Final sprint of the implementation.

There is not much time left as the joint clinical assessment of health technologies (EU HTA) is due to start in stages in January 2025 – less than three months from now. The EU HTA harmonises the clinical assessments of health technologies for medicinal products and medical devices.

The corresponding Regulation (EU) 2021/2282 came into force on 12 January 2022. However, some important regulations governing the details of implementation are still missing before the first European joint clinical assessments can actually take place from January 2025.

Fourth of six implementing regulations published

On 1 October, the European Commission presented a new draft implementing regulation on Health Technology Assessment (HTA). This is the fourth of a total of six implementing regulations. The planned implementing provisions are intended to regulate the scientific assessment of medicinal products. Specifications should be made that describe how Health Technology Developers (HTD) can obtain early indications of the evidence and data required to conduct a joint clinical assessment of their product. A public consultation was also launched when the draft was presented.

Inventory

The roadmap for the EU HTA, updated in September, provides an overview of the current implementation status. Of the six proposed implementing regulations, three have entered into force in November

The first implementing regulation was published by the European Commission on 6 March. It sets out procedural rules for cooperation in the preparation and updating of joint clinical assessments as well as regulations on information exchange and the involvement of experts. The German Social Insurance (DSV) commented on this in April and pointed out the insufficient clarity regarding the content and scope of the joint clinical assessments of medicinal products, pending the submission of the guidelines, including the methodology, which are still then being drafted. The implementing regulation was adopted on 23 May and published in the Official Journal. The regulation came into force on 13 June. It will apply from 12 January 2025.

The second implementing regulation aims to ensure that assessments of new health technologies at EU level are independent, non-partisan and free from conflicts of interest. A draft of this regulation was published on 29 May, and was published in the Offical Journal on 28 October.

The third implementing regulation has been finalised. A draft was published on 26 June and is intended to regulate the cooperation and exchange of information between the coordination group, the European Commission and the European Medicines Agency (EMA). The implementing regulation was published in the Offical Journal on 21 October and will come into force on 10 November.

As mentioned earlier, the draft of the fourth implementing regulation on cooperation in the preparation and updating of joint clinical assessments has been available this month onwards.

The fifth implementing regulation will contain provisions on joint scientific consultation for medical devices, while the sixth regulation will lay down the rules for joint clinical assessment of medical devices. The drafts of these regulations are to be presented by the European Commission in the course of this year. They also still need to be adopted this year.

EU HTA background

The HTA helps in assessing the added value of new health technologies in comparison to current standard therapy. HTA procedures have only taken place at national level to date, which has meant that health technology developers have had to submit their documents several times, sometimes in different formats, for the assessment procedures in the individual Member States. The EU HTA procedure is intended to reduce this administrative burden for developers and improve the quality of assessments in accordance with the international standards of evidence-based medicine. The joint assessment will provide national HTA organisations with scientific information that they can use in their decisions on pricing and reimbursement for a health technology. From the DSV's point of view, it was important that the national HTA organisations can decide for themselves to what extent they use and adopt the European assessment results.