Overcoming challenges in market access of generic medicines in the European Union

Abstract

Generic medicines have become essential contributors for governments in their effort to contain public health care budgets. Therefore, market access of generic medicines should be made possible immediately after expiry of the patent protecting the originator medicine. Generic medicines can only enter the market when the patent on the originator medicine is expired and when a marketing authorisation and pricing and reimbursement approval have been obtained from the national competent authorities. Arguments on patent validity or patent infringement which result in litigation before national courts, backlogs in national approval systems, defensive patenting strategies (‘evergreening’), patent linkage and third-party interventions during the process of marketing authorisation and pricing and reimbursement are well-documented causes for delayed market access of generic medicines. The establishment of a unitary European Union patent together with a unified and specialised patent litigation system, the reduction of backlogs in national agencies, avoiding third-party interventions as much as possible and automatic approval of pricing and reimbursement status upon marketing authorisation approval of the generic medicines are just a few examples of policies which could enhance market access of generic medicines in the European Union. This article aims to provide an overview of the regulatory framework regarding market access of generic medicines in the European Union and lists the hurdles which impede market access. Recommendations to enhance market access of generic medicines round off this article.