Changes Afoot in Pharmaceutical Laws and Regulations in Spain

In February, the Spanish Government released its Annual Regulatory Plan for 2023, which presents important regulatory changes and developments relating to legislation governing pharmaceuticals and healthcare. The country’s Ministry of Health has proposed three laws and three regulations—of particular note are the amending law on guarantees, the decree on pricing, and the decree on the assessment of health technologies.

Law amending the revised text on guarantees and rational use of medicinal products and medical devices

Amendments are to be made to the Law on Guarantees and Rational Use of Medicinal Products and Medical Devices aimed at updating the consolidated text in line with changes that have taken place in recent years. Modifications will therefore be made to the consolidated text of the law (RDL 1/2015), signed into law on 24 July 2015 (1).

The amending law aims to bring the current text up to date to meet the requirements and developments that have taken place in the field of human and veterinary medicinal products, medical devices, cosmetics, biocides for personal use, and personal care products, at both the national and European level (2). The aim is to also harmonize the legislation with the different European regulations that have been approved in recent years regarding products regulated by this law. Although further details are presently lacking, the law entails the “incorporation of new perspectives related to the public funding of medicinal products, rational use of medicinal products, and structures of governance bodies” (3).

Royal Decree regulating the funding and pricing of medicines and health products

Royal Decree 271/1990, passed on 23 February 1990, states that the “maximum ex-factory price of a reimbursed medicinal product should be equal to the cost of the product plus a given margin (12% to 18% on capital allocated to exploitation)” (4). However, in practice, it has been found that setting the price of a reimbursed medicinal product involves negotiating the price with the public authorities.

The proposed amendments to the Royal Decree regulating the funding and pricing of medicines and health products and their inclusion in the pharmaceutical provision of the National Health System (NHS) will therefore aim to develop the following aspects:

• inclusion of medicinal products and new indications for medicinal products in the pharmaceutical provision of the NHS
• special reserves and special conditions for the reimbursement of medicinal products

• special drug pricing regimes
• industrial price review regime for medicinal products, to be included in the pharmaceutical provision of the NHS new drug indications
• funding medicines available in special situations; supply of medicines in the pharmaceutical provision of the NHS
• exclusion of medicines from the pharmaceutical provision of the NHS
• reimbursement of medicinal products available under early access programmes
• inclusion of medical devices in the pharmaceutical provision of the NHS
• Information systems for the supply of medicines and monitoring of their funding in the NHS (3).

Royal Decree regulating the assessment of health technologies

A further Royal Decree regulating the assessment of health technologies will seek “to regulate an independent, transparent, and participatory system for the evaluation of the therapeutic positioning of health technologies by means of a scientific process based on contrasted data that makes it possible to determine the relative efficacy and efficiency of existing or new health technologies in comparison with others” (5).

The Royal Decree aims to include the involvement of different actors in this assessment (such as lay members representing the interests of patients), as well as develop those aspects that are not covered by the Health Technology Assessment (HTA) Regulation. It also aims to introduce modifications and incorporate new perspectives related to the public financing of medicines, their rational use, and structures of governance bodies. Additionally, the Royal Decree also aims to bring the system into line, as far as applicable, with the provisions of Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on Health Technology Assessment and Amending Directive 2011/24/EU (6).

As part of Spain’s overhaul of its HTA system, the Spanish authorities will draw on the experience of the United Kingdom’s (UK’s) National Institute for Health and Care Excellence (NICE) system, to speed up its own HTA process. The principal reason cited for this move is that the Spanish Ministry of Health does not believe it has sufficient resources to prepare adequate economic evaluations of the new medicines that are marketed in Spain (7). For this reason and following in the footsteps of other European countries, including the UK, the Spanish authorities will ask pharmaceutical companies to submit health economic evaluations for review.

According to Carlos Martín Saborido, advisory member of the General Directorate of Common Portfolio of Services of the SNS (Sistema Nacional de Salud) and Pharmacy, holders of Marketing Authorization (MA) will soon be asked for these pharmacoeconomic studies. In addition, the Ministry of Health is currently working on guidelines stipulating the characteristics of these evaluations, which will then be verified through published checklists to ensure they are “faithful to the methodology” in the name of transparency (7).

