Pharmaceutical and Life Sciences Law Archivos - Faus Moliner https://faus-moliner.com/en/category/publications/pharmaceutical-and-life-sciences-law-2/ Otro sitio realizado con WordPress Tue, 20 May 2025 08:22:46 +0000 en-US hourly 1 https://wordpress.org/?v=6.2.6 Faus Moliner participa en «Chambers Global Practices Guides – Life Sciences 2025» https://faus-moliner.com/en/faus-moliner-participa-en-chambers-global-practices-guides-life-sciences-2025/ Tue, 13 May 2025 13:11:35 +0000 https://faus-moliner.com/faus-moliner-participa-en-chambers-global-practices-guides-life-sciences-2025/ The new Life Sciences 2025 guide features close to 20 jurisdictions. The guide provides the latest legal information on the regulatory framework for life sciences; clinical trials; the marketing, manufacturing and distribution of pharmaceuticals and medical devices; their import, export and pricing; and regulatory reliance and fast-track registration.

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]]> The new Life Sciences 2025 guide features close to 20 jurisdictions. The guide provides the latest legal information on the regulatory framework for life sciences; clinical trials; the marketing, manufacturing and distribution of pharmaceuticals and medical devices; their import, export and pricing; and regulatory reliance and fast-track registration.

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]]> El medicamento en los tribunales 2024 https://faus-moliner.com/en/el-medicamento-en-los-tribunales-2024/ Thu, 08 May 2025 08:22:19 +0000 https://faus-moliner.com/el-medicamento-en-los-tribunales-2024/ La entrada El medicamento en los tribunales 2024 aparece primero en Faus Moliner.

]]> La entrada El medicamento en los tribunales 2024 aparece primero en Faus Moliner.

]]> Más sobre intercambiabilidad y sustitución de medicamentos biológicos https://faus-moliner.com/en/mas-sobre-intercambiabilidad-y-sustitucion-de-medicamentosbiologicos/ Thu, 10 Apr 2025 10:13:25 +0000 https://faus-moliner.com/mas-sobre-intercambiabilidad-y-sustitucion-de-medicamentosbiologicos/ The selection, interchangeability and substitution of biological medicines have been hot topicsin Spanish pharmaceutical law for many years. In 2014, a Non-Legislative Proposal was presented toCongress urging the Government to ‘Approve, as soon as possible, specific regulations on the substitution and interchangeability of biosimilar medicines’. Since then, legal arguments for and against substitution have been...

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]]> The selection, interchangeability and substitution of biological medicines have been hot topics
in Spanish pharmaceutical law for many years. In 2014, a Non-Legislative Proposal was presented to
Congress urging the Government to ‘Approve, as soon as possible, specific regulations on the substitution and interchangeability of biosimilar medicines’. Since then, legal arguments for and against substitution have been constructed. In this context, and after learning about the regulations approved in France in February 2025 regarding the substitution of biological medicines, the author proposes a review of the situation and the possibility of Spain adopting regulations similar to those in France.

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]]> Faus Moliner participates in the Chambers & Partners Guide to Pharmaceutical Advertising 2025 https://faus-moliner.com/en/faus-moliner-participa-en-chambers-global-practices-guides-pharmaceutical-advertising-2025/ Thu, 27 Mar 2025 14:40:27 +0000 https://faus-moliner.com/faus-moliner-participa-en-chambers-global-practices-guides-pharmaceutical-advertising-2025/ Anna Gerbolés and Laia Rull have contributed to the chapter dedicated to Spain, providing an analysis of the legal framework regulating the advertising of medicines and its practical application. The “Law & Practice” section offers key information to help companies operating in Spain navigate the legal system in terms of pharmaceutical advertising, transparency and anti-bribery...

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]]> Anna Gerbolés and Laia Rull have contributed to the chapter dedicated to Spain, providing an analysis of the legal framework regulating the advertising of medicines and its practical application.

The “Law & Practice” section offers key information to help companies operating in Spain navigate the legal system in terms of pharmaceutical advertising, transparency and anti-bribery measures.

On the other hand, the “Trends & Developments” section explores the latest developments in the advertising of medicines in Spain, providing relevant context on upcoming regulatory changes and their impact on the industry.

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]]> Entre la experiencia y la independencia: lecciones y retos en la gestión de conflictos de interés https://faus-moliner.com/en/entre-la-experiencia-y-la-independencia-lecciones-y-retos-en-la-gestion-de-conflictos-de-interes/ Thu, 09 Jan 2025 10:46:54 +0000 https://faus-moliner.com/entre-la-experiencia-y-la-independencia-lecciones-y-retos-en-la-gestion-de-conflictos-de-interes/ This article analyzes the recent rulings by the Court of Justice of the European Union in the Aplidin® and Hopveus® cases, which have highlighted the importance of properly managing conflicts of interest in the evaluation of medicinal products. These rulings have prompted the European Commission to review and tighten impartiality criteria in evaluation procedures, especially...

