1、RR453921EN.doc PE 300.127/fin. PE 300.127EN ENEUROPEAN PARLIAMENT1999 2004Session documentFINALA5-0391/20018 November 2001REPORTon the ethical, legal, economic and social implications of human geneticsTemporary Committee on Human Genetics and Other New Technologies in Modern MedicineRapporteur: Fran
2、cesco FioriPE 300.127/fin. 2/118 RR/453921EN.docENRR453921EN.doc 3/118 PE 300.127/fin.ENCONTENTSPagePROCEDURAL PAGE 5MOTION FOR A RESOLUTION6EXPLANATORY STATEMENT 33I. Introduction33II. Human genetics: a scientific and technological challenge amounting to nothing short of a revolution 34II.1. DNA Ge
3、nes Chromosomes .35II.2. Chromosomes37II.3. Genetic diseases 37II.4. The function of genes 41II.5. Consequences of the Human Genome Project 42III A working method in support of an integrated approach to promote a new relationship between science and technology .43IV Powers and responsibilities of th
4、e EU in the field of human genetics45V. International and European legal instruments.49VI. Work programme 53VI.1. Genetic tests 53VI.1.1 Ethical and social implications of genetic tests 54VI.1.2 Legal and regulatory implications of genetic testing 57VI.2 Care approaches to genetic diseases: treatmen
5、ts (therapy and medicine).58VI.2.1 Gene therapy .58VI.2.2 Genetic medicine.59(a) Medicines obtained from transgenic animals .59(b) Tissue and organ transplants 59(c) Pharmacogenetics .62VI.2.3 Ethical and social implications .63VI.3 Avenues to explore for Community action providing value added 66VI.
6、4 Economic implications of human genetics (diagnosis and therapy).68VI.4.1 Situation of the European gene therapy sector69VI.4.2 National and European gene therapy research output.71VI.4.3 To what extent does gene therapy constitute an explicit priority in the national systems used to fund science?.
7、72VI.4.4 Avenues to explore for possible recommendations to the Member States .73PE 300.127/fin. 4/118 RR/453921EN.docENVII. The use of genetic information 73VIII The patentability of living matter.74VIII.1 Legislative frame of reference at Community level.75VIII.2 Patented innovation as a driving f
8、orce of research 76VIII.3 Directive 98/44/EC on the legal protection of biotechnological inventions 77VIII.4 Human genome 79VIII.5 Patentability of gene sequences .80VIII.6 Arguments for and against the patentability of genes82IX. The sixth research framework programme 84X. Conclusions: what should
9、be the role of the Union? .86RR453921EN.doc 5/118 PE 300.127/fin.ENPROCEDURAL PAGEAt the sitting of 13 December 2000 Parliament pursuant to Article 150(2) of the Rules of Procedure, adopted a decision on setting up a temporary committee on human genetics and other new technologies in modern medicine
10、.To comply with its brief, the temporary committee appointed Francesco Fiori rapporteur at its constituent meeting of 16 January 2001.It considered the draft report at its meetings of 27 August, 10 September, 2, 8 and 10 October, 24 October and 5 and 6 November 2001.At the last meeting it adopted th
11、e motion for a resolution by 18 votes to 13, with 3 abstentions.The following were present for the vote: Robert Goebbels, chairman; Ria G. H. C. Oomen-Ruijten, Karin Scheele and Antonios Trakatellis, vice-chairmen; Francesco Fiori, rapporteur; Nuala Ahern (for Jillian Evans), Luis Berenguer Fuster (
12、for Grard Caudron), Hiltrud Breyer, David Robert Bowe, Hans Blokland, Willy C.E.H. De Clercq (for Diana Wallis), Jean-Maurice Dehousse, Gianfranco DellAlba (for Jean-Claude Martinez), Avril Doyle, Concepci Ferrer, Marialiese Flemming (for Franoise Grossette), Genevive Fraisse, Jos Mara Gil-Robles Gi
13、l-Delgado, Evelyne Gebhardt, Marie-Thrse Hermange, Eija-Riitta Anneli Korhola, Peter Liese, Jules Maaten (for Luciana Sbarbati), Minerva Melpomeni Malliori (for Eryl Margaret McNally), Emilia Franziska Mller, Riitta Myller (for Dagmar Roth-Behrendt), Elena Ornella Paciotti, Bernd Posselt (for Paolo
14、Pastorelli), John Purvis, Jos Ribeiro e Castro (for Sergio Berlato, pursuant to Rule 153(2), Dana Rosemary Scallon (for Jonathan Evans), Astrid Thors, Elena Valenciano Martnez-Orozco and Demetrio Volcic (for Carlos Candal, pursuant to Rule 153(2).The report was tabled on 8 November 2001.The deadline
15、 for tabling amendments will be indicated in the draft agenda for the relevant part-session.PE 300.127/fin. 6/118 RR/453921EN.docENMOTION FOR A RESOLUTIONEuropean Parliament resolution on the ethical, legal, economic and social implications of human geneticsThe European Parliament, having regard to
16、its decision of 13 December 2000 to set up a temporary committee on human genetics and other new technologies in modern medicine1,- having regard to the following Community documents: the Treaty on European Union (TEU) and in particular Articles 5, 95, 152, and 163 to 173 of the Treaty establishing
