Governance of the Collection, Access and Use of Human Genetic Information for Precision Medicine
Precision medicine is an emerging field for disease diagnostic, prevention and treatment, which takes into account individual variability in genes, environment and lifestyle. The genomic revolution and health-related big-data are combining and revolutionizing health care to create therapies that are fundamentally personalised and with improved health outcome. However, the development of precision medicine challenges the health and medical sector at large. Existing rules for clinical trials, establishing safety, efficacy and cost-effectiveness of treatments need to be adapted or revised. Relationships between patients, medical professionals, and other actors are getting very complex. New actors are offering genetic testing and diagnostic services, and expectations for better health are increasing in societies, however before the health systems (and related social systems) have been able to adapt or transform. Security and privacy risks, as well as the potential for discrimination, are also cause of concern.
Precision medicine is expected to deliver numerous benefits to society, and the conditions under which this can be achieved are developing progressively. Various countries have different cultures and approaches to it, often supported by important governmental initiatives.
On this topic, IRGC aims to help society, decision-makers and researchers find the best way to move forward collaboratively.
As part of this project, IRGC published a roadmap for the development of precision medicine, 2017. It recommends key elements to consider in the development of national and multi-stakeholder initiatives for data-driven personalised medicine that would:
- Work to create favorable context conditions by engaging early with the medical sector, industry, citizens, patients, regulators and payers
- Implement precision medicine in stages, depending on the level of certainty of the science and on cost
- Address data issues, regarding type and quality, consent, privacy and confidentiality, sharing and interoperability, and biobanks
- Plan to reform regulation, with a view to make space for planned adaptive authorisation and performance-based reimbursement
On 23-24 November 2017, IRGC organised a workshop on ‘Trust in precision medicine’. The workshop discussed how trustworthiness in actors and processes can create favourable context conditions to the development of precision medicine, by overcoming specific sources of resistance, especially those from citizens, the medical sector or regulators and payers
Workshop report: Governance of trust in precision medicine, 2018
In 2018, IRGC continues its commitment to support those who work to improve healthcare in society and address potential new challenges that may come during the process. A multi-stakeholder workshop on the ‘Economics of precision medicine’ was organised at Campus Biotech in Geneva, on 12-13 April. Issues of cost-effectiveness were addressed, as well as the need to revise how economic and social value can be valorised and financed, and to develop new business models for fundamentally personalised gene therapies with high up-front costs.
Workshop report: The economics of precision medicine, 2018
IRGC will continue work on precision medicine in 2019, focusing on ways to create value in health and precision medicine, with innovative approaches that go beyond narrow and restrictive decision modes based on short-term cost-effectiveness. However, this requires addressing certain economic and other risks, with which the medical sector is not familiar.
- Creating value in health, winter 2019
- Expert workshop The economics of precision medicine, Geneva, April 2018
- Expert workshop Trust in Precision Medicine, Geneva, November 2017, with support of the Swiss Personalized Health Network (SPHN) and the Swiss Secretariat for Education and Research (SERI). In April 2018, IRGC published the workshop report: Governance of trust in precision medicine
- Expert workshop Governance of Impacts of Precision Medicine, in the context of the Health 2030 Symposium Personalized Health in the Digital Age, Geneva, September 2016, organised by the EPFL International Risk Governance Center
- Dedicated session Adaptive Risk Governance in Precision Medicine at the Planned Adaptive Risk Regulation conference, London, January 2016
- Exploratory workshop on the Collection and Use of Human Genetic Information for Precision Medicine, Beijing, August 2015
The economics of precision medicine, (Workshop report, 2018)
Governance of trust in precision medicine, (Workshop report, 2018)
Roadmap for Precision Medicine (Policy Brief, 2017)
Collection and Use of Human Genetic Information for Precision Medicine (Workshop Highlights, 2015)