Are orphan drugs subject to reference pricing?
Judgment of the Supreme Court of 3 February 2022
Capsulas Nº 224
Background On 3 March 2020, a Resolution of the Council of Ministers excluded orphan medicinal products from the reference price system under two conditions: that no “therapeutic alternative” exists or, otherwise, that the relevant orphan medicinal product provides a “significant clinical benefit”. According to this Resolution, the Permanent Pharmacy Commission (PPC) is the body in... Read More
When does an enforceable agreement exist?
Judgment of the Supreme Court of 23 December 2021
Capsulas Nº 224
In the pharmaceutical sector, it is common for companies to agree and sign preliminary docu ments containing all or some of the provisions of future contracts (e.g., term-sheets, letters of intent, memoranda of understanding, etc.) prior to executing the final agreements (e.g., licensing and supply, manufacturing, co-development, co-marketing or co-promotion agreements, etc.). Given that there is... Read More
Construction of the principle of mutual recognition in the marketing of food supplements
Judgment of the National High Court of 22 November 2021
Capsulas Nº 224
Background This judgement was published on 26 January. It resolves an appeal lodged against a decision of the Spanish Medicines Agency (AEMPS) that declared, in June 2019, that a product being marketed as a food supplement in Spain should be classified as a medicinal product. The appellant relied on the principle of mutual recognition. The... Read More
Jordi Faus appointed Secretary of the International Bar Association (IBA)’s Healthcare & Science Committee
Our founding partner, Jordi Faus, has been appointed Secretary of the International Bar Association (IBA)’s Healthcare & Life Sciences Law Committee
The Healthcare and Life Sciences Law Committee is a fast-growing committee with a dynamic and diverse membership across the world, which provides a forum of discussion among health and life Science lawyers. It aims to provide regular updates of important changes in all aspects of healthcare law, pharmaceutical, biotech and medical devices regulatory law, intellectual... Read More
Lecciones del Covid
El Global
“For me, it is crystal clear – we need to build a stronger European Health Union”. Este fue el mensaje de Ursula von der Leyen, Presidenta de la Comisión, en su discurso sobre el Estado de la Unión de 2020. Es necesario extraer lecciones de la actual crisis y construir una Unión Europea de la... Read More
Huérfanos protegidos
El Global
La sentencia de la Audiencia Nacional de 2 de diciembre es conocida. Incluir los medicamentos huérfanos en los conjuntos de referencia impide que estos productos se beneficien de los incentivos previstos en el Reglamento (UE) 141/2000 para fomentar su investigación, desarrollo y comercialización. Por tanto, la normal legal española que podría obligar a incluirlos en... Read More
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