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]]> This article analyzes the recent rulings by the Court of Justice of the European Union in the Aplidin
® and Hopveus® cases, which have highlighted the importance of properly managing conflicts of interest in the evaluation of medicinal products. These rulings have prompted the European Commission to review and tighten impartiality criteria in evaluation procedures, especially regarding the involvement of experts with potential conflicts of interest. The management of conflicts of interest may also affect the evaluation of health technologies, both at the European level and within the new Spanish framework. In both cases, it is necessary to manage conflicts of interest in a balanced manner, particularly in rare disease areas where the number of conflict-free experts is limited. The search for a balance between impartiality and scientific quality is the key element underlying all the regulatory reforms currently being implemented in this field.

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]]> Global Legal Insights to: Pricing & Reimbursement 2024 https://faus-moliner.com/en/global-legal-insights-to-pricing-reimbursement-2024/ Tue, 10 Sep 2024 08:06:46 +0000 https://faus-moliner.com/global-legal-insights-to-pricing-reimbursement-2024/ The seventh edition of Pricing & Reimbursement has been recently published and as in previous years Jordi Faus, with the collaboration of Lluís Alcover and Joan Carles Bailach, has been in charge of the chapter dedicated to pricing and reimbursement in Spain. GLI Pricing & Reimbursement 2024 includes the following sections for each of the...

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]]> The seventh edition of Pricing & Reimbursement has been recently published and as in previous years Jordi Faus, with the collaboration of Lluís Alcover and Joan Carles Bailach, has been in charge of the chapter dedicated to pricing and reimbursement in Spain.

GLI Pricing & Reimbursement 2024 includes the following sections for each of the 18 analyzed countries:

  • Market overview;
  • Financing and pricing of medicinal products;
  • Policy issues that affect pricing and reimbursement; and
  • Emerging trends

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]]> Valoraciones sobre el proyecto de reforma de la publicidad de productos sanitarios https://faus-moliner.com/en/valoraciones-sobre-el-proyectode-reforma-de-la-publicidad-de-productos-sanitarios/ Wed, 04 Sep 2024 08:28:49 +0000 https://faus-moliner.com/valoraciones-sobre-el-proyectode-reforma-de-la-publicidad-de-productos-sanitarios/ The purpose of this article is to analyse the current regulatory framework for the advertising of medical devices and the changes that will be generated by the adoption of the new Royal Decree on the advertising of medical devices, which was submitted for public consultation in February 2024. It also analyses the impact that the...

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]]> The purpose of this article is to analyse the current regulatory framework for the advertising of medical devices and the changes that will be generated by the adoption of the new Royal Decree on the advertising of medical devices, which was submitted for public consultation in February 2024. It also analyses the impact that the measures of the new Royal Decree will have on effective competition for the industry, with special emphasis on the opinion issued by the CNMC on the subject in its report of April 2024.

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]]> Faus Moliner participa en «Chambers Global Practices Guides – Product Liability & Safety 2024» https://faus-moliner.com/en/faus-moliner-participa-en-chambers-global-practices-guides-product-liability-safety-2024/ Wed, 17 Jul 2024 14:05:19 +0000 https://faus-moliner.com/faus-moliner-participa-en-chambers-global-practices-guides-product-liability-safety-2024/ The “Chambers Global Practices Guides” publication is a practical reference that provides easily accessible information for browsing the legal system when conducting business in different jurisdictions. Leading lawyers in the sector explain local laws and practices in key transaction stages and for crucial aspects of doing business.

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]]> The “Chambers Global Practices Guides” publication is a practical reference that provides easily accessible information for browsing the legal system when conducting business in different jurisdictions. Leading lawyers in the sector explain local laws and practices in key transaction stages and for crucial aspects of doing business.

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]]> Faus Moliner participates in “Chambers Global Practices Guides Medical Cannabis & Cannabinoid Regulation 2024” https://faus-moliner.com/en/faus-moliner-participa-en-chambers-global-practices-guides-medical-cannabis-cannabinoid-regulation-2024/ Wed, 12 Jun 2024 13:16:00 +0000 https://faus-moliner.com/faus-moliner-participa-en-chambers-global-practices-guides-medical-cannabis-cannabinoid-regulation-2024/ The guide on the regulation of medical cannabis and cannabinoids 2024 provides easily accessible content on the legal framework, cross-jurisdictional rules and future developments in the regulation of medical cannabis and cannabinoids in Spain.

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]]> The guide on the regulation of medical cannabis and cannabinoids 2024 provides easily accessible content on the legal framework, cross-jurisdictional rules and future developments in the regulation of medical cannabis and cannabinoids in Spain.

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]]> El medicamento en los tribunales en el año 2023 https://faus-moliner.com/en/el-medicamento-en-lo-tribunales-en-el-ano-2023/ Thu, 30 May 2024 15:21:47 +0000 https://faus-moliner.com/el-medicamento-en-lo-tribunales-en-el-ano-2023/ By means of this article we go through the most important decisions by Spanish andEuropean courts regarding medicinal products during the year 2023

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]]> By means of this article we go through the most important decisions by Spanish and
European courts regarding medicinal products during the year 2023

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