Revista Cuadernos nº 91 con contenidos de gran actualidad para el sector farmacéutico, disponible para compra y descarga. ¡No os perdáis los contenidos de la Revista Cuadernos nº 91 This post is also available in: Spanish
Revista Cuadernos nº 90 con contenidos de gran actualidad para el sector farmacéutico, disponible para compra y descarga. ¡No os perdáis los contenidos de la Revista Cuadernos nº 90 This post is also available in: Spanish
Ya podéis acceder a los interesantes contenidos del número 102 de la revista Comunicaciones. Gracias a los colaboradores por sus magníficas aportaciones. This post is also available in: Spanish
Don’t miss out on this issue of Cuadernos de Derecho Farmacéutico, which examines the following: The current regulatory framework for advertising medical products, the changes brought about by the new Royal Decree on the advertising of medical products and the
We are pleased to share videos of each of the round tables at the 19th edition of the Pharmaceutical Law Course, held on 5 and 6 March 2024 This post is also available in: Spanish
INCENTIVES FOR HEALTH INNOVATION AS A COMPETITIVE ADVANTAGE FOR THE EU We would like to count on your participation in the debate on INCENTIVES FOR HEALTH INNOVATION AS A COMPETITIVE ADVANTAGE FOR THE EU, which will take place on 17 June 2024
Ya podéis accedes a los interesantes contenidos del número 101 de la revista Comunicaciones. Gracias a los colaboradores por sus magníficas aportaciones. This post is also available in: Spanish
Nos gustaría contar contigo para participar en el debate sobre LOS INCENTIVOS A LA INNOVACIÓN EN SALUD COMO VENTAJA COMPETITIVA DE LA UE, que tendrá lugar el próximo 17 de junio de 2024 en Madrid. En él analizaremos el marco actual de
To mark World Intellectual Property Day 2024, we would like to highlight the fundamental role of intellectual property in stimulating innovation and creativity. We share this video with three messages from representatives of the pharmaceutical industry regarding: 1. Spain’s leading position
Interesting content in the journal Cuadernos de Derecho Farmacéutico. Publication of a new version of the Government of Catalonia’s Guide on the advertising of medicinal products for human use. Montserrat Llopart Vidal and Damià Triay Gomila Liability regime for harm
This morning we held an event to commemorate the 100th issue of the journal Comunicaciones en Propiedad Industrial y Derecho de la Competencia (Communications on Intellectual Property and Competition Law). It was a special event, not only in terms of
Issue 87 of the journal Cuadernos, with highly topical content for the pharmaceutical sector, is available for purchase and download. Don’t miss out on issue 87 of the Cuadernos journal! This post is also available in: Spanish
This week, the registration period opened for the Pharmaceutical Law Course, which is set to feature highly topical subjects and excellent speakers. Don’t miss this opportunity to take part in the debate on the most salient pharmaceutical issues. https://cefi.es/categoria-producto/cursos-y-seminarios/cursos/cursos-de-derecho-farmaceutico/ This
The Department of Commercial Law and Procedural Law at the University of Alicante’s Law Faculty is organising an interesting seminar on patent law and biotechnology on 21 November, with collaboration from the Magister Lvcentinvs Master’s Course in Intellectual Property and
Issue 86 of the journal Cuadernos, with highly topical content for the pharmaceutical sector, is available for purchase and download. Don’t miss out on issue 86 of the Cuadernos journal! This post is also available in: Spanish
Issue 99 of the journal Comunicaciones, with highly topical content for the pharmaceutical sector, is available for purchase and download. Don’t miss out on issue 99 of the Comunicaciones journal! This post is also available in: Spanish
Issue 85 of the journal Cuadernos, with highly topical content for the pharmaceutical sector, is available for purchase and download. Don’t miss out on issue 85 of the Cuadernos journal! This post is also available in: Spanish
Issue 98 of the journal Comunicaciones, with highly topical content for the pharmaceutical sector, is available for purchase and download. Don’t miss out on issue 98 of the Comunicaciones journal! This post is also available in: Spanish
World Intellectual Property Day 2023. Women and IP: Accelerating Innovation and Creativity 26 April is World Intellectual Property Day. This year WIPO’s theme is Women and Intellectual Property: Accelerating Innovation and Creativity. To mark this day, we would like to
The CEFI Foundation has just celebrated its 40th anniversary. During these years, it has grown considerably, as has our network of collaborators when it comes to the content and focus of the journals. To adapt to this change without compromising
