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JUDIT SÁNDOR

JUDIT SCHVÉGER

PETRA BÁRD

THE LEGAL REGULATION OF BIOBANKS

National Report:

Malta

CENTER FOR ETHICS AND LAW IN BIOMEDICINE

No.6CELAB PAPER SERIES

Editors: Judit Sándor and Petra Bárd

© July 2009

Center for Ethics and Law in Biomedicine (CELAB)

ISSN 2074-4498ISBN 978-963-88404-3-1

Address: 1051 Budapest Nádor u. 9. HungaryTelephone: +36-1-472-3403Fax: +36-1-354-1599E-mail: [email protected]: http://www.ceu.hu/celabDesign and layout: Zsolt SándorPrinted in Hungary by AduPrint Kft.

The present publication has been supported by GeneBanC, a Specific TargetedResearch Project (STREP) funded by the European Commission in the Sixth FrameworkProgramme. Contract number: FP6-036-751

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N A T I O N A L R E P O R T : M A L T A 1

TABLE OF CONTENTS

I. CLASSICAL AND POPULATION BIOBANKS . . . . . . . . . . . . . 3

1. Definition of biobanks . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2. Relevant laws . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33. Establishment and management of biobanks . . . . . . . . . . 74. Pecuniary aspects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95. Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

5.1. Consent of minors, people with limited capacity and deceased persons . . . . . . . . . . . . . . . . 12

6. Access to data or samples, and anonymity . . . . . . . . . . . 147. Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158. Supervision, compensation, penalties . . . . . . . . . . . . . . . 15

8.1. Ethical committees . . . . . . . . . . . . . . . . . . . . . . . . . . 158.1.1. Bioethics Consultative Committee . . . . . . . . . 168.1.2. Health Ethics Committee . . . . . . . . . . . . . . . . 168.1.3. University Research Ethics Committee 8.1.4. Other Ethics Committees . . . . . . . . . . . . . . . . 17

9. Public debate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

II. FORENSIC BIOBANKS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

1. Definition of forensic biobanks . . . . . . . . . . . . . . . . . . . . 192. Relevant laws . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193. Establishment of forensic biobanks . . . . . . . . . . . . . . . . . 204. Samples and sample taking, consent . . . . . . . . . . . . . . . 215. Purpose and scope of collection . . . . . . . . . . . . . . . . . . . 236. Access to data and samples . . . . . . . . . . . . . . . . . . . . . . 247. Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

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As partners in the European UnionFramework Project entitled “Gene-BanC: Genetic bio and dataBanking:Confidentiality and protection of data”we are exploring the legal regulationsof genetic databanks. (http://www.genebanc.eu/) The Center for Ethicsand Law in Biomedicine established atthe Central European University, Buda-pest (http://www.ceu.hu/celab) aimedto investigate the existing regulatoryframework of biobanks across the EUand to focus on the collection andanalysis of legislation and regulationregarding the establishment, manage-ment and functioning of classical, pop-ulation and forensic biobanks acrossEurope. An important objective was tolook at the similarities and differencesin such legislation and regulations, inorder to formulate recommendationstowards a harmonization of Europeanpractices and regulations. The Euro-pean jurisdiction was divided up intotwo parts between CELAB and theBelgian project partner, the Centre forBiomedical Ethics and Law, K.U.Leu-ven. CELAB was focusing on the regu-latory framework of Cyprus, the CzechRepublic, Estonia, Greece, Hungary,Italy, Latvia, Lithuania, Malta, Poland,

Romania, the Slovak Republic andSlovenia.

In the framework of the research, wehave prepared questionnaires, whichwe sent out to national experts in thefield. We are very grateful to Dr BridgetEllul MB ChB, FRCPath, MRCPath,Head of the Department of Pathologyand Senior Lecturer in ForensicPathology and to John Charles Ellul BAMBA, Police Inspector at the ForensicScience Laboratory, for providing uswith useful information.

The present booklet summarizes theregulatory framework of biobanks inMalta and focuses on the collection andanalysis of legislation and regulationregarding the establishment, manage-ment and functioning of classical andforensic biobanks. The former will bediscussed in Part I, whereas forensicbiobanks invoking legal issues of differ-ent nature will be covered separately inPart II. The present analysis does notcover either international standards, orpieces of European Union law, but itshould be borne in mind that they arebinding on Malta being a EuropeanUnion Member State.

Budapest, 31 July 2009

THE REGULATORY FRAMEWORK OF THEESTABLISHMENT, MANAGEMENT ANDFUNCTIONING OF BIOBANKS IN MALTA


1. DEFINITION OF BIOBANKS

Malta has not adopted any special leg-islation for the regulation of biobanks.The lack of a special regulative frame-work on the establishment and man-agement of biobanks resulted in a frag-mented legislative structure of general-ly applied constitutional provisions,laws, regulations, legal notices, codesof practice, guidelines and so forth,which are potentially applicable tobiobanks.

The term biobank has not been offi-cially defined in Maltese law. Neverthe-less, Article 2 of Act IV of 2006 on reg-ulating the collection and testing ofhuman blood and blood componentsand establishing standards of qualityand safety for human tissues and cellsintended for human transplants (here-inafter referred to as Human Blood andTransplants Act1) sets out the definitionof “tissues and cells establishment”which “[...] means a tissue bank or aunit of a hospital or another bodywhere activities of processing, preser-

vation, storage or distribution of humantissues and cells are undertaken. It mayalso be responsible for procurement ortesting of tissues and cells” (hereinafterreferred to as tissue bank or tissue es-tablishment). It is also worth mention-ing that the Human Blood and Trans-plants Act has transposed all the rele-vant EU Directives concerning the reg-ulation of biobanks.

2. RELEVANT LAWS

As it is already mentioned, Malta hasnot established any specific legislationconcerning biobanks and the relevantlegal regulation consists of generallyapplied provisions of legal instruments.

The area that is most comprehensive-ly covered is transplantation. Transplan-tation standards for the quality andsafety of tissues and cells throughoutthe transplantation process are set inMaltese legislation via the HumanBlood and Transplants Act (Act IV of2006), furthermore through the Tissues

I. CLASSICAL AND POPULATION BIOBANKS

1 Human Blood and Transplants Act (Cap. 483) To regulate the collection and testing of human blood anblood components and to establish standards of quality and safety for human tissues and cells intended forhuman transplants. 15th September, 2006, Act IV of 2006, as amended by Legal Notice 427 of 2007. Inoriginal language: Kapitolu 483, Att dwar id-Demm Uman u Trapjanti. Biex jirregola t-teîid u l-eðami ta’demm uman u komponenti taddemm u biex jistabbilixxi livelli ta’ kwalità u sigurezza gîat-tessut u øelloliumani intiði gîat-trapjanti fil-bniedem. 15 ta’ Settembru, 2006 L-ATT IV ta’ l-2006, kif emendat bl-AvviðLegali 427 ta’ l-2007. Available at:http://docs.justice.gov.mt/lom/Legislation/English/Leg/VOL_15/Chapt483.pdf


and Cells (Quality and Safety) Regu-lations, 2006 (L.N.2 271 of 2006)3 andthe Human Tissues and Cells (Coding,Processing, Preservation, Storage andDistribution) Regulations, 2007 (L.N.337 of 2007)4. These legislations havetransposed three Directives dealingwith human tissues and cells that havebeen adopted by the Commission ofthe European Communities (Directive2004/23/EC, Directive 2006/17/EC andDirective 2006/86/EC). The Tissues andCells (Quality and Safety) Regulations,2006 L.N. 271 of 2006 transposeDirective 2004/23/EC on setting stan-dards of quality and safety for thedonation, procurement, testing, pro-cessing, preservation, storage and dis-tribution of human tissues and cells,and Directive 2006/17/EC as regardscertain technical requirements for thedonation, procurement and testing ofhuman tissues and cells. The HumanTissues and Cells (Coding, Processing,Preservation, Storage and Distribution)Regulations, 2007, (L.N. 337 of 2007)transpose Commission Directive

2006/86/EC which implements Direc-tive 2004/23/EC of the European Parlia-ment and of the Council as regardstraceability requirements, notificationof serious adverse reactions andevents and certain technical require-ments for the coding, processing,preservation, storage and distributionof human tissues and cells.

The Blood Quality and Safety Regula-tion of 2006 (L.N. 272 of 2006)5 imple-ments the requirements of three EUDirectives: Directive 2002/98/EC (set-ting standards of quality and safety forthe collection, testing, processing, sto-rage and distribution of human bloodand blood components), Directive2004/33/EC (implementing Directive2002/98/EC as regards certain techni-cal requirements for blood and bloodcomponents) and Directive 2005/62/EC– implementing Directive 2002/98/ECas regards Community standards andspecifications relating to a quality sys-tem for blood establishments).

