'Red tape, confusion': EU accidentally blocks cancer drug citing Brexit law, NI protocol

EU has ‘accidentally blocked’ the UK authorized critical lung cancer drug as it moved the production to Dublin citing the Brexit red tape on the exports, the Northern Ireland protocol, and other arrangements of the post-Brexit deal, according to UK's press reports. Hundreds of vital packages were wasted of the medication called Osimertinib sold under brand name Tagrisso for cancer treatment, after EU told the firm that it cannot be authorized under an international scheme.

The drug, used to treat non-small cell cancer, was supposed to have approval by the European Medicines Agency (EMA) last month. But the EU stalled the review, which was supposed to be held by the Committee for Medicinal Products for Human Use, a subgroup of the EMA. The medicine, however, has already been licensed in both the UK and EU since 2016. 

In May, although, the UK issued new usage of the medicine at an earlier stage in the cancer disease for the patients' post surgery to curb episodes of resurgence. This could increase the survival rates by up to 75 percent. EU on Saturday said that the drug will not be approved by the European Medicines Agency (EMA) and hence will not be available to the cancer patients living in Northern Ireland (NI).

The Northern Ireland protocol adheres to some of the EU rules and regulations, and the commission on Saturday insisted that because the EU block did not carry out the assessment of osimertinib, the drug cannot be prescribed within the bloc – or within Northern Ireland. Experts lashed out at the commission calling the EU’s understanding of the post Brexit regulations ‘an embarrassment as they reminded on British TV networks that Northern Ireland (NI) must have the same access to the full range of medicines as the rest of the UK. 

A Belfast news journalist Sam McBride first reported on the issue of the EU’s blockade of a cancer drug to NI in a report, carried by News Letter, that stated EU withheld the Osimertinib drug from patients in Northern Ireland citing the laws around the ‘Irish Sea border’ of the post-Brexit deal.

Shortly, the European Commission spokesman Daniel Ferrie fired tweets of denunciation at McBride saying “this is entirely incorrect”. Others called it a disreputable attempt by Boris Johnson’s government to undermine the protocol, including outgoing DUP Leader & NI First Minister  Arlene Foster.

GB and NI protocol divergence & implications

Cancer Research UK’s public affairs manager in Northern Ireland, Margaret Carr, warned in a statement to Mirror that the divergence of regulations between GB and NI will have implications on the cancer patients, who will be devoid of the medication. Meanwhile, the leader of the Traditional Unionist Voice party, Jim Allister termed the confusion a health disaster for those in need. He called for an “inquiry” as he insisted that the life-giving cancer drug’s prohibition in Northern Ireland was unfair to have been left under the control of the EU Medicines Agency. Being denied what fellow UK citizens can avail of is the iniquity of the protocol, Allister reportedly said.