You can now access issue 84 of the journal Cuadernos de Derecho Farmacéutico (Pharmaceutical Law Review) on our website: https://cefi.es/tienda/publicaciones/revista-cuadernos/revista-cuadernos-no-84-enero-marzo-2023 Remember that you can also arrange an annual subscription: https://cefi.es/tienda/suscripciones/suscripcion-a-revistas/ This post is also available in: Spanish
Congratulations to the women who break social and economic barriers every day to achieve a more egalitarian society. And especially to the women linked to CEFI (board members, collaborators and staff) who, with a majority representation, have worked to defend
This week we presented the report ‘Proposals for innovation in accessing innovative medicinal products in the Spanish NHS’. This report is part of CEFI’s Access Observatory, which we have been working on for a year, in collaboration with six renowned
Issue 97 of the journal Comunicaciones, with highly topical content for the pharmaceutical sector, is available for purchase and download. Don’t miss out on issue 97 of the Comunicaciones journal! This post is also available in: Spanish
You can now access issue 83 of the journal Cuadernos de Derecho Farmacéutico (Pharmaceutical Law Review) on our website: https://cefi.es/tienda/publicaciones/revista-cuadernos/revista-cuadernos-no-83-octubre-diciembre-2022/ Remember that you can also arrange an annual subscription: https://cefi.es/tienda/suscripciones/suscripcion-a-revistas/ This post is also available in: Spanish
Issue 82 of the journal Cuadernos, with highly topical content for the pharmaceutical sector, is available for purchase and download. Don’t miss out on issue 82 of the Cuadernos journal! This post is also available in: Spanish
BIOMEDICINE, MEDICINES AND PUBLIC HEALTH This post is also available in: Spanish
Issue 96 of the journal Comunicaciones, with highly topical content for the pharmaceutical sector, is available for purchase and download. Don’t miss out on issue 96 of the Comunicaciones journal! This post is also available in: Spanish
Save the dates! This year’s Pharmaceutical Law Course will be held on 27 and 28 September, with a prior online session on 26 September from 10am to 12pm. We will share details about the programme and begin the enrolment process
We are currently preparing the contents for the next Pharmaceutical Law Course, which will take place at the end of September. We will review the most relevant aspects and current issues related to medicinal products, analysing the research process, the
This is bad news for the biomedical innovation sector and in terms of having a robust intellectual property system. We express our disagreement with the recent WTO decision, which weakens the current framework of intellectual property protection and we ask
Issue 81 of the journal Cuadernos, with highly topical content for the pharmaceutical sector, is available for purchase and download. Don’t miss out on issue 81 of the Cuadernos journal! This post is also available in: Spanish
We would like to share this video we have made to mark our 40th Anniversary. It includes testimonies from CEFI’s friends and patrons on three questions: What is CEFI for you? What has enabled it to endure? What are your
Fantástico ambiente de colaboración entre instituciones, colaboradores, patronos y amigos de CEFI. On 25 May we celebrated our 40th Anniversary in an event in the gardens of the Lázaro Galdiano Museum. It was a very intimate evening, a reunion of
CEFI 40th Anniversary Celebration Last night CEFI celebrated its 40th anniversary at an event in the gardens of the Lázaro Galdiano Museum. The CEFI Foundation celebrated its 40th Anniversary last night in an event at the Lázaro Galdiano Museum attended
Introduction The CEFI Foundation is celebrating its 40th anniversary (1982-2022) while we are still struggling to overcome the COVID-19 pandemic. The pandemic has reminded us that, in the face of the greatest health challenges, effort and sacrifice (on the part
Issue 95 of the journal Comunicaciones, with highly topical content for the pharmaceutical sector, is available for purchase and download. Don’t miss out on issue 95 of the Comunicaciones journal! This post is also available in: Spanish
Summary of the research/innovation: In the clinical field today, we need to know how different patients with multiple myeloma respond to treatment prescribed in clinical practice, as well as the real duration of that treatment and factors that affect
Summary of the research/invention I work on prostate cancer research. Prostate cancer patients are often treated with androgen deprivation hormone therapies, but most eventually develop resistance to these treatments and progress poorly. In my research, I have generated cellular models
Summary of the research/invention: The research team patented a series of potent inhibitors of NLRP3 inflammasome formation, the dysregulation of which is associated with several inflammatory disorders with high unmet medical demand, such as Alzheimer’s disease and lung cancer. Novel
