Principles of Life Sciences Law
Definition and Scope of Life Sciences Law
Life sciences law is a specialized and complex area of the law that encompasses and regulates a wide range of scientific and technological disciplines primarily within the life sciences. These disciplines include, but are not limited to, the development, trial, approval, and distribution of biologic products, medical devices, and pharmaceuticals. As such, life sciences law guides and implements the rules of science in all stages of the learning, discovery, and development process . Products within the life sciences contribute to the prevention, treatment, and alleviation of diseases that afflict countless people across the globe. Since the inception of laws regulating this field, legislatures have enacted a plethora of statutes, laws, and regulations that govern the production and use of these products. In most countries, the federal government is responsible for regulating the life sciences, though some states also maintain an interest in the life sciences. The regulation of life sciences is divided in the United States into three primary sectors: biopharmaceutical, medical devices, and healthcare.
Legal Controls in Life Sciences
The life sciences industry is heavily regulated due to the potential impact on individual health and public welfare. The primary regulatory body is the U.S. FDA, which is responsible for protecting public health by assuring safety, efficacy and security of human and veterinary drugs, biological products, medical devices, food supply and cosmetics. The FDA achieves this through multiple programs, including drug approval and vaccine evaluation; this process can be lengthy and expensive, and often involves multiple administrative steps.
In Europe, the EMA (European Medicines Agency) is the European Union’s equivalent to the FDA, and is responsible for evaluating and supervising medicines and treatments within the EU.
In addition to these hazardous materials regulations, the life sciences industry is subject to a number of other federal, state and local regulations.
The FD&C Act (21 U.S.C. §§ 301-399) is a federal law that addresses misbranded and adulterated food and drugs. Implemented by the FDA, the FD&C Act is further regulated via the FDA Code of Federal Regulations, Title 21.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. §§ 136-136y) is a federal law that regulates the registration, distribution and labeling of pesticides. Ag in the Classroom Foundation has a simple explanation:
The Food Safety Modernization Act (FSMA), passed in 2011, gives the FDA additional authority to ensure safe food handling. The FSMA shifts the focus of the FDA’s oversight from responding to food contamination to preventing it. The FSMA gives the FDA the power to regulate the manufacture and storage of food, including the implementation of safe handling protocols within the food supply chain.
The OSHA regulations govern workplace safety, including those specific to laboratories. Laboratory Standard regulations apply to "any workplace where chemical manipulations are conducted," and are designed to protect laboratory employees from health effects resulting from exposure to hazardous chemicals.
The DOJ handles many major prosecutions regarding health care fraud, such as the one against FMC corporation for failure to obey a lawful order, failure to file an accurate report, and making false statements.
Intellectual Property and Life Sciences
Patents and trademarks are crucial in the life sciences for protecting innovations such as drugs, biologics, and medical devices. They also serve to protect the identity of a company’s products, which can have strong brand recognition in the marketplace. A company will typically use patents to protect its inventions and discoveries from other companies who may want to capitalize on the value of its research and development. Likewise, the trademark protection serves to prevent other companies from using the same or similar names or logos in a way that may potentially confuse consumers into thinking that their products are a part of or affiliated with the protected product.
However, in the life sciences, securing and enforcing intellectual property rights can prove to be very challenging. There are constant debates in Congress and the courts on the role that patent protection should have with regard to so-called breakthrough therapies, particularly biologics. Similarly, the rapidly evolving fields of pharmacology and biotechnology have led to challenges in protecting innovations such as drugs, biologics and medical devices through patents. Furthermore, the same can be said of trademarks, which can suffer from various challenges when it comes to securing ownership of a brand.
Regulatory Compliance, Risk Management, and Litigation Overview
Successful navigation of the complex legal and business landscape in the life sciences sector requires effective compliance and risk management strategies. Compliance with the myriad of life sciences regulations is crucial for companies to avoid legal pitfalls and reputational damage. Common areas of compliance include regulations relating to the marketing of pharmaceutical products, medical devices, clinical trials, and patient confidentiality.
