Putting patients at the centre of research projects is a long-standing priority for the European Patients’ Forum (EPF) and its membership, and is a pillar of the vision of the organisation.
EPF has been participating in projects of various shapes and forms for more than a decade now and our credo has always been to represent patients as meaningful partners, with co-deciding roles and strategic positions in the governing bodies.
Governance and Ethics
The economic crisis had a massive impact on budgets of EU Member States, including budgets for research and public health projects.
This new situation accelerated the development of public-private partnership (PPP) funding mechanisms in research, a cooperation arrangement between two or more public and private actors, putting together resources for potential projects.
PPPs can offer a sustainable alternative to research funding.
By leveraging larger resources, it enables more projects to be funded or continued and allows initiatives to grow with stability.
However, their complex and hybrid funding mechanism require a sound and serious budget management, with proper in-house checks and controls process while retaining flexibility and trust for the participants of the potential project.
This is where governance and ethics play an important role. We believe a true and mature partnership can only be achieved through solid and transparent governance measures and a strong ethical culture between all partners.
The European Patients Academy on Therapeutic Innovation – EUPATI project, for instance, offers a good example of a clear and genuine ethical governing structure.
This patient-led academy leads an ambitious programme to develop educational material, training courses and a public Internet library to educate patient representatives and the lay public about all processes involved in medicines development, with a current focus on training courses and expert meetings.
Under the framework programme of EPF, EUPATI brings more than 30 partners from academia, civil society, patient organisations and phar- maceutical industry together.
The governance principle of EUPATI sees an Executive Board comprising two representative of each stakeholder involved in the PPP with equal voting rights: patient organisations, NGOs & Academia, pharmaceutical industry, and the EUPATI National Platforms Network (national level PPPs replicating the EUPATI model)This ensures patient organisations are involved in all strategic decisions of the programme, with equal rights when it comes to steering the wheel in one direction or another.
However, a balanced and democratic governance structure is only one part of the equation. Having in place a strong ethics policy is another essential component of a well-organised PPP.
The EUPATI Ethical Framework establishes the core ethical principles to which all EUPATI Consortium members, as well as the members of sub-committees, are required to adhere to.
The elaboration of this EUPATI Ethical Framework was provided under the IMI project which established the EUPATI Programme by the EUPATI Ethics Panel (2 co- leaders from academia and a patient deputy co-leader).
The core remit of the EUPATI Ethics Panel was to provide the infrastructure and access to the required intelligence and genuine expertise in ethics and law as pertains to the medicines development processes and patient advocacy.
It advised the Project Steering Committee, Executive Committee and Work Packages on ethical aspects of the project, including conflicts of interest, including – amongst others:
› Interaction and communication within the Consortium;
› Generation and dissemination of infor- mation to patients;
› Communication within the EUPATI Network;
› Communication to patients and public at large.
Adherence to the EUPATI Code of Conduct by all EUPATI members ensures trustful and successful execution and completion of the project. The EUPATI Code of Conduct was collated with reference to:
› WMA Declaration of Helsinki, 2008 and 2011;
› CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects;
› EMA Policy on the handling of conflicts of interests of scientific committee members and experts, April 2012.
The ‘EUPATI Code of Conduct’ outlines the working culture and spirit of “assumed good intent” within the Project Consortium, while the ‘Ethical Framework’ outlines the ethical ground rules of the project.
Members of the ethics panel and advisory network continue to offer guidance to the EUPATI Programme since it was established as a permanent programme under EPF in April 2017.
We believe governance and ethics are critical success factors for a PPP to achieve its goals,
whilst maintaining the credibility, quality and resonance of their work, will be the strength of the collaboration between the partners and the creation of an environment and working culture for each of them to contribute in a constructive, productive way, and in a spirit of respect and dynamism.
The European Patients’ Forum (EPF) is an umbrella organisation that works with patients’ groups in public health and health advocacy across Europe.
Our 74 members represent specific chronic disease groups at EU level or are national coalitions of patients. EPF reflects the voice of an estimated 150 million patients affected by various chronic diseases throughout Europe.
More information: www.eu-patient.eu – firstname.lastname@example.org