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      Are good intentions putting the vaccination ecosystem at risk?

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          ABSTRACT

          Vaccination is made possible by an interconnected and interdependent ecosystem of vaccine producers, vaccination policy makers and implementers, and vaccine procurers and funders. The future of vaccination depends on the continued health of this ecosystem and its ability to produce, purchase, deliver, and innovate. However, the number of vaccine producers that also do significant research and development has decreased over the last several years. Many of these R&D-based producers have been forced to cease production of critical vaccines, despite global shortages, so that in several cases only one or two producers remain. We discuss the reasons for these changes and what might be done to maintain a healthy vaccination ecosystem.

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          Why is big Pharma getting out of antibacterial drug discovery?

          Since the advent of the antibiotic era in the late 1940s drug discovery and development has evolved into an expensive, time consuming, cumbersome and bureaucratic process involving multiple interest groups such as pharmaceutical manufacturers, governmental regulatory authorities, patent officers, academic and clinical researchers and trial lawyers. It would seem that the least involved among the interest groups are the consumers of health care themselves. Politicians and the public alike complain loudly about drug prices although fewer and fewer new therapies are being developed. The cost and complexities of drug discovery and development have shifted the investment equation away from the development of drugs targeting short course therapies for acute diseases and towards long-term treatment of chronic conditions. Coupled with the failure of large investments into target-based approaches to produce novel antibacterial agents, companies large and small have exited from this field despite a growing clinical need.
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            Assessing Dynamic Efficiency: Theory and Evidence

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              Differential pricing for pharmaceuticals: reconciling access, R&D and patents.

              This paper reviews the economic case for patents and the potential for differential pricing to increase affordability of on-patent drugs in developing countries while preserving incentives for innovation. Differential pricing, based on Ramsey pricing principles, is the second best efficient way of paying for the global joint costs of pharmaceutical R&D. Assuming demand elasticities are related to income, it would also be consistent with standard norms of equity. To achieve appropriate and sustainable price differences will require either that higher-income countries forego trying to "import" low drug prices from low-income countries, through parallel trade and external referencing, or that such practices become less feasible. The most promising approach that would prevent both parallel trade and external referencing is for payers/purchasers on behalf of developing countries to negotiate contracts with companies that include confidential rebates. With confidential rebates, final transactions prices to purchasers can differ across markets while manufacturers sell to distributors at uniform prices, thus eliminating opportunities for parallel trade and external referencing. The option of compulsory licensing of patented products to generic manufacturers may be important if they truly have lower production costs or originators charge prices above marginal cost, despite market separation. However, given the risks inherent in compulsory licensing, it seems best to first try the approach of strengthening market separation, to enable originator firms to maintain differential pricing. With assured market separation, originators may offer prices comparable to the prices that a local generic firm would charge, which eliminates the need for compulsory licensing. Differential pricing could go a long way to improve LDC access to drugs that have a high income market. However, other subsidy mechanisms will be needed to promote R&D for drugs that have no high income market.
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                Author and article information

                Journal
                Hum Vaccin Immunother
                Hum Vaccin Immunother
                KHVI
                khvi20
                Human Vaccines & Immunotherapeutics
                Taylor & Francis
                2164-5515
                2164-554X
                2016
                6 June 2016
                6 June 2016
                : 12
                : 9
                : 2469-2474
                Affiliations
                [a ]Valera Vaccines , Cambridge, MA, USA
                [b ]Vaccination Policy and Advocacy, Sanofi Pasteur , Lyon, France
                Author notes
                CONTACT Michael Watson mike.watson@ 123456valeratx.com Valera Vaccines, 320 Bent St., Cambridge, MA 02141
                [*]

                Author was affiliated with Vaccination Policy and Advocacy, Sanofi Pasteur, Lyon, France at time of writing.

                Article
                1172162
                10.1080/21645515.2016.1172162
                5027723
                27269046
                ca7aec31-f0a8-43c1-b503-f45718533c99
                © 2016 The Author(s). Published with license by Taylor & Francis Group, LLC

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted.

                History
                : 24 February 2016
                : 15 March 2016
                : 25 March 2016
                Page count
                Figures: 1, Tables: 2, References: 47, Pages: 6
                Categories
                Commentaries

                Molecular medicine
                economics,funding,health policy,non-governmental organization,vaccination program

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