Result card

  • LEG1: Is the voluntary participation of patients guaranteed properly?
Abdominal Aorta Aneurysm Screening
I0002
English
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Is the voluntary participation of patients guaranteed properly?

Authors: Pseudo108 Pseudo108

Internal reviewers: Pseudo99 Pseudo99

  • There is a right of access to healthcare (= access to the screening examination) on the EU level {1,2}.
  • There is no clear right about refusal by the patient, but for patient autonomy, and freedom of choice {3}.
  • There are regulations about advertising healthcare (national status) {4–6}, but structured healthcare marketing also takes place and even provides its own journal {7}. However for screening for AAA by ultrasound this should not be relevant.
  • Voluntary participation is closely linked to informed consent based on information about the advantages and disadvantages of screening or no screening.
  • A false result of a screening test can lead to damage compensation {8}.

AAA screening via abdominal ultrasound is almost free of physical harm, discomfort or pain (Exceptions are the psychological aspect in the case of false-positive results and rupture in the case of a false-negative result). The question about voluntary participation in a screening examination could be answered by turning it around: how could a patient be "forced" to participate in screening? The possibilities are

  • by aggressive advertisements by the providers, evoking ‘bad’ emotions
  • by inappropriate invitation processes or participation incentives
  • by inadequate information about the chances and risks in case of a positive or negative test result

These variations of forced participation act in a subtle, and not in a direct way.

What could the possible harm be for a patient forced into an AAA screening?

  • unwanted insecurity, anxiety
  • wasted time
  • misunderstanding of the process, the sense, or the results of screening

Several pieces of legislation secure the right of access to (best) healthcare {9–11}, but there is little legislation about refusal or forced participation. The law usually takes the view that patients want to have health services available.

Bodily harm is legally forbidden, except for physicians and related occupations in the case of treatment and with the implicit understanding and consent of the patient. {12} Therefore it is more or less the non-refusal or the explicit consensus of the patient joining a (nationwide) screening programme.

The patient's right to non-treatment is discussed controversially (Several legal rules against euthanasia {13}, legislation about genetic testing {14}) and more or less just in the view of death.

For the situation of dementia Gevers {15} states ‘From a legal point of view, however, there is no duty to submit to medical examinations, people have a right to know, and if the patient lacks capacity, a medical examination should only be undertaken if it is in his or her own interest.’

AAA screening is a preventive examination to which an asymptomatic person is invited. Usually the (invited) patient has to ask for the screening (in response to the invitation), so voluntary participation should be properly guaranteed. On the other hand, screening could be somehow insisted on by the general practitioner (GP) or by the radiologist, which could have an element of non-voluntary agreement. The provider of or inviter to the screening  should inform potential participants about the necessity of the screening and the risks of no screening. (For a screening programme on a national level additional adequate information material should be provided.) There is an existing court decision for damage compensation after screening with a false-negative result. (In a case of prenatal screening where a severe handicap of the child was not detected.) {16}

Important
Partially
Pseudo108 P Result Card LEG1 In: Pseudo108 P Legal aspects In: Jefferson T, Vicari N, Frønsdal K [eds.]. Abdominal Aorta Aneurysm Screening [Core HTA], Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy; 2013. [cited 28 May 2023]. Available from: http://corehta.info/ViewCover.aspx?id=106

References

1 WMA Declaration of Lisbon on the Rights of the Patient, Adopted by the 34th World Medical Assembly, Lisbon, Portugal, September/October 1981 and amended by the 47th WMA General Assembly, Bali, Indonesia, September 1995 and editorially revised by the 171st WMA Council Session, Santiago, Chile, October 2005;http://www.wma.net/en/30publications/10policies/l4/

2 Charter of Fundamental Rights of the European Union (2007/C 303/01); Article 34 (Social Security & Assistance) + Article 35 (Health Care) http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2007:303:0001:0016:EN:PDF

3 WMA Declaration of Lisbon on the Rights of the Patient, Adopted by the 34th World Medical Assembly, Lisbon, Portugal, September/October 1981 and amended by the 47th WMA General Assembly, Bali, Indonesia, September 1995 and editorially revised by the 171st WMA Council Session, Santiago, Chile, October 2005;http://www.wma.net/en/30publications/10policies/l4/

7 www.doctorix.eu

8 i.e. court decision (OGH-Urteil 11. 12. 2007) 5 Ob 148/07m, Austria http://www.ris.bka.gv.at/Dokument.wxe?Abfrage=Justiz&Dokumentnummer=JJT_20071211_OGH0002_0050OB00148_07M0000_000

12 criminal law on national level;i.e. A: §§ 83–88 StGB; D: § 223-§ 231, § 340 StGB; Pl: Dz.U. 1997 nr 88 poz. 553 - Kodeks karny;

13 German Court, Bundesgerichtshof 2 StR 454/09) 25th June 2010; Wet toetsing levensbeëindiging op verzoek en hulp bij zelfdoding http://www.st-ab.nl/wetten/0829_Wet_toetsing_levensbeeindiging_op_verzoek_en_hulp_bij_zelfdoding.htm

PROPOSITION DE LOI relative à l'euthanasie volontaire; http://www.senat.fr/leg/ppl10-031.html

La loi belge relative à l'euthanasie; http://www.ginsburgh.net/textes/Fin_che_si_compia.pdf

L'euthanasie et l'assistance au suicide | Loi du 16 mars 2009. Sommaire.

Sommaire. Préface. 6. Questions/réponses sur la loi sur l'euthanasie. 9 et l' assistance; http://www.legilux.public.lu/leg/a/archives/2009/0046/a046.pdf

14 Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes; Articles 1 - 22 and Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes; Articles 1 - 24; http://conventions.coe.int/treaty/en/treaties/html/203.htm

15 Gevers S. Dementia and the law. Eur J Health Law. 2006 Sep;13(3):209-17.

16 Court decision (OGH-Urteil vom 11. 12. 2007) 5Ob148/07m, Austria; http://www.ris.bka.gv.at/Dokument.wxe?Abfrage=Justiz&Dokumentnummer=JJT_20071211_OGH0002_0050OB00148_07M0000_000

No  547/72 from 21st March 1972; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1997:176:0001:0016:en:PDF

No  883/2004, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:166:0001:0123:en:PDF

No 988/2009; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32009R0988:en:NOT

Commission communication on Action against Cancer: European Partnership

European Parliament resolution of 6 May 2010 on the Commission communication on

Action Against Cancer: European Partnership (2009/2103(INI)); I 39

http://www.europarl.europa.eu/RegData/seance_pleniere/textes_adoptes/definitif/2010/05-06/0152/P7_TA(2010)0152_EN.pdf

Commission communication on Action against Cancer: European Partnership

European Parliament resolution of 6 May 2010 on the Commission communication on

Action Against Cancer: European Partnership (2009/2103(INI)); I 39

http://www.europarl.europa.eu/RegData/seance_pleniere/textes_adoptes/definitif/2010/05-06/0152/P7_TA(2010)0152_EN.pdf Abs 57