TEXTSADOPTED
1. Trainingofseafarers***I (procedure without report)
C5-0285/2000
Proposal for a European Parliament and Council directive on the minimum level of training of
seafarers(consolidatedversion)(COM(2000)3136dashC5-0285/20006dash2000/0131(COD))
(Codecision procedure: first reading)
The proposal was approved.
2. Coffeeandchicoryextracts***I (procedure without report)
C5-0485/2000
Proposal for a European Parliament and Council directive amending Directive 80/232/EEC as
regardstherangeofnominalweightsforcoffeeextractsandchicoryextracts(COM(2000)5686dash
C5-0485/20006dash2000/0235(COD))
(Codecision procedure: first reading)The proposal was approved.
3. Clinicaltrialsonmedicinalproductsforhumanuse***II
A5-0349/2000
European Parliament legislative resolution on the Council common position for adopting a Eur-
opeanParliamentandCouncildirectiveontheapproximationofthelaws,regulationsandadmin-istrativeprovisionsoftheMemberStatesrelatingtotheimplementationofgoodclinicalpractice
in the conduct of clinical trials on medicinal products for human use (8878/1/20006dash C5-0424/
20006dash1997/0197(COD))
(Codecision procedure: second reading)
The European Parliament,
Rdash having regard to the Council common position 8878/1/2000 Rdash C5-0424/2000)(
1),
Rdash having regard to its position at first reading(2) on the Commission proposal to Parliament and the
Council (COM(1997) 369)(3),
Rdash having regard to the Commission’s amended proposal (COM(1999) 193(4),
Rdash having regard to Article 251(2) of the EC Treaty,Rdash having regard to Rule 80of its Rules of Procedure,
Rdash having regard to the recommendation for second reading of the Committee on the Environment,
Public Health and Consumer Policy (A5-0349/2000),
(1) OJ C 300, 20.10.2000, p. 32.
(2) OJ C 379, 7.12.1998, p. 27.
(3) OJ C 306, 8.10.1997, p. 9.
(4) OJ C 161, 8.6.1999, p. 5.C 232/52 EN 17.8.2001 Official Journal of the European Communities
Tuesday12December2000
1. Amends the common position as follows;
2. Instructs its President to forward its position to the Council and Commission.
COUNCIL
COMMON POSITIONAMENDMENTS
BY PARLIAMENT
(Amendment 28)
Recital 3
(3) It is incumbent on Member States to lay down rules to safe-
guard the protection of individuals who are incapable of giving their
consent, such as minors and incapacitated adults.Since such personsare incapable of giving their free consent to taking part in a clinicaltrial, consent to their participation must be given by a person or bodyprovided for by law.(3)Personswhoareincapableofgivinglegalconsentto
clinical trials should be given special protection. It is
incumbent on the Member States to lay down rules tothis effect. Such persons may not be included in clinicaltrials if the same results can be obtained using personscapableofgivingconsent.Normallythesepersonsshouldonlybeincludedinclinicaltrialswhentherearegroundsforexpectingthattheadministeringofthemedicinalpro-duct would be of direct benefit to the patient, therebyoutweighingtherisks.However,thereisaneedforclini-cal trials involving children to improve the treatmentavailabletothem.Childrenrepresentavulnerablepopula-tion with developmental, physiological and psychologicaldifferences fromadults, which m ake age- and develop-ment-related research important for their benefit. Medic-inalproducts,including vaccines, forchildren need tobetested scientifically before widespread use. This can only
be achieved by ensuring that medicinal products which
are likely to be of significant clinical value for childrenarefully studied. The clinical trials required for this pur-poseshouldbecarriedoutunderconditionsaffordingthebest possible protection for the subjects. Criteria for theprotection of children in clinical trials therefore need tobelaiddown.
(Amendment 2)
Recital 3a (new)
(3a) Inthecaseofotherpersonsincapableofgivingtheir
consent, such as persons with dementia, psychiatricpatients etc., inclusion in clinical trials in such casesshould be on an even more restrictive basis. Medicinalproductsfortrialmaybeadministeredtoallsuchindivi-dualswhentherearegroundsforassumingthatthedirectbenefit to the patient outweighs the risks. Moreover, insuch cases the written agreement of the patient’s legal
representative,givenincooperationwiththetreatingdoc-
tor, is necessary before participation in any such clinicaltrial.
