Europe’s Grand HTA Experiment: Unifying Drug Assessments Across the EU

In January 2025, a long-awaited experiment in European healthcare quietly began. For the first time, all EU countries have started pooling their efforts to evaluate new medicines under a single framework. Historically, a cancer drug approved in Europe might reach patients in Germany within four months but take over two years in Poland or Portugal – an inequity rooted in fragmented national assessments. The new EU Health Technology Assessment Regulation (EU) 2021/2282, which came into force on 12 January 2025, promises to streamline this process.

By establishing joint health technology assessments (HTAs) at the European level, Brussels hopes to eliminate duplicate national reviews, accelerate patient access to innovative therapies, and perhaps even curb costs. It is an ambitious endeavor: a continent-wide effort to speak with one voice on the value of new drugs. As with any grand experiment, it faces both applause and skepticism in equal measure.

A Unified Approach – Goals, Structure and Timeline

At its core, the new regulation creates a harmonised clinical evaluation process for medicines and certain medical devices across EU member states. Rather than each country separately examining a drug’s clinical benefits, an EU-wide Joint Clinical Assessment (JCA) will produce a single scientific report on the medicine’s efficacy and safety relative to existing therapies. National authorities will then use this joint report as the basis for their own pricing and reimbursement decisions.

Crucially, only the clinical domains of HTA are done jointly – questions of cost-effectiveness, budget impact, or “value for money” remain the prerogative of each country (health.ec.europa.eu). The regulation’s intent is to avoid wasting resources on 27 redundant evaluations of the same clinical data, while still allowing countries to draw their own conclusions (and negotiate prices) according to local priorities. In the words of an EU factsheet, the joint work should be “high quality, timely and transparent” and “used in national HTA processes”, but it “contains no value judgement or conclusion on pricing and reimbursement”, leaving those decisions to member states (health.ec.europa.eu).

The governance of this joint HTA mechanism centers on a new Member State Coordination Group on HTA (HTACG), composed of representatives of all EU countries (plus non-EU European Economic Area states like Norway). This group oversees the joint assessments, appointing teams of national HTA experts to act as assessor and co-assessor for each evaluation. The European Commission provides a secretariat and has developed implementing rules and an IT platform to facilitate the process (health.ec.europa.eu).

When a pharmaceutical company submits a centralised marketing authorisation application to the European Medicines Agency (EMA), it now must simultaneously notify the HTA Coordination Group and provide key documents (like the draft product summary and clinical overview) to kick-start the joint assessment. The HTA Coordination Group then defines the scope of the assessment – identifying the patient population, relevant comparators, and outcomes (the PICO criteria) – and tasks an assessor pair with reviewing the evidence.

The goal is for the joint clinical assessment report to be finalised shortly after the EMA’s approval of the drug. In fact, the law dictates that the JCA report must be endorsed by the Coordination Group no later than 30 days after the European Commission grants marketing authorisation. This tight synchronization means that, in theory, national payers can have a ready-made clinical evaluation on hand almost as soon as a drug is approved at the EU level.

The implementation timeline for this scheme is phased over several years. Initially, only certain high-impact products are included. From January 2025, all new oncology medicines and advanced therapy medicinal products (ATMPs) (e.g. gene and cell therapies) coming through EMA are subject to a joint assessment. These categories were chosen first due to their high medical need, often high price tags, and the heavy HTA workload they create nationally. Next, from January 2028, all new orphan drugs (medicines for rare diseases) will be added to the joint process (health.ec.europa.eu).

Finally, by 2030, every new medicinal product that gets central EU approval will fall under the scope of the regulation (health.ec.europa.eu). In other words, a decade-long ramp up will take joint HTA from a niche concern to the new normal for all drugs in Europe. This gradual expansion is meant to give agencies time to adapt and to refine the procedures on the “easy” cases (if anything in oncology or gene therapy can be called easy) before widening to all therapeutic areas. A similar joint approach for certain medical devices will also be phased in, focusing on high-risk devices and diagnostics, though guidance for devices is trailing behind that for medicines.

