Academic literature on the topic 'Pharmaceutical industry'

Marketing is believed to maintain a steady supply of customers, which a business requires to survive. Pharmaceuticals are a global force; they include everything from domestic items to drugs and medical supplies that can save lives. Due to the dependence of the pharmaceutical industry on specialized training, pharmaceutical education is now a requirement for medical school. Distribution or marketing of pharmaceuticals makes drugs accessible to the public. Since most customers only actively seek out pharmaceuticals or medical supplies when they have an urgent need, pharma marketing is distinctive. Today, selling medications for a profit confronts this greatest obstacle. This Review article will examine the fundamental values of pharmaceutical marketing to comprehend it better. The study will also evaluate marketing materials for pharmaceuticals. This study draws on the knowledge of various academics and pharmaceutical marketing executives. The research focuses on the marketing balance, consumer drug attitudes, eco-friendly marketing, and pharmaceutical product promotion. The author’s choices and availability may necessitate that the examined articles and literature accurately reflect the study’s implication, and the findings may be suggestive rather than conclusive.

Abstract Effluents from the pharmaceutical industry have become more concerned in recent years due to rising worries about the presence and management of pharmaceutical pollutants, raw materials, intermediates, and solvents. The pharmaceutical industry is one of the largest water consumers due to the many processes that require water. Different drug and pharmaceutical production methods result in wastewater containing a wide range of chemicals such as diclofenac, ibuprofen, carbamazepine, and clorfibric acid are commonly found in water and wastewater. As part of wastewater management, it is essential to analyse and design techniques for treating pharmaceutical wastewater in light of the limited available water resources. Furthermore, the industry mandates the reuse of water after impurities such as pharmaceuticals and other toxins. In our study, the main sources of wastewater in the pharmaceutical sector are identified, and the most effective removal technologies are examined and evaluated with the assistance of the study results. Bulk medications, pharmaceutically active substances, and other pharmaceuticals generate wastewater that utilizes much water. This effluent has been analyzed, and solutions for recovering valuable molecules to a considerable extent have been proposed. Finally, the treatment of wastewater has been addressed. Due to the shortcomings of traditional treatment techniques, the authors modified the conventional treatment procedure here using membrane bioreactors and cutting-edge techniques like ozonation, creating a hybrid wastewater treatment technology that may be a better alternative for treating pharmaceutical wastewater.

A sound generic pharmaceutical industry is vital for any country in order to increase the access and affordability of pharmaceuticals to the society at large. In this context, the generic pharmaceutical industry in Malaysia is seen as one of the potential manufacturing sectors that contributes not only to the well-being of the population but also in terms of economic output to the nation. However, the viability of the generic pharmaceutical industry in Malaysia is not free from challenges. In this paper, an overview of the Malaysian pharmaceutical industry together with the opportunities and challenges facing the generic market will be discussed.

Subject. The article addresses Germany's competitive position in the global pharmaceutical market and R&D development in the pharmaceutical industry. Objectives. The purpose is to provide a unique comprehensive study of innovative processes development in the pharmaceutical industry, using the case of German companies, explore innovative approaches to solving production problems, identify leading German companies in the field of biotechnology, and reveal the most promising areas for the development of German pharmaceuticals. Methods. We employ statistical and cartographic methods, and methods of comparative and economic analysis. Results. In their activities, German pharmaceutical companies combine the production of medicines, medical equipment, innovative developments, and implementation of various treatment, therapy and diagnostic programs. In a highly competitive global generic market, in Germany, there is a trend towards intra-industry structural transformation of pharmaceutical companies. The paper analyzed R&D spending, the geography of research centers of German pharmaceutical companies in the world, and their activities. Conclusions. The specifics of German pharmaceutical industry is the manufacture of high-tech products, using medical biotechnologies, which provides the country's advantage in the world market. Despite the presence of competitors in the generic market, i.e. India and China, German biotechnology-based pharmaceuticals continue to be in high demand among consumers as a high-quality product.

AbstractFood dyes are largely used in the process of manufacturing pharmaceutical products. The aim of such a procedure is not only to increase the attractiveness of products, but also to help patients distinguish between pharmaceuticals. Various dyes, especially organic colouring agents, may in some cases have a negative impact on the human body. They are incorporated into pharmaceutical products including tablets, hard gelatine capsules or soft gelatine capsules, lozenges, syrups, etc. This article provides an overview of the most widely used colouring agents in pharmaceuticals, their characteristics and the EU legislation which regulates their use.

The decades-old debate over pharmaceutical industry prices, profits, and innovation has again intensified. A number of events coalesced to refocus public interest on pharmaceuticals. Contributing to public concern were Bureau of Labor Statistics price index increases for pharmaceuticals far outpacing those for the products of other industries. Another prominent characteristic of the pharmaceutical industry has been its extraordinarily high reported profitability. This article examines the phenomena that precipitated the current pharmaceuticals debate, their historical antecedents, and the principal questions at issue. In the author's considered judgment, a pell-mell march toward regulation of pharmaceutical industry pricing could seriously impair the industry's incentives for investment in new products.

