The challenges of the new EU Pharmaceutical Legislation
In the domain of public policy on pharmaceuticals, protecting public health requires a dual strategy: robust regulation on the one hand and stimulation of competitiveness and innovation on the other. Regulation must be robust to ensure that only medicines meeting exact standards of safety, quality and efficacy are authorised for human and animal use. At the same time, competitiveness and innovation must be stimulated. Without innovation in pharmaceuticals, the incurable diseases of today will remain incurable. Competitiveness drives innovation and innovation saves lives. Increased competitiveness of the pharmaceutical sector will not only better protect public health, but will also create high quality jobs and create growth. In this context the implementation of the G10 recommendations, particularly regarding the pricing and reimbursement of medicines by Member States, remains a considerable challenge. In order to make potentially life-saving pharmaceuticals available as soon as possible to patients and to enable industry to quickly recoup its investments and to reinvest into future R&D, still existing delays in some Member States between marketing authorization and the selling of the medicine have to be minimized. The proposed paediatric regulation, currently under discussion in Council and Parliament, is another example where a better protection of (children’s) health goes together with a stimulation of competitiveness and innovation in the European pharmaceutical industry. This publication focuses on the recent review of the EU pharmaceutical legislation. The revised legislation is a key part of the above-mentioned dual strategy.