The goals of the HTA Regulation are lofty. EU officials speak of “improving equal access to medicines across Europe” and “reducing duplication” of efforts for both industry and HTA bodies. The idea is that a single assessment can harness the collective expertise of Europe’s HTA agencies and free up national authorities to focus on local budgetary considerations. Smaller member states, in particular, stand to gain by piggybacking on analyses led by larger countries with more HTA capacity.

Ideally, a Latvian or Portuguese payer could trust the joint clinical report and make a reimbursement call faster, instead of waiting months or years to produce (or borrow) their own assessment. The regulation is also part of a broader European push to strengthen the EU’s hand in pharmaceutical policy – complementing efforts to revise the EU’s pharmaceutical legislation and encourage drugmakers to launch new therapies in all member states, not just the richer ones (efpia.eu).

In macroeconomic terms, European leaders hope that a more unified HTA process will make the continent more attractive for medical innovation and ensure that its 450 million citizens are not last in line for cutting-edge treatments.

Early Outcomes: The First Joint Assessments Begin

Though 2025 is still in its infancy, the new joint HTA system is already being put to the test. In April 2025, the European Commission announced the first two medicinal products selected for EU-wide joint clinical assessment (ec.europa.eu). The inaugural candidate was a new paediatric cancer drug: tovorafenib (to be marketed as Ojemda) for the treatment of low-grade glioma, a rare brain tumor in children. Tovorafenib’s developer, Day One Biopharmaceuticals (in partnership with France’s Ipsen), had filed for EMA approval, triggering the joint HTA process.

The National Centre for Pharmacoeconomics (NCPE) of Ireland was appointed as lead assessor, with Germany’s IQWiG (Institute for Quality and Efficiency in Health Care) as co-assessor (ec.europa.eu). In parallel, a second joint assessment kicked off for an advanced melanoma therapy – specifically an autologous tumor-infiltrating lymphocyte (TIL) cell therapy for skin cancer, widely understood to be lifileucel from Iovance Biotherapeutics.

France’s Haute Autorité de Santé (HAS) took the helm as assessor for the melanoma TIL therapy, joined by Poland’s Agency for HTA and Tariff System (AOTMiT) as co-assessor (ec.europa.eu). These transnational assessor teams are a tangible sign of the new era: Irish and German experts teaming up on a pediatric oncology review, French and Polish analysts collaborating on a cutting-edge cell therapy appraisal. Such pairings underscore the intent of spreading expertise and workload across Europe.

By mid-2025, the joint HTA pipeline was quickly filling. Pfizer’s sasanlimab, an immunotherapy for bladder cancer, became the third medicine to enter the EU joint assessment queue. In this case the Netherlands (Zorginstituut Nederland) and Denmark (Danish Medicines Council) were assigned to lead the evaluation – a Northern European tandem contributing to the effort. According to reports, work on sasanlimab’s assessment began in May 2025 and is expected to conclude by autumn 2026, aligning with the drug’s anticipated regulatory timeline. And there are more: as of July 2025, six medicines have entered the JCA process, all of them oncology therapies (some also qualifying as ATMPs.

Notably, no non-cancer ATMPs (for example, a gene therapy for a rare non-cancer condition) have yet started the joint assessment journey – reflecting the fact that the first half-year has been dominated by cancer drug filings. The pace of assessments is expected to accelerate as more companies submit oncology dossiers to EMA and as awareness of the new requirements spreads. Each joint assessment runs in parallel with EMA’s review, which itself takes around a year, so the fruits of these early JCAs (the final reports) will likely emerge toward late 2025 and 2026, as the drugs receive EU marketing approval.

It is too soon to declare winners or losers from these first cases – the outcomes of the joint assessments (i.e. the conclusions on each drug’s relative clinical benefit) have not yet been published, and the true test will be how national HTA bodies use them. But procedural milestones are being met. The new HTA Coordination Group has proven it can convene, assign assessors, and get the ball rolling on multi-country reviews. The tight timeline – delivering a draft JCA report within weeks of EMA approval – is daunting, but authorities insist it can be done (ec.europa.eu).

In fact, the regulation explicitly requires the Coordination Group to endorse a joint report no later than 30 days after approval, and for the Commission to publish it within 10 days after that. Whether those deadlines are realistic in practice remains to be seen. Coordination and communication also seem to be functioning: the Commission’s HTA Secretariat has set up an IT platform for dossier sharing and coordinated expert involvement (including patient and clinician input) in the assessments.

