The 35th Anniversary of Germany’s Embryo Protection Act: Model Legislation for the Ethical Protection of Human Embryos

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Preface

The 2022 Annual Summer Conference sponsored by The Center for Bioethics & Human Dignity took place between June 23 and June 25, 2022, on the campus of Trinity International University in Deerfield, Illinois. The well-attended conference erupted into rejoicing and gratitude to God when the United States Supreme Court made public its Dobbs decision on June 24, 2022. The following day, I delivered my CBHD presentation entitled “International Laws that Promote the Ethical Healthcare & Legal Protection of Human Embryos: Germany’s 1990 ‘Embryo Protection Act’ & Italy’s 2004 ‘Medically Assisted Reproduction Law.’”

This article will begin by summarizing my CBHD parallel presentation on June 25, 2022, which focused on the global significance of the Nuremberg Code on its 75th Anniversary and on its continued influence on international laws that protect the lives of human embryos. Then it will focus more specifically on the importance of Germany’s Embryo Protection Law on its 35th Anniversary in December of 2025.

Introduction

The heinous scientific experiments performed on living human beings at the hands of Nazi doctors and researchers was internationally condemned and prohibited as “crimes against humanity” by the Nuremberg Code that was formulated 75 years ago in August of 1947.

This paper will focus on the moral imperative to expand its universal legal protection to human embryos, who must be protected from all non-therapeutic, destructive experimentation and research at the hands of medical researchers. Just as the victims of Nazi experimentation were deprived of informed consent, so too human embryos cannot provide their informed consent.

In 1987, forty years after the Nuremberg Code was formulated, the Magisterium of the Catholic Church promulgated the Instruction Donum vitae, which carefully defined and prohibited artificial reproductive technologies (ART), including in vitro fertilization (IVF), and it responded with authoritative answers to some of the most critically important questions regarding the moral and ethical treatment of human embryos. For example:

Are Therapeutic Procedures Carried Out on the Human Embryo Licit?
As with all medical interventions on patients, one must uphold as licit procedures carried out on the human embryo which respect the life and integrity of the embryo and do not involve disproportionate risks for it but are directed towards its healing, the improvement of its health, or its individual survival.[1]
How is One Morally to Evaluate the Use for Research Purposes of Embryos Obtained by ‘In Vitro’ Fertilization?
Human embryos obtained in vitro are human beings and subjects with rights: their dignity and right to life must be respected from the first moment of their existence. It is immoral to produce human embryos destined to be exploited as disposable “biological material.”[2]

Eight years later, in the Catechism of the Catholic Church, the Magisterium unequivocally proclaimed, “Since it must be treated from conception as a person, the embryo must be defended in its integrity, cared for, and healed, as far as possible, like any other human being.”[3]

Surprisingly, in full accordance with the Nuremberg Code in 1947 and the Instruction Donum vitae in 1987, two former WWII axis nations passed strict legislation banning all non-therapeutic experimentation on human embryos—namely, Germany in 1990 with its Embryo Protection Law and Italy in 2004 with its Medically Assisted Reproduction Law. These international “biolaws” provide model legislation that ban cryopreservation and all non-therapeutic experimentation on human embryos in full accordance with the Nuremberg Code. The strict and humane regulations that were enacted in Germany and in Italy will be further explored and developed in this paper.

The 75th Anniversary of the Nuremberg Code (1947–2022)

The Nuremberg Code, formulated in August 1947, stands as one of the most influential ethical documents in history, shaping the way modern societies perceive and conduct medical research. Born out of the atrocities uncovered during the Nuremberg Trials, it aimed to safeguard human dignity against the misuse of science. The Code’s ten principles emphasize informed consent, the necessity of research for societal benefit, and the protection of participants from harm.

The Code’s first principle, “The voluntary consent of the human subject is absolutely essential,” established the ethical foundation for autonomy and human rights in medical research.[4] This tenet underscored the critical importance of ethical boundaries, reflecting a commitment to protecting individuals from coercion, exploitation, physical harm, or even death under the guise of scientific advancement.

