Requirements for donor disposal and compensation in the context of assisted human reproduction: European and North American international recommendation
Vigil Sanit Debate, Rio de Janeiro, 2026, v.14: e02533| Published on: 2026-05-04
DOI:
https://doi.org/10.22239/2317-269X.02533Keywords:
Reproductive Health Services, Assisted Reproductive Technique, Practice Guideline, Health Care Coordination and MonitoringAbstract
Introduction: The regulation of assisted human reproduction (AHR) involves ethical and technical guidelines that vary between countries and institutions, especially regarding Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) disposal and donor remuneration. Harmonization of these criteria is essential to ensure safety in reproductive processes. Objective: To identify requirements in assisted human reproduction regarding disposal and remuneration adopted by the international regulatory agencies Food and Drug Administration (FDA) and European Commission (EC) and by the recommending societies/institutions American Society for Reproductive Medicine (ASRM), European Society of Human Reproduction and Embryology (ESHRE), and Human Fertilization Embryology Authority (HFEA). Method: Documentary, descriptive, and exploratory review complemented by a scoping review. The documents were analyzed using normative and technical criteria related to tissue and cell disposal and donor compensation. Results: The EC (Directive 2006/86/EC) and the FDA (CFR 21 Part 1271) have regulations on disposal, emphasizing health safety and traceability. The HFEA limits compensation to fixed amounts to cover reasonable financial losses, prohibiting any gain. The ESHRE reinforces safe disposal practices and, together with the ASRM, allows limited compensation for time and expenses, discouraging financial motivations as the main reason for donation. European guidelines tend to favor altruistic models with controlled reimbursements, whereas in the USA, there is greater flexibility, although with ethical requirements. Conclusion: Although the European model prioritizes altruism and limits compensation, this rigidity can restrict donor availability and affect equity in access. In contrast, North American flexibility favors a greater supply but requires constant ethical oversight. Sanitary safety and traceability should remain universal principles in any regulatory donation system. The analysis demonstrates convergences and divergences in regulatory requirements, reflecting different sociocultural and ethical contexts. The findings may contribute to the development of more equitable and safe policies in assisted reproduction, especially in countries seeking to update their regulations according to international practices.
Downloads
Author Biographies
-
Aurélio Matos Andrade, Programa de Evidências para Políticas e Tecnologias de Saúde, Fundação Oswaldo Cruz (Fiocruz), Brasília, DF, Brasil
-
Maíra Catharina Ramos, Programa de Evidências para Políticas e Tecnologias de Saúde, Fundação Oswaldo Cruz (Fiocruz), Brasília, DF, Brasil | Programa de Pós-graduação em Saúde Coletiva, Faculdade de Ciências da Saúde, Universidade de Brasília, Brasília, DF, Brasil
-
Flávia Tavares Silva Elias, Programa de Evidências para Políticas e Tecnologias de Saúde, Fundação Oswaldo Cruz (Fiocruz), Brasília, DF, Brasil
References
1. American Society for Reproductive Medicine – ASRM. Limits on sperm and egg donations. Washington, DC: American Society for Reproductive Medicine; 2021[acesso 1 set 2025]. Disponível em: https://www.asrm.org/practice-guidance/practice-committee-documents/
guidance-regarding-gamete-and-embryo-donation-2021/
2. American Society for Reproductive Medicine – ASRM.Cryostorage of reproductive tissues in the in vitro fertilization laboratory: a committee opinion. Washington,DC: American Society for Reproductive Medicine;2020[acesso 3 out 2024]. Disponível em: https://www.
asrm.org/practice-guidance/practice-committeedocuments/cryostorage-of-reproductive-tissues-inthe-in-vitro-fertilization-laboratory-a-committeeopinion-2020/?_t_tags=siteid%3a01216f06-3dc9-4ac9-96da-555740dd020c%2clanguage%3aen&_t_hit.