17、the European Community (TEC), the CE Convention for the Protection of Human Rights and Fundamental Freedoms, as amended by Protocol No 11, adopted in Rome on 4 November 1950, the Charter of fundamental rights of the European Union, in particular Articles 1, 3, 8, 13, 21, and 35 thereof, Directive 95
18、/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data2, Directive 98/44/EC on the legal protection of biotechnological inventions3, Decision No 182/1999/EC of the European Parliament and of the Council concerning the fifth framew
19、ork programme of the European Community for research, technological development and demonstration activities (1998 to 2002)4, Council Decision 1999/167/EC adopting a specific programme for research, technological development and demonstration on quality of life and management of living resources (19
20、98 to 2002)5, the proposal for a decision of the European Parliament and of the Council concerning the sixth multiannual framework programme 2002-2006 for research, technological development and demonstration activities (COM(2001) 94)6 and the proposals for decisions concerning the specific programm
21、es (COM(2001) 279)7,1 OJ C 232, 17.8.2001, p. 75.2 OJ L 281, 23.11.1995, p. 31.3 OJ L 213, 30.7.1998, p. 13.4 OJ L 26, 1.2.1999, p. 1.5 OJ L 64, 12.3.1999, p. 1.6 OJ C 180 E, 26.6.2001, p. 156.7 OJ C 240 E, 28.8.2001, p. 259.RR453921EN.doc 7/118 PE 300.127/fin.EN its various resolutions and, in part
22、icular, its resolution of 7 September 2000, relating to the issues under consideration1, European Parliament and Council Regulation 45/2001/EC on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies2, the proposal for a Council directi
23、ve establishing a general framework for equal treatment in employment and occupation (COM(1999) 565)3 and Parliaments resolution thereon (A5-0264/2000)4, having regard to the following international documents: the United Nations Convention of 5 June 1992 on Biological Diversity, the World Trade Orga
24、nisation Agreement of 15 April 1994 on Trade-Related Aspects of Intellectual Property Rights, the Universal Declaration on the Human Genome and Human Rights, issued by the United Nations Educational, Scientific, and Cultural Organisation on 11 November 1997, the World Health Organisation resolution
25、of 16 May 1998 on the ethical, scientific, and social implications of cloning for human health, the Council of Europe Convention of 4 April 1997 on Human Rights and Biomedicine and the Additional Protocol of 12 January 1998 and the Council of Europe Resolution of 20 September 1996 on Biomedicine, Re
26、commendation 1046(1986) of the Parliamentary Assembly of the Council of Europe on the Use of Human Embryos, the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the World Medical Association in June 1964 and amended in 1996, the Nuremberg Code a
27、nd the trials of war criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946April 1949, Council of Europe Convention No 108 of 28 January 1981 on the protection of individuals with regard to automatic processing of personal data, having regard to o
28、pinion No 13 of the European Group on Ethics in Science and New Technologies (EGE) on ethical aspects of the use of health-related personal data in the information society and opinion No 15 on Ethical Aspects of Human Stem Cell Research 1 OJ C 135, 7.5.2001, p. 263.2 OJ L 8, 12.1.2001, p. 1.3 OJ C 1
29、77 E, 27.6.2000, p. 42.4 OJ C 178, 22.6.2001, p. 270.PE 300.127/fin. 8/118 RR/453921EN.docENand Use, having regard to the bill approved by the US House of Representatives banning the creation of human embryos by means of nuclear transfer, which is currently being debated in the US Senate, having reg
30、ard to the hearings from January to May 2001 held by the Temporary Committee on Human Genetics and attended by experts in the field, having regard to the meetings with representatives of the national parliaments of the Union Member States and the applicant countries, and with representatives of civi
31、l society, held respectively on 18 and 19 June and 9 and 10 July 2001, having regard to Rule 150(2) of its Rules of Procedure, having regard to the report of the Temporary Committee on Human Genetics and Other New Technologies in Modern Medicine (A5-0391/2001),As regards genomic researchA. having re
32、gard to the need for research to enable the genuine and continual advance of medicine and the improvement of the quality of life for the individual and for civil society,B. whereas respect for human dignity dictates that people cannot be reduced to biological aspects, assessed exclusively according
33、to biological criteria or made subject to utilitarian considerations,C. whereas the fundamental ethical principles with regard to bioethics issues must be applied and interpreted and whereas, in their interpretation, there may be differing views on individual questions,D. whereas the existence of di
