A civil society response to the challenges of regulating biosecurity

In November of last year, VERTIC Senior Legal Officer, Scott Spence, travelled to Italy to deliver a statement to the Landau Network-Centro Volta—an NGO supporting a global network of international experts on security, disarmament and cooperation.

The statement examined legal implementation challenges in the biosecurity field and discussed how VERTIC’s National Implementation Measures (NIM) Programme is providing assistance in this area. It concluded with views on how civil society can contribute to the ongoing development of a global network dedicated to ensuring dual-use biological materials and technology are only used for peaceful purposes.

The observations on implementation challenges are drawn from the NIM Programme’s wide field-experience in assisting governments with strengthening their legislative frameworks for implementation of the 1972 Biological Weapons Convention (BWC) and UN Security Council Resolution 1540. This version of the statement has been abridged and edited for Trust & Verify.

VERTIC statement

Implementation challenges
One of the main challenges to effectively regulating biological materials is the absence of an intergovernmental organization to oversee and support comprehensive coordinated implementation of the BWC. This absence stands in contrast to the presence of well-established intergovernmental organizations supporting implementation of agreements on chemical weapons and nuclear non-proliferation. An important component of this support is legislative assistance. These organizations’ legal offices, for example, have prepared guidance materials and carried out legal drafting workshops and follow-up activities for governments around the world, with the power of stable budgets and dedicated staff behind them.

An Organisation for the Prohibition of Biological Weapons (OPBW) was not meant to be, however, for the BWC. A few months before the 2001 Fifth Review Conference for the Convention, the United States indicated that it would no longer continue to support negotiations, which had been underway for several years, for the development of a protocol to the BWC. This protocol would have had several objectives, including the establishment of an OPBW. Instead, a resumed Fifth Review Conference in 2002 agreed to the launch of a new initiative—known as the ‘intersessional’ process—devoted to examining, among other topics, national implementation of the convention. This process was extended after the Sixth Review Conference in 2006 through to 2010. As well as saving the BWC regime from uncertainty and irrelevance, the annual sets of Meetings of Experts and States Parties since 2003 have engaged civil society in novel and exciting ways. They have also provided an opportunity for civil society actors to engage with states more directly on activities that have normally been associated with intergovernmental organizations.

But implementation of the convention is not only complicated by an institutional deficit, it also faces:

• a lack of universality in BWC membership;
• a perception among parties and non-parties alike that they do not have to implement effective controls on biological materials if they do not possess biological weapons;
• a lack of awareness in governments of the BWC and Security Council Resolution 1540 and their requirements and obligations, as well as a lack of political will to implement these instruments;
• limited or no technical, human or financial capacity for drafting implementing laws and regulations, training relevant officials, or enforcement;
• difficulty maintaining momentum in the implementation process due to turnover in staff, elections and changes in government, or internal or external conflicts; and
• competing legislative, parliamentary, budgetary or economic priorities.

Challenges to legal implementation of the BWC and regulation of biological materials also vary in and among regions. In order to give effect to the BWC, states should adopt penal measures criminalizing the development, production, manufacture, stockpiling, acquisition, retention, transfer and use of biological weapons. Preparatory measures to carry out such activities, including assistance, encouragement, or inducement, should also be penalized.

States should also adopt appropriate biosafety and biosecurity measures. These should include procedures to account for and secure the production, use, storage and transport of particularly dangerous pathogens, as well as measures to control activities involving human, plant or animal pathogens where infection may pose a risk. Licensing procedures will be needed too, as will safety and security measures for laboratories; containment measures; and genetic engineering regulations. Import and export controls should also be adopted, including export licenses for particularly dangerous toxins and pathogens, and measures should be in place ensuring general oversight on transfers. An official body should be designated to effectively enforce these measures. Enforcement measures will be needed to facilitate ongoing monitoring of life sciences activities and compliance with the convention, and to prosecute and punish offenders. Finally, other measures may be necessary to facilitate domestic and international cooperation and assistance.

These measures are important for several reasons. First, with effective legislation, states can investigate, prosecute and punish any offences, including preparations, associated with biological weapons activities committed by non-state actors, including terrorists. Second, it will strengthen their ability to monitor and supervise any activities, including transfers, involving especially dangerous pathogens and toxins. Third, states will enhance their national security and public health and safety. Fourth, they will send a strong signal to potential investors that they are a safe and responsible location for biotechnology and research. Fifth, their obligations under Articles III and IV of the BWC and UNSCR 1540 will be satisfied. And, finally, states will be able to comply effectively with international reporting requirements (BWC Confidence Building Measures, UNSCR 1540, etc.) if they have fully adopted effective legislation to implement the BWC.

In South and Central Asia, some states have little or no legislation to control even the most basic activities involving biological agents and toxins, while other states in the region have more robust biosecurity regulatory frameworks. These differences appear to be the result of two predominant factors: the negative impact of conflicts on a state’s ability to develop and maintain a fully functioning and comprehensive legal system, alongside a legacy of Soviet ‘anti-plague’ stations and biological weapons programmes which necessitated legal measures to protect personnel and the environment.

