The main speakers at the event were Herbert Altmann, VP market access and healthcare consulting, Europe, at PharmaLex, and Matias Olsen, senior manager, public affairs and policy, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE). 

During the presentation, Herbert highlighted the European Commission’s objectives with the regulation – to accelerate innovation, improve transparency, and drive equality in terms of patient access across the EU. 

Preparing the JCA report

There are two key instruments embedded in the HTAR: the Joint Clinical Assessment  (JCA) and the Joint Scientific Consultation (JSC). 

A core instrument of the HTAR, the JCA seeks to do away with duplicative assessments across the 27 member states plus Norway. 

Matias noted that EUCOPE has been supportive of the regulation to reduce the burden on companies having to submit the same data across 27 different jurisdictions. 

The JCA process is evaluating the degree of certainty of the relative effectiveness and relative safety, considering the strengths and limitations of the available evidence.

It’s important to emphasize that the JCA process is evaluating the degree of certainty of the relative effectiveness and relative safety, considering the strengths and limitations of the available evidence. Pricing and reimbursement processes remain under the full responsibility of the individual member states. However, it is expected that HTA bodies will give due consideration to the conclusions, and it is therefore likely to influence local processes and decision-making, Herbert added. 

The JCA is a complex analysis that is prepared by the Heath Technology Developer (HTD) – the Pharma/Biotech company – and then assessed by the HTA bodies, Matias noted.

There are different steps in the assessment, starting with defining the PICOs (population, intervention, comparator, outcome), which we have defined and described in detail in previous articles. 

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With just months to go before the EU joint clinical assessment (JCA) process takes effect, the focus on what it will mean from a country perspective is intensifying.

The JCA has been in place since January 12 this year for oncology and advanced therapy medicinal products (ATMPs). From 2028, orphan drugs will be included and from 2030, it will be mandatory for all newly registered products in Europe. 

While not a member of the EU, Norway joined the HTAR framework in January and has put together a national working group to assess how to integrate this reform into the Norwegian “New Methods” framework, Herbert said. 

The Norwegian Medical Products Agency (NOMA) has been involved with the JCA from early on, including development of the methodological guidelines which provide the details of how the assessments will be performed. Herbert mentioned how impressive the commitment of Norway is to fully implement and leverage the EU HTAR, finally generating faster access to innovative medicines and improving patient care.

Getting advice through the JCS

The JSC enables companies to get advice from the European Medicines Agency (EMA) and HTA bodies in Europe at the same time. As Herbert pointed out, the JSC provides non-binding scientific advice before the start of a pivotal clinical trial. The objective is to develop the clinical trial design in a way that the expected evidence package not only supports regulatory reasons – is a product efficacious and safe? – but also HTA assessment criteria.

There are selection criteria for health technologies to be eligible for the JSC, including unmet medical need, first in class, impact on patients and healthcare systems, significant added value, and research priorities in the EU. These are needed due to lack of sufficient resources in all member states to support all products, Herbert said. 

There are already 25 products going through JCAs.

For 2025, there are ten procedures available for the JSC: seven for pharmaceutical products and three for medical devices. 

To put that into perspective, Matias noted that there are already 25 products going through JCAs, underscoring the importance of scaling up the JSC process as soon as possible. 

Currently the JSC meetings are offered free of charge, unlike some of the advice meetings at the national level. This will be reviewed in 2028, where consideration could be given to introducing a fee system. 

“This is something we and all the industry associations in Brussels have been calling for,” Matias noted. “We would rather have more spots being offered and have companies pay for it.”

Reform on the horizon

During the discussion, Herbert pointed out that the HTAR is just one aspect of healthcare reform across the EU. Another reform is the general pharmaceutical legislation (GPL) expected to be implemented around 2028, or the recently published EHDS (European Health Data Space) regulation. All these reforms are connected so it’s important that the industry and other healthcare system stakeholders provide continuously feedback to the European Commission or the HTA coordination group to make sure that they optimize this process, Herbert emphasized.

All these reforms are connected so it’s important that the industry and other healthcare system stakeholders provide continuously feedback to the European Commission or the HTA coordination group to make sure that they optimize this process.

The HTAR and its two key instruments, the JCA and JSC, represent a big change for industry. While there will inevitably be a learning curve, the processes are largely being welcomed by industry groups. The challenge for companies will be preparing for and managing the process to successfully navigate the complexities of market access in Europe. 

About the author

Saila Schönberg is Senior Manager Nordics Communication and Public Relations at PharmaLex Finland Oy.