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JUDIT SÁNDOR

PETRA BÁRD

THE LEGAL REGULATION OF BIOBANKS

National Report:

Cyprus

CENTER FOR ETHICS AND LAW IN BIOMEDICINE

No.7CELAB PAPER SERIES

Editors: Judit Sándor and Petra Bárd

© July 2009

Center for Ethics and Law in Biomedicine (CELAB)

ISSN 2074-4498ISBN 978-963-88404-5-5

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 : C Y P R U S 1

TABLE OF CONTENTS

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

1. Definition of biobanks . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32. Relevant laws . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33. Establishment and management of biobanks . . . . . . . . . 74. Purpose and scope of collection . . . . . . . . . . . . . . . . . . . 95. Pecuniary aspects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116. Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127. Access to data or samples, and anonymity . . . . . . . . . . 138. Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159. Supervision, compensation, penalties . . . . . . . . . . . . . . 15

10. Public debate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

II. FORENSIC BIOBANKS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

1. Definition of forensic biobanks . . . . . . . . . . . . . . . . . . . 202. Relevant laws . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203. Establishment of forensic biobanks . . . . . . . . . . . . . . . . 204. Samples and sample taking, consent . . . . . . . . . . . . . . 235. Purpose and scope of collection . . . . . . . . . . . . . . . . . . 236. Access to data and samples . . . . . . . . . . . . . . . . . . . . . 237. Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

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As partners in the European UnionFramework Project entitled “Gene-BanC: Genetic bio and dataBanking:Confidentiality and protection ofdata” we are exploring the legalregulations of genetic databanks.(http://www.genebanc.eu/) The Cen-ter for Ethics and Law in Biomedicineestablished at the Central EuropeanUniversity, Budapest (http://www.ceu.hu/celab) aimed to investigatethe existing regulatory framework ofbiobanks across the EU and to focuson the collection and analysis oflegislation and regulation regardingthe establishment, management andfunctioning of classical, populationand forensic biobanks across Europe.An important objective was to look atthe similarities and differences insuch 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 Centrefor Biomedical Ethics and Law, K.U.

Leuven. CELAB was focusing on theregulatory framework of Cyprus, theCzech Republic, Estonia, Greece,Hungary, Italy, Latvia, Lithuania,Malta, Poland, Romania, the SlovakRepublic and Slovenia.

We would like to express ourgratitude to Dr. Judit Schvéger for hereditorial support.

The present booklet summarizes theregulatory framework of biobanks inCyprus and focuses on the collectionand analysis of legislation and regula-tion regarding the establishment, ma-nagement and functioning of classicaland forensic biobanks. The former willbe discussed in Part I, whereas for-ensic biobanks invoking legal issuesof different nature will be covered se-parately in Part II. The present analysisdoes not cover either internationalstandards, or pieces of EuropeanUnion law, but it should be borne inmind that they are binding on Cyprusbeing a European Union MemberState.

Budapest, 31 July 2009

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


I. CLASSICAL AND POPULATION BIOBANKS

1. DEFINITION OF BIOBANKS

Cyprus is known to have an increasedfrequency of inherited disorders, whichplace a heavy burden on the Governmentto provide sufficient legislative and socialframework for the services and research-es aimed towards early detection andprevention of such diseases.1 The provi-sion of high quality medical services andin general improvement in the quality oflife of the community is one of the maingoals of the Cypriot government in rela-tion to its Health Policy.2 Although Cyprushas not adopted special legislation forthe regulation of biobanks, the relevantlegal instruments that are applicable indata protection concerning tissue banksand transplantation are in compliancewith the European standards. In the ab-sence of a special regulative frameworkon the establishment and managementof biobanks, a fragmented legislativestructure of generally applied constitu-tional provisions, laws, regulations, legal

notices, codes of practice, guidelinesand so forth are potentially applied.

2. RELEVANT LAWS

Cyprus has transposed all the relevantpieces of the acquis communautaire thatare dealing with transplantation stan-dards for the quality and safety of tissuesand cells throughout the transplantationprocess. The respective legislations areDirective 2004/23/EC, Directive 2006/17/EC and Directive 2006/86/EC that areadopted by the Comission of theEuropean Communities. The Commis-sion Directive 2006/17/EC implementingDirective 2004/23/EC of the EuropeanParliament and of the Council as regardscertain technical requirements for thedonation, procurement and testing of hu-man tissues and cells has been trans-posed to Cypriot legislation via Law187(I)/2007 as regards the quality andsecurity standards (donation, procure-ment, testing, processing, preservation,

1 Diseases specific to people of Mediterranean origin, such as thalassaemia, a genetic blood disorder betterknown as Mediterranean anaemia.2 Further information is available at the website of the Cyprus Institute of Neurology and Genetics athttp://srs.dl.ac.uk/arch/SESAME/cyprus/kyriakou/kyriakou.htm and at http://www.cing.ac.cy/


storage and distribution) of human tis-sues, cells and derivative products3 andCommission Directive 2006/86/EC of 24October 2006 implementing Directive2004/23/EC is introduced into the Cypriotlaw via Regulations 438/2008 on thequality and security standards of humantissues, cells and derivative products(traceability, notification of seriousadverse reactions and events, coding,processing, preservation,storage anddistribution).4

Furthermore the implementing Di-rectives of the European Blood Direc-tive5 are also transposed into the Cyp-riot legislation. Commission Directive2005/61/EC of 30 September 2005 im-plementing Directive 2002/ 98/EC ofthe European Parliament and of theCouncil as regards traceability require-ments and notification of serious ad-

verse reactions and events as well asthe Commission Directive 2005/62/ECof 30 September 2005 implementingDirective 2002/98/EC of the EuropeanParliament and of the Council as re-gards Community standards and spe-cifications relating to a quality systemfor blood establishments are trans-posed into the national legal frame-work via the amending law Law No.10(I)/2007 on blood donation6. Com-mission Directive 2004/33/EC of 22March 2004 implementing Directive2002/98/EC of the European Par-liament and of the Council as regardscertain technical requirements forblood and blood components is trans-posed into national law via amendingLaw 3(I) /2006 as regards blood dona-tion7 and the amending Regulation67/2006 on blood donation (collection,

3 Law of 2007 as regards the quality and security standards (donation, procurement, testing, processing,preservation, storage and distribution) of human tissues, cells and derivative products. Legal act: Νόµος,number: Ν. 187(Ι)/2007; Official Journal: Cyprus Gazette, number: 4154, Publication date: 31/12/2007,Page: 01621-01714, Entry into force: 31/12/2007; Reference: (MNE(2008)50681). Originial text is pub-lished: Ο περί Προτύπων Ποιότητας και Ασφάλειας (∆ωρεά, Προµήθεια, Έλεγχος, Επεξεργασία,Συντήρηρση, Αποθήκευση και ∆ιανοµή) Ανθρώπινων Ιστών, Κυττάρων και Παράγωγων ΠροϊόντωνΝόµος του 2007. Available in original language at: http://www.moh.gov.cy/moh/moh.nsf/All/AAE443D58AB42999C22575900039A2E6/$file/ιστών.pdf?OpenElement4 Legal act: Κανονισµοί, number: Κ.∆.Π. 438/2008; Official Journal: Cyprus Gazette, number: 4318,Publication date: 05/12/2008, Page: 03533-03568, Entry into force: 05/12/2008; Reference:(MNE(2008)56589) Οι Περί Προτύπων Ποιότητας και Ασφάλειας Ανθρώπινων Ιστών, Κυττάρων καιΠαράγωγων Προϊόντων (Ιχνηλασιµότητα, Κοινοποίηση Σοβαρών Ανεπιθύµητων Αντιδράσεων καιΣυµβάντων, Κωδικοποίηση, Επεξεργασία, Συντήρηση, Αποθήκευση και ∆ιανοµή) Κανονισµοί του 2008.Available in original language at: http://www.moh.gov.cy/moh/moh.nsf/All/630D679F04A59F3AC22575900039BDBD/$file/kanonismoi.pdf?OpenElement5 Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting stan-dards of quality and safety for the collection, testing, processing, storage and distribution of human bloodand blood components and amending Directive 2001/83/EC, OJ L 33, 8.2.2003, p. 30–40. Available at:http://eur-lex.europa.eu/Notice.do?val=283913:cs&lang=en&list=432018:cs,393196:cs,283913:cs,&pos=3&page=1&nbl=3&pgs=10&hwords=6 The (amending) Law of 2007 as regards blood donation. Legal act: Νόµος, number: N.10(I)/2007;Official Journal: Cyprus Gazette, number: N.10(I)/2007, Publication date: 16/02/2007, Page: 00217-00256, Entry into force: 16/02/2007; Reference: (MNE(2007)51693). In original language: Ο περίΑιµοδοσίας (Τροποποιητικός) Νόµος του 20077 Legal act: Κανονισµοί, number: Ν.3(Ι)/2006; Official Journal: Cyprus Gazette, number: 4068,Publication date: 10/02/2006, Page: 00009-00029; Reference: (MNE(2006)51010). In original language: Οπερί Αιµοδοσίας (Τροποποιητικός) Νόµος του 2006.


security, testing and transfusion ofblood)8.

