ppp-guidelines_20211130_published.pdf
Ethical health data sharing in public-private partnerships
Guidelines
1. Partners must define an aligned vision for the PPP and how they create public value. 2. Partners should determine and agree upon fair distribution of benefits among themselves as well as with the public. 3. Partners must clearly define IP rights on outcomes at the start of a PPP, and not seek to patent or claim IP rights on data sets generated through Swiss Personalized Health Network (SPHN) funding. 4. SPHN-funded grantees should not negotiate exclusive use of data with private sector entities. 5. Data subjects should be informed about PPPs which utilize their data. 6. Partners should define how they plan to engage data subjects in the research activities enabled by the PPP. 7. All partners should agree on criteria to ensure due credit to the parties who provide the data, as well as to SPHN for funding the research activities leading to data collection. 8. After the PPP, partners should make data available for further public value, via deposit in public repositories with appropriate access controls.
Preamble
Purpose of this document
This document provides guidance for SPHN-funded grantees and private sector entities (together: the PPP partners) who intend to negotiate and establish public-private partnerships (PPPs), primarily for the purpose of accessing data generated, collected, or curated in the context of a SPHN-funded research project. This could include among others molecular / omics data, patient data from hospitals and clinics, or clinical research data. With these guidelines, SPHN aims to support the negotiation of ethically robust and fair conditions for such PPPs. The types of data referred to in this document are those generated or used within the context of SPHN-funded research, but not yet shared within a PPP. Finally, a reminder that clinical data generated in health contexts (e.g., medical history, treatment data) is governed by regulations beyond those specific to a research setting, that must also be taken into account.
This document seeks to support parties during the negotiation phase and is intended to supplement legal agreements. Templates for legal agreements which are suitable for PPPs can be found on the SPHN Website (https://sphn.ch/services/dtua/). SPHN-funded grantees must follow these guidelines when entering PPPs. Upon the completion of a PPP agreement involving SPHN data, the parties must report to the SPHN Management Office the specifics of how they met the guidelines. The term “data” in this document refers to data generated, collected, or curated in the context of an SPHN-funded research project.
SPHN’s mission and the need for private sector collaboration
SPHN’s objective is to advance personalized health research and innovation for the benefit of society. To leverage the potential of health-related data, SPHN is building a dynamic, scalable network of data providers who will establish a nationwide exchange of health-related data and oversee its effective use. As using and sharing data generates benefits for society, SPHN encourages its grantees to share data resulting from SPHN-funded initiatives with other organizations to further research and innovation in personalized health.
SPHN encourages collaboration between private and public entities, as these collaborations can lead to unique innovations and research, and thus further SPHN’s mission. Private and public entities have access to distinct, yet highly synergistic resources. Public parties have access to unique research data, bring scientific and medical expertise, and follow a public
mandate. Thus they enjoy public trust, and can function as custodians of the public’s interests and data. Corporate entities understand market needs, have drug and product development capabilities, and are responsible for a considerable share of health product/service delivery.
SPHN considers data generated through its funds to be a common good, which is nonexcludable and non-rivalrous (Malkin & Wildavsky, 1991), and which aims to ultimately benefit the public. Such data should be made broadly accessible to all eligible parties.
In order to share SPHN-funded data with private sector companies, several requirements must be met. SPHN is committed to a clear set of ethical principles which should be upheld (see below and Ethical Framework on Responsible Data Processing in Personalized Health Research issued by SPHN, 20181. Furthermore, SPHN-funded grantees receive public funds, both from SPHN and other resources. Private entities, in addition to prioritizing knowledge, are motivated by their fiduciary responsibility to generate a profit. These priorities are not necessarily at odds, but rather can serve the interest of the community to deepen scientific knowledge and improve medical treatments. If the interest of the community is at the heart of the PPP, profit-making interests should not be an argument against collaboration with private entities. However, the success of these PPP will depend on transparency, data fairness, and recognition of the contribution of those who made their data available for research.
PPPs are defined as “collaborative models based on a contractual agreement between (a) at least one not-for-profit organization and (b) at least one for-profit organization” (Stevens et al., 2013). PPPs combine the assets and strengths of for-profit and not-for-profit organizations. Examples of not-for-profit organizations include public-sector institutions, (inter)governmental agencies or civil society bodies, non-governmental organizations, and academia. For-profit organizations in the SPHN domain include pharmaceutical, medical device, biotechnology, and other technology-related companies.
In the context of the SPHN, PPPs must jointly define issues regarding access to resources, accountability, transparency, conflicts of interest, and intellectual property. PPPs can be
https://sphn.ch/network/projects/elsi-projects/
established as collaborations for specific projects or as long-term partnerships, both bi-lateral and multi-lateral.
Challenges in public-private collaboration
Data sharing between public and private entities presents challenges that must be balanced against expected benefits and opportunities. These challenges relate to aligning the objectives of the PPP and addressing priorities which may diverge (e.g., applicability vs. basic research), distributing benefits fairly, minimizing and acknowledging conflicts of interest, making data widely accessible, giving credit to data providers, maintaining and fostering public trust, obtaining informed consent about data use, and engaging those whose data are used, as well as acting transparently and accountably. When these challenges are tackled accordingly, PPPs can promote ethical data sharing in line with SPHN’s mission. The eight guidelines of this document set out how these challenges should be addressed.
Foundational SPHN principles
The following guidelines seek to ensure that PPPs which involve SPHN trustees or SPHNsponsored projects comply with the principles outlined in the Ethical Framework for Responsible Data Processing (SPHN, 2018). This Ethical Framework provides guidance on issues relating to collecting, storing, analyzing, and sharing data for SPHN-funded research, and is built on four principles:
− Respect for persons: The rights and dignity of individuals, families, and communities contributing personal data and/or human biological material in the context of research and clinical care, as well as any other type of data that can be useful for biomedical research, must be respected, protected, and promoted. − Privacy: The privacy of data subjects and the confidentiality of their personal information must be safeguarded. − Data fairness: Research data and results should be made available for further research use, to advance the common good of scientific knowledge. − Accountability: Accountability mechanisms should ensure fair, lawful, and transparent processing of personal data and handling of human biological material.
Recommendations Based on these four principles and informed by the outcomes of stakeholder engagement sessions, the ELSI advisory group has developed eight ethical recommendations for SPHNfunded grantees entering PPPs. A list of meeting attendees and workshop objectives are provided in the Appendix.