Lawyers warn of Irish Sea split over SPCs
The UK is facing a divergence in supplementary protection certificate (SPC) regulations across the Irish Sea post-Brexit.
Under UK government regulations published last week, marketing authorisations (MAs) issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA) will only apply in England, Scotland, and Wales. Products in Northern Ireland, meanwhile, must be approved by EU authorities. Failure to submit timely authorisation details could also lead to a loss of protection in the UK.
The arrangement is part of the Northern Ireland Protocol of the Withdrawal Agreement, a deal struck by the EU and UK aimed at preventing a hard border on the island of Ireland.
“After the UK’s transition period ends in the new year, the system of SPCs for medicinal products will be split in the Irish Sea, said Darren Smyth, partner at EIP.
“Practitioners and their clients will need to carefully monitor the dates of issuance of authorisations by the UK and EU authorities to ensure that the relevant deadlines are adhered to or face losing protection in the UK altogether,” Smyth added.
Last month, Médecins Sans Frontières (MSF) called for the European Commission to abolish the SPC system altogether.
According to MSF’s Access Campaign, the EU’s commitment to ensuring access to cheaper generic drugs could be undermined by any strengthening of SPCs.
The criticism came as the Commission outlined its Pharmaceutical Strategy for Europe, which prioritises clearing barriers to generics coming to market.
“The Commission’s strategy provides a historic opportunity to ensure the EU’s policies and legislation are aligned and geared towards access to essential medicines, vaccines, and diagnostics,” MSF said, continuing: “However, SPCs prolong the duration of a patent on a medicine up to five years, enabling companies to charge exorbitant prices for a longer period of time.”
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