rare diseases

Access to the drug: a two-speed Europe?

Access to the drug and reimbursement: a two-speed Europe? We talked about it to Dr. Enrico Bosone, president of SIAR (Italian Society for Regulatory Activities), a non-profit organization whose membership comprises about 200 professionals in Italy involved in regulatory activities related to the regulation of those products, including drugs, which require a production and/or marketing authorisation provided by Health Authority. The association’s objectives are to study and understand the regulation in the field of drugs, medical devices, food and food supplements, as well as the constant updating about laws and documents issued by the Italian, European and non European authorities, and the promotion of cooperation with the competent authorities and public and private institutions involved in the regulatory activities. To achieve these objectives, SIAR has established several working groups: the first deals with the R & D and has published a practical manual on clinical trials in Italy; the second deals with medical and scientific information, and organizes seminars to disseminate the results of the scientific activities; the third deals with access to the drug by patients. What is meant by "access to the drug?". "In the European Union, access means reimbursement" - explains Dr. Bosone, "This is because the medicines, especially the most innovative ones, are often expensive and, in principle, are reimbursed by the National Health Service in each country, which supplies them to patients free of charge or by a modest ticket payment (as in Italy). It happens, however, that normally a delay is generated between the marketing authorization and the reimbursement, or the availability of the drug to the patients, which in Europe varies from country to country. In fact there are two types of marketing authorization", clarifies Dr. Bosone,"the first [...]

2017-01-03T11:18:01+00:00 01/03/2016|Categories: News|Tags: , , , |

CVBF supports Rare Disease Day: Join us in making the voice of rare diseases heard

29 February 2016 marks the ninth international Rare Disease Day coordinated by EURORDIS. A call to solidarity and to the acknowledgement of rare diseases as a real problem, not to be dismissed under the veil of indifference.  On and around this day hundreds of patient organisations from countries and regions all over the world will hold awareness-raising activities based on the slogan “Join us in making the voice of rare diseases heard”. This year’s theme “Patient Voice” makes reference to and tries to bring to light and public appreciation the efforts made by rare disease patients, by their families and friends, recognizing the crucial role that patients play in voicing their needs and in instigating change that improves their lives and the lives of their families and carers. […]

2017-01-03T11:18:02+00:00 27/01/2016|Categories: News|Tags: , , , |

Corriere della Sera dedicates its issue “Speciale Salute” to the CVBF and its efforts in the fields of Rare diseases and Paediatrics

On March 1st, 2015 the national newspaper Corriere della Sera published, on its special issue Sezione Salute, an article entirely dedicated to CVBF and its contributions and goals in the fields of rare diseases and paediatrics. The article, entitled “Rare diseases and Paediatrics: the goals of the Consorzio per Valutazioni Biologiche e Farmacologiche – Clinical Trial, development of new methodologies and innovative drugs”, is an interview to Donato Bonifazi (CVBF Managing Director), who has outlined the main areas of interest and the activities undertaken by CVBF. Among the activities and the European initiatives coordinated by the Consortium in the field of the paediatric clinical research, a particular emphasis is given to the two European projects DEEP (DEferiprone Evaluation in Paediatrics) and GAPP (GAbapentin in Paediatric Pain) and the efforts made by both the European and non-European Countries of the Mediterranean area. In this respect, explained Dr. Bonifazi, a special attention is given to Albania, for potentials that this country offers in clinical research (and especially in paediatrics). […]

2017-01-03T11:18:10+00:00 03/03/2015|Categories: News, Press Releases|Tags: , , , |

CVBF is friend of Rare Disease Day

The “Rare Disease Day” campaign has reached its 8th edition this year, on February 28th, bringing once more, to public attention, the topic of rare diseases as a subject of medical, political and institutional concern. The initiative was founded by EURORDIS and its Council of National Alliances in 2008, triggering, ever since, a series of related events all around the globe, fastly turning from an European campaign to a world-renowned advocacy event that stands for dissolving ignorance and empowering collaboration for the better understanding and treatment of rare diseases. “Rare Disease Day” has notably contributed to the advancement of national plans and policies for rare diseases in a number of countries. This year’s theme, “Living with a rare disease”, makes reference to and tries to bring to light and to public appreciation the efforts made by rare disease patients, by their families and friends to cope. The slogan Day-by-day, hand-in-hand of the Official Rare Disease Day 2015 Video evokes the solidarity between families, patient organisations and communities. CVBF welcomes this initiatives by becoming a friend of Rare Disease Day and showing its support on its official website. We proudly join the “Rare Disease Day” manifesto and dedicate all our efforts to improve the healthcare system, also to search, test and provide better treatment and a better handling of these rare diseases.

2017-01-03T11:18:11+00:00 02/03/2015|Categories: News|Tags: , , |