A recurring theme at LSX Congress in Boston on 23–24 September was how quickly the centre of gravity in biotech is shifting. Chinese-origin assets are increasingly being developed for global markets. Capital is moving. Science is maturing. Rare disease, CNS and paediatric neurological disorders featured repeatedly in conversations across the conference.
But another pattern kept surfacing, one that concerns me more than the capital flows themselves.
Many emerging biotechs, Chinese and otherwise, are building US-first development strategies. Phase 2 asset. US trials. FDA pathway. Europe later.
That can be entirely rational. Capital is finite, the US remains the largest commercial market, and smaller companies have to prioritise. But "Europe later" is increasingly being interpreted as though Europe can simply be added once the US development plan is sufficiently mature. As though the evidence architecture, the pricing decisions and the access sequencing that shape European value can be deferred without consequence.
They cannot.
And for investors, that distinction is starting to matter in ways that are not yet fully reflected in standard diligence frameworks.
Europe has a competitiveness problem
The structural case that Europe is becoming harder to launch in is not disputed in serious circles. In September, the chairs of nine major pharmaceutical companies published an unusually direct open letter on Europe's declining competitiveness. Their argument was stark: Europe accounted for 43% of global pharmaceutical R&D in 1990; the figure today is approximately 31%. Europe's share of commercial clinical trials has fallen to 9%. Approximately 40% of newly approved therapies never become available to European patients.
These figures come from an industry-authored intervention and should be read with that in mind. But the underlying access problem is difficult to dispute. EFPIA's 2026 WAIT analysis found a median 532 days from marketing authorisation to patient availability across the countries examined, with substantial variation between markets.
For a biotech board or investor, the obvious conclusion might be: Europe is becoming less attractive. Discount it in the model. Focus elsewhere.
That conclusion is increasingly incomplete.
Because at exactly the moment Europe is becoming harder to commercialise in, European pricing is becoming more relevant to the economics of the world's most valuable pharmaceutical market.
The European price is becoming a US question
On 30 September, CMS finalised the GLOBE model. From 2027, selected Medicare Part B medicines will be subject to an alternative rebate methodology that explicitly uses international pricing benchmarks. The reference-country set spans 19 countries, anchored by the major EU markets, the UK, Japan and Canada, with the benchmark set at the lowest price across the basket.
GLOBE itself is narrower than some of the original MFN rhetoric. It applies to selected Part B products, and the final model excludes orphan-only medicines, plasma-derived products and certain cell and gene therapies. That distinction is particularly important for the rare-disease and gene-therapy companies I increasingly speak with. A DMD or rare-neurology programme should not automatically assume it is directly caught by GLOBE.
But nor should it conclude that international pricing is therefore irrelevant. The broader US MFN framework now extends well beyond GLOBE. The administration has reached voluntary arrangements with manufacturers representing the majority of the branded US market, and its stated policy framework distinguishes existing products from prospective treatment of future launches. The precise contractual terms are not uniformly public, and these arrangements should not be treated as one homogeneous statutory rule. But the strategic direction is clear.
"The question is no longer: what price can we achieve in Germany? It is: what does a pricing decision in Germany do to the economics of the US asset? That is a different problem."
Historically, European price corridors were principally an intra-European optimisation exercise: how do Germany, France, the UK, Italy and Spain interact through reference pricing, sequencing and negotiation? Increasingly, the question is the one above. And it is one that most biotech development teams are not yet building into their asset strategies.
For investors, access is now an enterprise-value variable
This matters well before a commercial team is hired.
When an investor values a clinical-stage biotech, much of the analysis understandably centres on the probability of technical and regulatory success: trial design, effect size, safety, competitive differentiation, addressable population and regulatory pathway. Access and reimbursement are typically modelled as execution assumptions at launch: a price corridor, a reimbursement lag, a discounted peak sales figure.
That framing misses something structurally important.
Two assets with identical clinical data can have materially different commercial value if one has preserved global access optionality and the other has not. The difference is not visible in the Phase 2 readout. It is embedded in the choices made during development: evidence architecture, comparator selection, endpoint strategy, trial populations, launch sequencing. And it surfaces only later, when the options have narrowed.
This is especially true in rare disease and advanced therapies, where populations are small, acquisition costs may be high, evidence packages can be constrained and payers may be asked to accept considerable uncertainty at launch. In these settings, the gap between what is epidemiologically addressable and what is genuinely reimbursable is often wide. Models that conflate the two overstate value.
