SIAR

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 & Events|Tags: , , , |