A Launch Duty Meets a Price Rule That Rewards Delay

A Launch Duty in Brussels Meets a US Price Rule That Rewards Delay

The EU will let governments demand that companies launch medicines, while a US rule that benchmarks Medicare prices to international prices makes a cheap launch costly. Which pressure sets launch order will show from 2028.

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The working assumption in 2026 is that the EU pharma package hands governments leverage over launch timing. The Council adopted it on 28 September, and EU countries will have the power to require pharmaceutical companies to supply medicines (Council of the EU, 28/09/2026). On this scan’s reading, that leverage meets a US rule that pays companies to wait: the final GLOBE rule, effective on 30 November 2026, sets Medicare rebates against a benchmark based on international drug pricing information (Federal Register, 02/10/2026). A low price in a reference country now carries a US cost.

Signal Identification

A collision between two access and price instruments. The EU penalises a company that does not launch; the US rule penalises one that launches low.

Time horizon: 1-3 years. Peak window: it binds 2028 to 2029, shown when a member state, regulator or manufacturer publicly confirms a formal launch request under the new duty. (Milestones: Parliament’s health committee vote, 10 November 2026; GLOBE performance years begin, 1 April 2027.)

Probability band: Medium (40 to 60%)

Geographic / Jurisdictional Scope: Primary: the European Union and the United States. Spillover: Switzerland, the United Kingdom, Canada and Japan, which sit in the US reference-country list.

PrimaryEuropean UnionUnited States

SpilloverSwitzerlandUnited KingdomCanadaJapan

Sectors exposed:

Innovator pharmaceutical and biotech companiesNational pricing and reimbursement authoritiesPatients in smaller EU marketsGeneric and biosimilar manufacturersHealthcare investors

What's Changing

Europe’s patients already wait. The mean time from central marketing authorisation to country availability is 607 days across 36 countries, against 509 days in the 2019 report (OHE, 02/07/2026). Launches then fell: in the 10 months after the US executive order, drug launches in EU markets fell by some 35%, according to Reuters as reported (Euronews, 14/09/2026).

The EU answer is a duty. A company must launch a new medicine if a country requests it within three years, or lose two years of monopoly rights (Euronews, 14/09/2026). Parliament still has to adopt the texts, and its health committee votes its second-reading recommendation on 10 November (EU Perspectives, 16/10/2026). Application is expected around 2028 (PwC Switzerland, 01/10/2026).

The US rule pulls the other way. Participation is mandatory for manufacturers of GLOBE Model drugs (Hogan Lovells Cadwalader, 05/10/2026). A Lancet study of 195 patented medicines found that for about 73% of 138 medicines (101 of 138) the estimated US cut would exceed the medicine’s entire annual sales in the reference country, which could push manufacturers to raise prices or delay launches (The Lancet, 13/09/2026).

Access already takes 607 days, and most US-linked cuts would exceed local sales

Left: mean days from central marketing authorisation to country availability, 2019 report and latest report (OHE, 02/07/2026). Right: medicines where the estimated US cut would exceed annual sales in the reference country (The Lancet via EurekAlert!, 13/09/2026).

Disruption Pathway

On the available evidence the path has three stages. First, Parliament completes the texts: the committee votes on 10 November (EU Perspectives, 16/10/2026) and application follows around 2028 (PwC Switzerland, 01/10/2026). Second, the US rule starts: it is effective on 30 November 2026, and its performance years begin on 1 April 2027 (Federal Register, 02/10/2026). Third, once the duty applies, member states can ask for launches, and each manufacturer must choose between a price that sets a low US benchmark and the risk of lost protection in that state.

Stress concentrates in smaller markets and in prices. The reference-country list includes Germany, France, Italy and Spain (Federal Register, 02/10/2026), so a low list price anywhere in it is costly. Exposure is uneven: CMS will waive participation for manufacturers in the voluntary GENEROUS Model and exclude orphan-only drugs (Hogan Lovells Cadwalader, 05/10/2026). Companies planning first launches in 2028 should model net prices and confidential arrangements now; ministries should decide which medicines they would ask for.

Why This Matters Now

This lands on market access heads, pricing teams, health ministries and healthcare investors. The assumption to revise is that a legal launch duty alone shortens waits. Patients already wait nearly 600 days between approval and access, in EFPIA’s words (EU Perspectives, 16/10/2026), and OHE treats the launch obligation as one factor among several (OHE, 02/07/2026). A request answered with a high list price would satisfy the law and leave waits unchanged. Plans should be tested against early launch at lower European prices and against delay with lost protection in small markets.