Law 138 (III)/2001 on the Processingof Personal Data (Protection of the Indi-viduals) (Processing of Personal DataLaw or Data Protection Act)9 is also rele-vant in relation to the protection of dataprocessing for personal data containedin biobanks. Since biobanks contain notonly biological samples but also person-al data about the donor of the biologicalmaterial such as data related to healthand genetic data, one of the most sig-nificant legal instruments on their regu-lations is the Protection of PersonalData Law which transposed Directive95/46/EC of the European Parliamentand of the Council of 24 October 1995on the protection of individuals withregard to the processing of personaldata and on the free movement of suchdata into national legislation in 2001.

The protection of data contained inbiobanks provided by Law No. 138 (III)/2001 on the Processing of PersonalData shall be interpreted together withthe Constitution of the Republic of Cyp-rus of 1960 (as amended in 1989, 1996,2002 and 2006).10

While Article 11 of the Cypriot Cons-titution states that “Every person hasthe right to liberty and security of per-son”, Article 15 sets forth that “everyperson has the right to respect of his pri-vate and family life”. Article 17 of theCypriot Constitution also provides that“every person has the right to respectfor, and to the secrecy of, his [or her] cor-respondence and other communication,if such communication is made throughmeans not prohibited by law”.

In addition to the above the Law forGood Clinical Practice involving drugs forhuman use (Laws for 2001 until 2004)11 isalso important. A specific biobank relat-ed legislation, the Law No. 150(I) of 2001on Providing for the Establishment andFunction of the National Bioethics Com-mittee (the so-called Bioethics Law) isalso considered significant. The afore-mentioned Bioethics Law established theCyprus National Bioethics Committee(CNBC), which was enacted in December2001. The CNBC has adopted with veryfew changes the “Operational Guidelinesfor Ethics Committees that Review Bio-medical Research” formulated by theWorld Health Organization, to form the

8 Legal act: Κανονισµοί, number: Κ.∆.Π. 67/2006; Official Journal: Cyprus Gazette, number: 4081,Publication date: 24/02/2006, Page: 00455-00473; Reference: (MNE(2006)51438). The Law has publishedin original language: Οι περί Αιµοδοσίας (Λήψη, Ασφάλεια, Έλεγχος και Μετάγγιση Αίµατος)(Τροποποιητικοί) Κανονισµοί του 2006.9 The Processing of Personal Data (Protection of Individuals) Law 138(I)2001 as amended by TheProcessing of Personal Data (Protection of Individuals) (Amendment) Law of 2003 (37(I)2003). Availableat: http://www.dataprotection.gov.cy/dataprotection/dataprotection.nsf/d1813d5911e138bdc2256cbd00313d1c/f8e24ef90a27f34fc2256eb4002854e7/$FILE/138(I)-2001_en.pdf In original language: Νόµος πουτροποποιεί τον Περι Επεξεργασίας ∆εδοµένων Προσωπικού Χαρακτήρα (Προστασία του Ατόµου) Νόµοτου 2001, αρ. 37(Ι)/2003. In original language available at: http://www.dataprotection.gov.cy/dataprotec-tion/dataprotection.nsf/All/B708D98FB15F8D09C2256D9B0032AE61/$file/138(I)-2001&37(I)-2003.pdf?OpenElement10 Constitution of the Republic of Cyprus adopted on 16 Aug 1960, Unofficial translation in English isavailable at: http://www.cyprus.gov.cy/portal/portal.nsf/All/C44572D7363776ACC2256EBD004F3BB3?OpenDocument. In original language available at: http://www.kypros.org/Constitution/Greek/11 Legal act: Κανονισµοί; Official Journal: Cyprus Gazette, Publication date: 30/04/2004; Reference:(MNE(2004)59467) In original language published at: Οι περί Φαρµάκων Ανθρώπινης Χρήσης (ΟρθήΚλινική Πρακτική) Κανονισµοί του 2004.


basis of the Operational Guidelines forEthics Committees that Review Bio-medical Research Involving HumanSubjects in Cyprus, which were enactedin 2005 (Operational Guidelines).12

The ethical and scientific standardsfor carrying out biomedical research onhuman subjects have been developedand established in international guide-lines, including the Declaration of Hel-sinki,13 the CIOMS International EthicalGuidelines for Biomedical Research In-volving Human Subjects,14 and theWHO and ICH Guidelines for Good Cli-nical Practice. Compliance with theseguidelines helps to ensure that the dig-nity, rights, safety, and well being ofresearch participants are promotedand that the results of the investiga-tions are credible. In the lack of specif-ic regulation the establishment andoperation of tissue banks in Cypruswere primary authorized by the guide-lines issued by the below mentionedethics committees.

It is also worthwhile to mention LawNo. 1(I) of 2005 on the Safeguardingand Protection of Patients’ RightsLaw,15 which provides enforceable le-gal provisions considering humanrights in the field of health and, in par-ticular, the right to life, the right tophysical and mental integrity and secu-rity, the right to respect for private lifeand to dignified treatment in the provi-sion of health services. The Law. No. 1(I) 2005 sets out provisions on the rightto protection of health through propermeasures of prevention of diseasesand health care, that are not regulatedexplicitly by other law.

Concerning the other important inter-national legislations, it is also worthmentioning that the Convention on Hu-man Rights and Biomedicine16 was rat-ified by Cyprus and Article 38 of Law31(III)/2001 on the Ratification of the Eu-ropean Convention on Human Rightsand Biomedicine (Ratification Law) en-tered into force in 2002. Cyprus has also

12 Operational Guidelines for the Establishment of Ethics Committees in Reviewing Biomedical ResearchInvolving Human Subjects in Cyprus (Operational Guidelines,2005) enacted on 31. 3. 2005 (Κ.∆.Π.175/2005) Available at: http://www.bioethics.gov.cy/Law/cnbc/cnbc.nsf/All/74ACE403567F843EC22571C9002C3F3A/$file/EEBK000 UK Operational Guidelines.pdf In original language: Για τη Συσταση καιΛειτουργια Επιτροπων Βιοηθικησ για τον Ελεγχο τησ Βιοιατρικησ Ερευνασ στην Κυπρο (Κ.Τ.Π175/2005). Available in original language at:http://www.bioethics.gov.cy/Law/cnbc/cnbc.nsf/All/521F178A5364E010C22571C9002C5199/$file/EEBK000 Operational Guidelines_Greek.pdf13 World Medical Association Declaration of Helsinki on the Ethical Principles for Medical ResearchInvolving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964.The current revision is available at: http://www.wma.net/e/policy/pdf/17c.pdf14 International Ethical Guidelines for Biomedical Research Involving Human Subjects. Prepared by theCouncil for International Organizations of Medical Sciences (CIOMS) in collaboration with the WorldHealth Organization (WHO) CIOM, Geneva 2002. Available at:http://www.cioms.ch/frame_guidelines_nov_2002.htm15 Law No. 1(I) of 2005 to provide for the safety and protection of patients’ rights and for related matters.Dated 29 October 2004. (The Safeguarding and Protection of Patients’ rights Law, 2004). Original textpublished in Episκme Ephκmerida tκs Kypriakκs Dκmokratias, 7 January 2005. Available at:http://apps.who.int/idhl-rils/idhl/Cypr.05002.pdf16 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to theApplication of Biology and Medicine: Convention on Human Rights and Biomedicine Oviedo, 4.IV.1997.Available at: http://conventions.coe.int/treaty/EN/Treaties/Html/164.htm

ratified the Convention for the Pro-tection of Human Rights and the Dig-nity of Human Beings with regard tothe Application of Biology and Me-dicine (Oviedo Convention) by Article 4of the Law 31 (III)/2001. The RatificationLaw also sets forth that the prohibitedactions of the Convention or any activitythat fails to comply with the provisionsof the Convention shall be regarded asoffences.17

Apart of the above mentioned piecesof legislation, the Private Medical CareInstitutions (Control of Establishmentand Operation) Law of 2001 is also rel-evant in the respective legal domain.18

3. ESTABLISHMENT ANDMANAGEMENT OF BIOBANKS

As it is mentioned before the establish-ment and management of biobanks ortissue banks are not covered with spe-cial legislative framework in Cyprus.

