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„Market in Germany“

Public Trust in Science and Industry-supported Research and Education: Benefits and Pitfalls Polish Academy of Sciences International Conference Warsaw, 8 May 2009. Industry-funded health research in Germany: benefits and challenges Prof. Elmar Doppelfeld MD

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„Market in Germany“

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  1. Public Trust in Science and Industry-supported Research and Education:Benefits and PitfallsPolish Academy of SciencesInternational ConferenceWarsaw, 8 May 2009 Industry-funded health research in Germany: benefits and challenges Prof. Elmar Doppelfeld MD Chairman of the Permanent Working Party of Research Ethics Committees in Germany Chair (2005-2007) of the „Steering Committee on Bioethics“ of the Council of Europe

  2. „Market in Germany“ • Total Health Expenditure 2007: 252 Billions € • Expenditure for Drugs 2008: 25,8 Billions € E. Doppelfeld Warsaw, 8 May 2009

  3. Fields of Interest for Industry • Drugs and vaccines • All kind of technical equipment • e.g. imaging devices, instruments, intensive care equipment, laboratory, energy support, infrastructure • Prevention • Wellness • Specific food E. Doppelfeld Warsaw, 8 May 2009

  4. Expenditure for Health ResearchExamples for R&D in different Sectors Industry • Drugs: 5.8 Billions €, 18.800 researchers (2008) • Equipment: 825 Mio € (2005) Public Funds • Federal Republic and States • “Protection and Improvement of Human Health”: 712 Mio € ( 2004) • Biotechnology : 273 Mio € (2004) • “Deutsche Forschungsgemeinschaft”: 243 Mio € (2004) • Federal Ministry of Education and Research: ~160 Mio € /year • Not – University Research: ~ 300 Mio € (2003) • N.B.: No research funding by social security! E. Doppelfeld Warsaw, 8 May 2009

  5. Identification of Benefits • Benefits for the health field • Identified exclusively in relation to the market? • To what extent is the need of healthcare included? • Benefits for the shareholders • Ethical obligation of industry to fund research without a foreseeable benefit, such as improvement of knowledge? E. Doppelfeld Warsaw, 8 May 2009

  6. The International Play • Industry produces drugs and medicinal products with the aim of licensing for the national or for the international market • Proven quality and acceptable research conditions • Influencing factors • Liability in case of negligence (The Thalidomid catastrophe is not forgotten!) • National and international competition • Trust of the public and of the social security systems • Favourable opinion and approval by competent bodies E. Doppelfeld Warsaw, 8 May 2009

  7. Conditions for Licensing • Suitability of a product proven in clinical trials • Scientific quality • Conformity with law • Ethical acceptability E. Doppelfeld Warsaw, 8 May 2009

  8. Scientific Quality • Industry is highly interested in scientific quality of results • Aims and methods of the envisaged project • Given quality or if appropriate education of researchers, specific training programs • Equipment and structure of study sites; additional equipment, for ”dual use” • But • All scientific benefits linked to the aim of bringing a product to the market • Financial or other awards for the researcher to accept and to participate at the proposed clinical trial • Undue influence? E. Doppelfeld Warsaw, 8 May 2009

  9. Conformity with Law • Industry carries out research in conformity with law • Accurate respect of relevant legal provisions including code of deontology of participating professions • Data protection • But • Specific interpretation of legal provisions by lawyers in service of companies, e.g. free informed consent: information sheets, person entitled to seek the informed consent; mixing national and international legally binding provisions • Further use of results, participant excluded? • Information on results of a study, not for the participant? • Treatment after the end of a study? E. Doppelfeld Warsaw, 8 May 2009

  10. Ethical Acceptability • Few remarks from representatives of companies, mostly: „There can only be one ethics in a country, on a continent or in the world“ • If appropriate: Appeal to the Declaration of Helsinki, to CIOMS-Guidelines etc. E. Doppelfeld Warsaw, 8 May 2009

  11. Problems of Contracts • Contract between funding company and investigatorusually in a standard form • Inspection by the legally competent REC • Conformity with legal provisions • Financial or other awards for the investigator • Decision on interrupting or premature termination of a clinical trial • Publication of results • NB: Information material for participants and the form for written consent are not considered as contracts but of course proved by the legally competent REC E. Doppelfeld Warsaw, 8 May 2009

  12. Relation to Competent Bodies • Competent bodies in Germany by the Federal Drug Law and by the Federal Law on Medicinal products • The Federal Institute for Drugs and Medicinal Products (BfArM) • The Federal Paul-Ehrlich-Institute (PEI) • Research Ethics Committees set up in conformity with States law by the Faculties of Medicine, by the Medical Associations in the States or by the States governments The relations between funding industry and the competent bodies are at present time good. Existing problems are discussed in a consultation group composed by representatives of the drug industry and of the competent bodies. However funding industry tries to change regulations to its best interest by lobbying! E. Doppelfeld Warsaw, 8 May 2009

  13. Present State of RECs in Germany • Universities, Medical Associations and States governments are entitled by States legislation to set up Ethics Committees • Only these RECs (53) are legally competent for ethical assessment of biomedical research on man • Total independence of the establishing institution • Ultimate responsibility to States Ministries of Health and/or Research • Force of RECs decision: in drug trials in combination with the approval by the competent authorityfavourable opinion compulsory condition for start; All other kind of research: decision advice to the researcher! • Decision may be revised by a court of administration • Financing by fees to be paid by the applicants • Administration and standing rules given by the institution • Principle of local autonomy E. Doppelfeld Warsaw, 8 May 2009

  14. Procedure in Clinical Drug Trials • Sponsor is applicant • Given application form • REC has a maximum of 60 days from the date of receipt of a valid application to give its reasoned opinion to the applicant and to the competent federal authority • Multi-centre clinical trials: opinion of the REC competent for the coordinating investigator is relevant, to be achieved with contribution of local RECs at all study sites; 60 days maximum! • Specific regulations for gene therapy projects! ( Federal Guideline on the Implementation of the 12th Drug Law/ EU Directive 2001/20/EC) E. Doppelfeld Warsaw, 8 May 2009

  15. Workload of German RECs • 53 Research Ethics Committees entitled to assess biomedical research projects • ~15.000 projects submitted per year • ~ 53 %: Clinical drug trials • ~ 47 %: Other projects of biomedical research E. Doppelfeld Warsaw, 8 May 2009

  16. Conclusions • Industry-funded health research contributes by its benefits to healthcare in specific fields • Industry-funded health research improves the scientific quality of research in fields of interest • Industry-funded health research has to respect the regulations adopted for health research by a democratic society • Cooperation of industry with the competent bodies for health research can balance the different interests • Competent bodies contribute to the quality of research and to the trust of public in research conditions • In Germany no “player” asks for a change of the existing system of health research assessment (Report [2008] of the Federal Government to the “Deutscher Bundestag” on the experience with RECs following the implementation of Directive 2001/20/EC into German legislation in 2004) E. Doppelfeld Warsaw, 8 May 2009

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