On the Code’s 50th anniversary in 1997, Dr. Evelyne Shuster, a medical ethicist, published an article in The New England Journal of Medicine, entitled “Fifty Years Later: The Significance of the Nuremberg Code.” In her article, she highlighted the Code’s role in institutionalizing ethical practices that prioritize human dignity and summarized the Code’s historical significance with these words:

The Nuremberg Code is the most important document in the history of the ethics of medical research. The Code was formulated 50 years ago, in August 1947, in Nuremberg, Germany, by American judges sitting in judgment of Nazi doctors accused of conducting murderous and tortuous human experiments in the concentration camps. It served as a blueprint for today’s principles that ensure the rights of subjects in medical research. . . .
By insisting that medical investigators alone cannot set the rules for ethical conduct of research, even when guided by beneficence and Hippocratic ethics, and by adopting a human-rights perspective that acknowledges the centrality of informed consent and the right of the subject to withdraw, the Nuremberg Code has changed forever the way both physicians and the public view the proper conduct of medical research on human subjects.[5]

Yet Shuster’s reflections neglected an entire population of vulnerable people whom the Nuremburg Code should be protecting. Ethical dilemmas surrounding the use of assisted reproductive technologies, including IVF, cryopreservation, and embryonic experimentation, proliferated exponentially between 1978 and 1997, with virtually no legal application of the Nuremberg Code’s ethical guidelines, except for the exceptional enactment of Germany’s Embryo Protection Act in 1990, nearly seven years before the Code’s fiftieth anniversary.

When the “world’s first test-tube baby,” Louise Joy Brown, was born in England on July 25, 1978, the news was celebrated in virtually every major newspaper around the world. Even Cardinal Albino Luciano, who within days would become Pope John Paul I, publicly welcomed the newborn baby into the world without endorsing artificial fertilization. But while her birth marked the beginning of a bold new era in reproductive medicine, the manner of her conception also immediately raised a great number of profound questions about the moral and legal status of human embryos when they are created by scientists using modern technology inside a laboratory.

Just three months later, following the unexpected, sudden death of Pope John Paul I, Cardinal Karol Wojtyla was elected as Pope John Paul II on October 16, 1978. The demand for in vitro fertilization began to spread exponentially around the globe. In addition, scientists almost immediately began creating human embryos solely for the purpose of research and experimentation. The so-called “14-Day Rule” was introduced just a year later in 1979 and permitted research on embryos up to 14 days after fertilization before requiring the destruction and the disposal of these human beings in their earliest stages of human development—namely, killing them prior to implantation and deliberately depriving them of maternal care and gestation.

In 2022, it was important to commemorate the 75th anniversary of the Nuremberg Code because its core ethical principles continue to be even more relevant today than ever before. It would have been an excellent moment to consider the moral imperative of extending and applying its global and universal ethical protections to human embryos from the first moment of their conception, recognizing them as a full member of the human family and as unborn children created by God in his image and likeness. Advances in biotechnology must always be strictly guided by ethical regulations that prioritize the inherent dignity and rights of every human being, regardless of his or her stage of development, from the very first instant of his or her existence until natural death.

The Vatican’s Instruction Donum vitae (1987)

On February 22, 1987—forty years after the Nuremberg Code and nine years after the birth of the first IVF baby—the Catholic Church finally promulgated the Instruction Donum vitae (The Gift of Life), On Respect for Human Life in Its Origin and On the Dignity of Procreation. Donum vitae is a magisterial document that fully explains and addresses the ethical and moral challenges posed by Assisted Reproductive Techniques (ART). Issued by the Congregation for the Doctrine of the Faith (CDF) and promulgated under the guidance of Pope John Paul II, Donum vitae provided a moral compass for navigating the many complex bioethical issues surrounding human embryos.

