Pharmaceutical Consortia Research Articles

Ready for risk sharing? Performance-based agreements as a catalyst of innovative pharmacotherapy

Since health authorities and pharmaceutical companies are risk-averse in the reimbursement process, risk-sharing agreements (RSAs) can be seen as a happy medium for ensuring that the inherent financial and clinical risks of implementing a new innovative treatment are minimized. Although a properly applied RSA lies in the interest of patients, payers and manufacturers, the initial analysis shows that implementation of performance-based RSAs (PBRSAs), tied to measurable health outcomes, faces numerous obstacles in Poland. The article seeks to propose solutions, taking into account the characteristics of PBRSAs in Italy and the United Kingdom. The analysis is in line with the current trend of gradual remodelling of the Polish system towards value-based healthcare. The methods employed include a broad conceptual and exploratory analysis of Polish and foreign literature and legal acts, data acquired from national health data repositories, materials published by pharmaceutical consortia, financial institutions and public authorities engaged in managing the medicine market in Europe.

The relationship of industry structure to open innovation: cooperative value creation in pharmaceutical consortia

With its focus on value creation and value capture, open innovation research explicitly or implicitly examines the competitive impacts of collaboration. However, to date such research has not considered the effects of a blockbuster industry structure upon open innovation. Here, we examine a particular form of multilateral collaboration, the open R&D consortium, in which the results from collaboration are allowed to spill over to members and nonmembers alike. We do so in the context of the pharmaceutical industry, a stable but fragmented industry defined by the ongoing search for blockbuster hits protected by strong appropriability. Using a novel data set, we identify 141 such consortia that involve two or more of the 30 largest pharma firms. We show that firms financially support such consortia, in part, because their value creation activities benefit members without disrupting the value capture or other aspects of the incumbent industry structure. We discuss the implications of these findings for research on multilateral collaboration in blockbuster industries, and open innovation more generally.

Collaboration vs. Competitive Advantage Across the Value Chain:A Study of Pharmaceutical Consortia

While the pharmaceutical industry provides a crucial role in improving human health, over the past 20 years established firms have faced declining efficiency and effectiveness of their R&D efforts....

Quinine, Malaria, and the Cinchona Bureau: Marketing Practices and Knowledge Circulation in a Dutch Transoceanic Cinchona-Quinine Enterprise (1920s-30s).

In this study, we will show how a Dutch pharmaceutical consortium of cinchona producers and quinine manufacturers was able to capitalize on one of the first international public health campaigns to fight malaria, thereby promoting the sale of quinine, an antimalarial medicine. During the 1920s and 1930s, the international markets for quinine were controlled by this Dutch consortium, which was a transoceanic cinchona-quinine enterprise centered in the Cinchona Bureau in the Netherlands. We will argue that during the interwar period, the Cinchona Bureau became the decision-making center of this Dutch cinchona-quinine pharmaceutical enterprise and monopolized the production and trade of an essential medicine. In addition, we will argue that capitalizing on the international public health campaign in the fight against malaria by the Dutch cinchona-quinine enterprise via the Cinchona Bureau can be regarded as an early example of corporate colonization of public health by a private pharmaceutical consortium. Furthermore, we will show how commercial interests prevailed over scientific interests within the Dutch cinchona-quinine consortium, thus interfering with and ultimately curtailing the transoceanic circulation of knowledge in the Dutch empire.

From crystal to compound: structure-based antimalarial drug discovery.

Despite a century of control and eradication campaigns, malaria remains one of the world's most devastating diseases. Our once-powerful therapeutic weapons are losing the war against the Plasmodium parasite, whose ability to rapidly develop and spread drug resistance hamper past and present malaria-control efforts. Finding new and effective treatments for malaria is now a top global health priority, fuelling an increase in funding and promoting open-source collaborations between researchers and pharmaceutical consortia around the world. The result of this is rapid advances in drug discovery approaches and technologies, with three major methods for antimalarial drug development emerging: (i) chemistry-based, (ii) target-based, and (iii) cell-based. Common to all three of these approaches is the unique ability of structural biology to inform and accelerate drug development. Where possible, SBDD (structure-based drug discovery) is a foundation for antimalarial drug development programmes, and has been invaluable to the development of a number of current pre-clinical and clinical candidates. However, as we expand our understanding of the malarial life cycle and mechanisms of resistance development, SBDD as a field must continue to evolve in order to develop compounds that adhere to the ideal characteristics for novel antimalarial therapeutics and to avoid high attrition rates pre- and post-clinic. In the present review, we aim to examine the contribution that SBDD has made to current antimalarial drug development efforts, covering hit discovery to lead optimization and prevention of parasite resistance. Finally, the potential for structural biology, particularly high-throughput structural genomics programmes, to identify future targets for drug discovery are discussed.

