Putting patients first? Reflections concerning the “Consensus Framework for Ethical Collaboration”
The “Consensus Framework for Ethical Collaboration between Patients’ Organisations, Healthcare Professionals and Pharmaceutical Industry” (1) was signed by five global healthcare organisations in January 2014. These are the International Alliance of Patients’ Organisations (IAPO), the World Medical Association (WMA), the International Council of Nurses (ICN), the International Pharmaceutical Federation (FIP), and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The framework is based on the following principles: (a) putting patients first, (b) supporting ethical research and innovation, (c) ensuring independence and ethical conduct, and (d) promoting transparency and accountability (1). Given that the document is intended to support high-quality patient care, we would like to make the following points with regard to these principles.
- More recognition needs to be given to global health inequity and “structural violence” (2) must be strongly confronted.The organisations’ move to forge partnerships to improve access to healthcare, especially for the most neglected diseases, is commendable, but the achievement of their objective will require the establishment of a fair international pharmaceutical policy (3). If these organisations are seeking to achieve “optimal care for all”, health equity needs to be a priority. Otherwise, it is the patients from developed countries who will come first.
- To support ethical research and innovation, the voice of the patients needs to be heard. The WMA’s Declaration of Helsinki was updated recently. Between 2012 and 2013, four conferences and a public consultation were held in favour of it. The IFPMA made its voice heard at two meetings, but representatives of neither the IAPO, nor other patients’ organisations spoke at those consultations (4).
- While it is laudable to have “ensure independence and ethical conduct” as an overarching principle, the framework needs to be stricter. It is good to place limits on gifts and insist on modest refreshments and meals, but what about the “ghost management”? (5) “What policies might restrain the effects of industry sponsorship?” (5).
- The principles of transparency and accountability are appropriate. The requirements to register clinical trials and publish negative research data, for example, are in keeping with the public interest. However, this principle is not clear on the question of what compensation is to be considered “proportionate with the services provided”?
The five organisations deserve to be congratulated for attempting to put patients first. However, as the framework is a living document, the next step is to clarify the indistinct terms. For example, what exactly is “inappropriate influence”? What is “appropriate care”? What is the “legitimate scientific purpose”?
We assume that the needful can be done to make this new framework serve as an instrument of social justice. Otherwise, it may turn out to be just a rhetorical, if not fallacious, framework.
Fernando Hellmann, Research Ethics Committee. University of Southern Santa Catarina, Palhoça, SC, Brazil; Marta Verdi, Department of Public Health. Federal University of Santa Catarina, Florianópolis, SC, Brazil; Sandra Caponi, Department of Sociology and Political Science. Federal University of Santa Catarina, Florianópolis, SC, Brazil; Bruno Rodolfo Schlemper Junior, Professor at the University of the West of Santa Catarina, Joaçaba, SC, Brazil.
- International Alliance of Patients’ Organisations. Consensus framework for ethical collaboration between patients’ organisations, healthcare professionals and the pharmaceutical industry.Geneva: IFPMA; 2014 Jan [cited 2014 Sep 14]. Available from: http://www.ifpma.org/fileadmin/content/Publication/2014/Consensus_Framework-vF.pdf
- Farmer P. Pathologies of power: health, human rights and the new war on the poor. Berkeley, CA: University of California Press, 2003, pp. 402. Int J Epidemiol. 2005 June; 34(3): 718. doi: 10.1093/ije/dyi095]
- Trouiller P, Olliaro P, Torreele E, Orbinski J, Laing R, Ford N. Drug development for neglected diseases: a deficient market and a public-health policy failure. Lancet. 2002 Jun 22;359(9324):2188-94.
- Schemper Jr BR, Hellmann F. Controvérsias em tempos de mudança na Declaração de Helsinque e a experiência brasileira em ética em pesquisa. In: Caponi S, Verdi M, Helmann F, Brzozowski FS. Medicalização da Vida: ética, Saúde Pública e Indústria Farmacêutica. 2nd edition. Curitiba: Prismas; 2013: vol. 1, pp. 37-66. [Portuguese].
- Sismondo S. How pharmaceutical industry funding affects trial outcomes: causal structures and responses. SocSci Med. 2008 May;66(9):1909-14. doi: 10.1016/j.socscimed.2008.01.010