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The 21st Century Cures Act Will Exacerbate Life Sciences Pharmaceutical Risk

Modern medicine and biotechnology accomplish amazing feats with cutting edge technology, but they are confronting complex and changing regulations.
By: | July 26, 2017 • 7 min read

Onco-Immunotherapy, CRISPR, Cybernetic Implants, Regenerative Medicine, Gene Therapy, Robotics – many of these recent life sciences breakthroughs sound like science fiction.

But they are very real. And the impact of discoveries such as these could redefine what it means to be human.

Although these advancements are being realized through the most cutting-edge science, the greatest risk associated with marketing these products remains one of the oldest challenges.

Regulations.

“Of all the underwriting factors, and there are many given the complexity of the life sciences industry, laws and regulations are not within our control,” said Ryann Elliott, Vice President, Underwriting, Life Sciences, CNA Healthcare.

The 21st Century Cures Act (the “Act”), signed into law in December 2016, is a perfect example of how regulatory risk may create destabilization and vulnerability for life sciences companies and their insurers.

While establishing an almost $9B dollar slush fund for the National Institutes of Health to tackle major biomedical research, the law also revised the drug approval process with the goal of expediting production and getting new drugs to consumers faster and at more affordable prices. But not all the changes are positive for the industry. For example, Section 1028 focuses on high-risk, high-reward research outcomes that inevitably will increase liability for the drug companies.

Specifically, the provision requires the director of each national research institute, as appropriate, “to establish programs to conduct or support research projects pursuing innovative approaches to major contemporary challenges in biomedical research involving inherent high risk, but have the potential to lead to breakthroughs.”

The measure also was subject to several revisions proposed by the FDA. Importantly, its implications for the industry remain unclear and continue to evolve, especially with a new administration establishing different regulatory goals for the years ahead.

“The industry is sitting on the fence, waiting to see what will happen, but regardless of how it shakes out, there will certainly be changes in the liability and risk landscape for drug manufacturers and insurers in the life science marketplace,” said Steven Pendergast, Industry Group Leader, Life Sciences, CNA Healthcare.

Four significant risks to the life sciences industry are presented by the 21st Century Cures Act:

1. Accelerating Drug Development Dramatically Changes Risk Profile

A core focus of the Act is its effort to reduce regulatory hurdles for pharmaceutical companies in order to speed drug development and reduce costs.

The bill encourages a shift to patient-focused drug development in order to capitalize on the patient experience in clinical trials, rather than focus primarily on adverse events in consideration of a drug’s benefits and risk (Subtitle A, Section 2001).

The Act also calls for expedited approval requirements for drugs “as early as possible” in the research, development and clinical trial testing process provided that the drug meets the standards of evidence of safety and effectiveness, thus enabling drug makers to “fast-track” new breakthrough therapies. (Subtitle E, Section 2081).

“Marketing and distributing drugs more expeditiously may reduce costs and enhance patient access, but it will increase risk as drugs spend less time in clinical trial and market surveillance, which means less time to identify potential adverse events,” Elliott said.

While expediting the development and commercialization of affordable drugs offers theoretical benefits for patients, notwithstanding the Act’s directive to require evidentiary standards for safety and effectiveness, it may potentially compromise safety as the drug latency impact period can be significantly protracted — ultimately creating litigation risk for pharmaceutical companies.

A jury listening to the drug manufacturer’s case might consider it reckless and irresponsible for speeding up processes without spending sufficient time monitoring a medication’s effects despite the governance process. Moreover, adherence to the new regulatory regime may not provide an adequate defense in the event that a liability claim arises.

“Risk management programs must adjust by contemplating the risk created by fast-tracking drugs,” Pendergast said. “If a company reduces its sample population from 3,000 to 1,500 participants and shortens the time span from seven years to five, how does that change its risk profile? How will insurers approach that risk if they provide coverage for the product when it is marketed?”

