Over the course of 2022, PharmaBoardroom spoke to over 50 leading stakeholders in the Spanish healthcare and life sciences, from top Spanish scientists to regional ministers of health, multinational affiliate managers, and the heads of some of the country’s leading domestic firms. These interviewees’ insights are catalogued in the downloadable Healthcare & Life Sciences Review Spain 2022 report, while analysis of all 50+ interviews shows the hot topics that were on their minds, from the impact of the COVID-19 pandemic to a rethinking of Spain’s role within Europe, the evolution of the country’s generics and biosimilars markets, and ongoing market access challenges.
The outbreak of the COVID-19 pandemic in Europe at the beginning of 2020 forced massive adjustments across the pharma industry, from rapidly developing new lifesaving vaccines and treatments, ensuring the supply of critical generics, working more collaboratively with public sector actors, and switching to remote communication.
As Sobi’s Pablo de Mora explains, “COVID-19 had a significant impact on all of us, bringing radical change to our lives and forcing us to act differently. Even though Sobi’s mission did not change, the pandemic presented a challenging situation for rare disease patients since they require personalized treatment and were unable to get face-to-face encounters with physicians.”
Spain has one of the world’s highest vaccination rates due to a successful effort from the government and autonomous communities. The successful campaign resulted in resilience against Omicron and other variants, with low hospitalisation rates
Ángel Luis Rodríguez de la Cuerda of generic manufacturers association AESEG adds, “Since the beginning of the pandemic, generic drug laboratories have been working at full capacity to guarantee the production and supply of drugs to all hospitals and pharmacies in the country, multiplying production by ten for some essential products used in ICUs (cisatracurium besilate, propofol, midazolam, fentanyl, chloroquine, and hydroxychloroquine, among others), and hospitals, where 70 percent of total products declared by AEMPS were generics, demonstrating their commitment and production capacity at a time when shortages were affecting countries worldwide… The first wave of COVID-19 was mainly treated with off-patent drugs.”
Since then, Spain has successfully vaccinated the vast majority of its adult population, as MSD’s Ana Argelich Hesse notes. “Spain has one of the world’s highest vaccination rates due to a successful effort from the government and autonomous communities. The successful campaign resulted in resilience against Omicron and other variants, with low hospitalisation rates. That means that the prioritisation of treatments against COVID-19 has been lower than other countries.”
For long-time Reig Jofre CEO Ignasi Biosca Reig, COVID represents an opportunity to rethink the value of pharmaceutical innovation. “We should look at what happened with COVID vaccines and the success of mRNA technology,” he claims. “It showed the market that new technology can disrupt the industry very quickly.”
Spain is an important member of the European Union and is set to receive EUR 140 billion – EUR 72 billion of which need not be repaid – from Next Generation EU recovery funding as part of its COVID recovery. The Spanish government expects to allocate 7.1 percent of these funds (EUR 4.94 billion) to healthcare.
According to Ignacio Vega of medtech producer and distributor Cardiva, this funding influx represents “a unique opportunity [for Spain] to take risks, betting on the future by investing in companies and people developing new technology. If given the chance, I would also use part of the EU funds to modernise the system; the country has top professionals but needs to invest to make the system more efficient, reducing unnecessary processes.”
The pandemic has revealed the importance of Europe having strong manufacturing capacity, so it does not have to rely on India and China during emergencies
Javier Urzay of innovative industry association Farmaindustria feels that data investment will take on greater importance in the coming years. He outlines, “One promising project is Data Lake, supported by European funds and completed by the Ministry of Economy and Digital Transformation and the Ministry of Health, aims to create a national strategy on health data. Farmaindustria hopes that the implementation of this project will enable collaboration with private companies to produce the real benefits of this data: access to new medicines, innovation, and better healthcare.”
