Prescription Drug Importation in the United States

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The increased expenditure on prescribed drugs has prompted both the US government and the consumers to look into alternative ways to reduce this spending.  It has also been confirmed that prescription drugs are very cheap in other countries due to price control. This has prompted proposals to import these drugs from other countries and selling them in the United States through a legalized system .This is seen as a long term solution to the escalating drug prices in the United States.  This proposal to import prescription drugs caused a heated debate in the country. The congress argued that patients should be able to access the prescription drugs in addition to life saving products any time they need them. This, they argued would be made possible if the country imported prescribed drugs from other countries. They saw their proposal as a part of a wider effort to reform the U.S. healthcare system, in large part, by cutting unnecessary costs. The proposal was by Sen. Byron Dorgan, who was trying to amend the healthcare bill. However, his proposal was rejected. The amendment would have allowed the wholesalers and retailers and other drug distributors, including pharmacies, to import products from Australia, Canada, Europe, Japan and New Zealand. In these countries, drugs are far mush cheaper that in the United States as a result of price control.  According to Sen. Dorgan. “The American people are charged the highest prices in the world. They want congress to stand up for their interests and do something about it.”
According to the supporters of the new legislation The United States spends $2.5 trillion on health care every year. Drug importation could therefore cut the country’s health spending by $80 billion. This proposal was however objected to when concerns were expressed over the assurance of safety and quality of the imported drugs. According to Sen. Thomas Carper one of the objectors of the new law, “Senator Dorgan’s amendment could potentially allow unsafe, counterfeited drugs into the United States, contaminating our drug supply. Sen. Dorgan who proposed the new law felt that the Food and Drug Administration (FDA) could ensure safety of the drugs. ‘ My amendment includes strong safeguards to prohibit drug counterfeiting and other practices that would put the consumer at risk,” in embracing the FDA he added that, ‘It applies only to FDA-approved prescription drugs produced in FDA-approved plants from countries with comparable safety standards.’
The Congressional Budget Office (CBO) evaluated several proposals and concluded that the reduction of drug prices would be still small. This, in addition to other negative impacts of importing prescribed drugs form the basis of this paper. This paper seeks to look at the various problems associated with legislation of the law that will allow importation of prescribed drugs and some of the solutions to this problem.

Importation of prescription drugs in the US, will put the citizen’s life at risk, as patients would be exposed to unsafe and ineffective drugs. Most of these drugs may not meet the high standards that have been set up by the (FDA).FDA’s standards have made the US prescription drug market be recognized as the safest in the world. Most of these drugs have been found to be dangerous to the users. This is because, they are usually exposed to very high temperatures which make degradation fast, packed in an improper manner, or even ineffective. This is especially under the circumstances where the drugs are completely destroyed in instances where they are diluted in order to alter the quantity, concentrated or even adulterated with other dangerous products. This is already a common occurrence and legalization of importation will further increase the entry of unsafe drugs in the country. This eventually will lead to availability of unsafe and ineffective drugs to the United States consumers. This therefore translates to increased risks posed by the consumers of these drugs due to the low standards.

The wholesale importation will also endanger the consumers in the country as these drugs will be flooded in the market and not only the few individuals who voluntarily obtain their drugs from other foreign countries outside the United States. According to Young, despite the fact that consumers in the U.S. are faced with high prices for prescription drugs, they should rely more on prescription drug discount cards rather than risk the many counterfeited and low standard drugs in the market (Young 233).

Another serious threat by importation is disruption on continued innovation in the bio technology industry. This will be an inconvenience to the patients who rely on this industry’s medical advancement that treat most life threatening illnesses. Research has shown that it is very easy for patients to attain the biological medicines though the internet, and even other dubious means since they are readily available. These drugs are usually cheaper than those produced in the country. The biotechnology industry will continue struggling as competition with the cheaper the foreign markets deepens.

        Besides the adverse effect on the innovative industry, the intellectual property rights will also be eroded causing a double tragedy to the industry that uses intellectual property rights as its backbone. This will have a very negative impact on the countries trade policies. Under the current laws foreign manufacturers are not allowed to enjoy full rights on their products which are marketed in the US. With the new importation legislation, foreign manufacturers will be allowed to enforce their patents without violating the patent laws even when they are competing with the U.S. FDA approved drugs. This in addition will have a very negative impact on the local companies which own very little except for the intellectual property rights.

         Counterfeiters and other criminals will also use their means to ensure that counterfeit drugs find their way in the market.  With importation, Counterfeiters will find a leeway in shopping versions of the approved drugs which might be dangerous to the consumers. This way unapproved and counterfeited products which are dangerous and substandard will find their way in the US market. This can be confirmed by the various testimonies from the FDA that the country’s prescription drugs supply is already riddled with attacks from threats which are increasingly sophisticated.

