On 11 June, the SPC manufacturing waiver was published in the Official Journal of the European Union (Regulation (EU) 2019/933, which introduces the waiver to Regulation (EC) No. 469/2009).
The approved text allows EU-based companies to manufacture generics and biosimilars throughout the life of an SPC not only for export but also for stockpiling in the six months before SPC expiry, i.e., ahead of day-1 entry into the EU market (for an analysis of the Commission’s original proposal of May 2018, see article entitled “Manufacturing Waiver: a new future for EU-based generic and biosimilar industries?”).
More stringent notification and labeling requirements have been introduced to reduce the risk of generics and biosimilars manufactured under this waiver being diverted to the EU market while the SPC is still valid (which would constitute an infringement of the SPC).
- Generic and biosimilar manufacturers must notify the competent authority in the member state of manufacture and the SPC holder at least three months before manufacturing starts. Notifications must take the standard form and not include confidential or commercially sensitive information.
- Generic and biosimilar manufacturers also have to notify all parties in their EU supply chain that the product is SPC-covered and that placement in the EU market is forbidden.
- A label must be affixed to the packaging of generics and biosimilars manufactured for export outside the EU that clearly indicates they are for export only.
Re-importing products covered by the waiver into the EU when an SPC is still in force is clearly forbidden. Manufacturers also need to be careful not to engage in any commercial activity outside the EU (inc. exportation) that would facilitate re-importation and thereby infringe – in countries whose legal systems include the principle of joint liability (e.g., Germany) – the patent rights in the country of re-importation.
The past few months have seen mixed reactions to the waiver. On the originator side, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has expressed concern about the waiver as a whole:
If adopted in the final text, the amendments risk impacting on European patients living with unmet medical needs. They will significantly weaken Europe’s research and development offering risking investment and jobs from our SMEs, our companies, our academic institutions and our healthcare systems.
Conversely, the approved regulation has been broadly welcomed by generic and biosimilar manufacturer associations. That said, they have expressed concern that the notification system could lead to more litigation depending on how the information provided is used by originator companies. Medicines for Europe “calls on authorities to closely monitor any potential misuse of the notification system for frivolous litigation which could delay competition from generic and biosimilar manufacturers in markets where SPCs have expired”.
Only once the regulation enters into force on 1 July and starts being applied will we able to see what effects the waiver will have and whether it will achieve the objectives.
Healthcare and Life sciences Focus Team
Authors: Giovanni Guglielmetti and Federica Franchetti