Pharmaceutical value chain: opportunities for outsourcing

Industry value chains take important place in the architecture of the global economy. In recent years, cross-border pharmaceutical value chains have been actively developing, the formation of which took place both through offshoring and outsourcing processes under the control of Big Pharma companies, which keep leading positions in the pharmaceutical markets. The study evaluates the possibilities of outsourcing, as well as identifies its features at various stages of the pharmaceutical chain. The multistage pharmaceutical chain, as well as its high degree of its modularity, have created favourable opportunities for outsourcing at every stage, from the lower stage of retail sales to the upper stage of RD. This is so-called bottom - up outsourcing. An increase in costs and a decrease in the efficiency of the entire pharmaceutical chain, caused by the complication of the development and production of drugs, led to a crisis in pharmaceutical innovation. Outsourcing allowed to partially solve arisen problems, increase the productivity of the chain and distribute financial risks, which has led to the emergence of contract organizations that have taken over the implementation of certain pharmaceutical services (contract development and manufacturing, sales, packaging, research organizations). The pharmaceutical RD market was one of the last to get involved in outsourcing processes, due to the fact, that Big Pharma, which manage outsourcing processes, on the one hand, strives to expand outsourcing in order to improve the efficiency of the pharmaceutical chain, and, on the other hand, are very wary of it, since they want to retain ownership and control over their key competencies, which in the case of outsourcing is not always possible.

Impact on Pharmaceutical Industry due to Sudden Pandemic Attack (COVID-19)

: The coronavirus disease (COVID-19) was first detected in Wuhan, China, in the month of December 2019. Further, in March 2020, the COVID-19 epidemic was described by the World Health Organisation (WHO) as a global pandemic. COVID-19 quickly spread around the world in the following months, affecting about 2.5 million individuals by April 2020. World markets, including the pharmaceutical industry, were devastated by this pandemic. Although no specific solution for this emerging infectious disease is currently available, the pharmaceutical industry is helping policymakers meet unmet COVID-19 desires, ranging from research and advancement initiatives on possible prevention methods to the management of the supply chain of drugs in times of crisis. Changes in demand, commodity shortages, contact adjustments, etc., are hindering developments in the mechanism of technology, research and development and are putting an impact on the health market of COVID-19. Other implications of COVID-19 on the physical condition and pharmaceutical market may include acceptance delays, heading to self-sufficiency in the delivery chain, etc. In addition, the pharmaceutical markets are battling to sustain natural consumer flows, as the latest pandemic has had an effect on access to essential drugs at reasonable rates, which is the key priority of all pharmaceutical systems.

Analysis of information asymmetry in the instructions for medical use on the example of Enterol

There may be variations in the texts of instructions for medical use of medicines (hereinafter – the instructions) containing the same active pharmaceutical ingredient, and registered in the pharmaceutical markets of different countries. First of all this applies to medicines manufactured in one country and distributed to other countries. Therefore, there are questions related to incorrect use of medicines due to the existing asymmetry of information. This problem is especially relevant in connection with tourist activity and labour migration. The aim of the study was to identify discrepancies in the instructions of Enterol, registered in different countries. The materials of the study were the registers of medicines in France, Ukraine, Belarus, Bulgaria, Poland, the Czech Republic and Russia, as well as the texts of instructions of Enterol (Biocodex, France), registered in the above countries. Methods of generalization, systematization, as well as contextual and comparative analysis were used. It was found that the original (French) instruction has two indications for the use of Enterol (treatment of acute diarrhea in children under 12 years old; prevention of antibiotic-associated diarrhea caused by Clostridium difficile or recurrence of diarrhea caused by Clostridium difficile), while Belarusian and Russian instructions have one indication. Polish instruction contains 5 indications, while Bulgarian and Czech – 8. The largest number of indications for the use of Enterol (11) is given in Ukrainian instruction. A contradictory information is in the sections «Therapeutic Indications», «Posology and method of administration», «Contraindications», «Undesirable effects», «Special warnings and precautions for use», including «Pregnancy and lactation». In the text of one instruction there is no information available in the text of another, and none of the instructions is identical to the instructions of Enterol, registered in France (country of manufacture). Actually, these information discrepancies, as well as the patient's perception of information, can lead to improper use of medicines and, as a consequence, drug-related problems. Thus, to minimize the asymmetry of information, the applicant during the registration of the drug must submit a notarized translation of the manufacturer's instructions.

Markups and Fixed Costs in Generic and Off-Patent Pharmaceutical Markets

There is wide dispersion in pharmaceutical prices across countries with comparable quality standards. Under monopoly, off-patent and generic drug prices are at least four times higher in the United States than in comparable Englishspeaking high income countries. With five or more competitors, off-patent drug prices are similar or lower. Our analysis shows that differential US markups are largely driven by the market power of drug suppliers and not due to wholesale intermediaries or pharmacies. Furthermore, we show that the traditional mechanism of reducing market power – free entry – is limited because implied entry costs are substantially higher in the US.

Cumulative Risks of Excipients in Pediatric Phytomucolytic Syrups: The Implications for Pharmacy Practice

Expectorant phytomucolytic syrups are widely used pediatric OTC-medicines. Physicians, pediatricians, and pharmacists are traditionally concerned with the efficacy of the active ingredients in cough syrups, and rarely consider the safety aspects of excipients that however are not absolutely “inactive” and are proved to initiate some negative reactions and interactions with other drugs. This paper presents a review, categorization, and comparative analysis of the safety profile of excipients contained in the 22 best-selling OTC pediatric phytomucolytic syrups available in pharmaceutical markets in Ukraine and Germany and proposes an approach to the consideration of the excipients’ safety risks for a pharmacist in the process of pharmaceutical care. The study has revealed that only one of the twenty-two analyzed syrups does not contain any potentially harmful excipients. The results of this analysis were used for developing a specific decision tool for pharmacists that can be used for minimizing excipient-initiated reactions when delivering OTC phytomucolytic syrups for children.

The trade-off between impartiality and freedom in the 21st Century Cures Act

Randomized controlled trials test new drugs using various debiasing devices to prevent participantsfrom manipulating the trials. But participants often dislike controls, arguing that they impose apaternalist constraint on their legitimate preferences. The 21st Century Cures Act, passed by USCongress in 2016, encourages the Food and Drug Administration to use alternative testing methods,incorporating participants’ preferences, for regulatory purposes. We discuss, from a historicalperspective, the trade-off between trial impartiality and participants’ freedom. We argue that the onlyway out is considering which methods improve upon the performance of conventional trials inkeeping dangerous or inefficacious compounds out of pharmaceutical markets.