L.N. 273 of 2006 (Traceability Requir-ements and Notification of Serious

2 L.N. means Legal Notices within the Maltese legislative framework. 3 L.N. 271 of 2006 Human Blood and Transplants Act, 2006 (Act no. IV of 2006) Tissues and Cells(Quality and Safety) Regulations, 2006, Government Gazette of Malta No. 17,994 – 10.11.2006. In origi-nal language: A.L. 271 ta’ l-2006 Att ta’ l-2006 dwar id-Demm Uman u t-Trapjanti (Att Nru. IV Ta’ l-2006) Regolamenti ta’ l-2006 dwar il-Kwalità u s-Sigurezza tat-Tessut u ø-Øelloli. Available at:http://docs.justice.gov.mt/LegalPub/Legal_Publications\Legal_Notices\English\2006\271 - 2006 - P3830-3844.pdf4 Human Blood and Transplants Act (Cap. 483) Human Tissues and Cells (Coding, Processing,Preservation, Storage and Distribution) Regulations, 2007, Government Gazette of Malta No. 18,141 –30.10.2007. In original language: A.L. 337 ta’ l-2007 Att ta’ l-dwar id-Demm Uman u t-Trapjanti (KAP.483) Regolamenti ta’ l-2007 dwar Tessuti u Celloli Umani (Kodifikazzjoni, Ipproøessar, Preservazzjoni, -Îðin u Distribuzzjoni). Available at:http://docs.justice.gov.mt/LegalPub/Legal_Publications\Legal_Notices\English\2007\337 - 2007 - P4207-4232.pdf5 L.N. 272 of 2006 Human Blood and Transplants Act, 2006 (Act no. IV of 2006) Blood (Quality andSafety) Regulations, 2006, Government Gazette of Malta No. 17,994 – 10.11.2006. In original language:A.L. 272 ta’ l-2006 Att ta’ l-2006 dwar id-Demm Uman u t-Trapjanti (Att Nru. IV Ta’ l-2006) Regolamentita’ l-2006 dwar il-Kwalità u s-Sigurezza tad-Demm. Available at:http://docs.justice.gov.mt/LegalPub/Legal_Publications\Legal_Notices\English\2006\272 - 2006 - P3855-3864.pdf


Adverse Reactions and Events Regu-lations, 2006)6 transposes Directive2005/61/EC (implementing Directive2002/98/EC as regards traceability re-quirements and notification of seriousadverse reactions and events).

In addition to the Human Blood andTransplants Act and its related legalnotices, Act XXVI of 2001 on makingprovision for the protection of individu-als against the violation of their privacyby the processing of personal data andfor matters connected therewith orancillary thereto (hereinafter referred toas the Data Protection Act7) is also rel-evant in the respective legal domain.Biobanks contain not only biologicalsamples but also personal data aboutthe donor of the biological materialsuch as data related to health andgenetic data. Therefore one of themain legal instruments on their regula-tions is the Data Protection Act whichtransposed Directive 95/46/EC of theEuropean Parliament and of the Coun-cil of 24 October 1995 on the protec-tion of individuals with regard to theprocessing of personal data and on thefree movement of such data into nati-onal legislation in 2001. The MalteseData Protection Act was the first leg-

islative instrument in Malta that regu-lates exclusively the protection of per-sonal data and it was in compliancewith Directive 96/46/EC even though atthe time of its introduction Malta wasnot a Member State of the EuropeanUnion. The Data Protection Act cameinto force on 15 July 2003.

Article 2 of the Data Protection Actlays down that “personal data that re-veals race or ethnic origin, politicalopinions, religious or philosophicalbeliefs, membership of a trade union,health, or sex life” are considered to besensitive. The individual’s genetic infor-mation that might be regarded as partof his or her health status, is alsodeemed to be sensitive personal data,though there is no explicit reference tothem in Article 2.

According to the Data Protection Actsensitive personal data is subjected tospecial rules hence Article 12 Section(1) sets forth that any processing ofsensitive data is prohibited. The pro-cessing of such data can only takeplace under certain conditions speci-fied in Article 12 Section (2), andArticles 13 to 16 of the Data ProtectionAct (see infra) in line with the relevantprovisions of Directive 95/46/EC. Addi-

6 L.N. 273 of 2006 Human Blood and Transplants Act, 2006, (Act no. IV of 2006) TraceabilityRequirements and Notification of Serious Adverse Reactions and Events Regulations, 2006, GovernmentGazette of Malta No. 17,994 – 10.11.2006, In original language: A.L. 273 ta’ l-2006 Att ta’ l-2006 dwar id-Demm Uman u t-Trapjanti (Att Nru. IV Ta’ l-2006) Regolamenti ta’ l-2006 dwar Îtiñiet ta’ Traççabilità uAvvið ta’ Reazzjonijiet u Okkorrenzi Gravi Avversi. Available at:http://docs.justice.gov.mt/LegalPub/Legal_Publications\Legal_Notices\English\2006\273 - 2006 - P3876-3886.pdf7 Data Protection Act (Cap. 440) To make provision for the protection of individuals against the violationof their privacy by the processing of personal data and for matters connected therewith or ancillary thereto.Act XXVI of 2001, as amended by Acts XXXI of 2002 and IX of 2003; and Legal Notices 181 and 186 of2006, and 426 of 2007. In original language: Kap. 440 Att dwar il-P rotezzjoni u l-Privatezza tad-DataSabiex jagîmel provvedimenti gîall-protezzjoni ta’ individwi kontra l- ksur tal-privatezza tagîhom bl-ipproøessar ta’ “data” personali u dwar dak li gîandu x’jaqsam ma’ dan jew li hu anøillari gîalih.Government Gazette of Malta No. 17,175 - 14th December, 2001. Available at:http://docs.justice.gov.mt/lom/legislation/english/leg/vol_13/chapt440.pdf


tionally sensitive personal data can alsobe processed in circumstances speci-fied in an order made by the Ministerresponsible for data protection withrespect to important public interests.

Although the Maltese Constitution8

does not provide explicit legal protec-tion for the collection and processing ofthe individual’s personal data, the DataProtection Act shall be interpretedtogether with the Maltese Constitution.Within the general provisions of Fun-damental Rights and Freedoms of theIndividual, Article 32 of the Maltese Con-stitution sets forth that “[...] every per-son in Malta is entitled to the fundamen-tal rights and freedoms of the individual,that is to say, the right, whatever hisrace, place of origin, political opinions,colour, creed or sex, but subject torespect for the rights and freedoms ofothers and for the public interest, toeach and all of the following, namelya) life, liberty, security of the person,

the enjoyment of property and theprotection of the law;

b) freedom of conscience, of ex-pression and of peaceful assemblyand association; and

c) respect for his private and familylife.”

Act XVII of 2002, the so called9 Pro-fessional Secrecy Act also proves to beimportant. Given the sensitivity of thegenetic data collected for tissue banksor biobanks, confidentiality and legallyestablished professional secrecy is con-sidered of great significance. Professio-nals’ confidentiality, including the obli-gation imposed on medical practitionersis also required by the Maltese CriminalCode,10 Article 257 of which sets forththat if any person, who by reason of hiscalling, profession or office, becomesthe depositary of any secret confided inhim or her, shall, except when com-pelled by law to give information to apublic authority, disclose such secret,he or she shall on conviction be liable toa fine (multa) not exceeding EUR46,587.47 or to imprisonment for a termnot exceeding two years or to both suchfine and imprisonment.

Apart of the above mentioned piecesof legislation, L.N. 490 of 2004, the socalled Clinical Trials Regulation11 trans-posed Directive 2001/20/EC into theMaltese national law and regulates the

8 The Malta Independence Order, 1964, as amended by Acts: XLI of 1965, XXXVII of 1966, IX of 1967,XXVI of 1970, XLVII of 1972, LVII, LVIII of 1974, XXXVIII of 1976, X of 1977, XXIX of 1979, IV of1987, XXIII of 1989; Proclamations Nos. II and VI of 1990; Acts XIX of 1991, IX of 1994; ProclamationsIV of 1995 and III of 1996; Acts: XI of 1996, XVI of 1997, III of 2000, XIII of 2001, V of 2003, and XIVand XXI of 2007.. Entered into force: 21st September, 1964. In original language: Kostituzzjoni ta’ Malta,Available at: http://docs.justice.gov.mt/lom/legislation/english/leg/vol_1/chapt0.pdf9 Professional Secrecy Act (Cap. 377) To establish general provisions protecting professional secrecy andto make consequential amendments to other laws. Act XXIV of 1994, as amended by Acts XVII of 1998,XVII of 2002 and X of 2004. In original language: Kap. 377 Att dwar Segrettezza Professionali Biexjagîmel disposizzjonijiet ñenerali dwar il-protezzjoni tas-segretezza professjonali u sabiex jagîmel emendikonsegwenzjali f ’liñijiet oîra. L-Att XXIV ta’ l-1994, kif emendat bl-Atti XVII ta’ l-1998, XVII ta’ l-2002 u X ta’ l-2004. Available at:http://docs.justice.gov.mt/lom/legislation/english/leg/vol_10/chapt377.pdf10 Criminal Code (Cap. 9) To amend and consolidate the Penal Laws and the Laws of Criminal Procedure.10th June, 1854. In original language: Kap. 9, Kodici Kriminali. Available at:http://docs.justice.gov.mt/lom/legislation/english/leg/vol_1/chapt9.pdf11 L.N. 490 of 2004 Subsidiary Legislation 458.43 Clinical Trials Regulations, 26th November, 2004, LegalNotice 490 of 2004, as amended by Legal Notice 248 of 2007. In original language: Available at:http://docs.justice.gov.mt/lom/Legislation/English/SubLeg/458/43.pdf


conduct of clinical trials, includingmulti-centre trials on human subjectsinvolving medicinal products as de-fined under the Medicines Act and inparticular relating to the implementa-tion of good clinical practice.

