The pharmaceutical industry is committed to Spain with investments of 9,000 million euros and asks the Prime Minister to continue supporting legislative reforms that favour innovation, strategic autonomy and predictability.

The President of the Government meets for the second time with around twenty representatives of the national, European and global pharmaceutical industry to intensify public-private collaboration and follow up on the plan launched in 2023.

Pedro Sánchez stresses that the pharmaceutical industry is a key asset for our country and a strategic sector on a global level

Pharmaceutical companies expect to close 2025 with an investment of 9,000 million euros in the last 3 years in Spain, a figure that could multiply in the next three years with an environment that favours investment.

Representatives of the pharmaceutical industry ask the President of the Government to ensure that the legislative reforms planned at European and national level give predictability to the sector, which will allow it to recover the competitiveness it has lost compared to other regions and cement strategic autonomy in innovative medicines.

“Group photo of the meeting between the Prime Minister, Pedro Sánchez, and representatives of the pharmaceutical industry.”

Farmaindustria.es

The President of the Spanish Government, Pedro Sánchez, together with the Minister of Health, Mónica García; the Minister of Industry and Tourism, Jordi Hereu, and the Secretary of State for Science, Innovation and Universities, Juan Cruz Cigudosa; the Secretary of State for Industry, Rebeca Torró, and the Director of the Office of Economic Affairs and G20, Manuel de la Rocha, met this Wednesday with around twenty representatives of the national, European and international pharmaceutical industry to intensify the dialogue that will allow them to continue promoting public-private collaboration and to follow up on the plan launched in 2023.

This is the second high-level meeting held in just over two years. The first, held in December 2022, was the start of a joint work plan that has had as its first result the publication of the Pharmaceutical Industry Strategy, which positions this sector as one of the key assets for Spain and aims to be the key to position Spain as a spearhead in biomedical research and production and access to new medicines – it is the first time that the Spanish government has developed an initiative of this nature for an industrial sector.

Precisely, this framework of collaboration is one of the factors that has favoured that between 2023 and 2025 Spain will exceed the investment of 8,000 million euros by pharmaceutical companies, the figure announced at the December 2022 meeting. By the end of this year, this amount is expected to increase by more than 1 billion euros. As the Prime Minister stressed, the pharmaceutical industry is a key asset and a ‘strategic sector for the country’. ‘We will continue to work in close public-private collaboration to offer citizens the best treatments and move towards a safer, more competitive and innovative pharmaceutical industry,’ he said.

At the meeting held today, in addition to reiterating to Sánchez the pharmaceutical industry’s commitment to Spain, the company representatives stressed the importance of continuing to maintain an open and constructive dialogue that guarantees an environment of stability and regulatory predictability for the sector, whose development and growth is not immediate, but requires a long time to see results due to the high risk of its investment (the R&D process for a drug takes 10 to 12 years). The government has a key role to play in removing some of the uncertainty in this process by supporting favourable regulation in both Europe and Spain.

‘The Strategy for the Pharmaceutical Industry in Spain 2024-2028 establishes a platform for dialogue between government and industry to address legislative initiatives and a roadmap of reforms for the next four years. Such dialogue and collaboration are essential to achieve a stable and predictable regulatory environment that encourages and attracts investment,’ says Farmaindustria’s president and Amgen’s CEO in Spain, Fina Lladós Canela.

‘The sector is committed to the health and well-being of society as a whole, contributing to improving healthcare and supporting economic growth, productivity and quality employment in Spain and Europe. To achieve this, we need the right regulatory conditions,’ adds Lladós.

The presidents, CEOs and senior executives of pharmaceutical companies and international (Ifpma), European (Efpia) and Spanish (Farmaindustria) employers’ associations have called on the Prime Minister to protect and boost the industry’s competitiveness by taking advantage of the reform of pharmaceutical regulation in the European Union (EU) and the legislative and regulatory reforms planned at national level. In the current global context, the industry needs more than ever measures to cement investor confidence in Spain and Europe.

Proposals to regain lost competitiveness at European level

Specifically, the focus was placed on two issues of impact for the pharmaceutical industry under debate at European level. On the one hand, the sector’s loss of competitiveness – reflected in its declining global presence in clinical trials and the development of advanced therapies – which will be further accentuated by the European Commission’s proposals on the review of pharmaceutical legislation. Among its proposals is the reduction from 8 to 6 years of the protection of regulatory base data (a key incentive for innovation), as well as the reduction from 10 to 9 years of market exclusivity for orphan drugs (for rare diseases).

In the industry’s view, Spain should position itself among the leading countries in pharmaceutical innovation in Europe and support keeping the base data protection period at 8 years.