It took the CDF almost ten years to carefully research and define the many serious moral issues involved in artificial procreation. The Instruction Donum Vitae was finally promulgated on February 22, 1987, on the Feast of the Chair of St. Peter, the Apostle. As a CDF Instruction it authoritatively defines artificial procreation as all of “the different technical procedures directed towards obtaining a human conception in a manner other than the sexual union of man and woman.”[6] Donum vitae specifically prohibits the “fertilization of an ovum in a test tube (in vitro fertilization) and artificial insemination through transfer into the woman’s genital tracts of previously collected sperm.”[7] In addition, the Instruction also formally prohibits commercial surrogacy—also called surrogate motherhood—“for the same reasons which lead one to reject heterologous artificial fertilization: for it is contrary to the unity of marriage and to the dignity of the procreation of the human person.”[8]

This outstanding Church document proclaims the inviolable dignity of human embryos as human beings from the first moment of conception and declares that they must be treated as human persons—and as patients—like all other human beings. These magisterial teachings can be found in the Instruction Donum vitae and in the Catechism of the Catholic Church:

The human being must be respected—as a person—from the very first instant of his existence.[9]
Since it must be treated from conception as a person, the embryo must be defended in its integrity, cared for, and healed, as far as possible, like any other human being.[10]
As with all medical interventions on patients, one must uphold as licit procedures carried out on the human embryo which respect the life and integrity of the embryo and do not involve disproportionate risks for it but are directed towards it healing, the improvement of its condition of health, its individual survival.[11]

Donum vitae categorically condemns non-therapeutic research and experimentation on embryos, affirming that no scientific objective, however noble, can justify the destruction or harm of embryonic life:

It is immoral to produce human embryos intended for exploitation as disposable biological material.[12]
“Certain attempts to influence chromosomic or genetic inheritance are not therapeutic but are aimed at producing human beings selected according to sex or other predetermined qualities. Such manipulations are contrary to the personal dignity of the human being and his integrity and identity” which are unique and unrepeatable.[13]

The Instruction carefully contrasts such immoral, non-therapeutic practices with the morally licit therapeutic procedures and medical interventions that are carried out on the human embryo and that are directed at the healing and the improvement of the health of embryos, which necessarily include using the therapeutic procedure known as embryo transfer, which is an absolutely necessary therapeutic procedure for the embryo’s individual survival. Reflecting the Church’s perennial commitment to the sanctity of life, Donum vitae declares that all therapeutic interventions on human embryos must be considered as morally licit and desirable—including embryo transfer—to a maternal womb for implantation, gestation, and birth.

In fact, both Donum vitae I.6 (in 1987) and Dignitas personae 18 (in 2008) prohibit the freezing of embryos: “even when carried out in order to preserve the life of an embryo”; and even “temporarily” as authoritatively taught by the Congregation for the Doctrine of the Faith in its most recent Instructions:

The freezing of embryos, even when carried out in order to preserve the life of an embryo—cryopreservation—constitutes an offence against the respect due to human beings by exposing them to grave risks of death or harm to their physical integrity and depriving them, at least temporarily, of maternal shelter and gestation, thus placing them in a situation in which further offences and manipulation are possible.[14]
Cryopreservation is incompatible with the respect owed to human embryos; it presupposed their production in vitro; it exposes them to the serious risk of death or physical harm, since a high percentage does not survive the process of freezing and thawing; it deprives them at least temporarily of maternal reception and gestation; it places them in a situation in which they are susceptible to further offense and manipulation.[15]

Through its teachings, Donum vitae has significantly shaped the international discourse on bioethics, and it continues to challenge legislators and policymakers in every nation to legally protect human embryos from physical harm, exploitation, and death. In fact, Part III of the Instruction is titled “Moral and Civil Law: The Values and Moral Obligations that Civil Legislation Must Respect and Sanction in this Matter.” Its core principles are cited in the Catechism of the Catholic Church n. 2273:

