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In: Studies in regulation
In: HEC Paris Research Paper No. MOSI-2018-1314
SSRN
Working paper
This comprehensive textbook is tailored for Pharma MBA students, part-time MBA students specializing in Pharma, and SCM enthusiasts. With 36 insightful chapters divided into 5 parts, this book delves into the core principles, strategies, and emerging trends essential for navigating the dynamic landscape of pharmaceutical supply chains.
In: Occasional paper no. 176
SSRN
Working paper
"This book presents a complex view of supply chain management in global pharmaceutical industry, theory and empirical research findings. It also provides the resources necessary for policy makers and managers to adopt and implement supply chain in developing nations across the globe"--
In: The annals of the American Academy of Political and Social Science, Band 525, Heft 1, S. 12-30
ISSN: 1552-3349
While the pharmaceutical industry arguably has the worst record of serious corporate crime of any industry, international law evasion rather than outright law violation has been the biggest problem in the industry. To understand how these problems can be and are being brought under control, a legal-pluralist analysis is needed that decenters criminal enforcement by the state. Consumer and professional activism and a variety of levels of self-regulation in combination with state, regional, and international regulation are all important to understanding how progress is possible. Creative work within this web of controls can actually transform lowest-common-denominator regulation into highest-common-factor regulation and self-regulation when actors are capable of thinking strategically in world-system terms.
ÖZETİlaç sanayisinde Ar-Ge faaliyetleri, keşif aşamasından ticarileştirme aşamasına kadar yaklaşık 10 yıl süren ve 1 milyon ABD doları maliyeti olan riskli bir süreçtir. Üretiminin toplumun genel sıhhatini ilgilendirmesi bakımında ilaç sanayi aynı zamanda yüksek derecede düzenlemeye tabidir. Buna sağlık hizmetleri veren kurum ve kuruluşların maliyet odaklı uygulamaları da eklenince, nakit akımları zayıflamaya başlayan Ar-Ge odaklı uluslararası ilaç şirketleri, 1990'lı yıllarda yoğun şekilde şirket birleşmeleri ve el değiştirmeleri ile stratejik işbirliği faaliyetlerine girişmiştir. Türk ilaç şirketlerinin Ar-Ge faaliyetlerinde bulunmaları açısından karşılaştıkları risk ve fırsatlar bu çalışmada; pazarı etkileyen unsurlar, Ar-Ge faaliyetlerinin özellikleri ve önemi, sınai ve fikri mülkiyet haklarının korunmasının önemi ve gelişmekte olan iş modelleri açılarından detaylı olarak irdelenmiştir. Dünyada ve Türkiye'deki öndegelen ilaç şirketlerinin kullandıkları finansal araçlar incelenmiş ve bir "spreadsheet" analiz modeli kurularak bu şirketlerin mali yapıları ile Ar-Ge'nin önemi ortaya çıkartılmıştır. Türkiye'nin 17 üyesi olan EFPIA içinde en büyük sekizinci ilaç pazarına sahip olmasına ve yaklaşık bir yüzyıldır yerli bir ilaç sanayisi bulunmasına rağmen, Türkiye'deki ilaç şirketlerinin buluşa dayalı temel Ar-Ge faaliyetleri yürütmediği, jenerik ilaçlara yönelik geliştirme faaliyetlerinde bulundukları anlaşılmaktadır. Bu durum kısmen pazarın dağınık yapısına, kısmen de ilaç ve bioteknoloji sektörlerinde Ar-Ge faaliyetleri sürdürmenin anahtarı olarak nitelenebilecek uzun vadeli finansman kaynaklarının mevcut olmamasından kaynaklanmaktadır. Türkiye'nin durumunda, kamunun ağırlığı nedeniyle özel sektör borçlanma senetlerinin piyasadan kalktığı, risk sermayesi fonlarının ve yatırımlarının kısıtlı miktarda kaldığı ve ilaç şirketlerince borsanın yetersiz derecede kullanıldığı anlaşılmaktadır. Bunun sebepleri arasında bu çalışmada ele alınan diğer faktörlerin yanısıra ilaç şirketlerini risk sermayesi ve borsa yatırımcıları açısından cazip olmaktan uzaklaştıran kanun ve yönetmelikler öne çıkmaktadır. Yurtdışı tecrübelerin aksine ve bazı önde gelen Türk ilaç şirketlerinin yabancı firmalarca satın alınmasına rağmen, Türk ilaç şirketleri arasında birleşmelere rastlanmamıştır. Türk ilaç sanayisinde Ar-Ge faaliyetlerinin başlatılması ve çeşitli finansman kaynaklarının yaratılabilmesi için gerekli olduğu düşünülen adımlar bu çalışmada listelenmiştir.ABSTRACTConducting R&D in the pharmaceutical industry is a highly challenging task that takes