Industry had been advised to notify the Secretariat early about upcoming drug submissions, and indeed companies like Day One, Iovance, and Pfizer engaged with the new system to get their products on the joint assessment list. For now, all initial JCAs have stuck to the mandated scope – only clinical evidence is being analyzed, with no attempts to set prices or make reimbursement recommendations at the EU level.

The final joint reports will explicitly avoid any value judgments (they will not say a drug has “high added value” or “low added value” overall); instead they will present the comparative efficacy and safety data versus relevant alternatives. It will then be up to each country’s HTA or pricing body to plug that into their national decision framework.

Red Team Analysis: Shortcomings, Bottlenecks, and Skeptics

No sweeping reform arrives without friction. As the joint HTA regulation moved from theory to practice, a chorus of criticism and concern rose from various stakeholders – industry, some HTA experts, and even national payers. From the “red team” perspective (the skeptics highlighting risks and shortcomings), the new system could simply be shifting problems to a new arena instead of solving them.

One major worry has been procedural bottlenecks and workability. The pharmaceutical industry, while supportive of harmonization in principle, has openly flagged that the initial rules “will create an unworkable framework for JCAs” unless adjusted (efpia.eu). A joint statement by industry associations complained that the draft procedures were shaping up to be “administratively complex and burdensome,” essentially “an amalgamation of national practices” rather than a truly streamlined approach (eucope.org). In other words, critics fear that instead of one smooth EU assessment, we might get 27 HTA agencies’ worth of questions stacked end-to-end.

The scoping phase has drawn particular ire. Under the implementing rules, once a company notifies a new drug, the member states (via the Coordination Group) take the first 140 days to define the assessment scope – formulating the precise PICO questions that the company’s dossier should answer. During this period, companies are largely in the dark: they have no visibility or input as the HTA experts decide which comparators and outcomes they want analyzed (efpia.eu). Only after the scope is fixed are companies given the list of questions, at which point they have a mere 90–100 days to compile and submit a comprehensive HTA dossier addressing them.

For complex oncology drugs, assembling such evidence (often including indirect comparisons, subgroup analyses, etc.) in under three months is a serious challenge – “unworkable and too short,” according to the European Federation of Pharmaceutical Industries (EFPIA). There is palpable concern that companies, especially smaller biotechs, might struggle to deliver a high-quality submission in this timeframe, leading to flawed assessments or requests for additional data later. EFPIA members warned that without early interaction to clarify the scope, firms risk wasting resources on a dossier that doesn’t hit the mark.

In their blunt assessment, the lack of manufacturer involvement and the tight timelines could cause joint HTA to “fail to deliver on its aim of better access” if not remedied (efpia.eu).

Another red-team critique focuses on coordination pitfalls and duplication in the transition period. The very problem the regulation seeks to solve – duplication of effort – may ironically persist in the short term. Consider Germany, Europe’s largest pharma market and one with an existing rigorous HTA process (the AMNOG early benefit assessment). German law was amended in 2025 to accommodate the EU joint assessments, but Germany pointedly decided not to delay its national timeline even if the European report isn’t ready. Under AMNOG, a company must submit a national HTA dossier to the German authority (G-BA) immediately upon product launch, and G-BA aims to conclude its benefit rating within six months.

Initially, German rules contemplated pausing the national process for up to 3 months to wait for the EU JCA, but the final ordinance removed that pause. The result: if a drug launches in Germany and the EU joint report is not yet available, the company has to go ahead and provide the full data package to G-BA as usual (even if that duplicates what it already gave to the EU assessors). The German HTA will proceed on its own; the EU report can be slotted in later if it arrives in time for the final G-BA hearing. This decision was quite intentional – German officials did not want to risk delays in pricing negotiations and patient access for the sake of coordination.

However, it exposes a potential lack of synchronization: companies may face double work (preparing both EU and German submissions simultaneously) and the supposed “single assessment” might be ignored in practice if its timing misaligns with national needs. Other countries are grappling with similar issues. Spain and Italy, for instance, may be willing to wait for the JCA to inform their process (since they typically take longer anyway), but fast-access markets like Germany and France are under pressure to stick to tight national schedules.

