Pricing and Public Financing Archivos - Faus Moliner https://faus-moliner.com/en/category/publications/pharmaceutical-and-life-sciences-law-2/pricing-and-public-financing-pharmaceutical-and-life-sciences-law-2-publications/ Otro sitio realizado con WordPress Tue, 23 Sep 2025 09:32:20 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.3 El interés público prevalece: las resoluciones de precio y reembolso de medicamentos son confidenciales https://faus-moliner.com/en/el-interes-publico-prevalece-las-resoluciones-de-precio-y-reembolso-de-medicamentos-son-confidenciales-2/ Tue, 02 Sep 2025 13:33:06 +0000 https://faus-moliner.com/el-interes-publico-prevalece-las-resoluciones-de-precio-y-reembolso-de-medicamentos-son-confidenciales-2/ This article analyzes the latest rulings by the Contentious-Administrative Chamber of the National High Court regarding the confidentiality of pricing & reimbursement decisions for two medicinal products.  Specifically the reasoning judgments to conclude that these documents must remain confidential and cannot be accessed through Law 19/2013 of December 9, on Transparency, Access to Public Information,...

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This article analyzes the latest rulings by the Contentious-Administrative Chamber of the National High Court regarding the confidentiality of pricing & reimbursement decisions for two medicinal products.  Specifically the reasoning judgments to conclude that these documents must remain confidential and cannot be accessed through Law 19/2013 of December 9, on Transparency, Access to Public Information, and Good Governance are analyzed.

La entrada El interés público prevalece: las resoluciones de precio y reembolso de medicamentos son confidenciales aparece primero en Faus Moliner.

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Global Legal Insights to: Pricing & Reimbursement 2025 https://faus-moliner.com/en/global-legal-insights-to-pricing-reimbursement-2025/ Mon, 01 Sep 2025 13:13:03 +0000 https://faus-moliner.com/global-legal-insights-to-pricing-reimbursement-2025/ The eighth 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 2025 includes the following sections for each of the...

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The eighth 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 2025 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

La entrada Global Legal Insights to: Pricing & Reimbursement 2025 aparece primero en Faus Moliner.

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El interés público prevalece: las resoluciones de precio y reembolso de medicamentos son confidenciales https://faus-moliner.com/en/el-interes-publico-prevalece-las-resoluciones-de-precio-y-reembolso-de-medicamentos-son-confidenciales/ Tue, 08 Jul 2025 14:00:47 +0000 https://faus-moliner.com/el-interes-publico-prevalece-las-resoluciones-de-precio-y-reembolso-de-medicamentos-son-confidenciales/ This article analyzes the latest rulings by the Contentious-Administrative Chamber of the National High Court regarding the confidentiality of pricing and reimbursement decisions for two medicinal products. Specifically, the reasoning of the judgments to conclude that these documents must remain confidential and cannot be accessed through Law 19/2013, of December 9, on Transparency, Access to...

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La entrada El interés público prevalece: las resoluciones de precio y reembolso de medicamentos son confidenciales aparece primero en Faus Moliner.

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This article analyzes the latest rulings by the Contentious-Administrative Chamber of the National High Court regarding the confidentiality of pricing and reimbursement decisions for two medicinal products. Specifically, the reasoning of the judgments to conclude that these documents must remain confidential and cannot be accessed through Law 19/2013, of December 9, on Transparency, Access to Public Information, and Good Governance are analyzed.

La entrada El interés público prevalece: las resoluciones de precio y reembolso de medicamentos son confidenciales aparece primero en Faus Moliner.

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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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La entrada Global Legal Insights to: Pricing & Reimbursement 2024 aparece primero en Faus Moliner.

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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

La entrada Global Legal Insights to: Pricing & Reimbursement 2024 aparece primero en Faus Moliner.

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Global Legal Insights to: Pricing & Reimbursement 2023 https://faus-moliner.com/en/global-legal-insights-to-pricing-reimbursement-2023/ Fri, 08 Sep 2023 09:29:46 +0000 https://faus-moliner.com/global-legal-insights-to-pricing-reimbursement-2023/ The sixth edition of Pricing & Reimbursement has been recently published and just like last year 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 2023 includes the following sections for each of the...

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La entrada Global Legal Insights to: Pricing & Reimbursement 2023 aparece primero en Faus Moliner.

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The sixth edition of Pricing & Reimbursement has been recently published and just like last year 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 2023 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

La entrada Global Legal Insights to: Pricing & Reimbursement 2023 aparece primero en Faus Moliner.

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Global Legal Insights to: Pricing & Reimbursement 2022 https://faus-moliner.com/en/global-legal-insights-to-pricing-reimbursement-2022/ Thu, 08 Sep 2022 13:10:34 +0000 https://faus-moliner.com/global-legal-insights-to-pricing-reimbursement-2022/ The fifth edition of Pricing & Reimbursement has been recently published and just like last year 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 includes the following sections for each of the 18...

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La entrada Global Legal Insights to: Pricing & Reimbursement 2022 aparece primero en Faus Moliner.

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The fifth edition of Pricing & Reimbursement has been recently published and just like last year 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 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

La entrada Global Legal Insights to: Pricing & Reimbursement 2022 aparece primero en Faus Moliner.

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Global Legal Insights to: Pricing & Reimbursement 2021 https://faus-moliner.com/en/global-legal-insights-to-pricing-reimbursement-2021/ Tue, 19 Oct 2021 14:19:44 +0000 https://faus-moliner.com/global-legal-insights-to-pricing-reimbursement-2021/ The fourth edition of Pricing & Reimbursement has been recently published and just like last year 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 includes the following sections for each of the 18...