(Amendment 29)
Recital 3b (new)
(3b) The notion of legal representative refers back to
existing national law and consequently may include nat-uralorlegalpersons,anauthorityand/orabodyprovidedforbynationallaw.17.8.2001 EN C 232/53 Official Journal of the European Communities
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(Amendment 3)
Recital 8a (new)
(8a) As a rule authorisation should be implicit, i.e. if
there hasbeen avotein favourbythe Ethics committeeand the competent authority has not objected within agiven period, it should be possible to begin the clinicaltrials.Inexceptionalcasesraisingespeciallycomplexpro-blems, explicit written authorisation shall however be
required.
(Amendment 30)
Recital 10a (new)
(10a) Non-commercial clinical trials conducted by re-
searcherswithouttheparticipationofthepharmaceuticalsindustry may be of great benefit to the patients con-cerned. The Directive should therefore take account ofthe special position of trials whose planning does notrequire particular manufacturing or packaging processes,if these trials are carried out with medicinal productswith a marketing authorisation within the meaning ofDirective 65/65/EEC,manufactured or imported in accor-dance with the provisions of Directives 75/319/EEC and91/356/EEC,andonpatientswiththesamecharacteristics
as those covered by the indication specified in this mar-
ketingauthorisation.Labellingoftheinvestigationalmed-icinal products for trials of this nature should be subjectto simplified provisions laid down in the good manufac-turingpracticeguidelines oninvestigationalproductsandinDirective91/356/EEC.
(Amendment 31)
Article 2(f)
(f) ‘Investigator’: A person responsible for the conduct of a
clinical trial at a trial site. If a trial is conducted by ateam of individuals at a trial site, the investigator is theleader responsible for the team and may be called the prin-cipal investigator;(f) ‘Investigator’: A doctorora personfollowing aprofes-
sion agreed in the Member State for investigationsbecause of the scientific background and the experi-ence in patient care it requires. The investigator isresponsible for the conduct of a clinical trial at a trialsite. If a trial is conducted by a team of individuals at atrial site, the investigator is the leader responsible for the
team and may be called the principal investigator;
(Amendment 32)
Article 2(j)
(j) ‘Informed consent’: decision to take part in a clinical trial,
taken freely after being duly informed of the detailsand
appropriately documented, by any person capable of giv-ing consent or, where the person is not capable of givingconsent, by his or her legal representative and/or an author-
ity and/or a person and/or body provided for by law.(j) ‘Informedwrittenconsent’: decision, which must be
dated and signed, to take part in a clinical trial, taken
freely after being duly informed of its nature, signifi-
cance, implications and risks and appropriately docu-
mented, by any person capable of giving consent or,where the person is not capable of giving consent, by hisC 232/54 EN 17.8.2001 Official Journal of the European Communities
Tuesday12December2000
COUNCIL
COMMON POSITIONAMENDMENTS
BY PARLIAMENT
or her legal representative. If the person concerned is
unable to write, oral consent in the presence of atleast one witness may be given in exceptional cases,
asprovidedforinnationallegislation;
(Amendment 7)
Article 3(1)
1. This Directive shall apply without prejudice to the
national provisions on the protection of clinical trial subjects
if they are more comprehensive than the provisions of this
Directive and consistent with the procedures and time-scalesspecified therein.1. This Directive shall apply without prejudice to the
national provisions on the protection of clinical trial subjects
if they are more comprehensive than the provisions of this
Directive and consistent with the procedures and time-scalesspecified therein. Member States shall, in so far as they
havenotalreadydoneso,adoptdetailed rulestoprotectfromabuse individuals who are incapable of giving their
informedconsent.
(Amendment 33)
Article 3(2)(a)
(a) the foreseeable risks and inconveniences have been
weighed against the anticipated benefit for the individual
trial subject and society. A clinical trial may be initiated
and continued only if anticipated benefits justify the risks ;(a) the foreseeable risks and inconveniences have been
weighed against the anticipated benefit for the individual
trial subject and other present and future patients .
