1 The Author took part in the preparatory works of the Convention, as a member of the delegation of Italy to the Committee of Experts on Trafficking in Human Organs, Tissues and Cells (PC-TO). The opinions expressed in this article are the Author's own and do not reflect the views of the Italian Government.

2 See full text of the Santiago de Compostela Convention (hereinafter: SCC), available at www.coe.int/en/web/conventions/full-list/-/conventions/rms/0900001680081562. The previous Istanbul Declaration on Organ Trafficking and Transplant Tourism of 2008 (available at www.declarationofistanbul.org/), being the final document of an international summit of scientific and medical bodies from 150 countries, is a benchmark of the effort at the international level to both combat organ trafficking and promote free donations.

3 See López-Fraga, M.et al., A needed Convention against trafficking in human organs, in (2014) 384 The Lancet 2187CrossRefGoogle Scholar, available at www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60835-7/abstract. Unlawful transplants are very difficult to detect, knowledge is often provided by the fact that some patients “disappear” from the waiting list of the official health care system and later return to get post transplantation treatment.

4 Further information in Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs, Joint Council of Europe/United Nations Study, 2009, at www.coe.int/t/dghl/monitoring/trafficking/Docs/News/OrganTrafficking_study (‘Joint Study’).

5 Tania Branigan, ‘Executed prisoners are main source of Chinese organ donations’, The Guardian, 26 August 2009, available at www.theguardian.com/world/2009/aug/26/china-organ-donation-prisoners.

6 See Art. 22 of the 2006 Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin, CETS No. 186 (2002), available at www.coe.int/en/web/conventions/full-list/-/conventions/rms/0900001680081562 (‘AP’). The AP has operated since 1 June 2006 and has only currently been ratified by 13 States of the Council of Europe (‘CoE’). The AP simply requires the Parties to ‘provide appropriate judicial protection to prevent or to put a stop to an unlawful infringement’ of the principle (Art. 24) and to provide for appropriate sanctions (Art. 26). This Protocol is meant to complete the 1999 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, CETS No. 164 (1997) (‘OC’). The OC entered into force on 1 December 1999 and has been ratified by 29 states.

7 So provide both the UN's 2003 Protocol to Prevent, Suppress and Punish Trafficking in Persons, especially Women and Children, 2237 UNTS 319 (2000) in Art. 3 and the 2008 Council of Europe Convention on Action against Trafficking in Human Beings, CETS No. 197 (2005) (‘CoE Convention’) in Art. 4 (see note 47, infra).

8 For instance, when the victim agrees to the removal but the consent is not valid, or in the case of illicit removal of organs from deceased persons.

9 See Explanatory Report to the SCC, (‘SCC-ER’), at www.conventions.coe.int/Treaty/Commun/ListeTraites.asp?CM=8&CL=ENG.

10 Joint Study, supra note 4, 57.

11 Ibid, 96.

12 According to Art. 2.2, trafficking in human organs ‘shall mean any illicit activity in respect of human organs’ as prescribed in Art. 4.1 and Arts. 5,7,8,9 of the SCC, supra note 2. According to the SCC-ER, the definition of human organ has to be taken from Art. 3 of the EU directive 2010/45 (note 15, infra), thus meaning ‘a differentiated part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with a significant level of autonomy’. Trafficking in tissues and cells (corneas, stem cells, bone marrow) is not dealt with by the SCC, as the matter has been left to a future agreement, not yet elaborated: see SCC-ER, supra note 9, 2.

13 SCC, supra note 2, Art. 13: other aggravating circumstances occur when the offence is committed by a person abusing his/her position; or is committed in the framework of a criminal organization, or the perpetrator has previously been convicted of offences established in accordance with the same convention.

14 States parties to the AP shall guarantee that an efficient transplantation system is established, by national legislation, in order to ‘provide equitable access to transplantation services for patients’ (supra note 6, Art. 1). So far, only 13 states have ratified this, including Bulgaria, Croatia, Estonia, Finland, Georgia, Hungary, Iceland, Moldova, Montenegro, Slovenia, Spain, Switzerland and the former Yugoslav Republic of Macedonia.

15 Directive 2010/45/EU, of the European Parliament and of the Council of 7 July 2010, in OJ, L 207 of 6 August 2010. The directive acknowledges the exchange of organs for transplantation between member states as common practice and is meant at providing an uniform legal framework, in order to ensure faster procurement, transport and use of organs at Union level (preamble, paras. 4–6).

