Sathguru-ABSP II Template

What is ABSPII?

ABSPII is a USAID-funded consortium of public and private sector institutions that supports scientists, regulators, extension workers, farmers and the general public in developing countries to make informed decisions about agricultural biotechnology. Where demand exists, ABSPII focuses on the safe and effective development and commercialization of bio-engineered crops as a complement to traditional and organic agricultural approaches. The project helps boost food security, economic growth, nutrition and environmental quality in East and West Africa, Indonesia, India, Bangladesh and the Philippines. The consortium develops innovative, pragmatic solutions, building on the successes of the Agricultural Biotechnology Support Project (ABSP) that was led for over a decade by Michigan State University. ABSPII works collaboratively with the Program for Biosafety Systems (PBS) and the South Asia Biosafety Program (SABP).

ABSPII has developed a Product Commercialization Package (PCP) for selected bio-engineered crop by geographical site. The PCP integrates activities on technology development, policy (including intellectual property), outreach and communication, and marketing and distribution, that take place across different stages of the product cycle.

1. Technology Development

In South Asia, the regulatory frameworks for bioengineered products are evolving, with the key goal of having robust frameworks for product approval and release.

Key concerns among the technology donors are the potential for liability claims associated with unwanted transgenes in local crops. This warrants a Freedom to Operate (FTO) review and calls for establishing licensing relationships for the bioengineered product(s). To ensure technology transfer, a tailor-made IP management and licensing strategy is developed by ABSPII in line with the scientific strategy for each product.

In each of the products being developed in South Asia, a key role was played by ABSPII in enabling technology access through an elaborate mechanism involving IP Audit, technology licensing and product development.

The overall licensing strategy had specific components to ensure product stewardship and technology assessment and monitoring by licensees.

2. Regulatory File Development

Bioengineering is one of the most extensively reviewed agricultural advancements to date. Some theoretical agro-ecological, economic and health risks are associated with bioengineered crop production, marketing, and use.

As such, it is mandated by the regulators that a proper regulatory package is developed. Regulatory file development is costly, and is likely to require a large portion of the resources for each project. As such, it is advisable, to the extent possible, to use information from existing regulatory dossiers generated in other countries for the same or similar products. Depending on the focus country involved, this activity can be governed by national biosafety legislation and the authorities responsible for its implementation.

At ABSPII we lay stress on our scientific personnel at partner institutions to conduct comprehensive biosafety and environmental safety studies (including gene flow assessments), allergenicity tests, acute oral studies, sub-chronic oral studies, primary skin irritation, mucous membrane test, soil microflora studies, entomological studies, and food safety studies.

In each of the focus country in South Asia, we lay stress on generating new data for the regulatory packages at the shortest time. ABSP II also invests in institutional capacity building to enable the scientists to work towards product approval and product validation.

3. Marketing and Distribution

A marketing and distribution system needs to be in place or be planned early in the project. Early involvement of downstream partners, particularly private sector suppliers of seed and other agricultural inputs, helps to build the momentum for successful product adoption. However, additional considerations can arise. For example, there could be loss of markets, such as the EU, that ban or avoid bioengineered crops. Or there could be reduced efforts to seek alternative solutions if bioengineered crops are overemphasized. This could be accompanied by reduced competition in input supply resulting in fewer choices or higher prices for farmers. Also, disputes could arise in the product and distribution system when national policies on intellectual property issues, for example patenting of life, can differ from those of multinational suppliers. These disputes could also involve accountability and liability regarding food safety and biosafety concerns because of the lack of clear and broadly accepted internationally accepted technical standards.

4. Communication and Outreach

A communication and outreach strategy is required to sensitize the public and educate them with the basics of biotechnology and of all the aspects pertaining to the specific bioengineered products.

Towards this end, ABSPII has developed a comprehensive communication strategy to provide regular, precise information on each of the bioengineered product(s) in South Asia to identified target groups to address stakeholder concerns as they arise and to eventually achieve product acceptance. As part of the strategy, studies are conducted by experts to assess baseline awareness of biotechnology in target groups, and develop appropriate strategies for each group.