Insights · Opinion

Who fixes the medicines supply chain?

In short

No single body does. Manufacturers decide what to make and where to sell it, and must give DHSC six months' notice of a discontinuation. Wholesalers must keep UK pharmacies supplied under regulation 43(2) of the Human Medicines Regulations 2012. DHSC manages shortages with notifications, Serious Shortage Protocols and price concessions. The MHRA licenses and enforces. Pharmacies absorb what is left.

Every pharmacy owner has asked it at the counter: whose job is this? The honest answer is that the medicines supply chain has no single owner. Manufacturers, wholesalers, the Department of Health and Social Care, the MHRA and NHS England each hold one lever, and each holds a legal duty to match. This article maps the levers, tests what each body is doing with them, and asks what a pharmacy can reasonably expect by 2027.

Last reviewed 22 April 2026 by Arham Jamaal, Superintendent Pharmacist. Legal duties are taken from the Human Medicines Regulations 2012 and the Health Service Products (Provision and Disclosure of Information) Regulations 2018; shortage figures are from Community Pharmacy England's 2024 and 2025 Medicines Supply Reports and the NHSBSA SSP list.

Is anyone in charge of medicines supply?

No. The chain from factory to counter passes through at least five bodies, and each holds a different lever. Manufacturers and marketing authorisation holders decide what to make, how much and for which market. Wholesalers move it and, when stock is short, decide who gets what. The Department of Health and Social Care (DHSC) watches the whole picture and reacts. The MHRA licenses products and sites and enforces the conditions. NHS England commissions the pharmacies at the end of the line. Nobody owns the outcome.

That is not an accident of drafting. Medicines are made by private companies for a global market, and the NHS is a customer, not an owner. What the law does instead is attach a duty to each link. The table below sets them out, with the source for each.

WhoLeverLegal duty or tool
Manufacturers and marketing authorisation holders.What is made, how much, and which market gets it.Must notify DHSC of a discontinuation or expected shortage at least six months ahead, or as soon as practicable. Regulation 29 of the Health Service Products (Provision and Disclosure of Information) Regulations 2018.
Wholesale dealers.Distribution and, in a shortage, allocation between accounts.Must ensure the continued supply of medicines to pharmacies so that UK patients' needs are met: regulation 43(2) of the Human Medicines Regulations 2012. May not parallel export or hoard listed medicines.
DHSC medicine supply team.National management of a shortage.Medicine Supply Notifications, Serious Shortage Protocols, price concessions, retrospective top-ups and the export restriction list.
MHRA.Licensing and enforcement.Expedited assessment of licences and variations, labelling exemptions, unlicensed imports, and suspension of a wholesale dealer's licence for breaches.
NHS England and NHSBSA.The contract and the money.Publishes the Community Pharmacy Contractual Framework with DHSC; the Drug Tariff sets what a pharmacy is paid for each item.
Community pharmacy.Supply to the patient.Must provide the drugs ordered with reasonable promptness: paragraph 5 of Schedule 4 to the NHS Pharmaceutical Services Regulations 2013.

Read down the right-hand column and the design is clear. Every link above the pharmacy has a duty to warn, to keep supplying or to react. Only the pharmacy has a duty to deliver the medicine to a named patient today. That is why the pharmacy feels every failure upstream, and why Community Pharmacy England (CPE) found in its 2025 Medicines Supply Report that 87% of pharmacy teams face supply issues daily. The numbers behind that are in why medicines shortages are getting worse.

What do manufacturers have to do?

Warn early, and not much else. Regulation 29 of the 2018 Regulations requires a producer of a notifiable presentation to tell DHSC when it intends to discontinue a medicine. The same duty applies when it anticipates a shortage likely to affect patients. The notice must arrive at least six months before supply stops or the impact begins. Where the decision is taken, or the problem discovered, inside that window, the producer must notify "as soon as reasonably practicable". The notification must state the reasons, the quantity available, the expected duration, the steps being taken and the producer's market share.

That gives DHSC a warning. It does not give it a medicine. No rule requires a manufacturer to keep making a product, to hold a UK stockpile or to send the UK a share of a global allocation. Some companies have set up their own safety valves. CPE lists about 30 manufacturers, including AstraZeneca, GSK, Lilly, Novo Nordisk and Pfizer, that take direct orders from a pharmacy when wholesalers have nothing. Those arrangements are voluntary, and they cover the branded end of the market. The generic end, where most shortages sit, has no equivalent.

CPE's briefing for prescribers, updated in June 2025, names the drivers plainly. It points to "manufacturing problems and global market share". Behind those sit "years of turbulence across supply chains with impacts linked to Brexit, COVID-19, war in Ukraine, and wider economic instability". Manufacturing problems are the ones a manufacturer can fix. Global market share is the one it will not fix for the UK's benefit, because it is a commercial decision.

