Spain, a European success story in clinical trials of new drugs

In 2023, Spain overtook Germany as the country that initiated the most clinical trials and became the European leader. This is reflected in the report Evaluating the clinical trial ecosystem in Europe, prepared by the consultancy firm Iqvia for Efpia and Vaccines Europe, which highlights Spain’s role, although it also warns of the continent’s loss of competitiveness compared to the US and China.

Between 2013 and 2023, the number of patients recruited for industry-driven clinical trials worldwide has increased by 12%, but the percentage of Europeans has decreased by 20%. This translates, as the report reflects, into 60,000 European patients losing the opportunity to access new investigational medicines between 2018 and 2023.

By volume, the number of clinical trials has increased by 38% in recent years, but the percentage of trials conducted in Europe has fallen from 22% to 12%. The number of trials has fallen in all but three European Economic Area (EEA) countries (Portugal, Slovakia and Greece; Spain has held steady with a slight decline of 0.2%), suggesting systemic problems common to the entire ecosystem. ‘European clinical trials are hampered by a slow and fragmented research ecosystem; current initiatives are insufficient to halt and reverse a decade of decline. For Europe to be competitive it must function as a unified region, not as individual Member States, and be backed by policies that attract investment. Only then will Europeans be able to enjoy the same opportunities for access to medical advances as other parts of the world,’ says Efpia CEO Nathalie Moll.

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In the same period that Europe was losing competitiveness, China has multiplied the number of tests from 5 to 18% of the total. The United States has dropped from 28 to 23% and Asia (excluding China and Japan) has gone from 11 to 15%.

The report analyses trials by area, with similar declines in oncology, immunisation, rare diseases and cell and gene therapies, where the share has fallen from 25% to 10% between 2013 and 2023. In the same period China has grown from 10% to 42%, thanks to a favourable regulatory environment, funding and a strategic focus on advanced therapies. The paper also warns of the decline in paediatric and phase 1 trials, because of their importance as a basis for further clinical development, investment and funding. It therefore stresses that the drop from 19% to 14% in the last decade will have negative consequences in the coming years.

Spain’s success story

In this context of loss of competitiveness and declining clinical research activity, the report presents Spain as a success story, reaching the top position by number of trials initiated in 2023.

Spain’s success is mainly due to the implementation of the European clinical trial regulation (CTR), which Spain was the first to adopt since 2016. Not surprisingly, investment in this area has grown at a rate of 5.7% per year from 479 million in 2012 to 834 million in 2022.

The report highlights that Spain has adopted a proactive, coordinated and cross-cutting approach to building its clinical trials ecosystem, driven by increased investment. Among the factors attracting such investment, the document highlights five:

Firstly, the quality of Spain’s healthcare system, e.g. the hospital infrastructure. Second, the successful implementation of new European legislation on clinical trials and the adaptation of its own legislation accordingly.

Third, an effective collaboration model between industry-led and public clinical trials. Fourth, the location of key research centres in several major cities, with – in general – more than three research centres per 10,000 square kilometres in the country. And finally, in terms of immunisation, excluding the years of the Covid-19 pandemic, approximately 20 trials per year are initiated in Spain.

Strengthening leadership

Although Spain has managed to position itself as a leader in clinical trials, the innovative pharmaceutical industry has a number of lines of work to consolidate and reinforce this leadership, in order to contribute to regaining European competitiveness.

One of them is the streamlining and reduction of management processes in clinical research, with the implementation of fast track processes for phase 1 trials; the reduction, simplification and streamlining of bureaucracy in the processes or trials combined with in vitro diagnostics.

Another of the strategies is the promotion of clinical research in Primary Care, with a guide of recommendations proposed by Farmaindustria that is being approached by the autonomous communities, or the promotion of decentralised and networked clinical trials. The use of real-life data, the promotion of diversity in studies and the dissemination of a guide of excellence for the conduct of CCEE in Hospital Pharmacy are other lines of work in the short and medium term.

‘The challenges to maintain competitiveness and reinforce leadership in Spain are increasing and therefore we must continue to work in a flexible and collaborative manner, anticipating changes and with an environment that allows us to develop the innovation of our companies,’ says the director of Clinical and Translational Research at Farmaindustria, Amelia Martín Uranga.

Urgently needed reform

Clinical trials bring health benefits, especially in rare diseases, by bringing the drug to the patient five to 10 years earlier. In addition, they bring economic and health system benefits, with increased employment and capacity in the system, thanks to the savings generated.

The report uses figures from the UK to extrapolate to the EU and estimates the benefits to systems from clinical trial payments and drug cost savings at between €1 billion and €1.5 billion.

The authors of the report therefore call for the loss of competitiveness to be addressed urgently, with the involvement of all parties and the implementation of public policies that take into account the importance of regulatory incentives for innovation, as outlined in the Draghi report. This includes an urgent assessment of the Clinical Trials Regulation and the adoption of measures to harmonise and simplify the clinical trials landscape across the EU to facilitate multinational clinical trials. In addition, they advocate expanding trial capacity, improving infrastructures and emulating Spain’s performance.