Assessing the impact of proposals for a Supplementary Protection Certificate (SPC) Manufacturing Exemption in the EU

Within the European Economic Area (EEA), a Supplementary Protection Certificate (SPC) confers the same rights as a patent, meaning that manufacturing or marketing of a generic pharmaceutical product cannot begin in an EEA country until the relevant SPC has expired.

SPCs were introduced in the European Union (EU) to maintain and stimulate pharmaceutical research in the EU, compensating innovators for insufficient 
effective period of patent protection due to long and costly development timelines.

The European Commission (EC) is currently working on an evaluation of the SPC Regulation. As part of that exercise, the EC is considering proposals to allow manufacturing in Europe during the SPC protection term, notably for export purposes. QuintilesIMS has looked at the historical evidence to assess what the potential impact of this could be.

Proponents of an “SPC Manufacturing Exemption” argue that if the European based industry were able to begin manufacturing (not selling) products in European countries where an SPC is still in place, these products could be exported to markets outside Europe where IP protection has expired or has never existed, thereby bringing an economic benefit to Europe.

In this report we outline three evidence-based arguments which highlight some of the potential impacts of such a policy for Europe.

The study is based on independent research and analysis undertaken by QuintilesIMS that was funded by EFPIA.