Profound changes to the regulatory data protection rules are expected any day now
As a part of the Pharmaceutical Strategy for Europe, the European Commission (EC) announced that it would launch a package revising the general pharmaceutical legislation, as well as the regulations on orphan medicinal products and paediatric medicines. Initially, the amendments were supposed to be announced in December 2022. From the newest information from the EC, they are expected soon.
Internal versions of the EC projects, stepwise coming to light, indicate that the planned changes are going to be far-reaching; we present three of them.
The most significant change concerns the reduction of the default exclusivity periods and the introduction of modality mechanisms, conditioning the total length of exclusivity on fulfilling additional criteria. Data exclusivity for reference medicines is likely to be 6 years (instead of eight years now). One additional year would be available if the medicine addresses hitherto unmet medical needs and one more year if the product is launched in all EU member states. Another six-month period is expected in case of conducting comparative trials. However, the maximum length of data exclusivity would be eight years. Similar reductions are expected for orphan exclusivity.
An important aspect of the revision is the criterion of Unmet Medical Needs (UMN), linked with additional exclusivity periods (as above). The way of interpreting this criterion can be crucial for the overall period of IP protection for these products, whose patent/SPC protection expires relatively early and which resort to the last years of data and market exclusivity.
“Transferable exclusivity vouchers” are planned to incentivise antimicrobial resistance R&D. Such vouchers, when granted for a new antibiotic, can be used by the MA holders to extend the relevant period of data exclusivity (probably not the SPC term, though) by one year or can be sold to another company. These and other changes are meant to bring more flexibility to the system. New provisions will require recalibrating future IP strategies in both innovative and generic companies to take into account a greater number of market factors and be generally more adjustable. While we are still looking forward to the announcement of the EC’s proposal, any strategic decisions should already now take the directions of changes into account.