Disclaimer
This information collection is a core HTA, i.e. an extensive analysis of one or more health technologies using all nine domains of the HTA Core Model. The core HTA is intended to be used as an information base for local (e.g. national or regional) HTAs.

Abdominal Aorta Aneurysm Screening

AAA Screening compared to not doing anything in the screening of Abdominal Aorta Aneurysm (AAA) in elderly at moderate risk of developing AAA

(See detailed scope below)

HTA Core Model Application for Screening Technologies 1.0
Core HTA
Published
Tom Jefferson (age.na.s, Italy), Nicola Vicari (age.na.s, Italy), Katrine Bjørnebek Frønsdal (NOKC, Norway)
Claudia Wild, LBI-HTA (Health problem and current use); Daniela Pertl and Sophie Brunner-Ziegler, GÖG (Description and technical characteristics); Iñaki Imaz, ISCIII-AETS (Safety); Katrine Frønsdal and Ingvil Sæterdal, NOKC (Clinical effectiveness), Suvi Mäklin and Taru Haula, THL-FINOHTA (Costs and economic evaluation); Gottfried Endel, HVB (Ethical analysis); Kristi Liiv and Raul Kiivet, UTA (Organisational aspects); Anne Lee, Lotte Groth Jensen and Claus Loevschall, SDU/CAST (Social aspects); Ingrid Wilbacher, HVB (Legal aspects)
Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy
Central Denmark (Denmark), GÖG (Austria), HVB (Austria), ISCIII – AETS (Spain), LBI-HTA (Austria), NOKC (Norway), SDU/CAST (Denmark), THL - FINOHTA (Finland), UTA (Estonia)
4.5.2011 15.16.00
31.1.2013 18.04.00
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 30 June 2022]. Available from: http://corehta.info/ViewCover.aspx?id=106

Abdominal Aorta Aneurysm Screening

<< Social aspectsCollection appendices >>

Authors: Pseudo108 Pseudo108

Summary

- Legally there should be no problem in guaranteeing that the participation of patients in AAA screening is voluntary.

- Appropriate measures should already be implemented to ensure, in a legally controlled manner, that patient data are secure.

- Laws or binding rules require that people have equal access to the technology, but the regulation of appropriate processes (such as in AAA screening) allows room for interpretation.

- Giving consent for minors and incompetent persons is legally regulated. No clear legislation exists about the limits and refusal of healthcare. Court decisions about overcoming the guardian or confirming the refusal by the guardian aim to achieve the best balance of benefit for the patient – in the case of AAA screening this will affect cases of positive screening results where there is a need for an open extensive surgical procedure.

- Laws or binding rules require that appropriate preventative or treatment measures are available for all. In the case of AAA a positive result requires the availability of high-level complex heart surgery structures, which can meet the epidemiological burden. Reimbursement by the national health system for necessary treatment abroad is decided by a court case. Structural limitations such as waiting lists or lack of resources need to be solved on a health system or governmental level.

- Laws or binding rules require appropriate counselling and information to be given to the user or patient. In the case of AAA screening appropriate information must be available, especially about the consequences of a positive result. Part of appropriate care is adherence to recommended follow-up examinations. Patients' adherence is not regulated legally, except on a contract level.

Introduction

The focus of the domain is to detect rules and regulations that have been established to protect the patient’s rights and societal interests. They may be part of patient rights legislation, data protection legislation, or provisions concerning healthcare personnel and their rights and duties in general. They may also incorporate prior approval processes by competent bodies. Finally, human rights law is interested in equal and non-discriminatory access to screening.

Methodology

Frame

The collection scope is used in this domain.

TechnologyAAA Screening
Description

Population-based systematic abdominal aortic aneurysm (AAA)screening. This includes one single invitation for the whole target population to do one ultrasound scan examination. Purpose of use: Detect abdominal aortic aneurysm in unruptured phase in order to treat those aneurysms with high risk of rupture.

Intended use of the technologyScreening

Screening programme for abdominal aortic aneurysm

Target condition
Abdominal Aorta Aneurysm (AAA)
Target condition description

All men and women aged 64 or more

Target population

Target population sex: Any. Target population age: elderly. Target population group: Possible future health condition.

Target population description

All men and women aged 64 or more

For: All men and women aged 64 or more.

