Annex 1 - Representative biosecurity laws, regulations and guidelines (based on Bubela et al., 2012)
- At the international level:
- the Biological and Toxin Weapons Convention (BTWC) that covers biological agents and toxins whatever their origin or method of production when they have no justification for prophylactic, protective or other peaceful purposes. The Convention was ratified by Belgium in 1975.
- the CBRN action plans (chemical, biological, radiological and nuclear defence measures)
- In the US:
- Select Agents Regulations regulates the possession, use and transfer of select agents (http://www.selectagents.gov/Legislation.html)
- The “Screening Framework Guidance for Producers of Double Stranded DNA” aims to cover potential harmful synthetic biological agents and toxins that are not covered by the Select Agents Regulations (http://www.phe.gov/Preparedness/legal/guidance/syndna/Documents/syndna-guidance.pdf)
- Canada: adoption of the HPTA (Human Pathogens and Toxins Act) administrated by the Public Health Agency of Canada (PHAC), a legislative tool overseeing the biosafety and the biosecurity of activities involving human pathogens and toxins (http://laws.justice.gc.ca/eng/acts/H-5.67/).
- In Europe, discussions have been underway since the publication of the "Green paper on bio-preparedness" in 2007 to reduce biological risks and improve preparation for and responses to biological threats (http://europa.eu/rapid/press-release_MEMO-07-289_en.htm). In particular, the Commission has suggested setting up a European Bio-Network (EBN), an advisory structure that would pull together European expertise on bio-preparedness from various sectors.
Other significant initiatives:
- In 2006 the WHO issued a Biorisk Management document entitled “Laboratory Biosecurity Guidance” as a complement of Laboratory Biosafety manual 3rd edition (WHO, 2006).
- In 2007 a code of conduct for biosecurity has been proposed by the Royal Netherlands Academy of Arts and Sciences to the scientific community. This code of conduct has been proposed as required by the BTWC.
- In the US the set-up of the National Science Advisory Board for Biosecurity (NSABB, http://oba.od.nih.gov/biosecurity/about_nsabb.html). Currently there is no equivalent Committee in Europe.
- Since 2003, new rules were adopted by several eminent scientific journals to select papers that can potentially lead to dual-use of biological agents : Biochemistry, Biosecurity and Bioterrorism, Journal of Virology, Nature, Science, Proceedings of the National Academy of Sciences, etc
Annex 2 - An example of GOF experiments and the community reactions: Highly pathogenic H5N1 experiments: an example of the debate on “Gain of Function” (GOF) and dual use of concern (DURC) research
In December 2011 an intense debate started within the scientific community about the possible public release of experimental data obtained concomitantly by two research teams, related to the in vitro production of H5N1 bird flu virus transformed into mutant forms falling into the category of highly pathogenic avian influenza (HPAI). The fact that these influenza viruses were able to spread among mammals has revived the controversy about the opportunity to publish or not such data.
In a first instance the US National Science Advisory Board for Biosecurity (NSABB) asked the scientific journals to withhold details about experiments with the H5N1 bird flu. As a result, a 60-day moratorium was agreed by the scientific community on research on mutant avian influenza H5N1 strains. A meeting was subsequently organized by the WHO about virus research with the conclusion that the detailed results of the above-mentioned researches could be published. As a result, the NSABB agreed on the full publication of the two papers (Yong, 2012).
The scientific community remains divided on this issue. On the one hand, some scientists argue that these data are of upmost importance to better understand the properties of the avian H5N1 influenza virus, including public health protection goals (e.g. virulence study, vaccine development, antiviral drugs). On the other hand, other scientists disagree with the WHO recommendations, being convinced that when these data are available, it will allow Biohackers, or worse (bio)-terrorists, to reproduce the experiments and to obtain mutant H5N1 strains “from scratch”. They are of the opinion that without any oversight this type of experimentation could represent a potential risk for human population in the form of a pandemic.
Fink report’s seven classes of experiments:
Experiments that would:
- demonstrate how to render a vaccine ineffective;
- confer resistance to therapeutically useful antibiotics or antiviral agents;
- enhance virulence of a pathogen or render a non-pathogen virulent;
- increase transmissibility of a pathogen;
- alter the host range of a pathogen;
- enable evasion of diagnostic/detection modalities;
- enable the weaponization of a biological agent or toxin.
