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27

Apr

2015

The EU Commission further regulates the exchange of samples

Two new EU Directives implementing Directives 2004/23/EC and 2006/86/EC have been adopted regarding the verification of quality and safety of imported tissues and cells and regarding certain technical requirements for the coding of human tissues and cells. ... Read more

20

Jun

2014

International Code of Conduct for Genomic and Health-Related Data Sharing - Public Consultation

BioSHaRE researchers are collaborating with P3G, the Global Alliance for Genomics and Health, IRDiRC (International Rare Diseases Research Consortium), H3Africa and other organizations on the development of an International Code of Conduct for Genomic and Health-Related Data Sharing. A draft version is available for external review. ... Read more

21

May

2014

Council of Europe: Public Consultation on its Recommendation 2006(4) on research on biological materials of human origin

The Committee of bioethics of the Council of Europe (DH-BIO) has made public a Working document presenting a preliminary updated version of the famous Recommendation (2006) 4 of the Committee of Ministers of the Council of Europe, for public comments. ... Read more

15

Nov

2013

Finland  The new Finnish Biobank Act 688/2012 entered into force in September 2013

On 1 September 2013, the Biobank Act entered into force in Finland. This Act aims to strengthen the due process of law regarding the sample donors and improve the researchers' prerequisites for utilising the human sample collections. ... Read more

21

Oct

2013

The WMA adopted and published the new version of the Helsinki Declaration

The World Medical Association (WMA) published the last version of its famous Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects including several news and updates taking notably into accounts biobanking activities ... Read more

21

Oct

2013

France  The CNIL simplifies formalities to declare personal data transfers abroad

The French National Data Protection Authority, the CNIL, has simplified the formalities to export personal data outside the EU by allowing to plan several transfers, with a same purpose, towards several processors, in a unique form. This also concerns personal data associated to biological samples to be used for research purposes. ... Read more

22

Apr

2013

The WMA opens a public consultation on the revision of the Declaration of Helsinki

A two-month public consultation on the revised version of the World Medical Association’s Declaration of Helsinki on medical research involving human subjects began today. The public and the WMA’s 102 national medical association members are invited to comment on the proposed changes. ... Read more

27

Nov

2012

EU Commission will collaborate with the Council of Europe to modernise the Data Protection Convention on behalf of EU

The 19 November 2012 the EU Commission adopted a recommendation allowing it to negotiate the modernisation of the Council of Europe's Convention 108 on data protection, on behalf of the EU. The Commission will ensure the Convention provides for a high level of protection of fundamental rights and freedoms which reflect the EU's internal rules. ... Read more

22

Oct

2012

The EU Parliament adopted a Resolution on voluntary and unpaid donation of tissues and cells

The 11 September 2012 the EU Parliament adopted a new Resolution reaffirming the principles of voluntary and unpaid donation of tissues and cells. This Resolution includes some provisions on tissues and cells banking for research uses, on stem cells and cord blood banking and provisions on the needs for national regulation and EU standardisation ... Read more

10

Oct

2012

The Council of Europe published a new document on the reform of the Convention STE n°108 concerning personal data protection

The Council of Europe Consultative Committee of the Convention for the Protection of individuals with regard to automatic processing of personal data STE n°108 (T-PD) published a new document on the modernisation of Convention. This makes the reform process going ahead ... Read more

19

Jul

2012

France  French government adopts a new Decree on Human Embryonic Stem Cells Research

Research on Human Embryonic Stem Cells is particularly regulated in France, as in some other EU countries. A new Decree adopted on 11th of April 2012 specify this legal regime and modifies current rules of the French Public Health Code, including disposals on the cross-border exchanges of such cells for research purposes ... Read more

19

Jul

2012

France  France continues integrating the Convention of Oviedo in the positive law

France ratified the Council of Europe Convention of Oviedo last year. A new Decree, Décret no 2012-855 du 5 juillet 2012 portant publication de la convention pour la protection des droits de l’homme et de la dignité de l’être humain à l’égard des applications de la biologie et de la médecine has been published ... Read more

17

Jul

2012

The Council of Europe Symposium on biobanks was a success

The Symposium on Biobanks and Biomedical Collections - An ethical framework for future research, organised by the Committee on Bioethics (DH-BIO), was held on 19-20 June 2012 in Strasbourg, France, in order to prepare the revision of the famous Council Recommendation Rec(2006)4 on research on biological materials of human origin ... Read more

25

Jun

2012

EU: New Expert's group Report on "Biobanks for Europe: A Challenge for Governance"

The EU Commission published a new Report from the Expert Group on Dealing with Ethical and Regulatory Challenges of International Biobank Research. The report provides up-to-date information on the state-of-art of biobanking, the challenges for governance and formulate proposals to go forward in harmonising the EU and national frameworks. ... Read more

14

Mar

2012

Finland  Proposal for a new Act on Biobanks is under study

The government of Finland is proposing to introduce a new act on biobanks with the objective of promoting research with human samples while securing the rights of individuals. The law is currently being presented to the Finnish parliament and, if adopted, would come into effect in 2013. ... Read more

26

Jan

2012

EU: The Commission proposes a comprehensive reform of the data protection rules

Work on the new EU data protection legal framework is ongoing and the Commission reform proposals issued on the 25th of January 2012 include rules applying to data processing and transfer for scientific research purposes. ... Read more

28

Nov

2011

Sweden  The Swedish National Council on Medical Ethics commented the government's report on a new biobank law - SOU 2010:81

Regulatory advances proposed by the Swedish Government concerning the current legal framework for biobanks used for research purposes have been commented by the National Medical Ethics Council; these comments have been published ... Read more

28

Oct

2011

EU: Public Consultation launched on access to genetic resources and benefit sharing

The European Commission launched a public consultation on the Nagoya Protocol, adopted under the UN Convention on Biological Diversity (CBD), whose the scope is not excluding materials from human origin (samples/data). Deadline to participate 19 December 2011. ... Read more

28

Jul

2011

Germany  German experts discuss the need for regulation of research with human biobanks

The German Ethics Council – Nationaler Ethikrat - and TMF – Technologie- und Methodenplattform für die vernetzte medizinische Forschung invited a number of experts to Berlin for a meeting to discuss the Opinion and recommendations of the Ethics Council for placing research with human biobanks on a statutory foundation. ... Read more

08

Jul

2011

France  The new French Bioethics Law has been adopted and published

The new French Bioethics Law n.2011-814 is now enforceable to medical and research activities performed by national entities or on the national territory. Among the news brought by this new Act, a few number of substantial adds are of interest concerning the requirements for research establishments performing analyses on genetic characteristics. ... Read more

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