The medicines business | A question to investigate
Before a shortage becomes everybody’s problem
A possible shortage becomes difficult long before a headline appears. Forecasts diverge, a manufacturing recovery date moves and different teams hold different versions of the same risk. For a marketing authorisation holder, the challenge is connecting those fragments quickly enough to support responsible reporting and a coherent response. NEUVIOR’s interest is the preparation and decision work around that moment, rather than promising to predict every interruption.
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Uncertainty moves between functions
Supply planning may see a shortfall against forecast while regulatory colleagues need to understand product and territory scope. Medical teams may receive questions before the commercial organisation has a stable recovery estimate. Each view can be correct yet insufficient. A readiness review should expose these handoffs: what triggers discussion, what information is missing, who confirms the position and how the organisation distinguishes a possible risk from an established supply problem.
Reporting is not one universal workflow
DHSC directs MAHs to report supply issues through DaSH (DHSC, 2019). EMA operates the European Shortages Monitoring Platform for its own reporting contexts (EMA, n.d.). These routes have different scope and requirements. Any proposed support would begin with the relevant products, authorisations and territories, then link to current official instructions. It would preserve regulatory ownership rather than inventing a single global shortage score that appears to satisfy every reporting obligation.
Give each uncertainty a useful name
An uncertain batch release, a packaging constraint and an unexpected increase in orders call for different evidence and different responses. Our proposed approach would distinguish the underlying event, confidence in its timing, available stock information and the consequences of alternative actions. A forecast date should remain a forecast date. Recording who supplied it and when it was reviewed can be more useful than presenting a precise-looking recovery countdown unsupported by the available evidence.
A versioned readiness brief
The proposed output would place the current estimate beside its source, owner and last review date, with contradictory information preserved for resolution. It would identify which facts are required before the next reporting or communication decision. That provides a concrete basis for a cross-functional meeting without implying certainty about when supply will recover.
A public decision brief | An illustrative example
Open the question.
Inspect the reasoning.
Choose a business question, then look beneath its claim. See what a public source supports, what depends on the local setting and what a useful next step could be.
A medicines or implementation team considering an AI-supported evidence review.
Would a quicker review make the decision better?
The interesting question is the complete piece of work: finding relevant material, checking it, correcting the draft and reaching an accountable decision.
A proposition to investigate
Less preparation. The same ability to challenge.
An evidence-review approach could be useful if it reduces avoidable preparation while preserving source access, relevant qualifications and professional checking. That is the proposed value to test. No time reduction, accuracy improvement or customer result is asserted in this example.
The proposition is constructed for this public brief. It is not a published finding about PHARMORIS.
What the next brief would contain
A decision someone
can commission.
- The decision
- Whether one defined review task merits an agreed evaluation.
- The comparator
- The team's existing complete review process, including checking and corrections.
- The evidence
- Representative cases, source records, reviewer decisions, complete-task effort and exceptions.
- Stop or redesign
- Stop or redesign if source checking weakens, errors are unacceptable or the complete task offers insufficient value.
Constructed public example | Not PHARMORIS-generated software output or a measured customer result.
Keep this example briefStart with a tabletop evaluation
A first PHARMORIS evaluation could revisit one completed shortage-management episode or a carefully constructed scenario agreed by the MAH. Inputs would include approved event summaries, versioned supply estimates, responsibility maps and the organisation’s reporting procedure. The comparator would be its current preparation process. The exercise would assess whether an evidence-linked brief makes missing information and ownership clearer, without submitting reports, communicating externally or changing supply arrangements.
Define useful outcomes before beginning
Candidate outcomes are the completeness of the evidence required for a reporting decision, the number of contradictory estimates identified, time to locate the accountable owner and the accuracy of changes between successive briefs. A small exercise cannot demonstrate prevention of shortages or improved patient outcomes. If it supports a further study, that study would need prospective data, an appropriate baseline and a clear distinction between better preparation and the eventual availability of the medicine.
What would make us pause
We would pause if essential manufacturing information cannot be shared lawfully, if the scenario conceals the decisions that actually mattered, or if experimental summaries begin replacing authorised reporting checks. Another stop condition is false reassurance: a missing event must not become evidence that no risk exists. The evaluation should retain uncertainty visibly and allow the accountable reviewer to reject both the proposed framing and any suggested next step.
A practical discussion for an MAH
The strongest starting point is one product-territory question with a named supply or regulatory owner. Explain where preparation becomes fragmented and which decision currently waits for information. We can then discuss a bounded evaluation, the confidentiality it needs and the evidence that would justify continuing. The commercial purpose is disciplined coordination around a material business problem, while reporting duties, quality decisions and external communication remain with the organisation responsible for them.
Sources and scope
DHSC | Shortage and discontinuation reporting | EMA | European Shortages Monitoring Platform
DHSC (2019) Shortage and discontinuation reporting. Available at: https://www.gov.uk/government/publications/reporting-requirements-for-medicine-shortages-and-discontinuations (Accessed: 14 October 2026).
EMA (n.d.) European Shortages Monitoring Platform (ESMP). Available at: https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/european-shortages-monitoring-platform (Accessed: 14 October 2026).
Another useful angle.
- Before a product leaves the portfolio
A proposed discontinuation decision review connecting commercial constraints, supply implications, reporting and alternatives.
- A recall message is only useful when the action is clear
Explore a proposed recall-readiness exercise focused on product identity, communication, ownership and evidence of completion.
- A forecast needs a reason to be believed
Explore demand uncertainty, stock movement and the evidence needed before a pharmaceutical supply decision changes.