Ethics, Patents and Genome Editing: A Critical Assessment of Three Options of Technology Governance

Abstract

Current methods of genome editing have been steadily realising the once remote possibilities of making effective and realistic genetic changes to humans, animals and plants. To underpin this, only 6 years passed between Charpentier and Doudna’s 2012 CRISPR-Cas9 paper and the first confirmed (more or less) case of gene-edited humans. While the traditional legislative and regulatory approach of governments and international bodies is evolving, there is still considerable divergence, unevenness and lack of clarity. However, alongside the technical progress, innovation has also been taking place in terms of ethical guidance from the field of patenting. The rise of so-called “ethical licensing” is one such innovation, where patent holders’ control over genome editing techniques, such as CRISPR, creates a form of private governance over possible uses of gene-editing through ethical constraints built into their licensing agreements. While there are some immediately apparent advantages (epistemic, speed, flexibility, global reach, court enforced), this route seems problematic for, at least, three important reasons: 1) lack of democratic legitimacy/procedural justice, 2) voluntariness, wider/global coordination, and sustainability/stability challenges and 3) potential motivational effects/problems. Unless these three concerns are addressed, it is not clear if this route is an improvement on the longer, slower traditional regulatory route (despite the aforementioned problems). Some of these concerns seem potentially addressed by another emerging patent-based approach. Parthasarathy proposes government-driven regulation using the patent system, which, she argues, has more transparency and legitimacy than the ethical licensing approach. This proposal includes the formation of an advisory committee that would guide this government-driven approach in terms of deciding when to exert control over gene editing patents. There seem to be some apparent advantages with this approach (over traditional regulation and over the ethical licensing approach mentioned above—speed and stability being central, as well as increased democratic legitimacy). However, problems also arise—such as a “half-way house” of global democratic legitimacy that may not be legitimate enough whilst still compromising speed of decision-making under the “ethical licensing” approach). This paper seeks to highlight the various advantages and disadvantages of the three main regulatory options—traditional regulation, ethical licensing and Parthasarathy’s approach—before suggesting an important, yet realistically achievable, amendment of TRIPS and an alternative proposal of a WTO ethics advisory committee.

Governing, Protecting, and Regulating the Future of Genome Editing

“…At the moment, there is only one patent pool on human genome editing technology, and there have been doubts expressed about its future success. 73 What the discussion above demonstrates is that there is unclarity about the application of competition law to different methods of disseminating technology that seem to be important in this particular sector. While it has not been argued above that the application of competition law will necessarily strike down these forms of dissemination, the legal uncertainty is problematic as such.…”

“…With this regard, the MA holder has a substantial scope of obligations: ensure the receival of all the relevant information about adverse reactions and the provision of such information to the EMA;69 ensure encouraging of patients to communicate any adverse reaction to healthcare professionals;70 record and report to the EMA of all the adverse reactions brought to the attention of the holder by healthcare professionals;71 submit periodic (every six months) safety update reports.72 If the product presents the negative risk-benefit balance, it shall be rapidly withdrawn from the market. 73 The described procedure applies to the whole combined product and thus covers any adverse reactions, including the ones related to the use of its AI element. However, the Medical Devices Framework also establishes its own regime for controlling a device after it is placed on the market -post-market surveillance.…”

“…The Commentators argue that patent offices lack the structure, technical expertise, institutional culture of transparency and accountability, or indeed the democratic mandate to make such determinations.72 Likewise, even the role of the CJEU and national courts in determining standards of morality for patent law purposes has been questioned. 73 Arguments linked to the nature of patents, as negative exclusionary rights, and its function as guarantee to economic incentive to innovation speak against the efficiency of such provisions as a governance tool. After all, granting a patent does not mean that the patent proprietor would be allowed to use the invention in any possible way.…”

Untitled

“…However, according to the Polish researcher D. Krekora-Zając (2020), the belief that legislative regulation will prohibit editing human genes in an extra-medical area, looks rather illusory, and O. Feeney et al (2021) argue that although genome reconstruction requires regulation and, in the optimal variant, it will include the latest international legal framework, the path to it is still too long, but even after appropriate adoption, it will lack satisfactory flexibility.…”

Transformation of Medical Care through Gene Therapy and Human Rights to Life and Health – Balancing Risks and Benefits

“…"34 The right to participate in and to enjoy the benefits of scientific progress and its applications assists States in making sure that these property rights are not realized to the detriment of the right to health. 35 This right becomes a significant mediator between a human right -the right to health -and a property right.36 Thus, State authorities should use, when necessary, all the flexibilities of the TRIPS Agreement, such as compulsory licences, to ensure access to essential medicines, especially for the most disadvantaged groups. State authorities should also refrain from granting disproportionately lengthy terms of patent protection for new medicines in order to allow, within a reasonable time, the production of safe and effective generic medicines for the same diseases.…”