The EU HTA regulation: a new frontier for access to innovative technologies
A new health technology regulation is due to be applied to help EU countries determine the effectiveness of novel technologies and decide on pricing and reimbursement by health insurers or health systems. Here, Professor Vincenzo Salvatore and Giuseppe Ragucci from BonelliErede reflect on what this means for the UK and other parts of the world.
ON 11 JANUARY 2022, Regulation (EU) 2021/2282 on health technology assessment (HTA) came into force.1 The regulation is the culmination of a long debate between European Union (EU) Member States and health sector stakeholders, triggered by joint actions such as European Network for Health Technology Assessment (EUnetHTA) and formalised through the European Commission (EC)’s proposal in January 2018.2
The regulation will be applied by 12 January 2025 and will therefore take three years to become effective in Member States (and thus to fully appreciate its impact). It introduces an evidence‑based process (HTA) that will allow the competent EU and national authorities to determine the effectiveness of new or existing health technologies (eg, medicinal products, medical devices, in vitro diagnostic medical devices, medical procedures and measures to prevent, diagnose or treat diseases).
To achieve this objective, the regulation amends Directive 2011/24/EU on the application of patients’ rights in cross‑border healthcare, specifically by repealing Article 15, which originally laid down the modalities and principles for co-operation between Member States in assessing new health technologies.
Article 15 proved that transparent and effective assessments of new technologies were crucial to ensure fair competition between stakeholders that operate in the EU.
Directive 2011/24/EU had the merit of drawing attention to the need for an appropriate and centralised assessment of health technologies but failed to ensure effective harmonisation on the issue.
In this respect, the regulation ensures a centralised assessment by establishing the Member States Coordination Group on Health Technology Assessment (better known as the Coordination Group).
Coordination Group to oversee assessments
The Coordination Group will be a highly competent and technical body comprising representatives from Member States and responsible for overseeing the implementation of joint clinical and scientific assessments.
Exactly how the Coordination Group will work has yet to be determined, but some considerations have already been made based on the regulation.
the regulation stipulates that the Coordination Group will develop its detailed procedural steps and timeframe for the joint clinical assessments and joint scientific consultations to ensure a coherent and consistent approach”
It should, for example, involve and consult with many different stakeholders to ensure that the joint work is inclusive and transparent. Stakeholders include patient organisations, healthcare professional associations, clinical and scientific societies, health-technology developer associations, consumer organisations, and other non‑governmental healthcare organisations.
This last consideration deserves further comment. It is indeed a crucial point and outcome that the EU institutions have understood that a valuable, meaningful and widely accepted assessment of new health technologies cannot be made without the opinion of direct consumers (patients). Involving patient organisations will certainly ensure the proper collection of all useful data.
Regarding the more formal aspects, eg, the decision-making procedure through which the joint clinical assessments will be carried out, the regulation stipulates that the Coordination Group will develop its detailed procedural steps and timeframe for the joint clinical assessments and joint scientific consultations to ensure a coherent and consistent approach.
It is thus clear that the criteria for the assessments, which will be based on scientific principles, will most likely follow a comparative method. This essentially means that the technologies to be assessed will be considered innovative if they offer advantages over existing similar products – especially in terms of cost‑effectiveness and therapeutic efficacy.
It is also clear that this aspect will inevitably lead to discussions, but the principles on which the composition and activities of the Coordinators’ Group have been established open up a new frontier of political and scientific co-ordination within the EU Member States.
Pros and cons of HTA regulation
As mentioned, the full extent of the long-term effects is not yet foreseeable, however the authors are of the opinion that at least one pro and one con are apparent.
The main benefit is that joint assessments establish a fair evaluation of innovative products, thus avoiding competition between Member States and the associated ‘jurisdiction shopping’ that would otherwise ensue (including as an indirect consequence or automatic effect).
Indeed, the HTA regulation will most likely guarantee fairness in determining the true value and pricing (including in relation to health product reimbursement) of new technologies.
This aspect will also greatly benefit stakeholders. After all, owners of new technologies whose product is fairly valued can make a higher profit from selling it.
However, this would not be an automatic consequence, as under Article 168, paragraph 7 of the Treaty on the Functioning of the European Union (TFEU), Member States are responsible for defining their health policy and for organising their health services and medical care. This means, for example, that the reimbursement price of a health product will ultimately continue to be set at national level by each Member State.
The other side of the coin is the uncertainty that will ensue over the next three years.
European institutions must find criteria and procedures compatible with the current health market. This means that a quick and standardised procedure will need to be established to ensure the aforementioned assessments are transparent and effective. If the administrative structure (in this case, the Coordination Group) was unable to co‑operate and function properly, it would become a burden for stakeholders – and that would serve only to benefit the innovative technologies market in other countries and continents.
What are the implications for the UK?
Given the above, when it comes to the UK, several scenarios emerge for political and administrative institutions.
Following Brexit, the UK is obviously no longer participating in the EU legislative process. This essentially implies that the UK will not apply the HTA regulation and thus not be involved in co‑ordinating and conducting assessments of new technologies.3
The UK not being involved in the Member States’ joint work is certainly a major issue, as it was considered a leader in the HTA field until Brexit.
Following Brexit, the UK is obviously no longer participating in the EU legislative process. This essentially implies that the UK will not apply the HTA regulation and thus not be involved in co-ordinating and conducting assessments of new technologies”
UK institutions thus have at least three options: (1) wait until the EU HTA regulation is fully applicable and align the UK legal framework with it; (2) create political relations with EU institutions and bodies to be (indirectly) involved in developing HTA policy; or (3) jump ahead of the EU and act as a sole player.
Waiting for the HTA regulation to become fully applicable and acting as a sole player (ie, Options 1 and 3) have clear disadvantages.
Indeed, should the UK fail to propose a policy for assessing new technologies based on sound and unambiguous scientific criteria, it would most likely lose its advantages over Member States. For instance, the UK’s HTA assessment could lead to new technologies being priced solely based on the economic value determined at national level, which could not compete with the value determined at EU level.
Hence, the most advisable scenario is that the UK plays a role in the EU policy-making processes on HTA. Indeed, although it is true that the UK cannot play a leading role in the EU policy process, this does not preclude UK health organisations and bodies, together with stakeholders and patient organisations, from helping to define the broad criteria for a comprehensive assessment system to be used across the European continent.
About the authors
Vincenzo Salvatore is of counsel and leader of the Healthcare and Life Sciences Focus Team at BonelliErede. Full Professor of European Union Law, he joined BonelliErede in 2015, bringing his specific regulatory and compliance skills in terms of clinical trials, marketing authorisation procedures, pharmacovigilance, promotion and marketing of medical devices, inspections and enforcement. Vincenzo has gained significant experience in complex litigation representing public and private entities before the European Court of Justice based in Luxembourg, in EU law disputes. In addition, he was Head of the Legal Service at the European Medicines Agency from 2004 to 2012.
Giuseppe Ragucci is an associate and member of the Healthcare and Life Sciences Focus Team at law firm BonelliErede. He joined BonelliErede in 2018 and specialises in regulatory and compliance matters related to pharmaceuticals, medical devices, medical technology, biotechnology, food, cosmetics and novel products.
- Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU. Official Journal of the European Union; 2021.
- Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on health technology assessment and amending Directive 2011/24/EU. European Commission; 2018.
- Lorgelly PK., The impact of Brexit on pharmaceuticals and HTA, PharmacoEconomics – Open. 2018; 2(2):87–91.