SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Joan Carles Bailach and Laia Rull, Faus Moliner
Moreover, the AEMPS has issued a document of instructions for the conduct of clinical trials with medicinal products in Spain and guidelines for con- ducting clinical investigations with medical devices, both of which are regularly updated. 2.2 Securing Authorisation to Undertake a Clinical Trial Medicinal Products To initiate a clinical trial with medicinal products, the following will be required: • prior authorisation by the AEMPS, after a scientific and ethical evaluation in accordance with Regula- tion (EU) No 536/2014; • a favourable opinion issued by an ethics commit- tee for research on medicinal products ( comité de ética de la investigación con medicamentos CEIm) in Spain; and • a written agreement between the sponsor and the sites (clinical trial agreement; CTA). The sponsor may select any CEIm within Spain to review the study and issue a favourable opinion. With respect to the CTA, there is no standardised template for all Spanish sites. In practice, each hospital/region usually has its own template. The sponsor may sign the CTA before obtaining the required authorisations (Article 17 of Royal Decree 1090/2015). In such cases, the CTA will become effective once both AEMPS and CEIm approvals are in place. Medical Devices Two different situations can be distinguished for clini- cal investigations involving medical devices: • clinical investigations involving medical devices without European Conformity ( Conformité Euro- péenne CE) for conformity assessment, as well as those with CE marking used outside the scope of their intended purpose, require a favourable CEIm opinion, AEMPS approval and a written agreement between the sponsor and the sites; and • clinical investigations involving medical devices that have CE marking and are used in accordance with their instructions for use, and in line with the approved, intended purpose when the CE marking was issued, require a favourable CEIm opinion and
a written agreement between the sponsor and the sites – AEMPS approval is exempted. In the first situation, the sponsor must submit the documentation described in Chapter II of Annex 15 of Regulation (EU) No 2017/745. The AEMPS shall evaluate the documentation submitted and decide to either authorise or reject the clinical investigation. Additionally, if patients will undergo procedures beyond those applied under normal conditions of use, and these procedures are invasive or burdensome, the sponsor shall notify this to the AEMPS through the database for clinical investigations involving CE- marked medical devices (NEOPS). 2.3 Public Availability of the Conduct of a Clinical Trial The Spanish Registry of Clinical Studies ( Registro Español de Estudios Clínicos REec) is a public data- base containing information on all clinical trials with medicinal products authorised by the AEMPS in Spain. It can be accessed through the AEMPS website. The sponsor must publish the results of the clinical trial, whether positive or negative, preferably in scien- tific journals before disclosure to the general public, as well as in the REec. For medical devices, there is currently no publicly available database specific for Spain. 2.4 Use of Online Tools to Support Clinical Trials The decentralisation of clinical trials (including the use of online tools for monitoring purposes) began with the COVID-19 pandemic, when the AEMPS amended its document of instructions to introduce exceptional measures regarding: • patient visits for ongoing clinical trials during the pandemic; • access to trial medicinal products; • the transfer of patients between sites; and • the procedure for obtaining patients’ informed consent.
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