Nevertheless it also has to be men-tioned that the legal instruments inrelation to the transplantation stan-dards for the quality and safety of tis-sues and cells throughout the trans-plantation process are fully in compli-

ance with the European standards andthis is the area that is regulated themost thoroughly in the country. As it ismentioned above, Directive 2004/23/EC as regards traceability require-ments, notification of serious adversereactions and events and certain tech-nical requirements for the coding, pro-cessing, preservation, storage anddistribution of human tissues and cellsis implemented via Regulations 438/2008 into Cypriot Law. The provisionsof the Data Protection Act concerningthe processing and storage of sensitivepersonal data is the most relevant reg-ulative instruments that are applicablein the case of biobanks.

In relation to the establishment ofbiobanks Article 7 of the Protection ofPersonal Data Law also sets forth thatthe data controller is obliged to notifythe Data Protection Commissioner19 inwriting about the establishment andoperation of a filing system or the com-mencement of processing.

In relation to the collection and pro-cessing of personal data, the Article 2of the Data protection Act also sets outthat the ‘personal data filing system’ or‘filing system’ means “any structuredset of personal data which constitute


17 Article 7 of Law 31 (III)/2001 also sets forth that the law allows research on embryos in vitro, if itensures adequate protection of the embryo. The creation of human embryos for research purposes howeveris prohibited. Furthermore the infringement of article 14 of the Convention is an offence that is punishedwith imprisonment for up to two years and/or a fine up to CYP 5.000. In: Mathiessen-Guyader L, ed.Survey on Opinions from National Ethics Committees or Similar Bodies, Public Debate and NationalLegislation in relation to Human Embryonic Stem Cell Research and Use. Brussels, Belgium. EuropeanCommission Research Directorate-General, 2003.18 Law No. 90(I) of 2001 on Private Medical Care Institutions (Control of Establishment and Operation).See also Article 2 of Law No. 1(I) of 2005 to provide for the safety and protection of patients’ rights andfor related matters. 19 The Data Protection Commissioner is responsible for monitoring the application of the Processing ofPersonal Data Law 2001 (see Article 18 Section (1)) Article 23 sets out the functions of the Commissioner.These include: b) to assist in the drawing up of codes of conduct; e) to report any contraventions of thelaw to the relevant authorities.; h) to conduct inquiries following complaints or on his own initiativehttp://www.dataprotection.gov.cy/dataprotection/dataprotection.nsf/index_en/index_en?opendocument


or may constitute the subject of pro-cessing and which are accessibleaccording to specific criteria.” While‘processing’ or ‘processing of personaldata’ means “any operation or set ofoperations which is performed by anyperson upon personal data, whether ornot by automatic means, and includesthe collection, recording, organization,preservation, storage, alteration, extrac-tion, use, transmission, disseminationor any other form of disposal, connec-tion or combination, blocking, erasureor destruction”.

In the aforementioned notification thedata controller shall state all the require-ments as set forth in Article 7 Section (2)of the Data Protection Act, such as (a)the full name, business name or title andaddress of the data controller if the con-troller is not established in Cyprus, he orshe must also state the full name, busi-ness name or title and address of his orher representative in Cyprus; (b) theaddress where the filing system is estab-lished; (c) a description of the purpose ofthe processing of the data which are orare intended to be included in the filingsystem; (d) a description of the categoryor categories of data subjects; (e) thecategories of data which are or areintended to be processed or which areincluded or intended to be included inthe filing system; (f) the period of timefor which he or she intends to carry outthe processing or to keep the filing sys-tem; (g) the recipients or categories ofrecipients to whom he or she commu-nicates or may communicate the data;(h) the proposed transmissions of datato third countries and the purposethereof; (i) the basic characteristics ofthe system and the measures for thesecurity of the filing system or of theprocessing.

According to Article 7 Section (4) theData Protection Commissioner is ob-liged to establish and maintain a Regis-ter of Filling Systems and Processing.

Nevertheless, the Protection ofPersonal Data Law provides a numberof cases, where data processors areexempted from their obligation to noti-fy the Data Protection Commissioner inorder to process sensitive data. There-fore Article 7 Section (6) d) sets out thatdata processors are exempted fromtheir obligation if the processing is per-formed by doctors or other personswho provide health services which con-cern medical data, provided that thecontroller is bound by medical confi-dentiality or other kind of confidentiali-ty required by law or code of conductand the data are neither transferred norcommunicated to third parties.

However, persons who providehealth services such as clinics, hospi-tals, health centres, recovery and de-toxication centres, insurance funds andinsurance companies as well as thecontrollers of personal data when theprocessing is performed in the frame-work of programs relating to telemedi-cine operations or provision of medicalservices through a network, are notexcluded from this provision.

According to the Opinion of theCyprus National Bioethics Committeeregarding bioethical dilemmas of um-bilical cord banking by private profitmaking companies adopted in 2004,“about 75% of cord blood banks arepublic or private non-profit banks,which offer a service for the benefit ofthe public. They store donated sam-ples for the purpose of transplantationor research. They also store cord bloodfor family use in case of a known risk ina family with a rare HLA (human leuko-


cyte antigen) group.”20 The Opinionalso sets out the CNBC’s endeavour toemphasize publicly that the legislationshould impose strict regulation andclose supervision of the procedures(both in the public and the privatedomain) in relation to the services ofcord blood banks and also to expressthat the protection of personal data ofcord blood banks customers and theirrelatives, needs to be safeguarded.

4. PURPOSE AND SCOPE OFCOLLECTION

According to Article 2 of the DataProtection Act, ‘personal data’ “meansany information relating to a living datasubject; whereas consolidated data ofa statistical nature, from which the datasubject cannot be identified, are notdeemed to be personal data.” Thesame provisions of the Act also setforth the definition of ‘sensitive data’,according to which it means data con-cerning racial or ethnic origin, politicalconvictions, religious or philosophicalbeliefs, participation in a body, associa-tion and trade union, health, sex lifeand erotic orientation as well as datarelevant to criminal prosecutions orconvictions. In line with Article 2 of theData Protection Act genetic informa-tion and other personal data based ongenetic samples shall be deemed assensitive personal data. AlthoughArticle 7 of the Data Protection Act pro-vides that the collection and process-

ing of sensitive data is prohibited, thecollection of sensitive data is permittedwhen one or more of the conditions asset forth in Article 7 Section (2) are ful-filled.

The collection of sensitive data ispermitted if e.g. (1) the data subjecthas given his or her explicit consent,unless such consent has been ob-tained illegally or is contrary to accept-ed moral values or a specific law pro-vides that consent does not lift the pro-hibition; (2) processing is necessary sothat the controller may fulfil his or herobligations or carry out his or her du-ties in the field of employment law; (3)processing is necessary to protect thevital interests of the data subject or ofanother person where the data subjectis physically or legally incapable of giv-ing his consent; (4) the processingrelates solely to data which are madepublic by the data subject or are nec-essary for the establishment, exerciseor defence of legal claims before theCourt; (5) the processing relates tomedical data and is performed by aperson providing health services byprofession and has a duty of confiden-tiality or is subject to relevant codes ofconduct, on condition that the pro-cessing is necessary for the purposesof preventive medicine, medical diag-nosis, the provision of care or themanagement of health-care services;(6) processing is necessary for thepurposes of national needs or nationalsecurity, as well as criminal andreform policy, and is performed by a

20 Opinion of the Cyprus National Bioethics Committee (CNBC) regarding bioethical dilemmas of umbili-cal cord banking by private profit making companies, 2004. Available at:http://www.bioethics.gov.cy/Law/cnbc/cnbc.nsf/All/B5D91DC497A2EB49C2257308004B46B2/$file/Opinion of CNBC on bioethical dilemmas of umbilical cord banking by private profit makingcompanies.pdf


service of the Republic or an Or-ganisation or Foundation authorized forthis purpose by a service of the Re-public and relates to the detection ofcrimes, criminal convictions, securitymeasures and investigation of massdestructions.

