Is the EU HTA Regulation ready for vaccine innovation and fill-in the promise of improved availability?

In just 7 months from now, the EU HTA Regulation (HTAR) will become applicable. The objectives set aside by the EU legislator will stop being a theoretical concept, hopefully translating into key performance indicators: efficiency of resources’ use, strengthening the HTAs quality, improvement of business predictability, and most importantly, improvement of the availability of innovative health technologies. How will the HTAR score when it comes to its preparedness and objectives’ fulfilment for vaccines? 

One could even ask – why should we talk about the HTAR applicability  for vaccines, and why now?

Vaccines differ from therapeutic medicines in many ways, but they will eventually fall under the scope of HTAR. Joint clinical assessments (JCAs) will only start for vaccines in 2030 [1]. Although they represent core activity of the HTA Coordination Group, the conduct of joint scientific consultations (JSCs), horizon scanning and voluntary collaboration cannot be omitted. Health technology developers of vaccines, just like any other centrally approved products, will be able to benefit from these joint activities as of 2025, pathing the way for efficient and meaningful assessments later on. And vaccines are not a marginal product. We observe a flourish in vaccine innovation over the past years and those to come.

By the end of August 2023, there were 103 vaccine candidates in the pipeline [2], of which 71 in the phase I and II clinical trials [3]. Perfect candidates to be enrolled in the JSCs – as of 2025, and likely before 2030. 

But will the joint HTA system and processes be ready to consider vaccines’ specificities and bring value to the vaccine development? 

The specificities of vaccines have been acknowledged in the recital 24 and the art. 4 of the HTAR, stressing the need to adapt methodologies for performing JCAs and JSCs as well as development of procedures for conducts of joint activities. As of today, no steps have been undertaken to implement these provisions in practice, whilst we are just 7 months before the HTAR become applicable.

Vaccines have demonstrated to be one of the most successful healthcare interventions of our time, saving up to 5 million lives globally each year. What’s more, they can play a significant role in addressing global threats to health such as AMR, ageing population, climate change, zoonoses, geopolitics. Being a strategic public health tool to protect people, it is somehow disappointing that a due consideration has not been given yet to vaccines in the context of HTAR implementation. 

What can we practically do so that HTAR scores better when it comes to its preparedness and objectives’ fulfilment for vaccines?

  1. Efficiency of resources’ use in the vaccine access pathways -> Systematically include National Immunisation Technical Advisory Groups (NITAGs) in all joint HTA activities, either via the HTA Coordination Group, ECDC NITAG network or respective national procedures, to plan assessment processes in advance and avoid unnecessary duplications.
  2. Strengthen the HTAs quality for vaccines -> Develop vaccine-specific methodologies to be applicable for the future joint clinical assessments, pooling the knowledge and expertise from different NITAGs and HTA bodies experienced in vaccine assessments at national level.
  3. Improve business predictability for vaccine developers -> Allow for sufficient amount of JSCs as of 2025, open for all products including vaccines, and involve relevant stakeholders, such as NITAGs, in their conduct.

All of the above, and potentially more, is critical to fill-in the essential goal of HTAR -improvement of the availability of innovative, in this case – vaccines, in the EU. It is not a mission impossible, as long as we work together and we start now, and not wait until 2030. 

[1] Joint clinical assessment could start as of 2025 for “cancer vaccines” given the HTAR gradual implementation will be dependent on the therapeutic indication of a new active substance defined as “the treatment of cancer”.


[3] Given an acceleration of development, phase I and phase II clinical trials are often merged by the developer, and hence, were captured under phase II clinical trial in the above referenced report.