Scope:

Evaluation of the Union policy framework for blood and tissues & cells - Directives 2002/98/EC and 2004/23/EC.

Evaluation findings:

The evaluation found that the EU blood, tissues and cells legislation had effectively increased the level of safety and quality of BTC across the EU. By doing so, it has played a key role in restoring public trust in the BTC sector and its oversight, which had been negatively impacted by large-scale transmission of infectious diseases by BTC in the 80’s and 90’s. However, the current rules are no longer up to date with all the developments in the dynamic BTC sectors, and have difficulty keeping pace with innovation and ensuring its safety and quality.

The evaluation identified the following areas for possible simplification: the oversight for the blood, tissue and cell sector (including inspection frequency), the approach to updating of technical requirements, the classification of novel therapies that might also involve other legal frameworks and interplay with these frameworks, the reporting requirements for professionals and authorities.

Which objective(s) does the Commission pursue?

The revision aimed at addressing the shortcomings identified by the evaluation and had the overall objective to ensure a high level of health protection for EU citizens and ensure they have access to safe and effective BTC. As new technologies or risks continue to emerge, the future framework should be more effectively implemented, future proof, crisis resistant and agile enough to accommodate new risks and trends while continuing to provide appropriate safety and quality requirements. Being a REFIT initiative, areas for improving the efficiency of the legislation and simplifying its implementation by all stakeholders were also explored.

The revision of the BTC legislation, with an approach proportionate to risks in different areas (authorisation or registration of establishments/entities, authorisation of new preparation processes, health monitoring of certain substances of human origin donors and offspring), brings opportunities for savings in the sector, and for carrying out some activities more efficiently with the same resources (e.g. risk-based inspections).

Digital impacts are also expected, as data in the substances of human origin sector can become valuable digital assets in the areas of public health and innovation. A single IT system will bring important benefits as it can host flexible solutions, allowing Member States and establishments to maintain and connect with their own system or re-use existing components.

Estimated savings and benefits:

Though cost savings opportunities have not always been fully quantified in the impact assessment, the table below gives an overview of the main opportunities under the preferred option.

REFIT Cost Savings – Preferred Option
Description	Amount	Comments
Graded oversight approach allows to oversee some establishments with lighter approach and less resources than today	EUR 4 m	750 establishments eligible1, mainly saving on inspection costs for authorities and for themselves
Common IT-platform to share assessments of new substances of human origin technologies reduces duplications	>EUR 2 m	Conservative estimate; Requests to authorise same new technologies are introduced and assessed in parallel across EU; Sensitive to unit cost of assessments and authorisations
Risk-based schedule allows to inspect same activities/establishments more efficiently (targeting high-risk activities)	Not quantified	Model has rather assumed this to be a cost-neutral measure as the same number of resources (inspectors) allow for more oversight on most complex activities
Recognition of authorisations of importing tissue establishments in other Member States, reduces need for ad-hoc import authorisations in different Member States	EUR 0.5 m	Applicable for almost 1 000 imports per year of blood stem cells (from bone marrow or peripheral blood) through a central registry (World Marrow Donor Association registry, subject to one joint authorisation)
Removing obsolete tests and systematic screening measures from the legislation	EUR 2 m (example – West Nile Virus NAT tests2)	Very high potential, given that every saving is multiplied by number of donations. Other examples could be the screening for tattoos/piercings or testing for syphilis.
Digitalisation allows for more efficient administrative processes in authorities and establishments	To be further quantified	The EU SoHO Platform, financed by the Commission, will facilitate local administration including registration and reporting by professionals as well as authorisations and oversight by authorities. E.g. annual reporting costs are estimated to go down from current EUR 5 000-15 000 to EUR 200-2 000 with an automated reporting tool.

¹ This concerns establishments that only do procurement of haematopoietic stem cells, lab testing, import or distribution, and are currently authorised as standard tissue/blood establishment.

² Individual NAT test for West Nile Virus can be replaced by pooled NAT test, which is EUR 7 cheaper per tested donation. Applicable to around 300 000 blood donations per year in countries affected by West Nile Virus, saving estimated based on 2016 calculation by NHSBT (UK blood service), see table 1 of the Evaluation {SWD (2019) 376 final}, section 5.3.1.2, p. 59.