According to UN convention on biological diversity, Biotechnology is defined as the process that involves using living organisms and systems (bio) to manufacture products, or the method of producing products technologically by using natural or living systems and products for a specific purpose or use. Biotech insurance for Life Science companies and Pharmaceutical companies is a needed service.
What is Biotech Insurance for Life Science Companies and Pharmaceutical Companies?
Biotech insurance is insurance products offered by biotech insurance companies for individuals using any biotech products. Biotech products can be used for various conditions, such as bodily injury.
Who Offers Biotech Insurance?
Various biotech insurance companies do. Biotech insurance is being provided by various biotech insurance companies through various unique insurance programs. The biotech companies ensure their enterprises through different insurance programs in order to participate in the multiple benefits of the insurance policy and services offered by the biotech insurance company.
Who Needs Biotech Insurance?
Workers, directors of biotech companies. Most workers and directors of biotech companies need biotech insurance for risk management and to reduce hazardous events, such as bodily injury, and to enjoy various benefits that come with working with biotech insurance companies, such as risk management and workers compensation.
Top 5 Most Pressing Ethical Issues in Biotech Medicine
1. Clinical Trials Protection for Human Subjects
This topic had generated considerable debate since 1999, when 18-year-old Jesse Gelsinger died while participating in a gene therapy trial at the University of Pennsylvania. The institution was widely criticized for failing to disclose crucial information on informed consent documents, relaxing criteria for accepting volunteers, and enrolling volunteers who were ineligible. The episode prompted a great deal of soul-searching among researchers and regulators, and many universities began implementing new standards as a result of the harsh spotlight that was cast on the clinical trial world.
In a 2002 article in Epidemiology Review, Jeremy Sugarman, MD, MPH, a professor of bioethics and medicine at the Johns Hopkins School of Medicine, wrote:
“It is critical to ensure that research is conducted responsibly throughout the entire study cycle, from the way participants are selected to the way data are entered, analyzed, and reported. Attention to each aspect of research conduct is necessary to the success of the scientific enterprise and the protection of study participants and others from unnecessary harm.”
Conundrum: At what point does cost sharing backfire? A 20 percent coinsurance on a $20,000 therapy may work actuarially but could foster patient nonadherence.
The issue, of course, is complicated, because of patients — especially suffering patients — are willing to try something new, even when physicians acknowledge that a complete side-effect profile isn’t known, according to Eric Wickstrom, Ph.D., a professor of biochemistry and molecular pharmacology at Jefferson Medical College. This headlong rush by ailing volunteers, he says, necessitates rigorous protection by review committees, even before patients see an informed consent form. This is especially true, he says, for some vaccines and gene therapy.
“Gene therapy hasn’t worked yet, and it necessitates a great deal of care,” explains Wickstrom.
The Gelsinger episode, though, raised another sticking point — financial conflicts of interest. In this case, the lead researcher, James Wilson, MD, failed to disclose in the consent form that he had founded a company that stood to profit from the research.
Arthur L. Caplan, Ph.D.,2 who heads the Center for Bioethics at the University of Pennsylvania, stressed in a recent interview with Biotechnology Healthcare that researchers must ensure that clinical trials are not distorted by incongruous arrangements. Also, he says, volunteers should not be recruited in a manner that would suggest that they are paid bribes, as opposed to reimbursement for legitimate expenses.
. Biotech insurance for Life Science companies and Pharmaceutical companies is a needed service.
2. Price and Degree of Affordability
The rising cost of healthcare — and the cost of medications in particular — is a political hot potato and will remain so. No matter what the U.S. Food and Drug Administration might say or attempt, a broad swath of the public, their federal representatives, and their governors, do not seem to believe the pharmaceutical industry’s argument that research and development are funded by today’s prices and that price controls could retard R&D.
The ethical concerns are likely to get still more heated when the value of expensive biotech treatments for chronic illnesses is debated. After all, a needed pill for cholesterol might cost $3 daily, which amounts to nearly $1,100 per year. Compare that to a biologic that carries a $20,000-per-year price tag — or something even more costly.
