
Trump Administration Executive Order (EO) Tracker
On 17 November 2020, the European Commission published an inception impact assessment for a revision of the Tissue Directive and the Blood Directive. With this proposal, the European Commission aims to tackle existing shortcomings and gaps in the current legislation. Three policy options are proposed in the impact assessment. The key differences among the three scenarios concern the body in charge of establishing the technical requirements, and the degree of enforcement at EU and national level. The European Commission’s potential legislative proposal is expected by the fourth quarter of 2021
On 17 November 2020, the European Commission published an inception impact assessment for a revision of the Directive 2004/23/EC on standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (“Tissues and Cells Directive”), and the Directive 2002/98/EC on standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components (“Blood Directive”). These Directives are collectively referred to in the document as the Blood, Tissues, and Cells Legislation (“BTC”).
The European Commission’s proposal pursues three main objectives. Firstly, to ensure safety and quality standards for patients, donors, and children born from in vitro fertilization; and to ensure enforcement of safety and quality requirements. Secondly, to optimise access to BTC therapies, and avoid shortages of this type of therapies. Thirdly, to ensure that the future framework facilitates the development of innovative BTC therapies.
Following an evaluation of the existing BTC legislation, the European Commission identified the following gaps and shortcomings:
According to the European Commission, these challenges have been emphasized due to the COVID-19 pandemic.
In order to tackle the regulatory deficiencies outlined above, the European Commission proposes three different scenarios. The key differences among the three scenarios concern the body in charge of establishing the technical requirements, and the degree of enforcement at EU and national level.
The first policy option relies on strengthened quality and safety requirements defined by BTC establishments, strengthened national inspection, EU audits, and classification advice (“self-regulation system”). The main features of this proposal are the following:
The second policy option would be supported by EU-level safety and quality requirements defined by European Expert Bodies, strengthened national inspection, EU audits, and classification advice (“co-regulation system”). This scenario would include the same features than the first policy option, with one relevant difference: BTC establishments would be required to take into account technical rules and specifications provided by authoritative bodies such as the European Centre for Disease Prevention and Control (“ECDC”), and the Council of Europe’s European Directorate for the Quality of Medicines & HealthCare (“EDQM”)
The third policy option provides EU-level safety and quality requirements laid down in EU legislation, improved national inspections systems, and classification advice. Binding technical rules and specifications for their implementation, along with a mechanism for regular updates, would be provided at EU level. This approach would be complemented by similar oversight measures as in the previous policy options. However, the European Commission would not carry out control system audits. The measures relating to ensuring sufficiency and supporting innovation proposed in the other two options would also apply in this scenario.
The inception impact assessment is open for feedback until 14 December 2020. After that date, the European Commission will publish an open public consultation for twelve weeks. The potential legislative proposal is expected by the fourth quarter of 2021.
This new development is particularly relevant to manufacturers of medicinal products or medical devices that use BTC as starting materials and those companies supplying equipment such as test kits for the BTC sector.
Authored by Fabien Roy and Silvia López Arnao