There is some international variance in the prevalence of AAA. In the western countries the prevalence varies between 5 to 10 % for the 65 – 74 years old men.

In Japan the prevalence is 1 % for the same group of men. The prevalence increases with age.

In England the prevalence is 2 % for men aged 50 – 64 year and 12 % for men aged 80 years or older.

In Denmark the prevalence is 4 % for men aged 65 – 69 and 6 % for men aged 70 – 74 years old. The prevalence for women is significant lower than the prevalence for men.

Comparisonnot doing anything
Description

No population-based AAA screening.

This includes incidental detection of AAA without age or sex limitation while performing abdominal ultrasound examinations due to other/unclear clinical indications and various opportunistic AAA-screening practices

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
I0002Autonomy of the patientIs the voluntary participation of patients guaranteed properly?yesIs the voluntary participation of patients guaranteed properly?
I0034Autonomy of the patientWho is allowed to give consent for minors and incompetent persons?yesWho is allowed to give consent for minors and incompetent persons?
I0036Autonomy of the patientDo laws/ binding rules require appropriate counseling and information to be given to the user or patient?yesDo laws/ binding rules require appropriate counseling and information to be given to the user or patient?
I0009Privacy of the patientDo laws/ binding rules require appropriate measures for securing patient data?yesDo laws/ binding rules require appropriate measures for securing patient data?
I0008Privacy of the patientDo laws/ binding rules require informing relatives about the results?noAltough genetic associations are reported for AAA there is no clear genetic definition to require further tests for relatives
I0011Equality in health careDo laws/ binding rules require appropriate processes or resources to guarantee equal access to the technology?yesDo laws/ binding rules require appropriate processes or resources to guarantee equal access to Abdominal Aorta Aneurysm Screening ?
I0035Equality in health careDo laws/ binding rules require appropriate preventive or treatment measures available for all?yesDo laws/ binding rules require appropriate preventive or treatment measures available for all?
I0012Equality in health careIs the technology subsidized by the society?noUltrasound is a known technology
I0015Authorisation and safetyHas the technology national/EU level authorisation (marketing authorisation, registration, certification of safety, monitoring, qualification control, quality control)?noUltrasound is a known and used technology
I0019Ownership and liabilityDoes the technology infringe some intellectual property right?noUltrasound is an already well implemented technology

Methodology description

Domain frame
Search international legislation:

EurLex

International Health Law and Ethics, André Exter, ISBN 978-90-466-0259-1

Journal References in the Core Model of Screening, chapter legal domain

European Union

RIS (for examples of national legislations)

Google

Information sources

The search was done according to the questions in a structured (international law - international court decisions - national law - national court decisions) non-systematic way (no database exists like that for medical literature) by keywords and/or starting in the overview-book from Exter. Additionally the references found were searched in detail and journal articles cited in the core model were used. The results are mainly cited by the database-link.

Quality assessment tools or criteria

Peer Review was done by Dr. Gottfried Endel (medical view), and by Dr. Herta Baumann (layer in HVB organisation).

Analysis and synthesis

Interpretation of the legal text/papers/court decisions according to the HTA questions.

Result cards

Autonomy of the patient

Result card for LEG1: "Is the voluntary participation of patients guaranteed properly?"

View full card
LEG1: Is the voluntary participation of patients guaranteed properly?
Result
Comment

Importance: Important

Transferability: Partially

Result card for LEG4: "Who is allowed to give consent for minors and incompetent persons?"

View full card
LEG4: Who is allowed to give consent for minors and incompetent persons?
Result
Comment

Importance: Important

Transferability: Completely

Result card for LEG6: "Do laws/ binding rules require appropriate counseling and information to be given to the user or patient?"

View full card
LEG6: Do laws/ binding rules require appropriate counseling and information to be given to the user or patient?
Result
Comment

Importance: Important

Transferability: Partially

Privacy of the patient

Result card for LEG2: "Do laws/ binding rules require appropriate measures for securing patient data?"

View full card
LEG2: Do laws/ binding rules require appropriate measures for securing patient data?
Result
Comment

Importance: Important

Transferability: Completely

Equality in health care

Result card for LEG3: "Do laws/ binding rules require appropriate processes or resources to guarantee equal access to Abdominal Aorta Aneurysm Screening ?"

