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Balancing Risk and Compassion: Life Sciences Companies Face New Risks from Expanded Access

Pharmaceutical companies operate with a singular objective: bring drugs to market. This is how they profit, how they ensure that their products help the most people, and how they maintain the resources to continue innovating.

The lifecycle of drug development can be complex and onerous, despite improvements to the regulatory approval process over the past several years. Now, a trend sweeping the industry is forcing many pharmaceutical companies to decide under which circumstances they’re willing to divert resources from their mission of helping the masses.

Expanded Access, or “Compassionate Use,” refers to the use of an experimental drug not yet approved by the FDA to treat a critically ill patient outside of a clinical trial. The FDA received more than 1,800 requests for access to experimental drugs last year and, over the last five years, it has approved 99% of these requests.

But ultimately, once requests are approved by the FDA, it’s up to manufacturers to provide the drug to these patients, many of whom are children, and many of whom have just months left to live.

Companies are then faced with a choice: to provide an unapproved drug to individual patients, which can delay the process of making the drug widely available, or to deny the request and risk backlash from the public, who see only a dying patient and the pharmaceutical company that could save them. In several cases, the latter has fueled social media campaigns demonizing companies for withholding potentially life-saving medicines.

How a company handles expanded access requests can affect its reputation and financial stability. Pharmaceutical executives often operate under a microscope, where patient outcomes are the key to keeping investors on board. As expanded access patients often do not qualify for clinical trials, they may be higher-risk candidates, so reporting their results to the FDA could potentially prolong approvals and market availability. On the other hand, a company that denies an expanded access request can face significant reputational damage and even legal action if investors believe that management decisions hindered the company’s progress.

Small and mid-size life science firms in particular may fear that they don’t have the resources to navigate expanded access cases. But requests for experimental drugs are on the rise: the FDA saw a 92% year-over-year increase in requests in 2014. Companies need to prepare their approach and policies before they find themselves in the throes of a difficult decision with pressures mounting from both sides. Here are four ways they can set themselves up to make informed decisions about balancing risk with compassion:

Monitor the Regulatory Environment

Over the last year, the FDA has been working to simplify the process for physicians requesting access to experimental drugs on behalf of patients. In February 2015, the agency streamlined the application form, which now requires physicians to submit just eight types of information, as compared with 26 types in the previous form.

The FDA has also been working with life sciences companies to find alternative solutions to expanded access when needed, such as designing expedited open-label trials for these patients.

Additionally, as of August 2015, 24 states have introduced right-to-try bills, which allow physicians to request experimental drugs without going through the FDA’s application process.

With both federal and state governing bodies paving the way for easier access to experimental drugs, the decision to provide these drugs falls squarely on the shoulders of corporate leadership at pharmaceutical companies. These firms also ought to keep in mind the need to prioritize building and maintaining relationships with the FDA, which can be key in developing a creative solution.

Update Your Crisis Management Plan

Crisis management plans are sometimes written in broad strokes. In preparing for expanded access cases, risk managers need to bring together leadership from various departments—senior management, investor relations, finance, human resources, etc.—to weigh in on the specific risks associated with experimental drugs. Many firms will seek outside counsel to guide the process.

At a basic level, a crisis plan should map out vulnerabilities across all risk areas. For example, companies need to consider the process for securing their facilities, fielding press inquiries, addressing social media backlash, managing investor concerns and navigating potential lawsuits.

Most importantly, companies need to develop the principles that will guide decisions in crisis situations. Rather than scrambling for direction in the heat of public scrutiny, companies should establish a clearly-stated policy and set of guidelines for participation in expanded access programs. This will serve as the foundation of a response if an issue arises. Management must then be prepared to defend that position to all stakeholders, including employees, investors, patients, physicians and potentially press.

Evaluate and Re-evaluate Your Insurance Policies

Organizations need to consider which financial risks they can transfer to their insurance policies. Not everything will be insurable, but a strong policy can provide protection if an expanded access case threatens a company’s financial stability.

This starts with a comprehensive review of a company’s insurance portfolio with the issue of expanded access in mind. Oftentimes, risk managers revisit their policy language through the lens of a specific issue and realize that their expectations for coverage don’t accommodate current events. This can be the case with expanded access.

When reviewing their policies, companies need to understand the intent of the language relevant to expanded access and work with their broker to make sure the coverages are as granular as possible.

Lead the Way

This year, Johnson & Johnson created a Compassionate-Use Advisory Committee composed of doctors, bioethicists and consumer advocates to evaluate expanded access requests and make recommendations to the company’s clinicians. While many have hailed this as a creative solution for maintaining ethical standards, smaller companies with fewer resources cannot as easily take such an approach. These firms have an opportunity to set the standard for managing expanded access cases by developing thoughtful policies, collaborating with regulators and academics and, of course, addressing risks to business from the onset.