“Affordability is, arguably, an issue across the board,” says Jeff Kimmell, RPh, vice president of healthcare services and chief pharma, in Bellevue, Wash. “In the United States, we say we want the best [treatments]. But it’s also an ethical dilemma. At what point will people say ‘Enough is enough?’”
This may place payers and purchasers, who are already struggling with the question of how much cost sharing is appropriate, on the defensive. Insurers and employers juggle actuarial concerns with the risks of patient nonadherence and its potential for poor clinical outcomes when coverage decisions are made. The ethical questions do not fit neatly into this decision-making process but, instead, transcend it.
What happens when some patients can’t afford the out-of-pocket share of a given treatment? What if an insurer declines to add a biologic to its formulary because of its acquisition cost? What happens when a patient on an expensive chronic therapy maxes out his life insurance benefit? Such instances may not be the norm, but their possibility disturbs some experts who see a pivotal clash between patients and profits.
“It’s certainly an economic issue if biologics are priced so high that some patients are priced out of the market,” says Sean Nicholson, Ph.D., assistant professor of policy analysis and management at Cornell University. “Perhaps an insurer may not cover a particular therapy. If there’s nothing else the patient could take to save his or her life, or to improve quality of life, that’s a dilemma.”
Talk about a Pandora’s box. Protecting patient privacy is a growing concern, thanks to technology that is making it possible to decode the human genome. But as scientists become adept at deciphering a person’s genetic composition, it is increasingly likely that compromising information about a person’s future health is going to become available.
This creates enormous problems. For instance, it may become possible to know that a 5-year-old is going to develop severe heart disease later in life, but does a prospective employer have the right to know that? How will this knowledge affect the individual’s ability to obtain a job, insurance, or a mortgage? Should such information be available to insurers and others? This is a thorny problem destined to become only spikier.
“Take a genetic test that comes back positive, and the biologic treatment of the patient costs $1 million,” says F. Randy Vogenberg, RPh, Ph.D., senior vice president and national practice council leader at Aon Consulting, in Providence, R.I. “What does an insurer do with that knowledge? It can’t tell the employer, but it does have a fiduciary responsibility as the health plan to remain within stated benefit coverage premiums and costs.
“It’s going to be very tricky for health plans to deal with this. And it won’t just be on a case-by-case basis, but it will come up during plan renewals and bidding.”
Sound far-fetched? Not really, says Vogenberg.
“Generally speaking, everybody so far has stuck their heads in the sand. HIPAA offers some protection, but as diagnostics expand, this issue will bubble to the surface. And probably, litigation will determine some boundaries.”
To nip the problem in the bud, some attempts are being made to put rules in place now. An American College of Physicians working group published one such effort in the Annals of Internal Medicine in July; an article titled “Ethics in Practice: Managed Care and the Changing Health Care Environment” spelled out a statement of ethical principles for health plans, purchasers, and physicians. One section opined that:
“All parties have an ethical obligation to protect the confidentiality of patient healthcare information. In general, identifiable patient information should not be shared without the patient’s consent — except where the health and safety of individual persons or the public may be threatened, or as required by law.”
4. Stem Cell Research
This one shouldn’t be a surprise. Stem cell research is anathema to the religious right and worked its way into the recent presidential election.
To circumvent the funding roadblocks in Washington, D.C., some states — such as New Jersey and California — are looking past ethical objections and taking severe steps to foster the establishment of stem cell research centers. In California, the birthplace of the biotech revolution and a state hard hit by the dot-com collapse, voters sized up the potential economic value of stem cell research and overwhelmingly passed Proposition 71, which guarantees $3 billion in state funding over the next decade. . Biotech insurance for Life Science companies and Pharmaceutical companies is a needed service.
It is somewhat ironic that a scientific area of research based on trials and data could be reconfigured into an emotional issue. The debate, of course, pits people who believe the study may one day find cures for diseases against others who say it violates human life.
On one side, the American Society of Clinical Oncology issued this policy statement in 1999:
“Whether privately or publicly funded, researchers should be mindful of the ethical issues that may be raised when research involves embryos, fetal tissue, cloning, or other controversial questions. Nevertheless, medical research often requires a balancing of perceived risks against potential benefits. The tremendous potential of stem cell research for the treatment of diseases means that the balance of benefits and risks is now clearly in favor of going forward with the research, even if it involves ethically sensitive areas.”
