Patent policy and public health in developing countries: lessons from Japan

The introduction of pharmaceutical product patents in India and other developing countries is expected to have a significant effect on public health and local pharmaceutical industries. This paper draws implications from the historical experience of Japan when it introduced product patents in 1976. In Japan, narrow patents and promotion of cross-licensing were effective tools to keep drug prices in check while ensuring the introduction of new drugs. While the global pharmaceutical market surrounding India today differs considerably from that of the 1970's, the Japanese experience offers a policy option that may profitably be considered by India today. The Indian patent system emphasizes the patentability requirement in contrast to the Japanese patent policy which relied on narrow patents and extensive licensing. R&D by local firms and the development of local products may be promoted more effectively under the Japanese model.

Inferring the Effects of Vertical Integration from Entry Games : An Analysis of the Generic Pharmaceutical Industry

This paper introduces a novel method for examining the effects of vertical integration. The basic idea is to estimate the parameters of a vertical entry game. By carefully specifying firms' payoff equations and constructing appropriate tests, it is possible to use estimates on rival profit effects to make inferences about the existence of vertical foreclosure. I estimate the vertical entry model using data from the US generic pharmaceutical industry. The estimates indicate that vertical integration is unlikely to generate anticompetitive foreclosure effects. On the other hand, significant efficiency effects are found to arise from vertical integration. I use the parameter estimates to simulate a policy that bans vertically integrated entry. The simulation results suggest that such a ban is counterproductive; it is likely to reduce entry into smaller markets.

Public–private interaction in pharmaceutical research

We empirically examine interaction between the public and private sectors in pharmaceutical research using qualitative data on the drug discovery process and quantitative data on the incidence of coauthorship between public and private institutions. We find evidence of significant reciprocal interaction, and reject a simple “linear” dichotomous model in which the public sector performs basic research and the private sector exploits it. Linkages to the public sector differ across firms, reflecting variation in internal incentives and policy choices, and the nature of these linkages correlates with their research performance.

Development of a Household Pharmaceutical Waste Collection Program for Atlanta, Georgia: An Analysis of Risk Factors and Public Awareness with a Comprehensive Collection Plan

Decades of mixed messages from three federal agencies left many Americans unaware of the hazards associated with the indiscriminate disposal of unwanted or expired medicines. For this Capstone project, a systematic review of state and federal regulations was undertaken to determine how these laws obstruct household pharmaceutical waste collection. In addition, a survey of 654 Atlanta residents was conducted to evaluate unwanted medicine disposal habits, awareness of pharmaceutical compounds being detected in drinking water, surface, and ground waters, and willingness to participate in a household pharmaceutical waste collection program. Survey responses were tabulated to provide overall results and by age group, gender, and race. A household pharmaceutical waste collection plan was developed for the city and included as an appendix.

The European Pharmaceutical Industry in a Global Economy: what drives EU exports of pharmaceuticals?. Bruges European Economic Research Papers (BEER) 31/2015.

The pharmaceutical industry is one of the most competitive sectors in the European Union. With its substantial investments in research and development, this industry represents a key asset for the European economy and a major source of growth and employment. However, despite the importance of the pharmaceutical sector for the European Union, few researchers have attempted to assess the determinants of the EU exports of pharmaceuticals. This paper aims at filling the aforementioned gap by examining what drives EU exports of pharmaceuticals. In order to tackle this question, this paper has derived hypotheses from the Gravity Model of Trade and the relevant academic literature on pharmaceuticals. Based on an econometric analysis, the research sheds light on the complex interaction of factors influencing the EU exports of pharmaceuticals. The paper finds that the protection of intellectual property in the receiving countries, their economic size, the importance of their health sector, and the quality of infrastructures constitute major drivers to the EU exports of pharmaceuticals. On the contrary, the research shows that transports costs as well as tariff barriers and non-tariff barriers tend to hinder the EU exports of pharmaceuticals.