Welcome to the inaugural issue of Pharmaceutical Communications-a biannual, open access, and peer-reviewed journal aiming to publish high-quality research articles in the field of basic & advanced pharmaceutics and pharmaceutical technology. Pharmaceutical Communications is a biannual, peer-reviewed journal published online and in print that primarily publishes research articles and reviews that focus on basic and advanced pharmaceutics. The journal accepts manuscripts related to but not limited to, the processing of pharmaceuticals, such as crystallization, lyophilization, chemical stability of drugs, pharmacokinetics, biopharmaceutics, pro-drug developments, metabolic disposition of bioactive agents, dosage form design, pharmaceutical technology, targeted drug delivery. Other topics include pharmaceutical marketing, pharmaceutical promotion, patient-provider communication, healthcare communication, patient safety, and innovations in the pharmaceutical industry. Pharmaceutical Communications primarily accepts original research articles and reviews. However, invited editorial summaries and letters to the editor are also occasionally published. The journal provides a platform for scientists, practitioners, and healthcare professionals to share their knowledge and experiences in the field of pharmaceutics. The journal also serves as a forum for discussing and debating current issues and trends in the pharmaceutical industry. The journal welcomes submissions from academics, practitioners, and industry professionals who wish to share their research and perspectives on topics related to pharmaceutics. In the last two decades, rapid technological advances have enabled researchers to investigate arcane technological phenomena and ask more profound questions. Several pharmaceutical processes involved in the manufacturing of various dosage forms are being unraveled at a rapid pace, high resolution, and with unprecedented details. Authors carrying out investigations leveraging these technologies dealing with the composition, formulation, preparation, or manufacturing and quality control of extemporaneously compounded or commercially manufactured drugs are encouraged to submit their findings to Pharmaceutical Communications. The purpose of this journal is to provide a platform to the scientific fraternity, especially regional and national academics, where they could get their studies published after a rapid, transparent, and high-quality peer review. All the articles published in Pharmaceutical Communications will be freely available to readers immediately after publication. The open-access policy of our journal is likely to increase the readership of articles and enhance their visibility and citation potential. The journal also welcomes submissions from authors from any country. Therefore, I invite you to submit your work to Pharmaceutical Communications. We look forward to receiving your submissions! Professor Dr. Fazli Nasir Editor-In-Chief Rehabilitation Communications

Abstract Understanding the actions taken by pharmaceutical companies to counter competition requires information on how the pharmaceutical sector is built. The pharmaceutical market, mentioned in this paper, contains all companies that produce or develop pharmaceuticals or compounds that are used to produce drugs and all other participants that interact with those companies for the purpose of selling or buying a drug. It is also necessary to understand market participants and the importance of an economy for maintaining this growing sector by supporting its production and development, in order to understand the anti-competitive actions taken by pharmaceutical innovators. This case study will provide an overview of the market defined below, applied strategies, and the elements constitutive of the pharmaceutical supply chain.

Compared to importation, the pharmaceutical production in Lebanon is still weak. The generics prescription is neglected according to the medicines of origin as only big brands dominate the Lebanese market. Despite the agreements between Lebanon and other Arab countries, the nature of the regulatory environment in the latter is likely to be a substantial obstacle that prevents the access of the Lebanese medicines to the markets of the Arab countries. On the other hand, the development of a new market access remains a necessity for increasing the volume of pharmaceutical exports. This paper aims to demonstrate, based on the Lebanese market analysis the significance of supporting local pharmaceutical manufacturing since it contributes as a primary factor in reducing the cost of the medical bill for citizens, public institutions, and payers. The paper concludes with a set of recommendations to strengthen the pharmaceutical sector as well as to stimulate and develop the local production of pharmaceutical medications.

