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Presented at the European Parliament a potential win-win economic-accounting solution driven by Italian experts and endorsed by 43 Patients' Advocacy Groups

All potential eligible patients have the right to access Advanced Therapies Medical Products (ATMPs). National health budget constrains cannot be a barrier for patients to have access to ATMPs. Nowadays traditional reimbursement and budgeting schemes are unable to amortize the value of the ATMPs, whose costs and benefits are not aligned. These types of therapies need new and different payment and accounting methods, which take into account the high initial costs and the large and lasting benefits over time, both for the patients and for the national health systems. It is time for an institutional mindset change to classify ATMPs expenditure as an investment and not a cost, possible if it is decided to review - from Eurostat downwards - the economic/financial classifications of healthcare expenditure currently in force.

Endorsed by 43 Patients' Advocacy Groups (PAGs), this was - in synthesis - the key message sent today to the European and Member States Institutions in order to leverage the potential of the advanced therapies for a large number of European citizens in compliance with the budget limits in which healthcare has been paying almost all of Europe for some time.

Developed by a group of Italian experts supported by the #VITA coalition, the proposal - detailed and concrete - was presented today for the first time at the European Parliament in Brussels during the event “Securing Equitable Patient Access to Advanced Therapies across Europe”.

Kindly hosted by the Member of the European Parliament Tomislav Sokol (EPP group) and supported by the MEPs Interest Group “European Patients' Rights and Cross-border Healthcare”, the initiative has been organized by Active Citizenship Network (ACN), the EU branch of the Italian NGO Cittadinanzattiva, with the unconditional support of the #VITA – Value and Innovation of Advanced Therapies coalition, coordinated by the global law firm LS CUBE.

The proposal has been officially supported by ad hoc Call to Action “Advanced Therapies Medicinal Products revolution & the respect of the patients’ right to access to care” launched by ACN and endorsed by 41 among global/European/national civic & patients’ organizations. Addressed to the EU institutions, it requires the respect of the principles established in the European Charter of Patients’ Rights also in the field of ATMPs: what decisions needed to be taken at the level of each Member State to make these therapies accessible to the largest number of eligible patients? How can European institutions facilitate this process? How combine social and economic aspects for the benefit of EU citizens in the cross-border healthcare sphere? What role do PAGs play? Issues debated this afternoon with European institutions, academia, healthcare professionals, citizen organizations & Patient Advocacy Groups (PAGs), private sector, and key stakeholders.

The initiative, in particular, allowed us to discuss - from a multi-stakeholder perspective - the disruptive aspects of ATMPs and paid attention to the opportunities and challenges of new advanced therapies, which are expected to increase significantly over the next decade: an encouraging but equally challenging scenario, considering the high costs and public budget constraints faced by several EU countries. Aspects that must be addressed today in order not to be unprepared tomorrow.

“The solution lies in a change of perspective that leads to considering this expenditure also as an investment and not only as a cost,” Mauro Marè, Professor of Public Economics at the University of Tuscia and LUISS University, explains. “Advanced Therapies, in fact, offer benefits not only in the short term, but especially in the long term. Not only for people's health and wellbeing, but also in terms of direct and indirect savings: in the case of curative therapies, there is a radical improvement in the natural history of the disease, with the complete elimination of therapies and treatments that would often last for the person's entire existence. In addition to the impact on health, there is an equally important impact on quality of life and productivity at work. For these reasons, it is important to consider spending on ATMPs also as an investment expenditure - given the durable effects in the long run - to remove any barriers and to ensure that there is equity of access for patients in each individual member because this means equity of access for all European citizen”.

“Expenditure for this kind of therapies are not accounted for as an investment in any European country today,” Giorgio Alleva, Professor of Statistics at Sapienza University of Rome and former President - ISTAT (Italian National Institute of Statistics) points out. “If it were allowed, however, the cost of these therapies could be amortised over the years in relation to the savings generated over time. A totally innovative approach, which would have the characteristic of a 'win win' formula: advantageous both for the patient, who would benefit from highly innovative and effective treatments, and for the National Health Service, which could amortise the cost of the therapy over the years. To achieve these results requires courage and a strong conviction on the part of the European Parliament. The current accounting conventions have always been updated periodically according to the evolution of the scientific and political-institutional debate The revisions of the national accounting system introduced since the 1990s by the international community (UN and EU) have always concerned a progressive enlargement of the perimeter of investments, classifying as such expenses previously considered current, thus recognizing the increase in the stock of a nation's capital. Therefore, decisive for the future of a country and its economic sustainability - and that for this reason, Advanced Therapies expenditures can be considered, at least in part, as investment expenditures. After all, with the 2010 ESA revision, military expenditure was also reclassified from current expenditure to investment expenditure”.

" To guarantee the right of access to treatment to the greatest number of potentially eligible patients, avoiding forms of rationing or problems of financial sustainability, it was demanded today to the European institutions a paradigm shift, that is also due to all those European citizens who still believe in a Europe capable of putting the concrete needs of its citizens first, who in this dark period we are going through risk remaining totally invisible” highlight Mariano Votta, Director of Active Citizenship Network. “Accounting rules established at EU level, and a "sylos" approach between institutions and DGs within the European Commission terribly clashes with the legitimate expectations of health and, in some cases, of recovery, placed by an ever-increasing number of European patients, whose health needs cannot wait or clash with cold accounting logic".

For further information please don’t hesitate to contact ACN staff at This email address is being protected from spambots. You need JavaScript enabled to view it..

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