Mar 31, 2011
The European Commission may extend its Transparency Directive covering pricing and reimbursement transparency of medicinal products to medical devices. EU regulators have launched a public consultation in conjunction with a process review of the Transparency Directive (89/105/EEC) intended to revise pharmaceutical pricing rules, which have not been updated since 1989.
In addition, the consultation will involve evaluating whether the directive should also apply to medical devices. Contributions from interested parties will be accepted until May 25; commissioners are particularly interested in comments from economic operators, health care professionals, public interest organizations and national authorities. If regulators ultimately do extend the Transparency Directive to medical devices, that could lead to a more simplified and efficient pricing and reimbursement infrastructure for manufacturers across Europe.
A new report examining European in vitro diagnostic (IVD) market performance in 2010 sees flat or negative growth across most major EU member states due to cost containment measures and worsening economic conditions.
According to the European Diagnostic Manufacturers Association’s (EDMA) study, the European IVD market totaled €10.5 billion last year, with revenue growth of only two percent from 2009. Cardiology testing and diabetes-related IVD sectors as well as products for managing hospital-acquired infections showed the strongest growth rates in 2010, but all other testing areas showed flat or negative growth.
New research by the European Health Technology Institute for Socio-Economic Research (EHTI) puts forth five recommendations to address the impact of more centralized medical technology procurement pol