Regulation of Clinical Trials under the European Union Law (Summary)
https://doi.org/10.24833/0869-0049-2013-1-129-141
Abstract
The European Union is a market leader in clinical research, and this status requires uniform legislation in this area. However, all attempts to unify legislation had the opposite effect, leading to a reduction of investment in R & D area. To remedy the situation, the EU adopted Regulation, which aims to promote investments in R & D area.
About the Authors
A. H. Abashidze
Russian Peoples’ Friendship University
Russian Federation
Russian Federation
Aslan H. Abashidze – Doctor of Laws, professor, head of the Chair of International law
V. S. Malichenko
MGIMO-University MFA Russia
Russian Federation
Russian Federation
Vladislav S. Malichenko – post-graduate student of the Chair of International Law
References
1. Право Европейского Союза: учебное пособие (отв. ред. С.Ю. Кашкин). М.: Юрайт, 2011. – 1120 стр
2. Пресс релиз. Европейская Комиссия сосредотачивает внимание на международном научном сотрудничестве для решения глобальных проблем. Брюссель, 17 Сентября 2012 .
3. Dimasi & H. G. Grabowski, “The Cost of Biopharmaceutical R&D: is Biotech Different?” Managerial and Decision Economics No. 28 2007.
4. J. Dimasi, R. W. Hansen, and H. G. Grabowski, “The Price of Innovation: New Estimates of Drug Development Costs,” Journal of Health Economics №22. 2003.
5. Pammolli, F., Magazzini, L., Riccaboni, M., “The Productivity Crisis in Pharmaceutical R&D,” Nature Reviews Drug Discovery, 10, 428-438 (June 2011).
6. European Commission. 2010. EC Joint Research Center’s 2010 Scoreboard presentation from 17/11/2010.
7. Available atiri.jrc.ec.europa.eu/research/docs/2010/SB2010_final_report.pdf
8. CRA. Policies that encourage innovation in middle-income countries. 2012
9. ‘Public-Private Research Initiative to boost the competitiveness of Europe’s pharmaceutical industry’, Press Release No. IP/08/662, 30 April 2008.
10. ‘The Pharmaceutical Industry in Figures 2007’, 2007.
11. Treaty on the Functioning of the European Union (TFEU). 13 December 2007.
12. Commission staff working document. Impact assessment on the revision of the “Clinical Trials Directive” 2001/20/EC. Brussels, 17.7.2012. SWD (2012) 200 Final. Volume I.
13. Fostering EU’s attractiveness in clinical research: Commission proposes to revamp rules on trials with Medicines 17 July 2012
14. Europe 2020. A strategy for smart, sustainable and inclusive growth. COM (2010) 2020, 3.3.2010.
15. Action Programme for Reducing Administrative Burdens in the European Union COM(2007) 23, 24.1.2007.
16. Response of EFPIA in the 2009/10 public consultation.
17. Impact on Clinical Research of European Legislation ICREL 2008.
Review
For citations:
Abashidze A.H., Malichenko V.S. Regulation of Clinical Trials under the European Union Law (Summary). Moscow Journal of International Law. 2013;(1):129-141. (In Russ.) https://doi.org/10.24833/0869-0049-2013-1-129-141
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