16 Ibid. According to its preamble (para. 7), the directive ‘although having as its first objective the safety and quality of organs, contributes indirectly to combating organ trafficking through the establishment of competent authorities, the authorisation of transplantation centres, the establishment of condition of procurement and systems of traceability’. Member states shall ensure not only that ‘all organs procured, allocated and transplanted on their territory can be traced from the donor to the recipient and vice versa’ but also ‘the implementation of a donor and recipient identification system that can identify each donation and each of the organs and recipients associated to it’ (Art. 10).

17 Concern has emerged about organ trafficking taking place in Azerbaijan (see CEDAW, Concluding observations on the fifth periodic report of Azerbaijan, UN Doc No. CEDAW/C/AZE/CO/5, 2015, para. 25; on CEDAW, infra, note 37) and in Turkey (see note 62, infra).

18 See WHO Guiding Principles of Human Cell, Tissues and Organ Transplantation, at www.who.int/transplantation/Guiding_PrinciplesTransplantation_WHA63.22en.pdf?ua=1. Strictly speaking, the consistency of the opting out system with the principle of the free consent of the donor may be controversial. In fact, the rule supporting it relies on a presumed consent (for example, even a person that does not express any will on the issue will be considered as a donor) rather than requiring at least an implicit consent of the donor (for example, some expression of the person's will in favour of donation, though not necessarily contained in a formal statement). The present article will not deal with this and other fundamental issues related to donations by deceased donors (like the determination of the moment when death occurs).

19 The SCC will not interfere with the choice of States: see SCC-ER, supra note 9, 5.

20 So that, for instance, the surgeon lawfully performing a removal in the first state could be prosecuted under criminal law in the second.

21 According to Art. 31 of the 1980 Vienna Convention on the Law of Treaties, 1155 UNTS 331 (1969), in interpreting a treaty ‘any relevant rules of international law applicable in the relations between the parties’ shall be taken into account. Interpretation of the SCC by reference to the AP or to other international conventions is both necessary and possible only as long as all the states concerned ratify the same related instruments. This is still far from being the case for the mentioned CoE conventions (see supra note 5, 14). Nevertheless, the SCC-ER assumes that the SCC and the related conventions are to be considered as a single system of norms within which inconsistencies are to be avoided. This applies, in particular, to the issue of consent. ‘[A]s a general principle’, the concept of consent included in the SCC ‘should be identical’ to the one expressed in the OC and in the AP (SCC-ER, supra note 9, 5).

22 See Art. 5 of the OC, supra note 6. The European Court of Human Rights (‘ECHR’) considered the issue, in a case concerning sterilization of a Roma woman performed while she was giving birth to her second child by Caesarean section. The patient's consent had been formally required and she had signed a form, but the Court considers that ‘it does not appear from the documents submitted that the applicant was fully informed about her health status, the proposed procedure and the alternatives to it. Furthermore, asking the applicant to consent to such an intervention while she was in labour and shortly before performing a Caesarean section clearly did not permit her to take a decision of her own free will, after consideration of all the relevant issues and, as she may have wished, after having reflected on the implications and discussed the matter with her partner’: V.C. v. Slovakia, ECHR, Judgment of 8 November 2011, para. 112.

23 Kidney donation is the most frequent procedure, but also part of a lung, the liver (which regenerates), the pancreas and a portion of the intestines can be removed from a living donor. Even the heart can be donated by a living person that -– needing not a new heart, but a lung transplant – for medical reasons gets a joint lung-heart transplantation, so that his/her heart can be donated to another patient: more at www.organdonor.gov/about/livedonation.html.

24 AP, supra note 6, Art. 13.

25 In several countries donation is restricted to benefit close relatives: to mention only a few, see The Transplantation of Human Organs and Tissues Act, of Punjab, of 18 March 2010, Art. 3, at www.punjablaws.gov.pk/index1.html; in India Art. 3 of the Transplantation of Human Organs Act of 1994 admits donation from a living person to a recipient, not being a near relative, ‘by reason of affection or attachment towards the recipient or for any other special reasons’ but ‘such human organ shall not be removed and transplanted without the prior approval of the Authorisation Committee’, see full text at www.indiankanoon.org/doc/1666741/. A few cases of organ trafficking have already come to courts in India, showing how this requirement is often violated by donors representing themselves as relatives of the recipient: see note 43, infra. In Israel, donation to a non-relative recipient is admitted following authorization by a Central Board, and the same rule applies to donations to non-residents of Israel: see Organ Transplant Act, 2008, at www.declarationofistanbul.org/resources/legislation/267-israel-transplant-law-organ-transplant-act-2008.

