Marketing Of Pharmaceutical Products Research Articles

Consumer Willingness to Pay for Dengue Vaccine (CYD-TDV, Dengvaxia®) in Brazil; Implications for Future Pricing Considerations.

Introduction and Objective: Dengue virus is a serious global health problem with an estimated 3.97 billion people at risk for infection worldwide. In December 2015, the first vaccine (CYD-TDV) for dengue prevention was approved in Brazil, developed by Sanofi Pasteur. However, given that the vaccine will potentially be paid via the public health system, information is need regarding consumers’ willingness to pay for the dengue vaccine in the country as well as discussions related to the possible inclusion of this vaccine into the public health system. This was the objective of this research.Methods: We conducted a cross-sectional study with residents of Greater Belo Horizonte, Minas Gerais, about their willingness to pay for the CYD-TDV vaccine.Results: 507 individuals were interviewed. These were mostly female (62.4%) had completed high school (62.17%), were working (74.4%), had private health insurance (64.5%) and did not have dengue (67.4%). The maximum median value of consumers’ willingness to pay for CYD-TDV vaccine is US$33.61 (120.00BRL) for the complete schedule and US$11.20 (40.00BRL) per dose. At the price determined by the Brazil’s regulatory chamber of pharmaceutical products market for the commercialization of Dengvaxia® for three doses, only 17% of the population expressed willingness to pay for this vaccine.Conclusion: Brazil is currently one of the largest markets for dengue vaccine and the price established is a key issue. We believe the manufacturer should asses the possibility of lower prices to reach a larger audience among the Brazilian population.

Analytical Method Development in Pharmaceutical Research: Steps involved in HPLC Method Development

High performance liquid chromatography (HPLC) has proven to one of the major analytical technique used in the qualitative and quantitative analysis of drugs worldwide. Majority of drugs prescribed in official pharmacopoeias are being analyzed HPLC. Method development and validation is the essential part in the drug development programme in pharmaceutical industries and are associated with various steps such as preformulation, formulation, production, quality control and quality assurance and marketing of pharmaceutical products. Analytical method development is complicated process which takes time from few hours to months. This review paper covers the basic practical aspects of HPLC and gives guidance on how to develop HPLC analytical methods. This review provides the brief introduction, need and various steps involved in HPLC analytical method development.

VP49 Brazilian Consumer Willingness To Pay For Dengue Vaccine (CYD-TDV)

INTRODUCTION:Dengue virus is a serious global health problem with an estimated 3.97 billion people at risk for infection worldwide. In December 2015, the first vaccine (CYD-TDV) for dengue prevention was approved in Brazil, developed by Sanofi Pasteur (1). However, given that the vaccine will potentially be paid via the public health system, information is needed regarding consumers willingness to pay for the dengue vaccine in the country, as well as discussions related to the possible inclusion of this vaccine into the public health system at prices suggested by the manufacturer. This was the objective of this research.METHODS:We conducted a cross-sectional study with residents of Greater Belo Horizonte, Minas Gerais, about their willingness to pay for the CYD-TDV vaccine. Respondents had to be over 18 years and not currently have the disease although they may have had dengue in the past (2,3).RESULTS:Five-hundred and seven individuals were interviewed, who were mostly female (62.4 percent), had completed high school (62.2 percent), were working (74.4 percent), had private health insurance (64.5 percent) and did not have dengue (67.4 percent). The maximum median value of consumers willingness to pay for the CYD-TDV vaccine, assuming vaccine efficacy against virologically-confirmed symptomatic dengue illness of approximately 60 percent, is USD33.61 (BRL120.00) for the complete 3-course schedule and USD11.20 (BRL40.00) per dose. At the price currently being assessed by the Brazil's regulatory chamber of pharmaceutical products market (CMED) for Dengvaxia® for three doses, only 17 percent of the population expressed a willingness to pay for the vaccine at this price.CONCLUSIONS:Brazil is currently one of the largest markets for dengue vaccine in the world and the price established is a key issue. The manufacturer should asses the possibility of lowering its price in Brazil to reach a larger audience among the Brazilian population, especially as other public health activities to control the disease will continue.