A perspective on Australia's national medicines policy

There is international interest in Australia's health care system for prescription medicines. The issue is particularly topical in Canada with the debate following publication of the Romanow Report into the future of health care in Canada. This Report recommended a new National Drug Agency. Australia has a National Medicines Policy with four arms-quality, safety and efficacy of medicines; equity of access; a viable and responsible pharmaceutical industry; quality use of medicines. The four arms of the Policy are interlinked and interdependent for optimal functioning. In this paper, an overview of how the prescription drug system in Australia works is presented. The manuscript focuses upon specific aspects of the Policy, describing how it functions and some of the processes integral to success, from the viewpoint of the author. The discussion includes some of the advantages of Australia's system for pharmaceuticals as well as some of the problems, as these present opportunities for development and change

Innovation in the pharmaceutical industry:a study of the effects of regulation on the U.K. pharmaceutical industry

A history of government drug regulation and the relationship between the pharmaceutical companies in the U.K. and the licensing authority is outlined. Phases of regulatory stringency are identified with the formation of the Committees on Safety of Drugs and Medicines viewed as watersheds. A study of the impact of government regulation on industrial R&D activities focuses on the effects on the rate and direction of new product innovation. A literature review examines the decline in new chemical entity innovation. Regulations are cited as a major but not singular cause of the decline. Previous research attempting to determine the causes of such a decline on an empirical basis is given and the methodological problems associated with such research are identified. The U.K. owned sector of the British pharmaceutical industry is selected for a study employing a bottom-up approach allowing disaggregation of data. A historical background to the industry is provided, with each company analysed or a case study basis. Variations between companies regarding the policies adopted for R&D are emphasised. The process of drug innovation is described in order to determine possible indicators of the rate and direction of inventive and innovative activity. All possible indicators are considered and their suitability assessed. R&D expenditure data for the period 1960-1983 is subsequently presented as an input indicator. Intermediate output indicators are treated in a similar way and patent data are identified as a readily-available and useful source. The advantages and disadvantages of using such data are considered. Using interview material, patenting policies for most of the U.K. companies are described providing a background for a patent-based study. Sources of patent data are examined with an emphasis on computerised systems. A number of searches using a variety of sources are presented. Patent family size is examined as a possible indicator of an invention's relative importance. The patenting activity of the companies over the period 1960-1983 is given and the variation between companies is noted. The relationship between patent data and other indicators used is analysed using statistical methods resulting in an apparent lack of correlation. An alternative approach taking into account variations in company policy and phases in research activity indicates a stronger relationship between patenting activity, R&D Expenditure and NCE output over the period. The relationship is not apparent at an aggregated company level. Some evidence is presented for a relationship between phases of regulatory stringency, inventive and innovative activity but the importance of other factors is emphasised.

A társadalmi felelősségvállalás tendenciái a gyógyszeriparban = Corporate Social Responsibility in the Pharmaceutical Industry

A gyógyszeripar egyszerre tartozik a leginkább csodált és a legtöbbet kritizált iparágak közé. Az iparág produktumai életeket menthetnek, emberek millióinak könnyítik meg az életét, és a gyógyszereknek köszönhetően számos korábbi gyilkos kór vált ismeretlenné a fejlett országokban. Mindezek mellett azonban az iparágat számos kritika is éri: túl magas árakkal dolgozik, etikátlan promóciós praktikákkal él, magára hagyja a világ szegényeit, kétes etikai hátterű klinikai kísérleteket végez, és állami intézményekkel köt háttéralkukat. A CSR koncepciójának intenzív jelenléte az iparágban többek között a fenti ellentmondásokra adott válaszként is értelmezhető (erre utalnak a későbbiekben bemutatandó kvalitatív kutatás eredményei is). Az alábbi tanulmányban arra teszek kísérletet, hogy feltárjam, a magyar gyógyszeripar szereplői hogyan látják társadalmi felelősségüket, milyen programokat valósítanak meg CSR kezdeményezéseik során. Milyen kihívások várnak a gyógyszeripari cégek vezetőire, és milyen dilemmákkal szembesülnek társadalmi felelősségvállalásuk kapcsán? Mennyiben találhatók meg a nemzetközi kutatások által feltárt nézőpontok a hazai cégek CSR interpretációiban, illetve vannak-e a magyar gyógyszeriparnak sajátosságai ebben a tekintetben? / === / The pharmaceutical industry is among the most admired and most criticized of all. The pharmaceutical products can save lives, they make the lives of millions of people lot easier, and many legendary diseases were eradicated from the world thanks to the innovations of the industry. However, the industry receives many criticisms in the same time: the big pharma is often accused of working with high prices, applying immoral marketing practices, abandoning the poor, having a no money-no cure attitude, doing ethically questionable clinical trials, etc. This contradiction can be one reason why pharmaceutical industry is among the most CSR-oriented sectors. In this paper I investigate what the CSR initiatives and activities of the pharmaceutical companies look like in Hungary. How do the managers of these firms react to the challenges of the industry? What is their perception about the contradictions described in the previous paragraph? Are there Hungarian peculiarities regarding CSR principles and actions? During research I also wanted to identify patterns of CSR activities of the Hungarian pharmaceutical firms in order to create clusters that group companies with similar characteristics.

