The European Council has taken its position on a package to reform the EU’s pharmaceutical sector, teeing up negotiations with the European Parliament on a final package. The Council’s amendments to the package include providing eight years of regulatory data protection for new drugs and up to two years of additional market exclusivity.
The pharmaceutical package would be the most significant overhaul of the regulatory landscape for drugs in the EU in more than twenty years. The Council stated that the goal of the proposal is to enhance competitiveness while ensuring that all Europeans have access to safe and effective medicines.
One of the most significant changes in the Council’s position has to do with market protections awarded to drugmakers. In contrast with the Parliament’s package, which would provide seven and a half years of regulatory data protection for newly authorized drugs (with the ability to extend that protection to a maximum of eight and a half years) and an additional two or three years of market protection, the Council’s proposal would provide eight years of regulatory data protection and up to two years of market protection…