According to Article 4 of the DataProtection Act, the data controller shallensure that the collected personal dataare (a) processed fairly and lawfully; (b)collected for specified, explicit and le-gitimate purposes and are not furtherprocessed in a way incompatible withthose purposes and (c) relevant, appro-priate and not excessive in relation tothe purposes of processing.

Taking into consideration the currentpractice on the processing and collec-tion of personal data in the respectivedomain in Cyprus, the following data-bases are worthwhile to mention.

CCyypprriioott NNaattiioonnaall GGeenneettiicc DDaattaabbaassee

The Cypriot National Genetic Databaseor Cypriot Disease National Database21

(CNGD) is a repository of informationabout mutations leading to the inherit-ed disorders in the Cypriot population.

The CNGD is a National MutationFrequency Database that providescomprehensive information on the ob-served frequency of disease-causingmutations in the Cypriot population.The Cypriot National Genetic Databaseresults from the collaboration amongseveral investigators from Erasmus Me-dical Center (The Netherlands) andCyprus Institute of Neurology andGenetics (CING)22 supported by theHuman Genome Variation Society andco-financed by the European FP6 INCOgrant MedGeNet23 and by AsclepionGenetics in Switzerland.

CCyypprruuss IInnssttiittuuttee ooff NNeeuurroollooggyy aannddGGeenneettiiccss

The Cyprus Foundation for MuscularDystrophy Research is the parentorganization of the Cyprus Institute ofNeurology and Genetics. It was estab-lished in 1987 under the name Mus-cular Dystrophy Research Trust of Cyp-rus by the Cyprus Muscular Dystrophypatients’ association (MDA Cyprus). In1990 the Muscular Dystrophy Re-search Trust created the Institute andin 1995 the Trust was renamed as the

21 The Cypriot National Genetic Database is online available at: http://www.goldenhelix.org/cypriot/22 Kypriako Idryma Erevnon Gia Ti Myiki Distrofia or in English, the Cyprus Institute of Neurology andGenetics (CING). Further information is available at: http://srs.dl.ac.uk/arch/sesame/cyprus/kyriakou/kyri-akou.htm23 MedGeNet (Euro-Mediterranean Network for Genetic Services) is a project funded within the Specificmeasures in support of International Cooperation (INCO) in the 6th Framework Programme for Researchand Technological Development of the European Union. The primary objectives of MedGeNet is toexpand the human expertise in clinical genetics and cancer genetics in Mediterranean Partner Countries(MPC) through the transfer of knowledge and technology between the two rims of the Mediterraneanwhich share a common burden of genetic diseases. Through the creation of a Euro-Mediterranean Networkof Genetic Telecounselling and Telepathology consultation and advanced education for health profession-als and medical staff, the MedGeNet Project will enable developing countries to share a diagnostic data-base and carry out distant diagnosis of genetic diseases with the help of international experts. More infor-mation is available on the project at:http://cordis.europa.eu/fetch?CALLER=FP6_PROJ&ACTION=D&DOC=1&CAT=PROJ&QUERY=01230393a474:3659:1decd513&RCN=80006

Cyprus Foundation for Muscular Dys-trophy Research. The Cyprus Instituteof Neurology and Genetics (CING) pro-vides specialized services and researchin neurology, genetics, molecular biolo-gy, histopathology and virology. Morespecifically, the Institute is dedicatedto preventing diseases through patientcare, research and educational pro-grammes on neurological and geneticconditions such as muscular dystro-phy, multiple sclerosis, epilepsy, chro-mosomal abnormalities and all otheraspects of molecular biology andgenetics such as thalassaemia, mo-lecular virology, mental retardation,cardiovascular disease, stroke, cysticfibrosis and neurogenetics.

CClliinniiccaall GGeenneettiiccss CClliinniicc

Clinical Genetics Clinic offers servicesto people affected by or who may be atrisk of a genetic condition, which aimat the best possible quality of life andreproduction. At the Institute, theClinical Genetics department carriesout diagnostic assessment, manage-ment, treatment and genetic coun-selling for the whole spectrum ofgenetic conditions. This includes chro-mosomal aberration syndromes (e.g.Down syndrome, Williams syndrome),single gene disorders (e.g. achon-droplasia, Marfan syndrome, neurofi-bromatosis), mitochondrial diseases,multi-factorial conditions (e.g. spinabifida) and prenatal exposure syn-dromes. The process of genetic coun-selling involves not only the exchange

of information relating to the geneticdisorder and relevant laboratory resultsbut also supportive counselling. Theclinical genetics team consists of aclinical geneticist and a genetic coun-sellor. Clinics are held both at the Ins-titute and the Archbishop Makarios IIIhospital in Nicosia. Families are re-ferred by a variety of health and otherprofessionals as well as self-referrals.The department serves as a referencecentre for the whole of the island. Agenetic registry exists which is usedfor epidemiological data regarding theincidence and frequency of specificgenetic disorders in Cyprus.

BBaannkk ooff CCyypprruuss OOnnccoollooggyy CCeennttrree24

The Oncology Centre was founded in1998 with the donation of the Bank ofCyprus and operates in Nicosia. TheBank of Cyprus Oncology Centre estab-lished a Medical Research Ethics Com-mittee to consider applications for clin-ical trials to be carried out at the Centrein accordance with the Good ClinicalPractice Guidelines. The Centre oper-ates as an independent medical unitwhich is dedicated to provide servicesto cancer patients.25

5. PECUNIARY ASPECTS

In line with the Opinion of the CyprusNational Bioethics Committee (CNBC)regarding bioethical dilemmas ofumbilical cord banking by private profitmaking companies, any financial re-


24 Further information is available in Greek language at: http://www.bococ.org.cy/25 Information concerning the biobanks operating in Cyprus is based on the online database of the PrivirealProject. Available at: http://www.privireal.org/content/rec/cyprus.php

ward to the individuals that participatein and donate biological samples forresearch programs, is generally prohib-ited. Cord blood haematopoietic stemcells are considered to be part of thehuman body and as such Article of 21of the Oviedo Convention applies, stat-ing that “the human body and its partsshall not, as such, give rise to financialgain “. Moreover, Article 2 of the Ad-ditional Protocol states that “The provi-sions of this Protocol applicable to tis-sues shall apply also to cells, includinghaematopoietic stem cells”.

According to Article 17 of the DataProtection Act, the controller shallcompensate a data subject who hassuffered damage by reason of violationof any provision of this Law, unless heproves that he or she is not responsiblefor the event that caused the damage.

6. CONSENT

In accordance with Article 2 of the DataProtection Act, ‘consent’ “means theconsent of the data subject, any freelygiven, express and specific indicationof his or her wishes, clearly expressedand informed, by which the data sub-ject, having been previously informed,consents to the processing of personaldata concerning him or her.”

Article 5 of the Act also providesthat personal data may be processedonly if the data subject has unambigu-ously given his consent to it. How-ever, the personal data may be pro-cessed without the data subject’sconsent in case the processing is nec-

essary (1) for compliance with a legalobligation to which the controller issubject; (2) for the performance of acontract to which the data subject isparty, or in order to take measures atthe data subject’s request prior toentering into a contract; (3) in order toprotect the vital interests of the datasubject, (4) for the performance of atask carried out in the public interestor in the exercise of public authorityvested in the controller or a third partyto whom the data are communicated;(5) for the purposes of the legitimateinterests pursued by the controller orby the third party to whom the person-al data are communicated, on condi-tion that such interests override therights, interests and fundamental free-doms of the data subjects.

CCoonnsseenntt ooff mmiinnoorrss

According to Article 5(1) b) of Law No.216 of 1990 on Relations of Parentsand Children Law26 the person whoexercises parental care may take anynecessary or legal steps in the interestof the child. The definition of parentalcare also provides with the same provi-sions according to which it includesthe determination of the child’s name,care of the child, administration of thechild’s property, and representation ofthe child in his or her personal andproperty relations. Law 216 of 1990also declares parental care as a dutyand a right exercised by both parentswho are the representatives of thechild in all litigation. Both parents’ sig-


26 Law 216 of 1990 on the Relations of Parents and Children

nature is required to indicate parentalconsent and to represent their minorchildren in conformity with the law.27

7. ACCESS TO DATA OR SAMPLES,AND ANONYMITY

With a view to the cross-linking of data,Article 8 of Law No. 138 (III)/2001 setsforth that the combination of filing sys-tems is permitted only in accordancewith the conditions referred to in Articles5 and 8 of the Data Protection Act.

