The Nuffield Trust, a London-based independent health think-tank, published a research report entitled “The future for health after Brexit” on 18 April 2024. Among the effects of Brexit on the UK’s “health landscape”, the report’s authors singled out “constantly elevated medicines shortages, in a new normal of frequent disruptions to crucial products” over the preceding two years. These shortages were noted to have reached “historic highs” by autumn 2022. The number of warnings about impending supply problems for certain products issued by pharmaceutical companies thus soared from 648 in 2020 to 1,634 in 2023.
The report’s authors refer to the contribution of regulatory and trade barriers created by the UK’s departure from the EU’s single market at the end of 2020. These include customs checks at UK-EU borders, the UK’s exclusion from the EU’s verification system for securing the single market against falsified medicine (Falsified Medicines Directive system of tags and identifiers), and delays in approval of new medicines under the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in place of the EU’s European Medicines Agency (EMA). The UK has also been left out of EU-wide initiatives to manage supplies and contain costs, including the Critical Medicines Alliance and the Voluntary Solidarity Mechanism.
Medicines shortages have many undesirable effects. Anxious consumers may experience delays in healthcare, failures of treatment, relapses of their underlying condition, and adverse events, including complications that may lead to potentially avoidable admission to hospital. Stressed suppliers have to spend more and more of their time chasing drugs in short supply, and face the wrath of angry members of the public deprived of much-needed treatments.
Medicine shortages arise from complex industry-wide issues, which affect all countries across the world. The supply-demand mismatch of medicines has many causes, some of which reflect the special characteristics of these markets.
Increased demand for certain medications, such as HRT (hormone replacement therapy), medications for ADHD (attention deficit hyperactivity disorder), GLP-1 (glucagon-like peptide 1) agonists, and antimicrobial drugs, reflects better awareness of menopausal symptoms, increased recognition of ADHD, new options to treat type 2 diabetes, and a surge of demand during epidemics and pandemics, respectively. Inappropriate overprescribing can further increase demand. Just-in-time inventory systems, in place of strategic stockpiles of supplies, may be unable to manage fluctuating demand in fragile supply-chain systems.
The timely supply of medications depends upon complex, long, fragmented, and often opaque supply chains. At the source, shortages of raw materials (from animal and plant sources) as well as of active pharmacological ingredients, inactive excipients, and packaging materials, and high energy costs stifle manufacture. Low profit margins for generic (off-patent) and biosimilar drugs, as well as for sterile injectable products are particularly costly to manufacture, have disincentivised investors and producers. The pricing policies of healthcare providers may also not reflect the true costs of manufacturing. Logistical issues that disrupt supply chains only add to the problem.
Medications in short supply may have to be rationed, or alternative products offered instead. The problem has been compounded by the net closure of 491 pharmacies in England between 2019 and 2022. Desperate patients are thus being forced to shop around for their prescribed medicines, in what is being referred to as “pharmacy bingo”, or may even be driven to attend emergency departments as a last resort. Responding to national shortages, the UK Government introduced Serious Shortage Protocols (SSPs) from 1 July 2019 onwards. In the face of shortages of certain drugs, community pharmacists can either offer an alternative generic product (different brand), or a different formulation (liquid formulation or capsules instead of pills), a different quantity, or a different strength of the original prescribed medication instead. However, to quote the Royal Pharmaceutical Society, SSPs are “bureaucratic, professionally frustrating and inflexible.”
Much work remains to be done to tackle the UK’s fragile supply chain systems for therapeutic medications. Multiple failures in the medicine markets demand constructive dialogue between pharmaceutical manufacturers, NHS procurers, the Commercial Medicines Unit of the Department of Health and Social Care, and devolved governments, all in the best interests of patients who depend on hard-to-find medications to stay alive and keep in good health. Government subsidies to ensure continued supplies of certain critically-important generic drug treatments may prove necessary.
Ashis Banerjee