Lorenzin announced the plan yesterday at the first meeting of the European Parliament’s Committee on the Environment, Public Health and Food Safety since Italy began its six-month presidency on July 1.
According to Italy’s programme the plan is to “explore whether and how to take forward the review of the Directive 89/105/EEC on the transparency of measures regulating the prices of medicinal products for human use and their inclusion within the scope of public health insurance systems.”
The directive in question is designed to ensure that EU member states which regulate drug prices and reimbursement by national healthcare systems do not contravene the principal of the free movement of goods by insisting that country's justify their decisions.
The problem - according to a the European Commission the rule – is that the directive does not take into account the emergence of the generics industry, newer expensive drugs or Member States’ adoption of complex pricing systems.
“This situation not only results in legal uncertainties but also in a reduced transparency of national pricing and reimbursement measures, which negatively affects the smooth functioning of the internal market to the detriment of European patients and pharmaceutical companies.”
What tangible progress Italy will make in the next six months is unclear, particularly given that efforts to revise Directive 89/105/ECC have already been going on for several years.
Italy will also look at on proposed changes to the rules governing medical devices and in-vitro diagnosticsaccording toLorenzin, who said the plan is to “seek to reach a compromise with Parliament on the Medical Devices and In Vitro Diagnostic medical devices regulations.”