2. Existing Bespoke Policy Language Could Act as a Liability Multiplier

The current insurance marketplace for life sciences is unique because it consists of customized policies written to meet the complex needs of the pharmaceutical world. While companies can enjoy coverage tailored to their risks, brokers face the challenge of studying and understanding the various policy language and forms that currently exist.

“Not all products are created the same. There is no single standardized offering in life sciences product liability policy forms in the marketplace,” Pendergast said.

This policy language incongruence will exacerbate the risk transfer challenges of adapting to the changing liability landscape presented by the 21st Century Cures Act. The lack of standardized and consistent policy language, coupled with changing risk profiles, increases insurance complexities for brokers and insureds exponentially, as new forms are issued in the marketplace.

“Multiply the number of insurers by the number of changes resulting from the 21st Century Cures Act, and the effect is a field of liability land mines, as well as potential errors for insurers, brokers and insureds,” Elliott said. “It creates a very complex horizon of shifting risks.”

3. Pricing Disruption: Moving Away from Ratable Revenue

Life sciences insurers typically assess risk based upon ratable revenue for sold products and trial subjects for clinical trials. During the Obama administration, the impact of the Affordable Care Act created a definitive move to less costly generic drugs. Furthermore, with drug pricing being hotly debated in Congress, and the new Trump administration immediately calling on big pharma to examine and find ways to reduce pricing, the pharmaceutical top line revenue is under stress.

While the fast-track provisions reflected in the 21st Century Cures Act provision will reduce drug development costs, thereby reducing allowing for reduced drug pricing, it may, however result in a trickle-down effect for insurers.

“Its impact, of necessity, will create a shift away from the ratable revenue-based methodology for insurers, to the point where it may no longer be a reasonable ratable baseline,” Pendergast said. “Instead, insurers will be under significant pressure to find new techniques to tangibly rate the risk associated with drugs in order to keep underwriting and pricing stable and consistent.”

Elliott emphasized that pricing also should consider the purpose and criticality of a medication.

“Take a critical drug and delivery system such as epinephrine, as an example. Its effectiveness is literally a matter of life or death. Product failure thus presents an enormous risk,” she said. “In this case, the drug’s function and delivery is what drives liability. Even if its price point decreases, the risk level remains the same.”

While insurers search for a better risk measure, volatile government activity and regulatory uncertainty will exacerbate pricing disruption in the insurance marketplace.

4. Continued Change Requires Constant Vigilance

The only real certainty around the 21st Century Cures Act is that it will continue to drive industry change.

Despite being signed into law with bipartisan support in December of 2016, several components have been rolled back or placed on hold until the new FDA Commissioner, Scott Gottlieb, M.D., settles into the role. The FDA has already introduced almost 1,000 pages that would represent changes to the law.

“However, Dr. Gottlieb has expressed support for the generic pharmaceutical industry, so it’s pure speculation at this point what he will do with this regulation and how it will align with the big business-focused perspective of the Trump administration,” Elliott said.

Discussion surrounding the potential impact of regulatory change on the life sciences industry and the forward impact on insurers providing coverage for life sciences companies raises more questions than answers.

To stay abreast of changes percolating on Capitol Hill and the consequent shifts in liability and risk, life sciences companies should seek an insurer with dedicated knowledge and experience in the drug development process and pharmaceutical marketplace, and that values long-term commitments with its customers.

With industry-leading experience in medical professional and product liability, as well as the mass tort environment in healthcare and life sciences, CNA is uniquely positioned to identify emerging trends. The insurer writes approximately $900 million in premium for physicians, nurses, hospitals, allied care facilities, life sciences products/services and entire health systems. This significant presence in the healthcare professional liability insurance industry provides the experience needed to recognize emerging problems with drugs or medical devices.

“We are one of a few insurers that write a large amount of medical malpractice in healthcare as well as product liability for life sciences companies, which gives us deep insight into emerging issues and allows us to get out in front of them,” Pendergast said. “When there are injuries in a clinical setting, it ultimately spills over into the drug and device world.”

That insight and expertise, combined with underwriting discipline, claim expertise and risk control services, makes CNA a leader and stable partner in weathering the regulatory volatility confronting life sciences companies.

