Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes

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1 Council of Europe Trety Series - No. 203 Additionl Protocol to the Convention on Humn Rights nd Biomedicine concerning Genetic Testing for Helth Purposes Strsourg, 27.XI.2008

2 2 CETS 203 Humn Rights nd Biomedicine (Protocol on Genetic Testing for Helth Purposes), 27.XI.2008 Premle The memer Sttes of the Council of Europe, the other Sttes nd the Europen Community, signtories to this Additionl Protocol to the Convention for the Protection of Humn Rights nd Dignity of the Humn Being with regrd to the Appliction of Biology nd Medicine (hereinfter referred to s the Convention on Humn Rights nd Biomedicine, ETS No. 164), Considering tht the im of the Council of Europe is the chievement of greter unity etween its memers nd tht one of the methods y which this im is pursued is the mintennce nd further relistion of humn rights nd fundmentl freedoms; Considering tht the im of the Convention on Humn Rights nd Biomedicine, s defined in Article 1, is to protect the dignity nd identity of ll humn eings nd gurntee everyone, without discrimintion, respect for their integrity nd other rights nd fundmentl freedoms with regrd to the ppliction of iology nd medicine; Bering in mind the Convention for the Protection of Individuls with regrd to Automtic Processing of Personl Dt (ETS No. 108) of 28 Jnury 1981; Bering in mind the work crried out y other intergovernmentl orgnistions, in prticulr the Universl Declrtion on the Humn Genome nd Humn Rights, endorsed y the Generl Assemly of the United Ntions on 9 Decemer 1998; Reclling tht the humn genome is shred y ll humn eings, therey forming mutul ond etween them while slight vritions contriute to the individulity of ech humn eing; Stressing the prticulr ond tht exists etween memers of the sme fmily; Considering tht progress in medicl science cn contriute to sving lives nd improving their qulity; Acknowledging the enefit of genetics, in prticulr genetic testing, in the field of helth; Considering tht genetic services in the field of helth form n integrl prt of the helth services offered to the popultion nd reclling the importnce of tking pproprite mesures, tking into ccount helth needs nd ville resources, with view to providing equitle ccess to genetic services of pproprite qulity; Awre lso of the concerns tht exist regrding possile improper use of genetic testing, in prticulr of the informtion generted therey;

3 3 CETS 203 Humn Rights nd Biomedicine (Protocol on Genetic Testing for Helth Purposes), 27.XI.2008 Reffirming the fundmentl principle of respect for humn dignity nd the prohiition of ll forms of discrimintion, in prticulr those sed on genetic chrcteristics; Tking into ccount ntionl nd interntionl professionl stndrds in the field of genetic services nd the previous work of the Committee of Ministers nd the Prlimentry Assemly of the Council of Europe in this field; Resolving to tke such mesures s re necessry to sfegurd humn dignity nd the fundmentl rights nd freedoms of the individul with regrd to genetic testing for helth purposes, Hve greed s follows: Chpter I Oject nd scope Article 1 Oject nd purpose Prties to this Protocol shll protect the dignity nd identity of ll humn eings nd gurntee everyone, without discrimintion, respect for their integrity nd other rights nd fundmentl freedoms with regrd to the tests to which this Protocol pplies in ccordnce with Article 2. Article 2 Scope 1 This Protocol pplies to tests, which re crried out for helth purposes, involving nlysis of iologicl smples of humn origin nd iming specificlly to identify the genetic chrcteristics of person which re inherited or cquired during erly prentl development (hereinfter referred to s genetic tests ). 2 This Protocol does not pply: to genetic tests crried out on the humn emryo or foetus; to genetic tests crried out for reserch purposes. 3 For the purposes of prgrph 1: nlysis refers to: i ii iii chromosoml nlysis, DNA or RNA nlysis, nlysis of ny other element enling informtion to e otined which is equivlent to tht otined with the methods referred to in su-prgrphs.i. nd.ii.; iologicl smples refers to: i ii iologicl mterils removed for the purpose of the test concerned, iologicl mterils previously removed for nother purpose.

