Biobanks for Europe - European Commission - Europa

More documents

Recommendations

Info

40T EThe inconsistencies between domestic laws are a direct result of that fact that Directive 95/46/EC allows for a margin of appreciation in implementation by member states, but also because itsprovisions are highly general in their scope. While this exibility can be bene cial allowing memberstates to determine the way that the Directive is implemented in a national internal system, thisis highly problematic for ongoing (and future) biomedical research on biobanks. To facilitate crossborderresearch will require more than the present piecemeal approach. Instead, there needs to bethe development of a common approach to regulation and the standardisation of data processingand the use of samples.The degree of national regulation makes it di cult to provide an updated, detailed and completeoverview of the (sometimes complex) legal framework in force in all jurisdictions across Europe.This can have a signi cant eect on the ability of scientists to collaborate and plan internationalinitiatives. Therefore, it is advantageous to have a coherent legal framework 105 and to ensure thatnational governance structures are in harmony with other jurisdictions and not in con ict. Harmonisationof this kind could have the eect of enhancing collaboration and the sharing of dataand samples. To combat these concerns the European Union has agreed to create a new legalstructure for biobanking in the form of a European Research Infrastructure Consortium (ERIC 58 ) (seesection 8.1).6.1.3.1• Common features of national regulatory instrumentsDespite the fact that there is signi cant heterogeneity in the legal instruments described above,there are some common traits that are starting to emerge. In particular, most of the national regulatoryinstruments (including those on population biobanks) provide that:• biobanks’ accreditation should be sought with the competent national authorities (usually theMinistry for Health, the Ministry of Research or local pharmacology agencies) 106 ;• the creation of a biobank should be noti ed, and the competent national authorities (includingthe data protection authorities) 107 should accordingly set up registries of biobanks 108 ;• supervision should be carried out by the competent national authorities alongside the supervisionby the national data protection authority 109 ;105 R. Lattanzi, Ricerca genetica e protezione dei dati personali, in P. Zatti – S. Rodotà, Trattato dibiodiritto, Milano, 2011.106 See the Belgian law 19 December 2008, Loi relative à l’obtention et à l’utilisation de matériel corporelhumain destiné à des applications médicales humaines ou à des fi ns de recherche scientifique (art. 7);art. 64, Spanish law n. 14/2007, de 3 de julio, de Investigación biomedical; see also § 25 Norvegian Act2008-06-20 No. 44, Act on medical and health research (the Health Research Act).107 See e.g. in Portugal, art. 19, Lei n. 12/2005, Informação genética pessoal e informação de saúde; Ch. 2,Sect. 5 seq. Swedish Biobanks in Medical Care Act (2002:297). In some cases the data protection lawsprovide a duty to notify the processing of genetic data: see, for instance, art. 37, Italian data protectionlaw (legislative decree n. 196/2003).108 See, for instance, § 4 Norvegian Act relating to Biobanks (2003); Ch. 2, Sect. 5 and 6, SwedishBiobanks in Medical Care Act (2002);109 See, for instance, § 17 Norwegian Act relating to Biobanks (2003); Sect. 9 and 21 seq. Latvian HumanGenome Research Law (2002); Ch. 6, Sect. 3, Swedish Biobanks in Medical Care Act (2002);
T E41• management of biobanks should be committed to a speci c individual/entity, usually from themedical (or biological) profession 110 ;• suitable security measures should be taken to protect biological samples (on top of thosealready set forth at domestic level to ensure the protection of personal data), oen providedthrough by-laws 111 ;• where it proves impossible to use anonymous or anonymised data or biological samplesbecause of the speci c features of a research, such data and samples may be used aerbeing “coded” (pseudonymised); ad-hoc safeguards are envisaged in some cases to ensurethat data and samples are pseudonymised under stringent con dentiality rules (e.g. doublecode) and the cases are speci ed in which it may prove necessary to de-code (de-crypt) theinformation in question;• research ethics committees should