Unhealthy marketing of pharmaceutical products: An international public health concern.

I consider the current state of pharmaceutical marketing vis-à-vis ethical and legal standards and advocate measures to improve it. There is abundant evidence of unethical or illicit marketing. It fuels growing concerns about undue corporate influence over pharmaceutical research, education, and consumption. The most extensive evidence of industry transgressions comes from the United States (US), where whistle-blowers are encouraged by financial rewards to help uncover illicit marketing and fraud. Outside the US increasing evidence of transgressions exists. Recently I have observed a range of new measures to align pharmaceutical marketing practices with ethical and legal standards. In the interest of public health, I highlight the need for additional and more profound reforms to ensure that information about medicines supports quality and resource-efficient care.

For the Establishment of an Informative Support Framework in Pharmacies: Informative Support System for Diabetes

According to the Japanese revitalization strategy endorsed by the government in June, 2013, pharmacies are expected to play an active role as the hub of health information. But this is not sufficiently organized: an infrastructure for providing neutral information which becomes the basis of such health information is not yet established for healthcare professionals, patients and consumers. As for drug information available subsequent to the marketing of pharmaceutical products, information from the pharmaceutical companies including Package Inserts and Interview-forms are often found. However, though such information from companies is important, it is necessary for healthcare professionals and patients to have access to the information evaluated by a trustworthy third party. With overseas distribution, the dissemination of drug information is provided by third parties, which are independent of regulatory agencies. For example, National Health Service (NHS) Evidence in the UK offers wide-ranging information based on evidence from a disease to pharmaceutical products, and is a widely available information source for healthcare professionals, patients and consumers. With regard to therapeutic medications, drug information and health foods in the Japanese community, it is necessary for patients and healthcare professionals that we establish neutral and common systematic information based on the research evidence. By providing information on the Internet, which enables people to access the information easily and to assess a product's usefulness objectively, we hope to eventually develop a system that ensures a patient's safety in the use of drugs.

Laboratorios Andr�maco: Origins of the First Subsidiary of a Spanish Pharmaceutical Multinational i

Laboratorios Andromaco was a Spanish pharmaceutical company that opened a commercial subsidiary in the United States in the early months of 1929. It was located right in the heart of Manhattan, at 11 West 47 th Street, in front of the New York Public Library. Despite the Wall Street crash, it remained open until 1946. The owner was the pharmacist-entrepreneur Fernando Rubio Tuduri (1900–1994). It was the first foreign direct investment made by a Spanish pharmaceutical multinational in the United States, using a maquila-style operation to export Spanish products made in the USA to Central American markets. Nothing has been published about this until now. Only interviews with Enrique and Merce Rubio Boada (son and daughter of Fernando Rubio), digitalized sources from the company held by the Fundacio Rubio Tuduri in Mahon, Minorca, and hard-to-access secondary sources have made the recovery of this history possible. The company closed its doors in the US and expanded in South American markets after World War II, but the short history of their investment in the United States reveals the potential and international capabilities of Spanish pharmaceutical companies before the Spanish Civil War. Moreover, it reveals how the Spanish Civil War was a disaster for millions of people but in some special cases it became an opportunity for companies in the science industries. Few pharmaceutical firms like Andromaco, with entrepreneurs, resources, and a long-term vision, took the decision to invest in the most profitable (though also the most difficult) market for pharmaceutical products in the world: the United States. Andromaco was created in Barcelona in 1923 by two scientist-entrepreneurs (Raul Roviralta and Fernando Rubio Tuduri). A nutritional product called Glefina (made with Norwegian cod oil from Alesund and sugar) brought the small firm considerable success in sales in Spain in the mid-1920s. Making use of impressive networks (with the Spanish royal family, Catalan political elites, and the medical and pharmaceutical profession in Spain and Germany) and innovative commercial approaches (sending free samples to selected clients like King Alfonso XIII’s family circle and Dr Gregorio Maranon) were key business strategies during those years. The commercial subsidiary had two employees that coordinated the outsourcing of the production to local US producers, with exports of their US-made Andromaco products going to Central American clients. Those clients loved buying a US-made product designed and sold by a Spanish pharmacist living in Long Island, with an office in Manhattan, who frequently travelled from the US to Latin America in the tough years of the Depression