Today, 26 April, is World Intellectual Property Day. This year is dedicated to intellectual property and youth: innovating for a better future. At CEFI we want to give a voice to young researchers in the biopharmaceutical sector. We are therefore
Issue 80 of the journal Cuadernos, with highly topical content for the pharmaceutical sector, is available for purchase and download. This post is also available in: Spanish
We at the CEFI Foundation are very proud to celebrate our 40th Anniversary this year. CEFI has been working in defence of innovation and intellectual property for 40 years, especially in the biomedical field. Thanks to the collaboration of leading
Issue 79 of the journal Cuadernos, with highly topical content for the pharmaceutical sector, is available for purchase and download. Don’t miss out on issue 94 of the Comunicaciones journal!! This post is also available in: Spanish
This paper analyses the promotion of medicines for human use that have already received marketing authorization, when the advertising is made before the resolution on pricing and inclusion in the Spanish National Health Service. This is an issue addressed by
On 15 October we had an interesting discussion on Observational Studies on Medications and patient support programmes in the new regulations that aroused a lot of interest. More than 90 people participated in the session with strong participation in questions
The promotion of medicines for human use that have already receive marketing authorization, before the resolution on pricing and the inclusión in the Nacional Health System. Angel García Vidal and Irene Fernández Puyol Health Data 29 Playbook as a gvernance
Superior Court of Justice of the Basque Country, Judicial Review Chamber, Judgment 246/2021 of 30 June resolved positively on a question widely debated in the sector: the possibility of advertising medicinal products that have been approved for sale but have
CEFI is organising a seminar on observational studies of medicinal products and patient support programmes, which is set to take place on 15 October. As of 2 January 2021, observational studies of medicinal products for human use (‘OSM’) are to
Available for download. The promotion of medicines for human use that have already receive marketing authorization, before the resolution on pricing and the inclusión in the Nacional Health System. Angel García Vidal and Irene Fernández Puyol Health Data 29 Playbook
In a recent ruling dated 22 April 2021, the National Court has upheld the Spanish National Markets and Competition Commission (CNMC) decision of 19 January 2017, which declared that the pricing system established by the defendant company did not amount
Considerations on the pricing system for medicinal products. Lourdes Fraguas Gadea Abuse of dominant position consisting on predatory prices. Spanish Competition Authority Astrazeneca inhalers Decision. Alfonso Gutiérrez Hernández and Alberto Pérez Hernández Public supply of medicines. Doctrine generated by the
It takes as its starting point, inter alia, the current situation as regards identifying intellectual property as a key asset for the EU, as a driver of innovation, competitiveness, economic growth and sustainable development. It highlights the contribution of intellectual
Rosa Romero Sánchez, Presidenta de la Comisión de Sanidad del Congreso de los Diputados and Katia Piñol, Presidenta de CEFI highlight the importance of holding this debate. Pharmaceutical sector and medicinal innovation are constantly searching for health improvement. We need
We cant think in a best way to end our 25th Pharmaceutical Law Course Aniversary . Moisés Ramírez, Patrono de CEFI together with Sergio Sinovas, Subdirector de Industria y Energía de la Dirección de Competencia de la CNMC, Borja Martínez
In this panel we are going to talk about promotion, digital aspects and compliance. As Speakers: Silvia Martínez, Patrono de CEFI, Jose Zamarriego Izquierdo, Director de la Unidad de la Supervisión Deontológica de Farmandustria, Alejandro González, Abogado de Hoyng Rokh
Alberto Dorrego. Abogado socio de Eversheds Sutherland claim for a specific regulación on public procurement for innovative medicines and vaccines. He also highlight the importance of price and hospital offers confidentiality Carme Briera, Cousel de Clifford Chance enter into a
Second week of the Pharmaceutical Law Course begin with one of the main issues for innovative medicines. Lead by Javier de Urquía Martí, member of CEFI Board we had as speakers: Jesús García Herrero, Jefe de la intervención de precios
Three of the most recognized experts on IP farma in Spain Ángel García Vidal, profesor de Derecho Mercantil de la Universidad de Santiago de Compostela y Consejero Académico de Gómez Acebo y Pombo, Kiko Carrión García de Parada, Abogado socio
Jorge Muñoz, Member of CEFI Board lead the debate on advanced therapies an biological medicinal products. Sol Ruíz, Jefe de División de Productos Biológicos, Terapias Avanzadas y Biotecnología de la Agencia Española de Medicamentos y Productos Sanitarios and Jordi Faus,
