Organization

The Committee organises its work in plenary meetings. For a more functional planning of the activities, on a reasoned proposal of the Committee’s President, special working groups may be set up with a DPCM and a measure by the Secretary General. Where required by the topic, other experts on the issue under specific discussion can be aggregated to the Committee and to the Groups. These experts are invited by the Committee’s President by letter.

Documents and proposals elaborated by the working Groups are reviewed by the Committee in plenary meetings and therefore subject to its approval.

The main issues tackled in recent years by various working Groups include: genetic testing, gene therapy, tissue engineering, development of biotechnologies in Italy, cloning, Italian and European legislation, clinical trials, GM, infrastructures, information, genetic screening, biobanks, bio-nanotechnologies.

Institutional responsibilities

The Committee performs the following functions:

1. assesses the risks arising from the use of biological agents, and to this end identifies the risk factors and conditions for their classification;
2. develops criteria for the definition of safety standards in relation to the applicative areas of biotechnology, biosafety and life sciences;
3. cooperates in drafting the regulations transposing European directives that in any way implicate the involvement of biotechnology, biosafety and life sciences;
4. as direct support of the President of the Council of Ministers:

• ensures, after considering the respective and specific competences, the coordination, harmonisation and integration of programs, initiatives and activities of ministries, institutions and organisations, both public and private, operating within the biotechnology, biosafety and life sciences sectors;
• favours the knowability of the sector’s initiatives and activities in order to allow national, uniform and homogeneous forms of intervention;
• collaborates in establishing the Italian position in the European Community and internationally, with regards to those institutions debating problems of biosafety, biotechnology and life sciences;

1. promotes and organises, within the limits of the expenditure allocated in the budget, conferences and seminars to disseminate knowledge and information on biotechnology, biosafety and life sciences;
2. anticipates and validates the collection of data on biotechnologies, to be included in the database of the National Observatory for Biosafety, Biotechnology and Life Sciences, see Article 6;
3. concludes agreements with public or private institutions;

Annually submits a report on the status of biotechnology, biosafety and life sciences in Italy, to the President of the Council of Ministers.