ESPL Regulatory Consulting

News

Regulatory News and Updates

UK consults on 'no deal' Brexit SPC waiver law

Generic and biosimilar medicines manufacturers will continue to benefit from existing qualified rights to make SPC-protected medicines in the UK for export or stockpiling in a 'no deal' Brexit scenario, the UK government has confirmed.

SPCs, or supplementary protection certificates, serve to extend the life of patents owned by pharmaceutical manufacturers by up to a maximum of five years. The rationale for SPCs is to compensate patent holders for the period of patent protection during which they are prevented from commercialising their products owing to the lengthy drug approval process. Patent protection lasts 20 years but it often takes drugs companies around a decade to develop new medicines and gain marketing authorisation.

Read more here.

Ian Abernethy