Take advantage of the latest tools, techniques, and deep healthcare expertise to create scalable resources, precision insights, and actionable ideas.
The increasing demands of an aging population, the complexity of new medical innovations, and the macroeconomic headwinds facing Europe require effective competition to generate savings and increase patient access, while positioning the European market as an attractive and innovative region for investment. Therefore, the intellectual property rights for pharmaceuticals that protect medicines from competition, and later permit competition, are important to understand, especially as regulations and practices evolve.
In 2008, a study entitled ‘Factors affecting Generic Entry in Europe’ was produced by CRA International (CRA) and IMS Consulting (IMS) to investigate the factors that affect generic entry when pharmaceutical products lose protection in Europe. Now, 15 years later, a new report has been commissioned to assess the current situation.
The market has changed significantly since 2008, with implementation of new regulations, new countries joining the EU, and the increased importance of biologics and specialty medicines. Many of the original findings remain relevant, however results around the importance of originator-molecule access, challenges to biologic competition, and the time to competitor entry are novel. This research aims to provide all stakeholders with a robust evidence base upon which policy can be developed.
This report examines the cohort of medicines that have lost protection across the past six years. The period for assessment (2016–2021) has been chosen to reflect 10 years since the alignment of the regulatory data protection (RDP) rules in Europe and creates more reliable results as more time has passed since markets entered the European Union.
Take advantage of the latest tools, techniques, and deep healthcare expertise to create scalable resources, precision insights, and actionable ideas.
Discover proven strategies and insights refined over more than 5,000 launches around the world.