Gene Technology and Legislation - Prospects and Possibilities

The number of pharmaceuticals produced by means of gene technology that are available on the world market is impressive. Most of them have been developed by North American companies. At present, a great number of approved speciality drugs are produced by genetic engineering and offered within the EU (905 as of November 2002).These are based on only 49 different active ingredients, however.
When a drug is produced by means of genetically modified organisms (GMO's), but does not itself contain GMO's, then the production process is covered by EU Gene Technology Legislation, whereas the product uncapable of multiplication is not. Live vaccines, which are themselves GMO's in the sense of EU Gene Technology Directives, are covered by this legislation not only during production, but also fundamentally as products. With EU-Directive 2309/93/EEC, the corresponding demands in the EU Gene Technology Directive (90/220/EEC) were taken over in the EU Medicines Legislation.

Up to now, four animal drugs with three different viral GMO's as active ingredient were subject to evaluation by The European Agency for the Evaluation of Medicinal Products, and have been given approval by the EU-Commission. Three further animal drugs including one new viral GMO are presently undergoing the approval procedure (as of November 2002). The manufacture and use of viral vectors, e.g. for somatic gene therapy and also for transfection in human tissue cultures, is covered by EC Gene Technology Legislation. It is to be expected that technical developments, such as the introduction and expression of nucleic acids in human or animal somatic cells, will lead in the future to an increasing occurrence of border cases, for which a decision will have to be made as to whether the Gene Technology Legislation is applicable or not.

In the case of nucleic acid transfer into somatic cells of an animal,but without any transmittable, recombinant viral vectors or similar being released by the animal, then, from the present day point of view, such an application would not be covered by EC Gene Technology Legislation. It would be different if recombinant viruses etc. (GMO's) were released as a result of the nucleic acid transfer. Genetic engineering and modern biotechnology offer many and diverse possibilities for developing new drugs and diagnostics. Highlights of the developments up till now include:
Stabilized DNA-constructions for transient expression of certain proteins in somatic cells, stabilized RNA-molecule with enzymatic or repressor function, such as so-called Spiegelmers (mirror-image isomers), discovery of new drugs, e.g. antibiotics, from non-culturable microorganisms, genetically modified plants as suppliers of edible vaccines, production of antibodies in genetically modified plants, and production of pharmacologically active constituents in genetically modified plants. There is therefore a great range open to R&D. But the question is still open how legislators worldwide will react, so that prospects and possibilities are not converted to barriers and hurdles.

Dr Hans-Jörg Buhk