Local American Working Group (LAWG), one of the most well-known associations dedicated to supporting patients, proposes the initiation of a fund through which Romanian patients will benefit from rapid access to innovative therapies. This project, part of a collaboration initiated in the last three years by LAWG, comes as a result of the launch of the study developed by the Office of Health Economics (OHE), which shows that in the last 20 years Romania has made insufficient progress in the field of health policies and that investments in health and improving Romanian patients’ access to innovative medicines could reduce mortality, improve their quality of life and lead to longer-term cost savings through a reduced need for healthcare.
In the current context, which generates major multi systemic pressure, rapid access of patients to innovative treatments that are not yet compensated in Romania is all the more important because it represents a chance at an effective treatment, a way to improve the quality of life, a way to reduce the pressure on the health system and the state budget and contribute to long-term economic growth. In this respect, building a fund for innovation in health for medicines, which would give Romanian patients quick access to innovative medicines, is an initiative generating new perspectives for both the patient, through faster social reintegration, and for the health system, by reducing long-term financial pressure.
Jorge Ruiz Benecke, President of LAWG, states:
“The Innovation Fund for Treatments is a budget dedicated to the early and temporary reimbursement of innovative medicines. The fund is not an alternative reimbursement system to the current system, but an advance compensation system, through which innovative medicines can be made available to patients until the formalities for including these medicines in the current reimbursement system are completed. OHE recommends that the Fund be administered by the National Health Insurance House (CNAS), and the National Agency for Medicines and Medical Devices in Romania (ANMDMR) be responsible for the process of assessing the eligibility of medicines. Administrative responsibilities and timelines should be developed in collaboration with all partners involved and should be coordinated in relation to current infrastructure and capacities. In addition, a legislative framework to implement the Fund needs to be investigated and developed. From the discussions with the experts we received the message and the encouragement to continue our approach, to accelerate this process and to demonstrate that together we can make a difference for patients in Romania. The innovation fund for medicines should not be the only solution we consider, efforts are being made on prevention, efforts are being made for early diagnosis. The Innovation Fund can be a valuable resource to support an active society, being an initiative designed to support prevention efforts, while contributing to state revenues and the economy”.
The LAWG initiative, started more than three years ago and which has included several national advisory steps with important decision-making actors, authorities and experts, has concrete proposals for contracts, protocols and ways of compensating medicines through this Innovation Fund and requires effective medium- and long-term collaboration of all actors in the public-private environment, in order to better coordinate and implement the programme at national level. Launching a health innovation fund and rapid access to innovative treatments could cover three types of medicines: medicines that prior to the acquisition of the APP (approval to put on the market) were approved under Order No. 1018/2014, medicinal products for which the APP has been issued under the PRIME (Priority Medicine) procedure by the European Medicines Agency and medicinal products proving a high degree of innovation and efficiency, which are assessed by ANMDMR on the basis of a grid of criteria. They can be the starting point, and once its effectiveness is confirmed and to the extent of the available budget, the Innovation Fund may also be open to other medicines considered innovative.
Dr. Corneliu-Florin Buicu, Chairman of the Health and Family Committee of the Chamber of Deputies, says:
“Improving access to treatment is one of the priorities of our Commission and over the past three years we have taken concrete steps in this direction through the Health Resources platform and the White Paper for Innovation in Health. I trust solid recommendations from OHE experts, which will form the basis for the development of health policies to make patients access to innovative therapies. Collaboration between patient associations, professional organizations and partnership with industry is necessary and mandatory. We also need a health pact, which we have asked for many times. Without this health pact, the good measures taken so far will be wiped off. I would like to see a completion of our initiative with the Innovation Fund for Medicine capable of ensuring patients’ access to modern medicines, without being a financial burden on the patient, and of improving the health and lives of patients. Regarding the financing recommendations, this year Romania has 30 billion not collected from VAT. We have over 3 billion uncollected from health contributions. Given that the project aims for a health fund of 30 million lei per year, we can say that we have money. We need to be very well calculated and see from where we can allocate these amounts. You have partners in the Health and Family Commission of the Chamber of Deputies and in the Senate Commission to successfully implement such measures”.
Dr. László Attila, Chairman of the Senate Public Health Committee, says:
“The development of modern solutions and policies for the Romanian health system is possible with the participation of all actors involved – institutions, the patient community, private entities. The Medicines Innovation Fund could be a viable solution to the need for additional funds for health and innovation. The OHE report provides us with practical solutions that we aim to develop in legislation to meet the needs of patients. This project requires a wide and very careful debate, a series of clarifications, analyzes, negotiations. It requires a series of commitments assumed by the whole political spectrum because in the end it is a political decision, which must be assumed. I think it is an exemplary way that we have witnessed in previous years and this consistency honors us. I hope to find that solution accepted by the vast majority of all those in this market and, at the same time, to succeed in convincing the entire political spectrum, to establish some very clear criteria that we can assume to go through, for that we need to solve this problem. We have been witnessing a major change in this area for decades. We need to create that predictable framework for any patient in this country. When we make these decisions we must have some very objective criteria, to have secured funding and, at the same time, to have the mechanisms. Society’s attention to health, access to health services, access to treatment or diagnosis has increased enormously and I think we should take advantage of this period”.
Following the model of other countries such as England France, Italy, the Czech Republic, where such a fund already exists, the LAWG Health Expert Working Group recommends as possible sources of funding for this programme: public funds, targeting of taxes collected in the name of health from the population (e.g. excise duty), the contribution of marketing authorization holder (DAPP) under the timely and provisionally facilitated access contract, the possibility of redirecting 2% of income tax to the Medicines Innovation Fund, the possibility of granting sponsorships by private entities, the possibility of restricting exceptions to the payment of health contributions (e.g. persons with income above certain thresholds).
The proposal to launch the Medicines Innovation Fund is a natural step after the launch of the ALBE Health Innovation Card, a project carried out in 2019 by the “Health Resources” Dialogue and Cooperation Platform, initiated by the Health and Family Committee of the Chamber of Deputies and the Senate Public Health Committee, together with the Local American Working Group – LAWG. The launch of the White Paper on Health Innovation was based on the report “European Models: Options for the Financing of Medical Services and Medicines in Romania”, developed by the Economist Intelligence Unit (EIU) and launched in 2018 by LAWG. On the basis of this report, three priority strands of action have been identified – the Health Innovation Programme, Health Value and Increased Funding for Health and Innovation by attracting additional resources.