id=ASRM_Models_Pages_ContentPage/_20ef6bd4-d4a3-478c-9a63-fa2bedf54de4_en&_t_hit.pos=42
3. American Society for Reproductive Medicine – ASRM. Development of an emergency plan for in vitro fertilization programs: a committee opinion.Washington, DC: American Society for Reproductive Medicine; 2021[acesso 3 out 2024]. Disponível em: https://www.asrm.org/practice-guidance/practice-committee-documents/development-of-anemergency-plan-for-in-vitro-fertilization-programs-acommittee-
opinion--2021/?_t_tags=siteid%3a01216f06-3dc9-4ac9-96da-555740dd020c%2clanguage%3aen&_t_hit. id=ASRM_Models_Pages_ContentPage/_e6ae31e7-2d82-436fbd16-37fbe13387b0_en&_t_hit.pos=34
4. European IVF Monitoring Consortium - EIM. European Society of Human Reproduction and Embryology –ESHRE. Smeenk J, Wyns C, De Geyter C, Kupka M, Bergh C, Cuevas Saiz I, De Neubourg D, Rezabek K, Tandler-Schneider A, Rugescu I, Goossens V. ART in Europe, 2019: results generated from European registries by ESHRE†. Hum Reprod. 2023;38(12):2321-38.https://doi.org/10.1093/humrep/dead197
5. European Commission - EC. Proposal for a regulation on standards of quality and safety for substances of human origin intended for human application. Geneva:European Commission; 2022[acesso 1 set 2025]. Disponível em: https://eur-lex.europa.eu/legal-content/EN/
TXT/?uri=CELEX%3A52022PC0338
6. Wyns C, De Geyter C, Calhaz-Jorge C, Kupka MS, Motrenko T, Wyns C et al. ART in Europe, 2019: results generated from European registries by ESHRE. Hum Reprod Open. 2022;2022(1):1-11.https://doi.org/10.1093/hropen/hoac017
7. Society for Assisted Reproductive Technology - SART. Clinic outcome reporting system (CORS).Vestavia Hills: Society for Assisted Reproductive Technology; 2025[acesso1 set 2025].Disponível em: https://www.sart.org
8. Centers for Disease Control and Prevention – CDC. 2021 Assisted Reproductive Technology Fertility Clinic Success Rates Report. Washington DC: US Department of Health and Human Services; 2023[acesso 1 set 2025]. Disponível em:https://www.cdc.gov/art/reports
9. United States. Fertility Clinic Success Rate and Certification Act of 1992, Pub. L. No. 102-493, 106 Stat. 3146 (Oct. 24, 1992), codified at 42 U.S.C.§ 263a-1 et seq.
10. Rede Latino-Americana de Reprodução Assistida - Redlara. Relatório anual de atividades 2023. São Paulo:Rede Latino-Americana de Reprodução Assistida; 2023.
11. Agência Nacional de Vigilância Sanitária - Anvisa. Resolução RDC Nº 23, de 27 de maio de 2011. Dispõe sobre o funcionamento dos bancos de células e tecidos germinativos. Diário Oficial União. 28 maio 2011.
12. European Commission. EU legislation on blood, tissues and cells. Brussels: European Commission;2022[acesso 22 maio 2025]. Disponível em: https://health.ec.europa.eu/blood-tissues-cells-and-organs/tissues-and-cells_en
13. Zegers-Hochschild F, Crosby JA, Musri C, Souza MCB, Martinez AG, Silva AA et al. Assisted reproductive technologies in Latin America: the Latin American registry, 2019. JBRA Assist Reprod. 2022;26(4):637-58.https://doi.org/10.5935/1518-0557.20220034
14. Cellard, A. A análise documental. In: Poupart J, Deslauriers J-P, Groulx, L-H, Laperriere A, Mayer, R, Pires A. A pesquisa qualitativa: enfoques epistemológicos e metodológicos. Petrópolis: Vozes; 2008.
15. Peters MDJ, Marnie C, Tricco AC, Pollock D, Munn Z, Alexander L et al. Updated methodological guidance for the conduct of scoping reviews. JBI Evid Synth. 2020;18(10):2119-26.https://doi.org/10.11124/JBIES-20-00167