Article 8 provides that every combi-nation shall be notified to the DataProtection Commissioner by a state-ment submitted jointly by the data con-trollers or by the controller who willcombine two or more filing systemswhich have different purposes. If atleast one of the filing systems whichare to be combined contains sensitivedata or if the combination results in thedisclosure of sensitive data or if thecombination to be carried out a singlecode number is to be used, the combi-nation is permitted only with the priorlicense of the Data Protection Com-missioner and shall be issued in accor-dance with a prescribed form on pay-ment of the prescribed fees. In additionto the above, the approval of Data Pro-tection Commissioner for the combina-tion of two or more filing systems issubjected to an administrative pro-ceeding, during which the data con-trollers shall provide information on thepurpose for which the combination is

considered necessary; the category ofpersonal data to which the combina-tion relates; the period of time forwhich the combination is permitted;and any terms and conditions whichmay be imposed in order to protect therights and liberties, especially the rightto privacy of the data subjects or thirdparties.

Both the statements made underArticle 8 of the Act, as well as thecopies of the licence for combination,shall be filed in the Register of Com-binations, kept and maintained by theData Protection Commissioner.

Article 9 of the Protection of PersonalData Law lays down the relevant provi-sions on the processing of personaldata to third parties that is subjected tothe adequate level of protection avail-able at the respective country of therecipient. The relevant provisions of theProtection of Personal Data Law setforth that transmission of data whichhave undergone processing or areintended for processing after theirtransmission to any country shall bepermitted after a license of the Com-missioner. The Commissioner shallissue the license only if he or she con-siders that the said country ensures anadequate level of protection. For thispurpose, he or she shall take into con-sideration the nature of the data, thepurposes and duration of the process-ing, the relevant general and specialrules of law, the codes of conduct andthe security measures for the protec-


27 There was no parental authority in former Cypriot legislation in line with the (Article 4 and 6 of Cap277) Greek Civil Code, according to which solely the father had the right to guardianship. On the parents’joint representation see also Vathrakokolis, The New Family Law (1990) at p. 584, Stylioanon v Stylianon(1988) 1 CHR 520, Civil Appeal 7835, 9 October 1988 in which Supreme Court adopted the approachexclaimed by that author (In: Andreas Neoclous & Co., Introduction to Cyprus Law, Limassol, Cyprus,2000. Available at: http://www.neocleous.biz/en/download/ebook/neobook.pdf)

tion of data, as well as the level of pro-tection in the countries of origin, trans-mission and final destination of the data.

The transmission of personal data toa country which does not ensure anadequate level of protection, is permit-ted exceptionally after a license of theCommissioner, where one or more ofthe conditions are fulfilled as set forthin Article 9 Sections (2)-(3). The trans-mission is permitted if the data subjecthas given his or her consent to thetransmission or the transmission isnecessary in order to protect the vitalinterests of the data subject, or for theconclusion and performance of a con-tract, or for the implementation of pre-contractual measures which have beentaken in response to the data subject’srequest. The transmission is also per-mitted if it is necessary in order to dealwith an exceptional necessity for thesafeguard of a superior public interest,especially for the performance of con-ventions of co-operation with the pub-lic Authorities of the other country orfor the establishment, exercise or de-fence of legal claims before a Court.

The Data Protection Commissionermay also allow the transmission ofdata to a country which does notensure an adequate level of protection,provided that the controller providessufficient guarantees for the protectionof privacy and fundamental libertiesand the exercise of relevant rights andsuch guarantees may result from ap-propriate contractual clauses.

Article 10 of the Data Protection Actalso sets out that the processing ofdata is confidential. It shall be carriedout only by persons acting under theauthority of the controller or theprocessor and only upon instructionsfrom the controller.

Articles 11-12 set forth the basicrights of the data subject to the accessof his or her data. The controller shall,at the time of collection of the person-al data from the data subject, providethe latter, in an appropriate and explicitway, with at least the following infor-mation:(a) its identity and the identity of its re-

presentative, if any and(b) the purpose of the processing.

The controller shall also inform thedata subject on (a) the recipients or the categories of

recipients of the data; (b) the existence of the right of access

to and rectification of the data and(c) whether the data subject is obliged

to provide assistance, the pro-visions setting out this obligation,and the consequences of his or herrefusal, if any, provided that thisnotification is necessary for secur-ing in each case the legitimate pro-cessing.

However, Article 11 Section (4) alsodeclares that the obligation to informunder subsections (1), (2) and (3) may,on the application of the controller, bewaived wholly or partly, by decision ofthe Commissioner in case the collec-tion of personal data is performed forthe purposes of defence, nationalneeds or national security of the Re-public or for the prevention, detection,investigation and prosecution of crimi-nal offences.

Article 12 of the Data Protection Actsets out the legal provisions concerning I.) Information on the personal data

relating to the data subject that are orwere processed: (1) all the personaldata relating to him or her which


have undergone processing, as wellas any available information as totheir source; (2) the purposes of theprocessing, the recipients or thecategories of recipients, as well asthe categories of data which are orare to be processed; (3) the progressof the processing since his or herprevious briefing; (4) the logic whichevery automated process of data inrelation to the data subject, is based.

II.) The rectification, erasure or block-ing of the data, the processing ofwhich has not been performed inaccordance with the provisions ofthe Data Protection Act, especiallydue to inaccuracies or shortages.

III.) The notification to third parties, towhom the data have been commu-nicated, of every rectification, era-sure or blocking which is done as itis stated above in point II), unlessthis is impossible or it requires dis-proportionate efforts.

8. STORAGE

According to Article 4 of the DataProtection Act, the data controller shallensure that the collected personal dataare accurate and, where necessary,kept up to date. The data collector is al-so obliged to keep the collected data ina form which permits identification ofdata subjects for no longer than is nec-essary, in the Data Protection Com-missioner’s discretion, for the fulfil-ment of the purposes for which theywere collected and processed.

After the expiry of this period, theCommissioner may, by a reasoned de-cision, allow the preservation of per-sonal data for historical, scientific orstatistical purposes if he or she consid-ers that the rights of the data subjectsor third parties are not affected.

The data controller shall also beresponsible for the destruction of per-sonal data which have been collectedor which are further processed in con-travention of the provisions of data col-lection for historical, scientific or statis-tical purposes. If the Commissionerascertains, either on his own initiativeor following a complaint, that thedestruction of personal data has notbeen accomplished, he or she shallorder the interruption of the collectionor processing and the destruction ofthe personal data already collected orprocessed.

9. SUPERVISION, COMPENSATION,PENALTIES

The Ministry of Health and the NationalHealth Authority operate as overall su-pervisory authorities in relation to theestablishment and operation of humantissue banks or databases.

Furthermore, the Human TissueAuthority28 is established under the Di-rector of Medical Services at the Mi-nistry of Health and regulates the safe-ty of human tissues in accordance withEU Directives 2004/23/EC, 2006/ 86/ECand 2006/17/EC. The Authority oper-ates as the licensing and supervisory


28 Further information is available at:http://www.moh.gov.cy/moh/moh.nsf/All/6EBB7741AA4C7359C225759000389FF4?OpenDocument29 Information concerning the Bioethics Committees operating in Cyprus is based on the online database ofthe Privireal Project. Available at: http://www.privireal.org/content/rec/cyprus.php

authority in relation to the establish-ment and operation of tissue banks.

Besides the aforementioned govern-mental bodies the operation of bio-ethics committees ensured the the re-view of legal, social and ethical issuesthat arisen in the domain of human tis-sues and transplantation.

There are four ethics committees inCyprus29. The first one is operated with-in the framework of the PancyprianMedical Association, the second isestablished by the Bank of CyprusOncology Centre and the Cyprus Ins-titute of Neurology and Genetics is alsoengaged in managing an ethical com-mittee and lastly the National BioethicsCommittee was established by theBioethics Law and has been operatedsince October 2002. The National Bio-ethics Committee discusses bioethicalissues and publishes its opinions to thepublic, it can consider issues that ittables on its own agenda, or that areproposed by the Ministry of Health, theParliament or the public. The NationalBioethics Committee consists of 13members who are appointed by theCouncil of Ministers.