The regulation says member states “shall not request information already submitted at EU level”, but if the EU dossier isn’t published by the time national work starts, this restriction enters a grey zone.

Germany has essentially put the onus on companies: a company can choose to delay launching in Germany until the JCA is out (to avoid duplicate submissions), but that means forfeiting months of revenue and patient availability. Most likely, big firms will launch without delay and deal with any duplication, while smaller firms might hold off – an unintended strategic wrinkle caused by timing misalignment.

Stakeholders also point to methodological and scientific challenges ahead. Achieving one-size-fits-all in clinical assessment is easier said than done. What if different countries have different gold-standard comparators for a disease? If the joint assessment picks, say, a French standard of care as the main comparator, but Polish clinicians use something else in practice, the Polish HTA folks might find the report less relevant.

In the preparatory phase, all member states can propose what comparators and outcomes they want included, which could lead to a bloated scope covering every conceivable angle – or conversely, if some payers don’t speak up in time, the JCA might omit a scenario that later turns out important for them. There is a risk that the JCA, in trying to please everyone, becomes overloaded with analyses and ends up pleasing no one.

“The approach merely exports today’s fragmentation to the European level,” as the industry sharply warned (eucope.org). Furthermore, differences in HTA philosophy persist: for example, Germany’s IQWiG has famously strict rules on considering indirect comparisons and a penchant for certain endpoints, while France’s HAS has its own clinical grading system. Reaching consensus on a joint report may require compromise on such methodological points.

Insiders worry that debates behind closed doors among 30+ agencies could slow down the process or water down conclusions to find a lowest common denominator acceptable to all.

While the regulation provides voting mechanisms, a scenario where a major country dissents from a joint conclusion would be a real test of the system’s credibility. So far, everything has operated by consensus – but these are still early, relatively clear-cut cases (if any cancer drug can be called clear-cut). The real tension may come when a high-profile medicine with mixed evidence is on the table, and HTA experts from different schools of thought must agree on how to interpret it.

Other friction points include resource strain and learning curve issues. National HTA agencies must now devote staff to the European joint work (some as assessors, many others reviewing and commenting as part of the Coordination Group), all while continuing their national duties. A survey of payers indicated widespread concern about human and financial resource shortages for this implementation.

Smaller HTA bodies in particular face the challenge of analyzing an additional comprehensive report (the JCA) in a foreign language, then translating its insights into their local context. Some countries have noted they may need to hire translators or additional analysts – a tough ask if budgets are tight. During a recent meeting of the Coordination Group, it was suggested that less-experienced countries start as observers on initial assessments to build capacity.

That learning-by-doing approach makes sense, but in the interim it means the heavy lifting falls to a subset of agencies (often the larger ones), potentially causing imbalances in workload. Finally, there is the question of stakeholder input. The regulation promises “stakeholder engagement and inclusiveness” (health.ec.europa.eu), but industry and patient groups have so far felt sidelined in the development of methodologies. Early guidance documents drafted by the EUnetHTA consortium reportedly incorporated little of the hundreds of comments submitted by external stakeholders (eucope.org).

Patient advocates are likewise pressing for a clearer role in JCAs, lest the assessments focus narrowly on clinical metrics and overlook quality-of-life aspects. The Commission has set up a stakeholder network, but it remains to be seen how influential it will be in practice. To skeptics, these procedural and cultural wrinkles suggest that significant teething problems lie ahead for the EU HTA regime.

Blue Team Analysis: Logic, Promise, and Early Defenses

On the other side of the debate, the “blue team” – defenders of the joint HTA initiative – argue that despite early frictions, the regulation’s logic is sound and its potential considerable. They acknowledge challenges but see them as inevitable startup issues in an undertaking of this magnitude, not fatal flaws. From this vantage point, the new system is a much-needed modernisation of Europe’s approach to valuing medical innovation, one that can yield long-term benefits for patients, health systems, and even drug developers.