Furthermore it should be mentionedthat the University Research EthicsCommittee (UREC) at the University ofMalta adopted the so-called UniversityGuidelines12 which is a set of guidancemanuals for the UREC. The Guidelinesset forth the ethical requirements ofthe research involving humans and alsothe sanctions that would apply in casethe Guidelines are not followed.

3. ESTABLISHMENT ANDMANAGEMENT OF BIOBANKS

According to Article 3 Sections (1)-(2)of the Human Blood and TransplantsAct the Superintendent of PublicHealth13 is the licensing and superviso-ry authority in relation to the establish-ment and operation of tissue banks(hereinafter referred to as LicensingAuthority). The Director General Healthwithin the Ministry of Health, is thehead of the Health Division and is alsothe Superintendent of Public Health.The Director General Health is directlyaccountable to the Minister for all mat-ters relating to health.

The Licensing Authority is entitled (a)to verify that the tissue bank is in com-

pliance with the requirements set outunder the Act and any regulationsmade thereunder; (b) to indicate activi-ties which may be undertaken by thetissue bank; (c) to establish conditionsapplicable to tissue bank; (d) to issue,renew, amend, vary, suspend or revokeany licence that may be required by orunder the Act; (e) to carry out inspec-tions of tissue banks and organize con-trol measures in such establishmentsregularly and in any case not less thanonce every two years; (f) to conductsuch additional inspections of estab-lishments as it considers necessary forthe purpose of ensuring compliancewith the requirements of the HumanBlood and Transplants Act and any reg-ulations made thereunder; (g) to ins-pect hospital blood banks to ensurethat such banks and persons responsi-ble for the management of such bankscomply with the requirements of theAct and any regulations made thereun-der; (h) to organize inspections andother control measures in case of anyserious adverse event or reaction orsuspicion thereof; (i) to establish guide-lines concerning the conditions of theinspections and control measures, andon the training and qualification of theofficials involved in order to reach aconsistent level of competence andperformance; (j) to establish and main-tain a publicly accessible register of tis-sue establishments specifying the ac-tivities for which they have been

12 The ‘Guidelines for UoM Research Ethics Committee’ is available at:http://www.um.edu.mt/__data/assets/pdf_file/0008/53396/ethicsguidelines.pdf.13 See also The Public Health Act, Act XIII of 2003 to promote and protect health (Cap. 465). Dated 21November 2003. In original language: Kap. 465 Att dwar is-saîîa Pubblika Biex jippromwovi u jipproteñis-saîîa. L-Att XIII ta’ l-2003, kif emendat bl-Att III ta’ l-2004; u bl-AvviðLegali 427 ta’ l-2007.Availableat: http://docs.justice.gov.mt/lom/Legislation/English/Leg/VOL_14/Chapt465.PDF


licensed; (k) to take all measures thatmay be necessary for the purpose ofensuring compliance with any of theprovisions of the Act or regulationsmade thereunder.

The Licensing Authority is also enti-tled to delegate any of its above men-tioned supervisory functions to the Me-dicines Authority established under theMedicines Act,14 or any other authorityor institution it deems competent.

The application for the grant of alicence with the aim of establishing tis-sue bank under Article 3 of the HumanBlood and Transplants Act shall be inthe form and contain the informationas set out by the Licensing Authorityand shall also be accompanied by theprescribed fee.

According to the granted licence thetissue bank is solely entitled to carryout activities as set out in Article 5. Theactivities referred to in Article 5 Section(1) are (a) the collection of human bloodcomponents; and (b) the testing of hu-man blood components, in both casesirrespectively of their intended pur-pose; and (c) their preparation, storageand distribution when intended fortransfusion. Article 5 Section (3) alsodeclares that a licence shall not be re-quired for (a) the storage and distribu-tion of, and the performance of com-patibility tests on blood and bloodcomponents exclusively for use withinhospital facilities, including transfusionactivities where such activities are per-formed by a hospital blood bank; or (b)any person carrying out any of the acti-

vities referred to in Article 5 Section (2)where that person carries out thatactivity on behalf of, and pursuant to, acontractual arrangement with - (i) ablood establishment which is licensedunder Part III of the Human Blood andTransplants Act to carry out the activityin question; or (ii) a person responsiblefor the management of a hospitalblood bank.

In accordance with the HumanTissues and Cells (Coding, Processing,Preservation, Storage and Distribution)Regulations, 2007 a tissue bank shall,for the purposes of its accreditation,designation, authorisation or licensing,comply with the requirements set outin Schedule I to the regulation. Sche-dule I of L.N. 337 of 2007 lays down therequirements for accreditation, desig-nation, authorisation or licensing of tis-sue establishments. The requirementsare grouped into six parts referring tothe (1) organization and managementof a tissue bank; (2) personnel in tissueestablishments; (3) equipment andmaterials used in an establishment; (4)facilities or premises; (5) documenta-tion and records and finally (6) qualityreview.

In terms of Article 29 of the DataProtection Act a data controller, anyperson or organisation processing per-sonal data, shall prior to carrying outany wholly or partially automated pro-cessing operations, notify the Data Pro-tection Commissioner of such process-ing. The law establishes an annual noti-fication fee of € 23.29 which is due by

14 Act III of 2003 to make provision for matters connected with the manufacture, preparation and assembly,

wholesale distribution, storage, destruction, disposal, advertising and authorisation of medicinal products

and any activity connected therewith and the regulation of the sale of medicinal products, pharmacies and

related pharmaceutical activities and for any other matters ancillary thereto or connected therewith. [Cap.

458] In original: Kapitolu 458 Att Dwar Il-Medi-Ini, available at http://docs.justice.gov.mt/lom/Legisla-

tion/English/Leg/VOL_14/Chapt458.PDF


data controllers who are obliged tonotify the Data Protection Commis-sioner about their processing opera-tions.

According to Article 30 Section (1) ofthe Data Protection Act, data con-trollers are entitled to appoint a Per-sonal Data Representative and in suchcase the notification to the DataCommissioner as set out in Article 29Sections (1) and (3) shall not berequired. The function of the PersonalData Representative is to independent-ly ensure that the controller processespersonal data in a lawful and correctmanner and in accordance with goodpractice. It is the intention of the DataProtection Commissioner to recom-mend the publication of regulations toestablish the qualifications regulatingPersonal Data Representatives. Perso-nal Data Representatives appointed be-fore the publication of the said regula-tions will have to meet the qualifica-tions eventually incorporated in theregulation.

As it is mentioned before, Article 3 ofthe Human Blood and Transplants Actalso lays down that the LicensingAuthority is obliged to establish andmaintain a publicly accessible registerof tissue banks specifying the activitiesfor which they have been licensed for.

It also has to be noted that theHuman Blood and Transplants Actentered into force on 15 September2006. Since the relevant legislationapplicable for biobanks is rather novel,according to the questionnaire provid-ed for the current research, no bio-banks have been established so farunder the Act and there are no legal re-quirements for existing biobanks.

The Laboratory of Molecular Gene-tics at the University of Malta has set

up and is responsible for a biobankcontaining collections of DNA andother biological materials from individ-uals with a number of diseases, be-sides banking of DNA from Maltesenewborn and senior citizens.

4. PECUNIARY ASPECTS

In Malta pecuniary aspects of the coll-ection and storage of genetic data inbiobanks or tissue banks is not coveredby legal regulations. The donor’s remu-neration is not addressed in the le-gislation, nonetheless the current prac-tice in relation to compensation is freecollection of relevant data for universitylaboratories and pathology labo-ratories, but collection of cord bloodsamples by private companies is sub-ject to payment.

