• 한국사회복지학
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• 제57권3호
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• pp.5-30
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• 2005

세계화는 제약정책에 모순적인 영향을 미친다. 세계화에 따른 '국민적 경쟁국가'로의 변화는 약제비 절감 정책을 강화하는 한편 다국적 제약자본의 영향에 의한 WTO TRIPS 협정은 신약에 대한 특허 보호를 강화하여 약제비를 증가시킨다. 현재 다국적 제약자본의 이해를 반영하는 초국적 기구(예로, 유럽연합)가 산업적 목표 때문에 국민국가 제약정책에 규제를 가함으로써 국민국가의 약제비 절감 정책의 자율성이 침해당하고 있는 실정이다. 우리나라도 예외는 아니다. 1990년대 후반까지 우리나라 제약정책의 특징은 성장제일주의 이데올로기에 의한 원가수준의 약제비 통제 정책이었으며 이는 우리나라의 고유한 발전국가적 정책수단이었다. 그러나 세계화로 인한 다국적 제약자본의 힘의 강화는 우리나라 제약정책 자율성을 침해하고 있다. 값비싼 수입의약품은 건강보험 급여 목록에서 제외되었으나 미국 정부의 오랫동안의 압력에 의해 1999년부터 수입의약품도 건강보험 급여 목록에 등재되었다. 또한 의약분업 실시 이후 값비싼 고가약 사용이 증가하자 건강보험 재정절감 차원에서 참조가격제 도입 방안이 마련되었으나 미국 정부 및 다국적 제약회사의 압력에 의해 제도 실시가 유보되어졌다. 뿐만 아니라 미국 정부의 압력에 의해 우리나라 보건의료정책 결정 과정에 영향을 미치는 워킹그룹이 만들어지게 되었다. 지금까지 세계화와 관련된 논의들은 주로 세계화에 따른 국민적 경쟁국가로의 변화가 복지지출을 축소시켰는가에 관한 것들이었다. 그러나 본 연구는 세계화가 약제비 절감정책을 통해 보건의료비 지출을 감소시킨 측면 뿐만 아니라 세계화가 민간영리 복지서비스 제공자인 다국적 제약자본의 힘을 강화시켜 복지지출을 증가시키는 측면에도 주목하였다. 본 연구는 세계화가 일국의 제약정책에 미치는 모순적인 측면에 주목하면서 이 모순이 어떻게 다국적 제약자본의 이해로 관철되는지를 우리나라의 사례를 통해 살펴보았다.

• 약학회지
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• 제56권2호
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• pp.116-125
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• 2012

Local pharmaceutical companies in Korea, which have grown focusing on domestic markets, have recently faced difficulties such as market saturation, price control policies and market-opening pressures by FTA. It seems to be an urgent issue for them to export pharmaceuticals to developed countries comprising the greater part of the global pharmaceutical market. Hence, this research was conducted to investigate and benchmark the strategies employed by India industry for the successful access to the global pharmaceutical markets. Drug policies as well as their influences on pharmaceutical market changes between India and Korea for the last 40 years have been searched and the differences have been comparatively analyzed. The pharmaceutical industry of India has the following strengths: low costs; experienced labor pool; excellent reverse-engineering skills; powerful IT; marketing capability; and established distribution network. After 2000, consolidations, M&A and alliances with domestic and multinational companies have been sharply increased in the industry of India. Indian companies unfolding both competition and cooperation with multinational corporations currently move up the value-added chain, and this enthusiastic strategy should be learned by local pharmaceutical companies.

• 약학회지
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• 제58권6호
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• pp.397-404
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• 2014