The arguments that this importation could also be cost saving has also been disapproved by report by the Congressional Budget Office. The congress found out that   in instances where an individual is filling a prescription from a foreign, they might save cost where only one patient is involved, but in the case where the entire health system is involved this cost effectiveness may not be achieved. This can be linked to the safety aspect where the individual will be in a position to make specific confirmation on what they are purchasing by traveling to that country. According Brink(Brink 54) the elderly in the unites states travel to Canada and Mexico to purchase more affordable prescription drugs  Wholesale importation however is very different from personal importation described above. This is because in wholesale importation, foreign drugs will  find a way of intermingling with  the other  products that are safe which have gone through the FDA system and have been approved as safe and effective by its gold standardized   process of approval.

Legalizing prescription drugs importation also makes the FDA unviable and also makes its value and contribution in approving the safety of drugs questionable. This is because the recently introduced registration on importation requires that all manufacturers of prescription drugs must submit a FDA application even if they already have   foreign approved drugs as long as the approval is non FDA.  This approval requires that the manufacturers differentiate between the foreign made drugs and products and those made in the US. In essence this legislation gives the authority to FDA to reject the manufacturer’s application technically. However, the clear message that the legislation sends out there is that the FDA should approve these applications. After approval FDA will be required to publish these notices and applications. With increased public pressure that is driving this legislation, it will be very difficult for the FDA to disapprove any of these applications. This is way the FDA will be forced to approve products that have not undergone the same safety and efficacy tests as those in the US giving the imported drugs an edge. This way the imported drugs will have circumvented the FDA approval process making its validity and appropriateness questionable. Practically, the FDA is not in a position to carry out the numerous requirements in addition to examining the voluminous paperwork under a new importation program. This is because the system is already bad and corrupted.  For instance, it is not possible for the FDA to register, monitor and regulate importers and exporters. This is in addition to ensuring that all the incoming drugs and products are prescribed properly in addition to inspecting the incoming parcels, products and other facilities in order to enhance and ensure product safety. Recognizing the infeasibility of these requirements those who are most probably going to benefit are criminals, counterfeiters, smugglers, and others whose are after making quick money regardless of  whether these drugs are safe or not. The US drug supply system which has been recognized as the safest in the world will end up being compromised. (Charatan 1443).

Besides the above threats of prescription the importation is also going to hurt the US economy. The biotechnology industry is a very thriving one and force to reckon with in the US economy. This is because the industry offers many employment opportunities   to the citizens and is also a very thriving base when it comes to paying taxes. The industry is very key in numerous states such as California, Pennsylvania, Massachusetts, North Carolina, among others. The importation legislation eventually will hamper economic growth from the taxes that the industries pay to the government. In addition it will also hinder development of treatment and cures which is one of its mandates. This means that a positive economic growth and public health will be compromised.

Solutions

         The fact that the country’s biotechnology industry produces medicine that is unique and not easily susceptible to counterfeiting should be embraced .The congress for instance, has for a long time embraced the uniqueness and sensitivity of the products produced by this industry. It is important to note that most of these imported drugs which are especially the biologics are easily adulterated and even counterfeited to levels that are undetectable. However, many of the medicines from the United States biotechnology industry are not easily administered by a patient safely, and therefore there is need for supervision during administration from an approved health care provider. This way, these products are hard to counterfeit since they are not available in the local pharmacies or as out patient prescriptions. This would ensure that consumers are protected.

The government should also ensure that all its citizens are insured and also assist those in need when purchasing prescription drugs. This will play a great role in ensuring that citizens afford medical care and also access to safe a drugs. The Medicare system is also a good plan, in that it is going to ensure that the beneficiaries are assisted when it comes to purchasing prescription drug and other related products. Lueck and Fuhrmans, observes that the new Medicare prescription drug benefit program has led to a scramble for health insurance.(Lueck and Fuhrmans A3) .Such a program guarantees safe drugs for its beneficiaries. The Medicare discount card so far has played a big role in protecting citizens from harmful drugs.

The importation is not just that of drugs but also importation of price controls.  Foreign governments impose pricing restrictions arbitrarily. This global trend issue must be addressed, since it is through such restrictions that consumers and companies are forced to subsidize their health care. Eventually this leads to an increase in the cost of drugs. This is in addition to the fact that, these restrictions and price controls hinder and discourage innovation

The Prescription drug importation legislation in addition is going to erode intellectual property rights.  The government should therefore put into considering the fact that some companies place their entire value on the existence of intellectual property rights, either to a material or a means to achieve a specific activity.  Failure by the government to protect patent rights which encourage innovation ends up discouraging investment and even efficient innovation.

Conclusion

       From the above findings, it is evident that importation of these drugs will have more negative than positive effects. This will harm the economy, the pharmaceutical companies and eventually the consumers who will not only buy the drugs at higher prices but will also be exposed to drugs of very poor quality. There is no doubt that incursions into trade policy, intellectual property protection, and economic incentives for U.S. business – all of which are part of this legislation will have unintended consequences. The benefits of a free-market economy for U.S. Although this legislation is aimed at providing patients with lower priced prescription drugs this move has been criticized in that it neither may nor guarantee any cost savings.  Economists and the Congressional Budget Office have dismissed the assumptions that this new law will save costs. This is because there many substantial costs that will be incurred by the middle men in addition to those associated to the pharmaceutical Industry and eventually these costs will be passed to the consumers who are the patients.

WE ACCEPT