Abstract

The debated about drug importation to the United States from other countries particularly Canada has been dominating the public domain for years now. The public policy that prohibits drug importation from Canada to the United States has received different views and has proven to extend beyond the issue of money to include concerns such as efficacy and safety of the public health in the country. Researchers have extensively used various theories of public policy in the past in the effort of understanding how the policymakers are actively involved in formulating policies related to drug control in the country through using the policy analysis process. As indicated in the background and literature review section of this paper, the United States government has prohibited the importation and re-importation of the drugs from Canada due to the severe consequences that are attributed to such importation. For instance, 90% of the imported drugs from Canada are counterfeit thus jeopardizing the public health of the Americans. One of the most effective policy options that is available to address the issue of importation of illegal drugs in the country is the formulation of policies that only allow the generic drugs that have met all the criteria and standards set by FDA enter into the country thus eliminating safety issues related to importation of counterfeit drugs in the country and also reduce the high costs of buying drugs. Moreover, the use of anti-counterfeiting technology for medication packages is one of the measures that can be recommended for use in addressing the problem of drug importation which is prohibited due to the negative consequences that it has on general health.

Introduction

The 21^st century has witnessed a rapid increase in public policies aimed at regulating foreign trade notably the purchase of drugs from Canada by the United States government. This research paper aims at discussing the current public policy that increasingly prevents the United States from buying drugs from Canada by addressing various aspects of this topic such as its history, literature review about this topic, discussion of different policy options that are available and which can be used to address this issue and lastly recommend the most appropriate approaches which can be used as alternatives to the various policy options prescribed in the section three.

The prohibition of the United States to purchase drugs from Canada is of the current heated debate and the critical issue that this research paper will focus on discussion in the effort of understanding this policy issue. The public policy that prohibits the United States from purchasing drugs from Canada extends beyond the point of money to include other matters such as efficacy, lobbyist, safety and therapeutic equivalence among others as it will be discussed in this paper (Boldt, 2010). It is essential to study public policy regarding the importation of drugs from Canada given the numerous health challenges that are faced by the Americans in their effort of acquiring health services unusually affordable drugs (Drucker, 2013).

For instance, the last four decades have seen a dramatic increase in expenditure that the Americans incur in the attempt of acquiring prescription drugs (Boldt, 2010). It has been discovered that most of the Americans in the medium and lower classes end up failing to take prescription drugs as a result of the continued increase in medication costs incurred in buying them from the hospitals or even in the chemists (Drucker, 2013). About 32% of the uninsured population which makes up about 10% to 15% of the total population the United States do not complete all their prescribed drugs since they cannot afford the cost of their medications that have been prescribed to them (Drucker, 2013).

The importation of unapproved drugs into the United States has significantly affected the health care sector. For instance, the health care sector has recorded a rapid increase in health care costs in the country as a result of the importation of the unapproved drugs illegally into the country from other countries such as Canada and Mexico (Drucker, 2013). Such importation has made the private healthcare sector have the upper hand in the delivery of healthcare since it can access cheap drugs from the foreign market thus leading to the scrambling of the existing drug manufacturing firms in the United States.

America is one of the leading countries in the manufacturing of drugs which are then distributed across the country and others exported to other nations (Drucker, 2013). Continued importation of drugs into the United States from other countries has significantly affected this drug industry in America(Drucker, 2013). Therefore, the study of the public policy on prohibition of drug importation into America from other countries is a significant topic of discussion in the effort of understanding drug policies and how they influence the healthcare sector

One of the most useful theories of public policy that can help in discussing the policies made in the attempt of regulation and prohibiting the importation of drugs into the United States from Canada and other countries is the Political Systems Theory which was first developed by David Easton (Fischer & Miller, 2017). According to this theory, the government is considered to be an organ that is capable of responding to both inputs and stimuli thus influencing it to promptly act in the effort of establishing a positive and productive outcome or results for the benefits of the public (Fischer & Miller, 2017). The outcomes produced which in this case are various statutes and laws set to achieve a specific goal through regulations become part of the government systems. These statutes and laws formulated by the government in its effort of responding to the general needs of the citizens are what constitutes the public policy( Fischer & Miller, 2017). Thus, the Political Systems Theory can be the most practical theory to be employed in discussing the public policy that has resulted to the prohibition of drug importation into the country especially those drugs that have not yet been approved,

Drug importation in the United States is one of the issues that has over the years received a lot of concern from both the public and the private sector thus the need of in-depth analysis of this issue (Boldt, 2010). The study is going to focus on the public policies that have seen the importation of drugs into the United States from Canada become highly prohibited. The various reasons that have contributed to this situation will be broadly discussed.

