The situation in China
Clinical trials in China
Due to the rapid growth of the Chinese pharmaceutical market, the availability of patients, and the relatively low cost of conducting trials, it is well-known worldwide Pharmaceutical companies and domestic pharmaceutical companies carry out more and more clinical trials in China every year.
In 2010, the State Food and Drug Administration's first annual report. In 2009, my country received a total of 638,996 adverse drug reaction reports. The drugs with the most adverse reactions were anti-infective drugs, followed by the cardiovascular system. Medication.
However, due to the uncertainty of adverse drug reactions, the defects of the clinical trial protocol, the researcher’s operational standards, and the subjects themselves, the number of deaths in the clinical trial Increasing year by year.
Statistics show that in 2002, the people's courts at all levels across the country accepted as many as 1.7 million medical litigation cases, of which 37% involved drug disputes. It is not uncommon for drug manufacturers and distributors to become defendants.
China Liability Insurance
Drug clinical trial liability insurance involves strong medical expertise, so it has higher requirements for the insurer. Only a few companies in the country have developed this type of insurance.
Background of the insurance category
Pharmaceutical clinical trial liability insurance originated in Western medical developed countries, and is mainly used to share the risk of adverse reactions caused by subjects during clinical trials of drugs. Series risks. The following table briefly lists the risk control modes in developed countries or regions:
Source of funding
Separate legislation for social relief
Purchase clinical trial insurance
Contributions to companies that manufacture and sell pharmaceuticals or biological products, as well as government and consortium funding.
Strict product liability system
and product liability insurance
Strict product liability is applied. The main body of responsibility and the amount of compensation are determined by market share, and enterprises can diversify risks by purchasing insurance.
Mandatory guarantee:< /p>
1. Purchase third-party insurance from an insurance company;
2. Guarantee provided by financial institutions.
Enterprises volunteer to participate.
Using a group insurance system, pharmaceutical manufacturers pay insurance premiums based on market occupancy rates.
Article 43 of my country's Pharmaceutical Clinical Trials (GCP) clearly states: Sponsors should participate in clinical trials Provide insurance, and bear the cost of treatment and corresponding financial compensation for subjects who experience damage or death related to the trial. The sponsor shall provide the researcher with legal and financial guarantees, except for those caused by medical malpractice.
Many clinical trials carried out in my country have not adopted active and effective risk control measures. As a result, after the occurrence of adverse reactions, the subjects will direct the spearhead at the research institution, and the further development of the contradiction is called medical treatment. Disputes, and even shocked medical incidents across the country.
The "Xianniu" incident
In May 2008, the SFDA received a report from a national drug clinical trial agency about " "Xianniu Jiangu Granules" is a report of serious adverse reactions. 1 case died and more than 20 cases of severe liver injury occurred in this trial.
After breaking the blinds urgently, the ethics committees of the hospitals concluded that the incident was related to the experimental drug.
Because the sponsor was unable to bear huge compensation, it declared bankruptcy. The subjects’ family members pointed the finger at the investigator. Serious violent acts such as attacking the hospital occurred. After the intervention of the Jiangsu Provincial Department of Health and other government departments, the hospital compensated the patient before it was calmed down.
*China Journal of New Drugs 2008 Vol.17 Issue 14
Korea Ginseng Pill Incident
From 1998 to 2001, Shen Xinlian, a peasant woman in Maqiao Town, Haining City, Zhejiang Province, participated as a "tester" in a Korean institution's drug trial of ginseng pills to prevent and treat colorectal cancer in my country.
In February 2004, Shen Xinlian died of uremia.
Shen Xinlian’s son Ye Shenming suspected that his mother’s death had something to do with testing the drug. In the end, he took the Haining Traditional Chinese Medicine Hospital, which was in charge of drug trials, to court.
This incident was widely reported by the media, first by "Southern Metropolis Daily", and then reprinted by major mainstream media websites.
The "etanercept" incident
In 2006, Ms. Shang accepted a clinical trial in a hospital of a new drug "etanercept" produced by a pharmaceutical company.
In 2007, shortly after the trial was completed, Ms. Shang was diagnosed with advanced gastric cancer. A few months later, Ms. Shang passed away.
After Ms. Shang passed away, the company believed that the experiment was in full compliance with the law and did not pay any compensation to the family.
The family then took the hospital and the pharmaceutical company to court.
Drug clinical trial liability insurance is to promote the development of new drugs, protect the rights and interests of drug clinical trial subjects and ensure their safety. Types of insurance developed.
The insured refers to the institution that is protected by the insurance contract, enjoys the right of insurance claims, and is qualified to apply for drug clinical trials as stated on the insurance policy. (The insured of this insurance can also include: doctors, nurses, consulting agencies, hospitals, drug trial centers, contract research organizations and ethics committees of drug clinical trials participating in drug clinical trials.)
During the insurance period, if the insured is engaged in drug clinical trials in China, the use of the experimental drugs listed on the insurance policy has caused serious adverse events and caused the personal injury or death of a third party. The insured shall be When responsible, according to the provisions of the insurance policy, the compensation shall be paid within the agreed compensation limit.
