About SPC manufacturing waiver we have discussed in different post (here, here and here).
The final Envi committee opinion makes genericists happy
The Envi Committee has essentially confirmed the possibility of producing and stocking the expiring products of SPC in view of the launch to “day 1”, the day when the additional protection ends. The provision concerns only the new SPC. Regarding the notification, the compromise amendments approved by Envi establish that the originator company receives written notification from the generic company – within 60 days before the beginning of production or any other act that falls within the protection conferred by the SPC – without, however, including confidential or commercially sensitive information in such notification. Envi has also canceled the request for special labeling for exports.
EMA General Director comment
Adrian van den Hoven, Director General of Medicines for Europe, said “We welcome the Health Committee’s efforts to improve the SPC manufacturing waiver in relation to day one launch and the protection of confidential business information. We hope that this progress, together with a more reasonable date of application, will be agreed by the Parliament and the Council in a future final agreement. We urge the Parliament’s Legal Committee to adopt a final Opinion that includes these important priorities for health, for jobs and for a robust pharmaceutical eco-system.”
The originator disappointment
On the other hand, EFPIA notes with concern the ENVI Committee’s adoption of the Compromise Amendments on its draft opinion relating to the SPC manufacturing waiver proposed regulation. “allowing the stockpiling of generic medicines while the innovator medicine is still under SPC protection and failing to guarantee a robust system for notifying innovator companies of applications for a manufacturing waiver makes Europe a less attractive destination for life science investment”.