Medicines for Europe welcomes today’s vote of the Legal Committee of the European Parliament (JURI), which combines the opinions of the Health (ENVI) and Trade (INTA) committees in support of a comprehensive SPC manufacturing waiver.
The compromise agreement by the JURI Committee includes the possibility to produce generic and biosimilar medicines during the SPC period for export purposes and to stockpile for two years to prepare for launch in the EU on day-1 after SPC expiry. This will stop the forced delocalization of pharmaceutical manufacturing outside of Europe and is a positive step forward to allow all manufacturers including SMEs to benefit from the manufacturing waiver. More importantly, patients and member states’ healthcare budgets will benefit from immediate access to generic and biosimilar medicines manufactured in Europe as soon as SPCs expire. The Parliament’s position is fully justified by the European Commission Impact assessment which underlines “an SPC manufacturing waiver for export and stockpiling would be the most effective and simplest option”.
The JURI committee also voted to implement the SPC manufacturing waiver starting in January 2021. While there is further room for improvement, this represents another step in the right direction to ensure that the SPC manufacturing waiver delivers on its promise of industrial jobs and lower costs for patients and healthcare systems.
The JURI committee also recognises the importance of protecting the right of manufacturers to keep commercially sensitive information confidential in the context of the notification procedure. We hope this common sense approach will be reflected in the final text of the SPC manufacturing waiver. However, we do not understand the logic of including falsified medicines requirements – which are for patient safety – into an EU regulation on pharmaceutical incentives.
Medicines for Europe Director General, Adrian van den Hoven, commented: “The Parliament has made a thorough review and introduced many positive changes to the SPC manufacturing waiver proposal. With some further fine-tuning of this text in the trialogue phase, the SPC manufacturing waiver will deliver on its promise for patient access, for pharmaceutical manufacturing jobs, and for sustainable healthcare budgets in Europe.”