Abstract
Cervical cancer is one of the most common cancers in women worldwide, and the traditional Pap smear screening is primarily used for preventive measures. The U.S. Food and Drug Administration (FDA) approved the human papillomavirus (HPV) vaccine, marketed as GardasilR by Merck & Co., Inc. (Merck), on June 8, 2006. This vaccine was the first of this type on the market, and the first prophylactic vaccine against cancers in medical history. GardasilR initiated a new era in preventive medicine, deemed "the beginning of the end for cervical cancer". However, after introducing the HPV vaccine to the market, Merck experienced a sales bottleneck. Profits did not meet expectations, and competitive challenges were strong. Several complex factors caused Merck serious business difficulties, including a public backlash to a negative lobbying campaign, out-of-patent products, weak finance due to declining sales and non-synergic impacts resulting from a horizontal business merger. The current HPV vaccine has met marketing barriers and restrictions. The public questions the cost-utility, side-effects, and moral aspects of this vaccine. Some governments have withheld implementing public vaccination policies due to controversies involving health inequalities and drug accessibility arisen from the expensive vaccine price. Furthermore, with increasing demands for public health, Merck's intellectual property right protections might be threatened. In this thesis, we will give the understanding of the natural history and developing progress of HPV and an in-depth analysis of Merck's challenges and difficulties in developing and marketing GardasilR since it first hit the market in 2006. We'll discuss the conflicts between Merck's profit target and the public health benefits, and intend to propose possible solutions. Cervical cancer is the first preventable cancer through vaccination and HPV vaccine, GardasilR, is the first non-infectious synthetic vaccine. In despite of GardasilR is such a unique and breakthrough biotechnology product, it still raises questions regarding moral obligations and business profits. We should first clarity the goals of patent, enterprise and medicine; then we can solve this dilemma and make an appropriate decision with clear conscience and ethical orientation. Patent protection is the key factor for the market success of vaccines. Politically, however, governments might implement compulsory licensing on the basis of "nonprofit charity" (according to the Doha Declaration) to satisfy demand and preserve public health. Our findings indicate that because "voluntary licensing" is a necessary step before implementing "compulsory licensing", it could be a strategic advantage to adopt voluntary licensing. By developing and connecting voluntary licensing, Merck could transform their "intellectual assets" into "intellectual capital", which creates a lot more viewpoints to value-creation process. A win-win-win situation for enterprise, society and medicine would result from management model of coordinated integration.