Determinants of pharmaceutical innovation diffusion: social contagion and prescribing characteristics

This article studies the determinants of pharmaceutical innovation diffusion among specialists. To this end, it investigates the influences of six categories of factors—social embeddedness, socio-demography, scientific orientation, prescribing patterns, practice characteristics, and patient panel composition—on the use of new drugs for the treatment of type 2 diabetes mellitus in Hungary. Here, in line with international trends, 11 brands were introduced between April 2008 and April 2010, outperforming all other therapeutic classes. The Cox proportional hazards model identifies three determinants—social contagion (in the social embeddedness category) and prescribing portfolio and insulin prescribing ratio (in the prescribing pattern category). First, social contagion has a positive effect among geographically close colleagues—the higher the adoption ratio, the higher the likelihood of early adoption—but no influence among former classmates and scientific collaborators. Second, the wider the prescribing portfolio, the earlier the new drug uptake. Third, the lower the insulin prescribing ratio, the earlier the new drug uptake—physicians’ therapeutic convictions and patients’ socioeconomic statuses act as underlying influencers. However, this finding does not extend to opinion-leading physicians such as scientific leaders and hospital department and outpatient center managers. This article concludes by arguing that healthcare policy strategists and pharmaceutical companies may rely exclusively on practice location and prescription data to perfect interventions and optimize budgets.

Evaluating health policy and legal responses : how to reduce barriers and improve access to orphan drugs for rare diseases in Canada

Abstract : Rare diseases are debilitating conditions often leading to severe clinical manifestations for affected patients. Orphan drugs have been developed to treat these rare diseases affecting a small number of individuals. Incentives in the legal framework aimed to recoup the research and development cost of orphan drugs for pharmaceutical companies have been implemented in the United States and the European Union. At the present time, Canada is still lacking a legal and policy framework for orphan drugs. Several problems at the federal and provincial levels remain: lack of research funds for rare diseases, discrepancies on orphan drug policies between provinces, difficulties to access and reimburse these high price drugs. Recommendations and measures are proposed, such as a pan-Canadian (national) scientific committee to establish evidence-based guidelines for patients to access orphan drugs uniformly in all provinces with a disease specific registry, a formal agreement for a centralized Canadian public funding reimbursement procedure, and increasing the role of “guardian” for prices by the Patented Medicines Review Board in Canada. These recommendations and measures will be beneficial for the implementation of a policy framework for orphan drugs in Canada.

25 years of knowledge creation processes in pharmaceutical contemporary trends

The pharmaceutical industry is knowledge and research-intensive. Due to technological, socio-political and organisational changes there has been a continuous evolution in the knowledge base utilized to achieve and maintain competitive advantages in this global industry. There is a gap in analysing the linkages and effects of those changes on knowledge creation processes associated with pharmaceutical R&D activities. Our paper looks to fill this gap. We built on an idiosyncratic research approach – the systematic literature review – and looked to unearth current trends affecting knowledge creation in international/global pharmaceutical R&D. We reviewed scientific papers published between 1980 and 2005. Key findings include promising trends in pharmaceutical innovation and human resource management, and their potential implications on current R&D practices within the pharmaceutical industry, from managerial and policy-making perspectives.

Community pharmacists’ understanding, attitudes, practice and perceived barriers related to providing pharmaceutical care: a questionnaire-based survey in Macao

Purpose: To explore the knowledge, attitudes, practice and perceived barriers of community pharmacists regarding provision of pharmaceutical care as well as provide recommendations on how to advance the service during the early stage of development in Macao. Methods: A questionnaire comprising 10 items was used to collect respondents’ demographic information and to evaluate their understanding of pharmaceutical care, attitude towards service provision, current practice and perceived barriers. Descriptive and comparative analysis of the results was conducted. Results: While 95 % of the participating pharmacists agreed that patients’ health was their primary responsibility, only 57 % believed that they can provide better pharmaceutical care in the future. The majority spent most of their work time counselling patients (90 %) and checking prescription (70 %). Only a small portion monitored adverse drug reaction and drug compliance (44 %), engaged in health screening or drug safety promotion (20 %) or maintained patient medication records (4 %). Insufficient communication with physicians (90 %), lack of time (79 %) and lack of physical space at the pharmacy (76 %) were considered the most significant barriers. Conclusion: A suboptimal level of pharmaceutical care is provided by pharmacists in Macao. Considering the barriers identified and integrating other country experiences, establishing an enabling atmosphere using policy and regulatory measures is the fundamental element for advancing pharmaceutical care by community pharmacists.