Trial lecture - time and Place
Adjudication committee
- Professor Christoffer Eriksen, University of Oslo (leader)
- Professor Ragna Aarli, University of Bergen (1. opponent)
- Professor Anna-Sara Lind, Uppsala University (2. opponent)
Chair of defence
Supervisors
Summary
- A medical revolution and a legal paradigm shift?
This thesis analyses the legal regulation of genetic mapping as one aspect of health care in patient pathways. Health care is more precisely defined in the law.
Genetic mapping means that the whole genome is examined in order to make diagnoses and provide suitable health care based on the patient’s genetics. Genetic mapping is described by the health authorities as being a medical revolution because of the increased opportunities it provides for being able to treat cancer, rare diagnoses and infectious diseases, adapted to suit individual genetics. 1
At the same time it creates competition in respect of services, results in differences in the treatments offered and means that more people acquire knowledge about their own genetics and those of others. Can these changes result in a paradigm shift in legal perspectives?
- Integrity and autonomy perspectives as a recurring theme
Genetic mapping challenges various aspects of integrity protection due to the legal liabilities which relate to diagnostics and uncertainty about the results which might be produced by mapping. As indicated by the title, integrity – and autonomy －are recurring themes in this thesis. Integrity comprises physical integrity and protection against damage resulting from health care or the fact that ineffective treatment methods are used.
It can also comprise other damage when individuals receive information about their own or others’ risks of contracting illnesses, as well as intervention in people’s private lives. Autonomy is associated with voluntariness and self-determination in respect of questions about whether or not the genome should be mapped, information about the results of examinations and other handling of mapping results. Questions arise about whether or not patients can protect themselves against information and at the same time provide valid consent to health care based on genetic findings.
Genetic mapping is assessed in this thesis as having a significant impact on integrity and as being necessary for being able to offer effective treatment. The various aspects of patient pathways can provide different perspectives on integrity protection and autonomy, and it can be difficult to draw clear dividing lines. In the same way rights and obligations are largely “reflected”.
Another characteristic is that genetic mapping affects more people than those who are analysed, including others with common genetics. The nature of such intervention is important for when genetic mapping can be used and whether or not it can involve an entitlement to undertake genetic mapping as a treatment method. It is also important in respect of information rights, for protecting oneself against information and for how genetic material can be used.
- Genetic mapping as justifiable and essential health care: some findings
This thesis assesses whether or not genetic mapping can, on given premises, be comprised by the right to receive essential health care and “equality norms” which are expressed in several sources of law. The relationship between the entitlement to receive essential health care and human rights is analysed in the thesis. Among other things it comprises obligations to make use of new medical knowledge when offering health services to the public. The thesis analyses whether or not an entitlement to receive essential health care can go beyond legislative criteria and comprise preventative intervention and clinical trials. Questions are raised about whether or not the contents of rights and obligations are changed when patient pathways are changed as a result of how genetic mapping is used.
The professional standards obligation and personal responsibility for health care personnel are referred to as being a “mainstay” in health legislation, being designed to reduce the risks for patients. With genetic mapping health care providers will be responsible for making more decisions due to dependence on medical equipment and ICT. The professional standards obligation will comprise the interpretation of genetic data and opportunities for checking indeterminate variants, and provide health care providers with increased responsibilities in respect of making adjustments. Boosting responsibilities in respect of system decisions is discussed, along with the relationship between system responsibility for patient security and the processing of genetic data, and between system responsibilities and the responsibilities of health care personnel.
Questions are also raised about how genetic material can/should be stored, protected and shared in the health service. The obligation to document genetic data for the purpose of providing individual patients with health care is assessed as being too restrictive for being able to comply with professional standards in respect of genetic mapping. The thesis discusses whether or not conditions can be stipulated for providing genetic data in connection with offers relating to genetic mapping, and whether or not new consent schemes could resolve the challenges relating to the storage and processing of genetic data.
The thesis formulates new terms and concepts which are based on the rules designed to establish integrity protection. Several legislative amendments are proposed, e.g. for developing new consent schemes, and an approval scheme for health care providers who can offer genetic mapping.
- Legislation, human rights and values
The thesis analyses the connections between the legal standards which are used in health legislation, and human rights and values, in the past and present, and how such values can be weighed up when they collide (collectively and individually). As regards questions relating to protection and the use of genetic data and biological material, reference is made to the connections and differences between human rights protection, GDPR and the confidentiality of health care personnel.
The thesis examines the relationship between medical technology and values, and between medical technology and the formulation of legislation. These analyses conclude by pointing out both the risks and benefits of the introduction of genetic mapping. The formulation of legislation, the use of legal standards and connections with other sources of law are highlighted as aresult of the fact that rapid developments are taking place in respect of medical technology at a different pace to the legislative ones. At the same time uncertainty can be created about how medical technology is regulated when it produces different effects to those assessed by the legislators.
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[1] https://helsedirektoratet.no/Lists/Publikasjoner/Attachments/1192/Nasjonal%20strategi%20for%20persontilpasset%20medisin%20i%20helsetjenesten%20IS-2446.pdf