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EF: What role does Spain have within the European life sciences and healthcare ecosystem?
JU: Spain is well positioned within the European market because the pharma industry has a substantial footprint in Spain, and we have a resilient and efficient national healthcare system. We spend about 6.9% of GDP on healthcare, which is lower than the European average, and we have good outcomes. Our region's healthcare access is exemplary and a real asset for the population. From a territorial and social perspective, the healthcare system is an equalizer for the whole population. Now, we need to learn how to exploit these assets. Our role as Farmaindustria is to promote an innovation-friendly ecosystem that creates the best possible playing field for the pharmaceutical industry. We need companies to invest and make long-term plans in Spain, and we are well-placed to grasp this opportunity.
EF: What will 2023 be remembered for in the Spanish life-sciences and healthcare sector, and what will 2024 bring?
JU: Last December, we brought together a group of more than 20 global CEOs and the Prime Minister for a summit that served as a kick-off for the strategic plan of the pharmaceutical industry. However, this year, we faced a complicated political environment. The strategic plan was supposed to be approved by the end of the first semester, but the political uncertainty has put it on standby. One of the main details still unsolved is whether we will have the same person responsible for the pharmaceutical issues in the coming years, but we will have to wait to see.
EF: Has 2023 been a year of transition?
JU: Our industry has been growing consistently at a rate of between 4 and 5 percent per year over the past several years. We are seeing a structural growth that considers the demand side—the aging population and demographics—and the supply side, which is the innovation of new products. The main issue we need to be aware of is how the European Union fiscal rules in 2024 will impact the governments. The pharmaceutical expenditure in Spain is decentralized to the regions rather than having one national budget. Because of this, there is no formal ceiling, but the fiscal rules may establish a ceiling and pressure governments. We will probably have more pressure on budgets in the future than in the past several years. Things are getting more challenging; we see this in countries like the UK, France, and Germany. In this most recent strategic plan, there was a specific pillar of patient access to innovation. We have been talking with the government at the Ministry of Health and the Ministry of Finance, and this is the first time we have had multiple ministries involved in the discussions about the strategic plan.
The government change and uncertainty have changed the estimated implementation date, but we will continue dialogue with this government or the next, depending on the outcome of these political changes. We will probably have discussions around sustainability with the new government.
EF: Maintaining momentum and discussing health's strategic importance is essential. Where do we stand today on the three pillars of Access and Sustainability, Research and Development, and Production and supply chain?
JU: The most crucial pillar is Access and Sustainability, which is the core of the discussions for the Government and companies. The access to new medicines in Spain has worsened over the past several years. Looking at the big 5 European markets, including the European Union, we are fifth in wait time, with just over 600 days. The availability rates are 58% (percentage of reimbursed drugs over total European approvals in the past four years), much lower than in other countries. We have been working closely with the government to overcome these difficulties. We are focusing on the reimbursement procedures, which is the system's core. We need to update the regulations and make them more predictable and objective for the companies and the governments. This access issue is our core responsibility and primary concern for our companies. For the government, it is essential because patients are waiting and have lower satisfaction rates. We are already working on specific solutions for managing uncertainties and agreements. We must implement modern tools to help companies and governments reach agreements to finance new medicines. We will have to wait through this period of government change, but this is the central pillar.
In the pillar of Research and Development, Spain has a strong position in clinical trials. This is the fruit of many years of working together and developing trust with all the stakeholders: government agencies, hospitals, ethics committees, and patient organizations. We also have a good position in early studies and are determined to maintain and continue this leadership. The Spanish government is proud of this achievement as well because other actors recognize the Spanish success in clinical trials. We had the fortune to have a very proactive regulator. Spain approved the new regulation for clinical trials even before the European Union regulations were binding, so we are working to increase the seamlessness between these two regulatory bodies. We are working on decentralized clinical trials and scientific approaches to clinical trials. We have this focus and are working with the Spanish agency to improve. We have a good research infrastructure but do not necessarily have the power in Science that other bigger countries have. However, we are working with companies and research scientists to attract new company investments for preclinical research. It is easier for clinical trials because clinical trial decisions are made every year so that you can compete there. However, competing in basic and preclinical research is much more challenging. To move forward with this component, we need first to solve the issue of access. When companies decide where to invest, they look at the whole picture of the country. Spain has good clinicians and a sound healthcare system, but products are available one year later than in other countries, which is a significant drawback. We must fight against that and convince the government that innovation considers many aspects of our work.
