EU regulations for maximum containment labs

Published in Science – March 14

In his Editorial “Safeguard the world’s worst pathogens” (20 October 2023, p. 243), P. Millett suggests that the proliferation of maximum containment laboratories around the world could put biosafety and biosecurity at risk. In regions such as Europe, however, there are effective safety mechanisms in place that could serve as a model for maximum containment laboratories worldwide. Although compliance with guidance from the World Health Organization and World Organization for Animal Health indeed “remains voluntary,” neither Europe’s maximum containment public research laboratories nor any laboratory that adheres to similar safety standards should be a cause for alarm.

Europe’s strict meshwork of biosafety regulations has been strengthened and refined over more than three decades. When appropriate, the European Group on Ethics in Science and New Technologies and the European Academies’ Science Advisory Council have provided input. Each EU member state has an obligation to incorporate into their respective national laws the EU directives and regulations, which include protecting professionals from exposure to biological agents (1), containing genetically modified organisms (2) and preventing their deliberate environmental release (3), and limiting the export of dual-use items (4), including biological material (5). After Brexit, the UK continued to implement all the relevant EU directives until the end of 2020, when they were transposed into a domestic regulatory framework. The International Experts Group of Biosafety and Biosecurity Regulators has developed a mobile app detailing the laws and regulations that apply in its members’ countries (6), so anyone can see the constraints under which researchers have to work.

The European Union is well prepared to lead and facilitate international laboratory safety policies. The European Research Infrastructure on Highly Pathogenic Agents (ERINHA) currently federates facilities from 10 European countries (7). In tandem with its corporate partner, the European Biosafety Association, ERINHA offers expertise and applied biorisk management training to researchers throughout the world. Recent funding from the European Commission for the Interceptor project (8) will allow ERINHA and select international maximum containment laboratories to explore whether this cooperative network offers a model for secure research that can be expanded beyond Europe. A nascent partnership with the Global Virus Network will help ensure that robust and effective regulatory oversight will continue to be a key priority of scientists worldwide.

We agree with Millett that technological advances, including in machine learning, will reduce the need for some types of experiment, but as he acknowledges, maximum containment laboratories remain an essential element in the development of countermeasures to the world’s most serious infectious disease threats. In some countries, notably the United States, maximum containment facilities are coming under increasing pressure from opponents with disparate motives, some political. In the current anti-science climate, we are concerned that Millett’s public critique of biosafety regulation encourages fearmongers and could damage vital efforts to protect the world from epidemics.

Christian Brechot^1,2, Åsa Szekely Björndal^3,4, Jonathan Ewbank^5,6*

¹President Emeritus and Board Vice-Chair, Global Virus Network, Baltimore, MD, USA. ²University of South Florida, Tampa, FL, USA. ³President, European Biosafety Association (EBSA), Gentbrugge, Belgium. ⁴Public Health Agency of Sweden, Solna, Sweden. ⁵Director General, European Research Infrastructure on Highly Pathogenic Agents AISBL, Brussels, Belgium. ⁶Institut National de la Santé et de la Recherche Médicale, Paris, France.

*Corresponding author. Email: jonathan.ewbank@erinha.eu

References and Notes

    1. European Agency for Safety and Health at Work, “Directive 2000/54/EC—biological agents at work” (2021); https://osha.europa.eu/en/legislation/directives/exposure-to-biological-agents/77.

    2. European Parliament and Council of the European Union, “Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms” (2009); https://eur-lex.europa.eu/eli/dir/2009/41/oj.

    3. European Parliament and Council of the European Union, “Consolidated text: Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC” (2001); https://eur-lex.europa.eu/eli/dir/2001/18/2021-03-27.

    4. European Parliament and Council of the European Union, “Regulation (EU) 2021/821 of the European Parliament and of the Council of 20 May 2021 setting up a Union regime for the control of exports, brokering, technical assistance, transit and transfer of dual-use items” (2021); https://eur-lex.europa.eu/eli/reg/2021/821/oj.

    5. European Parliament and Council of the European Union, “Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU” (2022).

    6. International Experts Group of Biosafety and Biosecurity Regulators, “IEGBBR Mobile Application of Biosafety, Biosecurity and Dual-Use Oversight” (2023); https://iegbbr.org/mobileapp.html.

    7. ERINHA, “Our members” (2024); https://erinha.eu/about-us/our-members/.

    8. “ERINHA launches the Interceptor project” (2024); https://erinha.eu/newsroom/erinha-launches-the-interceptor-project/.

Competing Interests

C.B. is chief medical officer at Theravectys Company and chairman of The Healthy Aging Company.

This is the author’s version of the work. It is posted here by permission of the AAAS for personal use, not for redistribution. The definitive version was published in Science 383 doi: 10.1126/science.adl5646