Medicines as a strategic asset
EL PAÍS and Farmaindustria address the tasks pending to achieve autonomy in the manufacture of pharmaceuticals.
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Spain stands out for its strong pharmaceutical industry. It has 174 production plants, of which 106 are dedicated to medicines for human use and 13 to biological products. This ecosystem generates 51,000 direct and indirect jobs, with pharmaceuticals being the third most exported good, with investments in innovation amounting to almost 1.4 billion euros. “The Spanish pharmaceutical industry has great specific weight in Europe,” Rebeca Mariola Torró, Secretary of State for Industry, stressed at a meeting organised by EL PAÍS and Farmaindustria. “We must also highlight three aspects that make the sector strategic: health, economic and social,” she added.
This competitive advantage is fundamental in an increasingly connected world, in which autonomy in the production of medicines is essential. “When we talk about strategic autonomy, the first thing we have to ask ourselves is which of the two souls of this we want to respond to,” explained Javier Padilla, Secretary of State for Health. “There is an autarchic and security aspect which, in a war context, appeals to the need to rearm. But there is also another strategic aspect that speaks to us of the need to cooperate in a global context of interdependence,” he added.
Spain is committed to the latter. “An example of the work we are doing is the commitment we have made to set up the European Alliance for Critical Medicines, a consultative mechanism that brings together different actors in the sector and public administrations to identify priorities for action and propose solutions to strengthen the supply of critical medicines throughout the region,” highlighted Mariola Torró during the meeting entitled Strategic autonomy of medicines: the value of producing innovative medicines in Spain. With this new tool, an example of public-private collaboration, an essential step is being taken to revitalise the production capacities of critical drugs in Europe and ensure their supply through the diversification of suppliers, said the Secretary of State. “This alliance, initially established for a period of five years, has selected 17 Spanish healthcare companies as guarantors of the supply of essential drugs”.
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Quality of life
“When we talk about availability of medicines, we have to consider two different aspects: access to innovations and physical availability, i.e. manufacturing. We all agree that pharmaceutical innovations improve the quality of life and survival of patients, being responsible for 73% of the increase in life expectancy in developed countries. Therefore, access to innovative drugs is crucial,” stressed Lidia Martín, Vice President of Farmaindustria and CEO of Almirall. The pharmaceutical industry shows a tangible commitment to innovation and its accessibility. Currently, one out of every five euros invested in R&D in Spain comes from the sector, said the industry representative. In addition, almost half of the R&D projects are carried out in collaboration with institutions, universities and public-private entities.
“Spain is the EU leader in clinical trials, with 50 new molecules approved each year in Europe,” Martín said. However, only 58% of new innovations are authorised in Spain, and the process takes more than 600 days. “When it comes to hospital drugs, regional and hospital access times can exceed two years,” Martín said. The pharmaceutical industry’s strategic plan, in collaboration with the government, seeks to solve these problems by reforming the financing and pricing system. This involves establishing objective and predictable criteria, early access programmes and streamlining public procurement processes in the hospital setting.
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In terms of manufacturing, Spain is in a privileged position. Therefore, it is essential to ensure incentives, means and adequate regulation to promote domestic drug production. “This not only has a positive economic impact, but is crucial for our strategic autonomy,” added Almirall’s CEO. In Spain, it is necessary to guarantee that no one is left behind, ensuring access to medicines according to the reality of each person, always prioritising the patient’s need and not just the disease, added Manuel Arellano, vice-president of the Platform of Patients’ Organisations. Similarly, a key point is personalisation. “In haematology, for example, each problem requires different treatments,” he said. Given this reality, Arellano said that patient involvement from the beginning of clinical trials is vital, as they can provide valuable insights throughout the process.
Eva Sánchez Morla, psychiatrist at the Gregorio Marañón University Hospital and associate professor at the Complutense University of Madrid, acknowledged that there is a significant difficulty in the access and availability of medicines, especially old and cheap drugs that do not have therapeutic equivalents. This situation is very common in clinical practice and is often discovered only after patients are unable to access their medication. “This problem is especially critical in areas such as psychiatry, where some drugs are irreplaceable,” he said. Lack of these can lead to patients visiting several pharmacies in vain, causing relapses that are costly for the patient, the family and society.
In addition to the problem of availability, he also faces challenges in accessing new therapeutic innovations. “These new therapies are crucial for the treatment of complex and heterogeneous pathologies, which require a personalised approach. From a clinical point of view, we are concerned that these gaps in the availability of essential medicines can and should be addressed. Administrations must facilitate solutions so that healthcare professionals can collaborate effectively in this process,” stressed Sánchez Morla.