On the other hand, although the pharmaceutical industry is fully committed to the ecological transition and is a leader among the different industrial sectors in environmental indicators, several simultaneous legislative initiatives with a high impact have emerged. The most advanced is the Urban Waste Water Treatment Directive, which, if implemented, will deal a severe blow to patients’ access to medicines and the overall competitiveness of the pharmaceutical sector in Europe. Its cost is disproportionate, as it provides for only two industries, pharmaceuticals and cosmetics, to bear almost the entire cost of quaternary treatment to remove chemical micropollutants.

Both measures will make Europe less attractive for investment in biomedical innovation compared to the US and China, with consequent impacts on patients, welfare and the continent’s economy.

In the national context, it has asked the President of the Government for a balanced development of the regulations on the table, such as the Royal Decree on the Evaluation of Health Technologies, the Royal Decree on Price and Financing and the Draft Bill on Medicines.

It is also a priority for the pharmaceutical industry to improve access times and availability of medicines so that patients have the best possible innovative treatments available to them in the shortest possible time, in a fair and equitable manner and ensuring the sustainability of the healthcare system.

‘Predictability is essential for the competitiveness of our industry and for the well-being of health systems and, most importantly, of the patients for whom we innovate,’ Lladós stresses. ‘We are committed to working together to build a more prosperous and equitable future for all people,’ she added.

At stake are the opportunities that the sector represents: consolidating Spain’s leadership in clinical trials and boosting translational and pre-clinical research; gaining strategic autonomy and resilience in the drug supply chain, modernising production processes and boosting environmental sustainability and the circular economy; implementing a true digital transformation in the health sector, taking advantage of the opportunities offered by artificial intelligence, data science, quantum computing and digital solutions, and the European Health Data Space, as well as contributing to job growth, especially among the under-30s.

Spain has the opportunity to become a global hub for drug research and production if the regulatory environment encourages investment by the innovative pharmaceutical industry.

The pharmaceutical industry, a valuable sector

The biopharmaceutical industry is a valuable sector in the countries where it is established due to its contribution to health, social and economic well-being, as recognised by the President of the European Commission, Ursula von der Leyen, in the priorities set for her second mandate; the Draghi Report and the Competitiveness Strategy for the life sciences sector, and the Strategy for the Pharmaceutical Industry in Spain itself.

The sector is a leader in R&D investment worldwide, with a percentage of 30% of its annual revenues dedicated to this item, which amounted to nearly 270,000 million euros in 2021. In Spain, the pharmaceutical industry has maintained a sustained growth in R&D investment of 5.7% over the last decade, with close to 1.4 billion euros in 2022. This figure represents 20% of all industrial R&D in the country and includes more than 830 million dedicated to clinical trials, making Spain an international leader in this field. With this base, the country has the unique opportunity to become a world leader in biomedical innovation, including basic, preclinical, translational and clinical research.

In the field of production, Spain has also positioned itself as one of the European countries with the greatest manufacturing potential at a time when medicines have proven to be a strategic and security asset for countries. There are currently 174 drug production plants in 13 autonomous communities, of which 106 are dedicated to medicines for human use. More than 80% of these plants belong to innovative laboratories that also market off-patent medicines, which are essential to guarantee healthcare, especially in times of emergency, as was seen during the pandemic. The production of medicines in Spain has increased by 40% in the last three years, to 23,000 million euros, and 6 out of every 10 euros of added value of high-tech goods (which also includes electronic products and the aerospace industry) is due to medicines. Medicines are the country’s fifth most exported product, reaching 21.1 billion euros in 2023.

In the section on the contribution of the pharmaceutical industry to the Spanish economy, a new report prepared by Analistas Financieros Internacionales (Afi) and presented last week, estimates that the pharmaceutical sector contributed to generate more than 27,200 million euros of added value in 2023, both directly, indirectly and induced, equivalent to 1.9% of the national GDP. These new data highlight the sector’s significant multiplier effect on other economic activities. Thus, the report highlights that each euro of added value generated in the pharmaceutical industry leads to the generation of an additional 1.5 euros by other companies and, on the other hand, that each additional euro of public investment in medicines contributes to the generation of almost 4 euros of added value in the country’s economy.

Finally, the pharmaceutical industry is a driver of the Spanish economy also because of its employment data: since 2017, the pharmaceutical sector has increased the weight of its workforce by 25.8% to reach 56,325 direct jobs in 2023, which, added to indirect and induced jobs, exceed 270,000 jobs throughout Spain. These are stable, quality and egalitarian jobs, with a commitment to youth employment -under 30 years of age-, which has doubled its weight in the last decade and which in 2023 accounted for more than 30% of new hires.