The inalienable right to life of every innocent human individual is a constitutive element of a civil society and its legislation:
     “The inalienable right of the person must be recognized and respected by civil society and the political authority. These human rights depend neither on single individuals nor on parents; nor do they represent a concession by society and the state; they belong to human nature and are inherent in the person by virtue of the creative act from which the person took his origin. Among such fundamental rights one should mention in this regard every human being’s right to life and physical integrity from the moment of conception until death.”[16]
     “The moment a positive law deprives a category of human beings of the protection which civil legislation ought to accord them, the state is denying the equality of all before the law, When the state does not place its power at the service of the rights of each citizen, and in particular of the more vulnerable, the very foundations of a state based on law are undermined. . . . As a consequence of the respect and protection which must be ensured for the unborn child from the moment of conception, the law must provide appropriate penal sanctions for every deliberate violation of the child’s rights.”[17]

International Biolaws

The principles articulated in both the Nuremberg Code and in Donum vitae have found legislative expression in certain nations committed to protecting embryonic life. Among the many Western European nations, Germany’s Embryo Protection Act (1990) and Italy’s Medically Assisted Reproduction Law (Law 40/2004) stand out as exemplary models of international legislation that articulate ethical regulations.

Germany’s “Embryo Protection Act” (1990)

Germany’s Embryo Protection Act, enacted on December 13, 1990, reflects a profound commitment to upholding human dignity. This law prohibits the creation, manipulation, or destruction of human embryos for non-therapeutic purposes. Its key provisions include:

  1. Banning the use of human embryos for research or experimentation.
  2. Prohibiting the unnecessary creation and freezing of surplus embryos through IVF.
  3. Criminalizing cloning and other forms of embryonic manipulation.
  4. Prohibiting surrogacy arrangements.

The Act imposes strict penalties for violations, ranging from thousands of dollars in fines to imprisonment. Germany’s Embryo Protection Act represents the nation’s resolve to protect embryonic human life. It embodies the ethical imperative to treat embryos not as commodities but as unborn children of the human family, deserving of respect and protection.

Italy’s Medically Assisted Reproduction Law (Law 40/2004)

Italy’s Law 40/2004 complements Germany’s approach, focusing on the rights and dignity of all parties involved in reproductive medicine, including embryos. Significant provisions include:

  1. Restricting access to reproductive technologies to medically infertile couples of childbearing age.
  2. Prohibiting embryo cryopreservation and destruction.
  3. Outlawing experimentation on embryos under any circumstances.

By banning practices that commodify or endanger embryonic human life, Law 40/2004 aligns with the ethical standards set forth in Donum vitae. It, too, underscores Italy’s commitment to legally protecting the lives of extrauterine unborn children from the first moment of conception.

The Nuremberg Code, Donum vitae, and international biolaws such as Germany’s Embryo Protection Act and Italy’s Law 40/2004 collectively highlight the ethical imperatives of protecting human embryonic life. These legal frameworks underscore the need for universal standards that protect and respect the dignity of all human beings, including pre-implantation human embryos from the first moment of their existence immediately following fertilization.

The Intersection of the Nuremberg Code & Germany’s Embryo Protection Act

On the occasion of the 75th anniversary of the Nuremberg Code, the international community should demand that the Code be revised to include equal ethical and legal protections for human embryos. The principles enshrined in the Code must be revised and updated to address the many serious ethical challenges that are prevalent in ART. Leadership is needed in order to incorporate into the Code the strict ART and IVF regulations that have been ethically articulated and enacted in both Germany’s Embryo Protection Act and Italy’s Law 40/2004. A revised Nuremberg Code that includes strict ethical and legal protections for human embryos conceived through IVF would not only honor its own legacy but also pave the way for a future where human life in all its stages is treated with the respect and care it deserves.

