UK Risks Critical Medicine Shortage as EU Lures Drugmakers

Britain risks running out of critical medicines because it’s failing to stay competitive on generics, according to the UK head of one of the industry leaders.

The European Union last year proposed legislation to fund new investments and repatriate production of drugs deemed essential. If the UK doesn’t take steps to make the country attractive to companies, it will face further shortages, said Diane DiGangi Trench, who heads Sandoz Group AG in the UK.

“We’re fighting for supply with the likes of Europe and the US,” she said in an interview. “If there’s only so many critical medicines that are available and if the UK doesn’t make the market more sustainable or commercially viable, I think ultimately it will lose out.”

The UK government has pushed to spur life-science innovation, championing companies like AstraZeneca Plc and GSK Plc. But it’s not supporting makers of generics the same way, DiGangi Trench said, even though these medicines account for most of the shortages.

Her warning underscores the difficult situation for British patients, with the latest data indicating that there are 101 drugs with supply issues in the UK – 86 of them generic. The February data, collated by the British Generic Manufacturers Association, indicates around 20% of the shortages have lasted a year or longer. The drugs affected include antibiotics as well as medicines for diabetes, Parkinson’s disease and multiple sclerosis.

“The complete absence of government policy supporting the generic-medicine sector has led to the shortage,” said Mark Samuels, the chief executive officer of the BGMA.

The situation also means the country could forgo massive savings, the group said, because 255 patents are set to expire in the next five years. Replacing those medicines with generics could save as much as ?18 billion ($22.9 billion).

A majority of pharmacists surveyed by Community Pharmacy England said in a survey last year that the shortages put their patients’ health at risk.

Sandoz is currently debating what new copycat drugs to launch in Britain and it’s not a given that the country will get the latest versions of biological medicines, DiGangi Trench said.

“If there is a phased launch of biosimilars across Europe, the UK most certainly has to fight for that supply,” she said.

Incentives Needed

Sandoz produces both generics and more complex biosimilars. It’s expanding production capacity for antibiotics in Austria, backed by the federal government, and investing millions in a German development center for biosimilars. Closely held rival Stada Arzneimittel AG is building a new supply-chain and packaging facility in Romania backed by a government grant that will allow it to produce over 700 million medicine packs a year.

Meantime in Britain there’s a lack of incentives to encourage Sandoz or others to consider large-scale investments, according to DiGangi Trench.

The group representing generic manufacturers launched an unsuccessful judicial review last year in an attempt to secure a seat at the table during negotiations for a new medicines-pricing plan.

In September, the CEOs of 16 of the world’s largest generics manufacturers co-signed a letter to Prime Minister Rishi Sunak asking for observer status at the negotiations. They were turned down, according to the BGMA’s Samuels. A separate letter from Sandoz Chief Executive Officer Richard Saynor went unanswered, DiGangi Trench said.

The UK’s Department of Health and Social Care didn’t respond to a request for comment.

Ignoring the generics industry, DiGangi Trench said, “sends the message loud and clear in terms of would we consider investing or not.”