HUMAN RIGHTS AND BIOMEDICINE

1. HUMAN RIGHTS AND BIOMEDICINE Removal of organs from deceased persons. Legal framework in Europe

2. Short overview • The need for protection of deceased donors • The actual framework at European level with special attention to the proposed EU directive ( 8 december 2008) • Discussion

3. Need for protection • Organ transplantation (OT) is the therapeutic use of human organs involving the substitution of a non-functional organ for another from a living (LOD) or deceased (DOD) donor • Nowadays, OT is an efficient and strong medicine with a lot of advantages for the patient ( recipient), his family and society at large • Like any other medicine OT has also undesirable consequences

4. Need for protection • These may vary from risks for the recipient due to the use of unsafe organs to the exploitation of living donors and even the killing of people for their organs • It took many years to reach a common legal framework for the protection of subjects of clinical trials at the European level • The clinical trial subject is for new medicines what the organ donor is for transplantation. Yet, until now the protection of the organ donor- especially the D.O.D.- received much less attention

5. Protection of the DOD • Biomedicine Convention • Additional Protocol on OT (2002) • Proposal Directive EU (2008)

6. Biomedicine Convention • Only contains protective measures for the LOD, not for DOD • However indirectly the BC regulates DOD • -> LOD is only allowed “ if there is no suitable organ available from a deceased person” (art.19.2 BC) ( the so called subsidiarity rule) -> makes the DOD extra vulnerable for abuse and reinforces the need for protective measures

7. Biomedicine Convention • Article 21 BC ( Prohibition of financial gain) : “ The human body and its parts shall not, as such, give rise to financial gain” Broad application, also for DOD

8. Additional Protocol OT • Article 9 ( Chapter III LOD) : “ no suitable organ from a deceased person”. • The EM §107 : “ living donation is to be minimized” • But important nuance of subsidiarity rule

9. Subsidiarity rule §61 EM “ however, if the results of a living donor transplantation are expected to be significantly better than those expected utilizing a graft removed from a deceased person, live donation may be the preferred therapeutic option for a particular recipient”.

10. Additional protocol and DOD Unlike the BC, the AP contains specific measures to protect DOD

11. Additional Protocol and DOD • Certification of death ( article 16) • Consent and authorisation (article 17) • Respect for the human body (article 18) • Promotion of donation ( article 19) • Anonynimity of donor and recipient towards each other and towards third parties is not provided for

12. Consent (art. 17) • “organs and tissues shall not be removed from the body of a deceased person unless consent or authorisation required by law has been obtained” • “the removal shall not be carried out if the deceased person has objected to it”

13. Questions raised by art.17 • Protection of incapacitated DOD? • Opting in /opting out • Non residing donor

14. Incapacitated DOD • The BC and the AP prohibit removal of organs from living incapacitated person • After his death an incapacitated person may become a donor • Article 17 requires “consent or authorisation” : see §79 ER to AP : “consent” refers to donors having the capacity to consent while “authorisation” refers to incapacitated donors • Can authorisation already given before certification of death?

15. Opting in/opting out • THe AP does not express any preference for one or another decision system : whereas art.17 §1 prohibits removal unless consent ( opting in); art.17 §2 prohibits removal if objection ( opting out). • This is quite understandable given growing consensus that the legal type of decisionmaking system is not the preponderant element in an organ retrieval programme • Decisive must always be the wish of the deceased : “ if a person has made known his wishes for giving or denying consent during his lifetime, these wishes should be respected after his death” (ER to AP §99).

16. Respect for the wish? • If the wish is not to be donor, this wish has to be respected. It is legally binding ( so called negative advance directive) • If the wish is to be a donor, this wish has to be respected as far as possible, but it is not binding ( so called positive advance directive) (recently cases of DOD after euthanasia in Belgium and the Netherlands)

17. No wish known? • THe AP does not offer clear guidance for this situation • §102 ER : “ Parties should make clear whether organ retrieval can take place if a deceased person’s wishes are not known and cannot be ascertained from relatives or friends” • From the point of view of protection of DOD this may create a very serious deficit and undermine art.17 AP

18. The non residing donor • No provision in the A.P. • §103 ER : “ when a person dies in a country in which he/she is not normally resident, the retrieval team shall take all reasonable measures to ascertain the wishes of the deceased. In case of doubt, the retrieval team should respect the relevant applicable laws in the country in which the deceased is normally resident, or by default, the law of the country of which the deceased person is a national”.

19. Promotion of donation • “Parties shall take all appropriate measures to promote the donation of organs and tissues” ( art.19) Has to be read in conjunction with art.8 : information for the public including matters relating to consent, in particular with regard to removal from deceased persons. How reconcile promotion of donation with removal without knowing someone’s wish?