around 10 years and costs approximately USD 1 billion from the discovery to the commercialization stage. At the same time, the pharmaceutical industry is one of the most regulated industries since its output is related with the health of the society. Coupled with the cost containment techniques of healthcare service providers, R&D based pharmaceutical companies have seen deteriorations in their cash flows and triggered a wave of M&A and alliance activities in the 1990s. The challenges and opportunities faced by Turkish pharmaceutical companies for conducting R&D activities are highlighted in this study based on extensive research of the forces that shape the market, characteristics of pharmaceutical R&D, significance of maintaining R&D programs, importance of protecting IPR and evolving business models. The types of financial instruments utilized by leading pharmaceutical companies internationally and in Turkey as well as the financial attributes of these companies are outlined according to the results of a spreadsheet analysis model. Despite the fact that Turkey is the eighth largest market among the 17 members of the EFPIA and the existence of a pharmaceutical industry for as long as a century, Turkish pharmaceutical companies do not seem to engage in basic R&D, but only in development activities for generic products. This situation results partly from the fragmented nature of the industry and the lack of long-term financing, which seems as the key to sustaining R&D programs in the pharmaceutical and biotechnology industries. In the case of Turkey, a market for corporate debt securities has become void due to the government's crowding out effect, access to venture capital has been highly limited and the ISE has been highly underutilized, among other reasons due to regulations that make pharmaceutical companies unattractive investment opportunities. Contrary to the international experience and the acquisitions of certain large Turkish pharmaceutical companies by their foreign counterparts, M&A activities have not occurred among Turkish companies. A list of actions that are deemed necessary for the initiation of R&D activities in the Turkish pharmaceutical industry and the creation of diverse financial resources are prescribed.
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In: World development: the multi-disciplinary international journal devoted to the study and promotion of world development, Band 14, S. 1141-1150
ISSN: 0305-750X
In: The annals of the American Academy of Political and Social Science, Band 525, S. 12-30
ISSN: 0002-7162
An exploration of white-collar crimes committed by transnational pharmaceutical corporations looks at interdiction problems. It is noted that the pharmaceutical industry, with the worst record for corporate crime, is involved in bribery, product-safety & antitrust offenses, misrepresentations of its products, & improprieties in the safety testing of drugs. Enforcement of legal restrictions on tax evasion practices (eg, profit shifting) is hindered by transnational corporations' ability to evade enforcers within national boundaries. Progress in law compliance can only be made by decentering criminal enforcement by the state, using a legal-pluralist analysis. In addition, consumer & professional activism, industry self-regulation, & strict enforcement of state, regional, & international standards are necessary. Adapted from the source document.
In: Environment and planning. A, Band 25, Heft 12, S. 1815-1838
ISSN: 1472-3409
Over the course of the 1980s, companies attempted to develop new organisational strategies to balance competition with collaboration. Although a variety of theoretical frameworks acknowledged this development there have been very few empirical studies in which the nature and extent of this collaborative integration and the implications for industries in the 1990s have been examined. In this paper, the Canadian pharmaceutical industry is used as the empirical context for an examination of collaboration. The author focuses on the relationship between small and large firms, biotechnology-based companies, and university research and argues that these collaborative linkages need to be more firmly developed in our theoretical discussions if we are to make sense of the corporate world in the 1990s.