The EU HTA Regulation: What Latin America Can Learn

Two European HTA leaders and four panelists from Latin America spent 90 minutes on the EU HTA Regulation at a webinar on 30 October 2026. It was hosted by PAHO with HTAi and was edition 53 of the RedETSA webinar series. The panel asked what countries in the Americas can take from the first joint clinical assessments the EU began producing in January 2025.

The regulation gives EU member states a shared clinical evidence base, while pricing and reimbursement stay with national governments. Both European speakers returned to that split. The Latin American panelists spent most of the session asking how much of the model could transfer to a region with uneven agencies and funding routes.

What the EU HTA Regulation covers

Marco Marchetti, director of the HTA unit at AGENAS, Italy’s national agency for regional healthcare services, and co-chair of the Member State Coordination Group on HTA (HTACG), set out the scope. He said the regulation assesses clinical evidence only:

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“What we are not doing at EU level is … everything that is connected with nonclinical assessment.”

Organization, economic, social and ethical impact are therefore left to member states. The 27 member states run different health systems, funding mechanisms and HTA bodies, so the EU assesses what can be shared: relative clinical effectiveness and relative safety against existing treatments. For medicines, the scope covers every product with a marketing authorization application, phased in step by step. For medical devices it is narrower and limited to high-risk products: class III devices and implantable class IIb devices.

The regulation was approved in 2021 and entered into force in 2022, but the first JCA started in January 2025. Marchetti said work on medical devices started in June 2026. He also said that, if he was not wrong, the Commission tracker updated on 15 October showed 19 JCAs ongoing for medicines and two for medical devices, with two more device products selected. Four JCAs had been published and four discontinued, mostly for lack of information.

Marchetti said the main methodological debate is how to define each PICO question: the population, intervention, comparator and outcomes. Wieseler later called the comparator the most determining factor in the assessment scope.

Marchetti named three conditions for cooperation: a common language for evidence, a shared space to assess different contexts and comparators, and governance that runs from assessment through implementation. He said the EU did not set out to reach the same decision everywhere, since there may be good reasons why countries “don’t have the same decision”. The aim was an assessment of the evidence.

The regulation is due for revision in 2028, three years after it began to apply. Marchetti also described a meeting in Dublin in late September, held under the Irish EU presidency, where the first year and a half of JCA work was reviewed for methodology, patient outcomes, evidence and data gaps.

How Germany connects its own process

Beate Wieseler, head of the drug assessment department at the Institute for Quality and Efficiency in Health Care (IQWiG), and chair of the HTACG subgroup for methodological and procedural guidance, described the German system. Germany has assessed all new drugs at market entry since 2011. There is no HTA gate before launch. Manufacturers set the launch price, and the assessment checks added benefit against an appropriate comparator defined by the G-BA, the decision-making body.

The assessment takes three months after launch. Appraisal follows for three months, with a public consultation, a hearing and a committee negotiation. Six months of price negotiation come after the added-benefit decision, and the new price takes effect six months after launch. If the launch price was too high, the manufacturer must pay back the difference. Wieseler stressed that manufacturers must submit all study data:

“If not all available data are submitted, the outcome of the assessment by definition is no added benefit.”

Germany changed its rules to fit the EU process. Manufacturers can reference a European dossier in their German submission, and the JCA report can serve as a basis for the German assessment. Wieseler said the German criteria have not changed:

“There is no change in the criteria the German system uses … to determine the clinical added benefit.”

Member states are free to use the reports as they choose. Wieseler said some use them in national assessment, some in price negotiations and some as the starting point for cost-effectiveness analysis. She called the decision to keep joint work at the level of clinical evidence a success:

“It is a success of the system and a very wise decision that we stopped with a joint work at this level of clinical evidence, because after that the European healthcare systems really become diverse.”

Her main lesson was that comparator data must be considered early in drug development, not once the questions arrive.

What Latin America can reuse

Adriana Robayo, executive director of the Instituto de Evaluación Tecnológica en Salud (IETS) in Colombia, separated two questions: the estimate of effect, and the value judgment. She said the relative effect “in principle is transferable between the systems”, but whether it applies “is not automatically done”, because “it depends on the comparisons available and how this is distributed.”

For Latin America, she proposed sharing the synthesis of evidence and concentrating local resources on economic evaluation and budget impact. She also noted that in Colombia part of access runs through legal routes and financing mechanisms outside the HTA process, so HTA is not a single path into the system. A mandatory model, she warned, would not necessarily produce harmonized results.

She pointed to thin evidence in oncology and advanced therapies, where single-arm trials predominate and indirect comparisons are hard to verify. Europe has the legal option to demand more evidence after approval. The region, she said, still operates with a great deal of uncertainty.

Madeline Martinez, director of economic and statistical studies at the Superintendence of Health and Occupational Risks (SISALRIL) in the Dominican Republic, said regional agencies differ in institutional strength, with some stronger and others with a more passive scope. She called for a common language, a standardized methodology and shared technical capabilities. A regional network is already working on structures for clinical assessments, with economic assessments to follow.

Virgilio Petrungaro, executive director of the National Commission for Health Technology Assessment (CONETEC) in Argentina, argued that the core of HTA is the comparison. Agencies must agree on what additional clinical benefit means against the real treatment, and on the minimal significant clinical difference in each country. That core is weakened by the price, ethical and equity debates that follow.

Petrungaro closed with a call for speed:

“It’s better before than after to work closer.”

“Let’s not take longer than we should in putting together or consolidating an assessment system in the whole Latin America.”

Where the panel agreed

Several panelists pointed to the same near-term steps. Petrungaro listed them as sharing a method, training a critical mass of high-level HTA specialists, and working on joint assessments. Discussion noted that Europe began with advanced therapies, where a single comparison is easier to agree on. Marchetti advised regions to choose their level of collaboration first, rather than aim for the same decision.

What comes next

RedETSA, the Health Technology Assessment Network of the Americas, was launched at the first Latin American HTA congress in Rio de Janeiro and turns 15 this year. The XVII RedETSA Meeting, which marks that anniversary, takes place in Lima in November 2026. Moderator Alexandre Lemgruber said a panel there will also examine how regulatory agencies and HTA bodies can integrate more closely.

Source: PAHO event page, “The EU HTA Regulation: How Does It Look From Latin America?” (paho.org), and the recording of RedETSA webinar 53 on YouTube. Speaker titles from the PAHO page. Quotes come from the recording’s captions, edited for filler words and transcription errors.