Generally, the compensation principles of drug clinical trial liability insurance are consistent with the principles of insurance principles and practices, which include:
Maximum integrity Principles
The principle of utmost good faith guarantees that both parties to the insurance contract can be honest and trustworthy, and perform their obligations in good faith. Including the following content:
Insurer’s obligation to inform
The insurer should clearly state the content of the insurance contract, namely the term and purpose.
The insured’s obligation of truthful notification
The insured should truthfully inform the status of the insured object.
Guaranty obligations of the applicant or the insured
Guarantee for the behavior or omission, the existence or non-existence of a certain state.
The principle of waiver and estoppel
A waiver is the waiver of a certain right of the parties in the contract. For example, the insured clearly informed the insurer that the degree of risk of the insurance subject matter was sufficient to affect the underwriting, but the insurer remained silent and charged the insurance premium, which constituted the insurer's waiver of the right to refuse insurance. Another example is the occurrence of an insured accident, and the beneficiary does not make a claim within the time limit stipulated in the contract, which constitutes the beneficiary’s waiver of the right to claim insurance money.
Forbidden estoppel means that since a certain right has been waived, the right shall not be claimed. For example, in the first example above, the insurer cannot claim the right of refusal to the insured after underwriting.
The principle of compensation for loss
The principle of compensation for loss is that the insurer must pay the beneficiary according to the scope of insurance liability when the insured accident occurs and the insured subject suffers losses. Compensation. Its meaning is that the insurer compensates for the loss caused by the agreed insurance accident, and the beneficiary cannot obtain additional benefits from the payment of insurance money. Generally speaking, property insurance follows this principle, but because it is difficult to estimate the value of a person’s life and body, life insurance does not apply this principle. However, some scholars believe that the medical expenses of health insurance should also be followed, otherwise there is a suspicion of improper profit. .
The principle of proximate cause
The principle of proximate cause refers to the determination of the relationship between the risk accident and the loss of the insured subject, so as to determine the insurance compensation or payment liability Basic principles. Proximity is the most direct, most effective, and most decisive cause of the damage to the insurance subject, rather than the most recent cause. If the proximate cause is an insured risk, the insurer shall compensate, and if the proximate cause is an exclusion or uninsured risk, the insurer shall not be responsible for compensation
Insurance premium rate
Clinical medicine The premium rate of experimental liability insurance is usually determined by three factors:
BasicPremium: It is determined by the insurer according to market conditions;< p>Number of insured persons: Refer to the actual number of insured cases;
Risk factor: The insurer's classification of experimental drugs and the incidence of adverse reactions based on clinical trials , The severity of adverse reactions, test drug formulations, usage and dosage, and other factors, combined with relevant clinical trial data and experience at home and abroad to evaluate and calculate the risk coefficient.
Choosing an insurance company
With the substantial increase in clinical trial projects in China and the rapid development of my country’s pharmaceutical market, drug clinical trial liability insurance has also become more and more domestic Accepted by researchers. Many factors have caused various insurance companies to gradually get involved in clinical trial risk management and control. Its products include both self-developed insurance types by state-owned insurance companies and reinsurance types borrowed from foreign insurance companies, giving policyholders a greater choice, but at the same time they are also facing more confusion. How to choose an insurance company? Consumers may wish to measure from the following aspects:
Good asset structure. In the insurance industry, whether an insurance company can be listed or whether it can be listed as a whole is one of the signs of evaluating whether an insurance company's overall assets are good. The so-called "holistic listing" refers to listing on the basis of all the company's assets. If an insurance company achieves an overall listing, it proves that the company's overall structure is good. Many insurance companies in the Mainland have already been listed or have met the conditions for listing.
Strong solvency. The solvency of insurance companies is very important to insurance consumers. The "Regulations on the Solvency Limits and Regulatory Indicators of Insurance Companies" that came into effect in March 2003 clearly stipulates the solvency limits of insurance companies. When the solvency quota is delivered to the Insurance Regulatory Commission, the solvency quota shall be disclosed in accordance with the regulations of the Insurance Regulatory Commission.
Excellent credit rating. There are many institutions in the world that specialize in evaluating the credit ratings of banks, insurance companies and other financial institutions, such as Moody’s and Standard & Poor’s in the United States. Their ratings of insurance companies can be used to evaluate the credit ratings of insurance companies. A reference.
High management efficiency. The high or low management efficiency of an insurance company determines the company’s survival. Management efficiency can be measured from the company's product innovation ability, market competitiveness, market appeal ability, company profitability, company decision-making ability, company resilience, and company cohesion.
The service quality is good. Insurance is different from other commodities in that it is not a one-time consumption. In the decades since the insurance contract has taken effect, insurers often require insurance companies to provide services for various matters, such as payment, receipt of survival allowance, address change, and settlement of claims. Whether insurance customers can become the gods of insurance companies, enjoy God's treatment, and happily accept the care of insurance, the quality of the insurance company's service is the key.
Prospects of drug clinical trial liability insurance
Due to the increase in the number of drug clinical trials in recent years, the clinical The risks in the trial process are huge, so my country's Food and Drug Administration is planning to force the sponsor to purchase drug clinical trial liability insurance for the subjects before the clinical trial is launched.
Other types of insurance
At the same time, due to the important role of researchers in the clinical trial process and the particularity of medical work, such as medical liability insurance during clinical trials, subjects Accidental injury insurance, drug quality insurance, and key personnel liability insurance are also being actively developed.