The European Commission is poised to introduce an SPC
manufacturing waiver as early as 2019. The controversial proposal aims to 'boost the competitiveness
of the generics and biosimilars sector, but without undermining the
market exclusivity granted under the SPC regime in protected
markets'. However, there are concerns about the impact of the
proposed waiver.
The proposal, which published on 28 May 2018, is to
introduce an SPC manufacturing waiver for export purposes.
This would allow the manufacture in the EU of a medicinal
product protected by an SPC, under the proviso that the manufacture
must be for the exclusive purpose of exporting the product to a
non-EU market. Any 'necessary' acts related to
manufacturing for export purposes will also be permitted; the
proposal lists upstream acts such as supply of intermediary
products and active ingredients, and downstream acts, which besides
transport, packaging, sorting and actual export include
'storing'.