El objetivo de esta tesis ha sido la de proporcionar un análisis económico sobre varios temas que rodean l industria farmacéutica. Mientras llevaba a cabo mi investigación, observe que la mayor parte de la investigación que analizaba esta industria era descriptiva y empírica, y que existía una carencia de un riguroso análisis teórico para explicar esta investigación. Por lo tanto, el objetivo de esta tesis es claro: usando modelos teóricos de la rama de economía industrial, he intentado explicar el funcionamiento de la industria farmacéutica para intentar dar una explicación formal desde un punto de vista económico. Por esta razón, me he concentrado en dos aspectos muy relevantes. En la primera parte, que incluye Capítulos 1 y 2, he llevado a cabo un análisis sobre los posibles efectos de implementar un sistema de precios de referencia, y cual puede ser la respuesta de las empresas a este sistema. El análisis se basa tanto en las decisiones a corto (precios) y largo (I&D) plazo. En la segunda parte, que incluye el Capítulo 3, se analiza la introducción de los llamados "branded generics", o genéricos de marca. La idea es intentar explicar la razón por la cual los productores de medicamentos de marca tienden a producir genéricos de su producto original una vez finalizada la patente sobre éste. Los medicamentos genéricos han crecido en importancia durante los últimos años. Por dar un ejemplo de su importancia, la cuota de estos medicamentos en EEUU alcanza ya el 50% del total del mercado.
Un sistema de precios de referencia es un sistema de reembolso que categoriza los productos en grupos con otros productos de similares efectos terapéuticos. El precio de referencia es el precio máximo que el pagador esta dispuesto a rembolsar por cualquier producto de ese grupo. Los productores tienen libertad a la hora de elegir sus precios. Si el precio elegido es superior al precio de referencia, será el consumidor quiena pague la diferencia. Este sistema pretende trasladar parte de la responsabilidad a los pacientes, incrementado su conciencia respecto a los costes, y dotándoles de incentivos. El objetivo de este sistema es doble: primero, se pretende incrementar la competencia en precios, y segundo, que debido a este incremento en la competencia, se reduzca el gasto público en medicamentos. La opinión de la industria es sin embargo contraria a este sistema, ya que creen que reducirá sus beneficios, disminuyendo los incentivos y medios para llevar a cabo la I&D. Nótese la importancia de la relación entre los precios de referencia y la existencia de los medicamentos genéricos (mas baratos normalmente). Los medicamentos genéricos son aquéllos que entran en el mercado una vez que la patente sobre el principio activo del medicamento original ha terminado. Su principal característica es que se venden sin marca de fantasía, y suelen ser más baratos. Estos genéricos están certificados por las correspondientes Autoridades Sanitarias como sustitutivos perfectos del medicamento de marca, dado que su principio activo es el mismo. Además, son bioequivalentes en el sentido de ser estadísticamente iguales al producto original en aspectos claves de su uso terapéutico. Sin embargo, pueden variar en las características de forma, color y empaquetamiento. Si tenemos en cuenta que no todos los pacientes cambian inmediatamente al medicamento genérico cuando entran en el mercado, esto nos hace suponer que ambos productos no son sustitutivos perfectos. Una condición necesaria para una eficiente implementación de un sistema de precios de referencia es un desarrollado mercado de genéricos. La razón de esta condición es que normalmente, el precio de referencia se suele fijar alrededor del precio mas barato del grupo. Si un genérico existiera, éste probablemente tendría el precio mas bajo. Hay que añadir que esta relación no es una condición suficiente para la eficiente implantación de este sistema. Si tenemos en cuenta que este sistema de precios de referencia esta intentando reducir precios, este sistema se tendría que implantar en mercados donde exista un elevado gasto publico en medicamentos debido a precios altos más que debido a un consumo elevado. Además, la diferencia de precios entre los productos pertenecientes al grupo debe ser considerable, si no, el ahorro potencial será mínimo.
Los precios de referencia se han implementado en varios países, el primero siendo Alemania en 1989. Desde entonces, muchos otros países han seguido el ejemplo, y más recientemente, España también los ha introducido. La manera de implementación no ha sido universal, por lo que analizaremos dos formas diferentes de implementarlos.
Los efectos de esta implantación será analizado en dos etapas, para así poder tener en consideración la naturaleza de esta industria y la importancia del I&D. En términos generales, el Capítulo 1 analiza las decisiones a corto plazo (precios y cantidades), mientras que el Capítulo 2 se concentra en la decisión a largo plazo de I&D. Específicamente, lo que tratamos de estudiar es el efecto que tendrá en precios la sustitución de un sistema de copagos por un sistema de precios de referencia. El mercado estará compuesto por un duopolio, con un medicamento de marca y otro genérico, y consideraremos dos posible escenarios. En cada escenario, queremos comparar entre dos estructuras de demanda; la primera estructura de demanda es la que resulta con un sistema de copagos, donde el paciente paga una proporción (o copago) del producto mientras que la segunda es la resultante de un sistema de precios de referencia. La diferencia entre los dos escenarios es que en el primero, bajo un sistema de copagos, el paciente paga el precio entero (es decir, el copago es igual a uno), y bajo precios de referencia el paciente sólo paga la diferencia entre el precio del producto y el precio de referencia. Implícitamente, este escenario esta asumiendo que el precio de referencia se sitúa siempre por debajo tanto del precio del medicamento de marca como del genérico. El segundo escenario, sin embargo, asume que con copagos, el paciente paga una fracción del precio (no paga el precio entero). La estructura de demanda en este escenario bajo precios de referencia también se obtiene asumiendo algo distinto al escenario anterior. Esta vez, el sistema a utilizar el es español, donde implica que el precio de referencia se sitúa por encima del precio del genérico pero por debajo del precio del medicamento de marca. Así pues, si el paciente desea comprar el genérico, esta vez pagará el mismo copago que antes, pero en cambio, si desea comprar el medicamento de marca, pagará el mismo copago que antes, pero esta vez asociado al precio de referencia, más la diferencia entre el precio del medicamento de marca y el precio de referencia. El estudio también analiza como los beneficios privados y el gasto público en medicamentos varía.
Como ya se ha comentado anteriormente, la forma de introducción de precios de referencia no ha sido universal. Hallar el precio de referencia óptimo esta más allá del objetivo de esta tesis. Por esta razón, hemos construido dos escenarios para tener en cuenta diferentes métodos de introducción de este sistema.
El principal resultado obtenido en el primer escenario es que los precios de los productos son más altos con precios de referencia, así como los costes totales del sistema, pero incrementa el bienestar. El precio neto pagado por el paciente se reduce. La intuición de este resultado es que se está comparando una situación inicial donde el consumidor paga el precio entero con una situación donde el Estado financia hasta el precio de referencia. Además, este sistema actúa como una especie de subsidio para los productores. Por lo tanto, lo que tenemos es que los consumidores compran más a un precio más barato.
Bajo el segundo escenario, el que llamamos "Precios de Referencia a la Española", y donde las Autoridades Sanitarias financian una proporción de ambos productos bajo el sistema de copagos, podemos demostrar que tanto precios como la factura farmacéutica se pueden reducir, pero a expensas de disminuir los beneficios de los productores. Esto es debido a los efectos contrapuestos que un sistema de precios de referencia implantado de este modo tiene sobre los productores de medicamentos de marca y genéricos respectivamente.
El Capítulo 2 complementa el Capítulo 1, ya que proporciona una idea sobre como la decisión de innovación de las empresas farmacéuticas se puede ver afectada con la introducción de un sistema de precios de referencia. En este capítulo usamos como modelo base la estructura de demanda del capítulo anterior que hemos denominado "precios de referencia a la Española" (segundo escenario). La importancia de este capítulo viene dada por el tipo de competencia observada en esta industria: empresas compiten tanto en precios como en innovación de producto, por lo que el objetivo de este capítulo es la de modelar explícitamente la decisión de I&D de las empresas (que en este caso sería la empresa que produce el medicamento de marca), y estudiar si esta decisión se ve afectada por el cambio de un sistema de copagos a un sistema de precios de referencia. El modelo incorpora dos tipos de medicamentos: "breakthrough" (o muy innovadores) y "me-too". Los primeros son los medicamentos de nueva generación y altamente innovadores y normalmente implican un gran esfuerzo económico para obtenerlos; los segundos se consideran mejoras de productos ya existentes, y el gasto necesario en I&D para sacarlo al mercado suele ser bastante menor. Los medicamentos "breakthrough" crean un nuevo mercado, debido a su elevado grado de innovación, y no tienen competidores directos, mientras que los me-too compiten directamente con los productos ya presentes en el mercado.
El punto de partida va a ser un mercado maduro, en el sentido que ya van a existir un medicamento de marca con su correspondiente genérico. Examinaremos los incentivos, si existieran, para que el productor del medicamento de marca se convierta en multi-productor; es decir, cuando serán los incentivos más altos, si bajo copagos o precios de referencia, para producir un medicamento breakthrough, un me-too o sustituir el medicamento antiguo por el nuevo.
