European Health & Pharmaceutical Law Review: First Assessment of the SoHO Proposal for a New Legislation on Blood, Tissues and Cells (The SoHO Regulation)

Published

Jul 04 2023

Written By

As co-head of our International Life Sciences & Healthcare group and head of Bird & Bird's Regulatory, Public & Administrative Law group in Brussels, I provide cutting edge strategic and regulatory advice to our life sciences clients and represent them in litigation.

Co-head of the International Life Sciences group Marc Martens and associate Lora Arifagic have recently been published in the European Health & Pharmaceutical Law Review.

Their article provides an overview of the proposed Regulation on the safety and quality of substances of human origin (SoHO) and its potential impact on the blood, tissues and cells (BTC) industry. The article highlights the challenges presented by the SoHO proposal, including legal uncertainty, the challenging interplay of the proposal with adjacent legislative frameworks, potential increased divergences between Member States, and concerns about transparency of SoHO preparation authorization dossiers and allocation of SoHOs. Although the SoHO proposal truly attempts to comprehend the needs of both patients and other actors in the SoHO industry, the article outlines several critical remarks and shortcomings which should be addressed to anticipate future challenges in the sector.

Read the full article here.