A proposed “export manufacturing waiver” (waiver) relating to supplementary protection certificates (SPCs) for medicinal products has been published here by the European Commission (EC) on 28 May 2018. The new legislation is expected to enter into force in 2019.
An SPC can extend the protection of a patented medicinal product for up to 5 years in EU member states, compensating the SPC holder for the time taken to obtain regulatory approval to market the medicine. Crucially, under current rules, SPCs can prohibit competitors from manufacturing the product in the EU.
The proposed waiver seeks to allow manufacture in the EU of medicinal products for export to non-EU markets where patent or SPC protection has expired or never existed; without infringing SPCs in EU member states.
The proposed waiver is not intended to affect SPC protection regarding placing products on the EU market. Patent protection in the EU should also be unaffected.
The proposed waiver is intended to benefit the EU economy by allowing EU-based generics/ biosimilars manufacturers to compete in global markets while SPCs remain in force at home.
The ability to establish manufacturing facilities (for export) during the SPC term would also enable EU-based companies to more rapidly enter the EU generics/ biosimilars market following SPC expiry.
The proposed waiver includes safeguards to ensure transparency and avoid diversion into the EU market of medicinal products manufactured for export:
- At least 28 days before the intended start date of manufacture in an EU member state, the designated national authority must be notified, including the intended start date and a list of export destination countries. The designated national authority will publish the details within 15 days of receipt
- The outer packaging of any product manufactured under the waiver must be labelled with a specific logo indicating “EU export”
- The maker must fully inform persons in their supply chain of the above conditions and that import or re-import of the product into the EU market would infringe the SPC
The required logo
Therefore, if you intend to take advantage of the waiver to manufacture generics or biosimilars in Ireland during the term of a relevant Irish SPC, you will need to be ready to notify the Irish Patents Office at least 28 days before your intended start date of manufacture, appropriately label the outer packaging of any resulting product, and complete the due diligence requirements in relation to your supply chain.
Likewise, Irish SPC holders will likely want to maintain a careful watch on the relevant details published by the Irish Patents Office after the new rules enter into force; as under the current proposed safeguards there will be no requirement to contact the SPC holder, and the notification might be published just 13 days before the intended start date of manufacture.
The proposed waiver will not apply to SPCs granted before a date about three months after the amended regulation is published in the Official Journal of the EU. The EC described this as a transitional period to accommodate pending SPC applications.
The proposal will be welcomed by many EU-based generics/biosimilars manufacturers, who have been advocating such a change for a number of years.
By contrast, innovator pharmaceutical companies may consider that the proposal essentially moves the goal posts for pending SPC applications if the transitional provisions are insufficient, or have concerns about effectiveness of the proposed safeguards in practice.