Help, hope and hype: ethical considerations of human microbiome research and applications
Recent years have witnessed an unprecedented explosion of scientific knowledge and advances in human microbiome research due to the emerging high-throughput molecular technologies. The term human microbiome refers to the population of microorganisms, including bacteria, viruses, fungi and protozoan, and their genetic material that live on and inside the human organisms (skin, mucous membranes, intestinal tract, etc.) (Honey, 2008). A search of the literature at PubMed for the term “microbiome” in the title and abstract illustrates the fast progression of microbiome science. From 2006 to 2010 there were just 304 papers that used the word microbiome in their title and/or abstract, whereas the number has increased to 11,128 from 2011 to 2017. Research on human microbiome, or our second genome, will inevitably bring about dramatic changes in our understanding of ourselves, normalcy, health and illness, and paradigm shift in the management of clinical practice and public health interventions, as well as the production and distribution of commercial products promising health benefits and disease prevention (e.g., individualized diet, probiotics, prebiotics and microbial-based interventions). For example, our commonly used diagnostic criteria for vaginal microbiota wherein the degree of “healthiness” is in part assessed by scoring the abundance of Lactobacillus morphotypes, but one study found a quarter of healthy women do not carry Lactobacillus in their vagina. This research calls for a better understanding of “normal” and “healthy” vaginal ecosystem that is based on its function, rather than simply on its composition (Ma et al., 2012). Another notable example is the increasing application of the new therapeutic modality of fecal microbiota transplantation (FMT), which runs the risk of being perceived as a panacea for a multitude of illnesses and also the risk of abuse, as increasing websites sprung up advertising home DIY FMT kits as a “self-treatment” salvage (Ma et al., 2017). Extreme care must be taken for microbiome-based interventions to be specific in risk-benefit evaluation and indications for application...
The Nagoya Protocol on Access to Genetic Resources and Benefit Sharing: Best practices for users of Lactic Acid Bacteria
Lactic Acid Bacteria (LAB) have great potential to advance human health and therefore see vast applications in pharmaceutical and food industries. Global collaboration and open innovation, where LAB are shared and their genomes are sequenced, are essential for the study and discovery of new underlying probiotic effects. However, recent efforts of the Nagoya Protocol (NP) to the Convention on Biological Diversity have created legal barriers on the access and use of genetic resources (such as LAB). This is to promote conservation and sustainable use of biodiversity, by protecting the rights of local communities and their traditional knowledge. While these objectives are positively supported, industry users of LAB indicate that the legislative burden of the NP can be disproportionally high and therefore hampers knowledge valorization and R&D activities aimed at probiotic innovation. To this end, we set out to explore the implications of the NP for commercial users of LAB by delineating best practice solutions for the probiotic industry. We also review the innovation barriers associated with the default implementation of the NP and express the need for a multilateral system in which a set of standardized rules for efficient access to LAB are agreed between ratifying parties.