26 AP, supra note 6, Art. 10: each state party to the AP shall provide for a definition of the ‘close relationship’ and of the conditions to be met in the absence of such a relationship.

27 Ibid., Art. 12.

28 Ibid., Art. 11.

29 See preamble of the Directive, para. 7.3 and 12.

30 To mention only a couple of examples: The Human Transplantation (Wales) Act, 2013, states as a general rule that the child, if competent, can validly express consent to the removal of an organ. If the child is not competent or is competent to deal with the issue but fails to do so, the consent may be issued by a ‘person who has parental responsibility for the child’ (Art. 6). In Switzerland, Art. 13 of the Transplantation Act provides for donations from minors or persons ‘incapable of judgement’. See also the Swedish Transplant Act of 1975. For an overview, see Lopp, L., Regulations Regarding Living Organ Donation in Europe (2012)Google Scholar.

31 SCC-ER, supra note 9, 6.

32 This could have been done by omitting the words ‘in the case of the deceased donor’, which relates to the possibility of the removal being authorized by law.

33 It was perceived that national Parliaments in those States would reject ratification the SCC if the possibility of lawful organ removal from non-competent donors been established by it as a rule, rather than as an exception. As normally required for a reservation of this kind, it shall contain ‘a brief statement of the relevant domestic law’.

34 By quoting the ER of the OC, the SCC-ER, supra note 9, states that ‘it is for domestic law to determine whether or not a person has the capacity to consent’ (para. 37).

35 The norm requires every state party to criminalize removals performed in violation of ‘its domestic law’. This assumes that the crime occurs within its jurisdiction, while the issue of transnational offences is considered in SCC, supra note 2, Art. 5.

36 Art. 4.2, b.

37 The meaning of the non-discrimination principle as recalled by Art. 3 of the SCC, supra note 2, is ‘identical to that given to it under Art. 14 of the European Convention on human rights’ (SCC-ER, supra note 9, at 6). States parties to the ECHR shall secure equality in the enjoyment of the rights set forth by the same ECHR to everyone within their jurisdiction. Illicit organ removal, as inhuman treatment, violates Art. 3 of the ECHR. However, had the crime been perpetrated in a foreign country, the victim would hardly come within the jurisdiction of a state party to the ECHR and SCC (and would probably not even benefit from the prosecution of the crime). In any case, even assuming that the non-discrimination principle as set by the ECHR would not come into consideration, the courts shall nonetheless grant the broadest application to that principle in every possible way to properly comply with other international law norms that require it. First of all, the 1981 Convention on elimination of all forms of discrimination against women 1249 UNTS 13 (1979) (‘CEDAW’), to which all member states of the CoE are parties, requires states ‘to do everything that is necessary’ to achieve the full realization of the rights of women: see Byrnes, A., ‘Art. 24’, in Freeman, M.A., Chinkin, C. and Rudolf, B. (eds.), CEDAW Commentary (2012), 541Google Scholar (emphasis added). As for the ECHR, Protocol no. 12 (presently in force only among 19 states) aims at broadening protection of the non-discrimination principle. While Art. 14 of the ECHR prohibits discrimination only with regard to the ‘enjoyment of the rights and freedoms’ set forth by the same convention, the Protocol states that the enjoyment of any right set forth by law, including international law, shall be secured without discrimination (Art. 1).

38 As no obligation exists in general international law compelling states to recognize legislative or administrative acts of foreign states, denying authoritative effect of such documents would not entail any international wrongful act: see Ruffert, M., Recognition of Foreign Legislative and Administrative Act, in MPEPIL (May 2011Google Scholar, available at opil.ouplaw.com/view/10.1093/law:epil/9780199231690/law-9780199231690-e1087).

39 See Art. 5, in CEDAW Commentary, supra note 37, 141. Special protection is needed by women in rural areas: see Art. 14, ivi, 357.