Interesting debate with Jesús Rubí, Adjunto a la Dirección de la Agencia Española de Protección de Datos, Amelia Martín Uranga, Responsable de la Plataforma de Medicamentos Innovadores de Farmaindustria and Lluis Alcover, Abogado de Faus y Moliner. Interestingf debate about main
With Javier Castrodeza, Ex Secretario General de Sanidad y Catedrático de Medicina Preventiva y Salud Pública, Lourdes Fraguas, Abogada of Cousel Herbert Smith Freehills Spain, César Hernández, Jefe del Departamento de Medicamentos de Uso Humano de la Agencia Española de
Katia Piñol Torres, our President and Patricia Lacruz. Directora General de Cartera Común de Servicios del Sistema Nacional de Salud y Farmacia del Ministerio de Sanidad at the opening of the course. Nice speakers and more tan 180 attendees. This
Royal Decree 957/2020 As of 2 January 2021, observational studies of medicinal products for human use (‘OSM’) are to be regulated in Spain by Royal Decree 957/2020, which repeals the previously applicable Order SAS/3470/2009. The main purpose of Royal Decree
Section One. Current Affairs Medicine in the courts in 2020. Jordi Faus, Xavier Moliner, Eduard Rodellar, Santiago Tomás, Anna Gerbolés, Lluís Alcover, Laura Marquès, Juan Martínez, and Joan Carles Bailach Data protection in the COVID-19 pandemic (Part II). Jesús Rubí
There is an ongoing debate about certain national and international policy initiatives concerning the mandatory licensing of COVID-19 vaccine patents and we see the need to clarify certain concepts. In the event of mandatory licensing, it is more than likely
As we all know, on 1 January 2021 the new version of the Code of Practice for the Pharmaceutical Industry (the ‘new Code’ or, simply, the ‘Code’) came into force. As well as incorporating the amendments introduced in June 2019
In light of the current COVID-19 health crisis, it is an apt moment to highlight the importance of intellectual property. Intellectual and industrial property, among others, allow us to turn ideas into concrete projects that create value, wealth, jobs, and
Interruption of supply or the withdrawal of medicines from the market and competition rules. Henar González Durántez y Pilar Carrasco del Olmo 2021 versión of Pharmaceutical Industry Code of Best Practices. Teresa Paz-Ares Rodríguez, Beatriz Cocina Arrieta y Nuria
Recent investigations of the pharmaceutical sector by the competition authorities demonstrate a focus on examining a number of actions that could entail an interruption of supply or even the withdrawal of medicinal products from the market by pharmaceutical companies. Specifically,
On 19 January CEFI organised a seminar to deepen our understanding of vaccines in times of pandemic. Interest in the debate, reflected in the number of registrations (298) and the quality of the speakers, most of whom are at the
Fascinating debate on vaccines with 266 registered participants and fantastic presentations by the speakers. This post is also available in: Spanish
On 19 January 2021, CEFI will hold the online conference entitled Deepening our understanding of vaccines in times of pandemic. Registration is free of charge. Programme and registration This post is also available in: Spanish
Two new issues of the journal published by CEFI are available: Cuadernos de Derecho Farmacéutico issue 75 (October-December 2020). Comunicaciones en Propiedad Industrial y Derecho de la Competencia issue 91 (September-December 2020). This post is also available in: Spanish
On 19 January 2021, CEFI will hold an online conference entitled Deepening our understanding of vaccines in times of pandemic. Programme and registration This post is also available in: Spanish
There have been some eventful days recently in terms of important pharmaceutical regulations and legislation: Community pharma strategy to which we dedicated a post on LinkedIn Proposal for a Data Governance Regulation. Re-use of certain public sector data, including health
Global action in the fight against the COVID-19 pandemic. Joint statement by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO), supported by the Spanish Medicines and Health Products Agency (AEMPS), with regulatory agencies adopting
In the next issue of the Comunicaciones journal, CEFI is pleased to count on the expert opinion of Jesús Rubí Navarrete, Deputy Director of the Spanish Data Protection Agency (AEPD) and Rafael Garcia Gozalo, Executive Advisor and Head of the
Natividad Calvente Cestafe, Director of Innovation, Training and Institutional Relations at the General Council of Pharmaceutical Associations contributes to a monographic issue of the journal Cuadernos de Derecho Farmacéutico [Pharmaceutical Law Review] with a magnificent article on early access to
Commentary on the Royalty Pharma Ruling of the CJEU of 30 April 2020. Full text: Comunicaciones ENG oct 2020 pag This post is also available in: Spanish