View full card
LEG3: Do laws/ binding rules require appropriate processes or resources to guarantee equal access to Abdominal Aorta Aneurysm Screening ?
Result
Comment

Importance: Important

Transferability: Completely

Result card for LEG5: "Do laws/ binding rules require appropriate preventive or treatment measures available for all?"

View full card
LEG5: Do laws/ binding rules require appropriate preventive or treatment measures available for all?
Result
Comment

Importance: Important

Transferability: Completely

Discussion

Who is responsible for a nationwide good quality screening?

"...some European countries-e.g., France and Germany-have recently come up with a new damage interpretation called loss of chance, i.e., the missed opportunity to get a more favorable outcome through different or more timely and efficient therapies.” (Molinelli 2011) {60}The authors are referring to the situation in ophthalmology in Italy, but this could also be relevant to screening for AAA.

Member States are responsible for the organisation and the delivery of healthcare. {61} Physicians have a responsibility, as guardians, for the quality of medical care. {62–65}

Conclusions:

- National governments are responsible for organisational quality.

- The physicians are responsible for the quality of AAA screening (appropriate examination,  interpretation and information).

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/

4 §§27, 28, 29 Berufsordnung (Satzung) of the Germans Physicians, Musterberufsordnung der Ärzte (MBO), Heilmittelwerbegesetz (HWG), Gesetz gegen den unlauteren Wettbewerb (UWG) http://www.aeksh.de/aerzte/arzt_und_recht/rechtsgrundlagen/berufsordnung/berufsordnung_satzung.htmland http://www.bvgd-online.de/media/039-0043_BVGD02-09_Heberer.pdf (2012-01-24)

5 §53 ÄrzteG 1998, BGBl. I 169/1998, Austria; http://www.ris.bka.gv.at/Dokument.wxe?Abfrage=Bundesnormen&Dokumentnummer=NOR30004852

6 VfGH RdM 1997/32, Austria: V56/00 ua http://www.ris.bka.gv.at/Dokument.wxe?Abfrage=Gesamtabfrage&Dokumentnummer=JFT_09988999_00V00056_00&ResultFunctionToken=2af216b9-0402-441c-9fd2-9e9429477464&SearchInAsylGH=&SearchInBegut=&SearchInBgblAlt=&SearchInBgblAuth=&SearchInBgblPdf=&SearchInBks=&SearchInBundesnormen=&SearchInDok=&SearchInDsk=&SearchInEbm=&SearchInEbmj=&SearchInGemeinderecht=&SearchInJustiz=&SearchInLgbl=&SearchInLrBgld=&SearchInLrK=&SearchInLrNo=&SearchInLrOO=&SearchInLrSbg=&SearchInLrStmk=&SearchInLrT=&SearchInLrVbg=&SearchInLrW=&SearchInNormenliste=&SearchInPvak=&SearchInRegV=&SearchInUbas=&SearchInUmse=&SearchInUvs=&SearchInVerg=&SearchInVfgh=&SearchInVwgh=&ImRisSeit=Undefined&ResultPageSize=100&Suchworte=werbung (27.09.2011)

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

9 International Covenant on Economic, Social and Cultural Rights (1966); Article 12; http://www2.ohchr.org/english/law/cescr.htm

10 European Code of Social Security (Revised); Article 8 + Article 10; http://conventions.coe.int/treaty/en/Treaties/Html/139.htm

11 A Declaration on the Promotion of Patients' Rights in Europe, WHO 1994; http://www.who.int/genomics/public/eu_declaration1994.pdf

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

17  Dementia – Etiology and Epidemiology: A systematic Review. Vol 1 June 2008. The Swedish Council on Technology Assessment in Health Care. Available at:  http://www.sbu.se/upload/Publikationer/Content1/1/Dementia_vol1.pdf  (04.10.2011)

18 http://www.cks.nhs.uk/dementia/background_information/epidemiology_and_societal_burden (04.10.2011)

19 Convetion on the Rights of Perosns with Disabilities; Article 25 (Health); http://www.un.org/disabilities/convention/conventionfull.shtml

20 Dissertation Mag. jur. Birgit Stranz. Die rechtliche Stellung minderjähriger Patienten im Wandel der Zeit unter besonderer Berücksichtigung der Einwilligung in medizinische Behandlungen (20./21. Jh.). http://othes.univie.ac.at/13759/1/2010-06-27_0001014.pdf

21 Bello BA. Dignity and informed consent in the treatment of mature minors. J Int Bioethique. 2010 Dec;21(4):103-22, 164-5.

