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In December 2020, the European Commission presented a proposal for a new Regulation on Batteries and Waste Batteries.  The proposed Regulation aims to replace the current framework of Directive 2006/66/EC and seeks to achieve objectives set out in the European Green Deal and subsequent strategies, such as the transition to a carbon neutral and circular economy and the growth of renewable energies and clean mobility.  (Covington lawyers hosted a webinar that outlines the main features of the proposed Regulation and the ordinary legislative procedure that the proposal will follow.)

The proposal includes a host of product sustainability and safety requirements, conformity assessments and end-of-life management obligations for the producers of all types of batteries.  These requirements concern, among many others, carbon footprints, recycled content, chemical restrictions, durability, removability, replaceability, supply chain due diligence, waste collection, treatment and recycling, conformity assessments and CE markings, etc.  The proposed rules are expected to have a significant regulatory impact on the emerging European markets for industrial batteries and e-vehicle batteries.

One of the most striking features of the proposal is that many of its provisions are limited to establishing general principles and empower the European Commission to adopt the regulatory details by means of “Commission Delegated Regulations” and “Commission Implementing Regulations.”  In effect, the Commission’s proposal would leave it to the officials of the Commission and Member States to decide many of the technical details, which will eventually shape the markets of e-vehicle, industrial, automotive and portable batteries in Europe.  While delegating powers to the Commission is very common in EU legislation, the extent to which the proposal leaves regulatory decision-making to the Commission seems unprecedented.  It is uncertain whether the European Parliament and Council will agree to relinquishing so many critical details to the Commission.

This substantial delegation of power to the Commission also means that companies active on these markets that wish to advocate their position on the regulatory framework of batteries will need to do so not only during the proposal’s ordinary legislative procedure, but also during the adoption of the implementing rules and guidance by the Commission.  This is likely to be a long and ongoing process that will take at least six years after the conclusion of the ordinary legislative procedure.


Continue Reading The European Commission’s Planned Role to Implement its Proposed Sustainable Batteries Regulation

 On January 21, 2021, the European Commission opened two public consultations on the review of the EU Blood Directive and the EU Tissues and Cells Directive.  Both Directives are more than fifteen years old, and their implementation diverges widely across the member states.  The rules on human blood and tissue gain increasing importance for

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.


Continue Reading The Commission’s Proposal on Health Technology Assessment – Will the EU Member States Accept its Mandatory Provisions?