SPC MANUFACTURING WAIVER: INITIAL AGREEMENT AMONG THE EU INSTITUTIONS
On February 20, the European Council published the text that will be voted by the JURI Committee of the European Parliament on February 26.
The main aspects of the negotiation focused on three points:
- The application date of the Regulation, that the Parliament proposed for those SPCs whose basic patents expire as of January 1, 2021 and which finally will be July 1, 2022 for all those SPCs that will become effective after the entry into force of the Regulation,
- The possibility that the exception also applies for the entry into the European Union the day one after the expiry date of the SPC, which would be limited to the possibility of manufacturing within 6 months before that date, and
- The limitation of communication and publication of sensitive trade data of those companies that apply for the exemption, which is proposed to include for medicinal products to be exported to third countries, the reference number of the marketing authorisation or equivalent in those territories, as soon as it is publicly available.
The protection conferred by the SPCs in the European Union has had the undesired effect that the EU pharmaceutical industry has not been competitive in markets where the patent has already expired and has delayed its entry even in the European Union as it has not been able to produce the medicaments until the expiry of the SPC. The exception will soon be reflected in a modification of Regulation EU/469/2009 and will allow European manufacturers of active pharmaceutical ingredients and generic and biosimilar medicines to be fully competitive in the world. As highlighted by the studies published by the European Union, only in terms of active pharmaceutical ingredients Spain produces 5% of the global production.