Current trend in pharmaceutical law in EU

Article type: Research Article

Authors: Cabezas, María Dolores

Affiliations: Pharmaceutical Technology Department, Faculty of Pharmacy, Universidad de Granada, 18071 Granada, Spain. Tel.: +34 958 243898/99; E-mail: mcabezas@ugr.es

Abstract: Major progress has been achieved over the last years in EU. Legislative initiatives have led to improved marketing authorisation procedures, the harmonisation of data protection in the EU, better access to medicines for children, and a new regulatory framework for advanced therapies. Nevertheless stakeholders continue to raise concerns with regard to the market fragmentation linked to disparities in national pricing and reimbursement schemes, unnecessary regulatory burdens caused by divergences in the implementation of Community legislation, and divergence in interpreting the relevant legislation and cumbersome procedures for multi-centre clinical trails in different Member States. New legislation are preparing. Establishing and enforcing international public health standards is essential to minimise the risk that unsafe products enter the EU market.

Keywords: Pricing, active substances, clinical trails, unique identifier, global cooperation, harmonisation

DOI: 10.3233/PPL-120354

Journal: Pharmaceuticals, Policy and Law, vol. 14, no. 2-4, pp. 195-207, 2012