Gauging the Impact of Reputational Risk

The following article is part of a continuing blog series that will explore ideas, concepts, discussions, arguments and applications associated with the field of enterprise and strategic risk management.

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In my previous article, I made the point that the public discussion of reputational risk lacks a set of common standards or definitions. This lack of consistency allows organizations to interpret or define the concept of reputational risk in very different ways. For some, reputation is beginning to be viewed as something like the “risk of risks” in the same way people are starting to discuss the concept of the “internet of things.” I questioned whether reputation or brand is actually a risk or a residual event stemming from other extenuating risk domains or actions.

Upon further reflection and discussions with academics and risk professionals who are thinking carefully about this issue, I would go further now to suggest that reputation or brand risk involves perceived or real human behaviors that are, to some extent, measured against societal, economic or moral standards. The adherence or deviation from established standards generates the basis for the risk, and the variability from the standard influences the duration of the outcome.

The bigger question is: What impact does reputational risk have on economic performance when possibly mitigated by the existence of a robust enterprise or strategic risk management methodology? Is the data available to see the “correlates” between a reputational risk event that trigger or influence operational key process indicators like EBIT, ROA, ROE and share price (public or private)?

What we do know from the Aon 2015 Global Risk Management Survey is that business leaders are concerned about reputational risk in general and the possible linkages with other hazard and operational risks within their organizations.

The respondents to the survey said that they worried that a reputational risk event would significantly impact financial performance.

reprisk1If reputation/brand risk was identified as a precipitating event, the respondents identified regulatory change, increasing competition, talent retention, cash flow/liquidity and share price volatility as “follow on” risk consequences. In effect, reputation/brand risk might constitute a “gateway” risk, where other related “follow on” risk consequences are triggered and serve to increase the overall volatility/impact of the reputation event.

Another way to view the data is to see what events could trigger a reputation event.

reprisk2In this case, the survey respondents identified nine non-correlated risks that could precipitate a reputation/brand event. Here social media plays an important role.

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The speed by which information, accurate or not, is transmitted, consumed and iterated across the nine risk categories may have a material impact on the basis and duration of the reputation/brand event. There is also an error component associated with social media.

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How many times have we witnessed an initial media report of a brand damaging event that turns out to be prematurely reported and the facts distorted, only to be corrected in a later reporting cycle?

Next up: Fat vs. thin tail distributions.

Defining Reputational Risk

The following article is part of a new blog series that will explore ideas, concepts, discussions, arguments and applications associated with the field of enterprise and strategic risk management.

One of the more striking conclusions contained in Aon’s 2015 Global Risk Management Survey is that damage to reputation and/or brand was considered by the survey cohort to be the most significant risk to the enterprise. The survey was conducted in Q4 of 2014 and received input from over 1,400 respondents coming from both the private and public business on a worldwide basis.

The “Top Ten” most identified risks included:

  1. Damage to reputation/brand
  2. Economic slowdown/slow recovery
  3. Regulatory/legislative changes
  4. Increasing competition
  5. Failure to act or retain top talent
  6. Failure to innovate/meet customer needs
  7. Business interruption
  8. Third-party liability
  9. Computer crime/hacking/viruses/malicious codes
  10. Property damage.

The survey results should not come as any real surprise given the number of sensational news stories coming from around the world that highlight potential or real reputational or brand problems. We have witnessed data breaches ranging from credit card identity theft in consumer retail, to serious product recall notifications in the food and beverage industry, to product performance/ warranty failures in the automotive arena, as well as “hints of reputational quality,” defined as “trust” in the early stage politics of the presidential selection process involving private vs. public use of email servers. There is little doubt that news, sensational or not, impacting reputational or brand, will continue for some to come. The real question is: Should anyone care?

Defining reputational/brand risk is hard to accomplish:

Based on some additional research done by my colleague Sylvesto Lorello, reputational risk is not a new concept, but it arguably has no established or universally agreed upon definition. Academic and business thinking about this subject continues to evolve. Within the insurance underwriting community that I have been in touch with, reputational or brand risk is being compared in scope to contingent liability risks, but with a serious caveat: the basis of the risk is highly variable and the duration of the risk event/loss event is difficult to pin down economically.

The concept of reputation and brand for example, are notably absent from the 2004 framework for enterprise risk management proposed by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). It is also overlooked in the Basel II international accord for regulating bank capital, which was also issued in 2004.

A lack of common standards or definitions of reputational risk mean that companies perceive it in different ways.

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Some risk practioners are beginning to view reputation as a “risk of risks” similar to the dialogue surrounding the “internet of things/objects.” Interestingly, an emerging dialogue is developing around whether reputation or brand is actually a risk or a residual event stemming from other extenuating risk domains or actions.

