Montserrat has extensive experience in pharmaceutical and health law, as well as in compliance, contract law, licensing, competition law and acquisitions in the pharmaceutical sector. She is the coordinator of the healthcare practice in the Barcelona office.
She assists healthcare companies throughout the life cycle of healthcare products (drugs, IVD and medical devices, combination products, cosmetics and food supplements), from R&D to commercialization and more specifically in the areas of clinical trials (agreements, regulatory procedures, processing of personal data), market access (pricing and reimbursement), products and companies regulations (MA/CE-marking, vigilances, required licenses, product classification, labelling), commercial relations between healthcare industries (distribution, (co)promotion, manufacturing, supply, licensing, partnership agreements), relations with healthcare professionals and/or patients including compliance (anti-gift and transparency laws); communication and advertising, e-health (connected devices, telemedicine, hosting of health data) and product liability. Her practice encompasses both advisory and litigation matters.
She also has considerable experience in the drafting of codes of professional ethics and conducting compliance audits, and advising on advertising and promotion of medicines and medical devices, including via the internet, online advertising and social media. Montserrat advises on a wide range of agreements related to the pharmaceutical industry, such as license and distribution agreements, clinical trial agreements, and supply and manufacturing agreements.

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Elisabet is a Senior Associate experienced Public Law/ Regulatory lawyer in Baker McKenzie's Barcelona office. She has more than 10 years' experience advising heavyweight companies on public law and regulatory issues. Elisabet advises both national and multinational companies on public procurement, administrative compliance, license schemes, environmental, ESG, regulatory, and products-related matters (circular economy and sustainability requirements, green claims, consumer protection issues, etc), including assistance before regulators, authorities, and courts. In addition, she regularly advises private companies on regulatory issues related to business expansion and the opening of new plants/premises. She also advises on litigation and trials related to the areas of specialization. She has extensive experience in the consumer & goods and life sciences sectors. Regarding the life sciences sector, she offers advice to Spanish and foreign life sciences companies and represent them before authorities and courts regarding public procurement issues, price & reimbursement procedures, authorization and registration, promotion and advertising of medicines, and other regulatory issues related to medicinal products, medical devices, cosmetics, food supplements and other foods for particular nutritional uses. She also professor at Pompeu Fabra University, UPF Barcelona School of Management and ESADE Law School in the field of Public Law. She regularly participates in publications and articles related to her specialty.

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Damià Triay is an Associate in Baker McKenzie, Barcelona office.

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