Background: History of the HTA Regulation
In November 2020, the EU Commission published a pharmaceutical Strategy for Europe through its Communication (COM(2020) 761 final). The aim of the pharmaceutical Strategy for Europe is to create a regulatory framework that supports industry in driving the research and development of pioneering new technologies that have a real added value for patients in Europe.
When it comes to market access for new technologies, a balance is needed between promoting the competitiveness of industry in Europe on the one hand and ensuring the financial stability of national social and healthcare systems within the EU on the other.
One module thereof could be harmonized regulations for the benefit assessment of new technologies with procedures for the mutual recognition of benefit assessment procedures.
On December 15, 2021, the European Parliament and the Council of the European Union finally adopted Regulation (EU) 2021/2282 on health technology assessment (hereinafter HTA Regulation). It will apply from January 12, 2025 (see Art. 36 para. 2 HTA Regulation).
What is the HTA regulation about?
Health technology assessment ("HTA") is described by the HTA Regulation – as a scientific evidence-based process to help competent authorities determine the relative effectiveness of new or existing health technologies (see recital 2 of the HTA Regulation ).
The HTA Regulation specifies (see Art. 1 para. 1 HTA Regulation):
- procedures for cooperation of Member States on health technologies at Union level;
- a mechanism which lays down that any information, data, analyses and other evidence required for the joint clinical assessment of health technologies is to be submitted by the health technology developer only once at Union level;
- common rules and methodologies for the joint clinical assessment of health technologies.
For this purpose, the Member State Coordination Group on Health Technology Assessment shall be established, whose members will be appointed by the Member States (see Art. 3 HTA Regulation ). The Coordination Group shall carry out its activities in an independent, impartial and transparent manner (see Art. 5 HTA Regulation ).
Scope of the HTA Regulation:
The HTA Regulation basically covers all "health technologies" within the meaning of Art. 3 lit l) of the Patient Mobility Directive 2011/24/EU, namely medicinal products, medical devices and in-vitro diagnostic medical devices (see definition in Art. 2 No. 4 HTA Regulation).
However, the "joint clinical evaluation" procedure only applies to certain health technologies. Thus, not all medical devices are included; but only so-called "high-risk devices", namely medical devices of class IIb or III, which are subject to the consultation procedure according to Art. 54 of the Medical Devices Regulation (EU) 2017/745 as well as in-vitro diagnostic medical devices of class D, which are subject to the consultation procedure according to Art. 48 para. 6 In Vitro Diagnostics Regulation (EU) 2017/746 (see Art. 7 para. 1 and para. 4 HTA Regulation).
Regulatory approach of the HTA Regulation
The Coordinating Group conducts joint clinical assessments of health technologies based on its annual work program.
After obtaining a recommendation from the Coordination Group, the Commission shall, at least every two years, by means of an implementing act, select the high-risk medical devices and in vitro diagnostic medical devices subject to joint clinical evaluation on the basis of the following criteria
- Unmet medical need
- First product of a new product category
- Potential impact on patients, public health or healthcare systems.
- Incorporating software using AI, machine learning technologies or algorithms.
- Significant cross-border dimensions
- Great Union-wide added value
Outlook on the impact of the HTA Regulation on medical devices in Germany
From the start of application on January 12, 2025, the HTA Regulation will have an impact on the evaluation of new investigation and treatment methods according to the procedure laid down in the German Social Code, Book V (Sozialgesetzbuch Buch V – hereinafter SGB V) in Sections 135, 137c, 137h SGB V.
The HTA Regulation initially has no effect on the procedure for evaluating digital health products in accordance with Sections 33a and 139 e of the SGB V, as these are not high-risk medical devices.