English

The importance of branding as a tool for differentiation in the highly competitive pharmaceutical industry in Ghana has come to the fore due to competition and the influx of fake drugs. The purpose of this study was to assess the perception of managers about the strategic role branding plays in the marketing of pharmaceutical products in Ghana. Sixty respondents were sampled from three pharmaceutical companies. A structured questionnaire was used to collect data from respondents. Data was analysed using descriptive and inferential statistic using Statistical Package for the Social Sciences (SPSS) software. The findings of the study indicate respondents perceive that branding plays a significant role in the sale of pharmaceutical products, helps consumers to easily identify with the brand and helps pharmaceutical companies in communicating tangible differences of their brands to differentiate them from competing brands. The study further revealed that there exists a significant relationship between perceived roles of branding and marketing of pharmaceutical products. Finally, the study clearly shows that the major challenge confronting pharmaceutical companies in Ghana is the sale of imitated pharmaceutical products on the market. The study recommends that management of pharmaceutical companies seek government support in terms of stricter enforcement of laws governing imitation of pharmaceutical products and also improve upon their quality and packaging. Key words: Branding; consumer decision making, pharmaceutical industry, Ghana.

PARTICULARITIES OF MODERN PHARMACEUTICAL PROMOTION

Pharmaceutical products market is one of the most saturated consumers’ markets. Characteristic features of it are: high competition, fierce struggle for the customer, specific technologies of promotion. In conditions of globalization and increase in competition both in world pharmaceutical market and in the market of medicines and goods of medical purpose in Russia modern marketing techniques of promotion of the products to the end consumers are the key tools for strengthening market positions – both of producers of pharmaceutical goods and their suppliers, distributors, big whole-sale companies. Among main tools of promotion are: advertising, public relations, stimulation of sales on the market of medicines, personal sales, computer technologies. The article describes different technologies of promotion of medicines: indoor-advertising, hot lines, pharmaceutical exhibitions, packing. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-1

Legal and Political Competitiveness for Pharmaceuticals

The pharmaceutical industry operates both as an important business sector and a vital contributor to the delivery of health services worldwide. In 2012, the total world market for pharmaceutical products amounted to nearly US$1 trillion (see Table 1). Although global in scope, some 60 percent of sales were in North America and Europe, which comprise only 15 percent of the world’s population. The industry plays an important economic role in many countries by contributing to national income and employing hundreds of thousands of educated workers. Studies in the United States and Germany have found that for each direct employee, the pharmaceutical industry also generates between 1.6 and 3.5 jobs in supporting industries [7, 9]. While Germany long boasted of its role as the “world’s apothecary,” firms in Switzerland, France, the United Kingdom, and the United States also have underwritten decades of research into new medicines and brought several thousand new medicines to market since the late 19th century [1]. However, since the early 2000s, a steady decline in global prescription drug sales has accompanied an international deterioration in the underlying conditions critical to pharmaceutical in novation [6]. Troubles can be found also in a declining number of new chemical or biological medicines approved for markets despite a steady rise in research spending [8]. Policy discussions in some countries reveal a shift against industry arguments that high profit margins on current drug sales are necessary to finance research into future pharmaceuticals. Countries across the OECD instead are looking for ways to reduce health spending and national pharmaceutical budgets have been held constant or even reduced. Policies including reference pricing and demands that the industry demonstrate the cost effectiveness of its products are now widespread, especially in Europe [4]. Articles in this special issue of Pharmaceuticals Policy and Law analyse factors governing the legal and competitive environment for the pharmaceutical sector. Key issues are explored across the full pharmaceutical value chain, including drug discovery, development, authorization, and marketing. The articles demonstrate widespread, typically longstanding, tensions between policies that on the one hand

Changing paradigms in the long‐term care market

Purpose – Long‐term care is getting more attention these days due to its impact on the growth of overall healthcare cost. With the implementation of the Medicare Part D prescription drug plan, the incentives and payment dynamics have changed the long‐term care market. This paper seeks to focus on the pharmaceutical market in the long‐term care space and to identify a few characteristics for the stakeholders' strategies.Design/methodology/approach – The study used the IMS data sets, complemented by the information and statistics available in the literature to isolate the long‐term care market with regard to pharmaceutical products, its characteristics and dynamics.Findings – The analysis showed that the market for pharmaceutical products in the long‐term‐care space is characterized by a couple of therapeutic classes, concentrated in a rather few geographical area in the USA. The traditional institutional based care is declining but the home health care use is increasing.Originality/value – Access to the IM...

