New Health Collaboration Touts Ethics, Aims To Put Patients First

Several health care organisations this week signed a “consensus framework” for ethical collaboration between patients’ organisations, healthcare professionals, and the pharmaceutical industry.

The International Alliance of Patients’ Organizations (IAPO), the International Council of Nurses (ICN), the International Federation of Pharmaceutical Manufacturers (IFPMA), the International Pharmaceutical Federation (FIP), and the World Medical Association (WMA), joined together to form a set of principles, the first of which is “putting patients first,” according to the speakers at the 20 January launch of the framework in Geneva.

Other principles of the consensus framework are supporting ethical research and innovation, ensuring independence and ethical conduct, and promoting transparency and accountability.

Joanna Groves, for the IAPO, said discussions among the group started in 2011. The main aim was to capture shared values to meet patients’ needs and advance ethical interaction between the members of the group to improve global health, she said. According to the consensus framework, it “outlines some of the key areas that should be considered by all partners to help guide ethical collaborations at the individual and organisational levels.”

The framework will complement various existing codes, she said, and does not constitute a single common policy for the co-signatory organisations. She also invited comments on what she described as a “living document” open to other stakeholders.

The WMA said healthcare has been increasingly effective and has become more complex, thus requiring a high degree of cooperation between the co-signatories. Trust and confidence by patients is also key, said Otmar Kloiber, the WMA secretary general. Innovation is indispensable to finding cures for many incurable diseases and avoiding much suffering, he said. To provide answers, health professionals, beyond cooperation between themselves, need the cooperation of the industry.

Russell Williams, chair of the IFPMA Code Compliance Network and president of Research and Development Canada, said good ethics is good business. “Corporate citizenship is the commitment to public trust,” he said, adding that the pharmaceutical industry is “dedicated” to helping people to live longer, healthier and more productive lives. The consensus framework is an occasion to build trust with our partners, he added.

Edward Kelley, director of the World Health Organization Department of Service Delivery and Safety, said the consensus framework addresses concerns in line with WHO’s commitment to put patients first. He welcomed the initiative and encourage co-signatories to “really walk the talk.”

Ethical Conduct of Clinical Trials

The nongovernmental Berne Declaration recently published a document entitled, “Clinical trials: human guinea-pigs on the cheap” [pdf] in which it said that industry-sponsored offshore clinical drug trials in developing countries involve ethical violations, based on their investigations (IPW, Public Health, 17 December 2013).

Asked whether the consensus framework could work to address concerns about the ethics of clinical trials in developing countries, Peter Shelby, IFPMA associate director for communications, told Intellectual Property Watch that “the Consensus Framework for Ethical Collaboration encourages ethical conduct of clinical research and sends an important message on behalf of patients, industry, pharmacists, nurses, and physicians, that illegal or unethical practices are not tolerated. In addition, the IFPMA Code of Practice prohibits unethical conduct of clinical research.”

“The purpose of these five global organisations collaborating on this framework is to promote high quality patient care and their shared principles. This can only be achieved by providing patients and healthcare providers with the best and most appropriate information and treatments, both of which rely on adherence high ethical standards,” he added.

Civil Society Hopeful

Asked about the initiative, Manica Balasegaram, executive director of the Médecins Sans Frontières Access Campaign, told Intellectual Property Watch that the consensus framework is broadly welcome. However, she said, it is largely voluntary and self-enforcing.

“Disclosure of clinical trial data, including negative data, is essential to ensure that there is full benefit arising from voluntary participation,” Balasegraram said. While compensation is important, it is also essential that it is not designed in a way that may compromise scientific integrity, she added.

“Scientific research should also not be just based on valid scientific principles but on public health needs and gaps, which should be prioritised. There should be incentives put in place to ensure this,” she said.

According to the IFPMA, the consensus framework “aims to serve as a model for similar collective initiatives at national level which would complement individual guidelines, policies and codes and lead to a better understanding among all stakeholders about common values of interactions.”