It also has to be noted, that Law No.150(I) of 2001, the so-called BioethicsLaw on the Establishment of theBioethics Committee sets forth the legaldefinition of bioethics. According to Bio-ethics Law “‘bioethics’ means the studyof ethical, deontological, social, humanis-tic and legal problems that emerge fromthe use of modern biotechnology, biolo-gy, medicine, genetics and pharmaceu-tics but mainly they are caused by humanintervention on the biological procedureand on the human genotype based on

the precautionary principle and thepromotion of health.”

The above mentioned OperationalGuidelines also provides detailed regu-lations on the establishment and man-agement of ethics committees includ-ing their composition and operation inCyprus. The Guidelines also sets outthat independently from the follow-upprocedures of a program by an ethicscommittee, the Cyprus National Bio-ethics Committee has the right, when-ever it considers necessary and/or app-ropriate within its terms of reference,to proceed with its own investigationson the ethical evaluation of any pro-gram and take any decisions it deemsappropriate for the reviewed program.Within these lines, the Cyprus NationalBioethics Committee has the right tomodify, suspend, terminate or to con-firm the initial decision of an ethicscommittee. The decision of the CyprusNational Ethics Committee is final andbinding to all parties.

PPaannccyypprriiaann MMeeddiiccaall AAssssoocciiaattiioonn3300

The Pancyprian Medical Association isresponsible for the approval of propos-als for medical research proposals.

CCyypprruuss NNaattiioonnaall BBiiooeetthhiiccss CCoommmmiitttteeee

The Cyprus National Bioethics Com-mittee (CNBC) was established by theParliament in April 2000. The thirteenmembers of the Committee are ap-pointed by the Council of Ministry ofHealth for a period of four years andmay be re-appointed for a second four-year term. The members of the CNBC


30 http://www.cyma.org.cy/

are responsible for considering propos-als for biomedical research and makingrecommendations to researchers ac-cording to the Helsinki Declaration.31

The National Bioethics Committee – ifpossible – is composed of 4 membersfrom the sociology or anthropology dis-ciplines, 4 members from the medicalor biological disciplines and 4 membersfrom any discipline, who have beenacknowledged in the country for theiracclaimed work. The CNBC is estab-lished by Law No. 150(I) of 2001 on theestablishment and operation of the Na-tional Bioethics Committee.32 The Cyp-rus National Bioethics Committee is anindependent body and is not subject tothe administrative control of any min-istry, independent officer, departmentor service and has the powers stipulat-ed by the Law No. 150(I) of 2001 Lawproviding for the Establishment andFunction of the National BioethicsCommittee or any other Law (Article 3Section (2)). The Bioethics Committee isoperated with particular regard for theconduct of research that may affect thephysical and mental condition of thepatient, the environment and animals.The CNBC determines ethical standardsor policies for research with human

beings and reviews the ethical aspectsof research projects. Anyone may sub-mit an application to the NationalBioethics Committee who intends toconduct a clinical trial. All clinical trialsare authorized to begin only uponapproval by the National BioethicsCommittee and the National HealthAuthority (so called Medicines Councilor Pharmaceutical services). Neverthe-less, there is no procedural interactionbetween the two authority during theapproval process.

The Cyprus National Bioethics Com-mittee has adopted with very fewchanges the “Operational Guidelinesfor Ethics Committees that ReviewBiomedical Research”33 formulated bythe World Health Organization, to formthe basis of the operational guidelinesfor the establishment of ethics commit-tees in reviewing biomedical researchinvolving human subjects in Cyprus.

The CNBC has been adopted the fol-lowing opinions as part of its duty.• Opinion of the Cyprus National Bio-

ethics Committee on choosing a futurechild´s sex using the preimplantationgenetic diagnosis (PGD) method (2006)

• Palliative Care (2008)• Genetically Modified Organisms (2008)


31 World Medical Association Declaration of Helsinki on the Ethical Principles for Medical ResearchInvolving Human Subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964.Available at: http://www.wma.net/e/policy/b3.htm32 Law No. 150(I) of 2001 on the establishment and operation of the National Bioethics Committee (Lawof 2001 on bioethics (establishment and operation of the National Bioethics Committee)). Original textpublished in Episκmκ Ephκmerida tκs Kypriakκs Dκmokratias, Part I, 14 December 2001, No. 3558, pp.1159 et seq.) Available at: http://www.bioethics.gov.cy/Law/cnbc/cnbc.nsf/All/C2E546EBAEB075EDC22571C9002BE3A1/$file/The Bioethics Establishment and Function of the National Bioethics CommitteeLaw - English Translation.pdf33 The Operational Guidelines for the establishment of ethics committees in reviewing biomedical researchinvolving human subjects in Cyprus which were enacted on 31.3.2005 (Κ.∆.Π. 175/2005) is available at:http://www.bioethics.gov.cy/Law/cnbc/cnbc.nsf/All/0CEAB26AC17DB109C22571C9002D8EE0/$file/EEBK000 UK Operational Guidelines.pdf


34 Further information is available at: http://srs.dl.ac.uk/arch/sesame/cyprus/kyriakou/kyriakou.htm

• Predictive health information for insu-rance purposes (2008)

• Opinion of the Cyprus National Bio-ethics Committee regarding bioethi-cal dilemmas of umbilical cord bloodbanking by private profit makingcompanies (2004)

• Prenuptial test for thalassaemia be-fore the conclusion of a civil weddingin Cyprus (2008)

• Opinion of the Cyprus National Bio-ethics Committee on Medically As-sisted Human Fertilization (2007)

In accordance with the aforementio-ned operational guidelines Law 150(I)/2001, the Committee formed threeReview Bioethics Committees theMembers of which are appointed for aperiod of two years:

I. The Review Bioethics Committee forBiomedical Research on HumanBeings and their biological substancesthat review protocols relating to bio-medical research on human beingsand their biological substances,

II. The Review Bioethics Committee forthe clinical trials on MedicinalProducts of Human Use and

III. The Review Bioethics Committee forBiomedical Research on HumanBeing and their biological substancesand the clinical trials on MedicinalProducts of Human Use that reviewprotocols relating to medical devicesapplied on human beings.

The Role of the Review BioethicsCommittees is to contribute to safe-guarding the dignity, rights, safety andwell-being of all actual or potential re-search participants. In order to fulfil their

duty the Committees provide indepen-dent review of the ethical aspects ofproposed studies and is responsible forcarrying out the review of research pro-posals before the commencement ofthe research.

The CNBC monitors, directs, coordi-nates, and reviews the work performedby the above three Review BioethicsCommittees.

MMeeddiiccaall RReesseeaarrcchh EEtthhiiccss CCoommmmiitttteeee oofftthhee BBaannkk ooff CCyypprruuss OOnnccoollooggyy CCeennttrree

The Bank of Cyprus Oncology Centre is anindependent legal entity registered as aCharity under the Charities Law, Cap. 41.The Bank of Cyprus Oncology Centre es-tablished a Medical Research Ethics Com-mittee to consider applications for clinicaltrials to be carried out at the Centre inaccordance with the Good ClinicalPractice Guidelines. The Committee,which was established based on theGuidelines of the Royal College ofPhysicians of London and the Code cur-rently used by the Greek National EthicsCommittee, operates according to theprinciples set out in the Helsinki De-claration. The Department of Pharma-ceutical Services of the Ministry of Healthin Cyprus is informed whenever a study isapproved and takes place at the Centre.

EEtthhiiccss CCoommmmiitttteeee ooff tthhee CCyypprruussIInnssttiittuuttee ooff NNeeuurroollooggyy aanndd GGeenneettiiccss

The Ethics Committee of the CyprusInstitute of Neurology and Genetics(CING)34 was established in 1994 by the


35 Opinion of the Cyprus National Bioethics Committee on the Choosing a future child’s sex using thePreimplantation Genetic Diagnosis (PGD) method. Adopted in Nicosia, 31 October 2006. Available at:http://www.bioethics.gov.cy/Law/cnbc/cnbc.nsf/All/180DFD1206CF2D06C22573090021A032/$file/OPINION OF THE CYPRUS NATIONAL BIOETHICS COMMITTEE CHOICE OF SEX.pdf36 http://www.cyprus-mail.com/news/main.php?id=42065&cat_id=1

Scientific Council of the Institute, thefirst of its kind in Cyprus. The aim of theCommittee is to review research proj-ects carried out at CING involvinghuman subjects and/or samples, whichnow require the Committee’s approval.The Ethics Committee adopted andperforms its duties in line with the pro-visions of the Helsinki Declaration andthe European Union’s guidelines ongood clinical practice. The Cyprus Go-vernment provides the Institute with anannual grant towards the services pro-vided to the public health sector (gov-ernment hospitals). The Institute alsohas an agreement with the governmentfor the provision of forensic services.