Background and Literature Review

Brief History

When discussing policy issues related to regulating the safety of medicine supply in the international context, the United States can be considered as the gold standard given its numerous contributions in fighting the importation of unapproved drugs in the country. The United States has always been cautious when it comes to the importation of drugs from countries that do not share the same strong drug standards as itself (Hall, 2010). The last four decades have seen a dramatic increase in the potential for counterfeit or adulterated products to infiltrate the pharmaceutical supply chain in the United States and result to life-threatening consequences as a result of lack of proper Food and Drug Administration oversight and enforcement of laws that are designed to protect the patient safety which in most cases is usually undermined by the importation schemes (Nguyen, et al., 2013).

In 2003, the numerous concerns from the health care sector in the United States particular from the private practitioners led to the enactment of the Medicare Modernization Act which was enabled the Secretary of Health and Human Services to have the power to import drugs from Canada but only under two conditions (Hornbrook, et al., 2014). Firstly, the Secretary of Health and Human Services was supposed to able to certify that such importation would manage to reduce costs incurred by the America consumers in purchasing drugs. Secondly, he or she was required to certify that the imports of these different drugs would not in any way tamper with the public health and safety of the Americans (Hornbrook et al., 2014).

These two conditions were to be fully met before any drug from Canada could legally be allowed to be imported in the United States. None of the Secretaries of Health and Human Services from either the republic or democratic administrations who have held this office have managed to meet these conditions even up-to-date (Hornbrook et al., 2014). Moreover, numerous states have tried to pilot drug importation programs which are all aimed at enabling them to purchase drugs from outside the United States legally but with little or no success (Hornbrook et al., 2014). The low costs of imported medicines from outside the United States are what has been driving the campaign of the private sector for new policies to be formulated by the government in the effort of legalizing drug importation from Canada where these drugs are sold at relatively lower process compared to the local prices in the United States.

Trend and Status of Drug Importation Policies

Some of the trends in the pharmaceutical industry that have contributed to the increase in concern about the public policies regarding drug importation include the increasing need for cheaper drugs from the Americans (Hall, 2010). Most of the Americans seem to prefer the over-the-counter medicines over the prescribed ones by the physicians due to the cost difference between the locally manufactured drugs and those that are imported from other countries such as Mexico, Wales, and Canada. Most of the states, local governments and even the pharmaceutical companies in the private sector in the United States have proposed importation schemes numerous times in the effort of reducing drug costs (Hall, 2010).

Most of these importation schemes have failed to acknowledge that the government of the United States will require to put into place numerous resources to make those importation scheme work and that may even result to further increase in costs associated with these drugs (Nguyen et al., 2013). It is important to note that to ensure the safety and efficacy of any medications that are being imported from other countries, the United States government is required to put into place numerous resources in form of capital and human resources to ensure that these imported drugs have met the desired national Drug Standards that have been set in the country (Nguyen et al., 2013). That means such importation would only end up outweighing any potential savings that are aimed at been accomplished through the imported drugs.

Furthermore, the proposed importation schemes have continuously ignored the fact about 65% of the United States market today is composed of the generic products including the drugs which patients can access at lower costs only for them to end up deteriorating the quality of their health status (Nguyen et al., 2013). The current poor health of most of the Americans in the United States can be attributed to the generic drugs which are accessed in the black market and which do not meet the desired Drug standards that the United States government has set (Nguyen et al., 2013). The cheap, adulterated and counterfeit drugs that are imported in the United States have proven to be capable of significantly harming the health status of most of the Americans for many years, and the problem persists even up-to-date.

