SPC Manufacturing Waiver
On May 2018, the European Commission released a proposal for a Regulation amending Regulation (EC) N°469/2009 concerning the supplementary protection certificate (SPC) for medicinal products.
This legislative initiative follows the European Parliament Resolution of 26/05/2016 on the Single Market Strategy (2015/2354(INI)) urging to boost the competitiveness of the generics and biosimilars sector, without undermining the market exclusivity granted under the SPC regime in protected markets.
The proposal introduces a so-called "manufacturing waiver" for export purposes, an exception to the SPC system in relation to exports to third countries, with the aim, for EU-based manufacturers of generics and biosimilars, to tackle loss of export markets outside the EU, and favor 'day-1' entry onto Member State markets following expiry of the SPC.
The proposal provides a number of safeguards which, according to the Commission, will ensure transparency and will leave SPC protection fully intact as regards placing products on the EU market :
- Notification requirement : companies intending to manufacture a SPC-protected product for export purposes will be under an obligation to notify the industrial property office of the Member State, and the information contained in that notification will be made public
- Due diligence requirement : there will be a requirement on the manufacturer to inform its supply chain that the product in question is only for export and that the placing on the market, import or re-import of the product might infringe the certificates
- Labelling requirement : the manufacturing waiver requires that any SPC-protected product made for the purpose of export complies with specific labelling requirements, involving affixing a logo :
Noteworthy, the manufacturing waiver introduce an exemption to the rights conferred by a SPC, but does not carve out protection conferred by the basic patent.
According to the European Commission, the SPC manufacturing waiver is expected to generate extra growth of at least 1€ billion per year in net additional export sales in the EU pharmaceutical sector, creating up to 25000 extra high-skilled jobs over 10 years. It is expected to particulary benefit the small and medium-sized enterprises in the fiedl, which cannot easily outsource or relocate their production outside the EU during the period of SPC protection.