SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Joan Carles Bailach and Laia Rull, Faus Moliner
In view of the positive experience acquired, it has been considered convenient to facilitate the use of these decentralised aspects in clinical trials beyond the COVID-19 pandemic period. In November 2024, the AEMPS published a guide for the implementation of decentralised elements in clinical trials, providing a series of recommendations on procedures performed with online tools to support clinical trials, such as online recruitment, electronic informed consent and telemedicine for remote monitoring. The use of these online tools is subject to appropriate safeguards to ensure participant safety and protect their rights. For example, the patient information sheet must clearly detail any decentralised elements, identify potential additional risks and specify the measures in place to protect patient privacy. 2.5 Use of Data From Clinical Trials Provided that it is not aggregated or anonymised, the data resulting from clinical trials is recognised as a special category of personal data and is therefore subject to restrictive guarantees by the personal data protection regulations applicable in the EU (ie, the General Data Protection Regulation; GDPR) and Spain (ie, Law 3/2018 on the Protection of Personal Data). Generally, personal data resulting from clinical trials may not be transferred to a third party, or an affiliate, in a country that does not provide an adequate level of protection without complying with the provisions of Chapter V of the GDPR. In such cases, the sponsor must adopt one of the safeguards set out in Article 46 of the GDPR. In those cases where there is an intention to use participants’ data for future research or outside the protocol of the clinical trial (secondary use), data pro- cessing must be grounded in one of the lawful bases set forth in the GDPR. Additional Disposition 17 of Law 3/2018 has established specific provisions for secondary use of health data. In this regard, the re- use of data from previous studies is considered lawful and compatible with clinical investigation purposes, provided that the new research is related to the scien- tific area of the original study for which consent was obtained. In such cases, the site or the sponsor must publish the information established by Article 13 of the GDPR in an easily accessible place on its website and
notify the data subjects. In addition, a prior favourable report from a CEIm is required. 2.6 Personal or Sensitive Data Databases containing personal data (eg, health data) are subject to the GDPR and Law 3/2018. In this regard, it is necessary to obtain the patient’s informed consent prior to entering their data in the database, or to rely on another lawful basis for the processing of the data (Article 6.1 of the GDPR), as well as a valid exception to the prohibition of processing health data (Article 9.2 of the GDPR). It is important to note that if a database involves the collection of information on medicinal products pre- scribed to patients, it may fall under the scope of observational studies involving medicinal products, as regulated by Royal Decree 967/2020, and thus be subject to the requirements established therein. 3. Marketing Authorisations 3.1 Product Classification Products are classified as medicinal products or medi- cal devices on a case-by-case basis. According to Directive 2001/83/EC and Royal Legisla- tive Decree 1/2015, a product shall be classified as a medicinal product if it achieves its intended effect by means of a pharmacological, immunological or meta- bolic action (medicinal product by function), or if it is presented as having therapeutic properties typical of medicinal products (medicinal product by presenta- tion). These are alternative conditions, meaning that a given substance or combination will be considered a medicinal product if either or both definitions apply to it. The AEMPS is responsible for attributing the status of a medicinal product to a substance in Spain. This can occur within the framework of a national marketing procedure or, subsequently, within the scope of the market surveillance functions of the AEMPS. However, in the centralised procedure, it is the Euro- pean Medicines Agency (EMA) that determines wheth- er a substance is a medicinal product. Moreover, the
325 CHAMBERS.COM
Powered by FlippingBook