The European Union’s (EU) Supplementary Protection Certificate (SPC) waiver for generic pharmaceutical products is now in force. The waiver came into force on July 1, 2019.
The waiver seeks to foster the competitiveness of EU producers of generic medicines and biosimilar products. The idea is to relax the rules on generic and biosimilar manufacturing during a product’s supplementary protection certificate period.
Pursuant to EU Regulation 469/2009 (SPC Regulation), SPCs extend patent protection for medicinal products for up to five years, extendable for a further six months in certain cases when the SPC relates to a pediatric indication for human medicinal products.
The regulation will only apply to SPCs applied for on or after July 1, 2019. If the SPC is applied for before, but takes effect after July 1, 2019, the waiver applies only to SPCs from July 2, 2022.
In its press release the Council said that “The regulation will remove the competitive disadvantages faced by EU-based manufacturers of generics and biosimilars vis-à-vis manufacturers established outside the EU in global markets.”
The regulation will remove the competitive disadvantages faced by EU-based manufacturers of generics and biosimilars vis-à-vis manufacturers established outside the EU in global markets.
The exception will operate only where:
- generics or biosimilars are produced exclusively for export to third countries where protection of the original medicine does not exist or has expired or for stockpiling purposes during the last six months of the validity of the SPC;
- the maker has provided the information required by the regulation to both the authorities of the member state of production and to the holder of the SPC at least three months in advance;
- the maker has duly informed all those involved in the commercialisation of the product;
- the maker has affixed to the packaging of the product the specific logo provided for by the regulation indicating clearly that it is only for export.