Los resultados obtenidos demuestran que la decisión sobre que tipo de medicamento obtenido se ve afectado al cambiar un sistema de copagos por un sistema de precios de referencia. Cuando el productor de los medicamentos de marca produce un breakthrough, sus beneficios pueden verse reducidos si un sistema de precio de referencia es introducido. Esto es debido a que este sistema puede reducir los precios elegidos por este productor, pero también puede reducir su demanda, lo que implica una reducción de beneficios. La historia se repite cuando este mismo productor decide producir un medicamento me-too. Sustituir el medicamento antiguo por el nuevo puede ocurrir cuando la demanda potencial del nuevo medicamento es suficientemente alta. Si no fuera este el caso, el productor tendría incentivos a mantener los dos productos en el mercado, repartiéndose los ingresos. Finalmente, el análisis llevado a cabo no muestra un resultado concluyente sobe la relación entre los beneficios obtenidos por este productor de producir o un medicamento breakthrough o un me-too, independientemente del sistema reinante (copagos o precios de referencia). De todas formas, podemos decir que parece más probable que se produzca un breakthrough en vez de un me-too cuando menor sea el coste de I&D del primero en comparación con el me-too, y menor sea el poder de mercado del productor original.
Estos dos capítulos son importantes porque ofrecen una explicación formal a varios resultados empíricos. Pavcnik (2000) expone los efectos de la introducción de un sistema de precios de referencia en Alemania, y demuestra que las empresas en el sector responden a esta introducción. Los productores reducen los precios, y además, cuando hay fuerte competencia con medicamentos genéricos, esta reducción es mayor. Como menciona Pavcnik, "esto demuestra que la competencia relevante ocurre entre genéricos y medicamentos de marca con el mismo principio activo" (Pavcnik 2000, Pág. 20). También demuestra que los productores de genéricos y de marca responden de forma diferente, tanto cuantitativa como cualitativamente. Los resultados obtenidos en esta tesis dan las condiciones teóricas para que esta reducción en precios se dé. Y respecto al Capitulo 2, es el primer trabajo hasta el momento que analiza explícitamente la decisión de innovación dado que un sistema de copagos o precios de referencia existe. Como la propia Pavcnik decía en su articulo, se tiene que llevar a cabo investigación para dilucidar si esta reducción en precios conlleva una reducción en I&D; y este capitulo es un primer paso en esta investigación.
La segunda parte de esta tesis, que incluye el Capítulo 3, investiga e intenta proporcionar una intuición económica sobre un proceso que hemos visto en la industria farmacéutica. Los productores de marca, una vez que su patente ha caducado, han estado produciendo sus propios genéricos. Es un proceso de canibalismo de sus propios consumidores, ya que están produciendo un medicamento en competencia directa con su producto original. La idea detrás de esta observación el apropiamiento de las llamadas "first-mover advantages" que existen en el mercado de genéricos. Por lo tanto, el productor del medicamento original tiene incentivos a ser el primero en el mercado de los genéricos, y producir así los llamados "branded generics" o genéricos de marca. Este articulo da fuelle al caso Roche-Bolar, ya que encontramos que si el productor original también produce el genérico, en vez de que se produzca por otra empresa, los precios resultantes pueden ser mas altos, y hay una reducción en el excedente del consumidor. La idea detrás del caso Roche-Bolar es la no-prohibición de que los productores de genéricos lleven acabo la investigación pertinente antes de acabe la patente sobre el principio activo, y así reducir al máximo el tiempo transcurrido entre que caduca la patente y la entrada del primer genérico.
En este trabajo, el mercado estará segmentado. Por un lado, tendremos a los consumidores leales a la marca original, donde su demanda del producto original no se verá afectada por la entrada del genérico. Por la otra, estarán los consumidores "sensibles", es decir, los consumidores cuya demanda si se verá afectada por la entrada del genérico. Estos consumidores consideran que el medicamento de marca y el genérico son sustitutivos (aunque no perfectos). Encontramos que el productor original si tiene incentivos a producir su propio genérico, debido a esta segmentación de mercado. Esto induce un incremento en el precio del medicamento de marca, y a su vez, se traduce en una disminución del bienestar. Es como si este productor, conociendo esta segmentación, estuviera discriminando en precios entre los consumidores. El productor prefiere incrementar el precio para sus consumidores leales en vez de disminuir el precio de su medicamento de marca para estos consumidores "sensibles" al precio.
The aim of this thesis is to try to give some economic analysis on pharmaceutical issues. While conducting my research, I observed that most analysis of this industry were descriptive and empirical, and found that there was a lack of economic theory to explain the data. Hence, the objective of this research is clear: using industrial economics theoretical models, I wanted to explain the functioning of this industry in order to give a formal economic explanation for some results. For this purpose, I concentrated on two aspects of the pharmaceutical industry. In the first section, which includes Chapters 1 and 2, I focused on explaining the effects of implementing a reference price (RP) system, and the response of pharmaceutical firms to a change in the price regulation these firms face. The analysis will focus on both short (prices) and long term (R&D decisions) issues. In the second section, which includes Chapter 3, the focus is on the so-called "branded generics". I aim to explain why branded good producers also tend to produce a generic version of their original drug once the patent for the original good expires. Throughout the whole thesis, we will consider the existence of generic drugs. During the last years, these drugs have become increasingly important in the pharmaceutical industry, as explained later. To give an example that illustrates their importance, generics' share can be up to 50% of total market share in the US.
A reference price reimbursement system categorises products into groups with similar therapeutic effects so that the reference price is the maximum reimbursement of the third-party payer to the manufacturers for all products in that group. Manufacturers are free to set prices. If prices set are higher than the reference price, it is the consumer who pays the difference. Such system tries to give some responsibility to patients, increasing their consciousness about costs, and providing them incentives. The objective of this system is twofold: first, it is believed that implementing a RP system encourages price competition, and second, with this increased price competition, expenditure of Health Authorities in ethical drugs will be reduced. However, the view of the pharmaceutical firms is that the introduction of such system will make them worse off due to lower profits, which will reduce their incentives to carry out R&D. Note the importance of the relation between reference prices and the existence of generic (cheaper) products. Generic goods are those goods that enter the market when the patent on the active ingredient of the original, branded, ethical drug has expired. Their main characteristic is that they are sold without a brand, and as a result are usually cheaper than the already established, branded, medicine. In all but few cases, these generics are certified by the respective Health Authorities to be perfect substitutes to the branded good since their active ingredient is identical. Furthermore, they are bioequivalent in the sense of being statistically indistinguishable from the established product in key aspects of therapeutic use. However, they could vary in characteristics such as shape, colour, packaging and labelling. Taking into account the fact that not all consumers switch immediately to generics gives support to the idea of both goods not being perfect substitutes. A necessary condition for an efficient implementation of a reference price system is a well-developed generic market. The reason for this is that the reference price is usually set around the price of the cheapest goods available. Should a generic good exist, it would normally have the lowest prices. However, the existence of such market is not a sufficient condition for an efficient implementation of such system. Broadly speaking, reference prices are aiming to reduce prices, so such system should be implemented in markets where the high pharmaceutical public expenditure was due to high average prices rather than due to high consumption levels. Moreover, the price difference between the drugs grouped should be significant; otherwise, the potential cost-savings of implementing a reference price system will be minimal.
RPs have been implemented in many developed countries, the first one being Germany in 1989. From then on, many other countries followed Germany, and recently, Spain has also introduced it. Notice that the way RP have been implemented in each country has not been universal, so we will analyse two different possibilities of introducing such system. I believe that the analysis conducted in this thesis regarding the effects of reference prices is important due to the lack of theoretical research about this important topic. Chapters 1 and 2 give some formal economic analysis on these issues.
