Presidency of Council of Ministers National Committee for Biosafety, Biotechnology and Life Sciences (D.P.C.M. March 19, 2007)

Composition Prof. Leonardo Santi Chairman A rapresentative appointed by: Ministry of Labour, Health and Social Politics Ministry of Labour, Health and Social Politics Minstry of Environment, Protection of the Territory and the Sea Minstry of Environment, Protection of the Territory and the Sea Ministry of Economic Development Ministry of Economic Development Ministry of Agricultural, Food and Forestry Politics Ministry of Agricultural, Food and Forestry Politics Ministry of Education, University and Research Ministry of Education, University and Research Ministry of Foreign Affairs Ministry of Foreign Affairs Ministry for the European Affairs Ministry for the European Affairs Ministry for Public Administration and Innovation Ministry for Public Administration and Innovation National Institute for the new Technologies,Energy and Environment (ENEA) National Institute for the new Technologies,Energy and Environment (ENEA) National Research Council (CNR) National Research Council (CNR) Assobiotec Assobiotec National Council of the Consumers and Users National Council of the Consumers and Users 11 experts in the field of biotechnology 11 experts in the field of biotechnology

Objectives Evaluation and control of the biological risks Drafting of opinions on national legislative acts in conpliance with European directives in the field of biotechnology, aiming to establish direct links with the European Union Technical support for governmental and legislative actions Elaboration of a framework of programmes, initiatives and action pertinent to biotechnology carried out by Ministries, Public and Private Research Institutions and by other organizations that provide for the evaluation of the implications of innovative biotechnology in different fields of research and productivity Coordination of activities related to areas of biotechnology Information and diffusion of techincal/ scientific awareness

Activities Guidelines for the safety of gene and cell therapy trials from both experimental and clinical standpoints Guidelines for the safety of gene and cell therapy trials from both experimental and clinical standpoints Analysis of issues pertinent to genetic testing entailing molecular diagnostics from medical, legal, ethical and psychological standpoints and with a view of allowing appropriate and effective therapy strategies Analysis of issues pertinent to genetic testing entailing molecular diagnostics from medical, legal, ethical and psychological standpoints and with a view of allowing appropriate and effective therapy strategies In-depth analysis of theme related to safety and quality of in vitro expanded cells and human tissues In-depth analysis of theme related to safety and quality of in vitro expanded cells and human tissues Studies related to the development of biotechnology in Italy which define the most convenient strategies Studies related to the development of biotechnology in Italy which define the most convenient strategies

ACTIVITIES Opinion about the directive on the biotechnological inventions Opinion about the directive on the biotechnological inventions Foster the diffusion of awareness of safety problems Foster the diffusion of awareness of safety problems Organization of conference and events Organization of conference and events Working out guidelines on cloning in order to provide a regulatory framework Working out guidelines on cloning in order to provide a regulatory framework Working out guidelines on xenotransplantings Working out guidelines on xenotransplantings Studies related on Italian position on biotechnology and to define the Italian research priorities Studies related on Italian position on biotechnology and to define the Italian research priorities

National Observatory of Biosafety and Biotechnology Art. 4 Decree Within the National Committee for Biosafety and Biotechnology (CNBB) and according to its guidelines, an Observatory has become operative with the aim of: Mapping the national distribution of the biotechnological infrastructures and activities Mapping the national distribution of the biotechnological infrastructures and activities Setting-up a biotech database to be connected with other similar databases at national and international level Setting-up a biotech database to be connected with other similar databases at national and international level

Objectives of the Observatory Monitoring of the industrial background of the biotechnological field at national and international level Monitoring of the industrial background of the biotechnological field at national and international level Identification and organisation of information concerning Identification and organisation of information concerning more prominent lines of research more prominent lines of research Planning and implementation of a network of centres of exellence for technology transfer Planning and implementation of a network of centres of exellence for technology transfer Planning of experimental actions to coordinate supply and demand in the field of biotechnology and arrangement of executive plans Planning of experimental actions to coordinate supply and demand in the field of biotechnology and arrangement of executive plans

Presidency of the Council of the Ministers National Committee for biosafety and biotechnology National Observatory for biosafety and biotechnology National Observatory for biosafety and biotechnology Collection and analysis of data Pubblic and Private research Productive infrastructu res Technology Transfer Communicati on Perception Training Entrepreneuri al politics and regulatory framework Biosafety Ethical Aspects Business plan

Guide Lines for Biotechnologies, key field of the economy. 1. To develop research in the field of biotechnology by promoting pubblic-private collaborations, by ruling the use of biobanks and developing European Technological Platforms. 2. To foster technology trasfer by protecting intellectual property, by optimizing economically results of the pubblic research and fostering the mobility of the researchers

3. To develop biotechnological industry 3. To develop biotechnological industry To boost immaterial investments to develop the hi- tech enterprises To boost immaterial investments to develop the hi- tech enterprises To stimulate the growth of the young hi-tech enterprises To stimulate the growth of the young hi-tech enterprises To foster the biotechnological enterpreneurship through tax relief To foster the biotechnological enterpreneurship through tax relief To ease the credit to the biotech enterprises To ease the credit to the biotech enterprises To develop the Venture Capital market with particular regard to seed and early stage capital To develop the Venture Capital market with particular regard to seed and early stage capital To mobilize further risk capital from business angels To mobilize further risk capital from business angels To speed the implementation of the community directives To speed the implementation of the community directives To boost the networking and clustering processes To boost the networking and clustering processes To stimulate the incoming of investments from abroad, to encourage the internationalization. To stimulate the incoming of investments from abroad, to encourage the internationalization.

4.Horizontal interventions by improving the governance, powering the National Observatory for biosafety and Biotechnology, bettering the social accessibility to biotechnologies and increasing the potentiality of human resources.