Considering clinical trials undertakenon minors, Article 5 of the Clinical TrialsRegulations sets forth that no incen-tives or financial inducements be givenfor the persons participating in a clini-cal trial except agreed compensation.In line with Article 6, the same provi-sions are applicable to incentives forthe participation in clinical trials under-taken on persons who are incapable ofgiving informed legal consent. In addi-tion to the above Article 7 Section (2) h)sets out that “in preparing its opinion,the Ethics Committee shall consider, inparticular [...] provision for indemnity orcompensation in the event of injury ordeath attributable to a clinical trial.” TheClinical Trials Regulations do not spec-ify the definition of compensation con-cerning the participation in such trials,however the aforementioned provi-sions suggest that the compensationserve as an agreed indemnification on-


ly if the trial subject has suffered injuryor deceased due to a clinical trial.Nevertheless, according to the EFGCPReport on Malta in relation to the ethi-cal review of protocols for clinicalresearch projects, “the amount andprocedure for compensation of studysubjects is evaluated on a case by casebasis. This includes a description of theamount paid for participation in the trialsuch as travel costs, loss of earningsand discomfort.”15

5. CONSENT

According to Article 9 of the DataProtection Act personal data may onlybe processed in case the data subjectconsented to it. Article 2 sets out thedefinition of ‘consent’ according towhich it “means any freely given spe-cific and informed indication”of his orher wishes by which the data subjectsignifies his or her agreement to per-sonal data relating to him or her beingprocessed.

As it is mentioned above, geneticdata can be considered as sensitivepersonal data. According to Article 12Section (2) of the Data Protection Actsensitive personal data can be pro-cessed with one of the following condi-tions: a) with the explicit consent of the data

subject to processing; orb) where the information on the sen-

sitive personal data has been madepublic by the data subject.

In addition to the above, Article 13sets forth that sensitive personal datacan be processed if appropriate safe-guards are adopted and the processingis necessary (a) for the purposes ofexercising or performing any right orobligation which is conferred or im-posed by law on the data controller inconnection with employment; or (b) toprotect the vital interests of the datasubject or another person where con-sent cannot be given or the data sub-ject is physically or legally incapable ofgiving his or her consent; or (c) it isnecessary for the purposes of estab-lishing, exercising or defending legalrights.

Part IV of the Data Protection Act laysdown the legal regulations on data pro-cessing for specific purposes accordingto which the data processing deems tobe lawful on the condition that it is car-ried out in the course of its legitimateactivities by anybody or any associationwhich exists for political, philosophical,religious or trade-union purposes andwhich is not established or conductedfor profit, and the sensitive personaldata relates only to individuals who areeither members of the body or associa-tion or who have regular contact with itin connection with its purposes. Suchdata processing does not involve disclo-sure of the personal data to a third partywithout the consent of the data subjecteither (Article 14).

According to Article 15 sensitive per-sonal data may also be processed formedical care purposes, provided that itis necessary for:

15 European Forum for Good Clinical Practice (EFGCP) Report on the Procedure for the Ethical Review of

Protocols for Clinical Research Projects in Europe, Report on Malta, updated in 2008.

http://www.efgcp.be/Downloads/EFGCPReportFiles/Flow Chart Malta (revised) 08-03-01.pdf

a) the purposes of preventive medi-cine and the protection of publichealth;

b) medical diagnosis;c) the provision of health care and

treatment; ord) the management of health care and

hospital care services.

Data processing necessary for pur-poses specified in Article 15 shall bedeemed to be lawful if it is undertakenby a health professional or other per-son who owes a duty of confidentialitywhich is equivalent to the one whichwould arise if that person was a healthprofessional.

In line with Directive 95/46/EC, Ar-ticle 16 also sets out that the process-ing of personal data can also take placefor research and statistical purposes,provided that the processing is neces-sary in order to protect the vital inter-ests of the data subject. Additionally,the precondition for collecting and pro-cessing of sensitive personal data incase of statistics is the prior consent ofthe Data Protection Commissioner andin the case of research, the prior per-mission of the Data Commissioner hasto be based on the advice of theresearch ethics committee of an insti-tution recognised by the Commissio-ner for the purposes of the Article.

In line with Article 19 of the Data Pro-tection Act, the data controller shallprovide the data subject from whomthe data has been collected, with atleast the information on the identityand habitual residence or principalplace of business of the data control-ler, on the purposes of the processingfor which the data are collected andany further related information (such asthe recipients or categories of the re-

cipients of data; whether the reply toany questions made to the data subjectis obligatory or voluntary, as well as thepossible consequence of failure to rep-ly; and the existence of the right toaccess, the right to rectify, and, whereapplicable, the right to erase the dataconcerning him or her, and, insofar assuch further information is necessary,having regard to the specific circum-stances in which the data is collected,to guarantee fair processing in respectof the data subject). Moreover, Article21 of the Data Protection Act estab-lished further obligations of the control-ler of personal data, according to whichat the request of the data subject thedata controller shall provide the datasubject, without delay and withoutexpense, with written information as towhether personal data concerning thedata subject is processed. Neverthe-less the request of the data subject hasto be made at reasonable intervals.Part VI of the Data Protection Act setsforth certain exemptions from theabove mentioned regulations. Article23 Section (2) sets out that the provi-sions of Article 21 shall not apply whendata is processed solely for purposesof scientific research or is kept in per-sonal form for a period which does notexceed the period necessary for thesole purpose of compiling statistics.

Consent should be the aftermath of anindependently made decision. An inde-pendent and freely made decisionrequires that the individuals, from whomthe biological specimens and samplesare to be collected, have been providedwith all the necessary information. Theconsent also has to be wholly voluntaryand shall not be forced in any way.

According to Article 3 of the ClinicalTrials Regulations an ‘informed con-


sent’ means a a dated and signed writ-ten decision in one of the official lan-guages of Malta or in a language un-derstandable to the clinical trial subject(or understandable to her or his legalrepresentative) on freely taking part in aclinical trial, after being duly informedof the nature, significance, implicationsand risks of such trial. The fact that theclinical trial subject was informed ac-cordingly has to be appropriately docu-mented and must be signed by the trialsubject if he or she is capable of givingconsent or, where this person is notcapable of giving consent, by his or herlegal representative. Furthermore if thetrial subject is unable to write, oral con-sent may be given in the presence of atleast one witness. According to Article12 of the University Guidelines for theUniversity of Malta Research EthicsCommittee16 when obtaining the con-sent, the researcher shall inform thedata subjects about the purpose of pro-cessing, and about their rights underthe Data Protection Act, namely theright to access, the right to rectify, andwhere applicable the right of the datasubjects to erase the data concerningthem. Article 12 also sets out that thedata subject may also request writteninformation about his or her personaldata being processed by the re-searcher. In order to enable the datasubject to exercise his or her right ofaccess, when obtaining consent theresearcher shall provide his or her iden-tity and habitual residence. The datasubject has the right to request theresearcher to correct, and where appli-cable erase personal data that has notbeen processed in accordance with theData Protection Act. Article 23 Section

(3) of the University Guidelines alsosets forth that in the case of researchon genetic material, the consent formmust indicate under what conditionsthe participant is giving consent, if atall, to the use of this material in furtherstudies.

Article 4 Point (b) of the Clinical TrialsRegulations also sets forth that if thetrial subject is not able to give informedconsent, his or her legal representative,has the opportunity, in a prior interviewwith the investigator or a member ofthe investigating team, to understandthe objectives, risks and inconvenienc-es of the trial, and the conditions underwhich it is to be conducted and alsohas to be informed of the data sub-ject’s right to withdraw from the trial atany time by revoking his or her in-formed consent without suffering anydetriment. The same Article of the Cli-nical Trials Act also declares that thetrial subject or, when the person is notable to give informed consent, his orher legal representative has to give hisor her written consent after beinginformed of the nature, significance,implications and risks of the clinicaltrial. In addition to the above if the indi-vidual is unable to write, oral consentmay be given in the presence of atleast one witness.

55..11.. CCoonnsseenntt ooff mmiinnoorrss,, ppeeooppllee wwiitthhlliimmiitteedd ccaappaacciittyy aanndd ddeecceeaasseedd ppeerrssoonnss

According to Article 157 of the CivilCode a minor is a person of either sexwho has not yet attained the age ofeighteen years. Additionally Article 158sets forth that any minor, whoseparents have died or have forfeited


16 See also Ethical Committees.

parental authority and who has notmarried, is subject to be placed undertutorship until he or she becomes ofage or until he or she marries. Article135 of Civil Code also sets forth that inall civil matters the parents jointlyrepresent their born or to be bornchildren.

According to Article 5 of the ClinicalTrials Regulations, clinical trial onminors may only be undertaken if theinformed consent of the parents orlegal representative has been obtained,and the consent must represent theminor’s presumed will and may berevoked at any time, without detrimentto the minor. Furthermore the minorhas to receive information according tohis or her capacity of understanding,from staff with experience with minors,regarding the trial, the risks and thebenefits. Nevertheless, the explicitwish of a minor who is capable of form-ing an opinion and assessing this infor-mation to refuse participation or towithdraw the consent from the clinicaltrial at any time shall be given due con-sideration by the investigator.

