The Moral Clause in Patent Law and Threats Posed by Human Germl ine Genome Editing

This article examines whether the lack of closure of moral clauses in patent laws, particularly in dealing with the issue of human germline genome editing, causes such clauses to fail to function as a moratorium in countries like Mexico. The hypothesis posed here is that a general, open, moral clause in intellectual property legislation, specifically in patent law, is ineffective when confronted with a foreseeable but strong innovation that alters an area of applied biology such as human germline genome editing. Using the deductive method, this research aims to determine whether countries like Mexico need to provide more specific guidance in their legislation on technological innovations like human germline modification in order to foster an atmosphere of legal certainty. A comparative analysis of the closed morals clause in the European Patent Convention and the open morals clause in Mexico’s intellectual property law confirms this hypothesis. Specifically, the lack of closure of a morals clause in patent law, when confronted with novel and complex technological advances, will likely fail to function as a moratorium.

Heritable human genome editing: our moral responsibilities towards future generations

The uncharted territory of genome editing technology, which can be described as the Copernican revolution of our age, presents the challenge of the trade-offs between the benefits to people now and the known unknowns concerning future dangers and risks. It is for this reason that critics of human germline modification argue that it is unethical to harvest benefits in the immediate future while causing a whirlwind in the far-distant future! The current generation has, therefore, to make sensible decisions about the research and clinical application of human gene editing technologies to prevent far-reaching deleterious impact on an indefinite number of generations yet to come. Certainly, techniques of heritable human genome editing could increase vulnerability, discrimination and division among and between generations without the guidance of social justice which is inseparable from solidarity. Since the descendants of edited human embryos may be exposed to unknown, possibly negative long-term effects, without consenting to having these risks imposed on them, the thorny issues of harm, safety and precaution are crucial to address the knowledge-gaps and uncertainties implied the clinical application of human genome editing. Thus, the intergenerational moral consciousness and conscientiousness on the benefits and risks of human genome editing have to remain vigilant and alert!

Rewriting the human genome, rewriting human rights law? Human rights, human dignity, and human germline modification in the CRISPR era

In most legal orders, human germline modification is either prohibited or severely restricted. A recurring thought in these legal frameworks is that heritable genome editing would result in practices that are at odds with principles of human rights, such as dignity, justice, and equality. However, now that CRISPR is bringing heritable genome editing within human reach, the question has risen as to whether these human rights bans still make sense. The call is growing louder to lift the ban on heritable genome editing for therapeutic purposes as soon as the technology is safe for introduction in the clinic. This article critically examines these recent proposals from a human rights perspective. First, it examines the question as to how realistic the proposed distinction between the therapeutic and the nontherapeutic uses of human germline modification is in the CRISPR era. Second, it argues that these proposals rely on a one-dimensional understanding of the meaning of human rights for this issue. Finally, it suggests that this one-dimensional understanding paves the way for a regime of self-regulation by the scientific community that leaves little room for public debate on the question as to whether or how human germline modification fits in the long-term aspirations of society.

Is the ‘serious’ factor in germline modification really relevant? A response to Kleiderman, Ravitsky and Knoppers

Should we use human germline genome modification (HGGM) only when serious diseases are involved? This belief is the underlying factor in the article written by Kleiderman, Ravitsky and Knoppers to which I now respond. In my opinion, the answer to this question should be negative. In this paper, I attempt to show that there are no good reasons to think that this technology should be limited to serious diseases once it is sufficiently proven to be safe and efficient. In fact, opting otherwise would negatively harm human beings’ right to the highest standard of health that unmodified embryos could promote. Therefore, the issue should not be so much to define adequately what a serious disease is, but rather to elucidate whether this concept should play any role beyond the context of preimplantation genetic testing (PGT). This paper argues that we should not accept the similarity between technologies such as PGT and HGGM because they face different challenges and offer totally different possibilities. Therefore, we are in urgent need to build a completely new ethical architecture that covers the application of germline editing in human embryos. As a part of that process, a much deeper debate on the necessity of distinguishing different disease types is required.

‘Serious’ science: a response to Kleiderman, Ravitsky and Knoppers

In their paper ‘The “serious” factor in germline modification’, Kleiderman, Ravitsky and Knoppers rightly highlight the ambiguity in the oft-utilised term ‘serious’ in legal discussions of human germline genome modification.1 They suggest interpretation of this term may benefit from a framework based on human rights rather than solely objectivist or constructivist frameworks. In this response, I show the authors provide a narrow and hasty dismissal of objectivist frameworks by defining objectivism broadly as ‘based on biological facts’ early on but later criticising genetic treatment lists, a single narrow implementation of only some of the facts. Furthermore, I will show their consideration of the right to science is biassed towards the material innovations of science, the authors succeed in recognising but fail in elaborating on the knowledge gained from scientific progress; knowledge which may ultimately update moral intuitions and change the nature of ethical conversation across cultures.

Editing the Best of All Possible Worlds

It has been argued that we have a moral obligation to explore human germline modification in order to create the best possible children. In contrast, this chapter argues that in order to flourish as human beings we need to recognize that there are many different ways of being good and that the pursuit of happiness is most likely to succeed not in the extraordinary, the larger than life and better than human and beyond average, but in the ordinary life, which has enough scope and depth to provide us with all the happiness that a human life can possibly have.

Les pièges de l’amélioration

Inactivation of the CCR5 gene by CRISPR editing in human embryos, as recently attempted in China, was touted as a positive change for the babies involved since it was expected to impart resistance to HIV infection. However, it turns out that the absence of CCR5 is not neutral but actually decreases fitness, as shown by survival analysis of population data in the UK biobank. This underlines the pitfalls of genetic enhancement, and emphasizes that any germline modification must be preceded by in-depth studies to exclude unforeseen negative effects. ‡