This section provides information on relevant European and international legislation, as well as guidelines (soft law) of areas where ethics issue may arise in research. Very commonly research projects involve activities that intersect the categories described below.
Clinical trials
- 2016/C 424/03 Commission notice on the application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000 on orphan medicinal products.
- Regulation EU No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.
- Regulation (EU) No 1027/2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance.
- Directive 2012/26/EU amending Directive 2001/83/EC as regards pharmacovigilance.
- Regulation (EU) No 1235/2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products.
- Directive 2010/84/EC amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
- Directive 2009/120/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products.
- Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products.
- Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004.
- Regulation (EC) No 1901/2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004.
- Regulation (EC) No 1902/2006 amending Regulation 1901/2006 on medicinal products for paediatric use.
- Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council.
- Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
- Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
- Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.
- Directive 2001/83/EC on the Community code relating to medicinal products for human use.
- Directive 2001/20/EC 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.
- Regulation (EC) No 847/2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts 'similar medicinal product' and 'clinical superiority'.
- Regulation (EC) No 141/2000 on orphan medicinal products.
Biomedicine
- Convention on Human Rights and Biomedicine Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (ETS No. 164).
- Universal Declaration on Human Genome and Human Rights Records of the General Conference, 29th session, Paris, 21 October to 12 November 1997, v. 1: Resolution.
- Additional Protocol on Biomedical Research Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (CETS No. 195).
- International Declaration on Human Genetic Data United Nations Educational, Scientific and Cultural Organization.>
- Additional Protocol for Testing for Health Purposes Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes (CETS No. 203)
Climate law
GMOs
- Directive (EU) 2015/412 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory.
- Directive 2009/41/EC on the contained use of genetically modified micro-organisms.
- Regulation (EC) 1946/2003 on transboundary movements of genetically modified organisms.
- Regulation (EC) 1830/2003 on the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms.
- Regulation (EC) 1829/2003 on genetically modified food and feed.
- Directive 2001/18/EC on the deliberate release of GMOs into the environment.
- Proposal for a Draft Regulation on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625.
Tissues and cells
- Directive (EU) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells.
- Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells.
- Directive 2006/86/EC amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells.
- Directive 2006/17/EC implementing Directive 2004/23/EC as regards certain technical requirements for the donation, procurement and testing of human tissues and cells.
- Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
- Directive 2002/98/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
- Additional Protocol on Transplantation of Organs and Tissues of Human Origin. Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin (ETS No. 186)
Artificial Intelligence
- Proposal for a Regulation laying down harmonized rules on Artificial intelligence Artificial Intelligence Act and amending certain Union Legislative Acts.
- Assessment List for Trustworthy Artificial Intelligence (ALTAI) for self-assessment by the High-Level Expert Group on Artificial Intelligence (AI HLEG).
Animals used for scientific purposes
Environment and biodiversity
- Directive 2004/35/CU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage.
- Regulation (EC) 1946/2003 on transboundary movements of genetically modified organisms.
- Regulation (EC) 1829/2003 on genetically modified food and feed.
- Regulation (EC) 1830/2003 on the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms.
- Directive 2001/18/EC on the deliberate release of GMOs into the environment.
- UN Convention on Biodiversity
- Cartagena protocol on biosafety to the convention on biological diversity - Declaration by the European Community in accordance with article 34(3) of the convention on biological diversity.
- Directive (EU) 2016/1148 concerning measures for a high common level of security of network and information systems across the Union.
- Proposal for a Regulation on European data governance (Data Governance Act).
- Proposal for a Regulation on harmonised rules on fair access to and use of data (Data Act).
- Proposal for a Regulation on the European Health Data Space
- UNESCO International Declaration on Human Genetic Data
- Directive 2004/48/EC on the enforcement of intellectual property rights.
- Regulation (EU) No 608/2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003.
- Directive 98/44/EC on the legal protection of biotechnological inventions.