Upon the Data Protection Commis-sioner’s recommendations to the gov-ernment the “Processing of PersonalData (Protection of Minors) Regu-lations” 17 were adopted in 2004 estab-lishing that the best interest of theminors prevails over the right to priva-cy.

Consequently the Regulations allowfor any teacher, member of a schooladministration, or any other person act-

ing in loco parentis or in a professionalcapacity in relation to a minor, to col-lect and in any other way process infor-mation without the need to request theparents’ consent. However this is sub-ject to the condition that said process-ing is required in the best interest ofthe minor. Article 2 Section (3) of L.N.125 of 2004 sets out that in such acase, no parent or other legal guardianof the minor shall have access to anypersonal data held in relation to theminor. Therefore the right of access,which is generally exercised by the par-ents on behalf of the child, is suspend-ed until this is deemed necessary inthe best interest of the minor. Notwith-standing these exemptions, any pro-cessing under these regulations mustbe compliant with the data protectionprinciples.

The University Guidelines provides inArticle 15 Section (3)d that the in-formed consent will be sought fromeach prospective subject or the sub-ject’s legally authorized representativeand when appropriate, the assent ofchildren participating in the researchshould be obtained as well as the con-sent should be obtained in the case ofchildren over 12 years of age.

In relation to clinical trials on personsincapable of giving informed legal con-sent, Article 6 of the Clinical Trial Actprovides that all relevant requirementslisted for persons capable of givingsuch consent shall also apply. Fur-thermore, clinical trials on incapacitat-ed adults who have not given and not


17 L.N. 125 of 2004, Data Protection Act (Cap. 440) Processing of Personal Data (Protection of Minors)Regulations, 2004. In original language: A.L. 125 ta’ l-2004 Att dwar il-Protezzjoni u l-Privatezza tad-Data (Kap. 440) Regolamenti ta’ l-2004 dwar l-Ipproøessar ta’ Data Personali Dwar MinurAvailable at:http://docs.justice.gov.mt/LegalPub/Legal_Publications\Legal_Notices\English\2004\125 - 2004 -P1582.pdf

refused informed consent before theonset of their incapacity, shall only beallowed to participate in a clinical trial ifthe informed consent of the legal rep-resentative has been obtained. Con-sent must represent the subject’s pre-sumed will and may be revoked at anytime, without detriment to the subject.In line with the provisions concerningclinical trials on minors, the person notable to give informed legal consentshall receive information according tohis or her capacity of understandingregarding the trial, the risks and thebenefits. The Clinical Trials Regulationalso declares that the interests of thepatient always prevail over those of sci-ence and society.

6. ACCESS TO DATA OR SAMPLES,AND ANONYMITY

Article 27 of the Data Protection Actsets forth the main regulation con-cerning personal data transfer to a thirdcountry. Data processing to thirdcountries that is undergoing pro-cessing or intended processing, mayonly take place subject to the pro-visions of the Data Protection Act andprovided that the third country to whichthe data is transferred ensures anadequate level of protection. Theadequate level of a third country’s dataprotection is subject to the decision ofthe Data Protection Commissioner.The decision shall be assessed with aspecial view to the surrounding cir-cumstances of the data transfer ope-ration or a set of data transfer operat-ions. In addition to the above particularconsideration shall be given to the na-ture of the data, the purpose andduration of the proposed processing

operation or operations, the country oforigin and country of final destination,the rules of law, both general andsectoral, in force in the third country inquestion and the professional rules andsecurity measures which are compliedwithin that country.

Certain exemptions are provided byArticle 28 of the Data Protection Actfrom the requirements of the transferof data to third countries. The relevantarticle of the Act sets out that personaldata transfer to a third country thatdoes not ensure an adequate level ofprotection may be effected by the con-troller if the data subject has given hisor her unambiguous consent to theproposed transfer or if the transfer a) is necessary for the performance of

a contract between the data subjectand the controller or the implemen-tation of precontractual measurestaken in response to the data sub-ject’s request;

b) is necessary for the performance orconclusion of a contract concludedor to be concluded in the interestsof the data subject between thecontroller and a third party;

c) is necessary or legally required onpublic interest grounds, or for theestablishment, exercise or defenceof legal claims;

d) is necessary in order to protect thevital interests of the data subject; or

e) is made from a register that accord-ing to laws or regulations is in-tended to provide information tothe public and which is open toconsultation either by the public ingeneral or by any person who candemonstrate legitimate interest,provided that the conditions laiddown by law for consultation arefulfilled in the particular case.


Furthermore, the Data ProtectionCommissioner is also entitled toauthorize transfer of personal data tothird countries if the controller providesadequate safeguards, which may resultparticularly by means of appropriatecontractual provisions, with respect tothe protection of the privacy and funda-mental rights and freedoms of individu-als and with respect to their exercise.

In relation to good information han-dling practice in a research project,Point 13 of the University Guidelinesdeclares that personal data shall not beretained for a period longer than neces-sary and all measures shall be taken toanonymise data if possible and ensureconfidentiality.

7. STORAGE

The Human Tissues and Cells (Coding,Processing, Preservation, Storage andDistribution) Regulation, 2007 sets outthat a tissue establishment shall, forthe purposes of its accreditation,designation, authorisation or licensing,comply with the requirements laiddown in Schedule I to the regulation.

According to Schedule I, Section 8 ofthe L.N. 337 of 2007, records on theoperation of the tissue bank must meetthe confidentiality requirements laiddown in Article 14 of Directive2004/23/EC. Access to registers anddata must be restricted to personsauthorised by the responsible person,and to the competent authority for thepurpose of inspection and control meas-ures. Article 14 of Directive 2004/23/EC

sets forth that Member States shall takeall necessary measures to ensure thatall data have been rendered anony-mous so that neither donors nor recipi-ents remain identifiable. The data alsoinclude genetic information, collectedwithin the scope of the Directive and towhich third parties have access. In linewith the Directive the Member Statesalso have to ensure whilst guarantee-ing the traceability of donations that (a)data security measures are in place, aswell as safeguards against any unau-thorised data additions, deletions ormodifications to donor files or deferralrecords, and transfer of information; (b)procedures are in place to resolve datadiscrepancies; and (3) no unauthoriseddisclosure of information occurs.

8. SUPERVISION, COMPENSATION,PENALTIES

As it is mentioned before, according toArticle 3 Sections (1)-(2) of the HumanBlood and Transplants Act the DirectorGeneral Health within the Ministry ofHealth is the Superintendent of PublicHealth which is operating as thelicensing and supervisory authority inrelation to the establishment andoperation of tissue banks.

88..11.. EEtthhiiccaall CCoommmmiitttteeeess18

In Malta the Bioethics ConsultativeCommittee, the Health Ethics Com-mittee,, the Ethics Research Committeeof Medical Teaching School at St Luke’sHospital, the Ethics Research Com-


18 Information concerning the Bioethics Committees operating in Malta is based on the online database of

the Privireal Project. Available at: http://www.privireal.org/content/rec/malta.php

mittee of the Institute of Health Care,the Ethics Subcommittee of theFaculty of Medicine and Surgery andfinally the University Research EthicsCommittee at the University of Maltaare the six different ethics committeesthat are worth mentioning consideringthe establishment and management ofbiobanks and other related activities.

8.1.1. Bioethics ConsultativeCommittee

The Bioethics Consultative Com-mittee19 (BCC) was established by theMinistry of Health in 1989 and it oper-ates as an advisory body to the Mi-nistry. The BCC’s role in research islimited to formulating guidelines to befollowed by various institutes and indi-viduals, as well as to prepare opinionson ethical issues, publish articles, pro-vide seminars and inform the publicby means of pronouncing its views onquestions relating to research ethicsas the need arises. The BCC is also en-deavour to sustain and encourageopen discussion on bioethical issues.The Committee is not involved in theethical assessment of individual re-search projects. The BCC is operatedas a multidisciplinary body and itsmembers come from medical, phar-macy, nursing, legal, ethical, and phi-losophical backgrounds and are ap-pointed by the Minister for Health for

the duration of one year on their ownindividual merit and capabilities. TheBioethics Consultative Committee hasalready adopted opinions on medical-ly assisted procreation, on stem cellresearch; it also published opinionson advanced therapy medical pro-ducts and on organ donation andtransplantation as well. The next twofuture topics to be covered by BCC’sopinions are the organ donation fromanencephalic newborn infants and anopinion on the draft embryo protec-tion Act.20

8.1.2. Health Ethics Committee

There is only one Ethical Committeeoperated in Malta, the Health EthicsCommittee (HEC)21 that has the powerof approval on proceeding clinical tri-als.