First, supporters emphasize the rationale behind the regulation. The fragmentation of HTA in Europe was not just inefficient for its own sake – it tangibly harmed patients by delaying or limiting access. On average, European patients wait 578 days (over 19 months) from EU approval to availability of a new medicine in their country, and disparities are stark (efpia.eu). This is an unacceptable lag in an age of breakthrough gene therapies and precision oncology. A joint clinical assessment tackles one critical piece of that puzzle: duplication of scientific review.

Instead of a company having to respond to dozens of slightly different questionnaires about its drug’s efficacy, it can make one comprehensive submission. Instead of each national agency re-analyzing the same Phase III trials, a single expert team can do it once for all. In theory, this convergence should enable faster national decisions. Resources currently spent reproducing reports could be redeployed to other work, such as health economic modeling or post-market evidence generation.

Smaller countries stand to gain the most. In the old world, if a small member state lacked capacity to assess a new cancer drug, it might wait to see what, say, France’s HAS concluded, leading to delays.

Now that country gets a high-quality EU report at around the same time as the drug’s approval, giving them a head start. Proponents highlight that the joint process leverages the collective expertise of Europe: a country strong in oncology can lead an assessment in that field, while another with strengths in say, rare diseases, can take the helm in 2028 when orphan drugs join the scope. The burden-sharing aspect should not be underestimated.

Denmark’s Medicines Council, which co-led the bladder cancer drug review, noted that being part of the first JCAs (linkedin.com) “is a great recognition” of its expertise and a chance to “influence the professional direction in Europe” while “strengthening the quality of our own assessments at home.” . Such enthusiasm from national agencies suggests many are eager to make the joint system work and see it as an enhancement, not a threat, to their role.

Second, the blue team points to early signs of success and the system’s built-in mechanisms to address issues. The fact that six joint assessments were launched in the first six months indicates a strong uptake. The machinery did not stall on Day 1; it’s operational. Yes, there were delays in finalizing guidelines (the implementing act came in May 2024, a few months later than hoped), but by and large the legal and technical infrastructure was in place by January 2025.

Where industry saw unworkable timelines, regulators did listen to some extent – for example, the final Implementing Act extended the company dossier submission deadline from 90 to 100 days, giving a bit more breathing room than the draft had.

An “explanation meeting” with the assessors after the scope is set is now allowed if the company requests it, a concession added to improve clarity (the draft had left that to assessor discretion). These tweaks show a degree of pragmatism as the process beds in. Moreover, the Coordination Group and Commission have signaled they will adopt an iterative approach – effectively learning and adjusting as they go. The first wave of JCAs is something of a pilot in itself, and everyone knows it. Even industry insiders, while critical, have acknowledged that success in the short term will be measured by “positive recommendations across EU jurisdictions” and in the long term by alignment of HTA methods and evidence requirements (mdpi.com).

In other words, there is a recognition that it will take time for the full benefits (like harmonised methodologies) to materialize, but the journey has begun. Metrics are being established to track efficiency and effectiveness of JCAs – stakeholders are watching timeline performance, consistency of outcomes, and eventual impacts on access. This transparency and monitoring will help identify bottlenecks to fix.

There is also a collaborative spirit emerging: payers and HTA bodies from across Europe have been convening in workshops to share readiness tips and concerns, which itself helps foster mutual understanding. Even those with reservations concede that the long-term vision is worthwhile.

A survey of national payers found that despite procedural ambiguities, most believe the HTA Regulation holds significant potential to create a more efficient, transparent, and collaborative environment for evaluating new therapies. Streamlining and standardizing clinical assessments across the EU is expected to promote consistency in evaluations and reduce redundant efforts, yielding benefits in the long run. In sum, the defenders argue, give it time – the first steps are promising, and the kinks can be ironed out through experience and goodwill.

Third, the blue team frames the joint HTA as part of a bigger picture of European healthcare improvement. This is not an isolated technocratic change, but a pillar of the EU’s aspiration to be more than the sum of its parts in healthcare. The COVID-19 pandemic showed the value of EU-level coordination (for example, joint vaccine procurement), and while HTA is a different domain, the principle of solidarity and collaboration applies.

By pooling their assessments, European countries can present a united front when dealing with global pharmaceutical companies – not necessarily in pricing (since joint price negotiation isn’t in scope here), but in the scientific argumentation about a drug’s benefits. Over time, if the joint reports are consistently of high quality, it might become harder for a company to “forum-shop” for a favorable assessment or to dismiss one country’s HTA as an outlier.

