New Data Ethics Charter provides a framework for the Danish Medicines Agency’s use of health data
The Danish Medicines Agency has adopted a Data Ethics Charter consisting of seven principles of data ethics. The charter is to set high ethical standards for the protection and handling of the health data included in the scientific and statistical analytical work performed by the agency.
Trust, fairness, equality, responsibility, transparency, diversity and global perspective. Those are the seven principles of data ethics set out in the Danish Medicines Agency’s new Data Ethics Charter, which are thus going to guide the agency’s work in respect of health data and handling thereof.
The Data Ethics Charter has been prepared based on input from the Danish Medicines Agency’s Citizens' Council, which represents a number of patient organisations in Denmark, and on the discussions at the agency’s data ethics event held in March among attending experts in ethics from Aalborg University and the University of Copenhagen and the CEO of Danish Patients.
Also, the charter is inspired by recommendations from the Danish Expert Group on Data Ethics, the national strategy for artificial intelligence, the European Commission’s high-level expert group on artificial intelligence and the OECD’s expert group on artificial intelligence.
“We have adapted the principles of the charter to the Danish Medicines Agency so that it makes sense in relation to our concrete work with data, but it has been important for us to involve national experts and patient representatives while ensuring that the charter is in line with national and international ethical guidelines and data protection legislation”, says Director General Lars Bo Nielsen.
He explains that the need for a Data Ethics Charter is closely linked with the rapid development and technological innovation in the area.
“A lot is happening these years. Both within computerised artificial intelligence in medicines and medical devices and within health data research that can give us a better understanding of the effects and side effects of medicines. Especially in Denmark, health data are of such a superior quality that there is enormous untapped potential for strengthening the evidence base and enhancing the quality of the healthcare sector for the benefit of patients and the general public. But as a public authority, we have a tremendous responsibility to maintain a fair balance to safeguard patient rights and data privacy, making sure that no one has their privacy and personal data compromised”, says Lars Bo Nielsen.
The seven principles of data ethics
1. Trust: In certain circumstances, the Danish Medicines Agency may lawfully perform scientific and statistical analyses based on collected health data without first having obtained the consent of data subjects. Since the data subjects have practically no influence on how the Danish Medicines Agency processes their data as part of the concrete analyses, it is crucial that they can trust that their personal data are being processed properly. To ensure the public can trust that the Danish Medicines Agency fulfils its responsibilities, an analytical team must declare that they have followed the principles of this charter before starting any analysis. The director general of the Danish Medicines Agency bears ultimate responsibility for ensuring that the agency follows the principles of data ethics.
2. Fairness: The mission of the Danish Medicines Agency is to: create value for people, animals and society through “efficient, safe and available medicines and safe medical devices”. Most likely all of us will need medicines or medical devices at some point in our lives, and therefore the analyses of the Danish Medicines Agency will benefit the wider public. The analyses will contribute to the improvement of existing medicines and treatment options and will also support the development of medicines and medical devices. Companies will also benefit from the analyses because they can support the commercial development of medicines and medical devices. The Danish Medicines Agency must ensure a fair balance between the rights of data subjects, on one hand, and the good of the community, on the other.
3. Equality: The Danish Medicines Agency will ensure that different groups are treated equally in all aspects of its work. The agency will endeavour to ensure that the analyses and algorithms applied do not reproduce prejudice or discriminate against certain populations. The agency will also endeavour to promote analytical work that targets rare diseases and neglected patient populations, e.g. children and pregnant women and others.
4. Accountability: The Danish Medicines Agency works systematically to ensure it complies with its obligations under data protection legislation, including maintaining high IT security standards, and that it observes this charter. The aim is to ensure that the persons about whom we hold data (the data subjects) can have absolute trust in the safety of our work. In this connection, we must ensure confidentiality of the health data of each individual to make sure that no one in any way has information about their health compromised through the fault of the Danish Medicines Agency.
5. Transparency and explainability: The Danish Medicines Agency must at any time endeavour to ensure transparency and explainability of its prioritisations and data analyses. This is especially important for the use of artificial intelligence because confidence in artificial intelligence – and in the Danish Medicines Agency as an organisation – is fully dependent on analysis results that can be explained and reproduced. The Danish Medicines Agency will keep abreast of the development on how to ensure transparency in the use of artificial intelligence and seek to implement best practice in its working procedures.
6. Diversity: The Danish Medicines Agency must contribute to beneficial data application developments in society to promote public health in an ethically acceptable manner. The Danish Medicines Agency will therefore endeavour to ensure that analytical teams reflect society as a whole and as far as possible consist of people from different professions of different gender, age and ethnic origin.
7. Global perspective – and responsibility: Data flow between countries and many of the challenges with data ethics have to do with cross-border concerns. The Danish Medicines Agency will work actively to ensure the widest possible dissemination of its principles of data ethics as specified in this charter among relevant European and global forums.