Opinion Uncategorized #BTColumn – Bioethics in a Barbadian pharmaceutical industry Barbados Today19/11/20220714 views Biopharmaceuticals require deft and aware management to navigate what can be many bioethical pitfalls, some of which vary in ways specific to a country. Disclaimer: The views and opinions expressed by the author(s) do not represent the official position of Barbados TODAY. By Melissa A. Goddard PhD Just in October, the Minister of Education, Technological and Vocational Training accepted responsibility for a survey that allegedly collected sensitive and identifying information from school-aged children without the informed consent and permission of parents or guardians. In many places, similar incidents are seen as major bioethical violations; the Nuremberg Code highlights the need for consent without coercion, omission or deception. Yet up to the time of this writing, no penalty has been reported for those responsible. Now plans to develop a pharmaceutical industry in Barbados have been announced, with a stated focus on mRNA-derived products. This means entering the complicated realm of what are known as biopharmaceuticals or biotherapeutics—products with a biological source like cells, genetic material, or blood. Given this source, biopharmaceuticals require deft and aware management to navigate what can be many bioethical pitfalls, some of which vary in ways specific to a country. It is not as simple as ticking off regulatory checkmarks for manufacturing, or finding jobs for some students, and Ethics Committees are not designed to handle this burden alone. Indeed, Cuba’s decades-strong foothold in pharmaceuticals in the region has lasted to bear good fruit because they developed supportive and culturally appropriate regulatory and research systems. Barbados cannot expect to establish a reputable pharmaceutical industry if local leadership is opaque about its regulatory planning, or refuses to enforce protections if violations occur. Safety, efficacy and transparency must be foundational parts of this process. Especially with biotherapeutics, where there is as much risk as there is promise. This cannot be about name dropping, or political support, loyalty and reputation. Instead, policymakers should put aside ego, celebrity and personal feeling and do what is necessary for the Barbadian people—our needs, our goals, and our development. There are standards that must be transparently set and enforced at the government level, and systems based on our unique situation should be in place—from bench-top to clinic—well before the first interest is signed on. We need Barbadian voices at the table who know biopharmaceutical development and know it well. We need Bajans at the table who understand the existing resources and how to bring those into the 21st century in a way that is best for independent Barbados, not America, Europe or Africa, and that does not recreate our colonial patterns even incidentally. We need Bajans at the table who are familiar with the history of biotherapeutics and the lessons you have to learn to work safely in that space. And we already have those Bajans. Over the last couple decades, Barbados has invested millions in training a number of professionals who should meet these criteria. Policymakers just have to get better at including these experts and their recommendations, rather than approaching them as political inconveniences to be co-opted or dismissed. Barbados has the bones to become a biomedical powerhouse, but it is exactly this that leaves us vulnerable, should we misstep. That should have been learned back in the early 2000s with the Vita Nova stem cell incident, but that seems to have been lost in the recent survey situation. Leadership should ensure that any pharmaceutical industry they tout has a strong bioethical and regulatory foundation, one built on the guidance of Barbadian expertise. Or they risk squandering all of our potential for empty, distracting boasting. Melissa A. Goddard PhD, Physiology & Pharmacology (Regenerative Medicine) Molecular Biology & Genetics. She is an an independent biomedical researcher. This column was offered as a Letter to the Editor.