Literature Review

Both public concern and congressional investigations have been sparked in the United States as a result of widely-publicized controversies that involve hikes and shortages of generic drugs. Most of the news headlines are now dominated by rising costs of drugs and the unscrupulous pricing practices that are being used by most of the pharmaceutical companies in the United States (Kim & Prasad, 2015). The policymakers are now being urged to put into place laws and regulations that will improve patient’s access to safe medicines and address the escalating prices of the generic drugs in the United States.

The United States has been at the forefront in the attempt of regulating drug importation by putting into place drug policies that control the quality of drugs being imported in the country. For instance, both the Senate and the Congress approved the Affordable and Safe Prescription Drug Importation Act (ASPDIA) that was aimed at avoiding the recreation of unregulated circumstances that happened in the early 2000s (Oriola, 2010). This Act was meant to help in putting into place desirable conditions that would enable drugs manufactured using the same route of administration, active ingredients and strengths as the prescription drugs that are have been approved by the United States Food and Drug Administration be allowed for importation into the country from existing Canadian sellers who must also be certified by the FDA (Oriola, 2010).

The Affordable and Safe Prescription Drug Importation Act (ASPDIA) was aimed at improving the well-being of the Americans especially those who did not have health insurance. However, contrary to the government’s expectations, this act proved to be an impractical way of addressing the drug-pricing problem in the country thus making the issue of prohibition of drug importation in to the United States from countries such as Canada to extend beyond the issues money to cover other aspects such as therapeutic equivalence, lobbyists, safety and efficacy (Kim & Prasad, 2015). One of the main reasons that has made this act fails to be an excellent way of solving high prices of drugs as one of the challenges facing the United States health care system is the lack of similarity between the process used to manufacture drugs in the United States and the one employed in Canada (Kim & Prasad, 2015). Such findings are what have influenced the United States government to continue prohibiting the importation or purchase of drugs from Canada.

Theories of Politics and Public Policy on Drug Importation in the United States and Policy Process Model

The United States government has over the years been using the Drug Control Policy to put into place a legal framework that deters the importation of substandard drugs in the country and help in eliminating cases of drug abuse in the country through the use of aggressive law enforcement (Jorgensen, 2013). A significant number of policymakers in the United States have raised their concerns over the increased spending by the United States government on drug control. They have managed to put into place several laws that are aimed at restructuring the United States Drug Policy in such a way that it helps reduce the high costs that the American patients are forced to incur in accessing prescribed drugs( Jorgensen, 2013). They have also attracted support from the federal government.

As supported by the Group Theory of Politics, the collaboration between the policymakers and the federal government has resulted in the significant strides that have been made in effectively controlling drug importation into the country (Petracca, 2018). According to Group Theory of Politics, support for a given public policy can only be achieved through the help of organized groups which in these case the federal government has collaborated with the policymakers both in the Senate and the Congress to formulate public policies that strengthen drug importation regulations thus preventing prohibited drugs from entering into the country (Petracca, 2018).

Although numerous efforts have been made by the policymakers in collaboration with the United States government to put into place enough laws that see to its proper control on drugs has been put into place especially rules relating to imported drugs, it is reasonable to assume that the United States Policy on Drug Control is yet to be considered as valid and reliable (Robertson, et al., 2014). For instance, the illegally imported generic drugs continue to be consumed in the United States despite the strict measures that have been put into place by the United States Food and Drugs Administration. Law enforcement pressure has been put into place across the United States in the attempt of interdicting illegal importation of the drugs at the borders, eliminating the continued production and processing of drugs in the country and disrupting the illicit various drug distribution networks taking place in the United States (Robertson, et al., 2014).

The Group Model can be used to illustrate the current policy process that is being followed in the United States in facilitating effective policymaking. According to this model, a system of forces and pressures from different public needs result to creation of public policy by the lawmakers in their effort of responding to the policy needs to be raised (Heaney & Lorenz, 2013). Public policy is aimed at meeting the interests of the group affected by a problem which may be economical, social, environmental, or political (Heaney & Lorenz, 2013). In the United States, the Group Model can be used to describe the efforts from both the government and the policy makers in putting into place enough regulations that are aimed at protecting the Americans from consumption of unapproved imported drugs from Canada.

