Supplementary Protection Certificates

Supplementary protection certificates (SPCs) are an intellectual property right that serve as an extension to a patent right on medical products that require authorisation by national regulatory authorities before they can be marketed. They are granted at the expiry of the patent term to compensate for the long time needed to register the medicine and obtain regulatory approval. During this time, the exclusive patent rights of the medicine cannot be exploited commercially. Read more about this subject here.

With the additional protection of an SPC, the holder of the patent rights will benefit from an overall 15 years maximum of market protection, from the moment the product first obtains the authorisation to be place on the market. This means that producers potentially must wait to market generic versions of new drugs for a whole 15 years.

High prices of medicines, enabled by patent or SPC market exclusivity, serve as a barrier to access to treatment, and the ability of healthcare systems to ensure availability of medicines for all patients. (Examples: Sofosbuvir – the highly effective hepatitis C treatment sofosbuvir is marketed at high prices that severely financially burden health systems globally)

While SPCs are intended as innovation incentives, in reality they can impede the availability and affordability of lifesaving medicines.

What is FTV/PAF doing about this topic?

FTV/PAF is currently studying how SPC’s have made access to the HAI/AIDS prevention product Truvada difficult in some EU countries.

Further reading

Pascale Boulet, ‘How patents, data exclusivity and SPCs interact to extend market exclusivity of medicines: the example of Truvada’ (Medicines Law & Policy)

https://medicineslawandpolicy.org/wp-content/uploads/2019/06/European-Union-Review-of-Pharma-Incentives-Supplementary-Protection-Certificates.pdf