Advertising of medicinal products on social media
Order of the Court of Appeals of Madrid of 1 October 2021
Capsulas Nº 223
Update of the advertising Bulletin On 30 December 2021, the Government of Catalonia updated its Bulletin on advertising of medicinal products on social media. This update expressly foresees the possibility of companies conveying scientific content via social media. At the same time, it recommends restricting the access to the public, by using the available tools,... Read More
When is a MA deemed transferred in the context of license and supply agreements of medicinal products?
Judgment of the Supreme Court of 7 December 2021
Capsulas Nº 223
Background Two companies entered into a license and supply agreement of medicinal products. Under such agreement, the licensor granted a licence to use certain documentation to obtain a marketing authorisation (MA) in Spain and other territories to the licensee. In consideration for the granting of such rights, the licensee undertook to pay a down payment... Read More
Compliance, internal whistleblowing channels and management of personal data
Consultation with the Spanish Data Protection Agency of 22 November 2021
Capsulas Nº 223
Internal whistleblowing channels are playing an increasingly significant role in the area of compliance. Since 2010, the Criminal Code (article 31 bis) provides that legal persons may be exempted from liability (or, where appropriate, their liability may be mitigated) for certain offences committed by their directors, managers or employees, if they have adopted and effectively... Read More
Use of the reputation of a medicinal product in the advertisement of a food supplement
Order of the Court of Appeals of Madrid of 1 October 2021
Capsulas Nº 223
Background In the context of a dispute between Exeltis and Italfarmaco regarding the dissemination of promotional materials by Italfarmaco of food supplement Oniria®, Exeltis requested a preliminary injunction prohibiting the dissemination of the materials and ordering their withdrawal. The Commercial Court granted the injunction and Italfarmaco appealed this decision. The decision of the Court of... Read More
Ensayos clínicos en la UE: better together
El Global
Este año 2022 que recién empezamos se inicia con muy importantes novedades en el ámbito de los ensayos clínicos con medicamentos. Como estaba previsto, este próximo 31 de enero entrarán en funcionamiento el portal del Sistema de Información de Ensayos Clínicos (“CTIS”, por sus siglas en inglés) y la base de datos de ensayos de... Read More
Orphan medicinal products should not be subject to reference pricing
Judgment of the National High Court of 2 December 2021
Capsulas Especial
Background This judgment, which is of utmost importance, was issued following an appeal lodged by Farmaindustria against the 2019 Reference Price Order. Farmaindustria argued that the price reduction resulting from the inclusion of orphan medicinal products in the reference price system prevents such products from benefiting from the incentives set out in Regulation 141/2000. Such... Read More
Novedades en relación con la transparencia del precio de los medicamentos
CUADERNOS DE DERECHO FARMACÉUTICO, NUM. 79, OCTOBER-DECEMBER 2021
The purpose of this article is to provide some analysis on the latest developments in the area of price transparency of medicines for human use. This article analyses a report issued by the Ministry of Health that defends maintaining a certain degree of confidentiality in the price of medicines, as well as the European Commission’s... Read More
Dispensing vs. delivery of medicines
Judgment of the Supreme Court of 2 November 2021
Capsulas Nº 222
Our CAPSULES of 23 June reported on the admission of a cassation appeal that granted the Supreme Court the opportunity to interpret the terms “dispensing” and “delivery” of medicines, which are hugely relevant to new business models and emerging platforms. The Judgment of 2 November 2021 resolves the appeal and offers interesting arguments as to... Read More
When is an administrative decision deemed notified?
Judgement of the Supreme Court of 10 November 2021
Capsulas Nº 222
Background This case is about whether the beneficiary of a subsidy must return the subsidy to the Administration that granted it or not. The Administration considered that the subsidy must be returned because the beneficiary had not complied with its terms. The matter was brought before the Spanish Audiencia Nacional which ruled that the beneficiary... Read More
Further clarity on the term of the statute of limitations for agency fees
Judgment of the Supreme Court of 23 November 2021
Capsulas Nº 222
Background In the case of agency contracts, the agent promotes commercial transactions on behalf of the principal in exchange for a commission. Unless a more beneficial contractual provision for the agent exists, the commission accrues upon execution of the commercial transaction promoted by the agent (art. 14 of Law 12/1992). Payment must be made before... Read More