In 2006 the Centre for Applied Philosophy and Public Ethics, Australia issued a report containing four additional points to the classes of experiments listed in the Fink report (Miller and Segelid, 2008):
- sequence the genes of a pathogen;
- synthesize a pathogenic organism;
- experiment in any way with Variola virus (smallpox);
- attempt to recover/revive past pathogens.
Denmark adopted its law on biosecurity in 2008 followed by an executive order in 2009. The legislation regulates biological substances, related materials, as well as delivery systems and intangible technology which can be used in biological weapons. In Denmark, it is compulsory for the users (private and public sectors) to obtain a license from the Centre for Biosecurity and Biopreparedness (CBB) to work with or possess biological materials and technologies with dual-use potential. Awareness raising among scientists and students, working with dual-use materials, is an important factor to avoid misuse of biological materials. Therefore, biosecurity in Denmark is a dynamic process of minimizing the risk of a biological attack. This law requires the designation of biosecurity Officers and describes an inspection regime.
In UK, one of the main trigger to reinforce Biosecurity regulation was the Foot and Mouth Disease (FMD) outbreak at Pirbright in 2007 following the accidental release of FMD virus into the environment. For details, see the report ordered by the House of Commons (House of the Commons, 2008). The oversight of laboratories involved in research activities with dual-use biological materials was already regulated under the counter-terrorism legal framework since 2001 (Anti-terrorism, Crime and Security Act).
After a thorough risk assessment of the situation in 2010 and 2011 the Dutch authorities decided to implement a biosecurity regime without including biosecurity into the already present biosafety field. Biosecurity regime in the Netherlands encloses inter alia: overview of locations where biological agents are contained; overview of legal framework (rules and legislation); development of a toolkit for institutions/inspection bodies. A document entitled “Implementing biosecurity in scientific research in the Netherlands” is available on the internet (Policy Brief, Nov 2011). In 2013 the Royal Netherlands Academy of Arts and Sciences (Biosecurity Committee) published an advisory report entitled “Improving biosecurity assessment of dual-use research”. The reflection was based on the “Fouchier case” showing that biosecurity is not limited to scientific considerations.
In collaboration with the Dutch platform of Biosafety professionals, an online self-assessment Biosecurity toolkit has been developed to enhance the anchorage of biorisk management inside life sciences, biotechnology and medical biology organizations. The biosecurity online toolkit consists of two separate parts. The first part is a self-check module for organizations to identify possible gaps in their security based on their current security status. The eight main aspects of Biosecurity will be addressed (the eight “biosecurity pillars”), The second part of the toolkit consists of measures to increase the institutional biosecurity regime with good practices such as the Code of Conduct (Sijnesael et al., 2014). In a second stage a toolkit for inspections and supervision will be developed based on the toolkit for organisations handling hazardous biological agents.
Since 2004, a legislation has been adopted in France regarding “Biosecurity” measures. See Article L5139-2 on the production, preparation, transport, exportation, etc. and use of the micro-organisms and toxins listed in Article L. 5139-1. The 30 of April 2012 Decision entered into force in May 2012.
An interesting dossier issued in 2012 by ANSES (Agence Nationale de Sécurité Sanitaire alimentation, environnement, travail) is available online : Euro Reference: Les cahiers de référence, cahier n°7 Spécial « Sécurité et sureté » (AFSSA, 2012).
It worth mentioning the case of Germany that is, in some extent quite comparable to the situation in Belgium. Legislation on Pathogen Security in Germany did not introduce a biosecurity framework after the 2001 events. Germany relies on an extensive framework of ‘biosafety’ laws and regulations, which are designed to ensure the safe handling of dangerous pathogens by legitimate researchers and to minimize the risks to public health and the environment from research conducted for peaceful purposes (‘biologische Sicherheit’ is generally understood to mean ‘biosafety’). Germany has extensive tracking and systems for dangerous pathogens and a well-developed infrastructure for inspection and training. The biosafety regulations are based on the inherent capacity of micro-organisms to cause illness and death in humans, animals, or plants. All known microbial agents are classified into four Risk Groups. Risk Group 4 includes pathogens such as the Ebola virus that are lethal and incurable, and hence demand highly stringent (Biosafety Level 4) containment measures, whereas Risk Group 1 agents require only minimal safety precautions. Because of this comprehensive approach, the total number of microbial and toxin agents covered by the German biosafety regulations is considerably larger than the US Select Agent List (comparable with Belgium or Switzerland).