Supplementary protection certificates in the EEA extend IP rights after the expiry of the original patent for medicines and biologics. They were created to compensate for the long approval waiting time for these products.
But the European Generic and Biosimilar Medicines Association (EGA) says an exemption to SPCs is “essential to increase manufacturing and R&D in Europe, create new high skill pharmaceutical jobs and stimulate economic growth in the EU.
Under the current system, European manufacturers are forced to outsource production to supply countries without SPCs, the EGA said, or to regions where SPCs expire earlier than in Europe, and to stimulate competition as soon as SPCs expire in Europe.
“The European generic and biosimilar medicines industry is on the cusp of creating many more jobs as it expands access to high quality medicines for patients. Europe needs to rapidly introduce a targeted SPC waiver to capitalize on this tremendous opportunity for pharmaceutical manufacturing in the EU,” said Adrian van den Hoven, EGA Director General.
Export waiver and ‘safe harbour’ clause
The European Commission announced the waiver in its strategy document A Single Market Strategy for Europe – Analysis and Evidence.
Pointing to evidence suggesting global spending on generics will rise from 27% in 2012 to 36% of total sales by 2017 and 80% by 2020, the report said an SPC manufacturing waiver “for export purposes to non-EU countries with no SPC protection could allow the EU generics and biosimilars industries both to create thousands of high-tech jobs in the EU and start many new companies.”
The EC plans a stakeholder consultation before implementing a “one-stop shop” for granting SPCs in Europe, with greater transparency and giving greater certainty to European regulators and generic companies about products’ IP status. The planned SPC export waiver will “allow EU-based manufacturers of generic and biosimilar medicines to compete on equal footing with competitors from non-EU countries,” it said.
It may also reform the scope of research exemptions (also known as safe harbour or Bolar exemptions), under which clinical research performed for a regulatory filing is not considered an IP infringement of an innovator drug. The exemption allows generic manufacturers to conduct research before the original drug comes off-patent. The EC said it will take into account the upcoming establishing of the Unified Patent Court, as well as “best practice implemented in certain Member States.”