The effects of implementing a reference price system will be analysed in two steps. The reason for this is to try to take into account the nature of the pharmaceutical industry, and the importance of R&D. Hence, and broadly speaking, we can say that Chapter 1 will focus on short-run decisions (prices, quantities), while Chapter 2 will focus on long-term variables (R&D). More specifically, in Chapter 1, we concentrate on what will be the effects price-wise of implementing a reference price system, compared to the situation with copayments. We will have a duopoly setting, with a branded and a generic good. We will consider two possible scenarios. In each scenario, we compare the outcomes between two forms of demand structures. Broadly speaking, the aim is to examine the differences between a situation where consumers pay a fixed proportion of the price (copayments) with a situation where RP exist. The difference between the two scenarios is that in the first scenario, under copayments, the consumer pays the full price i.e. the copayment is equal to one. Under reference prices, consumers will have to pay the difference between the price of the good and this reference price. This model implies that the reference price set is below the price of both the branded and the generic good. The second scenario analysed will compare the case where, under copayments, consumers pay a percentage of the price (i.e. do not have to pay the full price anymore) with reference prices. In this setting, reference prices will be modelled as the way they have been introduced in Spain. This case implies that the reference price is set higher than the price of the generic good but lower than the price of the branded. Hence, if the consumer buys the branded good, the net price paid by the consumer will be equal to the difference between the price of the branded good and the reference price, plus the same copayment as before associated this time to the reference price. If the consumer decides to buy the generic good, then (s)he would have to pay the same copayment as before the implementation of reference prices. Furthermore, we analyse how firms' profits and expenditure of Health Authorities vary accordingly. As mentioned before, how the reference price has been set has not been universal. Finding the optimal reference price is beyond the scope of this thesis, although future research will be focusing in this issue. For this purpose, we have constructed two scenarios to take into account two possibilities that we observe in countries with such systems: setting the reference price below or above the price of the price of the generic drug (but never above the price of the branded good).
The main result of the first case analysed is that prices are higher under reference prices, as well as total costs of the system, although reference prices are welfare enhancing. The net price paid by consumers is reduced under such system. The intuition is that we have compared a situation where consumers initially pay the full price with a situation where Health Authorities finance up to the reference price. Moreover, the reference price set in this way acts as a subsidy for the producers. Summarising, what we obtain is that consumers buy more, but at a cheaper price.
When reference prices are implemented in the Spanish way, and we allow that under copayments, Health Authorities finance a proportion of the price of both goods, we show that prices and pharmaceutical costs are reduced under reference prices only if the reference price is set in a certain interval. Also profits for the duopolists might be reduced. These results are due to the opposing effects that reference prices have on branded and generic producers respectively.
Chapter 2 complements Chapter 1, since it provides insights on firms' long-run decision (R&D). The aim of this chapter is to analyse how pharmaceutical firms' decision to innovate are affected by such RP system. We compare a situation with copayments with the situation where reference prices are introduced in the Spanish way. The importance of this chapter arises due to the type of competition we are observing in this industry. Firms also compete through product innovation, as well as in prices. This is due to the regulatory measures that many developed countries have in order to control for the prices of ethical drugs. The idea of this chapter is to model explicitly the decision of the firms undertaking R&D (the branded good producers), and see how this decision is affected by the introduction of reference prices instead of copayments. The model will incorporate the two types of goods that can arise after investing resources in R&D: breakthrough or me-too drugs. The former refers to very innovative drugs, and usually imply spending sufficiently high level of resources. The latter, however, involves fewer resources, although they are considered to be improvements of existing drugs. What we observe is that breakthrough drugs create a new market, while me-too drugs will have to compete with existing branded drugs and generics, if they exist. We will have a mature market, where the initial situation involves both a branded and a generic good. We examine the incentives that the incumbent has to become multiproduct i.e. we want to analyse whether and when will the incumbent have higher incentives to produce a breakthrough drug, a me-too drug, or substitute the old drug by the new one under reference prices or copayments. The idea is that the higher the resources spent on R&D, the more differentiated the new product will be with respect to the existing ones.
Results show that the decision of what type of new drug to produce is affected by changing a copayment system to a reference price system. When the incumbent firm produces a breakthrough drug, profits for the incumbent might be reduced if the latter system is introduced. This is because implementing a reference price system can achieve price reductions, but also demand reduction for the branded goods; hence, profits are reduced and the branded good producer is left worse off under reference prices than under copayments. The story is similar when the incumbent firm produces a me-too drug. Substitution of the old drug by the new one can also occur whenever the potential demand for the new drug is sufficiently high. If this is not the case, the incumbent firm will prefer to have both goods in the market, sharing revenues, rather than concentrating sales on one drug (the new one). Finally, results show that there is no clear-cut relationship between profits earned by the incumbent firm when producing either the breakthrough or the me-too drug, irrespectively of the price regulation system. However, we can say that it seems that production of a breakthrough drug is more probable the lower the R&D cost of this drug with respect to the me-too and the lower the degree of market power that the incumbent firm has.
These two chapters are important because they offer a formal explanation of various empirical results. Pavcnik (2000) shows the effects of implementing reference prices in Germany, and demonstrates that pharmaceutical firms respond to them. She shows that producers significantly reduce prices after the reference price system was implemented, and moreover, branded producers that face more generic competition reduce prices more. As Pavcnik mentions, this shows that "the relevant competition in the pharmaceutical market occurs between generics and the brand name version of the same active ingredient rather than across products that are therapeutic substitutes" (Pavcnik (2000), page 20). She also shows that branded and generic producers respond differently quantitative and qualitatively. Results of Chapters 1 and 2 of this thesis give the theoretical conditions under which this decrease in prices can be achieved. As with respect to the different incentives for R&D, Chapter 2 is the first paper that analyses explicitly the R&D decision given that either copayments or reference prices are enforced. As Pavcnik mentions in her paper, future research has to identify this trade off between lower prices and R&D investment; this is a first step to analyse formally this trade off.
Section 2, which includes Chapter 3, gives an economic intuition to a process we have been observing during the last years in the pharmaceutical industry. Branded good producers, once the patent for the active ingredient has expired, also enter the generic market producing their own generic alternative. It is hence like a process of cannibalising their own consumers by producing a drug that can potentially be competing directly with the original good. The idea behind this observation is that the incumbent firm can take advantage of the so called first-mover advantages that exist in the generic market. Hence, since the original firm knows that generics will enter the market, it is in his own interest to be the first one in that market, and produce the so-called "branded-generics". This paper gives fuel to the Roche-Bolar case, since we find that if the branded good producer produces its generic alternative, rather than another firm specialised in the production of generics, prices can be higher, and consumer surplus can be reduced. The idea underlying the Roche-Bolar case is allowing generic producers to carry out research about the (branded) ethical drug before the patent expires, so that the time lag between the patent expiration and the introduction of these independent generic producers is minimised.
In this chapter, we will have the market segmented. On the one hand, we will have the so-called "loyal" customers, whose demand for the branded good is unaffected by the existence of generics. On the other, the "sensitive" consumers may buy the generic good. These consumers see both the branded and the generic good as (imperfect) substitutes. We find that the firm producing the branded good has incentives to produce its own generic alternative, owing to this market segmentation effect. This induces an increase in the price of the branded good, which in turn, results in a welfare reduction. Hence, it is as if the incumbent firm is price discriminating between consumers. The branded-good seller prefers to increase the price in the loyal segment and produce its own generic version for the price-sensitive customers rather than reducing the price of the branded good to these sensitive consumers.