Learn more about CNA’s Life Sciences practice.

One or more of the CNA companies provide the products and/or services described. The information is intended to present a general overview for illustrative purposes only. It is not intended to constitute a binding contract. Please remember that only the relevant insurance policy can provide the actual terms, coverages, amounts, conditions and exclusions for an insured. All products and services may not be available in all states and may be subject to change without notice. “CNA” is a service mark registered by CNA Financial Corporation with the United States Patent and Trademark Office. Certain CNA Financial Corporation subsidiaries use the “CNA” service mark in connection with insurance underwriting and claims activities. Copyright © 2017 CNA. All rights reserved.
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This article was produced by the R&I Brand Studio, a unit of the advertising department of Risk & Insurance, in collaboration with CNA. The editorial staff of Risk & Insurance had no role in its preparation.




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Catastrophe Risk

Material Resiliency

New materials, methods and ideas are empowering property owners to rein in their catastrophe risks.
By: | October 12, 2017 • 11 min read

The 2017 hurricane season is one for the record books. Rebuilding efforts are underway, with builders working to make insureds whole again as soon as possible … at least until the next storm comes along.

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And therein lies the problem with recovery in disaster-prone regions. It evokes the oft-quoted definition of insanity: Doing the same thing over and over again and expecting a different result.

So what if we did it differently? What if instead of rebuilding to make structures “like new,” we rebuilt to make them better, more resilient, less prone to damage?

The reality is, we don’t really have a choice. Climate change is ushering in weather systems that are increasingly volatile. Wildfires are raging like never before. Sea-level rise is threatening our coasts, and there’s no way to dial any of it back.

Nevertheless, people will continue to build homes and businesses along the coast. Real estate developers will continue to nestle luxury homes into wooded foothills.

That means communities need to come to terms with the risk and plan for it intelligently.

Michael Brown, vice president and property manager, Golden Bear Insurance

“Natural disasters are going to happen,” said Michael Brown, vice president and property manager with Golden Bear Insurance. “But if we plan and build communities around the idea that something bad may happen someday, then that community can bounce back faster afterward.”

In any natural disaster, he added, “the property damage is extreme. But the biggest portion of the losses, both insured and uninsured, are the time element pieces. How long was the business closed? How long were homeowners unable to occupy their homes? Those are the pieces that drag on for months — years in some    cases — and really drive the economic loss.”

That’s the motivation behind new materials, designs and strategies being implemented in the construction and repair of at-risk residential and commercial properties.

Powerful Flood Solutions

Newer building products move the needle significantly in terms of efficacy.

For new or restored structures in flood-prone regions, Georgia Pacific produces gypsum panels that incorporate fiberglass mats instead of paper facings and comply with the latest FEMA requirements for flood damage resistance and mold resistance. Wall boards made from magnesium oxide (MgO) don’t absorb water at all and have the added benefits of being environmentally friendly and non-flammable.

In the UK, advanced flood-resilient structures built with water-resilient concrete-block partitions are being fitted with not only MgO wallboards, but also wood-look porcelain or ceramic flooring that’s non-permeable and fire-resistant — without sacrificing aesthetics. Drains are installed in the flooring, along with sub-flooring gullies and submersible pumps that push the water back outside. Outlets and appliance motors are all situated above expected flood levels. Doors are equipped with sliding flood panels.

In the event of flooding that exceeds a depth of two feet, automatic opening window panels (flood inlets) are triggered by sensors to allow flood water to enter the property slowly, to reduce external pressure that could damage the structure.

Carl Solly, vice president and chief engineer, FM Global

Controlled inflow buys time for a homeowner to raise furniture up on blocks, or for a business owner to raise pallets of goods up to higher shelves or move equipment to a higher elevation.

Water intrusion is reduced dramatically, and even when it happens, there is little to no damage. Water is pushed into the floor drains, surfaces are allowed to dry, and then it’s back to business as usual in days rather than months — likely with no insurance claim filed.

