Europe's Eternal Struggle with Safety and Innovation

Applied Clinical Trials, Applied Clinical Trials-04-01-2021, Volume 30, Issue 4

European Group on Ethics in Science and New Technologies issues cautious opinion on the use of gene editing amidst COVID vaccination controversy.

Precaution continues to dominate EU thinking on science and technology–with politics intervening to offer some intriguing impacts on human health. Amid the heated COVID-driven controversies over vaccination that are ruffling Europe, a specialized European advisory group on ethics has just issued a cautious opinion on the use of gene editing–including a call for a global guarantee that heritable human genome editing is not prematurely clinically applied. In addition to the intrinsic interest of the subject and of the opinion the group presents, the views it expresses offer an interesting comparison to–or contrast with–the apparently haphazard decisions by EU countries over recent weeks in respect of the AstraZeneca vaccine against COVID.

The European Group on Ethics in Science and New Technologies (EGE) is tasked with advising the European Commission with “high quality, independent advice on all aspects of EU legislation and policies, where ethical, societal and fundamental rights issues intersect with the development of science and new technologies.” In a new and broad-ranging opinion on genome editing, the group urges a degree of caution–notably that this technology should not be applied “for purposes other than against serious diseases that cannot be prevented or treated otherwise.” And it stresses the need for safeguards against enhancement or de-enhancement of traits, and to ensure that investments in research on germline genome editing have the purpose of protecting health. But at the same time, the opinion acknowledges that somatic genome editing has the potential to alleviate suffering from diseases that could not be treated effectively before, and recommends pursuing its use, along with providing access to clinical studies and clinical application in healthcare.

Particularly striking is the treatment of expertise in the opinion. This, it says, is vital to “ensure adequate competencies in expert bodies.” As it observes, genome editing technologies are evolving quickly and expertise to assess research and application has to keep pace with new developments, so it is important to widen the basis of expertise and broaden what counts as relevant knowledge at the level of expert committees, fora and other bodies established to examine and set guidelines and standards for research and application of genome editing technologies. It extends the advice to providing due guidance for ethics committees charged with approving and supervising clinical trials involving genome editing, covering safety assessments and risk/benefit determinations of clinical trials are developed, along with training modules for research ethics committees and other involved bodies “to ensure high-standing and consistent application of ethical standards.”

With a view to promoting broad alignment, the group has asked the European Commission to engage in global discussions on regulation of this emerging field with the World Health Organization and the World Medical Association, covering universal adoption of standards on the ethical use of genome editing in human beings. And within Europe it wants to see the creation of a specifically European platform to exchange information and promote “a broad and open public debate” on the ethical and social implications of germline genome editing in human beings. It stresses that this will require a “basis of sound and evidence-based information,” and a heightened awareness of the implications of widely used terminologies and distinctions such as somatic and germline editing, or prevention, therapy and enhancement.

What might the group have said if it had been asked to give an opinion on the EU’s recent performance in the use of vaccines–and specifically, the AstraZeneca vaccine? Not the squabbles between the UK and the EU (and even within the EU!) on delivery, which are almost too unseemly to merit attention here, but on the more sensitive area of efficacy and safety judgments concerning innovations. From the outset, there was disunity among the member states about whether, in the absence of trial data from the elderly, the vaccine should be given to older people–with France, notably, withholding it from those over 75 years of age. But then anecdotal reports of blood abnormalities among a handful of recipients sent national authorities in the EU into paroxysms of incoherent indecision, destroying any semblance of EU alignment on evidence-based decision-making, as some countries suspended use of the product pending the outcome of a European Medicines Agency (EMA) review of the case reports, others imposed some limitations relating to age, and others carried on with administration regardless. And when EMA delivered an interim clearance of the product, many countries still refused to use it.

The picture was of politics replacing evidence-based decision-making, as governments responded to public (and often ill-informed) anxiety rather than to scientific evaluation. The summit of incoherence was reached when member states subsequently reverted to following expert advice: governments that had ignored the advice of the EMA and suspended the use of the AstraZeneca vaccine then reinstated its use–in line with the advice from the same institution. It was another example of action driven by a European tendency to bow to uninformed public opinion, playing safe politically rather than scientifically. It epitomized a question that has assumed growing importance over the last 50 years: how to take account of public sentiment while science itself evolves. The exploitation of gene technology in food and agriculture from the 1980s has manifestly been impaired in Europe by public concerns, not always on the basis of a good understanding of the subject. A similar cloud already hangs over the development of nanotechnology. The debates have often not been edifying, since they have frequently relied on acute emotion rather than on accurate information. And the risks from widespread misinformation and even from conspiracy-driven dis-information are currently crystallizing conspicuously in vaccine hesitancy and frank anti-vaccination movements, frequently linked to the relative novelty of
mRNA vaccines.

The disarray among national governments in Europe will have done nothing to inspire confidence either in science in general, or in Europe’s regulatory institutions–and least of all, confidence in vaccines. Governments’ knee-jerk responses to lurid headlines, with the principal aim of avoiding blame if things go wrong, do not constitute a noble strategy in times of crisis. Defensive appeals to that “precautionary principle” beloved of many European policymakers are not necessarily the right approach to public debate on the relative risks and benefits of alternative courses of action. The advice of the EGE about ensuring “a broad and open public debate” on the “basis of sound and evidence-based information” might be a better guide. And above all, for those utterly obsessed with the precautionary principle, it should have been evident that seeking to protect the public from a minimal risk of vaccine side effects would in any case expose people to an even greater risk–of contracting a serious disease that has already killed hundreds of thousands across Europe.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium