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PublicationGesetzliche Regelungen der Gentechnik im Ausland und praktische Erfahrungen mit ihrem Vollzug. GutachtenThe study analyses practical experiences with the respective national laws and regulations for containded use and deliberate release of genetic engineered organisms in the USA, Japan, France, Great Britain, the Netherlands and Germany. For each country the approval procedures were investigated with respect to institutions involved, number of applications received and approvals given/refused, time and manpower requirements until approval of application is attained, costs, confidentiality and involvement of the public, alignment of regulation to present state of the art in science and technology, special problems and events. From the international experiences it can be concluded that the approval procedures will be most efficient if the following requirements are met: flexible interpretation of law or regulation, quick alignment of regulation to the dynamic development in science and technology, intensive cooperation and communication between applicant and competent authority, making hel p (forms, computer programmes, examples etc.) available to the applicants.
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PublicationStellungnahme für die öffentliche Anhörung des Gesundheitsausschusses des Deutschen Bundestages zum Gesetzentwurf der Fraktionen der CDU/CSU und F.D.P. zur Änderung des GentechnikgesetzesOn the basis of their study "Regulations of gentic engineering abroad and practical experience with their execution" the authors comment on a bill for an amendment of the German genetic engineering law. The proposed amendments conform with the relevant EU guidelines 90/219/EWG and 90/220/EWG. The authors welcome amendmends which aim at making approval procedures more efficient or adjust the regulations to the dynamic development in science and technology (e.g. shortening of time requirements until approval is obtained, streamlining procedures of no or low risk). With respect to the proposed abolition of public hearings in deliberate release experiments and commercial facilities of risk class 2 the authors point out that an unintended impact of this amendment may be the loss of public acceptance of genetic engineering. Moreover, it is pointed out that efficient approval procedures cannot be attained by amendments of the law alone if they are not complemented by appropriate administrative measures.
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PublicationBeobachtung der technisch-wissenschaftlichen Entwicklung. Ergebnisse des dritten Technikreports( 1992)
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PublicationDritter Technikreport. Finanzierung von Forschung und Technologie, Grundzüge der Forschungs- und Technologiepolitik, Staatliche Biotechnologieförderung im einzelnen, Vergleich ausgewählter Konkurrenzländer DeutschlandsIn order to elucidate the influence of government research policy on the development of science and technology, a broad overview over national R&D policies is given in the first part of the study: Based on OECD R&D statistics the USA, Japan, the Republic of Korea and the EC countries are characterized by their overall R&D expenditure, by the proportion of public to private funding and by government appropriations for socio-economic objectives. The second part of the study focusses on R&D policy in biotechnology. New trends within the publicly funded biotechnology research programmes in the USA Japan, France, Great Britain and the Republic of Korea are discribed and implications for Germany discussed. Despite its potential hazards biotechnology is regarded as a key technology and its development is publicly funded in the countries investigated. However, an international quantitative comparison of national R&D budgets for biotechnology is not possible to date due to the lack of comprehe nsive and coherent statistical data. Due to limited ressources the Korean government at present promotes biotechnology R&D only in certain niches while the other countries investigated the public funding covers the whole breadth of biotechnology. Especially in the USA and Japan emphasis is given to public funding of basic research. This tendency is consistent with the general observation that basic research is still crucial in more advanced stages of the development of science-based technologies. In each of the countries investigated several ministries or agencies are in charge of R&D in biotechnology. While their research policies were often poorly coordinated in the past a tendency towards better cooperation and coordination in biotechnology can now be observed in most countries. It is therefore concluded that the governments' role is being extended from pure funding of R&D and now also includes mediation between the different participants in the R&D process.