Dramatic improvements are happening on this side of the pond as well. For entities that need permanent on-site flood solutions, barriers like flood gates and retractable flood walls are the most sophisticated they’ve ever been.

After suffering $4 billion in damage during Superstorm Sandy, New York’s Metropolitan Transit Authority invested heavily in flexible fabric flood panels that are made with Kevlar® and can be unrolled quickly and easily. Additional flood gates hinged to air grates are passively activated by the weight of incoming water entering the grates.

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The transit authority is also testing a prototype “resilient tunnel plug” — essentially a giant air bag that can be deployed quickly to seal off sections of subway tunnel. The plug is designed to withstand not only flood but also biochemical attack.

Even temporary solutions are leaps and bounds beyond the days when sandbagging was typically the best option. New as-needed barrier methods include inflatable bladders that can be placed around a building’s perimeter and filled with water to keep floodwater and flood debris at bay.

“People have always said, ‘Well, I’m in a flood plain, it’s inevitable. It’s an act of God,’ ” said Carl Solly, vice president and chief engineer, FM Global. “In the last several years, we’ve really been trying to deliver the message that you can do something about your flood risk.”

Shake, Pummel and Burn

Flood is far from the only problem benefiting from smart engineering. FM Global is working with manufacturers to develop and certify roofing material designed to better withstand the localized hailstorms that often plague southeastern and midwestern states.

Current materials rated for severe hail can withstand hailstones up to 1 ¾ inches in diameter. The new product, rated for “very severe” hail can tolerate hailstones up to 2 ½ inches. The difference sounds small, but it’s far from it.

“It’s about three times the amount of impact energy when it hits the roof [compared to a 1 ¾ hailstone],” explained Solly. “That’s a big difference.”

As for “bouncing back” after a catastrophic fire, Solly said that’s a fairly tall order. But even there, technology is helping to reduce the severity of fires so that disruption is minimal.

FM Global researchers recently pioneered the concept of SMART sprinklers — shorthand for Simultaneous Monitoring and Assessment Response Technology — which can sense a fire earlier than traditional systems and activate targeted sprinkler heads when needed and shut off once the fire is out.

“You’ll catch it with less water, so from a water usage perspective, a water damage perspective and a smoke damage perspective, we think that has an opportunity to be a big difference-maker in the fire protection industry, particular with high-challenge fires,” said Solly.

“You’ve got a better chance of stopping what normally would be a really tough fire to catch.”

In addition, added Brown, smarter sprinkler systems, much like burglar alarms, could be programmed to notify the fire department instantly, even when a structure is unoccupied.

For earthquake risk, said Brown, resilient building efforts are less about new materials than they are about more strategic ways of using traditional materials.

“Here in California we wrap homes in stucco around the wood frame to help the whole building move as a unit. Stucco is concrete so it does crack. I end up with a building that’s got some cosmetic damage … but you don’t have to rebuild the building. It does its job in terms of absorbing a lot of the ground motion before it pushes the building beyond its design tolerances.”

Using stronger, larger steel brackets where the walls meet the roof or the floor or each other, said Brown, “keeps the north wall from moving in one direction while the west wall moves a different direction.”

Those kinds of stress points can push modest earthquake damage to catastrophic levels, he said.

One earthquake innovation still in the beta phase is a project out of the U.C. Berkeley Seismological lab, using the accelerometers in smartphones as virtual seismometers. Participating phones have an app that detects certain types of ground motion. As phones pick up earthquake wave patterns, they ping the server which checks nearby smartphones to see if they sensed the same pattern, all in microseconds. If an earthquake pattern can be confirmed, an alarm will be sent to every cellphone within a logical radius.

That might only buy people an extra two to five minutes before the event, said Brown, “but if you are the operators of Bay Area Rapid Transit commuter trains, that’s enough time to slow all the trains down to five miles an hour. If you are Google, that’s enough time to park a bunch of hard drives in your server farm so that they’re better able to resist shaking and not be damaged too badly.”