Do wholesalers ration medicines?

In effect, yes, whenever a manufacturer restricts what it releases. A wholesaler can only distribute what it receives, and when that is less than its customers order, it decides how to share it. The rules for that allocation are the wholesaler's own. From the pharmacy counter it looks like rationing, and in CPE's 2025 survey 81% of pharmacy teams said a wholesaler was out of stock of something every day.

The law sets an outer limit rather than a formula. Regulation 43(2) of the Human Medicines Regulations 2012 requires a wholesale dealer's licence holder to ensure "the continued supply of medicinal products to pharmacies" so that "the needs of patients in the United Kingdom are met". The duty runs "within the limits of the holder's responsibility". Since 3 October 2019 DHSC and the MHRA have also published a list of medicines that cannot be parallel exported or hoarded. Exporting a listed medicine is treated as a breach of regulation 43(2) and of the licence, and the MHRA can suspend the licence at once. The list has been updated regularly since. What the law does not do is tell a wholesaler which pharmacy should get the last pack.

What is the DHSC doing about shortages?

Running the machinery, and running it hard. DHSC's medicine supply team is the body that turns a manufacturer's warning into action. Its tools, and their status on 22 April 2026, are below. Counts are from the NHSBSA SSP list and CPE's reports and concession pages.

ToolWhat it doesStatus
Medicine Supply Notifications.Alerts with resupply dates and recommended alternatives, published on the SPS Medicines Supply Tool and graded from tier one (low) to tier four (critical).Ongoing; login needed to read them.
Serious Shortage Protocols.Let pharmacists supply a different quantity, strength, form or product without the prescriber, under regulation 226A of the Human Medicines Regulations 2012.87 issued since 9 February 2019; seven in force, the newest for ramipril 1.25 mg capsules from 22 April 2026.
Price concessions.A higher reimbursement price for a month when a generic cannot be bought at the Drug Tariff price, granted at CPE's request.1,524 granted between May 2024 and April 2025, an average of 127 a month.
Retrospective top-ups.Extra payment where DHSC's margin survey shows a concession price was set too low.Quarterly since April 2024.
Export and hoarding restrictions.Listed medicines cannot be parallel exported or hoarded by licence holders.List published 3 October 2019 and updated regularly since.
Discontinuation and shortage notices.Six months' warning from producers under regulation 29 of the 2018 Regulations.In force; the trigger for most of the above.

Judged as crisis management, this works. An SSP can be issued within days, a concession within weeks, and both reach every pharmacy in England at once. Judged as prevention, it does nothing. Every tool in the table is a reaction to a shortage that has already started. The one lever that would change the working day, a general power for pharmacists to alter strength, quantity or form outside an SSP, sits in CPE's asks, not in the law. For how the protocols work in practice, see when pharmacists can substitute under an SSP.

What does the MHRA do?

It shortens the paperwork and polices the licences. The MHRA's guidance on regulatory processes for supply disruptions, published on 23 May 2022, sets out what it can do once DHSC has verified a shortage of an essential medicine. It can expedite the assessment of a new marketing authorisation or a variation, so a new supplier or a new site can be approved faster. It can grant temporary exemptions from labelling rules, so stock packed for another market can be used. It can allow the import of a licensed medicine under quarantine, and it manages the import of unlicensed medicines to meet a patient's needs.

The other side of the MHRA's role is enforcement. It is the body that suspends a wholesale dealer's licence for exporting a listed medicine. That power is the sharpest tool in the whole system, and it is aimed at the middle of the chain rather than the ends. It cannot make a manufacturer produce, and it cannot make a pharmacy whole.

Where do NHS England and the contract fit?

NHS England commissions the pharmacies that absorb the disruption, and the Drug Tariff decides how much of it they can afford. NHS England's pharmacy pages describe its role. It publishes the Community Pharmacy Contractual Framework with DHSC, runs the Pharmacy Quality Scheme and the Pharmacy Integration Programme, and holds the Office of the Chief Pharmaceutical Officer. Its planned abolition, announced in March 2025, moves those functions into DHSC over time. It does not change the shape of the problem.

The money matters more than the org chart. CPE's 2024 report noted that about 30% of NHS pharmacy funding is delivered through medicines margin: the gap between what a pharmacy pays for a medicine and what the Tariff reimburses. When market prices run ahead of Tariff prices, that margin turns negative until a concession catches up. Between May 2024 and April 2025 CPE received more than a million reports of medicines bought above the Tariff price. The mechanism, and where it leaks, is explained in how price concessions work and why pharmacies dispense at a loss.

