Today, human biological specimens are seen as resources essential to advances in the life sciences and medicine. The analytical data obtained enable a better understanding of the various diseases and also make it possible to propose the appropriate treatment, notably in the field of regenerative medicine.Gathering, storing, processing and distributing them are all done by the biobanks – key players in the transfer of scientific knowledge to clinical practice. These biological databanks will enable researchers to identify new clinical biomarkers and develop new therapeutic approaches such as regenerative medicine. In this field, research into stem cells continues to be promising, stimulating as it does the body’s self-healing ability.
European Union adopted three directives
From 2004 to 2006, the European Union adopted three directives governing cells and human tissues in order to standardise their acquisition, their storage and their use for therapeutic purposes. These directives apply specifically to tissue and cell banks, including cord blood strains and cells used for regenerative medicine. However, they were used in very different ways from one country to another.
Furthermore, scientific developments in the use of human cells centre around new legal and institutional issues. More particularly, the development of research infrastructures at European level (BBMRI-ERIC, FCrin) means re-examining the relevance of all this in the light of rapidly expanding clinical practice which also has to take public health issues into account. Thus today, the areas of examination can be seen to be expanding, and hence the inadequacy of European legislation regarding cell research.
The European EUCelLEX Project
- EUCelLEX projectOpen or Close
The European EUCelLEX Project (Cell-based regenerative medicine: new challenges for EU legislation and governance) consists in a full examination of the application of the European rules regarding cell banks together with current practices in respect of the therapeutic use of human cells in the different countries concerned. The aim is to provide to the European Commission recommendations that will facilitate the use of stem cells in all aspects of the pipeline from research to healthcare.
The strength of EUcelLEX proposal is to analyse the impact of the Tissue and Cells Directive in the context of emergence of infrastructures at EU level and at national level. It is a unique chance to assess the impact of EU legislation on the whole pipeline from basic research to clinical applications.
- EUCelLEX objectivesOpen or Close
The main objective of this project is to assess the adequacy of the present European legal instruments in order to provide a regulatory framework for the use of stem cells, in light of the recent scientific, legal and institutional developments that have occurred within Europe. The aim is to provide recommendations that will facilitate the use of stem cells in all aspects of the pipeline from research to healthcare.
• Objective 1: to analyse the present European and national legal instruments and policies on the use of stem-cells.
• Objective 2: to compare the existing regulation and the practices that will develop for stem cells in the near future, in particular within research infrastructures, in order to highlight the gaps and to propose sustainable solutions.
• Objective 3: to clarify the legal rules to enforce the drug development chain using stem cells and to govern public/private partnerships (PPP) in the context of translational research and EU level.
This project aims at building an organised Task force on Stem Cells in Europe, a coherent and strong Consortium for collecting facts and figures to assess the current legislation on the therapeutic use of cells, and to bridge it with research infrastructure capacity building. This network will be composed by two levels of experts:
1. The first level will be composed of all project partners who are experts in the fields of biobanks, use of human biological samples and translational biomedicine, and who have strong expertise in law and/or in governance issues.
2. The second level will be composed of key external stakeholders consisting of EUCelLEX partners’ existing network, who will contribute to provide facts and figures with regards to the implementation of the Tissue and Cells Directives, and with regards to research infrastructures.
Project partners will organise several workshops with the relevant key stakeholders to deliver facts and figure and to provide recommendations and policy options :
- WP2, Workshop on Mapping the legal differences and Transnational Aspects of Stem cell procurement (Budapest, Month 20, organised by CEU)
- WP3, Stakeholder workshop on stem cell use in Europe (Oxford, Month 23, organised by Oxford University – HelLEx)
- WP4, Workshop on ethical and legal issues surrounding umbilical cord blood research (Leuven, Month 26, organised by KUL)
- WP5, Stakeholder workshop on translational research (Graz, Month 20, organised by MUG)
- WP6, Workshop on social issues & changes (Paris, Month 32, organised by Sciences Po – CEVIPOF)
The countries to be surveyed will be principally France, Germany, Netherlands, UK, Canada, Belgium, Austria, and Hungary. The panel of countries involved in our project could be enlarged on a case-by-case basis during the organisation of the workshops.
The project coordination will be in charge of organising 2 consensus conferences (Toulouse, Months 18 & 36, organized by Inserm).
Furthermore the project will summarise its results in a book and in a set of recommendations after an overall integration process.
- EUCelLEX impactsOpen or Close
1/ Concerning the impact on researchers in Europe and on their practices. The ethical, legal and governance issues are more and more seen as roadblocks by researchers notably because of the opacity of the rules they have to apply and the different legal regimes in place in the various jurisdictions.
The effort puts in the dissemination activities of our project will contribute to embark researchers in the societal reflections from the very beginning of their activities. We expect to deliver high quality standards which could be used as a reference for ethically and legally based Stem cells projects. Finally, this project intends to propose standards and recommendations on the one hand to researchers to facilitate their research and, on the other hand, to academic colleagues to pave the way for new thinking in the field of stem cells.
2/ Partnerships between academia and industry are sometimes difficult to implement. It is the development of this new model of partnership that we want to participate in providing relevant tools.
3/ Finally, the recommendations we will propose to the Commission may also be useful for the European ethical evaluation of future projects on stem cells to be granted in the next “Horizon 2020” framework. The structuration of the network and its excellence will be the best way to gather adequate data in order to assist the Commission on the way to assess the need to revise the current legislation of Tissue and Cells in the light of regenerative medicine practice.
These analyses, data and guidance will also help the Commission in the regulatory choices to be made for both, research infrastructures and cell therapies within the EU :
1/ to extend the current regulation,
2/ to propose a new regulation or
3/ to leave the floor to the relevant infrastructures to develop appropriate guidelines.
The final outcome for this project is to disseminate through the publication of a book, the results gathered by all the WPs. The spirit of the EUCelLEX book will be to deliver the picture of the ELSI issues on Stem cells by the end of the project, and to open rooms for discussions in the future.