Annotated Bibliography 9.1

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Annotated Bibliography 9 Brielle West Abbas, Muhammad Zaheer. “COVID-19 and the Global Public Health: Tiered Pricing of Pharmaceutical Drugs as a Price-Reducing Policy Tool.” Journal of Generic Medicines 17, no. 3 (October 7, 2020): 115–21. https://doi.org/10.1177/1741134320963146 . This paper by Muhammad Zaheer Abbas examines the legality and practicality of implementing tiered pricing as a way of reducing the prices of pharmaceuticals, and whether it is a viable policy option. The author proposes adopting a global framework for sustainable pricing and implementing tiered pricing of health technologies and argues that tiered pricing is a viable option to lower pharmaceutical prices. It not only improves the welfare of the consumer through the reduction in the price of health technologies but also does so without compromising the pharmaceutical manufacturer's incentives for continued innovation. As a policy option, it has the potential to alleviate some financial burdens to consumers, especially those as a result of the COVID-19 pandemic. However, the author points out that this policy solution is not a silver bullet and that there are limitations to this option. These limitations include manufacturers using tiered pricing as a profit-maximization strategy, it lacks effectiveness in addressing the broader issue of access to medicine, and pharmaceutical companies often restrict the implementation of differential pricing to governments, NGOs, and aid organizations. Bhosle, Monali J., and Rajesh Balkrishnan. “Drug Reimportation Practices in the United States.” Therapeutics of Clinical Risk Management 3, no. 1 (March 2007): 41–46. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1936287/ . This paper examines different perspectives held by different groups relating to the reimportation of prescription drugs into the US. The paper briefly goes over the legislative history of reimporting drugs, and how despite attempted legislation to legalize the reimportation of prescription drugs, it continues to be illegal. The major factor behind

this being that the FDA argue that there is currently no way to detect the origins of drugs, even though they are manufactured in the US. This paper is different in that it looks at the reimportation of prescription drugs not only from an American perspective, but also a Canadian perspective. A worry for some is that Canadian pharmacists will be unable to meet the increased demand that would come from US consumer and might order drugs from other nations like Thailand, India, and Africa, where counterfeit drugs are much more prevalent, and the drugs are not held to the approval standards of the FDA. Further, the major emphasis behind this policy option is the possible cost savings it offers consumer, however, the authors note numbers from the Congressional Budget Office that show this alternative would only reduce the total of prescription drug spending in the US by only 1%. Jonathan Ma, “Lowering Prescription Drug Prices in the United States: Are Reimportation and Internet Pharmacies the Answer,” Southern California Interdisciplinary Law Journal 15, no. 2 (Spring 2006): 345-376 With the rising costs of prescription drugs in the US, the idea of reimportation of prescription drugs has gained traction. The authors evaluate reimportation as a possible policy alternative to combat high pharmaceutical prices in the US. The paper begins by giving a brief overview of the reasons behind the high drug prices seen in the US compared to other countries around the world. Along with the free-market model employed in the US, the authors also point out that the pharmaceutical market is able to list high prices, not only because of a lack of competition thanks to patent laws but also because of the fact that the goods produced are essential and necessary, unlike cars, computers, etc. The main argument in favor of the reimportation of prescription drugs is the cost savings for American consumers, however, this alternative has been criticized on

the argument that reimporting drugs would put consumer health at risk. This is because a large portion of drugs that are imported are not FDA-approved. Another argument against reimportation is that reimporting drugs is a way for foreign governments to impose price controls on the US drug market. This would decrease the overall profit of pharmaceutical companies and disincentivize research and development. Overall, the authors argue that the reimportation of prescription drugs is a short-term solution as the pharmaceutical manufacturers control the supply of prescription drugs that are available, not the consumers. Kesselheim, Aaron S., and Niteesh K. Choudhry. “The International Pharmaceutical Market as a Source of Low-Cost Prescription Drugs for U.S. Patients.” Annals of Internal Medicine, April 4, 2008. https://search.ebscohost.com/login.aspx? direct=true&db=mdl&AN=18413623&site=ehost- live&scope=site&custid=liberty&authtype=ip,shib . This article examines the legality of importing prescription drugs in the US and shares the benefits and risks associated with implementing a policy such as this. The article begins by looking at the legal framework of prescription drugs in the US and how FDA approval is attached to a specific manufacturer's version of a drug, which not only includes the drug itself, but also its labeling and packaging. This highlights the intricacy of the prescription drug market and patent exclusivity in the US. The paper then looks at the benefits and risks of importing prescription drugs, there are three factors the authors recognize that policymakers can rely on other nations as sources to import prescription drugs from product integrity, the relative cost or the savings from imported drugs, and other policy implications of drug importation. In order for policymakers to be able to rely on another country, the imported prescription drug needs to be as safe and effective as the drugs available domestically. While nations like Canada have cheaper brand-name drugs

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compared to the US, generics on average are lower in the US compared to Canada. US policymakers would need to ensure that drugs are held to the same approval standards to that of the FDA. The importation of prescription drugs from foreign markets is a good option, particularly when essential medicines are unavailable and there are no generic alternatives available domestically due to US drug patents. In this case, international markets, like Canada offer an alternative for lower-priced products for patients. Somdyuti Das, "Patent Evergreening Prevention: Ensuring Innovation and Access to Affordable Medicines," Indian Journal of Law and Legal Research 5 (2023): 1-11 This study by Somdyuti Das discusses patent evergreening and its negative effects on American consumers. The author discusses how this form of patent extension can stifle innovation, increase prescription drug costs and restrict generics from entering the drug market. The author describes multiple implications of patent evergreening, these include longer market exclusivity, higher drug prices, potential reduction in generic competition, and innovation incentives and investment for pharmaceutical companies. However, the author also discusses how some of the negative implication listed above effect American consumers and suggests that in order for patents to only be issued for real inventions that reflect significant changes and improvements, one way is to enhance patent inspection and scrutiny. One way this could be done is for patent offices to establish higher standards for giving new patents and require new applicants to show their changes represent important advancements of the invention. This would prevent pharmaceutical companies from being issued patents for minor advancements that don’t really advance the invention. Other ways to ensure that patents are issued correctly is to enhance public monitoring in the patent system. This could be done by involving civil society organizations, patient groups, and public health organizations in the evaluation process.

Summary All of the articles listed above delve into and offer policy alternatives that can be implemented, or looked further into to combat high pharmaceutical pricing in the US. The first article “COVID-19 and the Global Public Health: Tiered Pricing of Pharmaceutical Drugs as a Price-Reducing Policy Tool” looks at tiered pricing as a possible alternative, “Drug Reimportation Practices in the United States” , “Lowering Prescription Drug Prices in the United States: Are Reimportation and Internet Pharmacies the Answer” and “The International Pharmaceutical Market as a Source of Low-Cost Prescription Drugs for U.S. Patients” all discuss prescription drug reimportation as a possible policy solution. The final article “Patent Evergreening Prevention: Ensuring Innovation and Access to Affordable Medicines” discusses patent evergreening and looks at ways to stop patent evergreening.

Annotated Bibliography 9.1

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