Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 (also referred to as “the SPC manufacturing waiver”) entered into force on 1 July 2019 following publication in the Official Journal of the EU on 11 June 2019 (see here).
The new regulation amends Regulation (EC) 469/2009 which is the legislation that governs SPCs for medicinal products.
As discussed (here), the EU regulation provides for an exemption for manufacturing and stockpiling activities to allow EU-based manufacturers of generics and biosimilars to:
make medicines inside the EU when those medicines are intended for export to markets outside the EU, or
make medicines inside the EU in the last 6 months before expiry of the SPC in order to prepare for EU market entry as soon as possible on expiry of the SPC.
The SPC manufacturing waiver affects any SPC application filed on or after 1 July 2019. On 2 July 2022, the manufacturing waiver will also affect any SPC application which was filed but not in force before 1 July 2019. The SPC manufacturing waiver will not affect any SPC in force prior to 1 July 2019.
Applicants of SPCs which were filed but not in force before 1 July 2019 will therefore be able to take advantage of a 3-year transitional period where the SPC manufacturing waiver does not apply.
The new regulation also requires the European Commission to review the effect of the waiver by 1 July 2024 and then every 5 years subsequently. It is therefore possible that there may be further changes to the legislation that governs SPCs for medicinal products.