assess the purposes to be achieved by setting up the givenbiobank 112 ; in some cases, ethics committees are required to assess each research projectthat is expected to rely on biological samples 113 . However, it is rarely the case that the speci cissues to be considered by ethics committees are spelled out and dierent approval proceduresbased on dierent arrangements are usually envisaged in the individual legal systems 114 ;• limitations and/or speci c safeguards should be applied in case biological samples are transferredabroad 115 ;• as a rule, it is provided by law that a proxy consent may be given in case children or othervulnerable individuals are involved in a research 116 ;• in some cases, the use of biological samples from deceased individuals is regulated expressly;110 § 7 Norwegian Act relating to Biobanks (2003)111 § 9 Norwegian Act relating to Biobanks (2003); Art. 4, Portugese Act on personal genetic informationand information regarding health No. 12/2008112 § 4 Norwegian Act relating to Biobanks (2003); art. 22, Belgian Loi relative à l’obtention et àl’utilisation de matériel corporel humain destiné à des applications médicales humaines ou à des fi ns derecherche scientifique (2008)113 Art. 12(2) (and 3), Lithuanian Law on Ethics of Biomedical Research (2000); Ch. 2, Sect. 3, SwedishBiobanks in Medical Care Act (2002); art. 2, Spanish Law on Biomedical Research, No. 14/2007;art. 22, Belgian Loi relative à l’obtention et à l’utilisation de matériel corporel humain destiné à desapplications médicales humaines ou à des fi ns de recherche scientifique (2008)114 Regarding the secondary uses of rest material, the art. 21, Belgian Loi relative à l’obtention et àl’utilisation de matériel corporel humain destiné à des applications médicales humaines ou à des fi nsde recherche scientifique (2008) provides that “Le comité d’éthique se prononce au moins sur lesmatières suivantes: 1° la pertinence de l’utilisation secondaire et son but; 2° le respect de la présenteloi et de ses arrêtés d’exécution; 3° l’adéquation des informations communiquées et la spécificité et laportée suffi santes du consentement; 4° dans les cas visés à l’article 20, § 1er, alinéa 3, l’impossibilitéde demander son consentement au donneur ou le caractère exceptionnellement inapproprié de cettedemande”.115 Ch. 4, Sect. 8, Swedish Biobanks in Medical Care Act (2002); Sect. 15, Latvian Human GenomeResearch Law (2002);in Portugal, art. 17, Lei n. 12/2005, Informação genética pessoal e informação desaúde; Sect. 12 Norwegian Health Research Act 2008116 Ch. 3, Sect. 1, Swedish Biobanks in Medical Care Act (2002); Sect. 20, Finnish Act on Medical Use ofHuman Organs and Tissues No. 101/2001
Page 1 and 2: Biobanks forEuropeA Challenge for G
Page 3 and 4: EUROPEAN COMMISSIONBiobanks for Eur
Page 5 and 6: TABLE OF CONTENTSExecutive summary
Page 7 and 8: E 5Executive summaryThe member stat
Page 9 and 10: E 7Recommendation 4: Sustainable g
Page 11 and 12: I9frameworks and the principles for
Page 13 and 14: W G11The bene t of a relevant and
Page 15: T S B133.1• What is a Biobank?Bi
Page 18 and 19: 16T S BEpidemiological case-contro
Page 20 and 21: 18T S BThere are several important
Page 22 and 23: 20B EBiobank networking and harmon
Page 24 and 25: 22B Etia are increasing, there are
Page 26 and 27: 24P A T BThis section of the report
Page 28 and 29: 26P A T BFigure 2: Would you be wil
Page 30 and 31: 28P A T BFigure 3: Form of consent
Page 32 and 33: 30P A T BFigure 4: Levels of concer
Page 34 and 35: 32P A T Bto consider modes of inqui
Page 36 and 37: 34T E6• The regulation of bio
Page 38 and 39: 36T E6.1.2• The European Unio
Page 40 and 41: 38T EAccordingly, the above pro
Page 44 and 45: 42T E• consent by the partici
Page 46 and 47: 44T E6.2.1• Research Ethics C
Page 48 and 49: 46C Gerty bene ts 132 ; and how to
Page 50 and 51: 48C GRecommendation 1Member states
Page 52 and 53: 50C G eld of biobanking, and in pa
Page 54 and 55: 52C Gawareness of the scienti c ne
Page 56 and 57: 54I B G8• Innovations in Biobank
Page 58 and 59: 56I B Gmore formal oversight bodie
Page 60 and 61: 58I B GCHRIS 179 projects for biob
Page 62 and 63: 60C R9• Conclusion andRecommenda
Page 64 and 65: 62A : S B EAnnex 1: Survey of Bi
Page 69: European CommissionEUR 25302 — Bi
Page 72: KI-NA-25-302-EN-CThis expert group

Biobanks for Europe - European Commission - Europa

Create successful ePaper yourself

Delete template?

Save as template?