Table 1.
Personalized Medicine policies’ overview from 1998 to 2020 issued from the institutions of European Union
| Year | Title | Institutional body | Topics |
|---|---|---|---|
| 1998 | Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices | European Parliament, Council of the EU | Harmonization of national legislation, setting standards for medical devices, safety for patients |
| 1999 | Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products | European Parliament, Council of the EU | Treatment of rare diseases by orphan medicinal products |
| 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 | European Parliament, Council of the EU | Good clinical practise, clinical trials for medicinal products |
| 2001 | Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use | European Parliament, Council of the EU | Drug safety, market authorization of medicinal products, key definition of terms |
| 2004 | Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 | European Parliament, Council of the EU | Establishing EMA as an independent entity, science over politics, transparency |
| 2006 | Council Conclusions on common values and principles in European Union Health Systems (2006/C 146/01) | Council of the EU | Setting common standards for health systems, patient-centred health |
| 2007 | Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products | European Parliament, Council of the EU | Advanced therapy medicinal products, combining medical devices and medicinal products, gene therapy, cell therapy, cell tissue production |
| 2008 | Article 168 of the Treaty on the Functioning of the European Union (2008) | European Commission | Stating the importance of public health, balancing responsibilities MS-EU |
| 2008 | Commission Recommendation of 2 July 2008 on cross-border interoperability of electronic health record systems (notified under document number C (2008) 3282) | European Commission | Interoperability of EHS, standardization, global outreach |
| 2009 | Council recommendation of 8 June 2009 on an action in the field of rare diseases 2009/C 151/02 | Council of the EU | Putting focus to rare diseases, recognizing their importance, coordination of research |
| 2011 | Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare | Council of the EU | Promotion of cross-border healthcare |
| 2011 | Council conclusions on innovation in the medical device sector 2011/C 202/03 | European Parliament, Council of the EU | Patient-centred innovation, importance of infrastructure and ICT |
| 2011 | Council conclusions: towards modern, responsive and sustainable health systems 2011/C 202/04 | Council of the EU | Creation of modern, responsive, efficient, effective and financially sustainable health systems |
| 2013 | Council conclusions on the ‘Reflection process on modern, responsive and sustainable health systems’ of 10 December 2013 | Council of the EU | Sustainability of health systems, accessibility of healthcare, integrations EU health information system |
| 2014 | Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (not yet in application) | European Commission | Creation of single EU portal and database, setting standards for authorization within EU |
| 2014 | Council conclusions on innovation for the benefit of patients 2014/C 438/06 | European Parliament, Council of the EU | Innovative products, services and treatments |
| 2014 | Communication from the Commission on effective, accessible and resilient health systems COM/2014/0215 final | Council of the EU | Strengthening the effectiveness of healthcare, increasing accessibility of health systems, improving resilience |
| 2015 | Council conclusions on personalised medicine for patients 2015/C 421/03 | Council of the EU | Information and awareness, patient-centred approaches, stakeholders’ networks, health professionals’ literacy |
| 2016 | Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) | European Parliament, Council of the EU | Specifies detailed when health data is permitted for processing, strengthens privacy rights of patients |
| 2017 | Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the implementation of the Digital Single Market Strategy A Connected Digital Single Market for All COM/2017/0228 final | European Parliament, Council of the EU | Supporting data infrastructure, to advance research, disease prevention and personalised health and care, EHR accessibility |
| 2017 | Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions European Interoperability Framework—Implementation Strategy COM/2017/0134 final | European Parliament, Council of the EU | Domain-specific interoperability framework, EHRs, digital health |
| 2017 | Council conclusions on Health in the Digital Society—making progress in data-driven innovation in the field of health (2017/C 440/05) | Council of the EU | New opportunities are arising from big data and improved data analytics capabilities, as well as from PM, mobile application, citizen empowerment, sustainability of health systems, health data governance frameworks |
| 2018 | Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society COM/2018/233 final (2018) | European Parliament, Council of the EU | Interoperability of EHS, standardization, accessibility of EHRs, citizen empowerment |
| 2019 (Updated) | Council Conclusions on the EPC-Commission Joint Report on health care and long-term care in the EU | Council of the EU | Recommendations based on 2016 EPC EC joint report, promotion of integrated care; promotion integrated care |
| 2019 | Commission Recommendation (EU) 2019/243 of 6 February 2019 on a European Electronic Health Record exchange format (Text with EEA relevance.) | Council of the EU | Accessibility of EHRs, digital solutions |
| 2019 | Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA and on information and communications technology cybersecurity certification | European Parliament, Council of the EU | Stating cybersecurity concerning ICT in health, cybersecurity certification framework |
| 2020 | Council conclusions on shaping Europe’s digital future 2020/C 202 I/01 | European Commission | Workflow optimizations in healthcare, epidemiological surveillance systems, sustainability of health systems |