What can you learn about medical product discovery, development and commercialization law?

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Working in the health care sector means understanding and complying with regulations concerning every facet of the industry. From the creation of new medical procedures to their effective use, every effort must be focused on keeping organizations in line with the law, and thereby taking steps to ensure patient safety and well-being.

The legal framework around the development, testing and sale of new medicines and other health care products is a specialized and important area of the health care industry. Organizations should frequently call upon the expert opinions of employees with a keen understanding of these rules, both on their legal teams and within their general staffs.

One way for individuals outside of the legal profession to gain a greater understanding of the health care sector’s numerous legal guidelines is to seek a Master’s in Health Law and Policy. This degree, which can be earned entirely online, is designed to convey the present state of related laws, as well as the processes by which rules are modified and administered. Medical professionals interested in increasing their engagement with legal matters and seeking out more specialized roles may find these courses especially helpful.

 

A scientist observes a sample with a microscope

 

Tracking the development of medical product law

Becoming more aware of the rules around developing new pharmaceuticals and biotechnology is a potentially valuable undertaking for employees at any organization with health care connections. In today’s fast-moving industry, with companies expanding across borders and interacting with multiple sets of regulations, it may be prudent to go beyond the laws set down by the U.S. Food and Drug Administration. Other government agencies and non-U.S. regulators are also part of the patchwork of organizations guiding the medical industry.

The following are a few of the most important concepts employees in the health care sector will encounter as they become more engaged in the specifics of drug trial processes and pharmaceutical approvals.

U.S. regulations

The drug approval process in the U.S. took on its modern form in 1997, when Congress passed the Food and Drug Administration Modernization Act. Section 113 of that law made information on clinical trials publicly accessible. The FDA and National Institute of Health released, promoted and revised an online database of clinical trial results, which won the Innovations in American Government Award from the Harvard Kennedy School in 2004.

In 2014, the NIH and FDA released plans to introduce increased transparency in the way trial results are viewed through the online portal. The goal of this update to the rules is to provide more comprehensive data from the trials logged in the database. The resulting rule debuted in 2016, with clarification about when and how to submit trial results, and when a product is considered to be in compliance.

Two new draft regulations emerged in 2018 to help organizations understand the process behind developing and reporting on adaptive trials of new pharmaceutical and biological products. These trials may be smaller or shorter than standard trials, and they do offer potential advantages beyond simply saving time, including reduced exposure to potentially risky medicines and increased subject willingness to participate. By adding these new considerations to medical product law, the FDA is keeping up with the pace of modernization.

International laws

The U.S. legal system isn’t the only body responsible for monitoring and regulating drug trials. With many companies operating internationally, even American businesses may require personnel to have a keen understanding of international standards, norms and best practices. The World Health Organization has mandated since 2006 that all clinical trials globally should be registered and accessible. The WHO’s system is connected to the NIH and FDA clinical trials database.

Public disclosure of trial results received more international support in 2008, when the World Medical Association added principles to its Ethical Principles for Medical Research Involving Human Subjects to emphasize registration and disclosure. The European Union has its own clinical regulations, issued in 2001 and replaced in 2014. Naming safety and transparency as the primary goals of the modernization process, the EU made the rules more consistent, suggesting the industry is able to be more efficient and less redundant in its trial processes under the new version of the law.

Taking the Law of Medical Product Discovery, Development and Commercialization course

When studying for a Master’s in Health Law and Policy online at Hofstra Law, students get a close view of the new pharmaceutical development process in Law of Medical Product Discovery, Development and Commercialization, one of the program’s core courses. The syllabus includes details from both U.S. and international legal frameworks to prepare graduates for the real-world situations organizations will encounter on the road to new product approval.

The legal processes around receiving approval and staying in compliance with local and international laws can call for intense lobbying and negotiation. Furthermore, the policies that determine pharmaceutical laws are subject to frequent amendment, revision and modernization. Students in this course will learn how lobbying for change occurs, and what kinds of government bodies are engaged in setting the marketing and promotion laws around pharmaceutical products, among many other aspects of the industry.

Medical product development and marketing is at least tangentially relevant to health care organizations of all kinds. Professionals who have studied this subject in detail may therefore be able to move into new and more specialized roles with their respective employers, assisting with complex compliance decisions.

Studying health care law online

Professionals don’t need to be lawyers for health care law knowledge to come in handy. No medical company can be consistently sure of its compliance status without staff members  understand applicable U.S. and international regulations. This is where a Master of Arts in Health Law in Policy may show true value, equipping an individual with information that can prove immediately and consistently relevant.

Earning a degree online at Hofstra Law is convenient and flexible, with classes designed to be taken on a student’s own schedule. This adaptive and asynchronous structure allows professionals to study medical law while remaining in their full-time positions. Upon graduation, they can leverage what they’ve learned to seek new responsibilities or excel in their current departments and roles.

Contact the Hofstra Law department of admissions learn more about the online Master’s in Health Law and Policy program.

 

 

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Sources:

U.S. National Library of Medicine – History, Policies, and Laws

U.S. Food and Drug Administration – FDA in Brief: FDA modernizes clinical trial designs and approaches for drug development, proposing new guidance on the use of adaptive designs and master protocols

European Medicines Agency – Clinical Trial Regulation