On 1 July, new legislation allowing generics and biosimilars firms in the EU to manufacture and stockpile medicines before the supplementary protection certificate on the originator drug expires will come into effect. All SPCs that have not yet been granted will be affected by the waiver, but the inclusion of a transition period means originator companies may be able to avoid its effects for three years if they file their SPC applications before 30 June.
Regulation (EU) 2019/933, which was adopted by the Council of the EU in May and published in the Official Journal on 11 June, provides an exemption to SPC rights by allowing generics and biosimilars companies to manufacture their versions of SPC-protected medicines in the EU for export to non-EU markets