According to Lord Frost, pharmaceutical businesses may withdraw up to 90% of their products from Northern Ireland (NI) when the Brexit grace period ends due to increased quality-control processes.
The higher expenses of executing new regulatory procedures, according to Informa Pharma Intelligence, may jeopardise manufacturers’ ability to export low-cost generic medications to Northern Ireland from within the UK.
Due to the lack of a clear political solution, the Brexit grace period is expected to expire at the beginning of 2022, and pharmaceutical businesses have expressed their fears.
“The Brexit vote, and the UK’s stance on leaving the single market, forced a separation between the UK’s MHRA and the EMA,” Ian Schofield, executive editor of Pharma Insights at Informa, explained.
“Whilst the separation itself is a lengthy process that requires a re-evaluation of each detail of the UK’s drug approval processes, the impact of the Northern Ireland protocol remains an ongoing area of tension with potentially significant impacts on the availability of generic drugs to Northern Irish citizens.”
“Worryingly, an easy solution to this is not forthcoming even with the deadline fast approaching.”
Northern Ireland would face further consequences if there were a possible shortage of key pharmaceuticals. Chilled meats cannot be imported from Britain to Northern Ireland under the conditions of the Protocol, which was approved as part of the 2019 Brexit divorce deal.
A six-month grace period was imposed on the implementation of the chilled meat prohibition when the Protocol went into effect at the beginning of this year.
Companies wishing to export from the United Kingdom to Northern Ireland must have set up specific batch control and release facilities that meet EU standards by 2022.
“Adherence to these rules is likely to be expensive, particularly for generics companies with high-volume, low turnover products, as they will need to foot the cost of compliance,” Mr Schofield told the i.
“Some companies say they may have to withdraw up to 90 percent of their medicines from the Northern Ireland market.”
“This could threaten the access of these companies to the Northern Ireland market, and more importantly the ability of Northern Irish citizens to purchase generic drugs.”
The government stated that the extension of the Brexit grace period would include medication imports into Northern Ireland.
“Under the standstill, all grace periods which come under the Northern Ireland protocol have been indefinitely extended – including customs, SPS [Sanitary and phytosanitary products] and medicines,” a spokesman for the Department of Health and Social Care stated.
“Though there are different original end dates for the grace periods, the extension applies to all of them.”
Mr Schofield, on the other hand, chastised the government for its interpretation of the grace period extension.
“This is a different grace period relating to the imposition of customs checks on trade in agri-food products,” he explained.
“They were supposed to take effect earlier this year, but their introduction was deferred in March and then again in June.”
“The grace period for pharmaceutical batch testing and release is a separate issue.”
According to the British Generic Manufacturers Association (BGMA), to avoid significant shortages of pharmaceuticals travelling between Great Britain and Northern Ireland, the two sides must agree on a UK-wide licencing arrangement.
Because of the Protocol, Northern Ireland will continue to be a part of the EU’s regulatory structure after Brexit. According to Mark Samuels, the association’s chief executive, up to 2,400 drugs have been placed on notice in Northern Ireland due to new regulatory requirements.