WHAT THIS MEANS FOR YOU

Three of the five levers are outside anyone's reach in the UK, and the two that are reachable react rather than prevent. So plan for the chain to keep failing. Report every above-Tariff purchase, because the concession system runs on those reports. Use SSPs when they exist and log the reasons when you do not. Keep manufacturer contingency numbers by the phone. And keep a record that shows what you did, because when supply fails, the only duty anyone will check is the one at the counter.

Why does the UK import so many medicines?

Because generic manufacturing has concentrated where it is cheapest, and UK prices reward the cheapest source. The NHS buys generics through a market that pushes reimbursement prices down, and that has kept the medicines bill low for years. The trade-off is that a product often has a handful of manufacturing sites worldwide, and the UK is a small share of their sales. When a site fails, every market that depends on it competes for what is left, and a market that pays less tends to wait longer.

That is the sense of CPE's phrase "global market share". It is not a claim that the UK cannot make medicines. It is a description of where the volume went. Reversing it would mean paying more, or paying for spare capacity that sits idle in normal times. Neither has been offered. The specials and imports route fills some gaps, at a price. An unlicensed import is reimbursed at invoice price and earns a £20 fee. But it needs a prescription written for the unlicensed product, and a record kept for five years.

Will shortages get better?

Not soon, and not because of anything decided so far. The causes CPE lists have not cleared. The daily frequency of supply issues rose from 67% of pharmacy teams in 2022 to 87% in 2025. The number of SSPs has kept climbing. The monthly concession count, eight in 2012/13 and 49 in 2020/21, averaged 149 in 2023 and 127 across the year to April 2025.

The asks are on the table. CPE's 2025 report calls for "continued progress to investigate and improve medicine supply chain resilience, from manufacturing through to community pharmacy supply to patients". It asks for measures giving pharmacists "more flexibility in making strength, quantity and formulation changes where there are supply issues". And it asks for "fair access to margin". The Royal Pharmaceutical Society's 2024 report, Medicines Shortages: solutions for empty shelves, made the same central call on substitution. As of 22 April 2026, none of the three has been delivered.

So who fixes the supply chain? On the evidence, nobody fixes it; several bodies manage it, and one absorbs it. Until that changes, the realistic goal for a pharmacy is not to avoid shortages but to run them well. The routine for doing that is in how to run a shortages workflow, and the words for the counter are in what to tell patients during shortages.

Key takeaways

  • No single body owns medicines supply: manufacturers, wholesalers, DHSC, the MHRA and NHS England each hold one lever and one duty.
  • Producers must give DHSC at least six months' notice of a discontinuation or expected shortage under regulation 29 of the 2018 Regulations, but need not keep making the product.
  • Wholesalers must ensure continued supply to pharmacies under regulation 43(2) of the Human Medicines Regulations 2012, and cannot export or hoard listed medicines; the MHRA can suspend the licence.
  • DHSC's tools all react: 87 SSPs since February 2019, 1,524 concessions in the year to April 2025, and quarterly top-ups since April 2024.
  • The MHRA can expedite licences, waive labelling rules and allow imports, under processes set out in May 2022.
  • About 30% of NHS pharmacy funding comes through medicines margin, so above-Tariff prices hit the core of the business until a concession lands.
  • As of April 2026 none of CPE's three asks has been delivered, so plan for shortages to continue and run them as a routine.

Sources and further reading

FAQs

Responsibility is split. Manufacturers and marketing authorisation holders decide what to make and must notify DHSC of discontinuations and expected shortages. Wholesale dealer licence holders must ensure the continued supply of medicines to pharmacies under regulation 43(2) of the Human Medicines Regulations 2012. DHSC's medicine supply team manages shortages with notifications, Serious Shortage Protocols, price concessions and export restrictions. The MHRA licenses products and enforces licence conditions. NHS England commissions community pharmacy. No single body owns the outcome.
AJ
WRITTEN BY
Arham Jamaal
Superintendent Pharmacist · Published researcher, pharmacokinetics
This is an opinion piece describing the position in England as at 22 April 2026. Survey figures are self-reported by pharmacy owners and staff. Serious Shortage Protocols, price concessions and the export restriction list change frequently, and policy commitments described as pending may have moved since publication. Check the NHSBSA, CPE and GOV.UK pages before relying on any figure. General guidance for professionals rather than legal, medical or regulatory advice. Last reviewed 22 April 2026.

You cannot fix the chain. You can fix your end of it.

Until the structural fixes arrive, the pharmacy is the shock absorber. A written shortages workflow keeps patients informed, owings tracked and above-Tariff purchases reported so the concession system can work.

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