On 14 May 2019, the council of the European Union adopted a new regulation, which introduces a manufacturing waiver for supplementary protection certificates (SPCs) that is aimed at removing the competitive disadvantages faced by EU-developers of generic or biosimilar therapies. However, the introduction of this new SPC waiver has prompted polarized opinions throughout the pharmaceutical industry.
To learn more about the SPC waiver, and its implications for the European pharmaceutical industry, Pharmaceutical Technology Europe spoke with Ayesha Raghib, an associate at the law firm Powell Gilbert, which specializes in intellectual property (IP) and EU pharmaceutical regulatory law.
Specifics of the manufacturing waiver
PTE: Could you outline the key aspects of the SPC manufacturing waiver, recently introduced by the EU council?
Raghib (Powell Gilbert): On 1 July 2019, EU Regulation 2019/933 (the 'Regulation') came into force, amending the current SPC Regulation 469/2009, and introducing an SPC manufacturing waiver (SMW). The SMW now permits manufacturing and storing of generic drugs/biosimilars of SPC-protected products in the EU during the entire term of the SPC for products intended exclusively for export to countries where patent protection for the original medicine does not exist or has expired, and manufacture and storing during the final six months of the SPC term for post-expiry Day 1 EU launch.
Generics/biosimilar manufacturers must comply with certain legal obligations including notifying national IP offices and the SPC holder at least three months in advance of manufacture (or first related act); affixing a specific logo to products manufactured for export; and due diligence requirements in respect of parties in the supply chain.
The SMW will apply to SPCs applied for on or after 1 July 2019 but not to SPCs in force before that date. However, for SPC applications applied for before 1 July 2019 and taking effect on or after that date, the SMW will apply from 2 July 2022, allowing for a three-year transition period.
Generics vs. branded
PTE: How is the industry viewing the SMW differently?
Raghib (Powell Gilbert): On one hand, the aim of introducing the SMW is to create a level global playing field between generic drug/biosimilar manufacturers established in the EU and third-country manufacturers, thereby creating jobs and promoting the manufacturing industry in the EU. Thus, the SMW has understandably been welcomed by the generic drug and biosimilar industry.
Conversely, from the perspective of the originator industry, introduction of the SMW has been vehemently opposed and perceived as a significant step towards eroding the EU IP framework, raising...