It takes two to launch a new medicine
Many of the decisions that impact when patients get access to a new medicine are outside a company’s control, in fact, two-thirds of the delays to access medicines occur after companies have filed for pricing and reimbursement. For example, in Greece, companies can only file for reimbursement once a medicine is reimbursed in at least five of 11 designated EU countries, delaying filing due to the external reference pricing system. This structural condition adds to other delays, including those linked to limited healthcare funding and launch decisions. As a consequence, measures like obligating companies to launch in all 27 member states will completely fail to address inequalities in access to medicines while proving to be highly damaging to the sector’s presence in the EU.
The proposal to reduce the Regulatory Data Protection (RDP) and Orphan Market Exclusivity would have a similar impact; the US already leads Europe on every investor metric from availability of capital to speed of approval and rewards for innovation. RDP for small molecules is the only appreciable benefit that the EU has over the US.
The proposed expansion of the Bolar exemption — a legal provision that permits the narrow use of a patented medicine to support a generic’s marketing authorization application before IP expiration — would further erode Europe’s IP framework. It would likely lead to more litigation, reduce legal certainty and predictability, and negatively impact patients, including potentially introducing co-payment. Instead, the EU should create a clear notification system to give both generic and innovative companies transparent, reliable ‘day one’ certainty and safeguard IP protection.
“If Europe truly wants to have research, development and manufacturing in the region, as well as delivering the best care for its citizens, it has to align the outcomes of discussions on the GPL with its ambition to be a world leader in medical innovation, maintain resilient supply chains and compete economically.” Nathalie Moll, director general, EFPIA.
High stakes, high risk
