The EU’s new Health Technology Assessments Framework is more than regulatory reform. It offers a rare opportunity to simplify compliance, accelerate market access, and shape cross-border legal strategy.

The first Health Technology Assessments (HTAs) performed in the US in the 1970s were designed to support decisions about allocating limited economic resources for large, costly, machine-based technologies. The regulator responsible became unpopular with stakeholders by issuing reports criticizing the medical profession, and medicinal product and medical device manufacturers.

Things have changed. HTAs are now an important part of the regulatory approval process, by offering a systematic and multidisciplinary evaluation of the properties of health technologies and interventions. Whilst certain elements are common to all HTAs, there is no single right approach, and HTAs are a reflection of a country's health system, just as the health system is influenced by the culture, history, values and priorities.

The introduction of the EU Health Technology Assessment Framework (HTAF) in 2021 marked a turning point. Implementation of this new regulatory mechanism began in January 2025, with the aim of helping national authorities make informed decisions on pricing and reimbursement, while also streamlining procedures for manufacturers.

The primary goal of the HTAF is to ensure that investments in new health technologies are both clinically effective and economically viable. The primary goal of the new mechanism is to offer a standardized, streamlined process operating across the EU.

Like any harmonization project, its success will come from balancing the needs of all stakeholders. In this case, that will mean accommodating the regional variability that exists across the current systems in EU member states, while striving for the shared goals for harmonized EU systems, and recognizing the commercial realities for manufacturers.

How is it being implemented?

Once a marketing authorization for a medicinal product is in place, HTAs are conducted in the phase of the regulatory process when national entities are making pricing and reimbursement decisions. The purpose of the assessment is to evaluate the added value of new health technologies compared to existing alternatives. Technologies in this context includes a wide range of health technologies, from medicinal products and medical devices to surgical procedures and diagnostic techniques.

One of the most significant features of the HTAF is the introduction of a Joint Clinical Assessment (JCA), implementation for which is happening in phases. The first types of technologies that will be subject to the new assessment process are advanced therapeutic medicinal products (ATMPs) and oncology medicinal products (which started in January 2025). From January 2028, orphan medicinal products will be in scope. By 2030, JCAs will be implemented for all patented medicinal products, in-vitro diagnostics, and high-risk medical devices.

How is it changing existing procedures?

Historically, each European member state conducted its own assessments, leading to a fragmented and often inconsistent regulatory landscape. The JCA aims to create a more harmonized approach, streamlining the evaluation process and reducing duplication of efforts. This is particularly crucial for companies developing cutting-edge therapies, as it can significantly shorten the time-to-market for innovative treatments.

Will it help patients?

For patients to access health technologies, the health technologies must be available, affordable and introduced in a timely way.

For national regulators, the underlying question will be "Is this health technology worth paying for?". For patients, it means that only the most effective and valuable health technologies are approved for use. Potentially, patients can expect faster access to more advanced and proven treatments.

Benefits and Potential Challenges

The HTAF offers numerous benefits. It will create a standardized process across the EU, making it easier for companies to navigate regulatory requirements and bringing new technologies to market faster. This means patients will benefit from quicker access to innovative treatments.

Systematically, the goal is to help allocate healthcare resources more efficiently, but the system is not without challenge. Implementation is complex, requiring coordinate assessments across multiple countries. This may necessitate significant adjustments to existing processes. In addition ensuring stakeholder alignment and adequate allocation of public resources.

For clients, this represents a great check-point.

First, legal teams should review regulatory pathways and update internal compliance protocols to reflect the centralized JCA process. This streamlining can reduce legal complexity and improve predictability for multi-jurisdictional launches. Ideally this would include participating in scientific advice and parallel consultations to align evidence generation with regulatory and HTA needs.

Next, by reassessing licensing and distribution agreements to take advantage of harmonized assessments, clients may be able to win broader geographic coverage with fewer legal hurdles and faster execution.

Recent updates from the European Commission and HTA Coordination Group (HTACG) show strong engagement and alignment among member states. The July 2025 conference emphasized collaboration and transparency, with stakeholders praising the framework’s clarity and efficiency.

For clients, this means the framework’s stability will reduce risk in long-term planning and investment. Clients can leverage this regulatory goodwill to support strategic transactions, joint ventures, and partnerships. Further, clients might be able to identify jurisdictions that offer competitive advantages by monitoring national-level implementation and identifying jurisdictions with early alignment. These markets may be ideal for pilot launches or strategic investments.

What comes next?

The framework presents an exciting opportunity, but it also introduces time pressure for companies preparing regulatory submissions. The JCA process requires early coordination across regulatory, legal, and clinical teams, and we are supporting many clients who are leading cross-functional readiness efforts, and ensuring legal teams are integrated into regulatory planning. Early engagement can prevent bottlenecks and support smoother submissions under the new framework.

We will be watching the implementation of the JCA requirement with interest, particularly as it expands to other technological products. Taking an EU-wide outlook, we will be working with clients to understand the implications of a single EU-level assessment on national pricing and reimbursement decisions.

Although the framework is EU-wide, member states retain discretion over pricing and reimbursement, so we will be tracking how individual countries are interpreting and applying the framework.

This will help our clients launch products across Europe with legal strategies tailored to reflect both centralized assessments and local market dynamics.