Problem Analysis and Steps in Policy Analysis Process

Most of the drug control regulations that have been made in the United States have been as a result of in-depth analysis of the healthcare problems facing the Americans in the country. Each of the regulation that has been made in the United States in the effort of prohibiting the importation of medication from Canada and other countries has been as a result of an increase in concerns from the public about the impacts that these imported drugs have on the consumers. (Birkland, 2015). The current poor health status of the Americans especially those from lower social status can be attributed to the continued consumption of unapproved and illegally imported generic drugs from Canada which most of the people seem to prefer given their low process. A recent survey show that three out of every ten patients in the United States do not buy prescription drugs but instead opt for the generic imported drugs (Birkland, 2015). Such an analysis of the problem facing the public is what has provided the basis on which the policymakers are starting formulating public policy on drug control.

Policymakers in the United States follow several steps during the policy-making process. They include setting the agenda which primarily involves politicians deciding which problems affecting the public that they intend to solve (Birkland, 2015). One of the significant issues that the policymakers have identified in the United States relating to the illegal importation of unapproved drugs from Canada to the United States thus resulting to the need of implementing a policy that can help eradicate this problem (Birkland, 2015). Secondly, the policymakers formulate a policy that can help eliminate the public issue at hand through extensive consultation with all the affected key parties (Birkland, 2015).

The lawmakers consulted all the interested parties such as the public and representatives from the pharmaceutical industry in the country while formulating the public policy that prohibits importation of unapproved drugs from Canada. The third step that was followed just like in most of the public-making processes was legitimizing the public policy which now became valid law in the country (Birkland, 2015). A policy must always move through the legislative process before it can be considered to be a law in the United States. The fourth step in policy-making involves implementing the formulated policy.

Once the public policy that prohibits drug importation from Canada to the United States has been implemented, the policy is put into action by the concerned policy implementers which in this case is the FDA department in conjunction with other officials mandated to facilitate this process. Lastly, the public policy on drug importation is currently being evaluated by the policymakers in the effort of determining areas that need improvement (Birkland, 2015).

The public policy that prohibits drug importation from Canada to the United States can be categorized as regulatory public policy since its sole aim has always being to control and prevent behaviors such as the importation of unapproved drugs into the country which has negatively affected the health sector in country due to continued distribution of generic drugs that do not meet the standards required for a drug to be eligible for use (Frewer & Salter, 2002). This public policy has been ensuring that the United States can control the illegal importation of drugs in the country. Other types of policy analysis that are common in the country include distributive public policy and redistributive public policy (Frewer & Salter, 2002).

Alternatives

There is an increased need of redefining the drugs and drug policy in the United States in such a manner that the public policy on drug control focuses more on the realm of public health as the root cause and not on foreign policies on drug supply (Fischer & Miller, 2017). Several alternative policy options can be constructed or employed in the United States in the effort of addressing the illegal importation of drugs into the United States from Canada despite this practice being prohibited. The notion that legalizing the importation of drugs from countries such as Canada can help save costs is entirely wrong.

For instance, according to a recent study that was conducted by the Congressional Budget Office, only about 1% or US$40 billion costs that is incurred in purchasing the prescription drugs is likely to be saved in the next decade if the House of Representative 2427 Bill is enacted which allows importation of drugs into the United States (Joyce, 2011). From these evidence, most of the researcher and economists in the country have come into consensus that importation of drugs from countries such as Canada, United Kingdom, Chile, Italy, Germany, France and Mexico where prices of the medicines are lower due to high rates counterfeit drugs is certainly not the solution to the high costs of medicines in the country and it cannot be considered as a panacea for the current soring drug costs in the United States (Joyce, 2011).

Drug importation or re-importation in the United States increases the threat of counterfeit drugs finding their way into the country market and has the potential of contributing to an increase in additional costs incurred in the American healthcare system. One of the best policy alternatives involves the policymakers actively formulating and promoting policies that will allow easy entry of only FDA-approved generic drugs that have undergone thorough screening to ensure that they have met the desired criteria and standards (Anand et al., 2011). Secondly, enactment of the Medicare Part D Act which is a benefits plan that can be used to enhance the Medicare Prescription Drug, Improvement and Modernization Act that was formulated in 2003 can significantly help the American patients have easy access to drugs and reduce the costs of the prescriptions drugs thus transforming the American healthcare delivery (Duggan & Scott, 2010).