40 Victims are mainly women and children, see CEDAW, Consideration of reports submitted by Pakistan, UN Doc No. CEDAW/C/PAK/4 2011, 59 at http://www2.ohchr.org/english/bodies/cedaw/docs/54/CEDAW-C-PAK-4.pdf. CEDAW, Consideration of reports submitted by Indonesia, UN Doc No. CEDAW-C/IDN/4-5, 2005, 21, ivi. Domestic violence is equally reported as a major problem.

41 The Committee is established by Art. 17 of the CEDAW, supra note 37, to which all states of the CoE are parties. The same relevance could be attributed to the reports of the UN Committee established by Art. 8 of the 1969 Convention on the Elimination of All Forms of Racial Discrimination 660 UNTS 195 (1965), or by Art. 43 of the 1990 Convention on the Rights of the Child 1577 UNTS 3 (1989).

42 See CEDAW, Concluding observations on the combined fourth and fifth periodic reports of India (CEDAW /C/IND/CO/4-5; 2014) available at http://tbinternet.ohchr.org/_layouts/treatybodyexternal/Download.aspx?symbolno=CEDAW/C/IND/CO/4-5. See also Trafficking in organs, Joint Study, supra note 4, 59. As for Turkey, ‘even after legislative reforms have removed the legal authorisation for discriminatory treatment, attitudes that pressure women to conform to certain codes of behaviour restrict women's life choices’: see Opuz v. Turkey, ECHR, Judgment of 9 June 2009, Application no. 33401/02, para. 100; selling of kidneys is reported in the country: see note 62, infra.

43 In the Indian State of Orissa, the High Court dealt with a case in which a woman had accepted to donate a kidney after being persuaded by a friend that it was the only means to save the life of a close relative of hers. The removal of the kidney was actually done to the benefit of a patient totally unknown to the donor. Upon denunciation by the husband of the victim, the director of the hospital was arrested. The Court investigated the events in order to decide on a writ of habeas corpus, see Ratnakumary v. State of Orissa, Orissa High Court, Cuttack, order of 24 July 2014. The Court held that the deceiver had changed the victim's identity documents to project her as a relative of the recipient and her signature ‘was taken on several written papers and blank papers against her will and she was not aware about the contents and meaning of those papers’. The transplantation had been performed with the approval of the clinic's director. A State Court of Gujarat acquitted eight people accused of organ trafficking, as the evidence provided did not reveal that any monetary transaction had taken place in respect of a number of donations of kidneys: see State of Gujarat v. Rajendrasinh, 22 March 2013. Actually, it had been proved that the donors had posed as relatives of the recipients, being induced to do so by middlemen.

44 Reports by Amnesty International and Human Rights Watch, for instance, were material to the conclusion that Italy had violated the principle of non-refoulement, in Hirsi Jamaa & Others v. Italy, Judgment of 23 February 2012, Application No. 27765/09.

45 Cheng, B., General Principles of Law as Applied by International Courts and Tribunals (1953)Google Scholar, at 141; M. Kotzur, Good Faith (Bona Fide), MPEPIL (January 2009, available at opil.ouplaw.com/view/10.1093/law:epil/9780199231690/law-9780199231690-e1412?prd=EPIL).

46 According to Art. 12 of the 1978 Protocol Additional to the Geneva Conventions of 12 August 1949, and relating to the Protection of Victims of International Armed Conflicts (Protocol I) 1125 UNTS 3 (1978) only consent to donation of blood for transplantation or skin for grafting could be lawful by these subjects, if ‘given voluntarily and without any coercion or inducement, and then only for therapeutic purposes, under conditions consistent with generally accepted medical standards and controls designed for the benefit of both the donor and the recipient’.See G. Novak, Wounded, Sick and Shipwrecked, in MPEPIL (December 2013, available at opil.ouplaw.com/view/10.1093/law:epil/9780199231690/law-9780199231690-e448). See also UK Ministry of Defence, The Manual of the Law of Armed Conflict (2005), at 124.

47 CoE Convention, supra note 7. According to the CoE Convention, trafficking in human beings ‘shall mean the recruitment, transportation, transfer harbouring or receipt of persons, by means of the threat of the use of force, or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability or the giving or receiving of payments or benefits to obtain the consent of a person having control over another person’. The crime is characterized by the purpose of exploitation, that ‘shall include, at the minimum, the exploitation of prostitution or other forms of sexual exploitation, forced labour or services, slavery or practices similar to slavery, servitude or the removal of organs’ and ‘the consent of a victim of trafficking in human beings . . . shall be irrelevant where any of the means indicated have been used’ (Art. 4, emphasis added).