A clinical trial may be initiated only if the Ethics com-
mittee and/or the competent authority comes to theconclusionthattheanticipatedtherapeuticandpublichealth benefits justify the risks and continued only if
compliance with this requirement is permanentlymonitored ;
(Amendment 34)
Article 3(2)(aa) (new)
(aa) the trial subject or,when the personis not able to
give informed consent, his legal representative hashad the opportunity, in a prior interview with theinvestigator or a member of the investigating team,tounderstandtheobjectives,risksandinconveniencesofthetrial,andtheconditionsunderwhichitistobeconducted. The subject will also be informed of hisrighttowithdrawfromthetrialatanytime;
(Amendment 35)
Article 3(2)(c)
(c) informed consent in the appropriate form has been obtained; (c)the trial subject or, when the person is not able to
give informed consent, his legal representative hasgivenhiswrittenconsentafterbeinginformedofthenature,significance,implicationsandrisksoftheclin-icaltrial.Iftheindividualisunabletowrite,oralcon-sent in the presence of at least one witness may begiveninexceptionalcases,asprovidedforinnationallegislation;17.8.2001 EN C 232/55 Official Journal of the European Communities
Tuesday12December2000
COUNCIL
COMMON POSITIONAMENDMENTS
BY PARLIAMENT
(Amendment 11)
Article 3(2)(da) (new)
(da) provisionhasbeenmadeforinsuranceorindemnity
tocovertheliabilityoftheinvestigatorandsponsor;
(Amendment 36)
Article 3a (new)
Article3a
ClinicaltrialsonminorsInadditiontoanyotherrelevantrestriction,aclinicaltrial
onminorsmaybeundertakenonlyif
(a) theinformedconsentoftheparentsorlegalrepresen-
tative hasbeen obtained; consent must represent theminor’s presumed will and may be revoked at anytime,withoutdetrimenttotheminor;
(b) the minor has received information according to its
capacityofunderstanding,fromstaffwithexperiencewithminors,regardingthetrial,therisksandtheben-efits;
(c) theexplicit wishofaminorwhoiscapableofform-
ing an opinion and assessing this information torefuseparticipationortobewithdrawnfromtheclin-icaltrialatanytimeisconsideredbytheinvestigatororwhereappropriatetheprincipalinvestigator;
(d) no incentives or financial inducements are given
exceptcompensation;
(e) some direct benefit for the group of patients is
obtained fromthe clinical trial and only where suchresearchisessentialtovalidatedataobtainedinclini-caltrialsonpersonsabletogiveinformedconsentorby other research methods. Additionally, such
researchshouldeitherrelatedirectlytoaclinicalcon-
ditionfromwhichtheminorconcernedsuffersorbeof such a nature that it can only be carried out onminors;
(f) thecorrespondingscientific guidelines oftheAgency
havebeenfollowed;
(g) clinical trials have been designed to minimise pain,
discomfort,fearandanyotherforeseeableriskinrela-tiontothediseaseanddevelopmentalstage;boththerisk threshold and the degree of distress have to bespeciallydefinedandconstantlymonitored;
(h) the Ethics committee, with paediatric expertise or
aftertakingadviceinclinical,ethicalandpsychosocialmatters in the field of paediatrics, has endorsed theprotocol;
(i) theinterests ofthepatient alwaysprevailoverthose
ofscienceandsociety.C 232/56 EN 17.8.2001 Official Journal of the European Communities
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COUNCIL
COMMON POSITIONAMENDMENTS
BY PARLIAMENT
(Amendment 37)
Article 3b (new)
Article3b
Clinical trials on incapacitated adults not able to give
informedlegalconsent
Inthecaseofotherpersonsincapableofgivinginformed
legalconsent,allrelevantrequirementslistedforpersonscapableofgivingconsentshallapply.Inadditiontothese
requirements, inclusion in clinical trials of incapacitated
adults who have not given ornot refused informed con-sentpriortotheonsetoftheirincapacityshallbeallowedonlyif:
(a) the informed consent of the legal representative has
been obtained; consent shall represent the subject’spresumedwillandmayberevokedatanytime,with-outdetrimenttothesubject;
(b) thepersonnotabletogivelegalinformedconsenthas
received information accordingto his/her capacityofunderstanding regarding the trial, the risks and thebenefits;
(c) theexplicitwishofasubjectwhoiscapableofform-
ing an opinion and assessing this information torefuseparticipationortobewithdrawnfromtheclin-icaltrialatanytimeisconsideredbytheinvestigatororwhereappropriatetheprincipalinvestigator;
(d) no incentives or financial inducements are given
exceptcompensation;
(e) suchresearchisessentialtovalidatedataobtainedin
clinical trials on persons able to give informed con-sentorbyotherresearchmethodsandwhichrelatesdirectly to a life-threatening or debilitating clinicalcondition fromwhich the incapacitated adult con-
cernedsuffers;
(f) clinical trials have been designed to minimise pain,
discomfort,fearandanyotherforeseeableriskinrela-tiontothediseaseanddevelopmentalstage;boththerisk threshold and the degree of distress have to bespeciallydefinedandconstantlymonitored;
(g) the Ethics committee, with expertise in the relevant
diseaseandthepatientpopulationconcernedoraftertakingadviceinclinical,ethicalandpsychosocialques-tions in the field of the relevant disease and patientpopulationconcerned,hasendorsedtheprotocol;
(h) theinterests ofthepatient alwaysprevailoverthose
ofscienceandsociety;17.8.2001 EN C 232/57 Official Journal of the European Communities
Tuesday12December2000
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COMMON POSITIONAMENDMENTS
BY PARLIAMENT
(i) therearegroundsforexpectingthatadministeringthe
medicinalproducttobetestedwillproduceabenefitto the patient outweighing the risks or produce noriskatall.