The establishment of the HEC is un-der the remit of the Ministry of Health.As it is mentioned above the Ministryalso appoints a Bioethics ConsultativeCommittee, which is an advisory com-mittee but which is not involved in theassessment of clinical trials. Thereforeall clinical trials are at the sole respon-sibility of the HEC as established inthe Clinical Trials Regulations. Ac-cording to the Clinical Trials GuidanceNotes22 adopted by the Health EthicsCommittee, the HEC is entitled togrant licence to commence clinical tri-


19 Information on the current composition and members of the Bioethics Consultative Committee is avail-

able at: http://www.sahha.gov.mt/pages.aspx?page=6720 Reference to the opinions of the BCC is found in the Brochure of the European Commission on the

International Dialogue on Bioethics Brussels, 19 February 2009. Available at http://ec.europa.eu/euro-

pean_group_ethics/docs/brochure090219.pdf. 21 Information on the Health Ethics Committee is available at:

http://www.sahha.gov.mt/pages.aspx?page=13422 The Clinical Trials Guidance Notes is available at: http://www.sahha.gov.mt/showdoc.aspx?id=134&file-

source=4&file=Guidancenotes_clinictrials.doc

als on medicinal products as per theMaltese Clinical Trials Regulations,2004 (L.N. 490) and the EuropeanClinical Trials Directive 2001/20/ECand to officially approve applicationsand grant licence to other clinical trialsincluding those involving devices andinterventions.

With reference to clinical trials,Article 7 of L.N. 490 of 2004 lays downthat the Licensing Authority is entitledto set up an ethics committee whichshall give its opinion, before a clinicaltrial commences, on any issue request-ed. The Ethics Committee provides itsreasoned opinion to the applicant andthe Licensing Authority within a maxi-mum of sixty days from the date of re-ceipt of a valid application. The HEC isalso entitled to evaluate proposals forresearch being conducted in the healthsector, including ethical and data pro-tection aspects. The Health EthicsCommittee is to carry out this responsi-bility in close collaboration with theResearch Ethics Committee within theFaculty of Medicine and Surgery in theUniversity of Malta and in line with theprovisions of the Data Protection Act.The HEC is self-funding; fees chargedfor the review of clinical trials are usedfor administrative purposes. For exam-ple, office supplies, subscription tomedical journals and the cost of obtain-ing the opinion of external experts dur-ing the assessment of clinical trials arepaid for in this way. Members of theHEC receive no remuneration. Aca-demic research without financial sup-port from industry and clinical trials onorphan drugs may apply for reducedfees. Applicants conducting other clini-cal trials may also ask for reduced fees.Their requests will be evaluated on acase by case basis.

8.1.3. University Research EthicsCommittee

The University Research Ethics Com-mittee (UREC) at the University ofMalta is also worth mentioning, with aspecial view to the ‘University Guide-lines’. The University Research EthicsCommittee is established by the Uni-versity Senate at the Medical SchoolUniversity of Malta. The UREC exam-ines research projects of a biomedicalnature submitted to it by anyone carry-ing out research involving humans atthe University. Researchers howeverhave no obligation to submit their proj-ect to this body. It reports to the Fa-culty of Medicine but has no authorityto supervise the research projects ithas authorised.

GGuuiiddeelliinneess ffoorr UUnniivveerrssiittyy RReesseeaarrcchhEEtthhiiccss CCoommmmiitttteeee aatt UUooMM

The University Research Ethics Com-mittee appointed in June 2002 set itselfthe task of drawing up a set of guide-lines which were first approved in 2004as ‘Guidelines for UoM Research EthicsCommittee’, and reviewed by UniversitySenate in September 2007. The guide-lines envisage a simple structure thatcan safeguard both ethical standardsand efficiency, while ensuring properaccountability. These guidelines weredrawn up in close consultation with theData Protection Commissioner’s Office,who has ensured that they are in accor-dance with the Data Protection Act.

Submitting research proposals to theUREC is conducted on a voluntary basis,therefore although the approval of theUniversity Ethics Committee of UoM isrequested to commence research with-in the institutional framework of the


University, there are no consequences ifthe researchers fail to submit or fail tofollow the review of the UREC. Never-theless the REC at the University ofMalta has to monitor all research it hasapproved and is entitled to halt the re-search in cases of non-compliance ac-cording to its guidelines (Section VI). Inthe case of non-compliance with theGuidelines the Dean and Senate of theUniversity decide on sanctions to betaken.

Section V of the Guidelines also setsforth the provisions on the researchers’responsibility for obtaining informedconsent in accordance with the guide-lines and for ensuring that no humansubject will be involved in the researchprior to obtaining such consent.

BBiioollooggiiccaall RReessoouurrccee CCoolllleeccttiioonn ooff tthheeUUnniivveerrssiittyy ooff MMaallttaa

The University of Malta and the De-partment of Health established theMolecular Genetics Laboratory, in1989. The initial priority of the labora-tory was to set up a Genetic Testingprogram for Abnormal Heamoglobinsand Thalassaemia, which later on ex-panded to include other conditions anda research programme on globin genecontrol. The Laboratory keeps a bankof 2000 DNA samples. It includes a ran-dom collection of cord blood DNA forpopulation study purposes and DNAsamples from patients with rarediseases. The Biological ResourceCollection of the University of Maltaconsists of DNA and the number of

available human samples are 2000 –including 200 control samples.

8.1.4. Other Ethics Committees

In addition to the above, further ethicscommittees also have to be mentionedwith a view to the management ofbiobanks in Malta. While the EthicsResearch Committee of the MedicalTeaching School at St Luke’s Hospitalprovides informal opinion and advice onthe submitted research proposals atnational level, the Ethics Subcommitteeof the Faculty of Medicine and Surgery isconcerned mainly with audit studies onpatients in the public healthcare system.

The Ethics Research Committee ofthe Institute of Health Care is alsoworthwhile to note, which providesinformal advice for researchers.

9. PUBLIC DEBATE

The establishment and service provisionof a privately owned laboratoryaccredited in Malta has drawn theattention of the public to the legal andethical aspects of the use of geneticinformation. The Bioethics ConsultativeCommittee was consulted by the Mal-tese government on the amendment ofthe L.N. 21 of 1998 Industrial Deve-lopment Act (Cap. 325) on Qualifying Ex-port Services Companies (MaximumRent Chargeable) Order, 1998 to makeprovisions for the above mentioned es-tablishment to provide DNA sequencingservices for non-residents in Malta23.


23 Beyleveld, Deryck: Implementation of the Data Protection Directive in relation to medical research inEurope, Ashgate Publishing, Ltd., 2004, 260.


1. DEFINITION OF FORENSICBIOBANKS

Although there is no legal definition forforensic databases in Maltese legis-lation, according to current practice thepolice is entitled to collect any in-formation of an evidential nature in theinterest of criminal investigation. TheMaltese Forensic Science Laboratorywas set up in 1976. Malta has notestablished any specific legislationconcerning forensic biobanks and therelevant legal regulation mainly con-sists of generally applied provisions oflegal instruments in relation to takingsamples and evidences in investigatingprocedures. It also has to be noted thatalthough the Criminal Code sets outthe main provisions in relation to thetaking of intimate and non-intimatesamples for forensic use by the police,the respective articles of the CriminalCode do not mention DNA or genetictests explicitly as a way of obtainingevidence.

2. RELEVANT LAWS

The main legal regulations concern-ing forensic databases and the col-lection of genetic information inMalta can be categorized into twogroups. Apart of the previously men-tioned usage of genetic informationin criminal investigations, certain me-thods of genetic testing and analysison genetic information are alsoapplicable in paternity cases24.

According to Article 73 of the Po-lice Act25 the police may hold, pro-cess and classify any information rel-evant to the commission of any crimein or outside Malta. The Police Act al-so provides relevant provisions(Article 68-74) on the collection, man-agement, processing and storage ofevidences such as personal informa-tion in the interest of criminal investi-gation.

Furthermore Articles 355AV-355BCof the Criminal Code provide relevantinformation on investigative proce-

II. FORENSIC BIOBANKS

24 Article 70 Section (1) (d) of the Civil Code sets forth the relevant provisions on proving paternity by

means of genetic and scientific tests and data. According to the regulations of the Civil Code, if the alleged

father proves that during the time in question the wife had committed adultery or that she had concealed

the pregnancy and the birth of the child, and further produces evidence of any other fact (which may also

be genetic and scientific tests and data) that tends to exclude such paternity.25 Ordinance II of 1961, Police Act (Cap. 164) To regulate the organization, discipline and duties of the

Malta Police Force.. In original language: Att Dwar il-Pulizija, Kapitolu 164. Available at: http://docs.jus-

tice.gov.mt/lom/legislation/english/leg/vol_4/chapt164.pdf


dures in relation to the collection ofevidences such as taking of samples,fingerprinting and other procedures.

