A specific sector of Life Sciences and Health law, pharmaceutical law concerns intellectual property and competition law in particular. Key issues include patents, patent licensing and patent extensions, generic products market entry and abuse of a dominant position. Since its 2008 pharmaceutical sector inquiry the EU Commission implemented annual monitoring of patent settlements – to understand the use of patent settlements and identify so-called ‘pay-for-delay’ agreements where the settlement is potentially being used to delay market entry of generic medicines to the detriment of EU consumers.
The EU legal framework for medicinal products for human use is based on the principle that medicinal products may only be placed on the market following specific authorisation – the conditions for which have been progressively harmonised across the whole European Economic Area. Even when a medicinal product is placed on the market, its safety continues to be monitored through the EU system of pharmacovigilance. Pharmaceutical pricing, state funding and parallel imports remain important issues within the EU and indeed worldwide even if the organisation of their health care sectors remains primarily the responsibility of individual Member States.