Liang BA.* A Dose of Reality: Promoting Access to Pharmaceuticals. Wake Forest Intell Prop LJ. 2007 Dec 1;8:301-386
Abstract. The U.S. uses and benefits substantially from prescription drugs. Pharmaceuticals save lives, relieve suffering, and promote the quality of life for those with access to them. However, access means both availability of the authentic drug and access at prices patients can afford. Unfortunately, current public policy does not effectively address either component. The result is the worst of all worlds: neither goal is accomplished.
Policymakers focusing on price fail to address safety, resulting in vulnerabilities that allow counterfeits and diverted drugs to enter into the supply chain; and those focusing on safety fail to address high prices, driving vulnerable patients to questionable and unsafe medication sources. A dose of reality that addresses these intertwined characteristics of access is proposed in this article.
This work first reviews the key safety-price interface: the problem of counterfeit drugs here and abroad. It identifies critical root causes that allow such a market to emerge, including the high costs of researching, developing, and selling authentic drugs that create the prices that drive vulnerable patients to alternate sources. Further, it details the other key infrastructural issues: the low financial and social costs of manufacturing fakes, a porous and poorly regulated U.S. domestic gray market and international parallel trade system, the limited accountability of drug sales via the Internet, and the limited provider and patient suspicion of fake drugs. It then critically assesses the primary safety effort that ignores price—drug pedigree and track-and-trace systems, and the primary price effort that ignores safety—drug importation. It finds that, beyond ignoring the complementary facet of access, both have striking limitations in dealing with the problems they purport to address.
Taking these analyses into consideration, this article presents a comprehensive legislative policy proposal that addresses both price and authenticity components of drug access, using extant private efforts and public expertise to promote efficient policy implementation. The resultant program has as its core a low cost/no cost drug program that segregates eligible patients from private markets. It also mandates both brand name and generic company participation as part of the social contract, requires identification and registration of legitimate wholesalers, bans Internet drug sales unless pharmacies are accredited by the National Association of Boards of Pharmacy, prohibits drug importation, directs the Centers for Disease Control and Prevention to create aggressive public and provider education on counterfeit drugs, and significantly increases penalties for counterfeiters to fit the crime of cheating the hopes of the sick and vulnerable.
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