Valuation models are used extensively in Finance and Accounting to investigate various empirical questions. Conventional valuation models express firm value as a function of discounted dividends, discounted abnormal earnings, discounted cash flows, or price multiples. One limitation from using these models is that they don’t capture unique industry valuation characteristics. However, modeling techniques can be used to modify a conventional model in order to reflect specific business processes. In the first chapter of this thesis I use modeling techniques to develop an industry-specific valuation model for pharmaceutical firms. This allows me to explore how investments in research and development, advertising, and production facilities create value for firms in this industry. In particular, the techniques used in this paper allow me to estimate and explore the economic rents generated by these investments. My valuation model is based on the cash inflows and outflows of a typical pharmaceutical firm. In the second chapter of this thesis I test whether the model is improved by adding a system of accounting accruals. I also compare the performance of my valuation model to a model with summary accounting measures to assess the importance of data disaggregation. The value of advertising investments is likely to have changed in the period investigated in this thesis because on August 8, 1997 the Food and Drug Administration announced that it would relax the rules on direct-to-consumer advertising of prescription drugs. The last chapter of this thesis is an event study of this regulatory change. I investigate the effect of the announcement on share price as well as the firm characteristics associated with the price reactions. Each chapter in this thesis answers a different question with respect to valuation in the pharmaceutical industry.