The Ministry of Health and Welfare proposed the "undergraduate program specializing in pharmaceutical industry" in 2013, as part of its roadmap to assist domestic pharmaceutical companies to become the top-tier pharma companies in near future and provide skilled personnel tailored for pharmaceutical industry. However, it is not clear whether this "undergraduate program" meets the needs of pharmaceutical industry, especially when the number of pharmacy students increased from 1,200 to 1,700 per year since 2009. The purpose of this paper is to identify which educational background is preferred by pharmaceutical companies, by surveying the CEOs of domestic pharmaceutical companies and referring to recruitment advertisements shown in medical newspapers, specified by the fields within the companies. Two independent reviewers referred to recruitment session in Yakup newspaper and Dailypharm from May 2012 until January 2014, focusing on recruitments from pharmaceutical companies targeting bachelors' degree holders with no prior experience. 749 recruitments were observed during the study period, more than 90% of which were provided by domestic pharmaceutical companies, and regardless of the companies being domestic or multinational, pharmaceutical companies' preference for pharmacists was remarkable (44.3% for domestic and 65.8% for multinational), and the preference was especially high in the fields such as Medical, R&D, Market Access (regulatory affair/pricing and reimbursement), Business Development, and Marketing. Survey results showed that the need of establishing the undergraduate program specializing in pharmaceutical industry is mixed, suggesting that although there is need for the educating personnel targeting pharmaceutical industry, the undergraduate program would not be an answer due to current PEET system. Our study concludes that in the example of pharmaceutical companies' recruitments shown in medical newspapers, pharmaceutical companies prefer pharmacy major in almost all fields of the pharmaceutical companies, yet the pharmaceutical companies still perceive the gap between current bachelor's degree holders(including pharmacy majors) and the ideal personnel required for advancing to the "top-class" pharmaceutical companies.

• 한국산학기술학회논문지
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• 제19권11호
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• pp.182-190
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• 2018

많은 제약기업에서 영업사원들을 위하여 SFA 시스템을 운영하고 있다. SFA 시스템은 영업사원들의 다양한 행동에 활용되고 있는데 국내에서는 SFA 활용성과에 대한 실증분석 연구가 부족한 실정이다. 본 연구에서는 제약회사 영업사원을 대상으로 SFA 시스템의 활용도와 그에 따른 비재무적 성과를 설문을 통해 조사하였다. 조사대상은 제약 영업사원으로 구성된 제약 커뮤니티 회원 347명을 대상으로 2018년 3월 13일부터 4월 30일까지 18일 동안 온라인으로 조사하였다. 유효 응답률은 23.1%(80/347)이었다. 분석 결과 SFA 시스템 활용 수준이 높을수록 비재무적 성과가 높은 것으로 나타났다. 회사 구분별로는 국내 기업보다는 외국계 기업이 활용 수준이 높았다. SFA 활용 수준 항목 중 지원 서비스 항목에 대해 외국기업이 국내 기업보다 1.47점(3.65, 2.18) 높게 나타났고, SFA 성과 항목 중에서는 고객만족도 항목에 대해 외국기업이 국내 기업보다 1.47점(3.16, 1.69) 높게 나타났다. 이는 국내사의 SFA 개발 및 운영방식이 영업사원에 대한 지원 서비스 및 고객만족 중심이 아닌 관리 통제에 중심을 두는 것을 시사한다. 이번 연구를 통하여 국내 기업의 경우 SFA 시스템 운영 시 영업사원 지원 및 고객만족 정보제공 기능이 강화되어야 할 것으로 사료되었다.

• 한국임상약학회지
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• 제28권2호
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• pp.146-153
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• 2018

Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.

• 보건행정학회지
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• 제20권1호
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• pp.64-86
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• 2010

Korea has had problems with the price and supply of essential drugs such as Gleevec for leukemia, Fuzeon for HIV/AIDS, and Tamiflu for both avian flu and swine flu. The shortage or refusal of patented drugs supply is imposing a heavy burden in not only developing countries but also developed countries. Thinking over the serious results, we need to concern about the limited access to patented drugs by multinational drug companies' patent monopoly especially for pandemic and life threatening diseases. The effective response regarding to pandemic and life threatening diseases. The effective response regarding to pandemic situation requests collaborative and unbiased provisions of all countries in the world, however, sometimes patent monopoly may hinder the efforts. Compulsory licensing has been considered to be a useful alternative to the abuse of patent rights. However, the Korean experiences of compulsory licensing have left some controversial issues in connection with the availability of it in Korea. 'Flexibility' allowed in TRIPS and Doha Declaration has not come into effect in Korea for several reasons. Although the situation shows the limitations of compulsory licensing as a pharmaceutical supply policy, it is clear that compulsory licensing still has the possibilities of enhancing the access to medicines of all countries in need. Through searching the institutionalization process and experiments of compulsory licensing in Korea, this article explores the possibilities and the limits.