There are 103 pharmaceutical production facilities in Spain. We are advanced in traditional drugs and synthetic chemistry, but only 11 of these pharmaceutical plants produce biotechnology products, so we need to improve our efforts in advanced therapies. We have a program called ProFarma that has been in Spain since the mid-1980s, and it is the oldest technology plan across all sectors in Spain. ProFarma is a ranking process for production and R&D companies. There is an expansive review of the strategies in R&D and production for each company, and they have to fill out a complete dossier every year. They are reviewed by independent experts, and they receive a qualification that ranges from excellent to poor. In general, companies have to pay a 2% tax on all retail sales in pharmacies across the country, but in accordance with their ProFarma score, they receive a discount. The companies that receive an "excellent " grade pay 25% less. ProFarma is the main program for production and R&D, managed by the Ministry of Industry with the participation of other Ministries (Health and Science and Innovation). There has been extensive discussion since the pandemic on the resilience of the supply chain and the pharmaceutical industry’s dependency on China. We have a reference price system, bringing the prices down and jeopardizing the feasibility of these products in Spain. If you can’t produce at European prices, you must import the goods elsewhere. The discussion about autonomy is difficult because no country is entirely self-sufficient, but Europe must have a strategy to deal with both off-patent products and innovation. If you do not have autonomy in innovation, you will always have to import innovation produced by others. Europe must wake up and invest heavily in R&D and the healthcare systems for the health of the EU. That is one of the main strategic assets of the European Union. There is considerable discussion in Europe about the new legislation, but the region is not considering that this is a very strategic sector for the economy, and we have to produce incentives for R&D.
Reports published by International Financial Analysts have reinforced that investment in healthcare brings extraordinary benefits to the population's health, and a healthier population is a more productive population, so GDP increases. We are asking the government to invest in the healthcare system because a healthier population is a happier, more productive society, which is good for us all. This report calculates that investing two additional points in healthcare would raise the GDP by four points in the next several years.
EF: What are you excited about? What would you like to see happen over the next 1 or 2 years that would make you feel proud?
JU: The digital area will be a real game changer in the immediate future. Digital is transforming our lives and the lives of companies and our industry at all levels-- from R&D to trials, access, promotion, and medical education. Our primary concern at Farmaindustria in Spain and Europe is to promote an open health data space in Europe. Only open data with all the caveats regarding protection would allow stakeholders to grasp the benefits of digitalization. Good data is the key driver of a fruitful dialogue with industry, government, regulators, scientific actors, healthcare professionals, and patient organizations. If we could better demonstrate the value of the medicines we bring to market, the conversation would be much easier. Data drives better healthcare for patients and a more efficient healthcare system. What will transform this situation is good data to support the conversation and make it much more objective. What is not measured cannot be improved.
We began this work in 2006 with clinical trials. We convinced the companies to share their data on clinical trial setup, and we created a database with clinical trial information provided by companies and with all of the dates of each step of the process included. We were able to measure how long they took from one stage to the next to get their various approvals, have the contract signed, and recruit the first patients, and we began to share this information with the companies. We weren’t giving privileged information, but the companies could see how their colleagues were performing against the standard of the whole industry. We could see which hospitals were the first to approve certain milestones. We didn’t grade the hospitals from best to worst; we were neutral, but we made it visible, and we were able to have discussions with the data in hand. We could ask why it took six months to sign a contract. So, that time was reduced from six months to a month and a half because we had the data to measure and improve that. It was straightforward, but it was the beginning of involving stakeholders. We wanted to be sure that we were in a position to ensure a good atmosphere for all stakeholders. We are engaged in many discussions about data availability and quality. If we can show the results of the medicines we bring to the market, we will succeed.
EF: If you could choose 2-3 KPIs to address the challenges you currently face, what would be the data that you would want?
JU: First, we need to solve the access issue, the timelines of approval, and the approval rate. We need to shorten the timelines and have better approval rates. The WAIT Indicators published by EFPIA measure what percentage of the products approved in the past four years are financed by each member state. For example, Germany funded about 90% of the medicines approved in the last four years. Italy and France are next. The main KPI is reducing the access timeline to less than one year, ideally six months, which is the regulation according to legislation, but it takes 20 months currently. And the rate of availability is essential as well.
