The following student post is by Karinne Marcolini (B.A., Michigan State University; J.D., Wayne State University Law School, expected 2015). While in law school, Karinne has worked at the U.S. District Court for the Eastern District of Michigan and the Crisis Centre in Nassau, Bahamas.
Prescription drug pollution in surface and groundwater is a growing economic and health concern. A recent study, Protecting the Great Lakes from Pharmaceutical Pollution, demonstrated that prescription drug pollution was present in Michigan groundwater and drinking water. The study sampled municipal water supplies in Ann Arbor, Grand Rapids and Monroe and found that water both before and after treatment contained varying levels of pharmaceuticals. Scientists have also discovered high levels of prescription drug contamination in Lake Michigan and Milwaukee’s sewage outfalls are a source of the pollution. Even if “out of the tap” drinking water in Michigan is not contaminated, prescription drug pollution can also affect ecosystems throughout the Great Lakes. Prescription drugs can kill the helpful bacteria in our water sources, build antibiotic immunity in harmful bacteria, and also affect the feeding and reproduction habits of larger organisms.
Drug disposal protocol varies from jurisdiction to jurisdiction. Federal statutes do not provide structure to prescription drug disposal protocol. The Clean Water Act does not address all issues with prescription drug water pollution because the act only applies to point sources such as sewage outfalls. Individuals are not liable under the Clean Water Act therefore there is no direct incentive to ensure safe disposal. Take-back programs in combination with better waste treatment processes would be a more effective approach to preventing prescription drug pollution.
In Michigan, prescription drug disposal programs vary by county. An official state document instructs residents to first check with local pharmacies to see if they have take-back programs, then to call local recycling centers, and finally, if they don’t have any other option, to dispose of the drugs in the trash after rendering them unusable. However, it is likely that prescription drugs will still be present in Michigan waterways if convenient disposal methods are not available and proper treatment processes are not implemented. Individuals have continued to dispose of prescription drugs improperly despite instructions such as those found on state websites. Not all water treatment plants use the same process and some are more adept at filtering out the chemicals. In fact, a recent study reflects that only about half of the prescription drugs and other contaminants are removed by treatment plants around the Great Lakes. Wastewater treatment reforms are a direct solution but drug take-back programs may also be a quick fix. Programs such as the one in Alameda County can prevent the contaminants from reaching waters sources in the first place. Considering the recent evidence of prescription drug pollution in Lake Michigan and the inconsistent disposal practices in the Great Lakes region, it may be beneficial for Michigan to consider implementing different disposal laws in coordination with neighboring states and Canada.
Some local governments are beginning to implement laws that shift the financial burden for prescription drug take-back from the taxpayers of the county to the prescription drug producers. This “producer responsibility” theory parallels the “polluter pays” theory as a key principle behind environmental laws.
A producer responsibility approach can be an advantageous. The producers likely have experts that are familiar with the drug properties and it should be fairly simple for them to apply their resources to developing appropriate disposal methods. Further, proponents of the policy laud it for shifting the costs from the general public back to the manufacturer. Though the producer may funnel the disposal costs into the cost of the drug, it would likely not be a noticeable amount and it would also ensure that the individuals benefitting from the drug are also responsible for safe disposal.
Last fall, Alameda County in California passed ordinance No. 0-2012-27, which significantly altered the protocol for handling excess prescription drugs. The ordinance requires producers of prescription drugs to fund or facilitate “take-back” programs if their drugs are sold in the county. It aims to provide a comprehensive approach to drug disposal, protecting residents by reducing the contamination of groundwater and unauthorized use of individuals using leftover or expired prescription drugs. It prohibits a direct fee on consumers at the point of sale, although it is not clear that producers cannot distribute the costs in other ways.
The prospect of shouldering disposal costs that were previously a taxpayer responsibility was not appealing to drug producers. PhRMA, a group representing drug producers, challenged the constitutionality of the ordinance as a violation the dormant commerce clause in Pharmaceutical Research and Manufacturers of American v. Alameda County. Under the dormant commerce clause, local regulations are unconstitutional if they directly regulate interstate commerce, discriminate against interstate commerce, or favor in-state economic interests over out-of-state interests. PhRMA claimed that the ordinance violates each of these three prongs. However, the court found that this ordinance does not favor in-state economic entities over out-of-state entities or discriminate against interstate commerce because there is not differential treatment favoring local entities over similar out-of-state entities. Further, the ordinance does not attempt to regulate interstate commerce because it only applies to producers’ actions within its jurisdiction. Ultimately the trial court denied their motion for summary judgment and granted the defendant’s cross-motion. PhRMA has appealed this decision and is also challenging a similar ordinance in King County, Washington.
The issue of prescription drug contamination in the Great Lakes is also interstate and international in nature. We share the Great Lakes with neighboring states and Canada and we may find that we also need to share a prescription drug disposal techniques and policies. More information may be needed about the current impact of prescription drug pollution in the Great Lakes. Even without extensive information about the effects of prescription drug pollution in Michigan, some may find that economic benefits justify creating new prescription drug disposal laws. Requiring producer responsibility could be advantageous for Michigan taxpayers. The survival of the Alameda County ordinance in the U.S. Court of Appeals will determine if it could serve as a model for Michigan and its neighbors in the future.