5. Bioterrorism Defense
Security is hugely important, and public fears over terrorism are unlikely to diminish. In response, the federal government wants Project Bioshield to spur the development of treatments, including preventive medications and vaccines, that would be available in sufficient quantities to protect the most significant possible number of people
Types of Insurance for Life Science and Pharmaceutical Companies
- Insurance for life-science companies: This is a type of insurance policy provided by insurance companies for individuals involved in the manufacturing of products that help alleviate symptoms and cure diseases. This kind of insurance policy is advisable for all the directors and workers of a life science The insurance covers a lot of areas such as property damage, risk management, bodily injury, worker,s compensation and clinical trials.
- Insurance for pharmaceutical companies: Due to the extreme risks and strict regulation applied by pharmaceutical companies, the directors and workers of most pharmaceutical companies find it challenging to strike a balance between producing a quality product, providing an excellent clinical trial, risk management, and workers compensation.
The solution to this dilemma is for the pharmaceutical company to participate in an excellent pharmaceutical insurance program that maximizes their business income. an excellent pharmaceutical insurance policy should include:
- Property damage and products liability insurance coverage
- Clinical trials liability
- Transport and marine cargo liabilities
- Medical devices cover
- Insurance policy covering the director, workers, and officer’s liabilities
- Insurance Coverage for international researchers and programmes
- Insurance policy that includes the business income spent on engineering part of the company
- Protection or prevention of business interruption
- Life science insurance coverage: The directors and workers of various life science companies are often stressed due to multiple strict programs and risk involved in their company. Different types of insurance companies provide an excellent insurance coverage for exposed biotech companies, especially those involved in life science
CHUBB insurance company is one of the most famous insurance companies in America that ensures that you get a good and flexible life-science insurance coverage through an insurance policy that includes benefits such as risk management control, maintenance of business income, reduction in profit loss, and lawsuits insurance
These insurance companies offer insurance policies that give flexible insurance coverage to life science industries and help them strike a balance between business income, workers compensation, and quality; products. . Biotech insurance for Life Science companies and Pharmaceutical companies is a needed service.
It is not enough to want a good life science insurance policy, .the life science companies would need an excellent life-science insurance broker to help them In their decision making, and selecting an insurance policy that would match the life-science company goals and ambitions.
- Prescription drug coverage: Having an excellent access to getting the right prescription drugs at a flexible price, is as essential as having a quality medical service and practitioner. This necessity for having access to the right prescription drug is the reason for the inclusion of prescription drug insurance coverages in health insurance plans.
If you are confused on how to manage your company or strike a balance between producing quality products and controlling risk management and workers compensation. Contact the nearest biotech insurance company near you. Biotech insurance for Life Science companies and Pharmaceutical companies is a needed service.
Duh, T. (2007). Biotech/Life Science Industry Boom. Asia-Pacific Biotech News, 11(12), pp.802-810.
Gallagher, B. (2017). Medical Device Insurance | Biotechnology Insurance | Healthcare IT Insurance. [online] Brittongallagher.com. Available at: http://www.brittongallagher.com/who-we-serve-life-sciences [Accessed 14 Oct. 2017].
Google.com.ua. (2017). Попередження про переадресування. [online] Available at: https://www.google.com.ua/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&ved=0ahUKEwjjz9-9lfDWAhUqLZoKHeXKBIMQFggxMAE&url=http%3A%2F%2Fwww.agcs.allian [Accessed 14 Oct. 2017].
Schultz, J. (2007). Corpus Interruptus: Biotech Drugs, Insurance Providers and the Treatment of Breast Cancer. Journal of Bioethical Inquiry, 4(2), pp.93-102.
SILVERMAN, E. (2017). [online] Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3570985/ [Accessed 14 Oct. 2017].
Www2.chubb.com. (2017). Life Sciences Insurance in the United States – Chubb. [online] Available at: https://www2.chubb.com/us-en/business-insurance/life-sciences.aspx [Accessed 14 Oct. 2017].