“It’s time for Europe to make up for lost ground in pharmaceutical innovation”
Farmaindustria brings together in Spain the main European National Associations representing the innovative pharmaceutical industry and the European Federation of the Pharmaceutical Industry together with the Spanish Medicines Agency to discuss how regulation can boost pharmaceutical innovation in the EU
The Director General of Farmaindustria, Juan Yermo, highlights the opportunity opened up by the Spanish Presidency of the Council of the European Union in the second half of 2023 to include the innovative pharmaceutical industry among the priorities of this mandate
The Director of the Aemps, María Jesús Lamas, points out that the current review of pharmaceutical legislation being carried out by the European Commission should serve to relaunch Europe’s role as a benchmark in pharmaceutical research
Source: farmaindustria.es
On 13 and 14 April, Farmaindustria brought together in Madrid the main heads of the regulatory area of some twenty European National Associations representing the innovative pharmaceutical industry and the European Federation of the Pharmaceutical Industry (Efpia), together with the Spanish Agency for Medicines and Health Products (Aemps), with the aim of sharing experiences and discussing how legislation can boost pharmaceutical innovation throughout the European Union. The meeting coincides with the current review of pharmaceutical legislation within the EU, the first in 20 years, which is being carried out by the European Commission, and which will ultimately result in a new European Pharmaceutical Strategy.
The meeting, held at Farmaindustria’s headquarters, was attended by representatives of the pharmaceutical associations of Austria, Belgium, Finland, France, Ireland, Luxembourg, Norway, Poland, Portugal, Romania, Sweden and Turkey, who agreed that this review of pharmaceutical legislation represents a unique opportunity to recover the competitiveness lost in recent years by the continent in terms of biomedical R&D compared to other territories such as Asia and the United States.
On behalf of Farmaindustria, the director general, Juan Yermo, pointed out the importance of 2023 for the pharmaceutical industry both in Spain and in Europe. “We are in a key year for the sector. In our country, we are already working with the Government on the development of the Strategic Plan for the Pharmaceutical Industry, scheduled for June, which will be based on three pillars: access to innovation, promotion of innovation and boosting the national manufacture of medicines”.
Furthermore, he added, the Spanish Presidency of the Council of the European Union in the second half of 2023 “is a great opportunity to include the innovative pharmaceutical industry among the priorities of this mandate and to promote a biomedical research ecosystem that will allow Europe to recover lost ground in pharmaceutical innovation, as well as to establish more resilient production and supply chains for medicines”.
Precisely, the director of the Aemps, María Jesús Lamas, conveyed to the members of the European pharmaceutical industry the importance of the current moment with the review of pharmaceutical legislation by the European Commission. “We have to take advantage of this momentum that the European Union’s interest in guaranteeing patients’ access to innovative, safe, efficient and high quality medicines, while stimulating the development of a renewed, innovative and patient-centred European pharmaceutical sector, and making it competitive with other regions”. “We need to put Europe at the forefront of clinical research. Stimulate biomedical innovation and integrate scientific and technical knowledge in the development and evaluation of medicines.
During the meeting, in addition to general regulatory issues in the sector, three other key aspects of the sector were discussed: clinical trials, advances in digitalisation and new technologies in the use of data, and the priorities of the upcoming Spanish Presidency of the EU Council in the area of healthcare.
Juan Estévez, from the Clinical Trials Area of the Aemps, and Amelia Martín, associate director of Clinical and Translational Research at Farmaindustria, gave voice to the current situation of clinical trials, highlighting the need to continue working to make Spain a world leader in clinical research, ensuring the rights and safety of patients, bearing in mind the monitoring of regulations with the aim of allowing access to new treatments.
On the other hand, José Manuel Simarro, ICT advisor of the Spanish Medicines Agency (AEMPS), presented the latest news on the digital transformation of the European regulatory network for medicines, illustrated how artificial intelligence is allowing to improve regulatory science to support decision-making and how the DARWIN platform is aligned with the European Health Data Space.
Finally, Cristina Arnés, manager of Farmaindustria’s International Department, informed the members of the meeting of the priorities of the Spanish Presidency of the Council of the EU, as well as the advocacy work being carried out by the employers’ association, such as the preparation of several high-level events during the first half of 2023.