Genetic information and other per-sonal data based on genetic samplesshall deem as sensitive personal datain line with Article 2 of the Data Pro-tection Act. Nevertheless, Article 5 onthe scope of the Data Protection Act,sets out that the Data Protection Actshall not apply to processing opera-tions of personal data concerningpublic security, defence, state securi-ty (including the economic well beingof the state when the processingoperation relates to security matters)and activities of the state in areas ofcriminal law. Therefore the Ministerresponsible for data protection afterconsultation with the Data ProtectionCommissioner and with the concur-rence of the Minister responsible forthe police may by regulations makeprovisions extending the applicationof the Data Protection Act or addingto or derogating from the provisionsmentioned above to enforce the pro-visions of any international obligation,convention or treaty relating to theprotection of personal data, to whichMalta is a party, or may become aparty.

In line with the above mentionedprovisions of the Data Protection Act,the subsidiary legislation, Legal No-tice 142 of 2004, (Cap. 440.05) DataProtection Regulations on the proces-sing of personal data in the policesector, entering into force on 30 Sep-tember, 2004 is the significant leg-islative instrument in the respective

domain. According to the L.N. 143 of2004, the Data Protection Act shall beextended to apply to public bodiesexercising police powers to the ex-tent provided in the Regulations26.

3. ESTABLISHMENT OF FORENSICBIOBANKS

The establishment and maintenanceof forensic biobanks (such asforensic laboratories and databases)are carried by the police on the basisof the Data Protection Act and relatedsubsidiary legislations.

With view to the Police Act, Article73 sets forth that the collection ofinformation for the detection ofcrimes may relate to fingerprints,photographs measurements, blood-samples, intimate or non-intimatesamples, patterns of criminal behav-iours and methodology in the perpe-tration of an offence and similardetails for the purposes of any futureidentification of offenders.

Article 350 of the Criminal Codeprovides that intimate sample meansa sample of blood, semen or anyother tissue fluid, or pubic hair, andincludes a swab taken from a per-son’s body orifice other than themouth. The same article of the Codealso sets forth that non-intimate sam-ple means “a sample of hair otherthan pubic hair, a sample taken froma nail or from under a nail, a swabtaken from any part of a person’sbody including the mouth but not anyother body orifice, urine or saliva, a

26 L.N. 142 of 2004, (Cap. 440.05) Data Protection Regulations (processing of personal data in the police

sector) Available at: http://docs.justice.gov.mt/lom/Legislation/English/SubLeg/440/05.pdf

footprint or a similar impression ofany part of a person’s body otherthan a part of his hand.”27

According to Article 4 of the DataProtection Regulation in the PoliceSector the data controller (such asCommissioner of Police or his or herrepresentative, or any other head of apublic authority or body exercisingpolice powers or his or her represen-tative) shall notify the Commissionerfor Data Protection where in theexercise of his or her duty, the con-troller is required to process person-al data for police purposes. The noti-fication shall cover the relevant infor-mation such as on the name andaddress of the controller and of anyother person authorised by him orher in that behalf, if any, also the pur-pose or purposes of processing, adescription of the category or cate-gories of the data subject and of thedata or categories of data relating tohim or her.

According to Article 17 of the DataProtection Act, data relating to offen-ces, criminal convictions or securitymeasures may only be processed un-der the control of a public authority.For this purpose, the Minister respon-sible for data protection may by regu-lations authorise any person toprocess the data subject to such suit-able specific safeguards as may beprescribed. The relevant provisionsalso set forth that a complete registerof criminal conviction may only bekept under the control of a publicauthority.

4. SAMPLES AND SAMPLE TAKING,CONSENT

Data collection for police purposes co-vers the data samples that are ma-naged and stored in forensic data-bases. According to the definition aslaid down in the Data Protection Re-gulations in the Police Sector, ‘policepurposes’ means all the tasks whichthe police (or other public entities, au-thorities or bodies exercising policepowers) must perform for the preven-tion and suppression of criminal offen-ces or the maintenance of public order.

According to the questionnaire28 pro-vided to the research the human bio-logical samples collected and stored inforensic databases are various tissues,such as blood, saliva, etc. Forensicdatabases also include the personaldata of the data subject, such as his orher name, sex, age and if relevant thedatabase also contains the health dataand criminal data of the data subject.

According to the current practice, thescope of collection is only limited tocertain suspects depending on thedegree of the potential charges, there-fore the collection and analysis of thesuspects’ genetic information is solelyapplicable for the detection of seriouscrimes.

The samples are usually being col-lected when the suspect is taken incustody but only upon the written con-sent of the suspect. The Criminal Codedifferentiates between the proceduresof taking intimate and non-intimatesamples from arrested persons. Article


27 Although it is disputed in the literature whether buccal swab taking is invasive or not, in the present

analysis we do not take a position, just indicate the existence of the controversy.28 Information provided by Dr Bridget Ellul MB ChB, FRCPath, MRCPath, Histopathologist, Head

University Department of Pathology, Senior Lecturer in Forensic Pathology.

355AV sets out that the investigatingofficer may submit a request to theMagistrate29 to obtain authorization forprocessing certain procedures in rela-tion to taking evidences from an arrest-ed person. Upon the request of theinvestigating officer a Magistrate mayauthorise the taking of intimate sam-ples from the person arrested but onlyif the request was reasonably ground-ed (Article 355AV Point (a)). In line withArticle 355AW of the Criminal Code anintimate sample may be solely takenfrom a person arrested if his or herappropriate consent is given.

In case the arrested person with-holds his or her consent, the Magis-trate decides upon the request of theinvestigating officer, and declares whe-ther the request is justified or not.Before making a decision, the Magis-trate shall visit the person arrested torequest his or her consent and the Ma-gistrate is obliged to explain to him orher the nature of the request and thereasons thereof.

According to Article 355AV Point (b),the Magistrate’s authorisation is alsonecessary to taking photographs, afilm, video recording or electronicimage of intimate parts of the arrestedperson’s body. Furthermore the Magis-trate can authorise any procedure if thearrested person refuses to cooperatewith the police forces during the inves-tigation (Article 355AV Point (c)).

It is also worth mentioning thataccording to the Article 355G of the Cri-minal Code the warrant of the Magis-trate on taking evidences in the interestof the criminal investigation shall not

extend to excluded materials such ashuman tissue or tissue fluid which havebeen taken for the purpose of diagno-sis or medical treatment and which aperson holds in confidence30.

Article 355BA also sets forth that theperson arrested may also request inwriting the investigating officer to carryout any of the procedures mentioned inArticle 355AV Points (a) and (b), inwhich case such request shall bereferred to a Magistrate without delay.

With regard to sample taking frompersons who are not in a custody, Ar-ticle 355BB provides that samples mayonly be taken with that person’s priorconsent in writing and for the taking ofan intimate sample a Magistrate’sauthorisation must also be obtainedupon application.

Minors under nine years of age shallbe exempt from criminal responsibilityfor any act or omission. Minors underfourteen years of age shall likewise beexempt from criminal responsibility forany act or omission done without mis-chievous discretion. On the contrary,Article 35 Section (3) sets out that thecourt on the application of the policemay require the parent or other personcharged with the upbringing of theminor to appear before it, and, if thefact alleged to have been committedby the minor is proved and is contem-plated by the law as an offence, thecourt may oblige the parent or otherperson to watch over the conduct ofthe minor under penalty for noncompli-ance of a sum of not less than EUR11.65 and not exceeding EUR 232.94regard being had to the means of the


29 Magistrate is a judge at the Court of Magistrates which is a court of criminal judicature.30 See also Professional Secrecy Act (Cap. 377).

person concerned and to the gravity ofthe fact. In case of an offence punish-able with a fine (ammenda), the courtmay in lieu of applying the above men-tioned provision, award the punish-ment against the parent or other per-son charged with the upbringing of theminor, if the fact could have been avoi-ded by his or her diligence. Article 36also sets out that minors under the ageof fourteen but over nine who, actingwith a mischievous discretion, commitan offence, shall be liable on convictionto the punishments established forcontraventions of the law.

Considering the consent for takingsample from minors, Article 350 of theCriminal Code sets out that appropriateconsent means in relation to a personwho has not attained the age of eight-een but has attained the age of four-teen years, the consent of that personand the consent of his or her parent orguardian. Furthermore in relation to aperson who has not attained the age offourteen years, the consent of his orher parent or guardian is enough forcollecting samples for criminal investi-gation. Nevertheless, it is also worthnoting that according to Article 135 ofthe Civil Code the parents jointly repre-sent their children, therefore both par-ents’ consent is required for an appro-priate consent.

Considering taking of samples frommentally disabled persons the FourthSchedule of the Police Act is worthmentioning that sets forth a code ofpractice for interrogation of arrestedpersons. According to Article 17 Point(a) of Schedule IV as far as practicable,a mentally handicapped person shallbe interviewed only in the presence ofa parent, or his or her tutor or other per-son, not being a member of the police

but who shall be for example the per-son providing effective care and cus-tody of the handicapped person, or asocial worker. With the view to the con-sent of a mentally disabled person tothe collection of personal data or sam-ples for criminal investigation, Article17 Point(b) also lays down that anydocument reporting an interview with amentally handicapped person (after theinvestigating officer shall have ascertai-ned that the interviewed person wascapable of making the statement)should be offered for signature not on-ly to the handicapped person, but alsoto the mother or father or other accom-panying person present during theinterview.

