Whenever it comes to the drug development process, research and drug safety assessment, there are a few constants. Any pharmaceutical research team will be tasked with operating under strict budgetary constraints, and equally stringent time limits for the completion of the study. In order to be successful, the team must be able to allocate the company’s resources not only towards the study itself, but also towards an understanding of the legal environment. The law has a great effect on how the study can be run, the amount of time it takes to complete, and the resultant impact on cost. But what resources do you have to allocate towards having a robust understanding of how the law affects your work?
Fortunately, new resources are available that can help fill in the gaps where your corporate counsel does not have any expertise. For example, a recent article titled Is Georgia a Common Law State? provides a great explanation of how legal principles governing this southern state impact its legal practices. This information is vital for your research team to understand if your pharmaceutical or drug treatment research will take place in the state of Georgia. This will help them understand what legal principles they must study in order to competently navigate the legal waters they will encounter.
But first, for anyone not familiar, what is a common law state? In general, states operate under either a common law or civil law approach to law. A common law state is one that uses mostly judicially created laws, with history and precedent being relied upon for future rulings. A civil law state these days tends to be one that uses mostly statutes and code, with fewer rulings from judicial review.
Technically Georgia is a common law state, but common law principles will not apply if the state is under dual sovereignty rules, in which case federal statutes and regulations will override the state provisions. Dual sovereignty states are those that intersect both state and federal government jurisdictions. Because Georgia has retained its common law designation and has not fully adopted the federal dual sovereignty requirement, it is still a common law state.
This distinction can be important for research teams who need to understand how their studies will be impacted by legal issues. Research teams cannot perform toxicological research tasks or drug support unless such a study will pass all state requirements that have been published in local statutes or are the result of prior judicial review of law. It is thus critical that contractual responsibilities are managed properly to allow for the study to be performed properly. Not everything that looks good in a contract is good in execution.
Take care to always remain knowledgeable about the law. It will save you time and money in the long run. For more information on common law and its implications, you can visit Wikipedia.