The increased transparency could also benefit public trust: a joint report will be published for all to see, which may foster greater accountability in national reimbursement decisions (a country will need strong reasons to diverge from the evidence in the joint report if patients ask why their drug isn’t covered). Some optimists even speculate that joint clinical assessments are a stepping stone to deeper cooperation, perhaps one day harmonising cost-effectiveness models or negotiating prices collectively for ultra-expensive therapies.

That is not on the immediate agenda – and many member states jealously guard their pricing sovereignty – but the HTA Regulation at least creates a forum where national agencies are routinely working together.

Trust and relationships are being built that could have spillover effects. Already, we have seen agencies like Italy’s AIFA plan to update their submission templates to incorporate the EU JCA outputs, and agencies like Denmark’s explicitly weaving participation in EU HTA into their strategy. These are signs that joint HTA is becoming ingrained in national processes rather than existing in a vacuum. The Commission, for its part, has convened events titled “Advent of a new era of collaboration” (health.ec.europa.eu) – a description that captures the hopeful tone of proponents.

Certainly, the blue team does not deny challenges remain. They simply argue these can be managed. On the timeline issue, for example, one might note that EMA itself had to evolve over years to streamline approvals; similarly, the HTA Coordination Group can refine its workflows. If some countries worry about missing their comparators in the JCA, they will likely learn to actively engage in the scoping surveys to make sure their voice is heard – a coordination learning curve. The Commission’s HTA secretariat is also ramping up training programs for member state assessors, and the regulation explicitly calls for “stakeholder inclusiveness,” so pressure is on to formalize patient and clinical expert input in a meaningful way (health.ec.europa.eu).

In defending the limited direct company role, regulators note that allowing manufacturers to steer the scope too much could compromise perceived independence; however, they acknowledge that clear guidance and some dialogue (like the post-scope explanation meeting) can ensure companies understand what’s expected. In short, the blue team’s view is that the logic of a single clinical assessment is fundamentally correct – Europe no longer needs 30 different answers to the question “Does this drug work better than current therapy?” – and that initial snares are being addressed through a collaborative, “iterative approach” (mdpi.com).

History is on their side, they might add: past voluntary joint assessments (under the EUnetHTA project) demonstrated that different countries can work together and produce a credible joint report. The difference now is scale and mandatory uptake, but those pilots provide a proof of concept on which to build. Every new system has growing pains, but the direction of travel – toward a more integrated European HTA landscape – is, in their view, the right one.

Impact on Pricing, Reimbursement, and Market Access

What does all this mean when it comes to the price tags of drugs and the speed of patient access in Europe’s major markets? This is where the rubber meets the road. It is still early days, and the joint assessments themselves do not set prices or make reimbursement decisions – those remain national prerogatives. However, the effects of the joint HTA mechanism are already starting to ripple through industry and payer strategies.

For one, pharmaceutical companies are adapting their launch plans to the new reality. They know that a negative or lukewarm joint clinical assessment could influence all the big European markets at once – a prospect far more consequential than a setback in just one country under the old system. This raises the stakes for the clinical evidence package they submit. Companies might invest in more robust comparative trials pre-launch or gather extra real-world evidence early to strengthen their case in the JCA.

There is talk in industry circles of aligning development programs to EU HTA needs from the outset (much as they currently do for FDA or EMA requirements).

The introduction of Joint Scientific Consultations (JSCs) in 2025, a sort of parallel to EMA’s scientific advice but involving HTA bodies, supports this: firms can get early feedback from European HTA experts on their trial design or evidence plans. All of this could improve the evidentiary basis for price negotiations. On the flip side, companies may also become more cautious – if they anticipate a tough joint assessment, they might delay or limit their European launch.

In the extreme, a company could decide not to market a drug in Europe at all if it expects that a joint report will be unfavorable and make pricing approvals uniformly difficult. Europe’s attractiveness as a launch region is a sensitive point; some in industry have warned that overly onerous HTA demands could deter launches.

