Mariano Votta and Bianca Ferraiolo from the Cittadinanzattiva-Active Citizenship Network discuss this year’s European Patients’ Rights Day which focuses on Advanced Therapy Medicinal Products in Europe.
This year, Active Citizenship Network, the European branch of the Italian NGO Cittadinanzattiva, will celebrate European Patients’ Rights Day which has reached its 17th edition. The event will be marked with a conference at the European Parliament in Brussels on April 26 from 15:00 to 17:00, kindly hosted by MEP Brando Benifei (S&D) and organised with the support of the MEP Interest Group ‘European Patients’ Rights & Cross-Border Healthcare’ and the TRANSFORM MEP Interest Group.
The 2023 conference represents the first in-person European celebration of the European Patients’ Rights Day since the beginning of the COVID-19 pandemic and, to give more people the opportunity to participate, it will also be streamed online.
Advanced Therapy Medicinal Products have presented new treatment opportunities
In recent decades, developments in molecular and cellular biology and progress made in the study of DNA have radically transformed the biomedical field in addressing the treatment of various genome-based diseases. In recent years, particularly, new genic, cellular, and tissue engineering therapies (the so-called ATMPs, Advanced Therapy Medicinal Products) have emerged, presenting new opportunities for the treatment and prevention of a variety of diseases or for restoring, correcting, or modifying compromised physiological functions in humans, including correcting mutations acquired on a genetic basis.
From research toward a growing number of ATMPs to their use once approved, the unifying themes seem to be sustainability, innovation, and equity. To these, from our point of view, two further elements must be added, which should also be considered as drivers in choices associated with ATMPs: respect for and reinforcement of patients’ rights. It is no coincidence that the issue of Advanced Therapy Medicinal Products is related to several rights set out in the European Charter of Patients’ Rights, which is at the heart of the EPRD celebrations:
- Patients’ right of access to care (‘Every individual has the right of access to the health services that his or her health needs require. The health services must guarantee equal access to everyone, without discriminating on the basis of financial resources, place of residence, kind of illness or time of access to services’);
- Patients’ right to personalised treatment (‘Each individual has the right to diagnostic or therapeutic programmes tailored as much as possible to his or her personal needs’);
- Patients’ right to innovation (‘Each individual has the right of access to innovative procedures, including diagnostic procedures, according to international standards and independently of economic or financial considerations’);
- Patients’ right to information (‘Every individual has the right to access to all kind of information regarding their state of health, the health services and how to use them, and all that scientific research and technological innovation makes available’).
The 17th European Patients’ Rights Day will focus on the field of Advanced Therapy Medicinal Products
The current narrative related to the European pharmaceutical legislation review seems to be limited to the following statement: ‘the fate of the pharmaceutical sector is at stake as well as the future of national health systems’. What about the justified expectations of patients? How can innovation and access be combined? To try to answer these questions, the 17th European Patients’ Rights Day will gather inputs from EU Institutions, the World Health Organization, Patient Advocacy Groups from different countries, independent experts and relevant stakeholders in the field of Advanced Therapy Medicinal Products.
The initiative also testifies to the commitment on the topic by Cittadinanzattiva. In Italy, by the Health Authorities it is officially involved in the National Ethics Committee for clinical trials on advanced therapies, and at EU level, a concrete proposal was presented last October and endorsed by 43 Patients Advocacy Groups (PAGs), to try to make up ground for patients’ right to access advanced therapies, calling for a change in institutional mentality to classify spending on ATMPs as an investment and not as a cost. The cost of these therapies could be amortised over the years in relation to the savings generated over time. In particular, they could be included in the state budget over several years and not all in the year of expenditure. This would significantly increase the financial sustainability of these costs by the public sector over time and promote greater and more equitable use of ATMP medicines in the population, without putting public finances at risk.
During the European Patients’ Rights Day 2023 Cittadinanzattiva wants to give this topic the importance it deserves. Certainly, it is a complex topic where information is still scarce among the whole population and also among the various PAGs. And for this reason, has invited as many leaders of patient associations as possible.