Clinical trials are a source of funding from outside the hospital that enables it to strengthen its infrastructure, recruit specialist staff, purchase equipment and improve processes.

diariomedico.com

Clinical trials are the primary source of evidence for determining the efficacy and safety of new medicines, and ensure that regulatory, clinical and funding decisions are based on robust data.

Furthermore, they have a distinctive feature of enormous significance: they offer patients the possibility of early access to innovative treatments prior to their marketing authorisation, “always within a highly regulated environment designed to manage the uncertainties inherent in clinical development”, explains Jorge Mestre, an economist, associate professor at Carlos III University and director of the Department of Strategic Intelligence & Policy Research at Weber.

Alongside this undeniable scientific and healthcare value, clinical trials also generate a significant economic impact. In this regard, it is worth noting that Spain has established itself as one of the world leaders in clinical research, as consistently reflected in the data published by the Spanish Agency for Medicines and Health Products (Aemps).

On the one hand, they provide a source of external funding that makes it possible to strengthen research structures, recruit specialist staff, purchase equipment and improve care processes. On the other hand, they generate direct savings because many of the costs associated with the care of patients included in the trial are borne by the sponsor, notes Jorge Mestre.

Furthermore, centres that actively participate in research tend to attract talent, enhance their scientific standing and improve their ability to secure new competitive projects, generating an economic impact that extends beyond the trial itself, this expert emphasises.

For the National Health Service (SNS), clinical trials represent external investment in biomedical R&D that reduces the need for public funding for certain healthcare and research activities. Furthermore, they allow patients in the trial to gain early access to innovative treatments, the cost of which is borne by the study sponsor.

Biomedical innovation hub

Beyond the National Health Service (SNS), and from a macroeconomic perspective, clinical trials help to attract international investment, create skilled jobs and position the country as a biomedical innovation hub.

To go into more detail, the economic impact is primarily evident in three areas. Firstly, savings on healthcare costs, as treatments, diagnostic tests and follow-up care are funded by the sponsor. Furthermore, they generate revenue through payments to hospitals, research foundations (which are the bodies within hospitals that manage these trials) and research groups for carrying out the studies.

And thirdly, there is an indirect economic return, linked to skilled employment, scientific activity, publications, knowledge transfer and the attraction of future investment.

Whilst clinical trials also generate costs for centres – relating to specific infrastructure, dedicated staff, administrative management, monitoring, pharmacovigilance, methodological support and regulatory compliance, amongst other aspects – in industry-sponsored trials these costs are usually covered by the contracts and are offset by payments made by the sponsor.

Cost savings

The main savings for the National Health Service (SNS) come from investigational treatments provided by the sponsor. “In many cases, the SNS avoids the cost of medicines that patients would have received under standard clinical practice.” Savings may also arise from diagnostic tests, visits or procedures included in the protocol and funded by the study.

Furthermore, clinical trials generate revenue through various channels, such as payments per patient recruited and monitored in the trial, funding for trial set-up costs, the recruitment of research staff, funding for clinical trial units, and the outsourcing of specialised laboratory, imaging or data analysis services.

These resources are channelled through foundations or health research institutes within hospitals.

With regard to the public’s understanding of the impact of clinical trials involving medicines, Jorge Mestre suggests that it is probably insufficient. “I would say that the public tends to associate clinical trials with the generation of knowledge and access to innovation, but is less aware of their economic contribution to the healthcare system.”

Investment decisions

Another important aspect to bear in mind is that the conduct of clinical trials is the result of investment decisions by sponsors – predominantly private-sector companies – who choose to locate their studies in countries capable of offering the best scientific, regulatory and healthcare conditions. “There is, therefore, international competition to attract this research activity and the investment associated with it,” explains Jorge Mestre.

Spain has managed to establish itself in a leading position thanks to a combination of factors, including a favourable regulatory framework, a high-quality hospital network, professionals with extensive research experience, increasingly professionalised research support structures, and close collaboration between public authorities, healthcare centres and the private research sector. “All of this has made it possible to attract a growing number of clinical trials, with benefits for patients, the healthcare system and the economy as a whole.”

Furthermore, there is one aspect that often goes unnoticed, Jorge Mestre emphasises. Clinical trials not only generate immediate economic value, but also strategic value. “Centres with research capacity tend to adopt innovation sooner, attract better professionals and offer more treatment options to their patients.”

Therefore, from a health economics perspective, clinical trials should be understood as an activity that simultaneously produces knowledge, health and investment. “It is clearly an area where the interests of patients, professionals, hospitals, industry and the healthcare system can be aligned to generate shared value,” concludes the expert.

Medicines as an investment

Medicines and the pharmaceutical industry provide health and economic value that society needs to be aware of, explains Pedro Luis Sánchez, director of the Economic Affairs Department at Farmaindustria, who highlights the importance of viewing medicines as an investment that contributes to the sustainability of the National Health Service (SNS), particularly in a context of an ageing population and rising prevalence of chronic conditions.

Medicines account for more than 70 per cent of the increase in life expectancy; they generate significant savings in healthcare and other public expenditure; and they are a source of economic growth through the increased productivity of a healthier population, thereby establishing medicines as an investment, says Pedro Luis Sánchez.

Public investment in medicines in Spain has fallen as a percentage of total public expenditure and has grown at a rate similar to that of GDP over the last two decades, but the per capita level is well below the average for Eurozone countries (33 per cent lower), according to data provided by the director of Farmaindustria’s Department of Economic Affairs.

Pharmaceutical expenditure is rising mainly due to increased demand for medicines in Spain, linked to factors such as an ageing population and chronic conditions, rather than due to the higher cost of innovative medicines, whose average price is rising at a slower rate than the CPI, explains Pedro Luis Sánchez.

“Spanish pharmaceutical regulation itself incorporates mechanisms to ensure sustainability within the economic framework: rigid price caps, references to historical prices, elements of individual financial sustainability, and regulatory automatic mechanisms (the Reference Price System), etc.,” states this expert.

Furthermore, in the 2024–2025 biennium, the industry contributed nearly 2,000 million euros through the deductions and contributions set out in the regulations. And, according to estimates by Farmaindustria, the expiry of patents due to take place throughout 2026, for both hospital and over-the-counter medicines, will result in annualised savings of more than 500 million euros.