The Council of the EU adopted on 14th May the SPC waiver text that was voted in the EU Parliament in April.
The regulation, approved during the Agriculture and Fisheries Council meeting, still needs to be published in the Official Journal, and is expected to enter into force on July 1, 2019. The waiver affects all SPCs applied for after the regulation enters into force and the text adds that “…the exception should apply, therefore, from 1 July 2022 to a certificate that takes effect from the date of entry into force of this Regulation”.
The supplementary protection certificate (SPC) manufacturing waiver will also allow producers of generics and biosimilars to stockpile their products for six months to sell in Europe the day after the patent extension expires.
A spokesperson of the EU’s current Romanian presidency added in a statement that “The new regulation will enable generics manufacturers based within the EU to compete with non-EU manufacturers on equal terms. It will create high-value jobs and boost the availability of generic medicines in the EU”.
You can find the text adopted both by the EU Parliament and Council here.