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Etablissement français du sang

EFS

Nous sommes le service public du sang en France.

Lobbying Activity

Response to Evaluation and revision of the general pharmaceutical legislation

19 Sept 2023

LEtablissement Français du Sang (EFS) remercie la Commission européenne pour sa proposition, qui répond à certaines attentes des parties prenantes, mais qui crée des incertitudes quant aux produits frontières. Nous tenons à saluer en particulier les points suivants : La réaffirmation du principe du don volontaire et non rémunéré Leffort dharmonisation de lencadrement des MTI préparés sous exemption hospitalière La possibilité de fabrication décentralisée de certains médicaments au plus proche des patients Nous regrettons cependant les incertitudes liées à : La définition de médicament dérivé de substances dorigine humaine (SoHO) Labsence de guichet unique pour répondre aux questions liées au statut règlementaire dun produit La disparition du Committee for Advanced Therapies (CAT) 1. Les incertitudes créées par la définition de médicament dérivé de SoHO Nous nous inquiétons de la définition proposée de « médicament dérivé de SoHO, autre que médicament de thérapie innovante (MTI) » dans larticle 4 (31), qui crée beaucoup dincertitudes et pourrait modifier le statut réglementaire de nombreux produits actuellement sous statut de produits sanguins labiles. En effet, la précision suivante « un processus industriel qui comprend la mise en commun des dons » pose problème. Les mélanges de dons sont courants dans les procédés de préparation de produits sanguins par exemple pour la production de mélanges de concentrés de plaquettes (n=8) ou de granulocytes (n=20) ou pour le mélange de plasma sécurisé par atténuation dagents pathogènes. La notion de « processus industriel » telle que prévue au considérant 16 est large, et les précisions indiquant quun processus industriel implique des manipulations « impliquant la systématisation, la reproductibilité et des opérations effectuées sur une base routinière ou par lots, aboutissant à un produit qui satisfait à des normes de conformité» ne permettent pas de distinguer le processus industriel pharmaceutique du procédé de production de préparations SoHO : en effet, les procédés de production de produits sanguins labiles peuvent répondre aussi à ces critères. Ainsi, il faudrait retirer la mention « qui comprend la mise en commun des dons », ou préciser le nombre de dons poolés à partir duquel un mélange de SoHO serait un médicament et les critères associés qui seraient considérés comme issus dun processus industriel pour ne pas faire basculer inutilement certains produits sanguins dans le champ du médicament et de cette directive. De manière plus générale, nous regrettons que la définition retenue soit compliquée, en visant lensemble des substances dorigine humaine autres que les MTI et en excluant les dérivés de tissus et de cellules. En outre, le terme médicament dérivé de SoHO nest pas utilisé dans la directive ailleurs que dans cette définition, pour privilégier notamment les termes de médicaments dérivés du sang ou de plasma humain aux articles 169, 193 et 194. Dans ce contexte, il serait plus pertinent de proposer une définition plus précise, en préférant les termes de médicament dérivé du sang ou de plasma humain telle quintroduite dans la Directive de 2001 à celle de médicament dérivé de SoHO autre que les MTI. (...)
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Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament, Rapporteur)

4 Nov 2022 · SoHO Regulation

Meeting with Marina Mesure (Member of the European Parliament)

26 Oct 2022 · Règlement SOHO

Meeting with Véronique Trillet-Lenoir (Member of the European Parliament)

11 May 2022 · prochaine révision des législations « sang, tissus, cellules »

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

14 Dec 2020

EFS fully supports the comments provided by the French Ministry of Health. The additional comments presented aim to address in more detail specific issues we identified in our areas of expertise. EFS does not agree with the statement “the lack of […] national monitoring provisions for the supply of BTC makes it difficult to predict EU supply interruptions and to take action to mitigate the risks to patients” when it comes to national monitoring. Contingency planning and crisis preparedness, mostly through constant monitoring of supply and demand, are already performed at the national level. EFS wants to remind that blood is not a commodity and its specificities should not be dealt with through the ECJ because the scopes of the directives overlap or are not clear enough. It should be legislated for at EU level, based on Public Health principles and not on internal market ones irrespective of its end-use. EFS supports the principle of VUD. As a fundamental notion, it should be maintained in the next directives and not be left entirely up to Member States (MS). Leaving the choice to MS on whether or not to implement VUD would deny the very concept of a common European framework. EFS supports the position set by the Council of Europe stating that compensation schemes, when existing, should not act as an inducement to donate. EFS does not support Policy option 1 as it will not support cross-country harmonisation and trust, which could be a source of an inhomogeneous situation in the European Union, thus not benefiting patients reliant on BTC therapies. It could also generate heavy bureaucracy and reporting duties. EFS supports Policy option 2 as national rules will have to take into consideration safety and quality requirements that will be kept up to date frequently. It is the option that will better address all the current problems identified, especially the fact that patients are not fully protected from avoidable risks. This option is the one that would better allow for the consultation and implication of representatives from BTC establishments and experts from all over Europe, which are crucial for such technical topics. The modalities of appointment, renewal and representativeness of the experts making up the basis of the comitology of the "European Expert Bodies" should be clarified. EFS supports a change in the scope of the BTC legislation in terms of clarity and increased flexibility, and to include novel substances of human origin both those currently used (in an unregulated fashion), as well as future ones. EFS welcomes the proposal to strengthen donor vigilance, in particular in reporting adverse reactions and ensuring more donor protection. VUD should be regarded as an essential component in the reinforcement of blood donors security. Policy option 3 is similar to the existing legislative framework which was proved to be too slow and not flexible enough. The role of the comitology would be a duplication of the EDQM and ECDC; it would call for additional costs and resources. When addressing likely impacts on fundamental rights, the legislators must bear in mind VUD and non-discrimination principles for all donors. Article 3 of the EU Charter of Fundamental Rights includes a “prohibition on making the human body and its parts as such a source of financial gain”, thus if VUD is not encouraged nor implemented fully it will necessarily have impacts on fundamental rights. The donor selection should be made on the grounds of a risk assessment based on regularly updated epidemiological data, and bearing in mind the right of blood recipients to the protection of their health, and the resulting obligation to minimise the risk of transmission of infectious diseases. We agree that option 2 would allow for faster updating of standards but option 1 would not allow simplification for blood establishments, on the contrary. The additional costs for the latter and competent authorities will be a source of inequality.
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Meeting with Anne Bucher (Director-General Health and Food Safety)

20 Nov 2019 · revision of the EU blood directives

Meeting with Anne Bucher (Director-General Health and Food Safety)

18 Feb 2019 · presentation of EFS

Meeting with Anne Bucher (Director-General Health and Food Safety)

22 Jan 2019 · courtesy visit, presentation of activities