Germany’s Embryo Protection Act directly echoes the principles enshrined in the Nuremberg Code, particularly the emphasis on protecting vulnerable human subjects from exploitation and harm in the name of science. The Code and the Act both underscore the importance of human dignity, the right to life, and the ethical limits of scientific research.

The German law extends the spirit of the Nuremberg Code by specifically safeguarding human embryos. Ontologically, human embryos are unquestionably early-stage human beings who, though small and vulnerable, are entitled to legal protection under Germany’s constitutional laws and ethical regulations.

The Embryo Protection Act, like the Nuremberg Code, envisions a legal structure where technological and scientific advancements must always respect fundamental and inalienable human rights, ensuring that technology serves humanity without infringing upon the inviolable dignity of the human person. The Act serves as a public demonstration that scientific progress can coexist with unwavering respect for human dignity and, finally, it provides a roadmap for integrating important ethical principles into the legislative systems of other nations worldwide.

The Legal and Ethical Implications of Germany’s Embryo Protection Law

The Embryo Protection Act has been instrumental in shaping the bioethical landscape of Germany by establishing clear legal boundaries for scientific research. In the context of bioethics, the Act addresses critical issues such as:

  1. Informed Consent: The law ensures that any experimentation involving human embryos must be carefully regulated, with strict oversight to prevent unethical practices.
  2. Protecting Vulnerable Populations: The protection of embryos aligns with the broader ethical principle of safeguarding vulnerable groups from exploitation.
  3. Human Dignity: The Act reinforces the German constitutional commitment to human dignity, which holds that every human being, regardless of his or her developmental stage, deserves respect and protection.

By explicitly prohibiting non-therapeutic experiments on embryos, the Embryo Protection Act ensures that human life is never used as a tool for scientific experimentation. It also maintains a strict ethical stance against such unethical practices as embryo cloning, human and animal hybrids, or the creation of human embryos solely for destructive research and experimentation purposes.

The Global Significance of Germany’s Embryo Protection Act on its 35th Anniversary

Germany’s legislation on embryo protection has garnered attention not only within Europe but also on the global stage. Over the past 35 years, Germany has become a strong international leader in protecting the rights and the dignity of human embryos. Germany’s commitment to legislatively preserving human dignity in scientific research should be carefully studied and imitated by legislators and policymakers in countries grappling with similar ethical dilemmas.

The Embryo Protection Act also represents a balancing act between scientific progress and the imperative to safeguard humanity from potential abuses from emerging technologies. It offers a bioethical blueprint for other nations seeking to establish guardrails and guidelines for so many grave issues emerging from reproductive technologies—including gene editing, cloning, and the introduction and use of Artificial Intelligence (AI) in IVF—that require constant ethical vigilance.

Challenges and Controversies

Despite its strong ethical foundation, Germany’s Embryo Protection Act has not been without controversy. As scientific techniques such as gene editing and embryonic stem cell research advance, questions persist about the balance between innovation and ethical responsibility. Critics argue that the Embryo Protection Act may hinder scientific progress in areas like medical research and advancement, particularly in the medical treatment of human genetic disorders.

However, the core principle of the Act—namely, protecting human embryos from exploitation—remains paramount and reflects the prescient ethical concerns of Christian ethicist Paul Ramsey, who in 1970, a full twenty years before Germany’s Embryo Protection Act, rightly observed in his highly influential book The Patient as Person: Explorations in Medical Ethics:

There may be valuable scientific knowledge which is morally impossible to obtain. There may be truths which would be of great and lasting benefit to mankind if they could be discovered without systematic and sustained violations of legitimate moral imperatives.[18]

As global medical research continues, countries must confront these ethical challenges while adhering to the fundamental human rights of every human being and the inviolable dignity of every human person. These anniversaries of the Nuremberg Code and Germany’s Embryo Protection Act serve as major historical reminders of the need for ensuring that scientific progress never again outpaces ethical considerations.