34、ffering views on bioethics issues must constitute the starting point for a rational, reasoned dialogue between persons holding those views,E. whereas the interpretation of fundamental ethical standards and principles will again and again have to address new issues that arise as biosciences develop,F
35、. whereas, in its resolution adopted on 7 September 2001, the European Parliament considered that any temporary committee set up by this Parliament to examine the ethical and legal issues raised by new developments in human genetics should take as a starting point the views already expressed in reso
36、lutions of this House, and whereas the committee should consider issues on which Parliament has not yet adopted a clear position,G. whereas in the Charter of fundamental rights, on the basis of the Convention on the Protection of Human Rights and Dignity of the Human Being with regard to the Applica
37、tion of Biology and Medicine, the EU has taken fresh steps to lay down Europe-wide ethical guidelines; whereas Article 3 of the Charter states that Everyone has the right to respect for his or her physical and mental integrity and that In the fields of RR453921EN.doc 9/118 PE 300.127/fin.ENmedicine
38、and biology, the following must be respected in particular: the free and informed consent of the person concerned, according to the procedures laid down by law, the prohibition of eugenic practices, in particular those aiming at the selection of persons, the prohibition on making the human body and
39、its parts a source of financial gain, and the prohibition of the reproductive cloning of human beings and whereas these principles represent minimum requirements for EU legislators and do not constitute an exhaustive list of all necessary regulations,H. whereas knowledge of the human genome marks de
40、cisive progress in the understanding of the way in which the human gene complex functions and interacts with the environment; whereas such understanding could eventually make it possible to diagnose, and possibly prevent, and treat many diseases much more accurately, by a far more personalised appro
41、ach, and much more effectively than is at present the case; whereas, however, the benefits to humankind, in terms of health, as well as the significant economic advantages for the Union will be impossible to exploit unless Europe creates the right general conditions for research in this sector, base
42、d on respect for human dignity, equality and the value of human life; whereas these advantages can be reaped to the full only if an open and informative debate is permitted and if members of the public are given a greater chance to understand opportunities and risks associated with the new methods,I
43、. whereas in the context described above, coordinated and integrated approaches are desirable; whereas integration in this area must not simply be taken to mean closer cooperation in which academic researchers, the private sector ranging from small biotechnology firms to large drugs companies and th
44、e medical profession seek to integrate research and development stages - although freedom of research must be maintained and the public benefit of medical research must always remain the most important objective and, as such, must not be subordinated to commercial considerations - but must also aim
45、to be such as to enable regulatory authorities to play an active role at the right time with a view to laying down the necessary standard-setting frames of reference and policies, as well as making for dialogue with end-users and social players,J. whereas substantial efforts are required to increase
46、 the general publics knowledge of genetic issues, as progress has been so rapid and discoveries so numerous in recent years; whereas an open dialogue between members of the public, their organisations, legislators, researchers and industry could create a climate of greater trust; whereas independent
47、 and impartial information is important with a view to fostering public confidence,K. whereas there are often substantial differences between men and women as regards the causes and courses of diseases and disorders, whereas, therefore, in accordance with the gender mainstreaming principle that is f
48、irmly established in the European Union, preventive and therapeutic measures, as well as research activities, in the field of modern biosciences must at all levels take account of gender-specific differences, and whereas, in particular as regards reproductive medicine and downstream technologies, th
49、e specific health interests of women must be taken into consideration,As regards the common ethical principlesL. whereas respect for human dignity is the foundation of all international and European PE 300.127/fin. 10/118 RR/453921EN.docENlegal instruments relating to fundamental rights, the foundation of all EU constitutions and the aim of all Member States; whereas freedom of research is also acknowledged as an important ethical principle essentially subordinate to the principle of respect for human dignity; w
