A moment of the meeting at Farmaindustria’s offices in Madrid.

Farmaindustria hosted a meeting in Madrid with the main heads of regulatory affairs from a number of National Associations in Europe representing innovative pharmaceutical industry and EFPIA, along with the Spanish Medicines Agency (AEMPS), with the aim of sharing experiences and to debate how regulation can boost pharmaceutical R&D across the EU. The meeting took place as the current EU regulatory framework for pharmaceuticals is under review by the European Commission – for the first time in 20 years –  which will result in a new Pharmaceutical Strategy for Europe.

The meeting, held at Farmaindustria’s offices in Madrid, was attended by representatives of National Associations based in Austria, Belgium, Finland, France, Ireland, Luxembourg, Norway, Poland, Portugal, Romania, Sweden and Turkey who agree that the current revision of the pharmaceutical legislation presents a unique opportunity for Europe to regain the competitiveness it has lost to countries like the US and China over recent years in terms of biomedical R&D.

Farmaindustria’s Director General, Juan Yermo.

Farmaindustria’s Director General, Juan Yermo, stressed how important 2023 is for the pharmaceutical industry not only in Spain but also in Europe. “It’s a key year for this sector. In Spain, we’re already working with the government to develop a Strategic Plan for the Pharmaceutical Industry, which is expected for July of this year and will rest on three pillars: access to innovations, fostering R&D, and boosting domestic manufacture of medicines.”

Yermo also added that the Spanish Presidency of the EU Council in the second half of 2023 “is a great opportunity for the research-based pharmaceutical industry to be included among the mandate’s priorities and to foster an ecosystem for biomedical research that allows Europe to make up lost ground in pharmaceutical research as well as establish more resilient supply chains for medicines.”

AEMPS’ Director, María Jesús Lamas.

AEMPS’ Director, María Jesús Lamas, pointed out that we are at a pivotal moment with the European Commission’s revision of pharmaceutical legislation. “We must take advantage of the impetus that the European Union’s interest affords us to guarantee patient access to innovative, safe, efficient and high-quality medicines while in turn promoting the growth of a renewed, innovative, patient-centred pharmaceutical industry and making it competitive compared to other regions,” said Lamas. “It is necessary to place Europe at the vanguard of clinical research, boost biomedical innovation, and integrate scientific and technical knowledge in the development and assessment of medicines.”

Sini Eskola (EFPIA) and Ana López de la Rica (Farmaindustria).

During the meeting, in addition to general regulatory matters of the sector, three key aspects were discussed: clinical trials, progress in digitalisation and new technology in the use of data, and health priorities of the upcoming Spanish Presidency of the EU Council.

To this end, Juan Estévez of the AEMPS’ Clinical Trials Department and Amelia Martín, Associate Director of Clinical and Translational Research at Farmaindsutria, spoke on the present state of clinical trials, highlighting the need to continue working towards making Spain a world leader in clinical research and to ensure patients’ rights and safety, keeping in mind the monitoring of regulations with the aim of allowing access to new treatments.

Juan Estévez (AEMPS).

Moreover, José Manuel Simarro, Head of IT at AEMPS, discussed updates in the digital transformation of the European medicines regulatory network, illustrating how artificial intelligence is helping improve scientific regulation to support decision-making and how the DARWIN platform is aligned with the European Health Data Space.

Emili Esteve (Farmaindustria), Ana López de la Rica (Farmaindustria) and José Manuel Simarro (AEMPS).

Lastly, Cristina Arnés, Manager of Farmaindustria’s International Affairs Department, reported on the priorities of the Spanish presidency of the EU Council as well as the advocacy efforts undertaken by Farmaindustria, such as the organisation of various high-level events during the first half of 2023.