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La entrada Global Legal Insights to: Pricing & Reimbursement 2021 aparece primero en Faus Moliner.

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The fourth edition of Pricing & Reimbursement has been recently published and just like last year 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 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

La entrada Global Legal Insights to: Pricing & Reimbursement 2021 aparece primero en Faus Moliner.

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Global Legal Insights to: Pricing & Reimbursement 2020 https://faus-moliner.com/en/global-legal-insights-to-pricing-reimbursement-2020/ Thu, 03 Sep 2020 14:00:38 +0000 https://faus-moliner.com/global-legal-insights-to-pricing-reimbursement-2020/ The third edition of Pricing & Reimbursement has been recently published and just like last year 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 includes the following sections for each of the 22...

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La entrada Global Legal Insights to: Pricing & Reimbursement 2020 aparece primero en Faus Moliner.

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The third edition of Pricing & Reimbursement has been recently published and just like last year 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 includes the following sections for each of the 22 analyzed countries:

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

La entrada Global Legal Insights to: Pricing & Reimbursement 2020 aparece primero en Faus Moliner.

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Global Legal Insights to: Pricing & Reimbursement 2019” https://faus-moliner.com/en/the-international-comparative-legal-guide-to-product-liability-2019-capitulo-25-espana-2/ Wed, 28 Aug 2019 13:36:04 +0000 https://faus-moliner.com/?p=21451 The second edition of Pricing & Reimbursement has been recently published and just like last year Jordi Faus has been in charge of the chapter dedicated to pricing and reimbursement in Spain. The GLI to: Pricing & Reimbursement 2019 covers Abstract, Market introduction/overview, Pharmaceutical pricing and reimbursement, Policy issues that affect pricing and reimbursement, Emerging...

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La entrada Global Legal Insights to: Pricing & Reimbursement 2019” aparece primero en Faus Moliner.

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The second edition of Pricing & Reimbursement has been recently published and just like last year Jordi Faus has been in charge of the chapter dedicated to pricing and reimbursement in Spain.

The GLI to: Pricing & Reimbursement 2019 covers Abstract, Market introduction/overview, Pharmaceutical pricing and reimbursement, Policy issues that affect pricing and reimbursement, Emerging trends, Successful market access and the year ahead in 22 jurisdictions.

La entrada Global Legal Insights to: Pricing & Reimbursement 2019” aparece primero en Faus Moliner.

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The future rules of the reference price system of medicines in the National Health System shall be submitted for consultation https://faus-moliner.com/en/the-future-rules-of-the-reference-price-system-of-medicines-in-the-national-health-system-shall-be-submitted-for-consultation/ Mon, 19 Feb 2018 09:35:11 +0000 https://faus-moliner.com/en/consulta-las-futuras-reglas-juego-del-sistema-precios-referencia-medicamentos-sistema-nacional-salud/ The reference price system of medicines in the Spanish National Health System (NHS) is approaching its second decade of existence. The purpose of this system -created in order to control public expenditure- is to divide medicines which are funded by the NHS into groups following certain criteria. Each group has the same reference price, which...

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The reference price system of medicines in the Spanish National Health System (NHS) is approaching its second decade of existence. The purpose of this system -created in order to control public expenditure- is to divide medicines which are funded by the NHS into groups following certain criteria. Each group has the same reference price, which is the maximum price for which these medicines are funded. The system was implemented in the late ‘90s and has been subject to numerous modifications in order to optimize its functioning. The experience accumulated over the last five years, however, has highlighted the need to continue correcting certain problems, such as the uncomfortable fit of biosimilar medicines, or the exit of interesting medicinal products from the NHS as a result of excessive price erosion. The opening of a period for public consultation, prior to drafting a proposal that modifies the rules that are currently contained in Royal Decree 177/2014, is certainly good news.

The consultation launched by the MoH identifies the main features on which the amendment of the system will focus. The aim is to articulate objective and transparent criteria to determine the identity of medicines’ presentations in terms of active ingredient and administration route, in order to decide when they can be included in the same group.

Achieving this aim will require the legislator to dig deeper, avoiding overly simplistic criteria such as resorting unreservedly to the ATC classification. It must be recalled that, in this sense, the WHO has pronounced itself against using this classification when it comes to medicines funding.

On the other hand, the new rules must be strictly in line with the decisions of the Courts regarding this matter. To such extent, the Supreme Court has highlighted in several judgments that when the competent regulatory agency has indicated that two active ingredients are different, they should not be considered as equals for the purposes of their inclusion into the same group in the reference price system.

Another important change of course is the intention of the MoH to enable the creation of different groups for presentations having the same active ingredient but different administration devices, pharmaceutical forms or specific administration routes, provided that doing so entails a relevant clinical advantage. This modification is essential. If products having administration devices with very high costs such as pre-filled syringes or pre-filled pens are included in the same group, matching their lowest price, it will be impossible to maintain the most innovative presentations in the NHS, with the consequent damage for patients.

Logically, it is also proposed to revise upwards the minimum reference price for each presentation, as the current minimum reference price has proven to be insufficient. Finally, and most importantly, the information included in the Nomenclator (database for medicines included in the NHS) will be regulated in order to be publicly accessible.

In short, this is an opportunity to correct important deficiencies in the current system. Achieving an adequate balance between public savings and stimulating innovation can only bring benefits for all the operators of the system and, very specially for patients.

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