The reference price system and annual reference price orders are intended to contribute to the sustainability of the SNS. They should also promote the right balance between innovative generic/biosimilar, competition and competitiveness in the pharmaceutical and health market. Price decisions
El sistema de precios de referencia y las sucesivas ordenes anuales de precios de referencia pretenden contribuir a la sostenibilidad del SNS. También deben fomentar el justo equilibrio entre innovador-genérico/biosimilar, la competencia y la competitividad en el mercado farmacéutico y
Issue 74 (July-September 2020) of the journal Cuadernos de Derecho Farmacéutico is available online. Monographic issue ‘Spanish National Health System changes for innovation, efficiency and patient service’. Contents: CEFI position paper. Spanish National Health System changes for innovation, efficiency and
The Ministry of Health has published Draft Order SND/ /2020, of, by which the price reference system for medicinal products in the Spanish National Health System will be updated in 2020. The text is available for consultation and comments on
Amidst the current health, social and economic crisis caused by the Covid-19 pandemic and in a context conducive to reflection and debate with the creation of the Commission for the Social and Economic Recovery of Spain after Covid-19, CEFI has
The European Council has reached a historic agreement on a EUR 750 billion package for rebuilding the European economy following the COVID-19 pandemic: EUR 390 billion in direct aid and EUR 360 billion in loans. Spain will receive EUR 140
Disponible en la web el número 73 (abril-junio 2020) de la revista Cuadernos de Derecho Farmacéutico. Sumario: La protección judicial de los datos de registro de los medicamentos y el derecho de exclusividad comercial: una asignatura pendiente en España, que
Una reciente sentencia del TJUE (asunto C‑786/18), pronunciándose sobre las cuestiones prejudiciales planteadas por el Tribunal Supremo alemán y tras estudiar el alcance del artículo 96, apartado 1, de la Directiva 2001/83, prohíbe la distribución de muestras gratuitas de medicamentos
El BOE de hoy, viernes 12 de junio, publica la Resolución de 2 de junio de 2020, de la Dirección General de Cartera Común de Servicios del Sistema Nacional de Salud y Farmacia, por la que se publica el Acuerdo
La CNMC ha publicado esta Guía que: Fue sometida a consulta pública en febrero de 2020 y recoge las aportaciones realizadas. Contiene los criterios que serían tomados en consideración por la CNMC para analizar la eficacia de un programa de
Cuadernos de Derecho Farmacéutico no. 72 (enero-marzo 2020) publicado y disponible en la web Índice: El precio de los medicamentos: transparencia versus confidencialidad. Francisco Valero Bonilla Criterio Interpretativo 17/2019 del Consejo de Transparencia y Buen Gobierno. Introducción y Criterio Interpretativo.
Desde el pasado 15 de marzo que entró en vigor el estado de alarma los plazos de los procedimientos judiciales quedaron en suspenso, incluidos los plazos de propiedad industrial. A partir del 15 abril el CGPJ permitió la notificación de
Comunicaciones en Propiedad Industrial y Derecho de la Competencia no. 89 (enero-abril 2020) publicado y disponible en la web Índice: Estado de alarma COVID-19: las medidas excepcionales para mejorar la disponibilidad de medicamentos y otros productos necesarios. Teresa Paz-Ares Rodríguez
Real Decreto-ley 16/2020, de 28 de abril, de medidas procesales y organizativas para hacer frente al COVID-19 en el ámbito de la Administración de Justicia. This post is also available in: Spanish
Medidas excepcionales aplicables a los ensayos clínicos para gestionar los problemas derivados de la emergencia por COVID-19. Recomendaciones de actuación en la industria de producción y distribución farmacéutica ante casos de infección por COVID-19. This post is also available in:
El BOE publica la Orden SND/276/2020, de 23 de marzo, por la que se establecen obligaciones de suministro de información, abastecimiento y fabricación de determinados medicamentos en la situación de crisis sanitaria ocasionada por el COVID-19. BOE 24-3-2020, p. 26762).
A primeros de abril estará disponible el numero 72 de nuestra revista Cuadernos de Derecho Farmacéutico con contenidos doctrinales y jurídicos de interés y actualidad que os adelantamos: La importancia de la innovación y la protección de la propiedad industrial.
BIOSIMILAR AND GENERIC DRUGS With the document of statements, the CEFI Foundation analyses each of the specific measures proposed in the Plan in detail but, in general, it believes that in the draft of the plan, the basic principles of
CEFI, as a member of the Interministerial Commission to act against activities which infringe intellectual and industrial property rights, backs the institutional anti-counterfeiting campaign carried out by the Ministry of Industry, Trade and Tourism together with the Spanish Patent and
This post is also available in: Spanish
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