By: Natalia Pérez Mas, Account Executive and Social Media Manager.
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The Draft Bill on Medicines and Medical Devices begins its parliamentary process in the National Parliament this September, following a complex drafting process that has spanned several years. During its preparation, the Central Government, and specifically the Ministry of Health, received almost 2,000 contributions aimed at improving the text, submitted by 123 entities, public administrations, organisations, companies and professionals.
The parliamentary groups must now turn their attention to assessing a similarly large number of amendments, holding hearings and determining further changes to the legislation in order to secure its approval. Given the current division within the National Parliament, this is expected to be a challenging process. The Popular Party insists that it will work to improve the bill, while Vox does not appear willing to participate in securing its approval. Once again, smaller pro-independence parties such as Junts per Catalunya could hold the future of a sector as vital as the pharmaceutical and health technology industries in their hands, if further concessions to their leaders and to Catalonia prove sufficient to secure their support for the ruling Socialist Party Group.
The main implications of the new healthcare legal framework
The text will replace the framework in force since 2015 and update it in response to scientific and technological developments, supply problems and the financial sustainability challenges facing the National Health System (NHS), as well as the need to incorporate innovation more swiftly. The Spanish Government considers this healthcare reform a key priority, as it will affect the entire lifecycle of medicines: from authorisation and availability to assessment, reimbursement, pricing, prescribing and monitoring.
Among its main objectives are the reform of the reference pricing and reimbursement system, the adaptation of Health Technology Assessment (HTA) to the European Regulation, the update of public funding criteria, the promotion of generic and biosimilar medicines, and the establishment of strategic medicines. It will also seek to reduce the time required for access to innovation, with the aim of reaching a target of 180 days from a medicine’s authorisation to its pricing and reimbursement.
However, the Medicines Act should be understood as the general legislative framework that will be further developed through the Royal Decree on the Advertising of Medical Devices and the Royal Decree on Pricing and Reimbursement, both of which are still pending approval and will constitute its main implementing instruments. Now, the Ministry of Health is closely monitoring the parliamentary process in order to decide whether to wait for approval of the new legislative framework so that it can coincide with the Royal Decree on Pricing, or whether to accelerate the latter and adapt it to the framework currently in force. In any case, this Royal Decree is expected to be approved before the end of the year, regardless of whether the new Medicines Act is adopted or not in Parliament.
The legislation also introduces an assessment system for medicines, medical devices and other health technologies aimed at informing decisions on their incorporation, reimbursement, pricing, modification of conditions of use or disinvestment. This new model will be aligned with the European Health Technology Assessment (HTA) Regulation, for which Spain has already approved the Royal Decree on Health Technology Assessment, in place since May. This is particularly relevant for innovative health technologies, including diagnostic tests, digital technologies, medical devices and other interventions, as their incorporation into the NHS will increasingly depend on the generation of evidence demonstrating their clinical, economic, organisational and social value.
The healthcare industry and patients: partially in agreement
Overall, the position of the main sectors affected is favourable towards updating the regulatory framework, although both the pharmaceutical and health technology industries have identified elements that they consider should be amended or clarified during the parliamentary process.
In the case of the pharmaceutical industry, Farmaindustria considers the reform a necessary update to the regulatory framework and welcomes elements such as the objective of meeting the 180-day deadline for pricing and reimbursement decisions, reduced to 90 days in the case of medicines with no therapeutic alternative. In addition, the approval of the legislation should be understood within the context of the 2024–2028 Pharmaceutical Industry Strategy, which is proposed as a roadmap for pharmaceutical and industrial policy and underpins a significant part of the legislative reform.
However, the sector has expressed reservations about the economic impact of certain measures and has called for the new pricing and reimbursement model to take into account not only the immediate impact on pharmaceutical expenditure, but also its consequences for industrial production, R&D investment and security of supply. This issue is particularly relevant in relation to the new dynamic pricing model. The reform aims to introduce greater competition among medicines containing the same active ingredient and promote the uptake of generics and biosimilars, but the pharmaceutical industry has warned of the need to ensure that pricing pressure does not affect production in Spain and Europe or create supply risks for mature medicines.
Fenin, the Spanish trade association representing the health technology industry, considers that the legislation recognizes, for the first time in Spanish healthcare policy, the sector’s specific characteristics, and could help improve its competitiveness, facilitate investment in Spain and accelerate the uptake of innovation within the NHS. Its main areas of support include the move towards value-based public procurement, the limit on the weighting of price in procurement awards and the commitment to promote a Protech Plan. However, Fenin insists that there are still aspects that need to be improved during the parliamentary process, such as the indexation of public contracts, as well as the need to ensure a stable and predictable framework that allows companies to plan investments and maintain supply capacity.
Patients, whose presence is being strengthened under the new law, believe they should have a greater role in governance bodies, particularly when the legislation seeks to expand their decision-making capacity regarding medication. It will be key for the Medicines Act to also be coordinated with the future Patient Organisations Act, currently under parliamentary debate.
The cross-cutting impact of the new healthcare regulatory framework
For all these reasons, the relevance of the future legislation goes beyond modifying the rules governing the authorisation or reimbursement of medicines. As noted above, its implementation will affect the entire healthcare innovation access ecosystem: from the assessment of medicines and health technologies to public funding, pricing mechanisms, public procurement, security of supply and industrial policies. This makes the lengthy and complex parliamentary process particularly important, as it will be key to addressing the unresolved areas of disagreement, both from the pharmaceutical and the health technology perspectives.
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