Raising Standards

Cost, of course, will impact the take-up of resilient materials and tools. If it’s three times more expensive to build a home out of the resilient materials, a lot of builders aren’t going to want to because the home will be tougher to sell.

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FM Global’s Approvals division tests and certifies a variety of products aimed at mitigating disaster peril. That can help increase property owner confidence in these materials, particularly for commercial structures.

“When you’re betting millions of dollars and the future of your business — or at least the near-term future of your business — you really need to know that it’s going to work,” said Solly.

With just-in-time manufacturing, a company may have a few days’ worth of stock on hand rather than three months’ worth.

“So you can’t afford to be out of business for weeks, because your customers are going to go somewhere else for your product,” he said.

Building standards and codes can help drive adoption of resilient measures in both commercial and residential construction. But more work needs to be done to raise standards to meet the goal of resilience.

Effecting real resilience is something leaders across the spectrum should be talking about, including brokers and carriers, government and research agencies, building products manufacturers, and corporate executives.

If lives are saved in an earthquake, but a building is still damaged to the point where it needs to be torn down, said Brown “that building owner, that community, is going to have a much longer path to full recovery. We want the building codes strengthened to an immediate occupancy [goal] — we want people to be able to move right back into that building so there’s a much shorter window of disruption.

“It’s certainly better for me as the insurer,” he said, “but it’s even better for the guy that owns the building or runs his business out of it because now his employees still have a place to come to work and they can still get paid.”

Every single business able to minimize its downtime in this way helps the entire community be more resilient, he added. It creates that snowball effect in a good way. When businesses are able to stay open or reopen quickly, he said, workers don’t lose a meaningful amount of pay. Everybody’s in a better position to continue shopping and supporting the local economy.

“If you just shorten the line of people who are looking for some sort of federal aid, or state aid because they’ve had a massive financial disaster — maybe we can turn those into moderate to small financial disasters. That’s the key, I think, to communities being more resilient.”

Driving Demand

As the likelihood increases that property owners will experience a second loss or even third loss, some insurers are looking at ways to invest in resilience — a smarter long-term business plan than paying to rebuild again and again.

One new initiative is Lex Flood Ready, the product of a partnership between Lexington Insurance and The Flood Insurance Agency (TFIA). Flood Ready is a coverage enhancement for Lexington Private Market Flood clients that will not only indemnify property owners that suffer flood damage but will also provide the funds to rebuild them to a higher standard of resiliency when replacing floors and walls.

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Resilience proponents advocate a variety of approaches to encourage take-up, including tax credits, resilience grants, insurance incentives and other partnerships, as well as encouraging lenders to engage borrowers by making the flood risk assessments part of the mortgage process.

A certification scheme similar to LEED could also help drive resilience efforts. The UK is currently beta-testing a certification program called Home Quality Mark, developed by the Building Research Establishment (BRE). Properties are rated on stringent criteria that considers not just disaster resilience, but energy performance and cost, durability and environmental impact.

“Getting people from diverse perspectives thinking about it and talking about it is going to be the avenue to finding the right answers.” — Michael Brown, VP and property manager, Golden Bear Insurance

That’s something builders would be able to use to add value to their properties, offsetting the cost of building in resilience and driving consumer demand for properties built to the highest standards.

With increased resilience will come questions for insurers, said Brown. “It will open up a can of worms.”

It will create something of an arms race among insurance companies, he said. “Who’s going to be the first one to figure out what’s the right way to insure that? What’s the right price? What are the right terms and conditions?” Admittedly, it’s a good problem to have.

Effecting real resilience is something leaders across the spectrum should be talking about, including brokers and carriers, government and research agencies, building products manufacturers, and corporate executives.

“Getting people from diverse perspectives thinking about it and talking about it is going to be the avenue to finding the right answers,” said Brown.

“That kind of mentality top to bottom in the industry is going to be necessary. It’s not the first time we’ve dealt with disruptive things and we will continue doing it. It’s what keeps the game interesting.” &

Michelle Kerr is associate editor of Risk & Insurance. She can be reached at [email protected]