OpenLobby.EU
Explore

European Eye Bank Association

EEBA

The Association is formed for the advancement of eye banking.

Lobbying Activity

Response to Revision of the Union legislation on blood, tissues and cells

14 Dec 2020

The European Eye Bank Association (EEBA) appreciates the opportunity to provide feedback and strongly supports all undertakings that seek to reduce the diversity of interpretation and implementation of BTC legislation in Member States, to assure the same levels of quality and safety throughout the EU, to protect patients from avoidable risks, and to break down barriers to cross-border exchanges. During the Evaluation and Impact Assessment process, it was clearly identified that there is need to provide a common framework on all substances of human origin. The proposal should outline clear provisions to tackle the borderlines between BTS, but also with other SoHO, covered by separate regulations. In “Summary of Responses to the Open Public Consultation for the Evaluation of the Blood, Tissues and Cells Legislation” the consultation concludes that there are “inconsistencies between the SoHO legal frameworks,… along with inconsistencies related to the borderlines with the EU legal frameworks on medicinal products and medical devices and with the international frameworks regulating these substances” (p3). The IIA does not take into account the fact that 45% of the respondents (p.9 of the above document) identified the inadequate definitions, especially the borderlines for novel BTC, as being a major challenge to maintaining compliance with EU legislation (notably when the legislation does not include the use of tissues and cells for manufacturing of ATMPs). As a minimum, this revision should establish a central body to provide instructions on what BTC clearly comprise and distinguish between them, and advise on: if and which rules should apply, on a mutually exclusive basis, and in such a way to increase the efficacy, by applying already existing “good practice” tools The lack of clarity and inconsistencies on the borderlines must be tackled. To support this process there needs to be an authentic participation of BTC expertise and regulators involved in defining these borders and consequently releasing the capacity of the BTC community to innovate and develop new therapeutic solutions, through a transparent and accessible “EU level mechanism” that represents all the key stakeholders. Drafting a revision that does not address this will be a great limitation. Furthermore, this revision is a good place to regulate how such a mechanism would be enforced, regulated and how the classifications would be devised and updated. The mechanism also should support the clarification of definitions and borders between blood, tissues and/or cells as well as with the other SoHO frameworks on medicinal products and medical devices. Moreover, EEBA would like to emphasise the following considerations: 1) Adequate protection from avoidable risks by enforcing the necessity to demonstrate clinical efficacy and safety for new/modified preparation processes (e.g. through long-term patient outcome monitoring in European registries, such as ECCTR, and adherence to recognized good practices for evaluating novel tissue and cell applications [EURO GTP II] as advocated by the GAPP JA). 2) EEBA is strongly committed to the principle of VUD and believes that payments to donor families could result in the withholding of critical medical or behavioural risk information with a consequent risk to the safety of recipients. 3) Vigilance obligations defined in legislation should be extended to the early & later phases of the donation-transplantation chain (procurement organisations & clinical centres for human application). 4) The legislation does not support adequately the achievement of sufficiency. Provisions are lacking that oblige MS to promote donation and ensure equal access to treatment with donated tissues. 5) Greater emphasis to promote consensus terminology to define and classify potential donors should be made, allowing for a better ..... The attached document provides the full text of the feedback submitted by the European Eye Bank Association.
Read full response