Practice of using gifts as promotional materials for marketing of pharmaceutical products in Bangladesh: A survey conducted on general physicians and representatives from pharmaceutical companies

The present study was undertaken to find out the promotional strategies followed by the pharmaceutical companies, attitudes and responses of physicians towards these promotional activities and influence of using gifts as promotional materials on the prescribing behavior of the physicians. In the study we found that most pharmaceutical companies believe that pharmaceuticals should be promoted by their quality and availability, not by any other promotional strategies. 84.62% pharmaceutical companies believe that gifts provided by them motivate the physicians to prescribe their products whereas 87% physicians admit that they consider the image of the company and quality of the product while prescribing. We also found that 50.5% physicians preferred information more rather than attractive gifts but only 11.77% pharmaceutical companies agreed with this statement. DOI: http://dx.doi.org/10.3329/sjps.v4i2.10434 S. J. Pharm. Sci. 4(2) 2011: 13-18

Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints.

Despite regulatory restrictions, off-label marketing of pharmaceutical products has been common in the US. However, the scope of off-label marketing remains poorly characterized. We developed a typology for the strategies and practices that constitute off-label marketing. We obtained unsealed whistleblower complaints against pharmaceutical companies filed in US federal fraud cases that contained allegations of off-label marketing (January 1996-October 2010) and conducted structured reviews of them. We coded and analyzed the strategic goals of each off-label marketing scheme and the practices used to achieve those goals, as reported by the whistleblowers. We identified 41 complaints arising from 18 unique cases for our analytic sample (leading to US$7.9 billion in recoveries). The off-label marketing schemes described in the complaints had three non-mutually exclusive goals: expansions to unapproved diseases (35/41, 85%), unapproved disease subtypes (22/41, 54%), and unapproved drug doses (14/41, 34%). Manufacturers were alleged to have pursued these goals using four non-mutually exclusive types of marketing practices: prescriber-related (41/41, 100%), business-related (37/41, 90%), payer-related (23/41, 56%), and consumer-related (18/41, 44%). Prescriber-related practices, the centerpiece of company strategies, included self-serving presentations of the literature (31/41, 76%), free samples (8/41, 20%), direct financial incentives to physicians (35/41, 85%), and teaching (22/41, 54%) and research activities (8/41, 20%). Off-label marketing practices appear to extend to many areas of the health care system. Unfortunately, the most common alleged off-label marketing practices also appear to be the most difficult to control through external regulatory approaches.

