Everyone agrees that the UK — or at least Great Britain — is at a crossroads when it comes to access to new medicines.
Despite leaving the European Union on 31 January 2020, the UK still has a heavy reliance on EU medicine approval procedures. While the UK may no longer have any representation at the European Medicines Agency (EMA), which famously moved from London to Amsterdam in March 2019, its decisions are mirrored in Great Britain and still automatically apply in Northern Ireland.
The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced the snappily named European Commission Decision Reliance Procedure, where companies can apply immediately for a marketing authorisation on receipt of a positive opinion from the EMA’s Committee for Medicinal Products for Human Use, using similar submission information. This fast-track mechanism to UK approval was meant to last for just two years post-Brexit, but was extended in January 2023 for another year.
However, there is evidence that this has led to slower novel medicines approvals. While the UK is still an important market for pharmaceutical companies, a review by Imperial College Business School found that, in 2021 — the first year of MHRA independence from the EMA — 35 novel drugs were approved in the UK, compared with 40 approvals in Europe and 52 approvals in the United States.
The UK government has announced the aim of introducing a new “international recognition framework” in 2024, which will take into account not just EU regulatory decisions, but those of other international regulatory bodies too. But we have yet to find out how this will work in practice, and there are some concerns that any accelerated process will lead to bad decision making.
Government advisers admit that the UK is slower than the EU average in getting new medicines to patients. In a letter to the Treasury in March 2023, then chief scientific adviser Patrick Vallance said there needed to be a “progressive UK regulatory offer” to promote innovation in diagnostics, drugs and medical technologies, although he added that any approvals process mirroring other regulators would need to be “paired with a rigorous surveillance process”. Again, precisely what that might look like is unclear.
What is becoming clear is that the UK has slipped behind in terms of medicines imports. In 2022, the Nuffield Trust published figures that showed, compared with other G7 states for which medicine imports have risen steadily in total value since 2016, in the UK, they have reversed and fallen back to where they were a decade ago. Of course, this could reflect previous stockpiling of medicines in preparation for Brexit, but also may be affected by new Brexit trade barriers, the drop in the value of the pound and a generally more negative attitude to investment in the UK.
Ease of access to medicines in the UK has all come into sharp focus as drug companies prepare for negotiations over medicines pricing. The ‘Voluntary Scheme for Branded Medicines Pricing and Access’ (VPAS), under which manufacturers pay the government a proportion of their net income from sales of branded medicines to the NHS in exchange for various incentives to support innovation, is due to be renewed by January 2024.
The aim of the agreement, which started in 2019, was to limit the growth in NHS spending on medicines to 2% each year by adjusting the payment percentage accordingly. However, the levy rose sharply from 9.6% in 2019 to 26.5% by 2023, largely the result of increased sales growth and the COVID-19 pandemic.
This tripling of the tax rate has led to a war of words between industry and the government as they prepare to start negotiations. The Association of the British Pharmaceutical Industry (ABPI) and the British Generic Manufacturers Association have said that the increasing rates could result in drug companies taking their research and manufacturing outside of the UK, which would ultimately cause delays to accessing new treatments for NHS patients and reduce supply of existing medicines.
The Pharmaceutical Journal also recently revealed that Sanofi could stop holding clinical trials in the UK because of the steep rise in the VPAS levy. The number of patients registered to pharmaceutical industry-funded trials in the UK is already suffering, having fallen 44% between 2017/2018 and 2021/2022, from 50,000 patients to 28,000, according to ABPI research published in October 2022.
Of course, every country has some limits on drug pricing, and it is hard to tell how much of the rhetoric is grandstanding by pharma companies as VPAS negotiations begin, but this row has come at an awkward time for the government.
The public is already keenly aware of the shortages that have hit a range of medicines, from hormone replacement therapies to thrombolytics, having been the subject of national headlines in recent months. The government’s response to such shortages, particularly around the supply of antibiotics for children in late 2022, has also faced significant scrutiny in the national media.
With these challenges in mind, it is clear that the UK cannot afford to slip into the slow lane of innovation in new medicines. To uphold high quality care for patients, the government will need to think radically — and present proposals soon — to prevent this from happening. However, medicines access is just one of many areas where government policy is badly needed, so it remains to be seen if there will be any significant progress made in the short term. PJ