濟世與營利的兩難：人類乳突病毒疫苗的藥物行銷

DILEMMA BETWEEN PUBLIC WELFARE AND BUSINESS PROFIT: MARKETING FOR HUMAN PAPILLOMAVIRUS (HPV) VACCINE

盧凡(Lu, Fran)

指導教授 ： 黎正中

國立清華大學/科技管理學院/高階主管經營管理碩士在職專班/碩士(2010年)

https://doi.org/10.6843/NTHU.2010.00674

摘要

子宮頸癌為目前世界各國婦女最常見的癌症之一，傳統上以子宮頸抹片篩檢為主要之防治措施。於2006年6月8日，美國食品與藥物管理局核准默克藥廠製造生產的人類乳突病毒疫苗上市之後，這個名為嘉喜（GARDASIL®）的子宮頸癌疫苗，成為人類醫療史上第一種獲准上市用來預防癌症的疫苗，讓醫藥學界多年以來的願景：The beginning of the end for cervical cancer，得以逐步實現，也為子宮頸癌的防治開創了新的紀元。

然而，這個疫苗上市後的銷售卻面臨瓶頸，非但成績未如預期，而且遭到同質產品的激烈挑戰，默克藥廠本身也因為先前形象受損不良記錄、專利藥物即將過期、銷售衰退財務不佳與水平併購衝擊綜效等因素而陷入整體營運困境。

除此之外，子宮頸癌疫苗的藥物行銷，遭遇到行銷策略的限制與障礙，而疫苗的成本效用、安全顧忌與道德面向也是多方質疑的焦點。昂貴的疫苗價格更引發健康不平等與藥物可近性的熱烈爭議，進而導致各國政府對於全面公費施打政策的制訂與實施之延滯，甚至可能影響智慧財產權的保障。

依照個案方式，本論文經由人類乳突病毒疫苗的發展歷史與過程，深入分析默克藥廠子宮頸癌疫苗從2006年上市迄今所面臨的銷售難題與推廣困境，來探討藥廠行銷的營利目標與民眾健康的公共利益間之矛盾，並意圖提出可能採取的解決方法。

子宮頸癌是第一個能夠經由疫苗注射而能預防的癌症，子宮頸癌疫苗是第一個不具感染性的合成疫苗，如此耀眼的生技明星產品所衍生之道德與利益兩難，應由「專利的目的」、「企業的目的」與「醫學的目的」三個方面進行正本清源的省思，才不至於迷失了方向。

專利保護期是疫苗藥物銷售成功與否的重要關鍵，然而各國政府可能在「非營利之公益使用」條件下實施「強制授權」，以滿足廣大民意之需求並達到維護公共健康之政治目的。本論文認為：由於「自願授權」是實施「強制授權」前之先決要件，採取自願授權能夠佔據戰略高點，並經由自願授權的連結與發展，可將默克藥廠的「智慧財產」轉變為「智慧資本」，得以更高更遠的角度來看待價值創造流程，藉由協調整合的管理模式，營造「企業、社會、醫學」三贏的局面。

關鍵字

人類乳突病毒 ； 自願授權 ； 強制授權 ； 行銷策略 ； 子宮頸癌疫苗

並列摘要

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 Gardasil® 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. Gardasil® 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 Gardasil® 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, Gardasil®, is the first non-infectious synthetic vaccine. In despite of Gardasil® 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.

並列關鍵字

human papillomavirus (HPV) ； cervical cancer vaccine ； marketing strategy ； compulsory licensing ； voluntary licensing

參考文獻

第參章 人類乳突病毒疫苗

1.Merck & Co. - Wikipedia, the free encyclopedia

2.Merck Executive Committee

3.Aaron Smith, Merck taps insider for CEO：Manufacturing

chief Clark to take drugmaker's reins, succeeding the