UKIPO seeks no-deal Brexit SPC comments
The UK Intellectual Property Office (IPO) has today, July 5, opened a consultation into supplementary protection certificate (SPC) law in the event of a ‘no deal’ Brexit.
At the beginning of the month, the controversial SPC manufacturing waiver came into force, allowing third-party manufacturers to make SPC-protected medicines in certain circumstances in the EU.
Manufacturers can make generic or biosimilar versions of SPC-protected medicines for the purpose of exporting out of the EU or, in the final six months, for storing to sell on the EU market once the SPC has expired.
“If the UK leaves the EU without a deal, these changes will automatically become UK law on exit day. Parts of the retained changes will need fixing so that they continue to work as UK law,” said the IPO.
The government is seeking views on a draft statutory instrument, which will fix various provisions relating to the waiver which will no longer function correctly after the UK leaves the EU.
“We are keen to ensure that the amendments will work in practice for users of the system and to avoid any unintended consequences,” said the IPO.
Post-Brexit, the current wording of the SPC waiver would seem to prevent various provisions from working effectively in the UK. According to the IPO, the statutory instrument needs to clearly set out the scope of the waiver in the UK.
“We propose that, after a no-deal exit, the legislation would allow UK-based manufacturers to make SPC-protected medicines for export outside of the UK, or, in the last six months of the SPC, for storage in the UK ready for sale on the UK market after the SPC expires. So, the UK will become the ‘home’ market,” said the draft.
The office has also proposed the removal of a provision which requires the European Commission to conduct an evaluation of the new waiver, and report to the other substantive bodies of the EU on its effectiveness.
“Retaining this provision would impose an obligation on a body outside the UK upon which we have no power, and it would therefore have no legal effect,” it said.
Did you enjoy reading this story? Sign up to our free newsletters and get stories like this sent straight to your inbox.
