SPAIN Trends and Developments Contributed by: Joan Carles Bailach, Lluís Alcover, Laia Rull and Pablo Mansilla, Faus Moliner
ability for stakeholders and clear rules regarding usage or non-usage during management. Regarding the reference pricing system, the Strategy deems it necessary to introduce trans- parency and flexibility, thereby eliminating the current imbalances in the system and reducing the risk of associated supply problems. Finally, other actions are outlined related to the public procurement of medicinal products, the promo- tion of generic and biosimilar medicinal prod- ucts and new economic return mechanisms to mitigate the impact of the growing budgetary expenditure dedicated to pharmaceutical ser- vices. To implement these measures, the Spanish Min- istry of Health (MOH) has been active in amend- ing the regulations governing medicinal prod- ucts and medical devices throughout 2024. It has also continued the reforms initiated by the previous government. Most of these regulations aim to provide a legal framework for realising the Strategy’s objectives. These efforts have made 2024 a productive year for legislation, with many reforms expected to be finalised in 2025. The main legislative amendments passed so far, and those expected to progress in 2025, are as follows. General Pharma Legislation The MOH opened a public consultation on the first draft of the law that will amend Royal Legis- lative Decree 1/2015( “RDL 1/2015” ). The associ- ated published document indicated that the pro- posed reform aimed to address three specific matters. Public financing of medicinal products The MOH document outlines new measures for rational pharmaceutical expenditure and
rational use of public funds. It proposes modify- ing the reference price system by introducing elements that increase competition and value, representing an incremental benefit of the use of medicines. Additionally, the document sug- gests changes to the co-payment system to protect those in greater need, though it does not address whether co-payments could also be used to modulate demand for certain prod- ucts. The document also announces measures to increase pressure on the pharmaceutical industry, including the possibility of quarterly contributions to medicines dispensed in health- care centres. COVID-19 and the impact of new technologies The COVID-19 pandemic highlighted limitations in the availability of medicinal products and medical devices. The MOH aims to consolidate the non-presential dispensing of medicines and telepharmacy within the NHS. Implementation of EU law The MOH document also proposes amendments to incorporate Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro medical devices into Spanish law. The government was expected to provide a first draft law around Q4 2024. However, the draft prepared by the MOH, including all its amend- ments, was leaked. While acknowledging the caution merited when analysing a leaked (unofficial) draft, the text nonetheless reveals a more substantial reform than initially anticipated. The text provides inter- esting ideas in relation to the criteria for reim- bursement of medicinal products and medi- cal devices, measures to speed up access to medicinal products, innovative measures in rela-
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