The EU’s response, however, has been to pair the HTA regulation with incentives for timely launch (for instance, proposed new pharmaceutical legislation would shorten market exclusivity for companies that don’t market their product in all member states within a certain time frame). In essence, the EU is nudging companies: engage with the joint HTA and launch broadly, or face penalties.

Most large manufacturers will likely comply and adapt, but it will be interesting to watch smaller biotechs – which often have fewer resources for multiple parallel processes – and how they handle the dual EMA and EU HTA pathway.

From the perspective of national payers and health systems, the joint clinical assessments are poised to become a valuable tool. While no country will blindly accept an EU report’s conclusions, those findings will frame the negotiations. If a JCA finds that a new cancer drug extends survival by, say, 3 months on average compared to standard care, that fact is now documented by a multilateral European review, not just the manufacturer’s claims. Payers in Germany, France, Italy and beyond can leverage that in price talks: the evidence agreed by all your peers is X, so your price should reflect that benefit.

Conversely, if a JCA highlights substantial uncertainty (perhaps the trial data is immature or only shows an intermediate endpoint), multiple countries may align in demanding risk-sharing arrangements or price reductions to account for that uncertainty. In the past, a company might exploit differences – maybe Germany’s HTA would rate a drug as having “major additional benefit” and the company would secure a high price there, even if England’s NICE or Sweden’s TLV was more skeptical.

Now, with a common evidentiary review, such divergence might narrow. It is conceivable that reimbursement decisions will converge in outcome if not in exact timing.

We may see fewer instances of a drug being hailed as a big advance in one country but deemed unworthy of coverage in another – because the underpinning clinical facts presented will be the same. To be clear, countries can still disagree: one health system might decide even a modest survival gain is worth paying for (if budget impact is manageable), while another might say the price is too high for that benefit. Those are value judgments outside the scope of the JCA. But at least the debate will center on a shared set of findings rather than dueling analyses.

In key EU markets, some specific adjustments are underway. We discussed Germany’s stance: it will not delay its own process for the JCA, meaning initial price negotiations will proceed as usual. However, Germany did incorporate the requirement that companies indicate which parts of their national dossier derive from the EU dossier, and it expects that G-BA will give “due consideration” to the joint report once it’s available.

In practice, this might mean G-BA revisiting or confirming its earlier assessment during the final negotiation stages if the JCA brings up something new. France’s HTA body, HAS, has been deeply involved in shaping the EU process (being assessor for one of the first drugs), and it is likely to use the joint reports to inform its SMR/ASMR clinical benefit ratings for new drugs.

French law is evolving in 2023–2024 with a broader health reform, and while details on HTA integration are scant, HAS officials have publicly supported the European collaboration as long as it remains scientifically rigorous.

One can expect France to still conduct its own appraisal meeting and perhaps add its judgments on comparative effectiveness (e.g. “major improvement” or not), but the foundational evidence review might be lifted from the JCA. In Italy, AIFA has hinted at modifying its dossier templates so that companies can simply attach the JCA report, incorporating it into the national evaluation workflow.

This suggests Italy foresees saving time – possibly shaving off months from the evaluation phase. Spain and others may follow suit. Smaller and mid-sized countries, as noted, are watching closely how to integrate the reports without overburdening staff; some might even adopt a policy of automatically recognizing the JCA conclusions for the clinical part of their assessment, focusing national deliberations purely on cost-effectiveness and budget impact going forward.

One area to watch is whether joint HTA leads to more joint price negotiations or cross-country deals. The regulation itself steers clear of pricing, to respect member state competencies. But there are existing coalitions (Beneluxa, the Valetta group, etc.) where countries band together for negotiating with pharma. A common clinical assessment could make it easier for such coalitions to form ad-hoc around a given drug, since they can skip straight to the pricing talks using the JCA as a reference.

For example, if a very expensive gene therapy emerges and the JCA confirms its benefits but also uncertainties, a cluster of smaller countries might collectively negotiate an outcome-based rebate scheme, citing the evidence from the JCA.

This isn’t orchestrated by the EU HTA regulation directly, but the timing and uniformity of the evidence base is an enabler for collaboration. There is also a competitive aspect: if every country has the same clinical facts at hand, those with traditionally tougher HTA stances (like NICE in England, though outside the EU now, or IQWiG in Germany) no longer “lead the way” in defining the evidence narrative.

