More shortages predicted, sparking fears over TB, Crohn’s, Parkinson’s and asthma medicines

Medicine shortages affecting hundreds of thousands of Britons will worsen in the next five years as manufacturers pull products out of the UK to avoid a Government levy, a leading industry body has warned.

Drugs to treat TB, bacterial infections, heart rhythm disorders, epilepsy, asthma, Crohn’s disease, Parkinson’s, severe and moderate pain and anaesthetics are among the medicines at risk of stock shortages.

Supply issues could even hit key cancer medication, according to the British Generic Manufacturers Association (BGMA), a trade body whose members make the majority of medicines used in the UK.

The warning follows a series of medicine shortages declared over the past year, on HRT, ADHD medications, antibiotics and over-the-counter cold and flu remedies, in some cases for months at a time.

Currently, 102 drugs in Britain are affected by supply issues, according to the BGMA. But it is warning the list is likely to grow over the next five years due to a little-known Government levy charged to manufacturers in order to limit the NHS’s drugs bill.

The Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) rebate is expected to add £37m annually for the next five years to the budgets of each of England’s 42 integrated care boards, according to BGMA analysis seen by i.
VPAS is a voluntary agreement between the Department of Health and Social Care (DHSC), NHS England and the Association of the British Pharmaceutical Industry which sets a cap on the total allowed sales value of branded medicines to the NHS each year.

The cap grows at an agreed rate of 2 per cent per year and a percentage of the revenue from any medicine sales over that cap is paid back to the DHSC via a levy.

Decisions have been taken to increase the percentage of those sales taken by the levy from 5.1 per cent in 2021 to 26.5 per cent today – and the BGMA believes it could rise again from 2024.

The DHSC said the VPAS levy would save the NHS £7bn by the end of this year and that thousands of NHS patients have benefitted from dozens of new treatments for a range of conditions.

But the BGMA claims it could increase shortages in supplies of vital drugs to patients as manufacturers who do not want to pay it will pull out of stocking the UK.

Mark Samuels, BGMA chief executive, told i: “One of the critical things that’s rarely understood is that there’s only a finite amount of generic medicines [off-patent drugs] manufactured worldwide, which means that the UK is competing with other countries for stock allocations of medicines.

“As a consequence of VPAS, which is currently running a 26.5 per cent tax rate, global multinational companies make rational decisions – if they’re going to make a loss on products in the UK, they’re going to allocate stock to other countries.”

A range of other factors are contributing to wide-ranging medicine shortages in the UK, experts have told i.

Martin Sawyer, director of the Healthcare Distribution Association, said raw materials being unavailable, poor supply chain communications, occasional uneven supply into wholesale distributors and specific manufacturer failures all play their part.

“We believe that the vast majority of daily availability issues are caused by manufacturing issues during production e.g. batch failure, an export ban in [a] country producing the API [active pharmaceutical ingredient] – e.g. China and India – regulatory failure of factory at production level or UK not able to pay a competitive price for generic supply, just to name a few,” he said.

Spikes in demand for certain medications, as was seen last year when GPs and pharmacies struggled to deal with extra demand for appointments and antibiotics caused by high Strep A infection rates, are another factor behind medicine shortages.

Manufacturers face challenges in quickly responding to such spikes, Mr Samuels said.

“It can take six to nine months to increase manufacturing of a medicine… the active pharmaceutical ingredients are often complex molecules that that need to be carefully manufactured.”

In September, the DHSC issued an alert about the unavailability of three ADHD medications – Methylphenidate, Lisdexamfetamine and Guanfacine. It comes as drugs to manage the condition have been in higher demand, with ADHD diagnoses on the rise.

Henry Shelford, CEO of ADHD UK, said the situation was “absolutely unprecedented within ADHD” and a wake up call for the Government.

A spokesperson for the DHSC said it is “working intensively with manufacturers to increase supply for the UK and ensure continuous access to ADHD medicines for those who need them”.

The shortages affecting ADHD medications are expected to be resolved by the end of the year, while a serious shortage protocol, a tool used to mitigate supply issues, for HRT medication Estradot is due to end in November.

Raj Matharu, chair of Community Pharmacy London, the representative body for community pharmacy owners, said pharmacists have adapted their approach to drug supplies after localised shortages during the Strep A outbreak.

“We [previously] tried to hold about six weeks of stock… now you tend to increase that to about eight weeks, or even 10 weeks, if you can afford it. But we shouldn’t have to do that,” Mr Matharu said.

David Watson, director of Patient Access, which helps people book GP appointments and order repeat prescriptions, said: “In recent years, we have seen the UK become less viable for companies to launch some new medicines, due to a combination of regulatory backlogs, slow uptake of new treatments, and high payment rebates required from companies by Government on branded medicines.”

The as yet unpublished analysis by the BGMA found that an increase in medicine shortages is inevitable as a result of a more volatile market stemming from fewer suppliers, potentially less stock being earmarked for the UK and product withdrawals.

“There is also a danger that reducing access to preventative treatments may mean people will be less able to manage chronic conditions and more likely to need costly, acute hospital treatment, resulting in potentially worse patient outcomes,” the BGMA said.

Mr Samuels said: “More than 85 biological medicines will lose their exclusivity in the next five years including blockbuster products such as cancer medicine Keytruda and wet macular product Eylea.

“These represent a great savings opportunity to the NHS, but they won’t fulfil their savings potential if competition is reduced because fewer companies enter the market.”

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