SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
four classes (A, B, C, D), taking into account the intended purpose of the devices and their inherent risks, in light of the classification rules in Annex VIII of Regulation (EU) No 2017/746. Except for custom-made devices, medical devic- es must bear the CE marking to be placed on the market in Spain, which provides evidence of the device’s conformity with the applicable require- ments. The evaluation and variation approval of medical devices are governed at the EU level in accordance with Regulation (EU) 2017/745. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations Medicinal Products Spain has two national exemption schemes, implemented under Article 5(1) of Directive 2001/83, which permit the importation of and patient access to medicinal products that do not have a valid MA in Spain – the so-called com- passionate use and foreign use of medicinal products – both of which are regulated under Royal Decree 1015/2009 on access to medicinal products in special situations. Compassionate use is allowed for patients with serious or life-threatening conditions when no authorised and commercialised alternatives are available; in such cases, the medicinal product must either be subject to an MA application or be part of a clinical trial. In practice, the AEMPS takes the view that, when a medicinal product already has a valid MA and is commercialised in Spain, no compassionate use programme can be opened for indications under investigation. This may raise issues in practice if companies wish to offer units of the commercialised prod- uct to be used for such unauthorised indica- tion free of charge. Meanwhile, the foreign use regime enables the import of medicinal products
approved in other countries but not yet author- ised in Spain. Both the compassionate use and the foreign use regimes require prior approval from the AEMPS, which manages these programmes with high efficiency through its website for medicines in special situations ( medicamentos en situa- ciones especiales MSE), allowing physician and healthcare centres to submit requests for indi- vidual or group patient access. Furthermore, under Spanish law, such uses are carried out under the exclusive responsibility of the physi- cian and require prior informed consent from the patient or their legal representative, a clini- cal report justifying the need for the treatment and approval from the healthcare centre where it will be administered. The price of the product concerned is fixed by the importer, normally after negotiation with the pharmacy service of the healthcare centre. In compassionate use cases, the AEMPS, hospitals and regional authorities frequently put pressure on the company to sup- ply the product free of charge. However, for the time being, Spanish law does not require that the supply be free of charge. Finally, off-label use of medicinal products is accepted when there are no authorised alter- natives for the patient. Off-label use does not require AEMPS approval and may be accom- plished under the healthcare provider’s authority. Medical Devices Medical devices without CE marking, and those used outside of a clinical investigation or for conditions not included in the instructions for use, may be permitted under a compassionate use programme in accordance with the con- ditions established in Circular 7/2004 issued by the AEMPS. According to this Circular, the compassionate use of medical devices is car-
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