Impact of Regulation on Innovation Indicators in the EU

The impact of the regulatory framework relevant for agro-food biotechnology and genetic engineering in the different regions can be analysed on various levels. In the following, respective data are presented for the areas of scientific research, field trials with GMOs, approval and cultivation of GMOs in the different regions.

In the EU there is still a broad pipeline of R&D activities related to agricultural and food GMOs, which is fuelled by differing organizations like large multinational companies, small and medium enterprises (SMEs), universities and non-university research institutions (Lheureux et al., 2003). In the EU, a broad variety of plants are used for genetic modification experiments, with model plants (Arabidopsis thaliana and tobacco), vegetables (including mainly potatoes and tomatoes), cereals (e.g. maize, wheat, barley) and specific field crops (in particular oilseed rape, sugarbeet) accounting for more than 80% of all GM projects in the laboratory phase (Lheureux et al., 2003). Other crop categories like fruits, trees (wood), grasses or flowers are of minor importance in the EU.

So-called input agronomic traits account for 38% of all genetic modification projects in the laboratory phase (Lheureux et al., 2003). Resistance against herbicides, insects and other plant pathogens is investigated in 21% of all projects. Approximately 13% of all identified projects deal with abiotic stress or the improvement of yield characteristics of plants. Output traits account for 39% of all traits with half of the projects referring to modification of specific nutrients or ingredients (Lheureux et al., 2003). The output trait category 'health-related ingredients' plays an important role as well, since it accounts for 11% of all projects related to GM plants in the laboratory phase; 17% of all projects are classified in the 'marker/other traits' category including projects in a very early phase of the development of a GM plant (Lheureux et al., 2003).

Another indicator for research activities in a specific area are scientific publications in reviewed journals. The analysis of publication activities in biotechnology in the EU member states indicates a strong growth of the scientific output in biotechnology between 1991 and 2000 in all countries (Reiss and Dominguez-Lacasa, 2003). In addition, the significance of biotechnology among all scientific activities in the member states increased during the recent decade with most European countries performing above the world average. However, the analysis of the dynamics of specialization patterns in biotechnology-related publications indicates that the area of plant biotechnology is the only sub-field of biotechnology research, which showed significant negative growth during the second half of the 1990s in the EU (Fig. 16.1).

On the basis of the analysis of an EU database on field trials with GM plants, it can be realized that the number of notifications for GMO field trials increased significantly between 1991 and 1997 to reach a peak in 1998, and declined rapidly afterwards to the level at the beginning of the decade. In 2001, there were no more than 61 notifications for field trials with GM plants with a small recovery in the last 2 years (Fig. 16.2). This strong decrease can be interpreted as a reaction of

■ Environmental Bt-

Basic Bt

-Animal Bt-

Diagnostics/therapeutics

Industrial Bt

Cell factory

Plant Bt

Fig. 16.1. Specialization trends in biotechnology across the EU between 1995 and 2000. (From Reiss and Dominguez-Lacasa, 2003.)

150-

100-

1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003

Year

Fig. 16.2. Number of field trial notifications with genetically modified (GM) plants in the EU between 1991 and 2003. (From Lheureux et al., 2003; Transgen, 2004.)

EU industry and research institutes to the 1999's decision on the de facto moratorium on GMOs in the EU.

The majority of EU field trial notifications with GM plants referred to four crops: maize (26.4%), oilseed rape (20.9%), sugarbeet (15.6%) and potato (11.4%) (Lheureux et al., 2003), whereas other crops like tomatoes, tobacco, chicory, vegetables, cotton, fodder beet and wheat ranked between 4.2% and 1.1%. The proportions of the main crops have not changed significantly between 1993 and 2001, but the total number of notifications has decreased dramatically, showing a decline in all major crops since 1999 (Lheureux et al., 2003). Over the whole period between 1991 and 2001, resistance traits against pathogens, insects and herbicides were predominant in field trial notifications (~60% of all notifications). Herbicide resistance accounted for 42% of all notifications followed by insect resistance with 11% and resistance against other pathogens with 13%. Output traits accounted for 19% of all EU field trials between 1991 and 2001 showing an increase in the importance of output traits until the mid-1990s. Afterwards a relatively steady decline of the percentage of output traits was registered reaching a level of 12% of all field trial notifications in 2001 (Lheureux et al., 2003).

Since the de facto moratorium in 1999, no market approval for GM plants has been granted in the recent years; a number of applications are still pending approval. According to the EU Commission, 14 GM crops and 4 GM products for pharmaceutical use (e.g. vaccines, test-kits) have been approved for commercialization until 2004 (European Commission, 2004). Approvals for GM plants concern maize, oilseed rape, carnation, chicory, soybean and tobacco. Concerning traits, herbicide resistance is predominant among the approved GM plants (European Commission, 2004). At the beginning of 2004, 22 GM products were pending approval under Directive 2001/18/EC (European Commission, 2004).

Due to the running de facto moratorium, the commercial planting of GM in the EU is very limited. The major exception is the cultivation of one variety of insect-resistant maize (the variety Compa CB (Bt 176) from Syngenta Seeds), which was approved by the European Commission for planting in 1998 (before the moratorium) and has been taken up on a commercial basis in Spain. This year Bt maize was first planted commercially in Spain on ~20,000 to 25,000 ha (Brookes, 2003). Until 2002 the cultivation area of Bt maize remained at this level (which equals to ~4-5% of the cultivation area of maize in Spain) because of a voluntary arrangement of Syngenta Seeds to limit seed availability until the EU moratorium is lifted. In 2003 the cultivated area with Bt maize was increased to 32,000 ha in Spain ( James, 2003). Besides field trials with GMOs or plantings in the context of research projects to analyse gene flow of GM plants (which are carried out in different EU member states like the UK, Germany, Denmark), no commercial cultivation of GM plants exists in other EU member states (Lheureux et al., 2003).

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