Although health is an exclusive competence of the EU’s Member States, the European Commission and European Parliament nonetheless play an ever-important role in shaping national health policies, through collaboration or research. In addition, medical device regulation is the exclusive responsibility of the EU’s Institutions. Furthermore, the EU has over the years constantly pushed towards further harmonisation between differing national legislation by establishing standards for consumer safety and information, market authorisation, and cross-border social security rights.
Avisa Partners has an excellent understanding of the sector’s very complex regulatory and political environment, thanks to our experience in this area but also because of our access to European decision makers at the highest levels.
Furthermore, the EU regulatory system includes fairly complex decision making processes for both human and animal health products, which involves the European Medicines Agency as well as specialised Council preparatory bodies and committees.
Avisa Partners has also worked for a number of companies in the health sector, including creating and running an association which provides renal care across the EU, and creating an alliance of companies which work in animal health. This work involves everything from advising to developing strategy to raising profile of their sectors’ particularities.
In addition, Avisa Partners has worked for several pharmaceutical companies –both originator and generic–on competition issues in antitrust and abuse of dominant position proceedings.
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