Launch Sequencing in Europe: How One Price Shapes Thirty Markets

Almost every European country sets medicine prices partly by looking at what other European countries pay. That single fact turns a sequence of national pricing decisions into one connected system — and it is why a European launch plan that treats each market independently will systematically erode its own price.

How connected the system is

The European Commission’s study of external reference pricing, covering 31 European countries, found that all of them applied external reference pricing except the United Kingdom and Sweden. Twenty-three used it as the main systematic criterion when setting the price of a new medicine; six — Belgium, Finland, Italy, Poland, Spain and Germany — used it as a supporting criterion.

Reference frequency is uneven. In that study France was in 19 baskets, Germany and the UK 17 each, Austria, Spain and Slovakia 16, and Greece 13. A later analysis put France, Germany and Spain at the top and confirmed Greece at 13. The most-referenced markets are the ones that launch early and price freely — which is precisely why a low price in a small market can matter more than its own revenue ever will.

The sequencing logic, stated plainly

The Commission’s own study describes the behaviour without euphemism: external reference pricing “becomes an incentive for pharmaceutical companies to adopt international pricing strategies. The launch sequence strategy is used to delay or avoid launching new drugs in countries with lower prices, especially if these are small markets referenced by countries with larger markets.” Its review of the literature concluded that all studies found incentives to launch in high-price countries first and to delay or skip low-price countries.

The Commission’s own simulation put numbers on it: launching first in lower-GDP-per-capita countries eroded price by around 3.2% over ten years relative to the base case, while launching first in higher-GDP countries produced a small gain. Independent work has estimated that a €1 price cut in Germany transmits roughly €0.09 directly to Austria plus a further €0.15 to €0.19 indirectly.

Consultancy analysis for industry identified eleven products across seven EU countries that were not launched over a six-year period specifically to avoid the expected low price. This is not a hypothetical mechanism.

What it costs patients

The EFPIA Patients W.A.I.T. Indicator is the standard measure. The 2025 survey, published in May 2026 and covering 168 medicines centrally authorised between 2021 and 2024, found:

  • An EU average of 597 days from marketing authorisation to availability, with a median of 532 days.
  • A range from Germany at 158 days (93% of the cohort available) to Romania at 1,110 days (17% available) — a spread of 952 days.
  • An EU average availability rate of 45%.
  • Greece at 641 days on average, with 41% of the cohort available — and of the 69 medicines that reached Greece, 52% fully available and 42% only on an individual-patient basis.

EFPIA’s access hurdles work separates the two causes: roughly 31% of the total time is company filing time, and 69% is the national pricing and reimbursement decision. “The impact of external reference pricing on other EU countries” appears explicitly among the named root causes for not filing.

Breaking the trap without breaking the price

Confidential agreements are the standard answer. As the Commission put it, publicly available prices are often facial prices that do not reflect managed entry agreements, and such arrangements have become common precisely to maintain access at a high list price while offering a substantial discount that reference pricing will not see.

Survey evidence across 22 European countries found that all of them use confidential agreements and none publishes net prices. The trade-off is honest and worth stating: this preserves the international price but hollows out the credibility of reference pricing itself, and clawback mechanisms have the same effect after the fact.

For Greece specifically, the confidential route is expressly available — listing decisions contemplate a reimbursement price agreed through negotiation that may be confidential, and the legislation permits outcome-based, risk-sharing and indication-based agreements.

Two structural changes to plan around

The EU HTA Regulation applies from 12 January 2025 for new oncology medicines and advanced therapy medicinal products, extends to orphan medicines from 13 January 2028, and to all new medicines from 13 January 2030. The Joint Clinical Assessment runs in parallel with EMA review, which pulls evidence decisions much earlier in development and reduces the scope for country-by-country evidence tailoring.

The EU pharmaceutical package, provisionally agreed in December 2025, had not been formally adopted as of mid-2026. The Commission’s original proposal tied part of the data protection period to launching across Member States; that construct did not survive the negotiation. What was agreed instead is a mechanism allowing a Member State to request that a product be made available, with loss of the one-year market protection in that Member State only if the company has not complied within three years of the request. As always with a text pending legal-linguistic revision, plan against the direction, not the article numbers.

How PQRA helps

We model reference-price spillover across your target markets, advise on filing order and on whether Greece should be sequenced early or late for a given product, build the evidence and negotiation strategy for a confidential agreement rather than a low list price, and prepare Greek HTA and negotiation dossiers with the European consequence in view.

Building a European launch sequence? Talk to PQRA before you file the first pricing application.

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