Europe Life Sciences Weekly Signal #56: The 189 Days Before Filing

Week of 21–27 September 2026 · Evidence checked through 26 September · 5-minute read

Europe’s pharma chairs want governments to improve access. Their industry’s own data also points to a commercial decision: which filing delays can be reduced, at what cost, and with what effect on funded treatment?

The signal: access conditions shape investment

On 22 September, the chairs of nine European drugmakers, including AstraZeneca, Novartis, Roche and Sanofi, issued an open letter on Europe’s pharmaceutical competitiveness. They called for stronger investment incentives and placed national health budgets, the speed of assessment and funding, and care modernisation at the centre of the response.

For commercial leaders, that raises an immediate question: which launch decisions can be taken while the policy debate continues?

An approval date and a revenue forecast are connected by a series of decisions about evidence, national submissions, pricing and investment. A useful launch review should show which of those decisions could bring funded access closer.

The operator’s take: find the decision inside the delay

The May 2026 CRA report for EFPIA’s European Access Hurdles Portal covers 91 medicines first authorised between January 2022 and June 2025. For cases already reimbursed, it reports this average breakdown:

Source: Figure 10, p. 17. Reimbursed observations only; unresolved and unfiled cases are excluded. Germany measures completion of the pricing process, not first reimbursed access. Timing does not establish responsibility: evidence requirements, national filing rules and commercial choices can all affect it.

CRA’s exploratory analysis of a small number of observations also says progress towards faster filing under EFPIA’s 2022 commitment “appears to have stalled” in recent cohorts. That commitment is to file within two years where local systems permit.

[Inference] The commercial opportunity is to distinguish a constraint the company must work around from a decision it has not yet taken. An aggregate waiting-time figure cannot tell leadership where additional investment would change the outcome.

I would therefore compare each market’s earliest feasible filing date with its planned date. Feasible means a credible application under documented evidence, resource and national-process assumptions. The gap then becomes a question about what to fund, resolve or consciously defer.

Those assumptions matter. A team could improve the apparent result by moving the feasible date later or submitting an incomplete application earlier. Record changes to the baseline and assess the quality of the submission alongside its timing. The objective is a better launch decision.

The implication: connect the filing decision to funded access

Joint clinical assessment (JCA) gives in-scope launches an opportunity to organise preparation differently. It initially covers new oncology medicines and advanced therapies, with endorsement due no later than 30 days after Commission authorisation. National pricing, reimbursement and additional analyses remain. Commission JCA factsheet; HTA Regulation, recitals 14–15 and Article 13.

For these launches, I would prepare national requirements alongside the shared clinical assessment, with country teams specifying the additional evidence they need. The investment question is where extra capacity could advance a credible submission. A completed global package alone does not answer it.

The regional launch review should put each material filing gap beside three things: the decision required to close it, the cost of doing so, and the next access milestone that could change.

Consider a hypothetical pair of markets. Both bring filing forward by six weeks. One catches a scheduled assessment round it would otherwise miss. In the other, the next decision date remains unchanged. The reported time saving is identical; the effect on the assessment timetable is different. Neither result, by itself, establishes six extra weeks of sales.

I would ask finance and market access to model the downstream consequence before approving extra launch spending. If earlier filing could move funding forward, show the assumptions and the value at stake. If it creates a buffer before a fixed decision point, judge whether that benefit warrants the cost. Where assessment is continuous, test whether earlier submission changes the expected decision date.

Keep markets with no filing planned visible in the same review. Otherwise, the dashboard can improve simply because the hardest markets disappear from it. A decision to defer may be commercially justified; it should still have an explicit rationale and a date or condition for reconsideration.

The chairs’ request for policy reform remains relevant. Commercial leadership also has a decision agenda it can advance now, country by country, without pretending every day of delay is within its control.

Every material filing gap needs an explicit decision, even when the decision is to wait.

Independent analysis by Piotr Wrzosinski. Developed with AI assistance for research, source checking and editing. Sources are linked. The market example is hypothetical; operating-model recommendations are the author’s interpretation of public evidence. Views are personal.