10. PUBLIC DEBATE

In ‘Social values, Science andTechnology’ (Special Eurobarometer225/ Wave 63.1) respondents wereasked: ‘How important do you thinkprotecting information about our pri-vate life from misuse and exploitationwill be for our society in ten yearstime?’. In all countries, a majoritybelieves that protecting such informa-tion is very important. Similarly in

Cyprus, 76 % thinks it is very importantand 17 % believes it is fairly important.

The Cyprus National Bioethics Com-mittee (CNBC), at a meeting on 31October 2006 considered an articlepublished on the internet reportingthat, couples from Sweden come toCyprus in order to perform Preimplan-tation Genetic Diagnosis (PGD) so as tochoose the sex of their future child. TheCNBC adopted its opinion on Choosinga future child’s sex using the Pre-implantation Genetic Diagnosis (PGD)method35 and emphasizes in its opinionthat according to Article 14, of theOviedo Convention “the use of tech-niques of medically assisted procre-ation shall not be allowed for the pur-pose of choosing a future child’s sex,except where serious hereditary sexrelated disease is to be avoided” .

In 2008, after its six years of opera-tion, the National Bioethics Committeesubmitted its request again for a de-cent amount of state support for cover-ing its management and activities. Al-though, the Bioethics ConsultativeCommittee was established in 2002 byLaw No. 150(I) of 2001, the budget app-roved by the Health Ministry was de-scribed as insufficient.36


1. DEFINITION OF FORENSIC BIOBANKS

Although there is no legal definition forforensic databases in the Cypriot legisla-tion, according to Article 6 of the PersonalData Protection Act, the collection and pro-cessing of sensitive data, is permitted forthe interest of criminal investigation.

It also has to be noted that despite pastviolence and the consequent division ofthe country to Northern Turkish andSouthern Greek Cypriot regions, statisticsfor the Republic of Cyprus point to a crimerate that is lower than that of most otherwestern European countries. A crime rateof 6.44 crimes per 1,000 inhabitants37

shows a low incidence of crime in Cyprus.Although, there is a low crimes rate inCyprus, the cases of missing persons inrelation to inter-communal fighting as wellas in connection to the events of July197438 and the period afterwards are con-sidered to be the most relevant field for theusage of forensic databases and services.

2. RELEVANT LAWS

Since there is no specific legal instrumentfor the regulation of forensic databases,the National Database operates under thescope of the Protection of Personal DataLaw. Thus the relevant provisions of theProtection of Personal Data Law are alsoapplicable to forensic databases and thecollection of genetic information in Cyprus

for investigating purposes. Apart of theabove mentioned provisions set forth inthe Protection of Personal Data Law, theCriminal Code (1962-L-72604), theEvidence Law of 1994 (Chap. 9, N. 94(I)/94) and its Regulations are worth men-tioning. In relation to the duties of thepolice the Police Law, Law No. 73(I.) 2004and the General Police Regulations (No.51/89) have to be noted.

Furthermore, it should be mentionedthat the Cypriot Police Force is operatedunder the guidance of the Code of PoliceEthics which is based on the EuropeanCode of Police Ethics, adopted by thecommittee of Ministers on 19 September2001 at the 765th Meeting of the Ministers’Deputies of the Council of Europe,Strasbourg.

3. ESTABLISHMENT OF FORENSICBIOBANKS

The establishment and maintenance offorensic biobanks (such as forensic labora-tories and databases) are carried by thepolice on the basis of the Personal DataProtection Law. There are three institu-tions that are worthwhile to mention inrelation to the provision of forensic servic-es and the maintenance of forensic data-bases in Cyprus: the so-called CriminalisticServices operated at the Police Headquar-ters, the State General Laboratory andfinally the Laboratory of Forensic Genetics

37 Further data is available at: http://www.country-data.com/cgi-bin/query/r-3616.html38 The Turkish invasion in Cyprus launched on 20 July 1974. Further information is available at the web-site of the Committee on Missing Persons in Cyprus http://www.cmp-cyprus.org/nqcontent.cfm?a_id=1343&tt=graphic&lang=l1

II. FORENSIC BIOBANKS

(LabFoG) of the Cyprus Institute of Neu-rology and Genetics. The National Data-base was established in 1998 and its man-aged by the Cyprus Police Headquarters inclose collaboration with the Laboratory ofForensic Genetics of the Cyprus Instituteof Neurology and Genetics. The databasecontains genetic profiles, name and sur-name of the donor, information on IDs andthe donor’s passport number.

The searches for matching profiles canbe asked on the basis of crime stains, con-victed individuals or missing persons. Inaddition to the above in the report of amatch, the sample numbers, date of entryof the profiles and the DNA samples areprovided to the requester.39

CCrriimmiinnaalliissttiicc SSeerrvviicceess

The Criminalistic Services (CSCP), situatedat the Police Headquarters, is the mainprovider of forensic science support to theCriminal Justice system of the Republic ofCyprus. The Criminalistic Services wasfounded in 1950. At the early stages, itsfive-member personnel provided only fin-gerprint expertise. Since Cyprus Indepen-dence in 1960, CSCP is the major providerof professional forensic science servicesto support the Police, the judicial investiga-tion and the prosecution of crime in theisland. Any exhibits requiring examinationsof forensic parameters that are not cov-ered in the Services are forwarded to otherOrganisations in Cyprus, with which excel-lent co-operation has been established,(Institute of Genetics, Governmental Gene-ral Lab, Geological Dept, Nicosia GeneralHospital, Veterinary Services) or to labora-tories operated abroad. The Criminalistic

Services consist of seven labs that carryout forensic examinations on fingerprints,firearms, toolmarks, shoemarks, trace evi-dence, forged documents, counterfeit cur-rency and crime scene work in seriouscases.40

SSttaattee GGeenneerraall LLaabboorraattoorryy

The State General Laboratory (S.G.L.) hasbeen developed to control, monitor andapply research and operate as an advisoryservices centre for the public sector, rec-ognized at local, national and Europeanlevel. It is the official Government Labo-ratory fulfilling the requirements embodiedin the laws pertaining to the chemical, bio-logical/microbiological and toxicologicalindustry in Cyprus, operating as a nationalcontrol centre of foodstuff, pharmaceuti-cals, narcotics and police exhibits.

The State General Laboratory comprises19 laboratories. Each laboratory is special-ized and dedicated to its own area of work.The function and scope of each laboratoryis stated in its own Quality Manual, whichis a part of the SGL’s Quality AssuranceSystem. The Laboratory No.3 is the Foren-sic Chemistry And Toxicology Laboratoryaccredited according to ISO/IEC/EN 17025(formerly ISO Guide 25 & EN45001 on theGeneral Requirements for the Compe-tence of Calibration and Testing Laborato-ries). The General State Laboratory has su-pervisory authority over the Forensic Che-mistry and Toxicology Laboratory.

The aim of the Forensic Chemistry andToxicology Laboratory (No. 3) is to providereliable analytical data in an impartial andobjective way. The Physical SciencesForensic Laboratory trace evidence analy-


39 Information is based on DNA Databases to Assist with Criminal Investigations, Replies to theQuestionnaire on National DNA Databases, Council of the European Union Brussels, 16 June 2006 40 http://www.police.gov.cy/police/police.nsf/dmldept5_en/dmldept5_en?OpenDocument

sis (paint/fibres/glass/plastics), performanalysis of inks and paper, examination ofhairs (for species identification), chemicalrestoration of erased numbers on metallicsurfaces, blood, semen stains identifica-tion (K.M. test / A. P. test) and visiting seri-ous scenes of crime for specialized takingsamples.