Others hope that the pandemic leads to an acknowledgement of the importance of keeping manufacturing within Spain and Europe as a whole. David Perdigó, CEO of new chemical entities, generic products and contract manufacturing firm Noucor asserts that “The pandemic has revealed the importance of Europe having strong manufacturing capacity, so it does not have to rely on India and China during emergencies.
Generic drugs are in important part of the Spanish pharma industry and account for 22.2 percent of of value in the national market but PharmaBoardroom’s Spanish interviewees have mixed feelings on the future of the segment.
“Unfortunately, generic penetration in Spain has stagnated after incentives to grow the market were removed in 2015,” states Mar Fabregas of STADA.
“A change is needed, and I hope that the COVID-19 pandemic has foregrounded the value that our industry can bring. For example, generics are vital to supply security and 70 percent of the medicines declared ‘essential’ by the Spanish Ministry of Health during the crisis had a generics option. My wish is for the contribution of the generic industry to be better valued by the Spanish authorities through the implementation of measures such as ensuring a price difference between generics and reference products. Without such incentives, the industry will not be able to grow.”
Generics are vital to supply security and 70 percent of the medicines declared ‘essential’ by the Spanish Ministry of Health during the crisis had a generics option
Kern Pharma’s Raúl Díaz-Varela is more positive. “I remain optimistic about the prospects of the generics industry in our country. If we look at the European Union’s pharmaceutical strategy, it is clear that the system will change in the following years, benefiting companies that produce locally in the continent. Some aspects, such as only looking at price when evaluating medicines, must change soon so that aspects like local manufacturing and proximity and safety of the supply chain are taken into account.”
It is a similar story in the biosimilars segment, where deputy director of the Spanish Biosimilar Medicines Association (BioSim) Isabel Del Rio points out that “We have observed big improvements in terms of trust [of biosimilars] from both healthcare professionals and patients in the last few years”
Joaquin Rodrigo of Sandoz adds, “The Spanish biosimilars industry is experiencing a reduction of prices, regulatory changes regarding product approval, and increased local and global competition, which is a complex topic in the country due to the decentralized healthcare system. We foresee more companies looking to enter the European markets, and Spain is a prime destination.”
A final topic on the mind of industry executives across the world, but especially those in Spain, is market access and ensuring that new innovations are approved and made available at a fair price as quickly as possible.
Many of our interviewees bemoaned a worsening access situation in Spain. Norberto Villarrasa Justicia, cluster head for Spain, Italy & Portugal at Japanese firm Kyowa Kirin, admits that “Spain has been lagging in recent years regarding access to innovation; statistics are there for everyone to see. It is getting closer to countries like Portugal in terms of time and conditions for approval when it used to be much higher in the rankings.”
Nabil Daoud of Eli Lilly sings a similar tune. “One of the greatest challenges has been the deterioration in access to innovation, including pharmaceutical innovation. In Spain in 2019, the ‘Patients WAIT’ (Patients Waiting to Access Innovative Therapies) indicator published by IQVIA measured that only 57 percent of medicines approved by the EMA between 2016 and 2019 were available in Spain for Spanish patients.”
The evaluation and financing process of medicines needs to be reworked, it must be a more open process that takes into account the point of view of experts and patients.
He goes on, “Furthermore, it takes approximately 450 days for the Spanish government to approve reimbursement of a new medicine for its citizens. The last two years are likely to demonstrate further deterioration given the challenges of the pandemic.”
In terms of solutions, UCB’s Pau Ricós suggests that “the evaluation and financing process of medicines needs to be reworked, it must be a more open process that takes into account the point of view of experts and patients. As in most things, we should aspire to create more synergies because we all have common objectives.”
Juan Vera of women’s health specialist Organon supplements this by saying that “we must secure access to innovation, but we must do it in a sustainable way, which could be addressed with new mechanisms to evaluate and finance medicines. The move to include real world evidence in such evaluations is a positive development in our opinion; however, the system, as it is today, is not capable of moving in that direction because of limited digitalisation.”