4 4 CETS 203 Humn Rights nd Biomedicine (Protocol on Genetic Testing for Helth Purposes), 27.XI.2008 Chpter II Generl provisions Article 3 Primcy of the humn eing The interests nd welfre of the humn eing concerned y genetic tests covered y this Protocol shll previl over the sole interest of society or science. Article 4 Non-discrimintion nd non-stigmtistion 1 Any form of discrimintion ginst person, either s n individul or s memer of group on grounds of his or her genetic heritge is prohiited. 2 Approprite mesures shll e tken in order to prevent stigmtistion of persons or groups in reltion to genetic chrcteristics. Chpter III Genetic services Article 5 Qulity of genetic services Prties shll tke the necessry mesures to ensure tht genetic services re of pproprite qulity. In prticulr, they shll see to it tht: c genetic tests meet generlly ccepted criteri of scientific vlidity nd clinicl vlidity; qulity ssurnce progrmme is implemented in ech lortory nd tht lortories re suject to regulr monitoring; persons providing genetic services hve pproprite qulifictions to enle them to perform their role in ccordnce with professionl oligtions nd stndrds. Article 6 Clinicl utility Clinicl utility of genetic test shll e n essentil criterion for deciding to offer this test to person or group of persons. Article 7 Individulised supervision 1 A genetic test for helth purposes my only e performed under individulised medicl supervision. 2 Exceptions to the generl rule referred to in prgrph 1 my e llowed y Prty, suject to pproprite mesures eing provided, tking into ccount the wy the test will e crried out, to give effect to the other provisions of this Protocol.

5 5 CETS 203 Humn Rights nd Biomedicine (Protocol on Genetic Testing for Helth Purposes), 27.XI.2008 However, such n exception my not e mde with regrd to genetic tests with importnt implictions for the helth of the persons concerned or memers of their fmily or with importnt implictions concerning procretion choices. Chpter IV Informtion, genetic counselling nd consent Article 8 Informtion nd genetic counselling 1 When genetic test is envisged, the person concerned shll e provided with prior pproprite informtion in prticulr on the purpose nd the nture of the test, s well s the implictions of its results. 2 For predictive genetic tests s referred to in Article 12 of the Convention on Humn Rights nd Biomedicine, pproprite genetic counselling shll lso e ville for the person concerned. The tests concerned re: tests predictive of monogenic disese, tests serving to detect genetic predisposition or genetic susceptiility to disese, tests serving to identify the suject s helthy crrier of gene responsile for disese. The form nd extent of this genetic counselling shll e defined ccording to the implictions of the results of the test nd their significnce for the person or the memers of his or her fmily, including possile implictions concerning procretion choices. Genetic counselling shll e given in non-directive mnner. Article 9 Consent 1 A genetic test my only e crried out fter the person concerned hs given free nd informed consent to it. Consent to tests referred to in Article 8, prgrph 2, shll e documented. 2 The person concerned my freely withdrw consent t ny time. Chpter V Persons not le to consent Article 10 Protection of persons not le to consent Suject to Article 13 of this Protocol, genetic test on person who does not hve the cpcity to consent my only e crried out for his or her direct enefit.

6 6 CETS 203 Humn Rights nd Biomedicine (Protocol on Genetic Testing for Helth Purposes), 27.XI.2008 Where, ccording to lw, minor does not hve the cpcity to consent, genetic test on this person shll e deferred until ttinment of such cpcity unless tht dely would e detrimentl to his or her helth or well-eing. Article 11 Informtion prior to uthoristion, genetic counselling nd support 1 When genetic test is envisged in respect of person not le to consent, the person, uthority or ody whose uthoristion is required shll e provided with prior pproprite informtion in prticulr with regrd to the purpose nd the nture of the test, s well s the implictions of its results. Approprite prior informtion shll lso e provided to the person not le to consent in respect of whom the test is envisged, to the extent of his or her cpcity to understnd. A qulified person shll e ville to nswer possile questions y the person, uthority or ody whose uthoristion is required, nd, if pproprite, the person in respect of whom the test is envisged. 2 The provisions of Article 8, prgrph 2, shll pply in the cse of persons not le to consent to the extent of their cpcity to understnd. Where relevnt, pproprite support shll e ville for the person whose uthoristion is required. Article 12 Authoristion 1 Where, ccording to lw, minor does not hve the cpcity to consent to genetic test, tht test my only e crried out with the uthoristion of his or her representtive or n uthority or person or ody provided for y lw. The opinion of the minor shll e tken into considertion s n incresingly determining fctor in proportion to his or her ge nd degree of mturity. 2 Where, ccording to lw, n dult does not hve the cpcity to consent to genetic test ecuse of mentl disility, disese or for similr resons, tht test my only e crried out with the uthoristion of his or her representtive or n uthority or person or ody provided for y lw. Wishes relting to genetic test expressed previously y n dult t time where he or she hd cpcity to consent shll e tken into ccount. The individul concerned shll, to the extent of his or her cpcity to understnd, tke prt in the uthoristion procedure.