16. Ishikawa K. Guia para o controle de qualidade. São Paulo: Pioneira; 1991.
17. European Commission – EC. Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells. Off J Eur Union.24 out 2006[acesso 22 maio 2025]. Disponível em:
https://eur-lex.europa.eu/legal-content/PT/TXT/HTML/?uri=CELEX:32006L0086
18. European Society of Human Reproduction and Embryology - ESHRE. Revised guidelines for good practice in IVF laboratories. Strombeek-Bever: European Society of Human Reproduction and Embryology; 2015[acesso 22 maio 2025].Disponível em: https://www.eshre.eu/Guidelines-and-Legal/Guidelines/Revised-guidelines-for-good-practice-in-IVF-laboratories-(2015)
19. European Society of Human Reproduction and Embryology - ESHRE. Preimplantation genetic testing (PGT): guidelines for good practice. Strombeek-Bever: European Society of Human Reproduction and Embryology; 2020[acesso 22 maio 2025]. Disponível em: https://www.eshre.eu/Guidelines-and-Legal/Guidelines/PGT
20. US Food and Drug Administration - FDA. Code of federal regulations title 21 – Sec. 1271.440: orders of retention, recall, destruction, and cessation of manufacturing. Silver Spring: US Food and Drug Administration; 2023[acesso 22 maio 2025]. Disponível em: https://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271&showFR=1&subpartNode=21:8.0.1.5.59.10
21. American Society for Reproductive Medicine - ASRM. Guidance regarding gamete and embryo donation. Washington, DC: American Society for Reproductive Medicine; 2021[acesso 22 maio 2025]. Disponível em: https://www.asrm.org/practiceguidance/practice-committee-documents/guidance-regarding-gamete-and-embryo-donation-2021
22. Human Fertilisation and Embryology Authority - HFEA. Code of Practice. 9th ed. Version 4. London: Human Fertilisation and Embryology Authority;2023[acesso 22 maio 2025]. Disponível em:https://portal.hfea.gov.uk/media/za0j5qqr/2023-10-26-code-of-practice-v9-4.pdf
23. European Society of Human Reproduction and Embryology - ESHRE. Good practice recommendations for providing information to those involved in reproductive donation. Hum Reprod Open. 2022;2022(1):1-26.https://doi.org/10.1093/hropen/hoac001
24. American Society for Reproductive Medicine -ASRM. Guidance regarding gamete and embryo donation. Washington, DC: American Society for Reproductive Medicine; 2021[acesso 22 maio 2025]. Disponível em: https://www.asrm.org/practice-guidance/practice-committee-documents/guidance-regarding-gamete-and-embryo-donation-2021
25. De Wert G, Dondorp W, Shenfield F, Devroey P, Tarlatzis B, Barri P et al. ESHRE Task Force on Ethics and Law 22: preimplantation genetic
diagnosis. Hum Reprod. 2014;29(8):1610-7.https://doi.org/10.1093/humrep/deu132
26. Ravitsky V, Birko S, Le Clerc-Blain J, Haidar H, Affdal AO, Lemoine ME et al. Noninvasive prenatal testing: views of canadian pregnant women and their partners regarding pressure and societal concerns. AJOB Empir Bioeth. 2021;12(1):53-62.https://doi.org/10.1080/23294515.2020
27. US Food and Drug Administration - FDA. Eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Silver Spring:US Food and Drug Administration; 2023.
28. Howard L. Respectful destruction. Voices Bioethics. 26 mar 2014[acesso 22 maio 2025]. Disponível em:https://journals.library.columbia.edu/index.php/bioethics/article/view/6594
29. Nuffield Council on Bioethics – NCB. Donor conception: ethical aspects of information sharing. London: Nuffield Council on Bioethics; 2013.
30. Pennings G, Mouzon J, Shenfield F, Ferraretti AP, Mardesic T, Ruiz A et al. Socio-demographic and fertility-related characteristics and motivations of oocyte donors in eleven European countries. Hum Reprod. 2014;29(5):1076-89.https://doi.org/10.1093/humrep/deu048
31. ESHRE Working Group on Reproductive Donation. Kirkman-Brown J, Calhaz-Jorge C, Dancet EAF, Lundin K, Martins M, Tilleman K et al. Good practice recommendations for information provision for those involved in reproductive donation†. Hum Reprod Open. 2022;2022(1):1-22.https://doi.org/10.1093/hropen/hoac001
32. Piersanti V, Consalvo F, Signore F, Del Rio A, Zaami S. Surrogacy and “Procreative Tourism”:what does the future hold from the ethical and legal perspectives? Medicina. 2021;57(1):1-16.https://doi.org/10.3390/medicina57010047
33. ESHRE Special Interest Group Safety and Quality in ART. Alteri A, Vermeulen N, Rugescu IA, Nogueira D, Veleva Z et al. Coding in medically assisted reproduction: the status of the implementation of the Single European Code for reproductive cells and tissues. Hum Reprod Open. 2020;2020(3):1-7.https://doi.org/10.1093/hropen/hoaa027
34. Machado CS. The fate of surplus embryos: ethical and emotional impacts on assisted reproduction. JBRA Assist Reprod. 020;24(3):310-5.
