New regulation for home delivery of medicines and other changes to the Madrid Pharmacy Law
On the approval of the new Law 13/2022, of 21 December, on Pharmaceutical Management and Care in the Community of Madrid
Capsulas Nº 234
Last Thursday, 22 December 2022, the new Madrid Pharmacy Law was published in the Official Gazette of the Community of Madrid, repealing the previous Law 19/1998, the main features of which are summarised below. Home delivery of medicinal products The regulation of home delivery was one of the novelties that has sparked the most debate... Read More
The starting date for the calculation of time-limits is the date of filing to the common electronic register, unless there is a specific electronic form or procedure
Judgment of the Chamber for Contentious-Administrative Proceedings of the Supreme Court (4th Section) of 25 October 2022
Capsulas Nº 234
Filing applications to the common electronic register The common electronic register (or general electronic register -art.16 of the Law no. 19/2015-, commonly known as RedSara) is a common point for submitting applications, documents and communications. It is a general register used for those applications that do not have an electronic procedure or a standardised form... Read More
Guidelines to facilitate the conduct of decentralised clinical trials of medicinal products in the European Union
European Commission, EMA and HMA recommendations on decentralised elements in clinical trials of 13 December 2022
Capsulas Nº 234
Decentralised clinical trials are those that are conducted largely outside the physical facilities of a healthcare centre, taking advantage of the use of technology. The increasing use of digital tools, and in particular the Covid-19 pandemic, has led to certain elements of clinical trials being conducted in a decentralised manner (e.g. informed consent management, investigational... Read More
A favor de un Real Decreto-ley
El Global
La normativa en materia de medicamentos está actualmente en proceso de evaluación y revisión tanto en Europa como en España. El proceso es complejo y requiere un debate sosegado entre todos los stakeholders del sector. Para ello se necesita tiempo; pero, ¿tenemos tiempo? Sin restar importancia ni urgencia a cualquiera de las propuestas que actualmente se están valorando; la realidad es... Read More
El “qué” y el “cómo” en la nueva legislación farmacéutica europea
El Global
La semana pasada tuve la oportunidad de participar en un interesante coloquio sobre la Estrategia Farmacéutica Europea. Es importante que los profesionales del derecho tengamos un papel activo en esta iniciativa que la Comisión Europea lanzó en noviembre de 2020. La Estrategia, como sabemos, incluye una lista de acciones orientadas a favorecer el acceso a... Read More
Diez años de transparencia en España; ¿qué retos nos deparan los próximos años?
REVISTA COMUNICACIONES Nº 100 SEPTEMBER-DECEMBER 2023
This article addresses the implications for the pharmaceutical sector of the application in Spain of Law 19/2013, of 9 December 2013, on transparency, access to public information and good governance, 10 years after its entry into force. In addition, the implications of the entry into force of the Tromsø Convention will be analyzed. Finally, the... Read More
Faus Moliner participates in the Conference on the impact of the European Pharmaceutical Strategy in Spain organized by Diariofarma
Jordi Faus focuses his intervention on the incentives for innovation in the upcoming reform of European pharmaceutical law
The “Pharmaceutical Strategy for Europe” is a programmatic initiative launched by the Commission in November 2020, which includes a list of actions aimed at promoting access to medicinal products, dealing with therapeutic gaps, establishing response mechanisms to crisis situations and strengthening the competitiveness of the EU in the sector. Within this initiative, the main action... Read More
Access to medicinal products and patients’ fundamental rights
Judgment of the Court of Justice of the European Union (Grand Chamber) of 22 November 2022
Capsulas Nº 233
Background A Russian citizen suffering from a rare form of leukaemia was receiving medical care in the Netherlands. The treatment consisted in the administration of medical cannabis for pain relief. The use of medical cannabis is not allowed in Russia. After applying for asylum in the Netherlands and being rejected several times, he was ordered... Read More
Repackaging and relabelling of parallel imports of medicinal products
Judgments of the Court of Justice of the European Union of 17 November 2022
Capsulas Nº 233
On 17 November 2022, the Court of Justice of the European Union (CJEU) issued four important judgments on parallel imports of medicinal products in cases Novartis Impexeco, C-253/20 and C-254/20; Novartis Pharma, C-147/20; Bayer Intellectual Property, C-204/20; and Merck Sharp & Dohme and Others; C-224/20. The Novartis Impexeco judgments, C-253/20 and C-254/20, relate to the... Read More
The scope of confidentiality in public procurement: beyond trade secrets
Judgment of the Court of Justice of the European Union of 17 November 2022 (Case C-54/21)
Capsulas Nº 233
Background This judgment was delivered in the context of a dispute concerning the award of a public contract in Poland. One of the tenderers appealed against the award decision and requested access to certain information relating to the successful tender and a re-evaluation of all the tenders submitted. The contracting authority refused to grant access... Read More