20. Conclusion • The BC and its AP offer in my opinion not enough protection against removal of organs from a deceaded person • The protection of DOD needs a more elaborated framework at international level

21. EU Directive Directive of the EP and Council on standards of quality and safety of human organs intended for transplantation Proposal presented by the Commission 8 December 2008

22. Subject of the Directive Lays down rules to ensure high standards of quality and safety for organs of human origin intended for transplantation to the human body, in order to ensure a high level of human health protection

23. Chapter 3 : donor and recipient protection Art.13 : principles governing OD Art.14 : consent and authorisation requirement prior to procurement Art.15 : protection of the living donor Art.16 : protection of personal data, confidentiality and security of processing Art.17 : anonymisation of donors and recipients

24. Proposed directive EU • Preliminary finding : The Directive does not contain specific protective measures for DOD. Most of the general protective measures – with the exception of those directed to living donors – apply also to DOD.

25. The subsidiarity rule • The provisions to protect the living donor do not contain the subsidiarity rule • §25 EM of directive qualifies “ the use of LOD as an increasing alternative given the failure to meet the growing need for organs with cadaveric donation” • “ being complementary to deceased donation, LOD is a real alternative to improving the availility of organs for transplantation ( Action Plan II of the Commission – 8 December 2008)

26. From subsidiarity to complementarity • §15 of the resolution of the EP asked the Member States that “ living donation should be seen as complementary to post-mortem donation” This shift may broaden the scope for LOD, but not diminish the demand for DOD and in this sense no consequences for the need to protection of DOD

27. Principles governing OD (art.13) • Donations from DD and LD are voluntary and unpaid • Prohibition of advertising the need for or availibility of organs with a view to offer of seeking financial gain or comparable advantage • Procurement of organs on a non-profit basis

28. Consent and authorisation ( art.14) • Procurement shall only be carried out after compliance with all mandatory consent or authorisation requirements in force in the Member State concerned

29. Protection of personal data, confidentiality and security of processing (art.16) • The fundamental right to protection of personal data is fully and effectively protected in all OT activities, in conformity with Community provisions on the protection of personal data

30. Anonymisation of donors and recipients (art.17) • MS shall take all necessary measures to ensure that all personal data of donors and recipients processed within the scope of this Directive are rendered anonymous so that neither donors nor recipients remain identifiable

31. Consent and authorisation • Is both applicable to LOD and DOD • Requirements are determined by the Member States • Comply with the principles of the Biomedicine Convention ( EM §24)

32. Consent for DOD • EM §24 : “Consent for procurement is as a general rule regulated by MS in very different ways, ranging from presumed consent systems to systems where the consent of relatives is required. The Commission believes that this is a very sensitive field that raises a number of ethical concerns that fall within the competence of the Member States and could not dealt with in this Directive”

33. Consent system is a public health issue • the Committee on Legal Affairs ( advice on EP Resolution) “ it is necessary to ensure that deceased donors are suitably managed, by ensuring appropriate safety and quality standards for donated organs, for which purpose a system should be adopted whereby consent for removal is always assumed except in the case of express refusal on the part of the donor”.

34. Also a public health issue • Citation not based on empirical data • Also the reference to “assumed consent” may easily misunderstood and become no consent at all • Nonetheless too simplistic to refer to ethics • Safety of organs is also served by transparent rules regarding removal of organs from deceased donors; lack of transparency diminishes confidence of the public and might lead to illegal and unethical practices that threaten the safety of organs

35. Incapacitated LOD • Also in this respect more guidance should be wellcome • Article 14 Directive refers to authorisation – same notion as in Biomedicine Convention?

36. Non national DOD • In the Commission Staff Working Document that accompanies the proposed Directive is stated : “ the mobility of potential organ donors and recipients is the second major challenge for the current quality and safety frameworks, after organ shortage. Evidence shows that more and more people might become organ donors while residing in another Member State. To ensure that organs available for therapy are not wasted, it is important that there are no legal barriers to the use of these organs and that the families of these donors have trust in the donation system so that they do not refuse donation”.

37. Non national DOD “ Given that it is impossible to know in advance whether a given healthcare provider will be confronted with a potential DOD coming from another MS, it is necessary that the requirements to ensure that organ removal is performed according to common principles and clear quality and safety standards are applicable to all healthcare services in order to ensure the freedom to provide and obtain cross border healthcare”

38. Patient Rights in cross-border healthcare • The previous citation is not from the directive on organ transplantation • It is an adapted citation from the EM to the proposal for a directive on the application of patients’ rights in cross-border healthcare • It took almost 10 years to convince the Commission of this point of view • It may serve as a crowbar for more common protection of DOD.

39. Thank you very much for your attention Herman NYS