Northern Ireland faces ‘huge’ rise in generic medicine prices

Northern Ireland will have to pay significantly higher prices for generic drugs once a Brexit grace period expires in December, a key political party leader has warned, echoing concerns of health experts on the future supply of medicines into the cash-strapped region.

Steve Aiken, outgoing leader of the Ulster Unionists, told the Financial Times that his party, which holds the health ministry in Northern Ireland’s power-sharing government, had “real concerns” about what will happen once the region has to test and license medicines under the EU’s regime while the rest of the UK implements national standards.

Under the Northern Ireland protocol, which governs the implementation of post-Brexit trade issues in the region, medicines made in Great Britain will have to be licensed separately for use in Northern Ireland and undergo separate safety inspections and quality testing from next January.

The change means that Northern Ireland may no longer be able to get drugs at the “very reasonable prices” secured by the NHS’s massive buying power, Aiken said. He added, without giving figures, there would be a “huge price differential” if Northern Ireland had to instead bulk buy with the Republic of Ireland or the EU.

In 2019 a study commissioned by the British Generic Manufacturers Association (BGMA) from Oxera, a consultancy, compared manufacturers’ actual selling prices across five European countries with mature markets. It found that prices of generic medicines in the UK were generally lower — often by a large amount.

Northern Ireland already has some of the longest treatment waiting lists in the UK and its health department recently warned it would need an extra £400m this year on top of its annual £6.5bn “just to stand still”. “Not only can we not afford to spend more on health, but why would we?” said Aiken. “We’re British citizens, why can’t we have the same opportunities as the rest of the UK has in terms of bulk purchasing?”

Northern Ireland’s health ministry referred queries to the UK Department of Health and Social Care, which oversees drugs purchasing across the UK. The DHSC said Northern Ireland would continue to benefit from price caps on branded medicines under the 2019 voluntary scheme for branded medicines pricing and access between the government and industry, which limits price rises of branded medicines at 2 per cent a year for five years.

“Historically, for unbranded and generic medicines, we rely on competition to keep the prices down,” the DHSC said. “This has led to some of the lowest prices in Europe and allowed prices to react to the market demand, ensuring we are always able to secure the availability of medicines for UK patients.”

The department would not speculate on Northern Ireland’s prices for generic drugs when it could not leverage the UK’s purchasing power, but a person familiar with the situation suggested it “may be able to negotiate commercial discounts on [its] own” or by buying with the Republic of Ireland.

However, Northern Ireland has a population of 2m, the Republic 5m and Great Britain 65m.

The generics industry makes four out of five drugs used by the NHS. Mark Samuels, BGMA chief executive, said the industry was able to deliver these high volumes at low prices by accepting slim commercial margins.

Unless the UK and Northern Ireland can agree mutual recognition of each others’ licensing and testing systems, companies would need to duplicate laboratory testing, technical specialists and warehousing for Northern Ireland-bound products. 

“Without political intervention, patients will face drug shortages, significantly reduced treatment choice and restrictions on access to new products,” Samuels said, adding health commissioners “could well be looking at increased medicines costs as a direct consequence”

Mark Dayan, a policy analyst at the Nuffield Trust who is an authority on Brexit, said pharmaceutical companies were more concerned about the situation in Northern Ireland than any other aspect of medicines supply following the UK’s departure from the EU.

A key issue concerned the EU Falsified Medicines Directive, which requires anti-tampering security and a barcode-like unique identifier on packaging to ensure items can be tracked.