In the Middle East and North Africa (MENA) region, there is some movement towards a more robust biosecurity regulatory environment, but the progress is slow and uneven. In East Asia and the Pacific, some larger countries are developing more robust biosecurity regulatory frameworks. However, the smaller, lightly populated Pacific Islands nations perceive the vulnerability resulting from having weak biosecurity frameworks and the risk of proliferation in biological weaponry to be negligible or at least, less urgent than other, competing priorities.

In sub-Saharan Africa, South Africa has very good legislation, in comparison to countries in the region and globally. There is progress in some other countries in the region. However, most have little or no law in place to prevent the proliferation of biological weapons including laboratory biosecurity measures and export/import controls. A small number of sub-Saharan countries do, however, criminalize terrorist offences involving biological agents. In general, it seems that many African countries are more concerned about the impact of genetically modified organisms (GMOs) on their agricultural sectors and so have given less priority to laboratory biosecurity and other measures to control pathogenic agents.

As might be expected, given the European Union’s strong role in biological weapon non-proliferation efforts, there is significant movement toward a more robust biosecurity regulatory environment throughout most of Europe and Eurasia. Nevertheless, many countries in both regions appear to require additional laboratory biosecurity measures, including some of the most advanced European economies.

Across the Atlantic, progress is somewhat uneven. Countries that have progressed the furthest in the Americas include Argentina, Brazil, Canada, Cuba and the US. Although other countries in the region have not advanced as far, they nevertheless have some controls over activities involving microorganisms and related biological products. These regulations—which include measures on laboratory biosafety and transfer controls— provide a platform on which stronger legislative frameworks could be built.

Some of the Caribbean states, in particular, have adopted short and simple, but effective, laws to implement the BWC. This may suggest that they have a higher degree of awareness of the need to counter the threat of biological weapons proliferation through effective legislation. On the other hand, there are still several states across the Americas that do not have adequate legislation since they lack provisions criminalizing biological weapons and basic controls over micro-organisms.

Building a global network
This statement began by noting the difficulties arising from the lack of an international organization for the BWC and other, regional, challenges. These issues are being responded to in a number of ways. For its part, VERTIC set up its National Implementation Measures or ‘NIM’ Programme to assist states in understanding what measures are required to comply with their international obligations, and how to implement them.

The NIM Programme was developed to work with states on a range of nuclear, biological and chemical weapons treaties and certain UN Security Council resolutions. Currently, it is largely—but not completely—focused on the BWC. The NIM Programme has four principal activity areas. Programme staff prepare comprehensive analyses of countries’ existing legislation for implementing the BWC and related provisions of UN Security Council Resolution 1540. Based on these ‘gap analyses’, the programme provides direct legislative drafting assistance, or other forms of assistance such as remote reviews of draft legislation, legal advice, and information exchanges.

To facilitate this work, the programme has developed an ‘Implementation Kit’ for BWC implementation consisting of fact sheets, a sample act for national implementation, and regulatory guidelines (available in several languages). The sample act and regulatory guidelines devote considerable space to biosecurity including licensing, inspections, enforcement mechanisms and transfer controls for particularly dangerous biological agents, toxins and dual-use biological equipment. The NIM Programme also engages in outreach at workshops and conferences, including at the BWC Meetings of Experts and States Parties.

VERTIC is one of many organizations and initiatives working to fill the BWC’s institutional deficit. Intergovernmental organizations such as the World Health Organization, the World Organization for Animal Health, the UN Food and Agriculture Organization, the World Customs Organization and Interpol engage in their respective fields. The BWC Implementation Support Unit (BWC ISU) provides a coordinating role. And members of the BioWeapons Prevention Project (BWPP) network provide outreach and research activities. The BWPP is a global network of civil society actors dedicated to the permanent elimination of biological weapons. It was launched in 2003 by a group of non-governmental organizations concerned at the failure of governments after 2001 to fortify the norm against the weaponization of disease.

There are numerous other projects being undertaken by civil society actors in this field. These provide education for scientists on the BWC; skills development for laboratories, universities and governments; industry engagement; and training on law enforcement. There are also projects on public health co-operation, disease surveillance, and development and implementation of codes of conduct.

The BWC Implementation Support Unit has often observed that implementation of the convention in its fullest sense is a global network activity in which civil society actors play a major role. But there are both strengths and weaknesses to this network approach. The strengths are that civil society action can be nimble and certainly more affordable than a large secretariat for an international organization. Due to funder requirements, civil society projects are increasingly tightly goal-oriented and time-bound. Many of those engaged in these activities have worked and been trained in government or in the treaty organizations and therefore have a deep understanding of the treaties, issues, and the people involved in their implementation.

Nevertheless, there are several weaknesses in the network approach: funding cycles for civil society can be unpredictable and the loss or shrinkage of an important civil society actor can disrupt new assistance activities, delay crucial follow-up, and curtail information and outreach exchanges and activities. Additionally, some governments may simply be unwilling to work with civil society actors for historical or political reasons. I am confident, however, that the non-proliferation community—and this includes intergovernmental organizations; international, regional and subregional organizations; and governments—is becoming increasingly comfortable and familiar with the elevated level of involvement of civil society actors in the implementation of the BWC. This comes with the responsibility, however, for civil society to be highly competent and effective, discrete and professional, and aware of the limits of what it can reasonably accomplish with states.

Delivered by Scott Spence, November 2010


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