Medical Law International

Contraceptives are vital healthcare for women and people with wombs. Recently, there has been a rise in the use of ‘digital contraceptives’, a type of ‘femtech’ software available for download on app stores which require data input in order to make predictions about users’ fertility. Digital contraceptives, when marketed as such, fall within the definition of a ‘medical device’ and under the authority of the Medical Devices Regulations 2002 are a ‘medium-risk’ device. However, not all femtech which may be used as contraception is captured by this framework. In this article it is argued that the regulatory category into which digital contraceptives have been placed by the medical devices regime is (a) unduly limited in scope, (b) insufficiently stringent to protect users, considering the grave and life-changing effects this technology can have if things go wrong, and (c) ill-conceived as a regulatory response to a technology that affects large sections of the population. It is suggested here that the broader context in which software as a contraceptive sits (i.e. within the general contraceptive market) is key to understanding the regulatory blindness that is occurring when it comes to digital contraceptives and some other forms of fertility-related femtech. As such, software which can be used as a contraceptive is in fact ‘high risk’ and should be reclassified as such.

This article examines, within China’s complex healthcare sector, the extent to which China’s legal frameworks can adapt to a data-driven context that requires the reconciliation of public and private interests for the use of health data. Current data-processing mechanisms operate through individual consent, and administrative authorisation in mobile health settings are insufficient and ineffective to meet societal needs while simultaneously protecting individuals’ interests. In light of this shift of regulation from individual control to collective governance, this article argues that the principle of the right to health may complement this collective governance model. The right to health principle emphasises solidarity, justice, confidentiality, and collective responsibility, which may balance power asymmetries in the use of health data among different stakeholders. The article proposes a solution that incorporates the state’s obligation with private actors’ responsibilities, while stressing the importance of data sharing and the fair use of health data.

Interventions in the human germline, whether for purposes of therapy for a hereditary disease or for purposes of enhancement, are controversial. While enhancement is almost unanimously rejected, therapy-oriented intervention is not a priori regarded as unacceptable. The legal discussion so far has focused primarily on the questions of whether manipulation of the embryo’s germline is permissible or whether the genetic manipulation of germ cells and the use of these germ cells for embryo generation is permissible. Up to now, the upstream questions regarding the systematic germline therapy development in clinical trials have been ignored, including questions as to whether the development of germline therapy would be legally permissible within the European Union framework of clinical studies. This article highlights the legal issues connected with the clinical development of germline intervention, provides an overview of the various answers to these legal questions, and indicates where further research and discussion are needed.

In Dobbs v. Jackson Women’s Health, a 6–3 majority of the US Supreme Court overturned 50 years of established precedent, ruling that the Constitution confers no right to abortion. Since first recognition that the constitutional right to privacy encompassed a (negative) right to pre-viability abortion in 1973, Supreme Court decisions have slowly chipped away at the substance of this right. Dobbs, however, marks a significant shift in abortion (and general) jurisprudence, by deploying an originalist interpretation of the constitution to deny that such a right exists. Consequently, States may now regulate abortion how they see fit, including by introducing complete prohibitions. This note illustrates how Dobbs has dire consequences for reproductive freedom as we have known it, with disastrous legal and practical ramifications for abortion-seekers, pregnant people, and all people with the physiology to become pregnant. Furthermore, the Court’s use of an originalist approach to rescind a constitutional protection signals further moves to derecognise other rights such as contraception, as well as same-sex intimacy.

In an unanimous judgment given by Lord Reed on 7 December 2022, the Supreme Court of the United Kingdom (UKSC) held that clause 5(2)(a) of the Abortion Services (Safe Access Zone) (Northern Ireland) Bill is a proportionate interference with the rights of those who wish to express opposition to abortion services in Northern Ireland. This clause would make it an offence to do an act within the safe access zone with the intention of or being reckless as to the possibility of directly or indirectly influencing a protected person. In this comment, I analyse the reasoning of the UKSC. I consider, first, the clarifications offered by the UKSC on issues related to the proportionality assessment itself. I then turn my attention to the application of the proportionality test by the UKSC to the facts of the reference. I conclude that the reasoning of the UKSC in Reference by the Attorney General for Northern Ireland – Abortion Services (Safe Access Zones) (Northern Ireland) Bill is sound. The UKSC’s decision is relevant to plans to introduce similar legislation in Scotland and to any future human rights based challenges to the English and Welsh Public Order Bill, which will create a similar offence to the one in clause 5(2)(a) of the Northern Ireland Bill when it becomes law later this year. Moreover, the decision is significant because the UKSC had not previously considered the proportionality of safe access zone legislation. The Abortion Services (Safe Access Zone) (Northern Ireland) Bill has now received Royal Assent.