5. PURPOSE AND SCOPE OFCOLLECTION

According to Article 5 of the DataProtection Regulations in the PoliceSector the collection of personal datafor police purposes can be orderedwhen it is necessary for the pre-vention, suppression, investigation,detection and prosecution of specificcriminal offences or for the preven-tion of real danger, or for other pur-poses specified by law. The abovementioned provision is in compliancewith Article 23 of the Data ProtectionAct, which provides exemptionsfrom the general provisions on dataprocessing in the interest of nationalsecurity, defence, public security,the prevention, investigation, detec-tion and prosecution of criminal of-fences, or of breaches of ethics forregulated professions, an importanteconomic or financial interest includ-ing monetary, budgetary and taxation


matters or a monitoring, inspectionor regulatory function connected,even occasionally, with the exerciseof an official authority in the field ofpublic security, criminal or taxationinvestigations. Another exemption isalso applicable when such informa-tion is being prejudicial to the pro-tection of the data subject or of therights and freedoms of others.

According to the questionnaire31

provided for the research, the currentpractice covers forensic databasesand biobanks for the purpose of iden-tifying the suspect and victims of acrime, or databanks established in or-der to find an attested link betweenthe suspect and the crime scene.Data collection also applies to theidentification of refugees seekingasylum in Malta or the identificationof deceased illegal immigrants.

The Data Protection Regulations inthe Police Sector also lays downthat when personal data are pro-cessed without the knowledge ofthe person concerned, the data sub-ject should only be informed, wherepracticable, about the fact that infor-mation is held about him or her, assoon as the object of police activi-ties is no longer likely to be preju-diced, and if the data have not beendeleted. As it is mentioned before,genetic information is considered assensitive personal data, thereforespecial provisions shall apply to theprocessing thereof. The processingof sensitive personal data is allowedif this is necessary for the purposesof a particular inquiry. Furthermore

Article 6 of the Data Protection Re-gulation in the Police Sector alsosets out that the processing of per-sonal data for police purposes shallas far as possible, be limited to ac-curate data and to such data as arenecessary to allow the public autho-rity exercising police powers to per-form their obligations as laid downin national legislation and to fulfilinternational obligations arising outof any convention, treaty or bilateralagreement relating to police mattersto which Malta is a party. In relationto the purposes of the data collec-tion the Regulation declares thatcollection of personal data for policepurposes shall not be processed forany other purpose that is incompati-ble with such police purposes.

6. ACCESS TO DATA ANDSAMPLES

Article 8 of the Data ProtectionRegulations in the Police Sector laysdown the relevant provisions on theprocessing of personal data to thirdparties. According to the Regulations,communication of personal data be-tween different bodies exercising po-lice powers shall only be permittedwhere there exists a legitimate inter-est for such communication withinthe framework of the legal powers ofsuch bodies. In addition to the above,personal data from bodies exercisingpolice powers, to other GovernmentDepartments or to bodies establishedby law, or to other private parties may


31 Information provided by Dr Bridget Ellul MB ChB, FRCPath, MRCPath, Histopathologist, Head

University Department of Pathology, Senior Lecturer in Forensic Pathology.

only be transferred on the basis of alegal obligation or authorisation toprocess such data or if the Com-missioner for Data Protection au-thorises such communication of data.Furthermore in exceptional casesdata processing may also be carriedout if it is clearly in the interest of thedata subject and either the data sub-ject him or herself has consented tothe communication or circumstancesare such as to allow a clear presump-tion of such consent or the data pro-cessing is necessary for the preven-tion of a serious and imminent dan-ger. Article 8 Section (4) also declaresthat bodies exercising police powersmay also communicate personal datato other Government Departments orbodies established by law, if the dataare necessary for the recipient toenable him or her to fulfil his or herlawful task and provided that the pur-pose of the processing to be per-formed by the recipient is not incom-patible with the original purpose ofprocessing or contrary to the legalobligations of the body exercising po-lice powers.

Nevertheless all the above mentio-ned data processing shall be madein compliance with Article 10 of theRegulations according to which therequests for communication of per-sonal data shall be submitted inwriting to the body exercising policepowers, and shall include an indica-tion of the person or body makingthe request and of the reason andpurpose for which the request ismade.

It also has to be mentioned that ac-cording to Article 12 of the Data Pro-tection Regulation in the Police Sec-tor in the course of executing theirduties the body exercising policepowers may have access to a person-al data filing system held for purpos-es other than police purposes, inaccordance with the law, providedthat the other body who maintainsthe personal data filing system or theData Protection Commissioner hasauthorised such access. With view tothe aforementioned provisions of thelaw, the police is entitled to cross linkthe personal data information andsamples stored in forensic databaseswith another database maintained byother authorities. This provision how-ever has to be red in conjunction withthe above mentioned Article 355G ofthe Criminal Code according to whichthe Magistrate’s warrant on takingevidences in the interest of the crimi-nal investigation shall not extend tomaterials such as human tissue or tis-sue fluid which have been taken forthe purpose of diagnosis or medicaltreatment.32

Article 73 of the Police Act alsosets forth that the police may, for thepurpose of establishing evidence inthe investigation into any criminaloffence, compare any information(such as fingerprints, photographs,measurements, blood-samples, inti-mate or non-intimate samples, pat-terns of criminal behaviours andmethodology in the perpetration ofan offence and similar details) rele-vant to the commission of any crime


32 See also Professional Secrecy Act (Cap. 377)

with any other information that maybecome available to it.

7. STORAGE

According to Article 73 of the PoliceAct, the information collected duringthe investigation process may bepreserved by any system, including inelectronic format, but in all cases thecollection of data must be in compli-ance with the provisions of data pro-tection regulations. Article 6 Sections(3)-(4) of the Data Protection Regu-lations in the Police Sector set forththat personal data processed for policepurposes shall not be kept for a periodlonger than is necessary having regardto the police purposes for which theyare processed.

The data controller shall take all rea-sonable measures to complete, cor-rect, block or erase personal data tothe extent that such data is incompleteor incorrect having regard to the policepurposes for which they are pro-cessed.

In line with the Police Act, Article 554of the Criminal Code also sets out thatthe Magistrate is entitled to order thatany suspect be photographed or meas-ured or that his or her fingerprints betaken or that any part of his or her bodyor clothing be examined during an in-quiry by experts appointed by the Ma-gistrate in the interest of the investiga-tion. Provided that where the Magis-trate is of the opinion that such photo-graphs (negatives and prints), finger-print impressions, records of measure-ments and any other potential evi-dence obtained from the body or cloth-ing as aforesaid are no longer requiredfor the purpose of the investigation,

the Magistrate shall order their de-struction or shall order that they behanded over to the person to whomthey refer.

Considering the storage of personaldata collected for police purposes,Article 68 of the Police Act lays downthat any person may, within one yearfrom the date of his or her acquittal bya final judgement of a court, demandthat all samples, fingerprints and doc-uments taken from him or her and anyrecordings of his or her voice or pho-tographs or video recordings be retur-ned to him or her or destroyed in thepresence of the person. Such requestof the data subject shall be made byapplication to a Magistrate who mayauthorize the request and in this caseensures that the material in questionis returned to the data subject or de-stroyed in the presence of the Magis-trate. Upon the decision of the Ma-gistrate, the material in question is notreturned to the data subject if is need-ed in connection with any other inves-tigation. In such case the Magistratemay order that the return or destruc-tion of any such material be detaineduntil it is no longer required for theother investigation.

If the data subject is a person whohas been arrested but not charged, theapplication may only be allowed if thepolice have already given their ownreply to this application. The request ofthe data subject shall not be granted ifit is opposed by the police and the peri-od of prescription for the exercise ofthe criminal action in respect of theoffence for which the applicant wasarrested and convicted has not lapsed(Article 71).

Article 72 of the Police Act provides,that where the person acquitted or the


person arrested but not charged fails tosubmit a request to a Magistrate, thepolice may transfer any and all evi-dences or samples and so forth to thePolice Academy if the material is con-sidered by the police to have a didacticor experimental value.

Article 73 also states that the policemay hold, process and classify anyinformation relevant to the commis-sion of any crime in or outside Maltawhich information may be preserved

by any system whatsoever, includingin electronic format, subject to theprovisions of any law on the protec-tion of data. Such information mayrelate to fingerprints, photographs,measurements, blood-samples, inti-mate or non-intimate samples, pat-terns of criminal behaviours andmethodology in the perpetration of anoffence and similar details for the pur-poses of any future identification ofoffenders.


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