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Lucas Falco

Lucas Falco, a Belgian qualified lawyer, is an associate in the Public Policy Practice Group. Lucas advises clients on EU public policy strategy and regulatory law with a particular focus on food, drugs and devices, environment, international trade, data privacy, and gaming.

His experience covers representing multiple international clients, such as EU trade associations on multiple aspects of EU law (including representation before courts and strategic advice).

Lucas also worked with EU Member States on EU public policy, providing him with considerable knowledge and insights in various procedures at national and EU level, such as the notification Directive, implementation of EU law at the national level (including drafting of national implementation acts) and infringement proceedings.

Lucas has significant experience in advocacy strategy and regulatory advice.

His expertise encompasses a broad range of environmental issues (e.g., single-use plastics, waste, hand hygiene), food and beverages (labeling requirements, market access), drugs and devices (market access, IPR), gaming, and international trade and customs (TRQs).

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This article was originally posted on our sister blog Global Policy Watch

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