(Amendment 14)
Article 4(3)(aa) (new)
(aa) whether the evaluation of the anticipated benefits
and risks as required under Article 3(2)(a)is satisfac-toryandwhethertheconclusionsarejustified;
(Amendment 38)
Article 4(3)(f)
(f) the adequacy and completeness of the written information
to be given and the procedure to be used for the purpose
of obtaining informed consent;(f) the adequacy and completeness of the written information
to be given and the procedure to be used for the purpose
of obtaining informed consent and the justification for
theresearchonpersonsincapableofgivinginformedconsentasregardsthespecific restrictionslaiddowninArticle3;
(Amendment 39)
Article 4(7)
7. No extension to the timeperiod referred to in paragraph 5
shall be permissible except in the case of trials involving med-icinal products for gene therapy andsomatic cell therapy ,
includingxenogenic cell therapy.7. No extension to the 60-dayperiod referred to in para-
graph 5 shall be permissible except in the case of trials invol-ving medicinal products for gene therapy orsomatic cell ther-
apyormedicinalproductscontaininggeneticallymodified
organisms, for which an extension of a maximum of30 days shall be permitted. For these products, this90-day period may be extended by a further 90 days inthe event of consultation of a group or a committee inaccordancewiththeMemberStateregulationsandproce-dures.Inthecaseof xenogenic cell therapy thereshallbeno
timelimittotheauthorisationperiod.
(Amendment 40)
Article 7(4)
4. Consideration of a valid request for authorisation by the
competent authority as stated in paragraph 2 mustnot exceed
60days. After those 60 days, the sponsor can consider that the
competent authority does not object to the commencement of thetrial if it has not notified the sponsor of any grounds for non-accep-tance.4. Consideration of a valid request for authorisation by the
competent authority as stated in paragraph 2 shallbecarried
outasrapidlyaspossibleandmay not exceed 60days. The
Member States may lay down a shorter period than60 days within their area of responsibility if that is incompliancewith currentpractice.Thecompetent author-itycanneverthelessnotifythesponsorbeforetheendofthisperiodthatithasnogroundsfornon-acceptance.
No extensions to the period referred to in the first subpara-
graph shall be permissible except in the case of trials involving
the medicinal products listed in paragraph 6.Nofurtherextensions to the period referred to in the first sub-
paragraph shall be permissible except in the case of trials invol-ving the medicinal products listed in paragraph 6 ,forwhichC 232/58 EN 17.8.2001 Official Journal of the European Communities
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COMMON POSITIONAMENDMENTS
BY PARLIAMENT
anextensionofamaximumof30daysshallbepermitted.
Fortheseproducts,the90-dayperiodmaybeextendedbyafurther90daysintheeventofconsultationofagroup
oracommitteeinaccordancewiththeMemberStatereg-
ulations and procedures. In the case of xenogenic celltherapy there shall be no time limit to the authorisationperiod.
(Amendment 41)
Article 7(5)
5. Without prejudice to paragraph 6, written authorisation
may be required before the commencement of clinical trialsfor such trials on medicinal products which do not have a mar-
keting authorisation within the meaning of Directive 65/65/
EEC and are referred to in Part A of the Annex to Regulation
(EEC) No 2309/93, and other medicinal products with special
characteristics the list of which is adopted in accordance with the
procedure referred to in Article 19(2) of this Directive.
