Intellectual property rights and biosafety guidelines

In 1993, the ABSP's initial attempts to raise awareness of IPR and biosafety issues in Egypt were met with interest, because everyone was excited about biotechnology at that time. The initial ABSP programme was designed to promote awareness of IPR and biosafety issues, including the general concepts of patent law and PVP as they affect biotechnology-based plant breeders. MSU and Stanford University pioneered an Intellectual Property/Patent Internship Program in April 1993 in California and brought Professor John Barton of Stanford to Egypt. ABSP held an international IPR workshop in Washington, DC, in July 1994, which received high visibility among domestic and foreign policymakers. In January 1994, AGERI, ABSP and United Nations Industrial Development Organization (UNIDO) hosted a regional IPR workshop in Cairo. One outcome of this workshop was that scientists and government officials were paired up to provide complementary inputs to the drafting of IPR legislation.

Unfortunately, drafting IPR legislation and biosafety guidelines is a complex issue and requires input from various stakeholders. IPR regulations are mandated by the WTO. The WTO had 147 members and 30 observers on 23 April 2004; with the exception of the Vatican (Holy See), observers must start the accession process within 5 years of becoming an observer. The members include developed and many developing countries; the observers are primarily developing countries. As part of the General Agreement on Tariffs and Trade (GATT), which became the WTO, members are bound by the TRIPS. The TRIPS Agreement specifies that each country must provide patent protection for IP; art. 27(3)b specifies that for plant varieties, each country must have a patent system or comparable sui generis system. The first important reason for allowing a sui generis system is that in developing countries farmers traditionally keep seeds from each harvest for the next planting, selecting seeds from the plants that have the most desirable characteristics and often exchanging seeds with their neighbours (exchange has often been used as a distribution mechanism for improved varieties (van Wijk, 2006)).

The second reason is to allow scientists a research exemption: they can use seed as a research input without negotiating MTAs.

The International Union for the Protection of New Varieties of Plants (UPOV) has been developed and is promoting a PVP system that meets the sui generis requirements of the WTO and emphasizes protections of breeders' rights. As of 1 June 2004, 46 countries were members of the union (UPOV, 2002a). UPOV certification of a new variety requires evidence of distinctness, uniformity, stability and market value. Developed countries, with capitalized breeding firms and organizations, tend to prefer a UPOV-type system. Developing countries with farmer or informal seed selection processes tend to dislike the UPOV system since farmers do not have the means to certify new varieties. These countries typically feel that the UPOV system is highly biased towards industrialized seed production and agriculture and diminishes the importance of genetic diversity in agriculture (GRAIN, 1999). One example is that the UPOV system explicitly recognizes and gives rights to 'breeders' who discover a new variety; in a traditional patent system, discoveries are not inventions and hence are not patentable (UPOV, 2002b). The UPOV system also allows for only a limited farmer exemption for saved seeds. A number of developing countries and consortia of developing countries are working to design their own sui generis systems that are more in line with their interests (GRAIN, 1999).

Biosafety issues, while technically separate from IPR issues, tend to complicate the situation even more. When deciding to move forward with biotechnology, developing countries determine that they need IPR, biosafety and food safety regulations, and tend to invest jointly in the development of these regulations. The WTO classifies all products, including food, by end use. This means that the WTO does not distinguish between GM crops (or food) and traditional crops (or food produced from traditionally bred crops), although exceptions are allowed for cultural or safety reasons. The primary international agreement on GM organisms is the Cartagena Protocol on Biosafety (CPB), ratified in 2000 by delegates of the 128 members of the Convention on Biological Diversity (CBD) (to which the USA is not a signatory). The CPB explicitly endorses the precautionary principle as applied to new foods, allowing for countries not to accept GM foods. This establishes the CPB as contrasting with the WTO stance on GM crops and foods, although the delegates tried to limit this contrast by explicitly adding language so that the CPB did not take precedence over the WTO.1 Many developing countries are signatories to the CPB. UPOV takes the position that their sui generis system provides sufficient incentive for breeders to maintain diversity in order to develop new and useful varieties, and, without making an explicit statement, that the CBD is largely unnecessary (UPOV, 2002b).

The result is that in the pairings of scientists and government officials from the 1994 Cairo conference, neither scientists nor officials wanted to spend time wading through the morass of international treaties to draft IPR legislation or biosafety protocols. There was little interest from the legal profession in pushing this agenda forward (few developing countries have IPR legislation for information technology, let alone agriculture). Commenting on a draft of a 1994 research proposal, Egyptian scientists requested ABSP to reallocate funds from IPR and biosafety development to increase funding for laboratories and equipment.

Several IPR questions remained outstanding in the minds of many scientists and policymakers. These issues included:

• If the government supports the research, why do we need to protect IP?

• If we patent a technology, can we still give it away without charging a fee?

• Will the agricultural company (e.g. Monsanto) have a multinational monopoly?

• Will farmers be able to store and reuse seeds or planting material?

• Will foreign (or domestic) corporations or organizations be able to patent indigenous knowledge?

• Will foreign (or domestic) corporations or organizations be able to patent traditional germplasm?

The result was a reticence on the part of both scientists and officials to engage in the complex debates required to create the legal infrastructure; everyone felt that there were more urgent needs.

This attitude rapidly changed in 1995 when the MSU-AGERI research team announced that they were ready to field-test their GM potato in Egypt. The priority for Egyptian potatoes suddenly shifted from technology development to technology transfer. In a matter of just a few years, AGERI was able to draft and approve national biosafety guidelines for safe handling and management of biotechnology products.

Approval came in time for the 1997 season, and Egyptian field trials on the US variety also started. While waiting for AID and Egyptian approval to conduct field trials in Egypt, the MSU-AGERI research team had turned their attention towards inducing PTM resistance in a Spunta potato variety (a Dutch variety currently in public domain). This activity was sufficiently developed and tested so that in 1998 two GM varieties - Spunta G2 and Spunta G3 - were under field testing in Egypt at two locations.

By 2000, the MSU-AGERI team had 4 years of data on PTM resistance and 2 years of data on Spunta PTM resistance. The results were conclusive: introduction of the Bt gene into the varieties reduced storage losses by 99-100% over a period of 2-3 months for nawalla storage, and there was virtually no storage loss over a 12-month period for cold storage technology.

The MSU-AGERI research team concluded that they had met their objective of developing a PTM-resistant potato and recommended commercialization of the product. The researchers turned their attention to imparting other types of resistance to the potato. ABSP trumpeted their success in developing a GM crop that was useful to poor farmers in developing countries and announced that the PTM-resistant potato was 'at the threshold of commercialization' (ABSPa, p. 9).

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