The European Health Technology Assessment Regulation, an opportunity to speed up access to new medicines for patients in Spain
Its application should also serve to put an end to repetitive and inefficient evaluations and guarantee rigour for patients and healthcare professionals, who will play an important role in the evaluation procedure.
Farmaindustria is organising a conference to analyse this regulation in depth and its translation to the national level at the European Parliament in Madrid.
Farmaindustria.es
The European Regulation on Health Technology Assessment (HTA), which entered into force in January 2022, will be implemented in a staggered manner from January 2025. This new regulatory framework is a great opportunity for a homogeneous analysis of the highest scientific quality in the field of the assessment of the clinical benefit added by new medicines and other health technologies.
It should also serve to put an end to repetitive and inefficient assessments at national, regional or local level; it should guarantee rigour for patients and healthcare professionals, who will also have a prominent role in the assessment procedure, but, above all, it should serve to improve patient access to new medicines.
These were the main conclusions of the conference European HTA Regulation: from theory to practice, organised this Tuesday by Farmaindustria, in collaboration with Novartis, at the headquarters of the European Parliament in Madrid, which was attended by representatives of the Ministry of Health, regional authorities, healthcare professionals, patients, pharmaceutical companies and other experts.
‘Without a doubt, the most important achievement of this new regulation is that it can reduce the evaluation time of medicines in our country, which is currently in the middle of the European table in terms of evaluation and financing times for new medicines,’ Jesús Ponce, president of Farmaindustria, stressed at the opening of the meeting.
The implementation of this regulation is quite a challenge as it will start in January 2025 with some of the most complex medicines to evaluate: oncology and advanced therapies. ‘All those involved in the development of therapies and health technologies must rise to this challenge. We are at a transformational moment, a true biorevolution thanks to the omic sciences and new digital technologies that can change the lives of patients”, said Ponce, who stressed that “we are not only talking about new therapies, but also about the implementation of biomarkers and genomic diagnosis for some diseases, which allow both improving the therapeutic target of treatments and implementing new prevention policies”.
In this regard, throughout the conference, emphasis was placed on the need for the evaluation process to consider the social value of the innovative medicine, which ‘goes beyond its therapeutic value and the savings it generates for the healthcare system’, as Juan Yermo, director general of Farmaindustria, pointed out.
The experts also agreed that the evaluation of new treatments should evolve towards a scheme based on the participation of all key stakeholders, especially patients, the creation of value for patients and society, and the separation of the evaluation and decision-making processes. ‘The European HTA Regulation foresees a very limited involvement of pharmaceutical companies in the evaluation procedure. They should be more involved, as they are the actor who knows the drug to be evaluated best,’ Yermo said.
The new regulatory framework in Spain
Moving down to the national level, the conference participants also agreed that Spain should take advantage of this opportunity to improve patient access to innovations and avoid re-evaluations and additional assessments that may provide little evidence and consume a lot of time and resources.
The Ministry of Health is already working on a draft Royal Decree on health technology assessment, in which it is essential to incorporate the European procedure for assessing the added clinical benefit in order to build the assessment on the basis of its conclusions. ‘The common objective is to make a robust assessment of the clinical benefit provided by a medicine and to improve the availability of innovative medicines in our country, both in terms of number of products and approval times,’ explained Yermo.
‘From Farmaindustria we are at the disposal of the health authorities to work on the development of the European and national regulatory framework as an active and necessary party, as we can contribute all the expertise and knowledge of our companies’, said the Association’s director general.
All of this, as was made clear at the meeting, within a framework of sustainability of the healthcare system, to which medicines make a decisive contribution, as demonstrated by the scientific evidence that has shown that investment in healthcare, medicines and biomedical research is not an expense, but an investment with health, economic and social returns.
‘All actors in the system must act together to meet these new regulatory challenges. If we do so, the rewards will be very high for society as a whole in the form of new medicines, more efficient healthcare systems, more and better cared for patients and a healthier and more prosperous society,’ concluded the president of Farmaindustria.
Also participating in the conference were Ana López de la Rica and Sonia Pulido, from the Spanish Agency for Medicines and Health Products (Aemps); Pedro Carrascal, Director General of the Platform of Patients’ Organisations (POP); César Rodríguez, President of the Spanish Society of Medical Oncology (SEOM); Carlos Martín, from the Directorate General for the Common Portfolio of NHS Services and Pharmacy; Josep Mª Guiu, Director of the Pharmacy and Medicines Area of the Health and Social Care Consortium of Catalonia; Silvia Fernández, Director General of Healthcare and Humanisation of Castilla y León; and Pedro Luis Sánchez and Isabel Pineros, from Farmaindustria.
