2. This new regulatory framework comprises five Directives: Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services(1), hereinafter the framework Directive; Directive 2002/20/EC of the European Parliament and of the Council of 7 March 2002 on the authorisation of electronic communications networks and services(2), hereinafter the authorisation Directive; Directive 2002/19/EC of the European Parliament and of the Council of 7 March 2002 on access to, and interconnection of, electronic communications networks and associated fac ...[+++]ilities(3), hereinafter the access Directive; Directive 2002/22/EC of the European Parliament and of the Council of 7 March 2002 on universal service and users' rights relating to electronic communications networks and services(4), hereinafter the universal service Directive; a Directive of the European Parliament and of the Council concerning the processing of personal data and the protection of privacy in the electronic communications sector(5).

(16) National regulatory authorities should have a harmonised set of objectives and principles to underpin, and should, where necessary, coordinate their actions with the regulatory authorities of other Member States in carrying out their tasks under this regulatory framework.

In view of the flexibility of the new model, which very prudently extends the scope of intervention of the international regulatory authorities, the main thrust of the new regulatory framework must be the need to guarantee the supervisory power that the Commission has laid down in respect of the national authorities, in order to ensure correct interpretation of the new framework and thereby avoid distortion of the competitiveness of the European market between geographical areas.

AE. whereas the first steps towards harmonisation of regulatory requirements have been taken where gene and cell therapy is concerned, since the European Agency for the Evaluation of Medicinal Products has drawn up guidelines for ‘good practice’; whereas, however, there is still no regulatory framework at national or Community level to govern new fields such as tissue engineering, artificial organs, and genetic testing,

13. Considers it essential, in order to make for a safe, beneficial, and responsible outcome in the new biomedical research, to lay down a harmonised regulatory framework to be recognised in all parts of Europe, providing for clear-cut rules focusing not just on development, but also on scientific and technological procedures, including guidelines on good laboratory, clinical, and industrial practice geared to the latest biomedical trends; calls on the Commission to review current practices in Member States which provide for the heterogeneity of genetic testing;

27. Believes that a harmonised regulatory framework needs to be established in order to give precedence to the interests of the public, health, and the research community, and to lay down strict and clear-cut rules to govern not only the development, but also testing and approval of new biotechnological drugs and reagents for genetic testing;