12 December 2015

DTC Genomics regulation in Europe

'Current developments in the regulation of direct-to-consumer genetic testing in Europe' by Louiza Kalokairinou, Heidi C. Howard and Pascal Borry in the latest Medical Law International comments
Over the past years, direct-to-consumer (DTC) genetic testing has provoked controversy regarding its still questionable risks and benefits. The safety and performance of such devices, when entering the European market, are currently regulated by the Directive 98/79 EC of the European Parliament and of the Council on in vitro diagnostic medical devices. In September 2012, a new Regulation was proposed to replace this Directive, and the legislative process is still ongoing. This article presents the main points of the European Commission’s proposal for the new Regulation and the subsequent amendments voted by the European Parliament, aiming to evaluate the potential contribution of the proposal for a more effective regulation of DTC genetic testing in Europe. In this regard, the proposal seems to enhance the current regulatory framework by further elucidating the scope of the Regulation and by establishing a risk-based classification system that guarantees increased pre-market scrutiny of the tests. Furthermore, the proposal attempts to establish higher safety and performance requirements and to enhance transparency. In addition, the European Parliament introduced amendments according to which appropriate genetic counselling is required in the context of genetic tests, and such tests are classified as prescription only, banning, at the same time, their DTC advertising. These developments have already provoked controversy among stakeholders and, if eventually adopted, they may lead to a radical change in the European DTC genetic testing landscape. In this light, the political decisions that will be taken imminently will be determinant.
In introducing the article they state
Even though proponents of [direct-to-consumer (DTC) genetic] tests claim that they enhance the autonomy of consumers and promote their education regarding genetics, there is great concern among policymakers, professional groups and scientists regarding various ethical, social and regulatory aspects associated with such services. These concerns include, among others, issues regarding the questionable validity and utility of DTC genetic tests and the often poor and misleading information accompanying them, as well as concerns regarding the privacy of results and the possible stigmatization and discrimination resulting from a privacy breach. In addition, it is feared that the absence of adequate medical supervision and genetic counselling in this context may lead to inappropriate health decisions and unnecessary burden on the healthcare system if consumers request and obtain unnecessary consultations with medical professionals. Moreover, the effectiveness of regulation regarding DTC genetic testing has been widely debated, both in Europe and in the United States, and it is further complicated by such tests being mostly marketed through the Internet, rendering the enforcement of relevant legislation more challenging.
The aim of this article is to outline exactly how regulation of DTC genetic testing in Europe is likely to be affected by the proposed Regulation on In Vitro Diagnostic Medical Devices, which is currently under discussion in a trialogue between the European Parliament, the Council of the European Union (EU) and the European Commission. More specifically, after providing a brief introduction to the historical background of the proposed regulation, the proposed amendments will be summarized and assessed, focusing especially on the scope of protection provided by the proposed regulation, the risk classification of devices, the regulation of self-tests, clinical evidence and clinical utility, transparency and truth in labelling, canalization and advertising of genetic tests and, finally, regarding genetic counselling and informed consent.
The authors conclude
Adopting the current proposed Regulation and the amendments introduced by the Parliament will mean that a very broad range of genetic tests, including tests for both health-related and lifestyle purposes may fall within the scope of the Regulation, regardless of the jurisdiction in which the manufacturer is established, as long as they are offered to people residing in EU Member States. Furthermore, DTC genetic tests will be subject to additional requirements set for self-testing devices, whilst, according to the new risk-based classification system, (DTC) genetic tests will have to go through a pre-market assessment by independent notified bodies. In this respect, the proposed Regulation and the amendments voted by the European Parliament improve upon the current regulatory framework and may raise the standards of safety and performance for genetic tests entering the European market. Nevertheless, the lack of definition and requirements for the assessment of clinical utility might render its inclusion in the pre-market evaluation of IVD devices meaningless and/or burdensome for the notified bodies.
Furthermore, the European Parliament’s amendments make mandatory the involvement of health-care professionals in the process of genetic testing by requiring appropriate genetic counselling for every type of genetic test as well as by classifying all genetic tests as prescription only and banning DTC advertising for such tests. A full implementation of these provisions would mean, in theory, that genetic testing companies will have to redirect the provision of their products and their marketing campaigns to health-care professionals since directly accessing consumers in the EU will be illegal. In this way, the amendments attempt to bring genetic testing back to the traditional, physician-centred model of healthcare, despite the recent shift to a model focusing on consumer empowerment, as initiated by DTC genetic testing companies.