Until the said list is adopted, Member States shall continue to apply
their national procedures.5. Without prejudice to paragraph 6, written authorisation
may be required before the commencement of clinical trialsfor such trials on medicinal products which do not have a mar-
keting authorisation within the meaning of Directive 65/65/
EEC and are referred to in Part A of the Annex to Regulation
(EEC) No 2309/93, and other medicinal products with special
characteristics, such as medicinal products whose active
ingredient(s) is a biological product of human or animalorigin, or contains biological components of human oranimal origin, or manufacturing of which requires suchcomponents.
(Amendment 42)
Article 7(6)
6. Written authorisation shall be required before commen-
cing clinical trials involving medicinal products for gene ther-
apy, somatic cell therapy including xenogenic cell therapy and
all medicinal products containing genetically modified organ-
isms.6. Written authorisation shall be required before commen-
cing clinical trials involving medicinal products for gene ther-
apy, somatic cell therapy including xenogenic cell therapy and
all medicinal products containing genetically modified organ-
isms.No gene therapy trials may be carried out which
result in modifications to the subject’s germ line geneticidentity.
(Amendment 21)
Article 10(1), first subparagraph a (new)
Before the Member State reaches its decision it shall ask
the sponsor and/or the investigator for their opinion, tobe delivered within one week 6dash except where delayinvolvesrisk.
(Amendment 43)
Article 12, second paragraph (new)
Inaddition,theseguidelinesshalllaydownadaptedprovi-
sions relating to labelling for investigational medicinalproductsforclinicaltrialswiththefollowingcharacteris-tics:
6dash the planning of the trial does not require particular
manufacturingorpackagingprocesses;
6dash the trial is conducted with medicinal products with,
intheMemberStatesconcernedbythestudy,amar-keting authorisation within the meaning of Directive65/65/EEC, manufactured or imported in accordancewiththeprovisionsofDirective75/319/EEC;17.8.2001 EN C 232/59 Official Journal of the European Communities
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COMMON POSITIONAMENDMENTS
BY PARLIAMENT
6dash the patients participating in the trial have the same
characteristicsasthosecoveredbytheindicationspe-cifiedintheabovementionedauthorisation.
(Amendment 23)
Article 15(3)(a)
(a) Each Member State shall ensure that all suspected unex-
pected serious adverse reactions to an investigational med-
icinal product which are brought to its attention are
reportedimmediately tothe Agency by the sponsor of the clin-
ical trial.(a) Each Member State shall ensure that all suspected unex-
pected serious adverse reactions to an investigational med-
icinal product which are brought to its attention are
immediatelyenteredinaEuropeandatabasetowhich,
in accordance with Article 9(1), only the competentauthorities of the Member States, the Agencyand the
Commission,shallhaveaccess .
4. Summer-time***I
A5-0356/2000
Proposal for a European Parliament and Council directive on summer-time arrangements
(COM(2000)3026dashC5-0322/20006dash2000/0140(COD))
The proposal was amended as follows:
TEXT PROPOSED
BY THE COMMISSION(1)AMENDMENTS
BY PARLIAMENT
(Amendment 3)
Recital 4
(4) The proper functioning of certain sectors, not only trans-
port and communications, but also other sectors of industry,requires stable, long-term planning. Provisions concerning sum-
mer-time should therefore be laid down for an unlimitedperiod.
Article 4 of Directive 97/44/EC provides, in that respect, thatthe European Parliament and the Council are to adopt, by 1 Jan-uary 2001, the arrangements to apply from 2002 onwards.(4) The proper functioning of certain sectors, not only trans-
port and communications, but also other sectors of industry,requires stable, long-term planning. Provisions concerning sum-
mer-time should therefore be laid down for an unspecified
period. Article 4 of Directive 97/44/EC provides, in thatrespect, that the European Parliament and the Council are toadopt, by 1 January 2001, the arrangements to apply from2002 onwards.
(Amendment 4)
Article 5, 2nd paragraph (new)
TheCommissionshall,ifnecessaryandfollowingthecon-
clusionsofthereport,makeappropriateproposals.
(1) OJ C 337 E, 28.11.2000, p. 136.C 232/60 EN 17.8.2001 Official Journal of the European Communities
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COMMON POSITIONAMENDMENTS
BY PARLIAMENT