Other healthcare developments in Spain

Of notable consideration, the government plans to make “substantial reforms to early access (before and after authorization) to establish rapid decision-making procedures for drugs that offer greater potential for improvement and mechanisms to manage uncertainty in access to funding and price” (3).

In July 2022, Spain’s pharmaceutical industry association, Farmaindustria, published a document outlining various proposals for the Spanish government to consider, aimed at increasing access to medicines across the country. These proposals include:

• modifying the pharmaceutical contribution system to achieve a better redistribution of the economic burden derived from the pharmaceutical co-payment, based on the socioeconomic level of the citizen
• pursuing a fairer model that guarantees more equity in access to medicines
• modifying the reference price system by introducing elements that increase competition and value the contributions that represent an incremental benefit in the use of medicines
• modifying the system to calculate the four-monthly contribution made to the SNS by manufacturers, importers, and suppliers of medicines and health products financed with public funds (3).

Delays in approval and the availability of medicines in Spain have increased in recent years, leading it to lag regional peers such as Germany, France, Italy, and the UK. As such, Spain is regularly criticized for its slow reimbursement times for innovative medicines, particularly for orphan drugs. For pharmaceutical manufacturers, market access delays translate directly to reductions in revenue as reimbursement often cannot be secured until the IPT (Informes de Posicionamiento Terapéutico) process is complete.

Research conducted by Fitch Solutions for H122 found that “the average time taken to complete an ITP was 362 days, while for medicines taking part in the pilot project for the new ITP method, the process took between 297 and 780 days” as opposed to the target of 93 days (8). In February 2023, the Spanish Association of Orphan Drug Manufacturers (AELMHU) released its Annual Report on Access to Orphan Drugs in Spain 2022, which shows that just 23% of orphan drugs with a centralized MA have full, unrestricted reimbursement in the country (9). In response, Farmaindustria has called for an in-depth reform of the pricing and financing system, a review of the ITP system, and the implementation of early access schemes for drugs that provide greater clinical benefit to patients (8). The association has also proposed 12 measures aimed at improving access for patients with rare diseases to new treatments. It is therefore important that the pharmaceutical industry follow these initiatives closely and begin thinking about how organisations can adjust to the proposed processes and strategies.

References

1. Osborne Clarke. Amendment of the Law on Guarantees and Use of Medicines and Medical Devices. Osborneclarke.com, Article, 20 July 2022.
2. Abad, A. Major Regulatory Changes in Pharmaceutical Laws, and Regulations in Spain for 2023. Hogan Lovells, 8 Feb. 2023.
3. Eversana. Spain to Pass New HTA Legislation in 2023. Navlin Daily, 2 Feb. 2023.
4. Faus, J.; Moliner, X.; Rodellar, E.; et al. Medicinal Product Regulation and Product Liability in Spain: Overview. Thomson Reuters Practical Law, Country Q&A, 1 Aug. 2021.
5. Grubert, N. Spain Will Pass Major New Legislation on Drug Pricing and HTA in 2023. LinkedIn Post, February 2023.
6. EC. Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on Health Technology Assessment and Amending Directive 2011/24/EU (Text with EEA relevance), 22 Dec. 2021.
7. Rudd, A. Spain’s Ministry of Health copies NICE, and Asks Pharma for their Economic Evaluations. Remap Consulting, 17 Feb. 2023.
8. Fitch Solutions. Spain’s Pharmaceutical Industry Calls for Pricing System Reform as Market Access Delays Persist. Article, 2 Sep. 2022.
9. AELMHU. Annual Report on Access to Orphan Drugs in Spain 2022. Access Report, February 2023.

About the author

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Article details

Pharmaceutical Technology Europe
Vol. 35, No. 4
April 2023
Pages: 7–8

Citation

When referring to this article, please cite it as Piachaud-Moustakis, B. Changfes Afoot in Pharmaceutical Laws and Regulations in Spain. Pharmaceutical Technology Europe, 2023, 35 (4), 7–8.