The animals used for the creation of a new genetically altered animal line (including crossing of two lines) intended to be used for the purposes of basic research (e.g. developmental biology, immunology) should be recorded according to the purpose they are being created for.

Regrets that the Commission does not put enough emphasis on the gender dimension of poverty; believes the EU must invest in the specific needs of women and design social protection packages that address the challenges faced by women; emphasises that gender equality and women’s empowerment (GEWE) are essential to the attainment of international development goals; highlights the fact that the economic and political empowerment of women is not only a driving force for gender equality but is also fundamental to achieving overall economic growth in developing countries and reducing poverty; urges the Commission to ensure that gender equal ...[+++]ity and the empowerment of women will be mainstreamed in all EU development policies and programmes through its 2010 Gender Action Plan;

This Directive is based on international experience drawn upon through an extensive consultation, the Council of Europe’s Guide to safety and quality assurance for organs, tissues and cells, the European Convention on Human Rights, the Council of Europe’s Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo, 4.IV.1997), with its additional protocols, and recommendations from the World Health Organisation.

This Directive is based on international experience drawn upon through an extensive consultation, the Council of Europe’s Guide to safety and quality assurance for organs, tissues and cells, the European Convention on Human Rights, the Council of Europe’s Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo, 4.IV.1997), with its additional protocols, and recommendations from the World Health Organisation.

(22) This Directive respects the fundamental rights and observes the principles reflected in the Charter of Fundamental Rights of the European Union(9) and takes into account as appropriate the Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicine.

(2) The accepted basis for the conduct of clinical trials in humans is founded in the protection of human rights and the dignity of the human being with regard to the application of biology and medicine, as for instance reflected in the 1996 version of the Helsinki Declaration. The clinical trial subject's protection is safeguarded through risk assessment based on the results of toxicological experiments prior to any clinical trial, screening by ethics committees and Member States' competent authorities, and rules on the protection of personal data.