7 7 CETS 203 Humn Rights nd Biomedicine (Protocol on Genetic Testing for Helth Purposes), 27.XI Authoristion to tests referred to in Article 8, prgrph 2, shll e documented. 4 The uthoristion referred to in prgrphs 1 nd 2 ove my e withdrwn t ny time in the est interests of the person concerned. Chpter VI Tests for the enefit of fmily memers Article 13 Tests on persons not le to consent Exceptionlly, nd y derogtion from the provisions of Article 6, prgrph 1, of the Convention on Humn Rights nd Biomedicine nd of Article 10 of this Protocol, the lw my llow genetic test to e crried out, for the enefit of fmily memers, on person who does not hve the cpcity to consent, if the following conditions re met: c d e f the purpose of the test is to llow the fmily memer(s) concerned to otin preventive, dignostic or therpeutic enefit tht hs een independently evluted s importnt for their helth, or to llow them to mke n informed choice with respect to procretion; the enefit envisged cnnot e otined without crrying out this test; the risk nd urden of the intervention re miniml for the person who is undergoing the test; the expected enefit hs een independently evluted s sustntilly outweighing the risk for privte life tht my rise from the collection, processing or communiction of the results of the test; the uthoristion of the representtive of the person not le to consent, or n uthority or person or ody provided for y lw hs een given; the person not le to consent shll, in proportion to his or her cpcity to understnd nd degree of mturity, tke prt in the uthoristion procedure. The test shll not e crried out if this person ojects to it. Article 14 Tests on iologicl mterils when it is not possile to contct the person concerned When it is not possile, with resonle efforts, to contct person for genetic test for the enefit of his or her fmily memer(s) on his or her iologicl mteril previously removed for nother purpose, the lw my llow the test to e crried out in ccordnce with the principle of proportionlity, where the expected enefit cnnot e otherwise otined nd where the test cnnot e deferred.

8 8 CETS 203 Humn Rights nd Biomedicine (Protocol on Genetic Testing for Helth Purposes), 27.XI.2008 Provisions shll e mde, in ccordnce with Article 22 of the Convention on Humn Rights nd Biomedicine, for the cse where the person concerned hs expressly opposed such test. Article 15 Tests on decesed persons A genetic test for the enefit of other fmily memers my e crried out on iologicl smples: removed from the ody of decesed person, or removed, when he or she ws live, from person now decesed, only if the consent or uthoristion required y lw hs een otined. Chpter VII Privte life nd right to informtion Article 16 Respect for privte life nd right to informtion 1 Everyone hs the right to respect for his or her privte life, in prticulr to protection of his or her personl dt derived from genetic test. 2 Everyone undergoing genetic test is entitled to know ny informtion collected out his or her helth derived from this test. The conclusions drwn from the test shll e ccessile to the person concerned in comprehensile form. 3 The wish of person not to e informed shll e respected. 4 In exceptionl cses, restrictions my e plced y lw on the exercise of the rights contined in prgrphs 2 nd 3 ove in the interests of the person concerned. Article 17 Biologicl smples Biologicl smples referred to in Article 2 shll only e used nd stored in such conditions s to ensure their security nd the confidentility of the informtion which cn e otined therefrom. Article 18 Informtion relevnt to fmily memers Where the results of genetic test undertken on person cn e relevnt to the helth of other fmily memers, the person tested shll e informed.