This study emphasizes the assessment of efficiency and the degree of operating efficiency of mergers and acquisitions in the pharmaceutical industry worldwide. This industry encounters various challenges such as expiring patents, the rise of genetics pharmaceuticals, the entrance of biotechnology companies in the pharmaceutical market, the increasing research and development expenses, government regulations of the pharmaceutical industry, distribution channels, and drug prices. All these challenges result in an intensely competitive environment in which pharmaceuticals suffering from shortcomings (e.g., operational and/or financial inefficiencies) are not easy to catch up with the competition. Mergers and acquisitions are major activities to overcome shortcomings and achieve growth. Mergers and acquisitions have been widely used in the pharmaceutical industry for many years and are expected to accelerate. The objective of this work is to identify whether mergers and acquisitions between pharmaceutical companies can be successful and to highlight the most favourable consolidations. The assessment of mergers and acquisitions is realized through conventional and stochastic data envelopment analysis approaches. The empirical analysis draws on a sample of 371 pharmaceutical companies. The original sample was extended by 870 possible combinations between firms. Our empirical analysis reveals a positive impact of mergers and acquisitions on the efficiency of pharmaceutical companies.

The pharmaceutical industry is an important field of activity that contributes to the diagnosis, treatment, maintenance of the health of the population. The need of pharmaceuticals has led to an increase in both the number of drug manufacturers and the number of distributors. A significant part of the specialized studies deals with the problem of the profitability of the pharmaceutical industry. The study of the financial performance of the economic entities in the pharmaceutical field in Romania is a necessary concern in the conditions of a progressive annual increase of the profitability of this sector. The main purpose of this paper is the analysis and presentation of the evolution of profitability indicators (return on assets, return on capital, return on sales) as part of the activity of assessing the financial performance of economic entities operating in Romania in the pharmaceutical industry (manufacturing of basic pharmaceutical products - CAEN code 2110). Profitability indicators were analyzed for a number of 46 entities in the pharmaceutical industry in Romania for a period of 20 years (1999-2018). We are talking in this case about a turnover of 1.1 Billion lei (249.2 million euros), a number of employees of 3,098 employees, a profit of 135.2 million lei (30.7 million euros) - representing 0.12% of the net profit made in Romania. The research results show that in the period 2008-2009, the financial crisis left a strong mark on the evolution of profitability in the pharmaceutical industry. However, during the 20 years we talk about a positive evolution, in the sense of increasing the profitability of this field, which justifies the increase in the consumption of pharmaceuticals products.

