On 17 April 2019, the European Parliament approved, by a large majority, an amendment of the Regulation on Supplementary Protection Certificates (“SPCs”). This much debated amendment, the latest version of which can be found here, introduces two new exemptions from SPC infringement for acts in relation to export-bound manufacturing and end-of-term storage of SPC protected medicinal products (the “Waiver Regulation”).
Not only manufacturing, but also stockpiling and related acts
Under the Waiver Regulation, SPC holders will no longer be able to block third parties from manufacturing (pharmaceutical) products for the purpose of exporting them to third countries. This exemption will also extend to related acts by third parties contractually involved in such production or export. The Recitals cite as examples of such related acts, inter alia, the possession, supply, offer to supply, use, synthesis of an active ingredient, temporary storage of the product, or advertising for the exclusive purpose of exporting. Importantly, the Waiver Regulation will also extend to acts of storage. The latter exemption will be limited in time to the final six months of SPC protection, as it aims to allow effective day-1 commercialisation upon expiry on the SPC.
To counter the risk of illicit market entries beyond the ambit foreseen by the Waiver Regulation, those benefiting from the waivers will have to comply with a series of anti-diversion measures:
- Notify the SPC holder and the national authority that granted the SPC right(s) concerned at least three months before any act of manufacturing or related act.
- Inform third parties involved in the process that the Waiver Regulation is applicable and that the given product is destined solely for export outside the EU.
- Label products manufactured for such export with a specific mark.
Subject to a final approval by the European Council, the Waiver Regulation will enter into force on the twentieth day after its publication in the Official Journal of the European Union. This is expected to occur by mid-2019. SPCs already granted and effective will not be affected by the waivers. However, SPCs that have been applied but are not yet granted and effective will be facing the waivers from the third year after the effective date of the Waiver Regulation (mid-2022).
A more elaborate analysis can be found here.