22 Charter of Fundamental Rights of the European Union (2007/C 303/01); Articles 1 - 4; 7,8; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2007:303:0001:0016:EN:PDF

23 Charter of Fundamental Rights of the European Union (2007/C 303/01); Articles 1 - 4; 7,8 http://eur-lex.europa.eu/en/treaties/dat/32007X1214/htm/C2007303EN.01000101.htm

24 Referring to Austrian legislation http://ingridriedl.net/01_patienten_info/Patientenrecht.htm, interpreted by Ingrid Wilbacher

25 Referring to to Austrian legislation http://ingridriedl.net/01_patienten_info/Patientenrecht.htm, interpreted by Ingrid Wilbacher

26 Gigerenzer G, Wegwarth O. Risikoanschätzung in der Medizin am Beispiel der Krebsfrüherkennung. Z. Evid. Fortbild. Qual. Gesundh. Wesen (ZEFQ) 102 (2008) 513-519.

27 Schaffartzik W, Neu J. Ergebnisse der Gutachterkommissionen und Schlichtungsstellen. Z. Evid. Fortbild. Qual. Gesundh. Wesen (ZEFQ) 102 (2008) 525-528, Abb. 1.

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29 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31995L0046:en:NOT

30 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31995L0046:en:NOT

31 i.e.:  D: Bundesdatenschutzgesetz (BDSG), Art. 1 G vom 14. August 2009 (BGBl. I S. 2814); A: DSG 2000, 30. Dezember 2009 (BGBl 135/2009); CH: DSG, AS 2007 4983. http://www.admin.ch/ch/d/as/2007/4983.pdf; UK: Data Protection Act 1998, 16th June 1998(Royal Assent); http://hrmgt.co.uk/law.htm

32 DIRECTIVE 2011/24/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2011 on the application of patients' rights in cross-border healthcare http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065:EN:PDF

33 International Convention on the Elimination of all forms of Racial Discrimination; Article 5; http://www2.ohchr.org/english/law/cerd.htm

34 International Convention on the Protection of the Rights of All Migrant Workers and Members of their Families (1990), Art. 28; http://www2.ohchr.org/english/law/cmw.htm

35 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine; Oviedo, 1997, European Treaty Series - No. 164; http://conventions.coe.int/Treaty/en/Treaties/html/164.htm

36 Charter of Fundamental Rights of the European Union (2007/C 303/01), Article 35; http://eur-lex.europa.eu/en/treaties/dat/32007X1214/htm/C2007303EN.01000101.htm

37 Council Regulations (EC) No 1408/71of 14 June on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the Community; especially Article 22A.; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1971R1408:20060428:en:PDF

38 A Declaration on the Promotion of Patients' Rights in Europe, WHO 1994; http://www.who.int/genomics/public/eu_declaration1994.pdf

39 World Medical Association Statement on Access to Health Care. Adopted by the 40th World medical Assembly Vienna, Austria, September 1988 and revised by the WMA General Assembly, Pilanesberg, South Africa, October 2006. http://www.wma.net/en/30publications/20journal/pdf/wmj16.pdf

40 States Parties are countries which have adhered to the World Heritage Convention. http://whc.unesco.org/en/statesparties

41 Convention on the Elimination of all Forms of Discrimination against Women; Article 12; http://www.childinfo.org/files/childmarriage_cedaw.pdf

42 https://wcd.coe.int/ViewDoc.jsp?id=955747

43 Recommendation No. R(98) 71 of the Committee of Ministers to Member States concerning the ethical and organisational aspects of health care in prison; https://wcd.coe.int/com.instranet.InstraServlet?command=com.instranet.CmdBlobGet&InstranetImage=530914&SecMode=1&DocId=463258&Usage=2

44 Council Regulations (EC) No 1408/71of 14 June on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the Community; especially Art. 22A; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1971R1408:20060428:en:PDF

45 Regulations (EEC) No 1408/71 from 14th June 1971; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1971R1408:20070102:EN:PDF

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

46 DIRECTIVE 2011/24/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2011 on the application of patients' rights in cross-border healthcare http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065:EN:PDF

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50 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/

51 Perlin ML. "Too stubborn to ever be governed by enforced insanity": Some therapeutic jurisprudence dilemmas in the representation of criminal defendants in incompetency and insanity cases. Int J Law Psychiatry. 2010 Nov-Dec;33(5-6):475-81. Epub 2010 Oct 14.