9 9 CETS 203 Humn Rights nd Biomedicine (Protocol on Genetic Testing for Helth Purposes), 27.XI.2008 Chpter VIII Genetic screening progrmmes for helth purposes Article 19 Genetic screening progrmmes for helth purposes A helth screening progrmme involving the use of genetic tests my only e implemented if it hs een pproved y the competent ody. This pprovl my only e given fter independent evlution of its ethicl cceptility nd fulfilment of the following specific conditions: c d e the progrmme is recognised for its helth relevnce for the whole popultion or section of popultion concerned; the scientific vlidity nd effectiveness of the progrmme hve een estlished; pproprite preventive or tretment mesures in respect of the disese or disorder which is the suject of the screening, re ville to the persons concerned; pproprite mesures re provided to ensure equitle ccess to the progrmme; the progrmme provides mesures to dequtely inform the popultion or section of popultion concerned of the existence, purposes nd mens of ccessing the screening progrmme s well s the voluntry nture of prticiption in it. Chpter IX Pulic informtion Article 20 Pulic informtion Prties shll tke pproprite mesures to fcilitte ccess for the pulic to ojective generl informtion on genetic tests, including their nture nd the potentil implictions of their results. Chpter X Reltion etween this Protocol nd other provisions nd re-exmintion of the Protocol Article 21 Reltion etween this Protocol nd the Convention As etween the Prties, the provisions of Articles 1 to 20 of this Protocol shll e regrded s dditionl rticles to the Convention on Humn Rights nd Biomedicine, nd ll the provisions of the Convention shll pply ccordingly. Article 22 Wider protection None of the provisions of this Protocol shll e interpreted s limiting or otherwise ffecting the possiility for Prty to grnt persons concerned y genetic testing for helth purposes wider mesure of protection thn is stipulted in this Protocol.

10 10 CETS 203 Humn Rights nd Biomedicine (Protocol on Genetic Testing for Helth Purposes), 27.XI.2008 Article 23 Re-exmintion of the Protocol In order to monitor scientific developments, the present Protocol shll e exmined within the Committee referred to in Article 32 of the Convention on Humn Rights nd Biomedicine no lter thn five yers from the entry into force of this Protocol nd therefter t such intervls s the Committee my determine. Chpter XI Finl cluses Article 24 Signture nd rtifiction This Protocol shll e open for signture y Signtories to the Convention on Humn Rights nd Biomedicine. It is suject to rtifiction, cceptnce or pprovl. A Signtory my not rtify, ccept or pprove this Protocol unless it hs previously or simultneously rtified, ccepted or pproved the Convention. Instruments of rtifiction, cceptnce or pprovl shll e deposited with the Secretry Generl of the Council of Europe. Article 25 Entry into force 1 This Protocol shll enter into force on the first dy of the month following the expirtion of period of three months fter the dte on which five Sttes, including t lest four memer Sttes of the Council of Europe, hve expressed their consent to e ound y the Protocol in ccordnce with the provisions of Article In respect of ny Signtory which susequently expresses its consent to e ound y it, the Protocol shll enter into force on the first dy of the month following the expirtion of period of three months fter the dte of the deposit of the instrument of rtifiction, cceptnce or pprovl. Article 26 Accession 1 After the entry into force of this Protocol, ny Stte which hs cceded to the Convention on Humn Rights nd Biomedicine my lso ccede to this Protocol. 2 Accession shll e effected y the deposit with the Secretry Generl of the Council of Europe of n instrument of ccession which shll tke effect on the first dy of the month following the expirtion of period of three months fter the dte of its deposit. Article 27 Denuncition 1 Any Prty my t ny time denounce this Protocol y mens of notifiction ddressed to the Secretry Generl of the Council of Europe. 2 Such denuncition shll ecome effective on the first dy of the month following the expirtion of period of three months fter the dte of receipt of such notifiction y the Secretry Generl.

11 11 CETS 203 Humn Rights nd Biomedicine (Protocol on Genetic Testing for Helth Purposes), 27.XI.2008 Article 28 Notifiction The Secretry Generl of the Council of Europe shll notify the memer Sttes of the Council of Europe, the Europen Community, ny Signtory, ny Prty nd ny other Stte which hs een invited to ccede to the Convention on Humn Rights nd Biomedicine of: ny signture; the deposit of ny instrument of rtifiction, cceptnce, pprovl or ccession; c ny dte of entry into force of this Protocol in ccordnce with Articles 25 nd 26; d ny other ct, notifiction or communiction relting to this Protocol. In witness whereof the undersigned, eing duly uthorised thereto, hve signed this Protocol. Done t Strsourg, this 27th dy of Novemer 2008, in English nd in French, oth texts eing eqully uthentic, in single copy which shll e deposited in the rchives of the Council of Europe. The Secretry Generl of the Council of Europe shll trnsmit certified copies to ech memer Stte of the Council of Europe, to the non-memer Sttes which hve prticipted in the elortion of this Protocol, to ny Stte invited to ccede to the Convention on Humn Rights nd Biomedicine nd to the Europen Community.

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