Revolution in healthcare has led to the implementation of new policies that are aimed at streamlining the American health care system. The third policy option available that can be used is the Affordable Care Act which was signed into law in 2010 by President Barrack Obama which needs more improvements to eliminate the weaknesses that have seen it face objection from the public (Miller, 2012). This policy has enabled the country to reduce the high health spending and costs problem associated with prescription drugs through protecting all the Americans with insurance coverage whereby the Medicaid public program has enabled individuals with a disability and those from lower income class access health care services including prescription drugs at a relatively low costs(Miller, 2012). Moreover, Medicare for both older and younger people who have specific disabilities is also provided under the Affordable Care Act (Miller, 2012). Thus improving the provision of this alternative public policy option can help address the problem being addressed in this paper.

Another available policy options for use in dealing with the high costs of health care particularly in accessing prescription drugs in the United States is the welfare and social security policy. It is composed of various welfare programs such as the Supplemental Nutrition Assistance Program, Medicaid, Housing Assistance, Temporary Assistance for Needy Families and Supplemental Security Income which are all provided by the federal government and then administered by the individual states in the country (Kuitto, 2016). The Welfare and Social Security Policy can be the best alternative for the available public policy that prohibits the importation of drugs from Canada into the country. For instance, it will help reduce the many costs that the Americans incur in meeting their social needs thus allowing them to afford the prescription drugs sold in the country which are high quality and have no adverse effects on one’s health.

Lastly, the Education Policy on drug usage in the United States is also an excellent policy alternative that can be employed in limiting the problem associated with consumption of counterfeit drugs in the country which is mostly imported from other countries such as Canada and Mexico. Through the help of Education Policy, Department of Health Services can collaborate with other government agencies such as Office of National Drug Control Policy to educate the public on the importance of consuming prescription drugs instead of the generic and substandard imported in medicines that are sold in the country at relatively lower prices (Shapiro & Stefkovich, 2016). Increasing the awareness of the public about possible consequences of these counterfeit drugs on their health which in most cases lead to more costs in fighting the health consequences incurred can help.

All of the above-suggested policy options that are available to address the importation issues of drugs from Canada and other countries into America must meet several criteria for them to be considered eligible for use. Some of the elements of the criteria used in judging whether these public policy options are viable for use include being cost-effective, valid, reliable, equity, efficiency, effectiveness and political feasibility (Greenfield & Paoli, 2012). Moreover, there are several ethical issues, questions or concerns that emerge in the public policymaking. For instance, the policy made must be purely based on the interest of the public and self-gains of the policymakers.

As supported by the Rational-Choice Theory, most of the policymakers have been found guilty of pursuing their interest at the expense of those of the public in the past thus contributing wrong policies being formulated (Myatt, 2012). Such cases have raised ethical concerns from the public who at times have questioned the motives of the lawmakers in making public policies in the United States especially when it comes to the issue of drug control (Myatt, 2012). Some politicians and lawmakers have  the h been accused of taking advantage of the current position that they hold in the political sphere to promote policies that allow easy smuggling of unapproved drugs in to the country for self-benefits without minding the potential consequences that such policies may have on the public health (Shapiro & Stefkovich, 2016). Another ethical issue in public policymaking in the United States relates to the high rate of uncertainty regarding the possible outcomes from the policies formulated and implemented (Shapiro & Stefkovich, 2016).

Recommendations

The suggested alternatives in this section are as a result of conclusions made after critical analysis of the policy options discussed above. The primary objective against the importation of drugs from Canada into the United States is to maintain the safety and authenticity of the drugs being imported since they have the potential of jeopardizing the American public health and reducing the costs incurred in purchasing drugs locally.

Based on the evidence that has been provided in the alternative policies that have been described as the best policy options that can be used to address the issue of high costs of prescription drugs in the country, there are several alternative strategies that can be recommended for use in the attempt of entirely eradicating importation problem which has led to rapid increase in counterfeit and generic drugs in the United States market. For instance, the use of anti-counterfeiting technology for medication packages that helps in eliminating any incidence of entry of spurious prescriptions drugs in the United States can help in ensuring the safety and authenticity of the imported drugs especially those that have shown to meet all the recommended standards that have been set by the Food and Drugs Administration department.