The Belgian presidency of the Council of the EU says it agrees in principle with the European Commission’s proposed “modulated approach” to regulatory data protection (RDP) and market exclusivity (ME), including a cut in the baseline RDP period, as part of the pharmaceutical reform package.
EU Pharma Reform Talks Heat Up As Health Ministers Prepare To Challenge Proposals
In a sign of difficult negotiations to come on the European Commission’s pharma reform package, the presidency of the Council of the EU has drawn up its own set of proposals on regulatory data protection and market exclusivity that differ in several respects from those of the commission and the European Parliament.