Equivalence Considerations for Orally Inhaled Products for Local Action—ISAM/IPAC-RS European Workshop Report

The purpose of this article is to document the discussions at the 2010 European Workshop on Equivalence Determinations for Orally Inhaled Drugs for Local Action, cohosted by the International Society for Aerosols in Medicine (ISAM) and the International Pharmaceutical Consortium on Regulation and Science (IPAC-RS). The article summarizes current regulatory approaches in Europe, the United States, and Canada, and presents points of consensus as well as ongoing debate in the four major areas: in vitro testing, pharmacokinetic and pharmacodynamic studies, and device similarity. Specific issues in need of further research and discussion are also identified.

Transferring the financial risks of pharmaceutical benefits from a large health care provider in Argentina to a consortium of pharmaceutical companies.

The National Institute of Social Services for Retirees and Pensioners (NISSRP) is a nationwide health care financing agency and service provider in Argentina. Among its services, the NISSRP provides outpatient drug coverage to more than 3.3 million beneficiaries, mainly senior citizens and disabled persons. In 1997, to help cope with its rising costs, the NISSRP agreed to transfer the risk for the cost of outpatient medications and cancer-treatment drugs to a consortium of pharmaceutical companies in exchange for a fixed monthly payment. The objective of this study was to determine the impact that this new approach had on three things: (1) the level of expenditures for the medicines that were included in the agreement, (2) the pattern of nonrational prescribing for NISSRP beneficiaries, and (3) this pattern's relationship with macroeconomic variables and the pattern of prescribing for Argentina as a whole. We compared outpatient-medicine consumption in 1999 with consumption before the agreement went into effect. The actual amount that NISSRP beneficiaries spent out-of-pocket climbed from US$ 336.13 million in 1996 to US$ 473.36 million in 1999, an increase of almost 41%. The nominal amount "spent" by the NISSRP in 1999 was US$ 601.11 million, versus a real amount of US$ 374.75 million in 1996, an "increase" of 60% (that increase for the NISSRP was only theoretical since the agreement specified the fixed monthly amount that the NISSRP would have to pay to the pharmaceutical consortium). In contrast with the increased real spending by NISSRP beneficiaries, Argentina's economy remained stable over the assessed period, with the consumer price index even falling by 0.8%. We found high levels of nonrational drug use in the NISSRP system in both 1996 and 1999, indicating a serious ongoing problem. An agreement with pharmaceutical companies, like the one we have described, might add an element of financial predictability for institutions such as the NISSRP. However, such an agreement can easily result in an increased economic burden for health care beneficiaries, and without any improvement in the services that they receive. This type of agreement requires extensive mechanisms for control, follow-up, and updating, and it also risks making nonrational drug prescribing the accepted rule. While perhaps feasible, the requirements for this kind of agreement are actually very difficult to put into place, requiring additional efforts from institutions such as the NISSRP.

蛋白質構造解析コンソーシアムの創薬産業ビームライン

The Pharmaceutical Industry Beamline was constructed by the Pharmaceutical Consortium for Protein Structure Analysis which was established in April 2001. The consortium is composed of 22 pharmaceutical companies affiliating with the Japan Pharmaceutical Manufacturers Association. The beamline is the first exclusive one that is owned by pharmaceutical enterprises at SPring-8. The specification and equipments of the Pharmaceutical Industry Beamline is almost same as that of RIKEN Structural Genomics Beamline I & II.

Approaches and Challenges to Use Freon Propellant Replacements

Freon propellants commonly referred to as chlorofluorocarbons (CFCs) are involved in the destruction of the ozone layer. The countries participating in the Montreal Protocol voted in 1990 to require a phase-out of CFC production by the year 2000. In 1992, the phase-out was moved forward to 1996. There are two pharmaceutical consortia evaluating replacements for CFCs in metered dose inhalers (MDIs), which include the development of HFA-134a by IPACT-I and the development of HFA-227 by IPACT-II. Neither of these replacement propellants contains chlorine so they have no potential to destroy ozone. In addition, each of these new propellants has less global warming potential than currently used CFCs. The IPACT organizations have comprehensive testing programs developed from consultation with global regulatory authorities. These programs are largely complete with respect to subchronic evaluations and current work is focused on long-term evaluations. Results have indicated that the new propellants are extremely ...