Pharma reform should provide for more timely patient access in Europe

The revision of the European pharmaceutical legislation, the reform of the Supplementary Protection Certificate (SPC) system and the review of the SPC manufacturing waiver are now fundamental reforms to stimulate a strong off-patent pharmaceutical industry in Europe whose medicines account for the vast majority of those dispensed in Europe, trade group Medicines for Europe announced today.

The European Union is getting closer to a reformed pharmaceutical legislation. A good and balanced incentives system for pharmaceuticals is essential to support the development, production, and supply of generic, biosimilar and value-added medicines.

The group said that timely access to generic and biosimilar medicines is needed to ensure that the patent system is well equipped to prevent misuses or abuses that delay generic and biosimilar competition at patent or SPC expiry. Europe now has an unmissable opportunity to include the right guardrails in the unified patent system for high quality standards in the interest of patients and rewards true innovation over evergreening. Carefully assessing the validity of SPCs before their enforcement is essential to avoid unnecessary litigation, patient access delays and lost savings for healthcare systems.