The introduction of comprehensive SPC manufacturing waiver key to unlocking huge industrial opportunities and healthcare savings, with €90 billion of blockbuster medicines coming off patent in 2020.
The Parliament’s Health Committee (ENVI) sent a clear signal of support with the adoption of a “day one” launch possibility to supply European patients with European manufactured medicines.
The SPC manufacturing waiver aims to correct the current implementation of Supplementary Protection Certificate system which blocks manufacturers from producing generic or biosimilar medicines for export to non-EU countries where the SPC does not apply, or from producing and stockpiling these medicines to allow for ‘Day One’ launches after SPC expiry in the EU. Because of the current restrictions, the EU pharma industry is forced to delocalise production to non-EU countries, like Canada, India, China or the United States.
The Health Committee also recognised the need to protect commercially confidential information in the context of a notification procedure.
Regrettably, the Health Committee maintained the very long lead time for implementing the waiver which will delay its ability to create manufacturing and access opportunities for many years.
Commenting, 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.”