A listing is not access: market access teams must own availability
This week's records show regulators bridging gaps with imports, special programmes and allocation. Pricing and access teams that stop at the listing are measuring the wrong thing.
The paper and the pharmacy
Market access teams are rewarded for decisions: a reimbursement listing, a price agreed, a status changed. This week's records suggest those decisions are only half the story, and sometimes the lesser half.
Take Czech regulator SÚKL. It moved Zentiva's erdostein 300 mg capsules from prescription-only to over-the-counter supply from 29 October 2026. The same notice says the product is not yet marketed in the Czech Republic. The status has changed, but no patient can use it. In the same week SÚKL called for proposals for a Specific Treatment Programme for oral ferrous sulfate for neonates and young children, because no suitable product is marketed in the country. And it published a draft price and reimbursement list for foods for special medical purposes, with manufacturer prices, reimbursement levels and co-payments, open for comment until the 20th. The Czech system is doing detailed work on what should be paid for. It is also admitting, in the same breath, that some needs have no product behind them.
The pattern repeats elsewhere. Slovenia's JAZMP has asked wholesalers to import two strengths of cefaclor oral suspension from other EU states, with bridging quantities set for six months. France's ANSM says tensions in contrast agents have persisted since a change in distribution circuit, and lists what Bayer and Bracco can currently supply. Estonia's Ravimiamet reports 53,000 Vaxigrip doses, about 20,000 of them open to all, and warns that November supplies will not cover everyone who wants a jab.
My position
Availability is an access outcome, and access teams should own it. A reimbursed product that cannot be obtained delivers nothing to the patient or the payer. The authorities in these records are not waiting for supply teams to fix it. They are stepping in with import calls, special programmes, allocation between pre-booked institutions and the open market, and published lists of what is on hand. Those are access mechanisms, and they come with their own rules, timelines and commercial consequences.
The records do not say why each gap arose. The cefaclor notice gives no cause in the material we have, and only the ANSM update points to a distribution change. That is the point. Causes differ, but the access consequence is the same: when supply fails, the price or reimbursement status on file stops meaning much, and national authorities improvise.
The strongest counter-argument
The fair objection is that supply is a manufacturing and logistics problem, and access teams cannot make a plant run or a wholesaler stock a shelf. Loading availability onto the access function risks diluting its core work, which is already stretched across HTA submissions, price negotiations and listing deadlines. And nothing in these records shows that price or reimbursement caused any of these gaps.
I accept all of that. But owning an outcome is not the same as controlling every input. Access teams already own outcomes they cannot control, such as an HTA verdict or a payer's budget impact view. What they can control is whether availability is visible in their planning. A launch tracker that records a listing but not a marketing status will report success while patients wait. The erdostein case is exactly that gap.
What it looks like in practice
It means asking, for every market, whether the product is actually on sale and what happens if it is not. It means knowing the local fallback routes: import calls, special programmes, allocation schemes. It means treating supply continuity as a live term in price and reimbursement discussions rather than a footnote. Public sources already help. MHRA publishes monthly lists of new and of terminated or cancelled UK manufacturing and wholesale licences, which gives teams a free monthly check on supply-chain partners.
- Add a 'marketed and obtainable' status next to every listing, price or OTC-switch milestone in your access tracker, and review it as often as the decision itself.
- Map the local fallback mechanisms in your key markets, such as import requests, special treatment programmes and allocation schemes, and agree who responds when an authority calls.
- Fold regulator supply notices and monthly licence lists into routine access monitoring, and diarise comment windows like the Czech FSMP list's 20th-of-the-month deadline.
Sources this column is based on
- Commission publishes One Health framework on zoonotic avian influenza prevention, preparedness and response European Commission (DG SANTE) · Wed 11 Nov 2026
- MHRA publishes November 2026 list of terminated and cancelled UK manufacturing and wholesale licences MHRA · Tue 10 Nov 2026
- MHRA publishes November 2026 list of new UK manufacturer and wholesale dealer licences MHRA · Tue 10 Nov 2026
- Dutch inspectorate publishes report on September 2025 inspection of Waymade BV in Amsterdam IGJ · Wed 11 Nov 2026
- Estonia receives 53,000 Vaxigrip doses, about 20,000 open to all Ravimiamet · Wed 11 Nov 2026
- bioMérieux warns of false positive KPC results on BioFire pneumonia and joint infection panels IGJ · Tue 10 Nov 2026
- ANSM updates list of contrast agents available in France amid continuing supply tensions ANSM · Tue 10 Nov 2026
- Slovenia asks wholesalers to import cefaclor suspensions after supply disruption JAZMP · Tue 10 Nov 2026
Opinion: this column argues a position. Written by VigiEye's editorial system with AI assistance (model claude-sonnet-5-5) strictly from the official records listed above. It can contain errors: check the sources before acting. Not legal, medical or investment advice.
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