52 Rezende EJ ; Melo Mdo C ; Tavares EC ; Santos Ade F ; Souza C. [Ethics and eHealth: reflections for a safe practice]. Rev Panam Salud Publica. 2010 Jul;28(1):58-65.

53 Loeber JG. Legal issues in neonatal screening. Ann Acad Med Singapore. 2008 Dec;37(12 Suppl):92-2.

54 P7_TA(2010)0152

Commission communication on Action against Cancer: European Partnership

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

55 P7_TA(2010)0152

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56 Baughman KR ; Ludwick RE ; Merolla DM ; Palmisano BR ; Hazelett S ; Winchell J ; Hewit M. Professional Judgments About Advance Care Planning with Community-Dwelling Consumers. J Pain Symptom Manage. 2011 Jul 13.

57 Judgment of the Court (Grand Chamber) of 16 May 2006. The Queen, on the application of Yvonne Watts v Bedford Primary Care Trust and Secretary of State for Health. Reference for a preliminary ruling: Court of Appeal (England & Wales) (Civil Division) - United Kingdom. Social security - National health system funded by the State - Medical expenses incurred in another Member State - Articles 48 EC to 50 EC and 152(5) EC - Article 22 of Regulation (EEC) No 1408/71. Case C-372/04.   http://eur-lex.europa.eu/Notice.do?val=426362:cs&lang=de&list=432665:cs,439339:cs,427772:cs,426362:cs,420145:cs,418803:cs,418258:cs,401136:cs,417775:cs,401132:cs,&pos=4&page=6&nbl=64&pgs=10&hwords=&checktexte=checkbox&visu=#texte (5.10.2011)

58 Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the European Union Official Journal C 115 , 09/05/2008 P. 0001 - 0388; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2008:115:0001:01:en:HTML

59 Directive 2011/24 of the European Parliament and of the Council on the application of patients' rights in cross-border healthcare. Commission of the European Communities (Articles 1 - 22). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065:EN:PDF

60 Molinelli A ; Bonsignore A ; Capecchi M ; Calabria G. Loss of chance: a new kind of damage to ophthalmologic patients from Europe to Italy. Eur J Ophthalmol. 2011 May-Jun;21(3):310-4. doi: 10.5301/EJO.2010.6211.

61 Directive 2011/24 of the European Parliament and of the Council on the application of patients' rights in cross-border healthcare. Commission of the European Communities (Articles 1 - 22). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065:EN:PDF

62 World Medical Association Statement on Access to Health Care. Adopted by the 40th World medical Assembly Vienna, Austria, September 1988 and revised by the WMA General Assembly, Pilanesberg, South Africa, October 2006. In André den Exter. International Health Law and Ethics. 2009. ISBN 978-90-466-0259-1

63 World Medical Association Declaration of Geneva. Adopted by the 2nd General Assembly of the Worls Medical Association, Geneva, Switzerland, September 1948 and amended by the 22nd World Medical Assembly, Sydny, Australia, August 1968 and the 35th World Medical Assembly, Venice, Italy, October 1983 and the 46th WMA General Assembly, Stockholm, Sweden, September 1994 and editorially revised at the 170th Council Session, Divonne-les bains, France, May 2005 and the 173rd Council Session, Divonne-les-Bains, France, May 2006. In André den Exter. International Health Law and Ethics. 2009. ISBN 978-90-466-0259-1, p453

64 Principles of Medical Ethics relevant to the Role of Health Personnel, particularly Physicians, in the Protection of Prisoners and Detainees against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment; Principles 1 - 6. http://www2.ohchr.org/english/law/medicalethics.htm

65 World Medical Association Declaration on Patient Safety, adopted by the WMA General Assembly, Washington 2002; http://www.wma.net/en/30publications/10policies/p6/

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