Decision-action posture for this signal: Prepare: model both launch orders for 2028 now, and commit once Parliament has voted and the first member-state requests are visible.

Counter-Argument

The strongest objection is that the US rule reaches few firms. CMS will waive participation for GENEROUS Model manufacturers, cutting the estimated eligible manufacturers from 19 to 4, and will exclude orphan-only drugs, plasma-derived products and certain cell and gene therapies (Hogan Lovells Cadwalader, 05/10/2026). The EU texts also await Parliament’s adoption (Council of the EU, 28/09/2026), so the duty could still change.

The reply is that exposure need not be wide to shape behaviour. The Lancet study found the estimated cut exceeds local sales for most medicines studied, and its authors say policymakers should ensure availability is not delayed (The Lancet, 13/09/2026). Launch order is set globally, so a few exposed products can move a whole portfolio.

Implications

The shift in leverage is durable; its effect on sequencing is not yet visible. The inflection window is 2028, when the first requests can be made and the first GLOBE benchmarks bite. Firms with flexible sequencing and clear net-price rules are better placed; those that assume list prices stay public are exposed. The 35% fall in EU launches (Euronews, 14/09/2026) shows the behaviour is visible before either rule fully applies.

Early Indicators to Monitor

Parliament’s health committee backs the Council text on 10 November without amendment.If this happens: The duty stays as drafted; plan for application around 2028.
Parliament amends the launch duty and forces a further round of negotiation.If this happens: Timing slips; move sequencing decisions beyond 2028.
CMS publishes benchmarks before the 1 April 2027 start that rely on an EU price for more than half of listed drugs.If this happens: Low EU list prices will be costly; expect delayed or confidential EU launches.
A major manufacturer announces a skipped or postponed EU launch and cites US pricing.If this happens: Sequencing has shifted; expect member-state requests to follow.
A member state publicly names the medicines it will ask for once the duty applies.If this happens: The duty is becoming operational; prepare launch dossiers for 2028.

Disconfirming Signals

The next OHE availability report shows mean time to availability below 509 days.
EU launches recover to their level before the US executive order during 2027.
CMS withdraws or suspends the GLOBE rule before 1 April 2027.
The estimated number of manufacturers eligible for GLOBE falls below 4.
No member state publicly invokes the launch duty by the end of 2029.

Strategic Questions

Should 2028 launch plans assume that smaller EU markets will invoke the duty, or ignore it?
At what net price does a reference-country launch become acceptable given the US rebate exposure?
Which of our current activities looks least wise if this signal lands?

Keywords

EU pharma package; launch obligation; supply on request; GLOBE Model; most-favored-nation pricing; international reference pricing; time to patient access; Medicare Part B; regulatory market protection; launch sequencing; GENEROUS Model

Bibliography

Source tiers: Tier 1, governments, regulators and intergovernmental bodies. Tier 2, think-tanks, academic institutes, major consultancies and quality data providers. Tier 3, quality journalism and specialist trade press. Tier 4, vendor, company and practitioner sources, used only as directional corroboration.

Tier 1 Pharma package: Council adopts new rules for a fairer and more competitive EU pharmaceutical sector. Council of the European Union (28/09/2026).
Tier 1 Global Benchmark for Efficient Drug Pricing (GLOBE) Model. Federal Register (CMS) (02/10/2026).
Tier 2 The Lancet: New US Medicare pricing policies could reshape global pharmaceutical markets. The Lancet (via EurekAlert!) (13/09/2026).
Tier 2 Time to rethink your operating model (EU pharmaceutical reform). PwC Switzerland (01/10/2026).
Tier 2 CMS finalizes mandatory GLOBE Model implementing most-favored-nation drug pricing in Medicare Part B. Hogan Lovells Cadwalader (05/10/2026).
Tier 2 How long are patients WAITing for new treatments?. Office of Health Economics (OHE) (02/07/2026).
Tier 3 US push to cut drug prices could mean longer waits for European patients. Euronews (14/09/2026).
Tier 3 United, we set the terms: Parliament pushes Europe to stand up to US drug pricing. EU Perspectives (16/10/2026).