Access Debt
Access debt is the accumulated cost of decisions made, or deferred, during clinical development that constrain the commercial, pricing or reimbursement viability of an asset at launch or beyond.
Like financial debt, it is not always visible when it is incurred. Unlike financial debt, it does not appear on a balance sheet. It surfaces in negotiations, in payer rejections, in evidence gap studies and in delayed cash flow. By then, the options for resolving it cheaply have often closed.
JCA makes "Europe later" more expensive
The EU HTA Regulation is being introduced progressively. Cancer medicines and advanced therapy medicinal products are already within Joint Clinical Assessment scope. Orphan medicinal products follow from January 2028, with remaining medicines entering from 2030.
JCA does not determine national price or reimbursement. Those decisions remain with Member States. But it changes the environment in which clinical evidence is assessed across all participating countries simultaneously. And because the evidence submitted at launch is largely the product of choices made years earlier: comparators, endpoints, populations, subgroups and trial design. And access risk can become embedded in an asset long before it is labelled a market-access problem.
The EU framework itself recognises the value of earlier interaction: Joint Scientific Consultations, through which companies can align their development programmes with HTA expectations, are already operating in 2026. The mechanism exists. The discipline of using it is less consistently applied.
For investors, this creates a practical liability. A company can postpone building European capability. It cannot necessarily postpone the decisions that determine whether Europe will later be viable. And the cost of discovering access debt after a pivotal programme has read out is not a few months of consulting work. It may be another study. Another analysis. Another financing round. Or several years of delayed cash flow from markets that were always in the model.
The access questions that should move upstream
Is the pivotal evidence package capable of supporting not only FDA approval, but the relevant future JCA and national HTA questions: on comparators, endpoints and subgroup populations?
What proportion of the modelled ex-US opportunity is genuinely reimbursable, and on what timeline, rather than simply epidemiologically addressable? Models that conflate the two overstate value in rare disease and advanced therapy settings.
Does the launch sequence preserve price and access optionality across markets, including the potential US international-pricing exposure created by GLOBE and the broader MFN framework?
If ex-US rights are partnered, do milestone and royalty assumptions depend on access choices the licensor no longer fully controls? Where does access responsibility sit in the deal structure?
How much additional capital and time could be required if European evidence gaps are discovered after the pivotal programme is effectively locked? Has this been stress-tested in the financing model?
Europe's paradox
This creates what I think is one of the more consequential strategic paradoxes currently facing global biotech. Europe is becoming harder to launch in. And simultaneously harder to ignore.
Europe's relative investment attractiveness has weakened. Its patient-access environment remains fragmented. Its HTA architecture is becoming more coordinated but not less demanding. And US policy is simultaneously increasing the potential global consequence of European pricing decisions.
The response should not be to assume every biotech needs a full European organisation in Phase 2. Most do not. The response is to preserve optionality: to ask early enough whether the development programme, evidence architecture and pricing choices preserve the ability to generate value in Europe without foreclosing US commercial economics in the process.
That is a much cheaper question to answer before the pivotal programme is finalised than after it reads out.
The investor implication
For venture, growth equity and private equity investors evaluating life sciences businesses, access diligence needs to evolve beyond the standard questions.
The question is not simply: what price might this drug achieve in Europe? Nor: how large is the European addressable market?
"The more important question is: has this asset been developed in a way that preserves global commercial value? Or are there access liabilities sitting invisibly inside the investment thesis?"
Answering that question requires bringing together disciplines that are too often assessed separately: clinical evidence strategy, JCA, national HTA methodology, pricing and reference pricing dynamics, launch sequencing, policy and partnering economics. It requires asking those questions at the stage of development when the answers are still cheap. Not at the point when they have become urgent.
The same is true for biotech leadership teams. Europe does not need to be the first market. But by the time Europe becomes urgent, many of the decisions that determine its value may already have been made.
And in an increasingly interconnected pricing environment, those decisions may no longer stay in Europe.
The real strategic shift is this: global market access is moving upstream: from launch execution into asset strategy, investment diligence and value creation. That is where boards, investors and biotech leadership teams need to start looking.
Faisal Latif advises biotech and pharma leadership on market access, pricing and evidence strategy at the intersection of EU HTA, JCA and international pricing policy. He works with clinical-stage companies, growth equity investors and private equity funds navigating European access complexity.