https://doi.org/10.5935/1518-0557.20200015
35. Araújo TM. O estado regulatório da reprodução humana assistida no Brasil: da ausência de legislação ordinária ao regulamento deontológico atual. Cad Ibero-Am Direito Sanit. 2023;12(1):10-23.https://doi.org/10.17566/ciads.v12i1.968
36. Shenfield F, Pennings G, De Mouzon J, Ferraretti AP, Goossens V. ESHRE Task Force ‘Cross Border Reproductive Care’. ESHRE’s good practice guide for cross-border reproductive care for centers and practitioners. Hum Reprod. 2011;26(7):1625-7.https://doi.org/10.1093/humrep/der090
37. Van Zyl L, Walker R. Beyond altruism: a feminist analysis of egg donation and surrogacy in a global market. J Bioeth Inq.2015;12(3):447-58.
38. Ezeome IV. Gamete donation: a review of ethical and legal issues. Afr J Reprod Health. 2023;26(3):15-22.https://doi.org/10.29063/ajrh2022/v26i3.14
39. Inhorn MC, Patrizio P. The global landscape of cross-border reproductive care: twenty key findings for the new millennium.Curr Opin Obstet Gynecol. 2012;24(3):158-63.https://doi.org/10.1097/GCO.0b013e328352140a
40. Pennings G. Reproductive tourism as moral pluralism in motion. J Med Ethics. 2002;28(6):337-41.https://doi.org/10.1136/jme.28.6.337
41. Degli Esposti S, Pavone V. Oocyte provision as a (quasi) social market: insights from Spain. Soc Sci Med. 2019;234.https://doi.org/10.1016/j.socscimed.2019.112381
42. Salama M, Isachenko V, Isachenko E, Rahimi G, Mallmann P, Westphal LM et al. Cross border reproductive care (CBRC): a growing global phenomenon with multidimensional implications (a systematic and critical review). J Assist Reprod Genet. 2018;35(7):1277-88.
https://doi.org/10.1007/s10815-018-1181-x
43. Saxena P, Mishra A, Malik S. Surrogacy: ethical and legal issues. Indian J Comm Med. 2012;37(4):211-3.https://doi.org/10.4103/0970-0218.103466
44. Thorn P, Daniels K, Götestam KG. The motivation, experiences and expectations of sperm donors in Sweden. J Assist Reprod Genet. 2008;25(11–12):489-98.
45. Sauer MV. Ethical aspects of human reproductive cloning: raising the awareness of a global community. Reprod Biomed Online. 2015;31(2):150-7.
Downloads
Published
Issue
Section
Categories
License
Copyright (c) 2026 Health Surveillance under Debate: Society, Science & Technology
This work is licensed under a Creative Commons Attribution 4.0 International License.
COPYRIGHT ALLOWANCE The author (s) hereinafter designated as the ASSIGNOR hereby assign and transfer, free of charge, the ownership of the copyrights related to this ARTICLE to the Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debate, represented by FUNDAÇÃO OSWALDO CRUZ, established at Av. Brasil, nº 4365, Manguinhos, Rio de Janeiro, RJ, Brazil, CEP 21045-900, under the conditions set out below: (a) The terms and conditions set forth in this Agreement shall apply to the following: 1. The ASSIGNOR declares that they s(he) is (are) the author (s) and owner (s) of the copyrighted property of the ARTICLE submitted. 2. The ASSIGNOR declares that the ARTICLE does not infringe the copyrights and / or other property rights of third parties, that the disclosure of images (if any) has been authorized and that they s(he) assume(s) full moral and / or property liability for its content, before third parties. 3. THE ASSIGNOR assigns and transfers all copyrights relating to the ARTICLE to the ASSIGNEE, especially the rights of editing, publication, translation into another language and reproduction by any process or technique. The ASSIGNEE becomes the exclusive owner of the rights related to the ARTICLE, and any reproduction, totally or partially, is prohibited in any other means of publicity, printed or electronic, without prior written authorization from the ASSIGNEE. 4. The assignment is free and, therefore, there will be no remuneration for the use of the ARTICLE by the ASSIGNEE.
