Amid growing public concerns, bioscience firms begin formalizing ethical decision-making practices

Five interrelated approaches in use at 13 firms today show way for others in the industry

Pharmaceutical, biotechnology and bio-agricultural companies, grappling with an array of complex ethical issues, are gradually formalizing systematic approaches to ethical decision-making, according to a two-year study by leading international ethics and bioscience researchers.

Bioscience companies operations pose many ethical dilemmas. They produce and sell genetically modified foods, conduct gene therapy experiments and embryonic stem cell research to produce new therapies, use animals to test new pharmaceuticals, manipulate life'TMs building blocks, create transgenic animals to produce drugs, commercialize genetic and biological materials, compile and use personal genetic information, and set drug prices for domestic and developing country markets.

Companies of all sizes and in all sectors, faced with growing questions and concerns, are recognizing and acting on public pressure to demonstrate business methods that are not just legal but ethical too, according to research conducted jointly by the Joint Centre for Bioethics (JCB) at the University of Toronto, the Keck Graduate Institute of Applied Life Sciences (Claremont CA), Stanford University (Palo Alto, CA), and l'TMUniversite de Montreal.

More than 100 in-depth interviews with managers and top executives at 13 diverse bioscience firms, large and small, all with reputations for developing new approaches, were conducted to capture and summarize the way the industry innovators today address ethical challenges. The research represents some of the first empirical evidence of how bioscience companies are dealing with ethical issues now, establishing a constructive starting point on which to build.

The research results are newly published in the book Bioindustry Ethics (Elsevier Academic Press), with a summary (and accompanying editorial) published today by PLOS Medicine, the paper entitled "Lessons on Ethical Decision Making from the Bioscience Industry." The research will also be disseminated at and discussed with delegates to the annual international convention of the Biotechnology Industry Association in Chicago April 9-12 (www.bio.org).

"Because they operate near the cutting edge of scientific research and development, with processes and products that are often controversial, the ethical commitment of bioscience companies is regularly called into question," says Jocelyn Mackie, who led the JCB investigation.

"Our analysis uncovered five interrelated approaches, each with several mechanisms, used to address ethical issues. The case studies show how bioscience companies have reacted constructively to pressure from regulators and consumers and begun the process of internalizing principles to the point where they are an integral part of day-to-day decision-making," she says.

Each case provides a detailed examination of the company, the ethical issues faced, and the mechanisms being used to address them.

Says Peter A. Singer, MD, JCB Director and a report co-author: "For bioscience companies, the choice is clear: Pay serious attention to ethics now and lead the way, or be pushed along the path later. Either way the final result will be similar."

He notes that bioscience industries are at a stage in their evolution similar to that of medical profession in the 1970s '" a time when public pressure about patients'TM rights forced a new approach to be taken and precipitated the formal consideration of ethics in decision-making processes, ideas now long assimilated in medical schools and hospitals.

"Doctors were seen as too paternalistic; patients wanted more say in their treatment and this pressure helped formalize the field of bioethics," says Dr. Singer. "In a parallel way, pressure on the bioscience industry has caused it to think through how to internalize and institutionalize a decision-making process that reflects high ethical standards.

"After two decades of medical ethics and bioethics, we are at the dawn of an era in bioindustry ethics. The focus here is not hospitals and medical schools but bioscience companies. What we know from medical ethics is that for ethics to stick, it needs to be embraced and internalized by leaders and penetrate to all reaches of an organization. The way to do this is to identify good practices and build upon them. Our study takes the first step."

"Based on our findings, a company of any size can start with strong ethical leadership and seek external ethics expertise early on. Internal ethics mechanisms and external ethics engagement mechanisms are other approaches that a bioscience company of any size can implement," says Prof. David Finegold of the Keck Graduate Institute of Applied Life Sciences, who led the project overall.

"Larger companies in the study developed ethics evaluation and reporting mechanisms to keep themselves on track, to encourage management and to monitor the outcomes of their ethical decision making."

He says the five mechanisms identified through this research demonstrate ways in which management throughout the bioscience industry can begin to address complex ethical issues facing their companies. They are:

Ethical leadership: Often such leadership is driven by a commitment of the company'TMs founder or CEO, then reinforced by executives, the researchers found. In larger companies, whole departments are dedicated to ethical issues; one such firm has divisions that drive and monitor its "triple bottom line" (social, environmental, financial) and a Bioethics Director focused on environmental, human and animal-related issues.

External expertise: Several companies used external consultants to provide ethics expertise not available internally. Others formed Ethics Advisory Boards composed of outside members representing medicine, law, religion and ethics, to provide guidance on specific issues.

Internal ethics mechanisms: Some companies now weigh candidates'TM values when hiring. Others have incorporated ethics into employee performance reviews. Many have developed formal and informal ethics education and discussion forums and all companies use techniques to reinforce ethics within the company.

External ethics engagement: More than half of the companies studied require business partners to match their ethical approaches. One firm requires suppliers to complete a social / environmental questionnaire and works with any supplier violating any of the company'TMs standards to improve its performance. Most firms in the study are engaged in open, transparent exchanges with external stakeholders on ethical issues. One invited animal welfare activists to tour its laboratories and discuss potential solutions to their differences. Another firm with plans to build a genetically modified pig farm held a public meeting to educate community residents about their science and answer questions (the company committed to finding another location if residents decided they did not want the farm there). One launched a corporate philanthropy programme in Africa.

Ethics evaluation and reporting mechanisms: A few companies studied have formalized the way they evaluate and report to stakeholders on their ethical commitments. However, findings in this area demonstrate a need for considerable work in the field of ethics evaluation mechanisms.

"There are many good reasons why bioscience companies are working so hard to improve their ethical performance," says report co-author Abdallah S. Daar, MD, Director of Ethics and Policy at the McLaughlin Centre for Molecular Medicine, University of Toronto.

"In the current climate of public distrust, companies not only want to do the right thing, they also want to be seen to be doing the right thing. The research shows ethics are essential to the reputation and bottom line of a bioscience corporation. Adherence to sound ethical principles can also help to guide companies through the uncharted waters of scientific research and development and, in the end, can only help to promote good science."

According to co-author Andrew Taylor, the five mutually-reinforcing approaches identified provide insight and ideas on how other bioscience companies could implement mechanisms in their firms to address their own ethical issues. Among issues yet to be studied are the effectiveness of these mechanisms in achieving ethical decisions, and the influence these mechanisms have on investment and marketing decisions, he noted.

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Principal funding for the study came from Genome Canada through the Ontario Genomics Institute and the Ontario Research and Development Challenge Fund and a non-profit foundation, the Seaver Institute of Los Angeles, California. Matching funding information is online at www.geneticsethics.net

University of Toronto Joint Centre for Bioethics
Innovative. Interdisciplinary. International. Improving health care through bioethics. The JCB is a partnership among the University of Toronto and 15 health care organizations. It provides leadership in bioethics research, education, and clinical activities. Its vision is to be a model of interdisciplinary collaboration in order to create new knowledge and improve practices with respect to bioethics. The JCB does not advocate positions on specific issues, although its individual members may do so. For more information: http://www.utoronto.ca/jcb/

Keck Graduate Institute (KGI), member of the Claremont Colleges
Developing Leaders for the Life Science Industry
KGI integrates science, business and ethics to prepare scientists and engineers to assume leadership roles in the life science industry and to conduct applied research that translates the promise of the life sciences into reality. For more information: www.kgi.edu. Study contact: david_finegold@kgi.edu.


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