The November 14, 2012, Lab seminar was led by Edmond J. Safra Lab Fellow, Jennifer Miller. During her fellowship, Jennifer will explore the possibility of addressing prominent ethical concerns and trust gaps in the pharmaceutical industry through a number of reform strategies, particularly policy amendments and a third party ethics accreditation or rating system.
This will involve first mapping the prominent bioethical concerns challenging the industry. Second, she will develop a set of ethics standards that can be reasonably asked of companies to address the ethics concerns. Third, she will measure the prevalence of the perceived ethics concerns in companies, today. Finally, she will calibrate a scoring system for the results of the prevalence studies to be built into a rating system that she will pilot. The results of her field studies will help nuance understandings of the root causes and actual pervasiveness of ethics challenges within the industry. They will also speak to the efficacy of using transparency, naming and shaming, and co-regulatory strategies to improve behaviors within companies.
Jennifer began the seminar with a presentation introducing her pilot third party "ethics accreditation" program for pharmaceutical companies. She explained how the accreditation program could work. If using methods similar to how schools are accredited, the program would first provide a drug company with a comprehensive self-assessment, followed by an onsite interview process, and then eventually an up down vote by an accreditation council. For those companies that fail to gain the council's approval, the accrediting agency would supply the company with a robust report citing specific deficiencies and detailing areas needing improvement. At this point in the presentation, Lab participants were curious about the incentives that might exist for pharmaceutical companies to reform corrupt practices and seek accreditation. Jennifer explained the historical reasons accreditation programs have benefited institutions like universities, IRBs and timber companies as well as the diamond and canned tuna industries. For example, accreditation could offer a way for companies to genuinely improve their trustworthiness with the public, increase employee pride within the institution, attract socially conscious investors, and perhaps most importantly, create a network of stakeholders to work together to supplement federal regulations, such as in the case of AAHRPP, the accrediting entity for IRB boards.
From the outset of the presentation, many Lab participants had specific questions concerning state sponsorship of the program and the efficacy of the onsite interview process. When asked if her proposed accreditation program would have any sponsorship by the state, such as through the NIH or FDA, Jennifer indicated that such sponsorship does not exist at the time. However, she agreed that historically many of these types of programs become co-regulatory strategies. Many eventually inform the decision-making of government entities in various capacities. For example, Joint Commission accreditation has been used to qualify a hospital for government funding. Sometimes this is referred to as receiving a "blessing" from a state agency, as it tends to give more legitimacy to accreditation and rating programs.
The conversation then developed into one on economic governance and the delegation of rules and oversight to Congress, regulatory agencies, and at the most local level, the firm. In particular, one participant remarked on the issue of state sponsorship, relating it to the complex task of delegating different layers of oversight to different agencies, such as in the Dodd Frank Act. Another Lab participant voiced her concern about an accrediting entity's ability to collect truthful and reliable information during onsite interviews. She argued that tasks within an institution are often segregated and compartmentalized, and that responsibilities are often split. Considering this, how then, she asked, would an accrediting entity be able to uncover fallacious information? Jennifer remarked that these are all valid question concerns, and that she is specifically working with ethnographers to explore the most efficient and effective methods of inquiry for information gathering. However, she also noted that she would explore developing a system that was based more on public data and fulfillment of outcomes, rather than interviews and reviewing corporate policies.
In summary, Jennifer discussed the guidelines, standards, and structure of her proposed accreditation program for pharmaceutical companies. Lab participants discussed, among other things, competing incentives that an accreditation program might offer to companies, the reliability of information gathered by an accrediting entity, and the efficacy of such a program in an industry as diversified and complex as the pharmaceutical industry. The seminar proved pivotal, as the feedback helped Jennifer discern which model to field test: a rating or accreditation system. Ultimately, she leaned away from accreditation, towards public reporting and rating to both inform stakeholders about the state of specific ethics concerns in companies today and to incentivize companies to address genuine problems.