The laboratory covers the forensic areasof illegal drugs and psychotropic sub-stances, arson, explosives and explosiveresidues, criminal traces. As a forensic tox-icology service it covers the analysis ofblood alcohol, illegal drugs/psychotropicsubstances, drugs, pesticides, carbonmonoxide and other poisons. It also coverschemicals/metals in biological samples.Applied research is implemented in casesof method development and/or where fur-ther analytical investigation of certaincases can enhance the gathering of evi-dence as well as facilitate justice in thejudicial process. The laboratory staff pro-vides expert witness testimony for courtsconcerning examinations conducted bythe laboratory after official request by sum-mons. Credibility, honesty and impartialityfollowed by the ability to transfer scientificevidence and opinion to court are the aimsof the laboratory. Its activities coverexchanging forensic science knowledgewith Forensic Laboratories in Europe andUSA for combating crime and participatingin the sharing of information on illegal/psy-chotropic substances through an officialchannel established by the Drug Enfor-cement Agency (USA) for controlling theirabuse and trafficking. The laboratory car-ries out gunshot residue analysis with theElectron Microscope on samples takenfrom the hands, clothes etc. of suspects.These analyses concern serious cases ofmurder, shootings, suicides etc.

The aim of the Forensic Science andToxicology Laboratory is to provide reliablelaboratory data and to give impartial andobjective scientific expert witnessing incourt, to support the police, law enforce-ment authorities as well as internationalefforts in the fight against crime, drug traf-ficking and terrorism. Also, its assistanceto forensic coroners in unnatural deathinvestigations as well as its role in assist-ing with emergency hospital poisoningcases is of vital importance. The laboratorycovers the following areas of activity:Analysis of narcotics and psychoactivesubstances. Analysis of exhibits fromcrime scenes involving arson, explosivesand other trace evidence. Analysis of bio-logical samples for the determination ofalcohol, narcotics and psychoactive drugs,pesticides, carbon monoxide, heavy met-als and other poisons.

CCyypprruuss IInnssttiittuuttee ooff NNeeuurroollooggyy aanndd GGeenneettiiccss

The Institute also has an agreement withthe government for the provision of foren-sic services and plays a key role in the fightagainst crime by providing specialized DNAservices to the police authorities and expertcourt testimony for criminal and civil inves-tigations. The Institute provides services, asrequested, to all doctors, clinics, hospitals,lawyers and the Police Authorities.

According to the website of the Com-mittee of Missing Persons in Cyprus,41 theLaboratory of Forensic Genetics (LabFoG)of the Cyprus Institute of Neurology andGenetics in Nicosia is responsible for carry-ing out the Genetics phase (DNA analysisand matching) of the CMP (Committee ofMissing Persons) project.42 According toArticle 7 of the Terms of Reference of theCommittee on Missing Persons in Cyp-


41 http://www.cmp-cyprus.org/nqcontent.cfm?a_id=1&tt=graphic&lang=l142 http://www.cmp-cyprus.org/nqcontent.cfm?a_id=1316&tt=graphic&lang=l1

rus:43 “The Committee [on Missing Per-sons in Cyprus] shall look only into casesof persons reported missing in the inter-communal fighting as well as in the eventsof July 1974 and afterwards.”44

4. SAMPLES AND SAMPLE TAKING,CONSENT

According to Article 6 of the Data Pro-tection Act, processing of sensitive data isprohibited, unless the processing is neces-sary for the purposes of national needs ornational security, as well as criminal andreform policy, and is performed by a serviceof the Republic or an Organisation orFoundation authorized for this purpose by aservice of the Republic and relates to thedetection of crimes, criminal convictions,security measures and investigation ofmass destructions.

The police are allowed to take a samplefrom minors if the legal guardian consentsor upon court order. In the latter case, thecourt shall take the legal guardian’s positionand the case circumstances into account.The same requirements are also valid formentally ill persons with the additional con-dition that a medical advice is needed.45

5. PURPOSE AND SCOPE OFCOLLECTION

Beside the provisions sets out underArticle 4 of the Protection of Personal DataLaw, Article 35-36 of the Police Ethic Code

repeat the regulations on the legal bound-aries of collecting, processing and storingof personal data. The Police Ethics Codeprovides that the police is allowed to inter-fere with an individual’s right to privacywhen it is strictly necessary and only toobtain a legitimate objective. AdditionallyArticle 36 sets forth that the collection,storage and use of personal data by thepolice is carried out in accordance with theProtection of Personal Data Law (Law No.138/(I) 2001) and international data protec-tion principles. In particular, this is limitedto the extent necessary for the perform-ance of lawful, legitimate and specific pur-poses.

The police can only coercively sample acrime suspect upon court order. Other-wise, written consent of the suspect isneeded. A sample can be taken from aconvicted offender as soon as he or shehas been sentenced. There are no restric-tions to the collection of crime scenestains46.

6. ACCESS TO DATA AND SAMPLES

The request for obtaining information fromthe National Database must be submittedthrough the Cyprus Police Headquartersand the Director of the Laboratory ofForensic Genetics is entitled to grant ac-cess to the information stored in the data-base. Solely the Director of the Laboratoryof Forensic Genetics and the personnel(e.g. staff members) are authorized by the


43 Terms of Reference on the Establishment of the Committee on Missing Persons in Cyprus, 1981.Available at: http://www.cmp-cyprus.org/media/attachments/CMP/CMP docs/Terms_of_Reference_1981.pdf44 As a result of the violence generated during those times, a total of 502 Turkish Cypriots and 1493 GreekCypriots were officially reported as missing by both communities to the Committee on Missing Persons inCyprus (CMP). 45 Information is based on N. van Camp, et al., National Forensic DNA Databases in the EU, EuropeanEthical-Legal Papers N°9, Leuven, 2007. pp. 39-40.46 Information is based on N. van Camp, et al., National Forensic DNA Databases in the EU, EuropeanEthical-Legal Papers N°9, Leuven, 2007. pp. 39-40.

Director to have access to the NationalDatabase.47

Considering the usage of cross-linkingdata, Article 8 of Law No. 138 (III)/2001sets forth that the combination of filingsystems is permitted only in accordancewith the conditions referred to in Article 5and Article 8 of the Data Protection Act.Furthermore, Article 24 Section (1) ofProtection of Personal Data Law providesthe Data Protection Commissioners dutyon keeping the Registers as set out in theAct. Article 24 Section (1) e) stipulates thatthe Commissioner is obliged to maintain a‘Register of Confidential Filing Systems’, inwhich there shall be recorded, after anapplication of the controller and a decisionof the Commissioner, the filing systemskept by the Ministers of Justice and PublicOrder and Defence and the Public Infor-mation Office, for purposes of national se-curity or the detection of particularly seri-ous crimes. Combinations with at leastone such filing system shall also be filed inthe Register of Confidential Filing Sys-tems. According to the Protection ofPersonal Data Law, the Registers set out inArticle 24 Section (1) a)-d) shall be accessi-ble to every person, however the access tothe Register of Confidential Filing Systemsis limited and subjected to the approval ofthe Data Protection Commissioner.

With a view to the right of access to per-sonal data, as it is set forth in Article 12 ofthe Data Protection Act, the Act also dec-lares, that by a decision of the Com-missioner, on application by the controller,the obligation to inform the data subject inline with Article 12 Sections (1)-(2) may be

waived, wholly or partly, where the pro-cessing of personal data is performed forpurposes relating to national needs or tothe national security of the Republic or forthe prevention, investigation, detectionand prosecution of criminal offences. Con-sidering the international cooperation,DNA profiles can be exchanged with otherEU Member States through Interpol con-tact points. Furthermore the cooperationagreements of Cyprus and all Interpolmember countries allow mutual consulta-tion of DNA databases and exchange ofprofiles.

7. STORAGE

The DNA profiles of crime suspects col-lected for police purposes have to beremoved from the database when nocharges have been filed against them orupon their acquittal. Nevertheless the DNAprofiles of convicted offenders has to beretained indefinitely unless the person’scriminal record is cleared according to theRe-establishment Act. The DNA profilesthat are derived from unidentified crimescene stains are retained on the databaseuntil they are identified. Although DNAsamples of crime suspects can be retainedup to the stage of court hearing or until thecompletion of an investigation, if no char-ges are filed or the person is not sen-tenced by the court, the DNA sample hasto be removed from the database. TheDNA samples of convicted offenders areretained indefinitely unless the person’scriminal record is cleared according to theRe-establishment Act.48


47 Information is based on N. van Camp, et al., National Forensic DNA Databases in the EU, EuropeanEthical-Legal Papers N°9, Leuven, 2007. pp. 39-40.48 N. van Camp, et al., National Forensic DNA Databases in the EU, European Ethical-Legal Papers N°9,Leuven, 2007. pp. 39-40.

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