The British Generic Manufacturers Association (BGMA) has published a positioning paper which sets out the objectives that need to be delivered through the
next Voluntary Pricing and Access Scheme (VPAS) on Thursday (15 June).
The paper details how a financially sustainable VPAS can support widened medicines access to patients.
VPAS is an agreement between the Department of Health and Social Care (DHSC), NHS England and The Association of the British Pharmaceutical Industry (ABPI).
The scheme aims to limit increases in spending on branded medicines to no more than 2% per year via a rebate system which is charged on companies' sales revenues.
Two years ago, the rate was 5.1% but for 2023 it has soared to 26.5%. Last year, the association had raised concerns over the rise in the VPAS rate for 2023 to
26.5 per cent.
"The rocketing rate is in large part due to the growth in spend in on-patent medicines since 2019. Looking at the four completed years of the current VPAS scheme,
data shows that the average annual growth rate for on-patent medicine sales value from 2019-22 was 18% compared to just 2% for off-patent products," said the
association.
The British Generic Manufacturers Association (BGMA) on Monday alerted the Health and Social Care Committee that medicines shortages have increased and
are "around double what they were a year ago."
BGMA chief executive Mark Samuels told the committee that they have been highlighting the medicine shortage risk to ministers since July 2021 and the association
is "very concerned" about the current situation.
"We've been monitoring it for several years now, and as you saw in the written evidence, shortages have increased. They're around double what they were a year ago.
We have them at 101 shortages in February this year," said Samuels.
Dr Rick Greville, director of distribution and supply at the Association of the British Pharmaceutical Industry (ABPI), highlighted that the problem of drug
shortages in the UK is a "long-standing issue" and the scarcity of certain medications "continues to be challenging".
The government has launched a consultation into radically changing the Statutory Scheme for branded medicines (known as the Statutory Scheme).
The consultation comes as delicate negotiations for replacing the alternative Voluntary Scheme are underway, potentially undermining these talks, while also further
damaging industry confidence in the UK as a viable place to research, launch and supply medicine.
The government proposals seek to hold average revenue clawback rates under the Statutory Scheme at historic highs of between 21-27%, compared to the pre-pandemic
averages of 9.4% for the Statutory Scheme (2019-2021), and 6.88% for the Voluntary Scheme (2014-2021). The accompanying cost-benefit analysis ignores any negative
impact this may have on medicine supply and wrongly claims it will boost investment.
The consultation comes on the heels of government data last week showing UK life sciences foreign direct investment (FDI) fell by 47% between 2021 and 2022, down
by £900m year on year. This large fall in investment coincided with a rise in the main UK clawback rate under the Voluntary Scheme from 5% to 15%, and led to the
UK falling from 2nd to 9th out of 18 comparator countries for life sciences FDI in 2022. The Voluntary Scheme clawback rate now sits at a record 26.5% in 2023.
The British Generic Manufacturers Association (BGMA) has warned that England's 42 integrated care boards (ICBs) may need to allocate an extra £37 million
from their budgets annually for the next five years due to the spiralling tax rates.
The government's Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) rebate rate increased more than five-fold in the past two years, the BGMA said
in its white paper released on Monday (October 30).
The report, conducted by consultancy firm Conclusio in consultation with local NHS leaders, examined the potential effects of the VPAS on ICB budgets.
BGMA said that due to the elevated VPAS rate, each ICB in England will experience significant increases in expenses for branded generics and biosimilars
annually - a consequence of reduced competition.