Authors: Václav Audes, Kateřina Slavíková, Denisa Fuchsová
In late 2021, the European Parliament adopted Regulation (EU) 2021/2282 of the European Parliament and of the Council on health technology assessment (the “Regulation”), which had been under discussion for several years. The European Union hopes that the adoption of the Regulation will establish a joint instrument that will help to enhance cooperation between the Member States in health technologies and reduce the administrative burden for applicants. As a result, it should provide a higher level of protection for patients and users and ensure better availability of innovative health technologies. The applicability of the adopted regulation has been postponed until 12 January 2025, giving stakeholders sufficient time to prepare for the new rules. Below is a brief summary of the main aspects of the Regulation.
The health technology assessment under the new Regulation will cover medicinal products, medical devices and in vitro diagnostic medical devices, medical procedures as well as measures for disease prevention, diagnosis or treatment. The assessment will cover both the clinical and non-clinical aspects of a health technology, including in particular a cost and economic evaluation and its ethical, organisational, social and legal aspects.
To accomplish the purpose of the Regulation, a coordination group will be established with responsibility for overseeing joint clinical assessments and providing methodological guidance to stakeholders by issuing guidelines and detailed procedures. The members of the coordination group will be appointed by each Member State. These members must not have any financial or other interests in the health technology development sector that could affect their independence or impartiality.
The Coordination Group’s task will also be preparing regular reports on emerging health technologies expected to have a major impact on patients, public health or healthcare systems.
The key element of the new Regulation is the joint clinical assessment that is to be carried out for new medicinal products subject to centralised marketing authorisation or for medicinal products authorised for a new therapeutic indication, and for medical devices and in vitro diagnostic medical devices of the highest risk classes for which the applicable regulations require the notified bodies to consult with an expert panel at the Commission level.
Joint clinical assessment will be conducted based on the annual work programme of the Coordination Group and to the extent of and according to the parameters defined by the relevant assessment subgroup for the given assessment. A health technology should be included in the programme based on activities such as ‘horizon scanning’. The joint clinical assessment will compare the given health technology against other health technologies and existing practices. If the Commission contacts a specific health technology developer to carry out a joint clinical assessment, that entity will be required to submit the required dossier.
Interestingly, the Regulation does not define in more detail the health technology developer; given the definition of health technology, it will primarily include manufacturers of medicinal products, medical devices and in vitro diagnostic medical devices. However, in principle, it cannot be ruled out that the Commission could contact anyone if it finds that they are an entity having the dossier required to conduct a joint clinical assessment, including, for example, entities that are yet to enter the market as manufacturers. One can only hope that these issues will be clarified in detail in the implementing acts that the Commission is authorised to issue under the Regulation.
The joint clinical assessment should then result in a joint clinical assessment report, which should describe the effects of the assessed health technology on the health outcomes against the chosen parameters, taking into account the strengths and limitations of the available evidence, but should not contain any conclusions in relation to the overall clinical added value of the assessed technology. The report will be made publicly available on a website set up by the Commission.
Besides joint clinical assessment, the Regulation provides for a procedure for joint scientific consultations to be carried out for the purpose of exchanging information between the Commission and health technology developers regarding their development plans for a specific health technology. These scientific consultations will be conducted for health technologies that are likely to be subject to joint clinical assessment in the future.
For completeness, please note that the adoption of the Regulation in no way affects the existing rules for clinical trials of medicinal products and medical devices (we presented our newsletter relating to the entry into force of the new regulation on clinical trials on medicinal products for human use here), nor the conduct of performance studies concerning in vitro diagnostic medical devices. Joint clinical assessments will be conducted independently and separately from the “regulatory” trials carried out to place a specific product on the market.
As for responses from the field, the new Regulation has been commented on, for example, by the European Federation of Pharmaceutical Industry Associations (EFPIA), supporting its adoption but wishing to see an even more ambitious form of the legislation. [1] For example, the Commission’s original proposal required Member States to apply the results of joint assessments carried out under the Regulation in their own assessments. However, the final proposal only includes an obligation to ‘give due consideration’ to such assessments. The extent to which the new system will bring uniformity in the field of health technology assessment will therefore depend to a large extent on how consistently Member States will apply and build on the results of joint clinical assessments in their own national assessments. It can be assumed that the quality of the outputs of joint clinical assessments will also play a major role in this.
By contrast, MedTech Europe (the European trade association for the medical technology industry) was highly critical of the Regulation. It expressed scepticism about the real added value of the Regulation.[2] In particular, the association pointed to the very different processes applied in practice in the pharmaceutical and medical device sectors and stressed the need to ensure that joint clinical assessments of health technologies do not interfere with the CE marking of medical devices nor delay their market access.