Even though requiring genetic counselling and the involvement of health-care professionals in the genetic testing process might mitigate the risks stemming from particular subsets of tests, the competence of the EU to regulate clinical practice in such detail has been contested. There are concerns that the very broad definition of genetic tests provided by the proposal, in combination with particularly strict requirements for pre-market approval, without taking into account risks and benefits associated with each type of test, would be overly restrictive and stifle innovation and competitiveness in Europe. Hence, it may be important for the restrictions imposed on the tests to be proportionate with the potential risks stemming from such tests in order to achieve an appropriate balance between the protection of public health and the right of the individuals for self-determination and access to their genetic information.
As a general comment, it may be noted that the amendments introduced by Parliament emphasize medical supervision and genetic counselling in order to address some of the risks potentially stemming from DTC genetic testing. At the same time, an opportunity to establish robust criteria of clinical validity is being missed, whilst the inclusion of clinical utility in the pre-market assessment is not likely to have any impact on DTC genetic tests. In this regard, it may be argued that the medical prescription model and the mandatory pre- and post-test genetic counselling have been valued more than ensuring the good quality of the tests. This policy choice might prove to be problematic since it shifts responsibility to health-care professionals who may often not be adequately equipped to assume the role of gatekeepers.
The Council, on the other hand, seems to move closer to the position of the Commission and attempts to ensure that IVD devices are thoroughly assessed when entering or being put into service in the European market and they are adequately surveyed after that.
When it comes to DTC genetic testing, the approaches adopted by the Parliament and the Council are divergent. It remains to be seen how this opportunity to change the DTC genetic testing landscape will be handled on the political level and on which side the pendulum will settle.
Finally, it should be kept in mind that the Regulation is still a long way from implementation. A trialogue among the Commission, the Parliament and the Council started in October 2015. This procedure might last for several months. Taking into account that the proposal of the Parliament provides a 3-year transition period before implementation of the Regulation, whilst the Commission and the Council propose a 5-year period, and given the rapid developments in the DTC industry, it is not clear to what extent the reforms will impact the DTC genetic testing market.
'Should Extinction be Forever? Restitution, Restoration, and Reviving Extinct Species' by Christian Diehm in (2015) 37(2) Environmental Ethics comments
 “De-extinction” projects propose to re-create or “resurrect” extinct species. Perhaps the most common justification offered for these projects is that humans have an obligation to make restitution to species we have eradicated. There are three versions of this argument for de-extinction—one individualistic, one concerned with species, and one that emphasizes ecological restoration—and all three fail to provide a compelling case for species revival. A general critique of de-extinction can be sketched that highlights how it can both facilitate inattentiveness to biological and ecological boundaries and foster a managerial mentality toward the natural world.
'Towards a Law of the Mammoth? Climate Engineering in Contemporary EU Environmental Law' (Tilburg Law School Research Paper No. 07/2015) by Han Somsen comments
 In an article that made waves when it was first published in 1996, judge Easterbrook scorned the idea that the technological reality of cyberspace justified talk about or a need for ‘Cyber Law’. Just as there is no need for a ‘Law of the Horse’ merely because horses give rise to legal claims, he argued, conventional legal principles and reasoning are sufficiently accommodating to absorb new legal challenges that arise in the wake of cyberspace. We may likewise doubt the need for a ‘Law of the Mammoth’, even though technologies emerge that harbour the prospect of bringing back the woolly mammoth from extinction, reversing climate change, and creating new life forms. Cyber Law is now firmly established, of course, and Easterbrook also appears to have lost the academic debate from the likes of Lawrence Lessig. That fact notwithstanding, the onus to show that the time has come for a Law of the Mammoth clearly is on those staking the claim. 
The purpose of this article essentially is to prepare the ground for that argument, with particular but by no means exclusive reference to climate engineering. Instead of framing the question as one of a confrontation between environmental law and climate engineering, a multitude of technologies instrumental in intentionally enhancing the environment suggests that it is appropriate more generically to consider the introduction of a novel concept in environmental law that captures the essence of such efforts. In the same vein as ‘human enhancement’ has come to be distinguished from ‘medical therapy’, in view of novel environmental policy uses of technologies it is submitted that we should consider the virtues of distinguishing environmental ‘enhancement’ from environmental ‘improvement’.