Latin American Physicians’ Attitudes Toward Participation in Clinical Trials

Introduction: Latin America currently represents a relatively small but constant number of clinical sites for commercially funded studies. This article describes the profiles of sites and investigators involved in commercial clinical research and compares the results with published results of similar US investigators. In addition, the research examines investigators’ motives for taking part in clinical research and the concerns these investigators have with the operational challenge of conducting these studies. Methods: The data were drawn from a survey of investigators involved in commercially funded clinical trials in Argentina, Brazil, Chile, Colombia, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Peru and Venezuela. The questionnaire comprised a list of 12 reasons related to why an investigator might participate in a phase III clinical trial of a new compound being tested by a pharmaceutical company, and respondents were asked to rate the importance of each reason on a scale of 12–10, with 1 being not important at all and 10 being very important. Surveys were conducted in 2008–9 and data were compared with a published analysis of US clinical investigators. Factor analysis, ANOVA, chi-square, gamma statistics and approximate significance measures were used to analyse the survey responses. All analyses were conducted using SPSS version 17. Results: The clinical experience of Latin American investigators is generally somewhat less than that of US investigators. Among other things, Latin America conducts a vastly greater portion of its research in hospitals compared with the US; few investigators work in private practice, in contrast to the US pattern. In addition, a far larger percentage of clinical research is conducted at dedicated sites than is the case in the US. Latin American investigators, along with their US counterparts, stress the importance of taking part in medical innovation as the primary reason for their involvement in commercially funded clinical research. Latin American investigators especially value the opportunity to work with other physicians on the study. Financial considerations, while not unimportant in Latin America, are secondary to this desire to be a part of medical innovation. Latin American investigators do differ somewhat from the US respondents in the importance they place on certain operational aspects of a clinical study. For instance, Latin American investigators are distinctly more concerned that a major pharmaceutical company sponsors the study than is the case with US investigators. In general, with the one noteworthy exception of serious adverse event reporting, Latin American and US investigators seem to have fairly comparable areas of dissatisfaction in the conduct of clinical trials. Conclusions: Latin America represents a particularly attractive growth market for pharmaceutical products. With a population in the hundreds of millions the demand for prescription drugs will make the need to conduct clinical research there essential for global pharmaceutical companies. Understanding the motivation of Latin American investigators should be valuable in helping such companies develop their clinical trial strategies and tactics.

<b>Política de propriedade intelectual em medicamentos: uma visão do início da década de 2000</b>

This paper aims at an analysis of the intellectual property policy in the health field by emphasizing the program of production and distribution of antiretrovirals and the generic drugs market, also reviewing the process of articulation and implementation of the intellectual property policy in this sector. From a methodological viewpoint, the paper favors the analysis of data related to the structuring of the pharmaceutical products market and of impacts both from the new institutionality and the intellectual property policies developed by the Ministry of Health in the first half of the 2000’s decade.

Intellectual property policy on pharmaceutical products: a view in the beginning of the 2000 decade

This paper aims at an analysis of the intellectual property policy in the health field by emphasizing the program of production and distribution of antiretrovirals and the generic drugs market, also reviewing the process of articulation and implementation of the intellectual property policy in this sector. From a methodological viewpoint, the paper favors the analysis of data related to the structuring of the pharmaceutical products market and of impacts both from the new institutionality and the intellectual property policies developed by the Ministry of Health in the first half of the 2000’s decade.

The Use Of Market Intelligence Tools To Optimize The Economic Impact Of A Chronic Disease In Mexico

The pharmaceutical products market in Mexico involves four main actors: health providers, health payers, patients and pharmaceutical companies. The relationship between health providers and the pharmaceutical companies that supply the products required to prevent and treat illnesses is of particular interest. This relationship can be described within the frame of the treatment of diabetes mellitus (DM), a major health issue in most countries, and an urgent one in Mexico. The financial impact of the treatment of diabetes could be optimized through the use of the tools provided by market intelligence systems and best clinical practices. These results would also have an impact on major health metrics for the relevant population.

Accuracy of drug advertisements in medical journals under new law regulating the marketing of pharmaceutical products in Switzerland

BackgroundNew legal regulations for the marketing of pharmaceutical products were introduced in 2002 in Switzerland. We investigated whether claims in drug advertisements citing published scientific studies were justified by these studies after the introduction of these new regulations.MethodsIn this cross-sectional study, two independent reviewers screened all issues of six major Swiss medical journals published in the year 2005 to identify all drug advertisements for analgesic, gastrointestinal and psychopharmacologic drugs and evaluated all drug advertisements referring to at least one publication. The pharmaceutical claim was rated as being supported, being based on a potentially biased study or not to be supported by the cited study according to pre-specified criteria. We also explored factors likely to be associated with supported advertisement claims.ResultsOf 2068 advertisements 577 (28%) promoted analgesic, psychopharmacologic or gastrointestinal drugs. Among them were 323 (56%) advertisements citing at least one reference. After excluding multiple publications of the same drug advertisement and advertisements with non-informative references, there remained 29 unique advertisements with at least one reference to a scientific study. These 29 advertisements contained 78 distinct pairs of claims of analgesic, gastrointestinal and psychopharmacologic drugs and referenced studies. Thirty-seven (47%) claims were supported, 16 (21%) claims were not supported by the corresponding reference, and 25 (32%) claims were based on potentially biased evidence, with no relevant differences between drug groups. Studies with conflict of interest and studies stating industry funding were more likely to support the corresponding claim (RR 1.52, 95% CI 1.07–2.17 and RR 1.50, 95% CI 0.98–2.28) than studies without identified conflict of interest and studies without information on type of funding.ConclusionFollowing the introduction of new regulations for drug advertisement in Switzerland, 53% of all assessed pharmaceutical claims published in major medical journals are not supported by the cited referenced studies or based on potentially biased study information. In light of the discrepancy between the new legislation and the endorsement of these regulations, physicians should not trust drug advertisement claims even when they seem to refer to scientific studies.

