EU pharmaceutical strategy: Member States welcome European Commission’s adoption of regulation on Health Technology Assessment

The long awaited regulation on Health Technology Assessment (HTA Regulation), adopted on 13 December 2021 and published in the EU Official Journal on 22 December 2021, is a deliverable of the EU Pharmaceutical Strategy that aims to revolutionise patient access to vital and innovative technologies.

Although the HTA Regulation has been in force since 11 January 2022, it will not fully apply until 12 January 2025.

The new rules will improve the medical offering to patients by ensuring that they have better access to state of the art medicines, medical devices, prevention and treatment methods, and aim to build a “new type of cooperation in health”, leading to a more robust European healthcare industry.

What is a Health Technology Assessment (HTA)?

A HTA is a scientific evidence-based and multidisciplinary process to evaluate medical, economic, social and ethical issues arising from the use of health technologies and their impact on patients, in order to inform policy making such as clinical guidelines or use of a product.

This process is critical to ensure high quality, accessible and sustainable healthcare is available across the EU.

Key objectives

The HTA Regulation seeks to:

  • Create collaborative structures and procedures, enabling Joint Clinical Assessments of new medicines and high-risk medical devices to be carried out by Member States.
  • Focus on the clinical effectiveness and safety of new health technologies allowing Member States to jointly identify these technologies as they come to market.
  • Liaise with technology developers on clinical study designs via Joint Scientific Consultations – which provided non-binding scientific advice before the start of clinical trials - to generate appropriate evidence.

It also establishes a Coordination Group of HTA national or regional authorities and a Stakeholder Network who will participate in Joint Scientific Consultations and Joint Clinical Assessments.

It also intends to ensure the efficient use of resources by pooling EU areas of competencies to strengthen the quality of HTAs across Member States. This voluntary cooperation will save national HTA bodies and industry from “duplicating their efforts, reassure business and ensure the long-term sustainability of EU HTA cooperation”.

The HTA Regulation will be a key tool in providing policy-makers with evidence based information to assist with the creation of safe, effective, patient-focused and cost-effective health policies. 

Who will benefit?

The Joint Scientific Consultations and Joint Clinical Assessment reports – which are high quality scientific reports - will benefit the following groups:

  • Patients – by supporting Member States in providing more broad, timely, evidence based decisions to allow access to vital health technologies, new medicines and medical devices that improve patient care and will offer new and developed health solutions.
  • Clinicians - by addressing unmet medical needs and facilitate access to innovative medicines and some high-risk medical devices so clinicians are able to provide the best quality medical care.
  • Manufacturers – the new framework for joint work aims to provide more clarity and predictability to pharmaceutical and medical device manufacturers in respect of medical device development, which may improve clinical based evidence and cost-effectiveness.

Looking ahead

The implementation stages of the HTA Regulation will be gradual.

The European Commission will create a Coordination Group later this year composed of representatives designated by EU Member States. Initially, the focus of the Joint Clinical Assessments carried out under the Coordination Group will be limited to oncology products. They will then be extended to orphan and advanced therapy medicinal products (ATMPs), after which all other therapeutic areas will be addressed.

The delayed period for implementation will allow enough time to establish an organisational framework, namely the Coordination Group, its sub-groups and Stakeholder Network, and to adopt the delegated acts to supplement non-essential elements of EU legislation and the assessment methodology guidance documents, which will be used to provide practical support. It will also enable Member States to adjust national HTA legislation and amend processes in accordance with the HTA Regulation, as necessary.

Life sciences and healthcare industry stakeholders will also be afforded time to digest and comply with new regulatory requirements, as provided by the new framework.

Companies should also use this time to re-examine their current operations and determine practical solutions for the anticipated changes.

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