The Single Text for Rare Diseases it is law. Today, November 3 was unanimously approved definitively by the Senate, a result of over 3 and a half years of difficult and intense work, carried out between the world of national reference associations and politics. L’Rare Diseases Observatory (OMaR), which represents about 250 associations and had begun to urge Parliament starting from the 2018 general elections under pressure from the world of organizations, expresses “great satisfaction”: “the Consolidated Law on Rare Diseases is finally a state law, the first that defines organically rare diseases, the rights of the people involved and the organizational framework, previously there were only ministerial decrees “, he comments to Ilfattoquotidiano.it Ilaria Ciancaleoni Bartoli, director of OMaR. “Today we celebrate, but from tomorrow we start to monitor compliance with the implementation times, no delay can be accepted. It is clear however – adds Ciancaleoni Bartoli – that we are facing a framework law, with which the foundations for a change have been laid, but there is still a lot to do starting from the next implementing decrees ”. The story that led to the approval of the first law on rare diseases is also retraced in a video, made public today on YouTube by OMaR.
The comment of the policy after the belated approval of the first law on rare diseases – The legislative process was concluded on the commitment of the deputy of Coraggio Italia in particular Fabiola Bologna (secretary of the XII Social Affairs Commission of the Chamber) and of the UDC senator Paola Binetti (President of the Parliamentary Intergroup for Rare Diseases) who underline the importance of this Consolidated Text but add: “Now we need to approve and finance the new National Rare Diseases Plan”. The Undersecretary of Health with responsibility for rare diseases also spoke on the issue Pierpaolo Sileri: “I am very happy to have been present at the conclusion of the parliamentary process of the bill on rare diseases. It is a text – says Sileri – the result of a fruitful interparliamentary and inter-institutional collaboration, which saw the active contribution of the interested parties, primarily the patient associations, who were listened to and involved “. However, he specifies that “it is certainly not a point of arrival but on the contrary the finger pressed on the start of the timer to mark the timing of the definition and emanation of related implementing decrees, on which I put my personal commitment “. On this, the undersecretary adds, “the Technical Roundtable on rare diseases, set up on my impulse at the Ministry of Health, which has already identified the priorities for action and possible intervention proposals, will also help.”
What was approved today with the Consolidated Law on Rare Diseases – There are several aspects that the new law has established. For the first time in Italy the Solidarity fund of 1 million euros per year, starting from 2022, to support the care and assistance work. According to the associations “this is an absolute novelty, but the resources are very low and must be increased because they are largely insufficient compared to the needs”, explains OMaR. They are also recognized for the first time the rare sufferers, giving shape to a series of rules dedicated to them. For example, there is the recognition of a tax incentive for scientific research, with a tax credit of 65%, in favor of subjects, public or private, for the expenses incurred for projects on rare and very rare diseases. “We are really happy that the institutions of our country have wanted to launch a signal of concrete interest for patients and families who face a rare genetic disease and for the research dedicated to them. Precisely because of their rarity, these pathologies tend to be neglected by public and private funding, which is why there are realities such as our Foundation, which open ways to increase knowledge and give life to new treatments “he said. Francesca Pasinelli, General Manager of the Telethon Foundation.
A National Plan for Rare Diseases will be created and also a National Committee with the participation of the reference associations – Furthermore, within 3 months of publication in the Official Gazette, the creation of a new one was established in black and white National Plan of Rare Diseases, “We are very happy with this act but we must also state very clearly that to make the Plan operational and effective, new funding is needed to be allocated perhaps already through the next Budget Law”, the director of OMaR tells ilfattoquotidiano.it. Another important novelty is that the Ministry of Health has undertaken (through its decree) to establish, within two months, a National Committee for Rare Diseases, a new control room within which the presence of associations and entities from the Third Sector is also foreseen. Finally, there are two important agreements that must be made at the State-Regions Conference: one is that relating to the approval of the Second National Rare Diseases Plan and reorganization of the Network, “an act expected by associations for many years now, which must be adopted, during the first implementation, within three months ”, specifies OMaR. There is also a second agreement under the jurisdiction of State-Regions Conference, with which the methods to ensure adequate information of health professionals, patients and families must be defined, to be adopted (always within 3 months). “In any case – says Ciancaleoni Bartoli – within 6 months of publication in the Gazzetta, and therefore by April-June, all these acts must be ordered. Only towards the end of 2022 will we be able to begin to see the real effects of this law. These are the times, and we will have to wait for them, but not a day longer ”, concludes the director of OMaR.