L121/34 Official Journal of the European Communities 1.5.2001 DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission ('), Having regard to the opinion of the Economic and Social Committee (%), Acting in accordance with the procedure laid down in Article 251 of the Treaty (%), Whereas: (1)  Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regula- tion or administrative action relating to medicinal prod- ucts (*) requires that applications for authorisation to place a medicinal product on the market should be accompanied by a dossier containing particulars and documents relating to the results of tests and clinical trials carried out on the product. Council Directive 75/ 318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco- toxicological and clinical standards and protocols in respect of the testing of medicinal products (°) lays down uniform rules on the compilation of dossiers including their presentation. (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 toxico- logical experiments prior to any clinical trial, screening by ethics committees and Member States' competent authorities, and rules on the protection of personal data. () OJ C 306, 8.10.1997, p. 9 and O] C 161, 8.6.1999, p. 5. () O] C 95, 30.3.1998, p. 1. (*) Opinion of the European Parliament of 17 November 1998 (O] C 379, 7. 12. 1998, p. 27). Council Common Position of 20 July 2000 (O] C 300, 20.10.2000, p. 32) and Decision of the European Parliament of 12 December 2000. Council Decision of 26 February 2001. (*) O] 22, 9.2.1965, p. 1/65. Directive as last amended by Council Directive 93/39/EEC (O] L 214, 24.8.1993, p. 22). () OJ L 147, 9.6.1975, p. 1. Directive as last amended by Commission Directive 1999/83EC (O] L 243, 15.9.1999, p. 9). () (6) Persons who are incapable of giving legal consent to clinical trials should be given special protection. It is incumbent on the Member States to lay down rules to this effect. Such persons may not be included in clinical trials if the same results can be obtained using persons capable of giving consent. Normally these persons should be included in clinical trials only when there are grounds for expecting that the administering of the medicinal product would be of direct benefit to the patient, thereby outweighing the risks. However, there is a need for clinical trials involving children to improve the treatment available to them. Children represent a vulnerable population with developmental, physiological and psychological differences from adults, which make age- and development- related research important for their benefit. Medicinal products, including vaccines, for children need to be tested scientifically before wide- spread use. This can only be achieved by ensuring that medicinal products which are likely to be of significant clinical value for children are fully studied. The clinical trials required for this purpose should be carried out under conditions affording the best possible protection for the subjects. Criteria for the protection of children in clinical trials therefore need to be laid down. In the case of other persons incapable of giving their consent, such as persons with dementia, psychiatric patients, etc., inclusion in clinical trials in such cases should be on an even more restrictive basis. Medicinal products for trial may be administered to all such indi- viduals only when there are grounds for assuming that the direct benefit to the patient outweighs the risks. Moreover, in such cases the written consent of the patient's legal representative, given in cooperation with the treating doctor, is necessary before participation in any such clinical trial. The notion of legal representative refers back to existing national law and consequently may include natural or legal persons, an authority andfor a body provided for by national law. In order to achieve optimum protection of health, obso- lete or repetitive tests will not be carried out, whether within the Community or in third countries. The harmo- nisation of technical requirements for the development