Regulatory responses to assisted reproductive technology: a comparative analysis of Spain and Israel

Abstract

Purpose

The market of assisted reproductive technologies (ARTs) is rapidly evolving, raising growing ethical and social dilemmas. This paper compares the regulatory responses to technological and market developments in Israel and Spain, both intensive users of ART. We identify strengths and deficiencies in the regulation of ART in these two countries.

Methods

We developed a conceptual framework to classify the factors affecting regulations and priority setting, and applied it using a Delphi survey combined with in-depth interviews. We selected two panels of experts from various fields, trying to simulate the bioethics committees of Israel and Spain.

Results

ART is often wrongfully perceived as a solution to age-related infertility. Both panels embraced alternative solutions. The impact of private commercial interest on regulations is resulting in excessive practices such as the repeat of ineffective cycles and the push of sometimes unnecessary treatment add-ons. Our findings show experts dissatisfaction with the regulations of donor-eggs concerning reimbursement and registries in both countries.

Conclusions

The adequacy of ART to solve age-related infertility should be confronted with alternative approaches, with emphasis on the distribution of accurate information. The magnitude of ART markets, particularly the use of donor-eggs, should raise the need for additional societal debate and the reform of regulations. The impact factors analysis leads us to question the current regulatory framework, which could be improved by nominating a non-governmental statutory central regulatory agency in Israel and by reforming the Spanish agency.

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Notes

  1. 1.

    In Spain, Law 35/1988 on Assisted Reproduction Techniques, revised by laws 10/1995 of the Penal Code and Law 45/2003. Reformed by Law 14/2006 on Assisted Reproduction Techniques and partially revised by Law 19/2015 of administrative reform measures in the field of the Administration of Justice and the Civil Registry. In Israel, Public Health Regulations (In Vitro Fertilization), 1987, revised by National Health Insurance Law, 1994; revised again by Health Ministry guidelines, 2014.

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Acknowledgments

This work was possible thanks to the contribution of many individuals who participated in interviews and replied to the survey voluntarily and without remuneration. We are especially grateful to Prof. Vardit Ravitsky, who guided and revised the questionnaire, to Dr. Javier Rey del Castillo, Prof. Eitan Lunenfeld, Dr. Inmaculada Molina Botella and Prof. Carlos Romeo Casabona who contributed and revised the data collection, and to Yardena Kop-Yosef, who revised the manuscript.

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Alon, I., Guimón, J. & Urbanos-Garrido, R. Regulatory responses to assisted reproductive technology: a comparative analysis of Spain and Israel. J Assist Reprod Genet 36, 1665–1681 (2019). https://doi.org/10.1007/s10815-019-01525-7

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Keywords

  • Assisted Reproductive Technology (ART)
  • In-Vitro Fertilization (IVF)
  • Regulatory Assessment
  • Delphi
  • Spain
  • Israel