Commercial drying methods are limited either by high production costs or significant quality loss due to process-related stresses. The near-ubiquitous use of freeze-drying in the pharmaceutical industry makes it the standard to which other drying technologies are compared. However, the shortcomings of lyophilization warrant evaluation of new techniques and the benefits they offer, such as compatibility with continuous manufacturing. Novel drying technologies must also overcome barriers to commercial implementation including, but not limited to, scalability and integration into a GMP environment. There remain several opportunities for further research which direct focus and investment strategy for the next generation pharmaceutical drying technologies. Keywords: pharmaceuticals; manufacturing technology; implementation; lyophilization; scalability

В данной статье рассматривается возможность подготовки специалистов для фармацевтического производства на уровне программ специалитета 33.05.01 «Фармация». Сложившиеся в настоящее время политическая, экономическая и социальная обстановка в мире привела к активности в области импортозамещения фармацевтической продукции на отечественном рынке, и, как следствие, повышению интереса студентов, обучающихся по программам специалитета 33.05.01 к сфере производства лекарственных средств. Цель данного исследования – изучение интереса обучающихся к фармацевтической промышленности как направлению будущей профессиональной деятельности, а также анализ факторов, влияющих на его формирование. Проведен социологический опрос в форме анкетирования с последующим статистическим анализом. Авторами статьи поднимаются вопросы о необходимости формирования у студентов в процессе обучения в специалитете компетенций, связанных с различными направлениями производства лекарственных средств, а также мотивирование обучающихся, на прямое участие в развитии отечественной фармацевтической индустрии.

In the modern era, information technology (IT) is significantly transforming the pharmaceutical industry through the application of distance learning tools. These technologies enable pharmaceutical professionals to engage in continuous professional development regardless of location, tailored to individual needs and learning pace. This paper explores the advantages and challenges of these applications, including improvements in the quality of education, access to the latest information and methodologies, and enhanced coordination of healthcare teams. Additionally, the need for high-quality content and user data protection is emphasized for the effective implementation of these technologies. The integration of IT into pharmaceutical practice not only supports continuous professional development for pharmaceutical professionals but also improves team coordination and the speed of critical information exchange. With ongoing technological advancements, the prospects for further progress in the pharmaceutical industry are promising, creating opportunities to enhance patient health outcomes and, consequently, more effective healthcare services.

The prevalence of substandard medicines in Africa is high but not well documented. Low and Middle-Income Countries (LMICs) are likely to face considerable challenges with substandard medications. Africa faces inadequate drug regulatory practices, and in general, compliance with Good Manufacturing Practices (GMP) in most of the pharmaceutical industries is lacking. The majority of pharmaceutical manufacturers in developing countries are often overwhelmed by the GMP requirements and therefore are unable to operate in line with internationally acceptable standards. Non-conformances observed during regulatory inspections provide the status of the compliance to GMP requirements. The study aimed to identify the GMP non-conformances during regulatory inspections and gaps in the production of pharmaceuticals locally manufactured in Uganda by review of the available 50 GMP reports of 21 local pharmaceutical companies in Uganda from 2016. The binary logistic generalized estimating equations (GEE) model was applied to estimate the association between odds of a company failing to comply with the GMP requirements and non-conformances under each GMP inspection parameter. Analysis using dummy estimation to linear regression included determination of the relationship that existed between the selected variables (GMP inspection parameters) and the production capacity of the local pharmaceutical industry. Oral liquids, external liquid preparations, powders, creams, and ointments were the main categories of products manufactured locally. The results indicated that 86% of the non-conformances were major, 11% were minor, and 3% critical. The majority of the non-conformances were related to production (30.1%), documentation (24.5%), and quality control (17.6%). Regression results indicated that for every non-conformance under premises, equipment, and utilities, there was a 7-fold likelihood of the manufacturer failing to comply with the GMP standards (aOR=6.81, P=0.001). The results showed that major non-conformances were significantly higher in industries of small scale (B=6.77, P=0.02) and medium scale (B=8.40, P=0.04), as compared to those of large scale. This study highlights the failures in quality assurance systems and stagnated GMP improvements in these industries that need to be addressed by the manufacturers with support from the regulator. The addition of risk assessment to critical production and quality control operations and establishment of appropriate corrective and preventive actions as part of quality management systems are required to ensure that quality pharmaceuticals are manufactured locally.