The ISO 31000 (2009)/ISO Guide 73:2002 definition of risk is the “effect of uncertainty on objectives.” In this definition, uncertainties include events (which may or may not happen) and uncertainties caused by ambiguity or a lack of information.

The U.S. Federal Reserve in 1995 defined reputational risk as “…the potential that negative publicity regarding an institution’s business practices, whether true or not, will cause a decline in the customer base, costly litigation or revenue reductions.

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In this case, the definition points to the potential for hard data from which basis and duration can be calculated.

Definitional issues aside, eventually societies will develop benchmarks with which to measure reputational or brand acceptability. One way of thinking about this approach is shown in the following exhibit.

UntitledHere we ignore some of the more difficult definitional discussion around a combined reputation/brand perspective, and limit our view to reputation alone.

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From a practical early stage standpoint, an entities reputation could be view from potential threat and potential impact perspective. On the threat side, it may be possible to segregate threats into four categories:

  • Risk to reputation stemming from employment activities;
  • Risk to reputation coming from product or customer issues;
  • Risk to reputation derived from governance; and,
  • Other less easily classified risks to reputation.

These categories appear for graphical purposes as if they are mutually exclusive, but in reality, there are good examples of causal overlap that increased risk volatility and severity. Recent oil spills and automobile product failure/recalls are enduring situations where more than one causal category created a economically catastrophic reputational problem.

On the other side of the graphic we outline the potential impacts to reputation coming from the threat categories. Again, while not mutually exclusive or exhaustive, the impact areas include:

  • Customer base
  • Financial valuation
  • Brand and media
  • Staf
  • Other less easily defined impacts.

Coming next, who are the stakeholders and how might one approach measuring reputational risk.

What to Do About Reputation Risk

Of executives surveyed, 87% rate reputation risk as either more important or much more important than any other strategic risks their companies face, according to a new study from Forbes Insights and Deloitte Touche Tohmatsu Limited. Further, 88% say their companies are explicitly focusing on managing reputation risk.

Yet a bevy of factors contribute to reputation risk, making monitoring and mitigating the dangers seem particularly unwieldy. These include business decisions and performance in the following areas:

Financial performance: Shareholders, investors, lenders, and many other stakeholders consider financial performance when assessing a firm’s reputation.

Quality: An organization’s willingness to adhere to quality standards goes a long way to enhancing its reputation. Product defects and recalls have an adverse impact.

Innovation: Firms that differentiate themselves from their competitors through innovative processes and unique/niche products tend to have strong name recognition and high reputation value.

Ethics and integrity: Firms with strong ethical policies are more trustworthy in the eyes of stakeholders.

Crisis response: Stakeholders keep a close eye on how a company responds to difficult situations. Any action during a crisis can ultimately affect the company’s reputation.

Safety: Strong safety policies affirm that safety and risk management are top strategic priorities for the company, building trust, and value creation.

Corporate social responsibility: Actively promoting sound environmental management and social responsibility programs helps create a reputation “safety net” that reduces risk.

Security: Strong infrastructure to defend against physical and cybersecurity threats helps avoid security breaches that could damage a company’s reputation.

But brand crises make headlines with increasing frequency, and companies are laying responsibility at the feet of the C-suite, particularly chief risk officers. Deloitte reports that respondents considered the primary responsibility to rest with: the chief executive officer (36%), chief risk officer (21%), board of directors (14%), or chief financial officer (11%).

What can they do? The study offered these key points to consider when crafting a crisis management plan:

  • Don’t wait until a crisis hits to get ready. Monitoring, preparation and rehearsal are the most effective ways to get ready for a crisis event. Organizations that can plan and rehearse potential crisis scenarios should be better positioned to respond effectively when a crisis actually hits.
  • Every decision during a major crisis can affect stakeholder value. Reputation risks destroy value more quickly than operational risks.
  • Response times should be in minutes, not hours or days. Teams on the ground need to take control, lead with flexibility, make decisions with less-than-perfect information, communicate well internally and externally, and inspire confidence. This often requires outside-the-box thinking and innovation.
  • You can emerge stronger. Almost every crisis creates opportunities for companies to rebound. However, those opportunities will surface only if you’re looking for them.
  • When a crisis seems like it’s over, it’s not. The work goes on long after you breathe a sigh of relief. The way you capture and manage data, log decisions, manage finances, handle insurance claims, and meet legal requirements on the road back to normality can determine how strongly you recover.

But the real objective should be preventing these potential crises to begin with. Deloitte recommends exploring the possibilities of “risk sensing” – using real-time data to monitor the issues that might impact a company’s reputation:

Crisis management for C-suite executives

Check out the infographic below for more insights from the Deloitte Reputation@Risk survey:

Deloitte Reputation@Risk Global Survey