Ticking time bomb: Poorly managed product safety

A key paradigm of the pharmaceutical industry has changed. With increased attention towards ensuring the safety of drugs and medical devices, the ability of firms to conduct risk management based on high-quality pharmacovigilance (PV) – starting early on in clinical development – is becoming increasingly important to the successful marketing of pharmaceutical products. Indeed, the repercussions of recent litigation regarding the Cox-II class of compounds are just an example of how safety management will continue to impact the marketability of both existing and future drugs and medical devices. Firms without satisfactory safety data handling and reporting operations in place are now vulnerable to significant business risks with potential long-term drug safety issues. While this has often been considered a necessity, a small proportion of companies have actively pursued excellence in this area. Companies are taking different approaches to address the increasing demands in this area – from focusing on efficiency to driving higher levels of rigorousness in their PV practices. PRTM various has identified a number of key practices common among firms demonstrating excellence within PV. Results of a pioneering study of 23 top Western and Japanese pharmaceutical companies confirm that, overall, the industry has yet to achieve both a high-level of quality and productivity in firms' PV operations. As the burden for conducting efficient, effective PV becomes increasingly difficult, senior management will seek targeted improvement strategies in order to balance a high level of efficiency with a high level of rigorousness among their safety data handling practices. With this in mind, this article seeks to demonstrate how a company can most effectively comply with ever-changing requirements, strategically improve the thoroughness of the practices within their PV operations and achieve greater efficiency. In addressing these challenges, top management will be focusing a greater amount of attention on one more thing – pharmacovigilance.

Innovationseffekte von Patentrechtsreform und neuer Festbetragsregel

Der Pharmamarkt ist einer der am starksten regulierten Markte. Seitens der Hersteller von pharmazeutischen Praparaten wird immer wieder argumentiert, dass regulatorische Eingriffe des Staates zu einer Senkung der Innovationstatigkeiten der Hersteller im Inland fuhren. In diesem Beitrag untersuchen wir zwei bedeutende neuere Anderungen des regulatorischen Rahmens im Hinblick auf die von ihnen ausgehenden Anreize auf das Innovationsverhalten der Pharmahersteller. Es handelt sich dabei um Regulierungsmasnahmen mit vollkommen verschiedenen Hintergrunden. Zum einen befassen wir uns mit den jungst in Kraft getretenen Anderungen des Patentgesetzes, insbesondere den Neuregelungen bei der Patentierbarkeit biotechnologischer Innovationen in der Folge der EU-Biopatentrichtlinie. Man wollte hiermit den (teilweise umstrittenen) naturwissenschaftlich-technischen Entwicklungen in diesem Bereich gerecht werden und Rechtsunsicherheiten beseitigen. Zum anderen befassen wir uns mit dem Gesundheitssystemmodernisierungsgesetz (GMG), das vor allem der Steigerung der Effizienz der gesetzlichen Krankenversicherung dienen soll. Wir kommen zu dem Ergebnis, dass sich die Regelungen von GMG und PatG hinsichtlich der von ihnen ausgehenden Innovationsanreize in einigen Bereichen erganzen, es in anderen Bereichen jedoch zur wechselseitigen Aufhebung positiver Innovationseffekte kommen kann, die ansonsten von je einer der beiden genannten Regelungen ausgehen wurden.

Is Evidence-Based Medicine Evidence Based?

Is Evidence-Based Medicine Evidence Based?