One of the main compliance issues for pharmaceutical and medical device companies is ensuring that their marketing practices comply with federal and state regulations, such as the False Claims Act, which imposes liability for companies found to be advertising and marketing their products in a false or misleading manner.
To manage compliance and mitigate risk, life sciences companies should establish clear internal policies and procedures to monitor their sales and marketing practices, and ensure that all employees receive regular training on the company’s compliance program. In addition, companies should conduct regular audits of their sales and marketing activities, to identify and rectify any potential compliance issues before they become major legal problems .
Proactive legal strategies can help life sciences companies stay abreast of the ever-changing legal landscape, and avoid missteps that could lead to regulatory investigations or enforcement actions. This can include hiring legal counsel with expertise in life sciences law to guide the company through the legal requirements that apply to its business practices and provide advice on a range of legal issues, such as intellectual property protection, data privacy, clinical trials, and mergers and acquisitions.
Likewise, lifecycle management also plays a key role in compliance and risk management, because this process ensures that companies are prepared to respond to changes in the market or other external factors that may impact their products or business. Effective lifecycle management strategies help companies identify and capitalize on new opportunities, while at the same time anticipating and addressing any potential risks associated with bringing new products to market.
Investing in compliance and risk management is an important step for life sciences companies to protect their interests, and better position themselves for future success in the global marketplace.
Considerations of Medical Ethics in Life Sciences
The life sciences industry is rife with ethical challenges. These challenges include bioethics—the study of questions regarding human biology and medicine, particularly with respect to issues such as drug development, fertility, genetic engineering, or stem cell research—as well as the adjudication of bioethical concerns within the regulated parameters of government policies involving abortion, contraception or contraception coverage, and federal funding of fetal tissue research.
Clinical trial conduct also poses certain ethical dilemmas for research sponsors. Potential clinical study subjects have historically been subject to coercive policies in developing countries, including highly subsidized medical treatment, cash compensation for partaking in medical research, and the incorporation of groups into a study versus the exclusion of those who do not express interest. Such policies have effectively reduced the degree of autonomy inherent to the subjects’ consent for participation in clinical trials. The informed consent process—a key component to the ethical conduct of clinical trials—may be impaired when legal guidance on language and content is not handed down from the institutional review board overseeing the study. Some universities and medical centers even impose restrictions on their own faculty members involved in clinical trials by eliminating pay or attempting to infringe on intellectual property rights.
Finally, there is the question of the balance between innovation and patient safety. This debate extends to the medical devices industry, where patients have grown increasingly frustrated with the U.S. government’s slow and close scrutiny of new drugs and devices. On the one hand, industry leaders and innovative inventors are eager for streamlined U.S. Food and Drug Administration (FDA) testing and manufacturing processes. On the other, there is public concern about risky device issues that have affected many patients. Any innovations that the FDA adopts must weigh the benefits of improved health against the risk of adverse effects and medical complications.
Emerging Patterns and Projections
Continuing the trend of shifting beyond purely reactionary strategies, the life sciences sector has begun to show a strong preference for proactive planning based on their available data. Predictive analytics, for instance, can forecast potential patent infringements and guide businesses on how to avoid making the kinds of missteps that can result in litigation. As more law firms and other service providers offer this service, clients and their lawyers will be able to more effectively allocate their resources and refine their processes.
Additionally, there is the potential for litigation finance to gain traction in the life sciences realm . While it has already been popular for many years in commercial litigation, the prevalence of these arrangements in the life sciences sector is still in its infancy. In the coming years, however, it may become a go-to alternative funding source for life sciences companies pursuing patent or trade secrecy protections in court.
Because technologies such as CRISPR editing come with an array of new legal challenges for the life sciences industry, the legal field will be challenged to address complicating factors, such as patent eligibility. As inventions grow more complex, there will be more questions about which aspects of sophisticated technologies are patentable. This could open the door to increased regulatory scrutiny of new inventions.