Pharmaceuticals Policy and Law - Volume 15, issue 3-4
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The new international review,
Pharmaceuticals Policy and Law, appears with the aim of studying and evaluating the
legal status of medicinal products in the European Union, and its implications in other markets such as the USA and Japan, without neglecting the specific problems of developing countries.
Pharmaceuticals Policy and Law intends to participate in the process of world convergence of pharmaceutical legislation helped by a network of academic centers specializing in pharmaceutical law, without omitting a scientific, economic and social approach to medicinal products.
The specificity of medicinal products conditions their legal status. Legislation regulating other goods cannot be applied to them. To begin with, they are the result of scientific and technical innovation. Research policies determine their progress. The pharmaceutical industry is, by nature, multinational. But, next to these global trends, different traditions still remain at a national level. Within the EU, barriers to free trade in medicinal products still remain despite more than thirty years of harmonisation. The social dimension of medicinal products is complex and very significant in the preoccupations of our societies. Patenting is essential but not sufficient. The life-cycle of medicinal products is protected by professional responsibility, required in the general concept of health safety. It is important to remember their ethical dimension, including research and innovation in new fields such as genetic manipulation and biotechnology, which requires social consent to preserve human dignity and fundamental rights.
Abstract: Over the past 200 years, the real GDP in western industrialized countries rose continuously. The decisive factor of long-term economic growth is technical progress. Beside its macroeconomic importance it is the key vehicle of competition between research-based pharmaceutical companies. Further innovative drugs are an integral part of national health care systems in most industrialized countries. Innovative medicines contribute to the increase in life expectancy and an improved quality of life. To evaluate the share of…pharmacologic-technical progress in the increase in life expectancy at the micro- and macroeconomic level it is initially helpful to clarify the economic relevance of technical progress in general. This will be the purpose of chapter two. Furthermore, the discussion encompasses the different approaches to define pharmacological innovations and the associated difficulties to discriminate between the different types of innovation. The focus of chapter three is the description of incentive mechanisms, which are fundamental to the Research and Development (R&D) activities leading to innovative pharmaceuticals. Beyond that, the micro- and macroeconomic positive effects of pharmaceutical innovations will be represented and interpreted with the help of existing results stemming from selected empirical studies. The last chapter gives a detailed overview on the current empirical results, which illustrate the versatile interdependencies on macroeconomic level between health and growth. It demonstrates the channels through which better health can have growth-enhancing effects.
Abstract: Fiercely contested before, during, and after its passage, the 2010 Patient Protection and Affordable Care Act (ACA) is presently restructuring the U.S. healthcare market. This article describes the history of healthcare reform initiatives in the United States, analyzes the policy context in which the ACA was passed, and develops forecasts for the pharmaceutical market as insurance coverage grows. The institutional history of the U.S. healthcare system is revealing of the power of entrenched private interests, especially…insurance and pharmaceutical firms, and of widespread opposition to price controls on prescription drugs or other forms of care. The ACA conforms to path dependency in the U.S. health system, continuing a unique mix of public and private insurance and private delivery of care. Building on the institutional analysis, the article develops specific projections for the U.S. prescription drug market in 2015 and 2020. The article concludes with a discussion of anticipated changes to pharmaceutical market structure under the ACA and the sustainability of free-market pricing for prescription drugs in the United States.
Keywords: Health policy, pharmaceutical industry, drug prices, health insurance, affordable care act
Abstract: A medical system is anticipated, where high-quality medical services are accessible without anxieties whenever we are ill. Innovative cell-based regenerative medical/medicinal products, and tissue-engineered medical products, have been used successfully to overcome certain life-threatening diseases, and there is still a need to design/produce more of these products. We translational researchers in regenerative medicine have been trying to translate our scientific findings from bench to bedside. Advanced therapies with cell-based regenerative medical/medicinal products…constitute one of the most complex regulatory areas currently approached by clinical research and development in order to generate novel therapeutic applications for patients with incurable disease. We often lack the multidisciplinary skills needed to overcome intricate and complex regulatory tracks and might feel tired from pursuing clinical realization. Basic researchers and clinicians trying to translate stem cell biology into clinical practice might feel defeated by the endless regulatory requirements that apply. In order to help bridge this gap, in this chapter, we review practical issues that must be confronted in order to move from "confidence in mechanism" studies in animals into "proof of concept" studies in human. First, we briefly outline the basic definitions for cell products in the USA, EU and Japan, followed by a focused discussion of the pertinent actions of authorities in Japan.
Abstract: While the safety and availability of medicinal products for the majority of adult patients has steadily improved in recent decades, for children and people suffering from rare diseases (orphan diseases) there is a lack of approved medicinal products for these patient populations. Since the research and development of medicinal products is associated with high costs, the costs for paediatric medicinal products and medicines for rare diseases (orphan drugs) may barely be covered under normal market conditions…due to the small patient populations. In order to prevent the continued exclusion of children and persons suffering from rare diseases from medical progress and to eliminate the deficits in the research and development of medicinal products for these patient groups, the European Union created, along the lines of the U.S. model, a system of incentives and constraints. Since 2000, under Regulation (EC) No. 141/2000 (Orphan Drug Regulation) there has been an incentive system to encourage the research and development of orphan drugs. With the goal of improving the health of children in Europe, Regulation (EC) No. 1901/2006 (Paediatric Regulation) combines economic incentives with the requirement to conduct paediatric studies. This article explains and comments on the specific regulatory framework for orphan drugs and paediatric medicinal products in the European Union.
Keywords: European law, medical law, orphan drugs, orphan disease, paediatric medicinal products, Regulation (EC) No. 141/2000, EU orphan drug legislation, Regulation (EC) No. 1901/2006, EU paediatric legislation, EU pharmaceutical law, Swiss pharmaceutical law