Precision medicine and new medicines require the modernisation of evaluation and funding processes, including the social perspective and the economic contribution to the country.
Funcas and Farmaindustria held a conference on ‘The economic regulation of the pharmaceutical industry. Current situation and future prospects in Spain’, which was attended by more than 300 people.
Experts and authorities have analysed, among other issues, how future European pharmaceutical legislation and the Royal Decree on the evaluation of health technologies should be articulated.
The Minister of Health, Mónica García, highlights the Strategic Plan for the Pharmaceutical Industry as a government priority: “Only through close collaboration between all agents, with a clear and proactive vision, will we be able to overcome the current challenges”.
“Pharmaceutical regulation must facilitate that biomedical innovation is available to all patients and that it is built on an ultimate goal: to serve society,” said Jesús Ponce, president of Farmaindustria.
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Scientific evidence has shown that innovation in medicines is not an expense, but an investment, an investment with measurable returns from the triple health, economic and social perspective. In fact, every euro invested in medicines saves between 2 and 7 euros in other healthcare costs and adds indirect savings in productivity and other social costs, as pointed out in the report The Value of Medicines from a Social Perspective, produced by the Weber Foundation.
The impact of new drugs will be even greater with the advances being made in biomedical science and their translation into new therapies and new mechanisms of action leading to precision medicine and a new paradigm in the treatment of disease. These new treatments have come to revolutionise the way patients are being treated and must also involve a revolution in the way their value is measured.
This was the central theme of the conference The economic regulation of the pharmaceutical industry. Current situation and future prospects in Spain, organised by Funcas and Farmaindustria and held in Madrid on Thursday, with the participation of representatives from health authorities and regulators, universities, the pharmaceutical industry and expert economists, with more than 300 people attending and following the online broadcast.
“Pharmaceutical regulation must facilitate that biomedical innovation is available to all patients and that it is built on the basis of an ultimate goal: to serve society”, said the president of Farmaindustria, Jesús Ponce, at the beginning of the meeting. “We must ensure that the proposed revision of pharmaceutical and industrial property legislation meets the needs of patients, health systems and Member States without undermining the current innovation ecosystem in Europe, while improving the competitiveness that our region has lost to third countries in the last two decades,” he said, referring to the European context.
Moving down to the national level, Ponce referred to the royal decrees on health technology assessment and price and financing that have been announced by various authorities of the Ministry of Health, which “must contribute to establishing a robust, objective, participatory, transparent and modern regulatory system for the pharmaceutical industry”.
“We want to work with the Administration, the healthcare system, the scientific community and society as a whole to put medicines in their rightful place and define the appropriate strategy for Spain to have the productive and research fabric it deserves,” concluded the Farmaindustria president.
The pharmaceutical industry, a sector of value for society
Finally, Ponce stressed that the pharmaceutical industry is one of the main sectors responsible for generating health, economic and social value, “contributing innovation, quality employment and competitiveness to developed economies”.
Another of the conclusions of the meeting was the need to separate the process of evaluating new medicines from the decision on financing and to guarantee the necessary transparency in procedures, especially in terms of price and financing. Likewise, a necessary reform of the reference price system was proposed, as a way to avoid discouraging innovation with added therapeutic value and to improve the situation of many medicines considered strategic.
The new pharmaceutical regulation should also take advantage of the potential of the use of real-life data and, in general, of the opportunities offered by digitalisation and artificial intelligence, as Pedro Luis Sánchez, director of Farmaindustria’s Research Department, pointed out.
The Minister of Health, Mónica García, was in charge of closing the meeting and reminded the audience that the regulation of the pharmaceutical and drug industry is “one of the most important issues for the future of Spain and Europe” and that the Strategic Plan for the Pharmaceutical Industry is one of the Government’s priorities.
“Spain is a key player in clinical trials in the international context and one of the reasons for this is that our health system is capillary and decentralised. This, far from being a weakness, is a strength, and we need to promote synergies between our health system, its professionals, researchers, centres and the pharmaceutical industry to facilitate the achievement of innovative projects. We must also be aware of the role that patients must play in the whole process, as they are the ones who allow this innovation to develop,” said the Minister of Health. She added: “Only through close collaboration between all the agents, with a clear and proactive vision, will we be able to overcome the current challenges”.
Also taking part in the conference were María Jesús Lamas, Director of the Spanish Agency for Medicines and Health Products (Aemps); Magda Chlebus, Executive Director for Scientific and Regulatory Affairs of the European Federation of the Pharmaceutical Industry (Efpia); Rainer Becker, Deputy Director General for Medical Products and Innovation of the European Commission’s Directorate General for Health and Food Safety; Jaume Puig-Junoy, from the Ernest Lluch-UPF Barcelona School of Management Foundation; Georges Siotis, from the Economics Department of the Carlos III University (Madrid); and Marta Trapero, Serra Hunter Lecturer at the Faculty of Law, Economics and Tourism of the University of Lleida.
