Challenges

To facilitate the adoption of agricultural products and health programmes enhanced by modern biotechnologies, it has become imperative to define and implement policies in biosafety. Most developing countries have yet to begin or are still at the nascent stages of establishing the requisite regulatory domains. As a result, heterogeneous patchworks of national and regional regulations are emerging. These asynchronous and diverse regulatory frameworks are limiting the capacity of bioinnovators, negatively affecting research collaborations, disrupting commodity trade and impeding food security and innovations in public health, thereby threatening sustainable development. There is a tremendous need for support in the form of partnerships and international cooperation to implement fully operational regulatory systems in the Global South.

Toward a Solution

The effective and safe use of biotechnologies requires a broad portfolio of policies, regulations and processes to support national decision makers. Under its mandate, the Regulatory Science Group of the International Centre for Genetic Engineering and Biotechnology assists countries in the global South in improving national capacities in biotechnology regulation by applying an integrated, synergistic and tailored approach.

The Group focuses primarily on improving institutional capacities to ensure regulatory effectiveness in the changing landscape of evolving technologies and human resource mobilization. In the past 10?years, the Group has strengthened the institutional capacities of governments from sub-Saharan Africa, Central America and the Caribbean to regulate biotechnology products in line with their policy objectives.

The Group provides a range of administrative tools and approaches to help improve the effectiveness of competent national authorities and their technical committees. It works in partnership with the relevant government officials and experts to ensure that the resulting procedures and processes are tailored to the national regulatory framework and immediately applicable. This collaborative effort also helps guide and improve the skills of regulatory officials and encourages them to network with their regional and international peers. In this way, they are empowered to address their needs more autonomously, while becoming more aware of the regulatory challenges facing other countries, thereby increasing their preparedness. The ultimate goal is to develop robust, non-fragmented regulatory mechanisms that are independent of human resource fluctuations.

Peer networking is facilitated via regulatory exchanges. Regulators from the Global South are assigned to short-term placements in regulatory offices in Argentina, Australia, Canada and Uganda. Experienced staff from those offices are also embedded in institutions in beneficiary countries for a short period to provide local assistance in improving regulatory effectiveness. As a result of these efforts that rely on South-South (Africa-Africa, Africa-Latin America, Caribbean-Latin America) and North-South cooperation (Africa-Canada, Africa-Australia), 28?regulators have been trained, and 5?more will be participating in future trainings.

The Group also brings together regulators, scientific advisors and inspectors from the global South to attend mentoring forums of 3?to?5?days, in order to enhance their contributions to decisions regarding emerging biotechnologies. This well-established, interactive training format empowers local officials to design and implement key regulatory activities and promotes knowledge transfer and exchange of experiences. To date, at least 896?regulators and scientists (574 from Africa and 322 from the Caribbean) have attended forums on various technical and administrative aspects of biotechnology regulation.

In addition, the Group has awarded 15?fellowships to regulators and researchers to obtain biosafety-related master’s degrees, in collaboration with British and Australian universities.

The sustainability of these capacity-building efforts has been improved by the creation of an online e-learning training portfolio, developed for and administered by competent national authorities in the global South to address their training needs autonomously. The blended learning experience incorporates new teaching methods and approaches for technology-assisted education. The portfolio is hosted in the cloud and delivered online at a low cost. It is continuously available to multiple audiences and can be accessed from anywhere in the world on an as-needed basis. Currently, 274?African regulators are active users of this online training platform.

The Group’s highly respected international reputation in regulatory science has grown through collaborations with prestigious donors, such as the Bill and Melinda Gates Foundation, United Nations Environment Programme, the Secretariat of the Convention on Biological Diversity, the European Commission, and the Ministry of Environment of Italy.

In summary, the Group’s activities support and facilitate triangular cooperation to energize and strengthen biotechnology regulatory offices in the Global South. A strategic approach for personal and institutional capacity-building has been employed, which includes South-South partnerships, triangular cooperation and strategic alliances. The goal of autonomous, robust and structured regulation is to increase the availability of healthier and safer food and health products from fewer resources while reducing pressure on natural ecosystems, as well as to support the value-added commodities trade to improve sustainable development.