The Chamber of the Chamber unanimously YES to the rules for the treatment of rare diseases and for the support of research and production of orphan drugs. The text was approved in Montecitorio with 357 votes in favor, no against and one abstention. Go to the Senate.
The text approved at Montecitorio aims to guarantee the uniformity of the provision in the national territory of services and services medicines, including orphans, ie those destined for the treatment of diseases so rare that they do not allow pharmaceutical companies to realize revenues that allow them to recover the costs incurred for their development. The personalized diagnostic therapeutic assistance plan is established, which includes the treatments and monitoring that the person suffering from a rare disease needs, also guaranteeing a structured path in the transition from pediatric age to adulthood.
I Lea
It is expected that the health treatments contained in the essential levels of assistance or qualified life-saving, included in the personalized diagnostic therapeutic assistance plan and indicated as essential, which consist of health and social and health services, types of care, including palliative and rehabilitation, in drug therapies and medical devices. Then comes a Solidarity Fund for people suffering from rare diseases, with an endowment equal to 1 million euros per year, starting from 2022, intended to finance measures to support the work of care and assistance of people suffering from diseases rare, with a percentage of disability equal to 100 percent, with connotations of particular gravity.
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Research
The text therefore contains provisions relating to the structures responsible for research, consultancy, guidance and documentation on rare diseases and orphan drugs, aimed at the prevention and treatment of these diseases. The National Center for Rare Diseases and the National Committee for Rare Diseases are established Article 11 therefore provides that, starting from 2022, the National Fund for the use of orphan drugs for rare diseases and drugs that represent a hope of treatment, pending marketing, for particular and serious pathologies, is supplemented with a further payment equal to 2 per cent of the self-certified expenses by April 30 of each year by the pharmaceutical companies on the total amount of expenses incurred in the previous year for promotional activities aimed at healthcare personnel.
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What will be financed
These resources are intended for the following activities: pre-clinical and clinical studies promoted in the field of rare diseases, observational studies and compassionate use registries of drugs not yet marketed in Italy, surveillance programs on orphan drugs and other innovative treatments placed on the market , based on biological hypotheses and initial evidence of efficacy, but lacking certain knowledge on the efficacy and safety of their medium and long-term use, research and development of plasma-derived orphan drugs and development projects for neonatal screening tests for the diagnosis of rare diseases. Finally, the orphan drugs. A tax relief arrives in favor of public or private entities that carry out research on rare diseases or orphan drugs, carried out by public or private research bodies, which have been recognized since 2022, a tax credit of 65 percent of the expenses incurred for the start-up and implementation of research projects, up to the maximum annual amount of € 200,000 for each beneficiary, within the overall expenditure limit of € 10 million per year.
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