48 See SCC-ER, supra note 9, 4. This also underlines that ‘the interpretation of the word intentionally is left to domestic law, but the requirement for intentional conduct relates to all the elements of the offence’.

49 Through making this list officially available to the public, it would become easier to admit that the criminal intent took the shape of dolus eventualis. Compared to a non-intentional offence, more effective and dissuasive sanctions could apply as required by Art. 12 of the SCC, supra note 2. Deprivation of liberty shall be provided for offences committed intentionally by natural persons under Art. 12.

50 SCC, supra note 2, Art. 26.2.

51 SCC-ER, supra note 9, 6.

52 The issue has been under discussion in the US for many years. See, for example, Crespi, G., ‘Overcoming the Legal Obstacles to the Creation of a Futures Market in Bodily Organs’ (1994) 55 Ohio State Law Journal 2Google ScholarPubMed. Other forms of state policies aimed at encouraging organ donation are reported to have little to no effect: P. Chatterjee et al., The Effect of State Policies on Organ Donation and Transplantation in the United States (2015) at JAMA Intern Med. doi:10.1001/jamainternmed.2015.2194. On the possibility of offering some form of incentive to families of deceased donors, see Nagral, S. and Amalorpavanathan, J., ‘Deceased organ donation in India: Where do we go from here?’ (2014) 11 Indian Journal of Medical Ethics 162Google Scholar.

53 See Farrell, A., ‘Adding Value? EU Governance of Organ Donation and Transplantation’ (2010) European Journal of Health Law 51CrossRefGoogle ScholarPubMed and Robertson, J., ‘Paid Organ Donations and the Constitutionality of the National Organ Transplant Act’ (2013) 40 (2)Hastings Constitutional Law Quarterly 221Google Scholar. Selling a kidney is legal in Iran: see Alesi, F. and Muzi, L., ‘Kidneys for sale: Iran's trade in organs’, The Guardian, 10 May 2015Google Scholar (available at www.theguardian.com/society/2015/may/10/kidneys-for-sale-organ-donation-iran).

54 Should a paid donation occur in a state where it is permitted by law and should the organ, then, be used in a state party to the SCC, a conflict of law issue would arise, quite similar to the one considered above, para. 6.

55 Several implications and risks are involved for both the donor (or vendor) and the recipient: see Mone, T., ‘Transplant Tourism: The Ethical Implications’ (2011) XI (1)Journal of Humanitarian MedicineGoogle Scholar.

56 Even embassy officials are reported to facilitate the business: see Joint Study, supra note 4, 58.

57 SCC, supra note 2, Art. 10.2; in the convention ‘there are no provisions providing for the elimination of the usual rule of dual criminality’: SCC-ER, supra note 9, 9.

58 SCC, supra note 2, Art. 15; SCC-ER, supra note 9, 13.

59 See K. Connolly, ‘Mass donor organ fraud shakes Germany’, The Guardian, 9 January 2013 (available at www.theguardian.com/world/2013/jan/09/mass-donor-organ-fraud-germany). The case involved several important clinics.

60 News concerning organ trafficking and even rumours ‘may damage the image of donation and trans-plantation to such an extent that they undermine public trust in the system’: see Joint Study, supra note 4, 64.

61 The reservation refers to Art. 5 (use of illicitly removed organs) as well as to Art. 7 (illicit solicitation, recruitment, offering and requesting of undue advantages). States are free to totally exclude criminalizing such conduct when not aimed at transplantation, or to specify which ‘other purposes’ they will consider as legitimate – SCC, supra note 2.

62 The case was tried by an EU-led court, see BBC News, ‘Medicus: Five guilty in Kosovo human organ trade case’, BBC News, 29 April 2013 (available at www.bbc.com/news/world-europe-22343589). Seven people have been recently charged in Israel with having organized or performed transplants in Kosovo as well as in Azerbaijan, Sri Lanka, and Turkey, using paid local donors for Israeli recipients, see more at The Straits Times, ‘Israel Charges Seven with International Organ Trafficking’, The Straits Times, 14 May 2015 (available at www.straitstimes.com/news/world/middle-east/story/israel-charges-seven-international-organ-trafficking-20150514#sthash.ZOfCX4C3.dpuf).