23andMe Company had been doing well in the provision of DNA tests, and other related services() However, the nature of the business and the services that the company provided failed to comply with a number of business ethics. Moreover, the failure to comply with some requirements made the company face a number of legal suits. In addition to the lawsuits that the company has already faced, there are other possible legal difficulties that it may face in future if it does not change its operations and structure. This work will discuss a number of issues regarding the company.
Recommended Ownership Structure
Initially, 23andMe was a private entity in the healthcare sector. The business entailed activities, such as DNA analysis, which could provide certain information to clients. For instance, the company would inform clients of their hereditary characteristics. However, the ownership structure of the business might have been one of the factors responsible for the legal difficulties that it faced. First, it is stated that the company failed to obtain legal approvals for its operations. For instance, the company was spotted selling some of the individual tests with non-health related results.
It is prudent that the operations of such a business require legal regulation. For this reason, privately owning the business might not have been a good idea. Admittedly, privately owned businesses, such as those in the healthcare sector may have difficulties in meeting some of the legal requirements. For this reason, a person would recommend that 23andMe should have been a public corporation, which has a number of rights in terms of liabilities, and legal issues.
How the23andMe should have prevented the difficulties
According to the FDA, 23andMe might be using the DNA tests for other non-health purposes. For instance, it has been reported to sell personal hereditary information to a number of third parties, such as insurance companies (). The purpose of this transaction is that some of the third parties would also find the information important. A good example is that insurance companies may want to know certain risks that an individual faces to provide them with insurance coverage. At the same time, pharmaceuticals may find it important to get hold of the information for the purpose of knowing the right products to sell them to individuals at a certain price .
In order to prevent all these difficulties, the company should have stated its terms and conditions well. It would be important to have its clear terms and conditions so that the clients would regard them as being a contract. In this case, some of the activities done by the company would be dictated by the stipulations of the contract.
Another way to prevent all these legal and regulatory difficulties would be to avoid the use of personal information for non-health related purposes. In this case, all the lawsuits regarding the company’s sale of the DNA test results to the undesired clients would be avoided For instance, FDA claims that the company sold DNA test results of Canadians to non-Canadians, as a way of promoting its services.
Another way would have to make strong relations with legal regulators. Considering that the company was a private organization, it would be prudent to face legal issues. Therefore, one of the ways of preventing the emergence of such issues would have been the establishment of proper relations with some of the regulators. The relations would mean that the company would comply with each regulation that is set by the federal and state laws.
Legal Difficulties the company might face in future
In addition to the legal difficulties that the company faced, it might face others in the future. For instance, clients may sue the company for misleading them in terms of the risks that they face. Considering the fact that the company uses DNA analysis and statistics to advise a client regarding the risks they face, it is prudent that the results may not be coherent with what they are about to face . Some health problems are caused by lifestyle. Therefore, informing clients about their health risks after doing a hereditary analysis may not be sufficient to use as tools for advising clients.
Another lawsuit that might emerge from the operations of the company would revolve around the fact that it should take responsibility of the risks that face the clients. As a result of false advertisement, the company has the responsibility of taking charge of the health risks associated with false advertisement . For instance, a client that may contract a health condition that is not hereditary related may sue the company for misleading him/her. This case also comes as a result of the fact that not all health risks and problems are predicted by the company.
In summary, the operations of 23andMe Company might have crossed the requirements of the federal and state laws, but the situation could have been avoided. By the consideration of an effective ownership structure, the company could have prevented the occurrence of such legal difficulties. It is time that such companies comply with the requirements of the law, and their contracts in order to survive in their industries.
23andMe – Genetic kit for ancestry | DNA service. (2013, April 13)
23andMe and the future of home DNA testing.Medical News Today.
Gene Company 23andme launches in UK after us regulatory hurdle. Reuters.