Conclusion

The commemorations of the 75th anniversary of the Nuremberg Code as well as of the 35th Anniversary of Germany’s Embryo Protection Act offer the world the opportunity to never forget the heinous crimes against humanity that were committed seventy-five years ago by Nazi scientists and doctors. At the same time, we need to recognize and commemorate Germany’s truly outstanding political leadership in 1990, 35 years ago, to condemn and to prohibit any further crimes against human beings during the earliest 23 stages of human development as human embryos, regardless of their location or any other circumstances. Germany has courageously legislated and enacted strict ART and IVF regulations that ban the creation of human embryos for experimentation; ban the creation of surplus embryos; ban the eugenic testing of human embryos; and ban the freezing of embryos, except in a medical emergency.

Tragically, the United States and the majority of the world’s nations have few if any ART and IVF regulations. In the United States alone, it is estimated that there may be well over 1.5 million frozen embryos who have been immorally frozen and who are being horrifically abused in an absurd and unjust situation of frozen captivity in “concentration cans”—cryostorage tanks—located in fertility clinics throughout the United States. Most of these “orphaned” unborn children have been unethically abandoned by their own parents, who have the duty to return for them and to “parent” them, or who should lovingly and courageously place them for adoption.

Both Germany and Italy have realized the need to legally protect human embryos from the moment of conception by enacting laws that strictly regulate both ART and IVF, and by doing so, are also protecting the proper advancement of science, ethics, and natural law. The United States and the entire world can learn from both Germany and Italy to develop their own national laws that ensure that ART and IVF are regulated to protect human dignity at every stage of life.

In conclusion, as the global community continues to advance in fields such as genetic research, stem cell technology, and biotechnology, it is crucial that international leaders remain committed to the principles set forth in the Nuremberg Code. On its 35th Anniversary, Germany’s Embryo Protection Act strands as model legislation for the world, reflecting Germany’s dedication to ensuring that technology does not violate human rights or human dignity by enacting laws that safeguard the ethical integrity of research while legally protecting vulnerable human lives. Through continued vigilance and legal protection, we, too, can ensure that science serves humanity by upholding the ideals of justice, dignity, and human rights for generations to come.

References

[1] Congregation for the Doctrine of the Faith (CDF), Donum vitae (February 22, 1987), I.3, https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_19870222_respect-for-human-life_en.html (emphasis original).

[2] CDF, Donum vitae, I.5 (emphasis original).

[3] Catechism of the Catholic Church, 2nd ed. (US Conference of Catholic Bishops—Libreria Editrice Vaticana, 2018), n. 2274.

[4] Evelyne Shuster, “Fifty Years Later: The Significance of the Nuremberg Code,” The New England Journal of Medicine 337, no. 20 (1997): https://doi.org/10.1056/NEJM199711133372006.

[5] Shuster, “Fifty Years Later.”

[6] CDF, Donum vitae, II.

[7] CDF, Donum vitae, II.

[8] CDF, Donum vitae, II.A.3.

[9] CDF, Donum vitae, I.1.

[10] Catechism of the Catholic Church, n. 2274.

[11] CDF, Donum vitae, I.3 (emphasis original); cited in Catechism of the Catholic Church, n. 2275.

[12] Catechism of the Catholic Church, n. 2275; citing CDF, Donum vitae, I.5 (emphasis original).

[13] Catechism of the Catholic Church, n. 2275; citing CDF, Donum vitae, I.6 (emphasis original).

[14] CDF, Donum vitae, I.6 (emphasis original).

[15] CDF, Dignitas personae (December 8, 2008), 18, https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_20081208_dignitas-personae_en.html.

[16] Catechism of the Catholic Church, n. 2273; citing CDF, Donum vitae III.

[17] Catechism of the Catholic Church, n. 2273; citing CDF, Donum vitae III.

[18] Paul Ramsey, The Patient as Person: Explorations in Medical Ethics (Yale University Press, 1970).