Introduction

Health technology assessment (“HTA”) is a multidisciplinary assessment process that seeks to evaluate the added therapeutic value of health technologies (i.e., drugs, certain medical devices, medical treatments including surgical procedures, and measures for disease prevention and diagnosis) based on both clinical and non-clinical elements.  Until now, HTA has strictly fallen in the purview of EU Member States; they have cooperated among themselves in this field for more than 20 years on a purely voluntary basis.  This has led to initiatives such as EUnetHTA, which is a network of national HTA bodies, and its various Joint Actions.  Article 15 of the Cross-Border Healthcare Directive (Directive 2011/24) also provides for that national bodies responsible for HTA should cooperate on a voluntary basis.  Gradually, these various actions have developed common criteria for the performance of HTA at national level.  For example, the last “Joint Action 3” of EUnetHTA seeks to define common assessment methodologies, develop common ICT tools, and conduct and produce joint clinical assessments and HTA reports.

EU Member States have acknowledged the significant role that HTA plays and called on the European Commission to continue to support such initiatives (see, e.g., Council conclusions of December 6, 2014, on innovation for the benefit of patients).  However, in a resolution of March 2, 2017, the European Parliament went a step further and called on the Commission to propose legislation on health technology assessment at the EU level to provide transparent and harmonized criteria to evaluate the added therapeutic value of drugs and other health technologies.

The Proposal For an EU HTA Regulation

On January 31, 2018, the European Commission introduced its proposal for a Regulation on Health Technology Assessment.

The Commission identifies several problems with the existing situation.  It considers that health technology developers suffer from distorted market access, because the lack of common criteria means that they are confronted with data and evidence requests which vary between EU Member States.  In addition, under the existing regime, national HTA bodies are responsible for the clinical assessment required to evaluate the added therapeutic value of health technologies; this means that all national HTA bodies perform their own clinical assessments in parallel, which generate costs and a duplication of work.  Finally, the Commission deems that the current voluntary approach is not sustainable, because it is based on projects that are always run for a limited timeframe, with a limited budget, and are therefore subject to new negotiations at the end of each financial cycle.

The Commission therefore aims to provide a viable solution at the EU level to ensure the continuity of HTAs.  It argues that this would benefit patients, by enhancing their access to innovative health technologies in the EU; national HTA bodies, by reducing their efforts and benefiting from uniform criteria; and the industry, by improving predictability, enhancing transparency, and avoiding the duplication of work – ultimately leading to a reduction in costs.

Scope of the Proposal 

HTAs rely on both clinical and non-clinical elements.  The proposal outlines nine in total.  The four clinical criteria are defined as: “the identification of a health problem and current technology, the examination of the technical characteristics of the technology under assessment, its relative safety, and its relative clinical effectiveness.”  The other five non-clinical elements are the ethical, social, legal, and organizational aspects of the health technology, and in particular its cost and economic evaluation.

The Commission only seeks to harmonize the clinical aspects of HTA.  The five non-clinical aspects remain therefore at the discretion of EU Member States.  This means that this proposal does not affect the national competence in terms of pricing and reimbursement.  In particular, EU Member States remain free to define their own criteria to determine the price of health technologies.

The proposal introduces four areas of mandatory joint collaboration among EU Member States:

1. Joint Clinical Assessment.  This assessment will be performed by the new EU HTA Coordination Group, which will be composed of representatives of national HTA bodies.  The joint clinical assessment will apply, under specified conditions, to drugs subject to an authorization under EU Regulation 726/2004, class IIb and III medical devices under the Medical Devices Regulation, as well as class D in vitro diagnostic medical devices under the In Vitro Medical Devices Regulation.

The proposal introduces the obligation for national HTA bodies to rely on the Coordination Group’s joint clinical assessment report.  This is a significant novelty for national HTA bodies, because they will no longer be allowed to use their own clinical assessment report.

1. Joint Scientific Consultations.  This would allow any health technology developers to request an early joint scientific consultation with the EU Coordination Group to obtain guidance on data and evidence that will likely be requested during the joint clinical assessment.  The Coordination Group would approve the request at its discretion.

1. Annual Horizon Scanning.  The Coordination Group will be required to prepare a yearly study on emerging health technologies that are expected to have a significant impact on public health, patients and healthcare systems.

1. Voluntary Cooperation on non-clinical criteria.

Next Steps 

The future HTA Regulation would apply within three years from the date it enters into force.  An additional three-year transitional period from the date of entry into force is granted for EU Member States to fully comply with the provisions of the proposed Regulation.

However, the proposal is still at a very early stage, and its fate remains unclear.  The parliamentary Committee on Environment, Public Health and Food Safety (“ENVI”) is preparing the draft parliamentary position.  A vote in committee is expected to take place on September 10, 2018.  The position will then have to be subject to a vote in the Parliament’s plenary session to become the formal European Parliament’s position at first reading.  The Parliament’s position at first reading will then have to be agreed by the Council of the EU, as is, or subject to amendments, under the rules of the ordinary legislative procedure.

However, two obstacles may block or at least delay the adoption of the proposal.

First, where no position is adopted in plenary before the next parliamentary elections in May 2019, a new parliamentary position may have to be prepared and adopted (under Rule 229 of the European Parliament’s Rules of Procedure).

Second, not all Member States seem to favor this proposal.  Four EU Member States have raised objections – Germany, France, Poland and the Czech Republic.  These four EU Member States form a blocking minority in the Council of the EU, which would prevent the text from being passed into law without amendments.

A harmonized HTA system will significantly enhance transparency and especially reduce the costs that health technology developers face in the EU.  Industry will therefore need to monitor closely the developments on this initiative over the coming year.