In the EU, that narrative will be set jointly. Some have speculated this could lead to a sort of implicit reference HTA standard – where if the joint report is positive, countries feel some pressure to reimburse (lest their patients ask why they’re denying a drug Europe-wide experts found effective), and if it’s negative, countries have political cover to say no as well.

Over time, it could influence how innovative pricing models are adopted. Payers might collectively push for more evidence generation (e.g. requiring companies to run post-market studies) if the JCA highlights gaps; indeed, the joint assessment could recommend areas for further research, which national bodies could then mandate as conditions for coverage.

What about time-to-access metrics – will patients actually get drugs faster? The clock is ticking, but early indications are cautiously optimistic. The Commission’s hope is that by removing one major source of delay (duplicative clinical assessments), the overall timeline from EMA approval to patient access will shrink. If a country previously waited for its national HTA (which could take 6-12 months), and now the JCA report is ready almost immediately, in theory that saves those months.

Already, we see some countries like Belgium and Ireland (which historically often waited for bigger countries’ HTA outcomes) committing to use the joint report and potentially fast-track their processes. Eastern European countries too, which sometimes lag by years in access, could use the JCA to accelerate decision-making, assuming budget or pricing hurdles can be cleared. The true test will be statistical: by 2026 or 2027, data should show whether the average gap of 578 days has begun to narrow. If not, it means other bottlenecks (pricing disagreements, company launch strategies, etc.) are still dominating.

But if we observe a notable reduction – say the EU average time to reimbursement drops by a few months – that will be a vindication of the joint HTA’s role. Stakeholders are indeed gathering such data; EFPIA’s annual Patients WAIT indicator will surely track if the class of drugs under the JCA (oncology and ATMPs) see improved availability trends relative to previous years.

From a macroeconomic standpoint, the joint HTA mechanism is a fascinating policy experiment. It tests whether deeper European integration in a sensitive field like healthcare can deliver both efficiency gains and solidarity. If successful, Europe’s model could influence other regions or at least bolster the EU’s argument that a united market benefits all members.

Financially, more coordinated HTA could help payers contain costs – for instance, by avoiding paying high prices for drugs that offer negligible benefit, since a robust joint assessment might make it easier for multiple countries to say no or negotiate hard. Conversely, if it facilitates faster uptake of truly effective innovations, the health gains (and potentially economic gains from healthier populations) are substantial.

The pharmaceutical industry might see some short-term adjustment costs (needing to handle a new complex process), but in the long run, a single submission for clinical evidence could be more efficient than navigating dozens of separate ones. It might also reduce the uncertainty companies face – rather than the gamble of 27 different HTA verdicts, they get one coordinated scientific verdict for Europe (with the variability moved to the pricing arena).

That could be a net positive, providing “business predictability and ultimately accelerating access”, as EFPIA itself noted when welcoming the concept of the regulation (efpia.eu). Of course, if the system falters – say, if joint assessments are chronically delayed or perceived as low-quality – it could backfire, causing slower access and frustration all around. But so far, that doomsday scenario has been averted.

In sum, the EU Joint HTA Regulation is a bold attempt to resolve a longstanding paradox in Europe: a single medicines market with disparate value assessments. It seeks to marry the strengths of unity and diversity – a unified scientific review feeding diverse national decisions. The first months have delivered a mix of optimism and hiccups. The bureaucratic gears are turning, albeit with some grinding noises. As a grand experiment in health policy, it is being watched closely not just in Brussels, but in capitals across the world.

Will a German cancer patient and a Bulgarian cancer patient soon benefit from the same timely access to a new therapy thanks to a joint assessment? Will Europe speak collectively when assessing the next $2-million gene cure, and will that collective voice be louder or smarter than individual ones?

The answers will unfold in the coming years. For now, the new joint HTA mechanism represents a significant evolution in how Europe evaluates innovation – one that, if successful, could indeed justify its comparison to the Economist’s favorite metaphor for the EU: the slow, sometimes ungainly, but ultimately forward-moving bicycle of integration. Europe has set off on this bicycle, wobbly at first, but determined to pick up speed in the race to improve health outcomes across its member states.