Access to Innovative Therapies in Spain: Challenges and Opportunities

Despite advances in recent years, the inclusion of new therapies in the Spanish National Health System/Sistema Nacional de Salud (SNS) still poses a challenge. The availability of new treatments in the SNS is determined by several factors, including regulatory approval at multiple levels, financing of treatments within the public health system, and patient access to these treatments.

Availability of Innovative Therapies in Spain Today

Spain has access to a wide range of medical treatments, with 15,5411 different human-use medications authorized on the market, according to the latest data from “La Agencia Española de Medicamentos y Productos Sanitarios.”

The EFPIA Patients W.A.I.T. Indicator 2023 Survey annual report analyzes the state of public funding as of January 1, 2024, for medications authorized between 2019 and 2022. According to the report, Spain’s availability of new treatments approved in the European Union (EU) has increased from 58% to 62% in that timeframe. While this marks a slight improvement, Spain still lags behind the access figures reported by other EU countries such as Germany (88%) and Italy (77%).

Existing Barriers Delaying Access to Innovative Therapies 

In Spain, as in other countries, certain barriers can delay the inclusion of medicines in the SNS catalog and, consequently, affect patient access. Although the European Medicines Agency (EMA) approves drugs for marketing in the EU, each member state must carry out its own evaluation and approval for inclusion in its individual health system. One barrier is the evaluation and approval processes that all pharma and biotech companies must face at country level.  Other factors include price negotiations for new medications, funding and budgeting by public health systems to cover the cost of new medicines, and the lack of separation between the economic and clinical evaluation bodies.

Additionally, companies face a challenging decentralized health system that stakeholders could improve through standardized, predictable processes. One problem is that companies must manage additional barriers at the hospital level, including the high cost of the medicines and requests from hospital pharmacy committees to provide new evidence on efficacy and safety. This situation poses a significant challenge for all companies, especially those with fewer resources.

Patient Implications of Delayed Drug Incorporations 

The average time between EU authorization and the incorporation of the drug into the SNS has increased in just two years from 517 to 661 days on average. This substantially exceeds the 180 days established by EU pharmaceutical legislation and significantly impacts Spanish patients, who lose access to more effective, safer, and more convenient treatments than those they currently receive.

The delay in accessing new medications also increases the risk of complications and disease progression, which results in higher healthcare costs for the SNS and patients, who may have to pay out of pocket for alternative therapeutic options. 
Patients with rare diseases are at an even greater disadvantage because in most cases, they lack therapeutic options; access to new medications and innovative therapies may represent their only hope. Innovation, therefore, must focus on serving patients, a shared challenge among researchers, companies, the administration, and healthcare professionals.

Keys to Improve Access to Innovative Therapies in Spain

The SNS should prioritize the creation of fast-track access routes, especially for treatments aimed at unmet medical needs. Establishing more agile and transparent processes would increase predictability and make it easier for companies to carry out access processes, positively impacting the availability of innovative therapies in Spain’s SNS.

Importantly, new European regulations contemplate the creation of regulatory sandboxes. The EMA can establish these when companies cannot develop a product that meets the applicable requirements for human-use medications due to scientific or regulatory challenges arising from the characteristics or methods related to the product. The sandbox concept will facilitate research into cutting-edge therapies and their subsequent approval.

A fundamental aspect of improving access to innovative medications is the regulation governing the financing and pricing of drugs and medical products. With the EU’s new Regulation on Health Technology Assessment and Pharma Package, the government is already taking steps in this direction. A regulatory framework should always facilitate the inclusion of new therapies, and to achieve this, the pathway for market approval of a new medication must be transparent and predictable.

But for access to exist, development must occur first. The key is an incentivizing framework that boosts collaboration between mature and early-stage companies for drug development.

References:

1.    AEMPS (Agencia Española de Medicamentos y Productos Sanitarios). Accessed October 3rd 2024:
2.    EFPIA Patients W.A.I.T. Indicator 2023 Survey