Medical Sanctions and the Response of Pharmaceutical Companies to Russia’s Invasion of Ukraine: A Thematic Analysis

The objective of this study was to comprehend the pricing differentiation of essential drugs between the local pharmaceutical companies (LPC) and multinational pharmaceutical companies (MNC) of Bangladesh. Thirty five (35) essential drug prices were collected from a local drug directory, namely Bangladesh National Formulary 2006. The mean and standard deviation of the prices of drugs belonging to all therapeutics categories (Anti-infective drugs, Central nervous system, Respiratory system, cardiovascular system, gastrointestinal system, Endocrine system drugs, Vitamin, drugs for Skin and Analgesic/painkillers) were analyzed. Managers of two multinational companies (MNCs) named GlaxoSmithKline Bangladesh Limited Bangladesh and Sanafi Aventis Bangladesh; and three local pharmaceutical companies (LPCs) named Square Pharmaceuticals Limited, Beximco Pharmaceuticals Limited and Incepta Pharmaceuticals Limited were interviewed after data analysis. A wide range of price variations (p < 0.01) between MNC and LPC essential drug products exist. Antibiotics have higher prices than drug products belonging to other therapeutic groups. Since infectious diseases are the major cause of morbidity and mortality in Bangladesh, the government should consider bearing part of the burden of antibiotic manufacturing costs and deliver antibiotics to the market at reduced price promoting rational prescribing. Further studies are needed to delve the causes of anti-infectives high prices and to propose affordability for treating infectious diseases. This study evaluates the present situation of the pharmaceutical marketing and pricing strategies in Bangladesh in light of the status of the essential drug market. This study will be helpful to assess essential drug affordability, to keep pricing strategies appraised, to advise the drug administration of options and to arrange for appropriate levels of public healthcare. Key words: Local pharmaceutical company (LPC), multinational pharmaceutical company (MNC), essential drugs, Bangladesh.

Pharmaceutical genocide.

Regulation failing to keep up with India's trials boom

Essential and non-essential drugs marketed by the 20 largest European pharmaceutical companies in developing countries

BackgroundUniversal access to high quality essential medicines is critical to sustainable development (SDG 3.8). However low- and middle-income countries struggle to ensure access to all medicines on their national essential medicines lists (EML). Market registration is the first step in determining both access and availability yet the extent to which essential medicines are registered for use at country level is not known. Companies apply for a marketing authorisation, however low price or lack of a market is a disincentive. Local production has been promoted to ensure availability of essential medicines but research in this area is also limited.MethodsThe study took place between 2011 and 2015. We systematically examined the registration status of medicines and vaccines listed in the Ugandan 2012 EML and conducted 20 interviews with regulators, ministry of health representatives, donors, and pharmaceutical producers and analysed quality assurance issues affecting registration, procurement, and local production of medicines in Uganda. In 2017 we conducted a further three interviews to clarify issues around non-registration of essential medicines highlighted by our analysis.ResultsOf the 566 essential medicines and vaccines nearly half (49%; 275/566) had no registered product in 2012. Of the 3130 registered products, just over a quarter (28%; 880/3130) were listed on the EML. Six local producers had registered 138 products of which 40 corresponded to 32 unique essential medicines. Interviews highlighted alternative routes to availability other than registration. Local producers faced considerable barriers to achieving international quality standards required for international procurement of medicines for the domestic market.ConclusionsMonitoring and audit of the registration of essential and non-essential medicines should be a priority nationally and, regionally through harmonisation of registration requirements in the East African Community. National and regional manufacturing plans should consider local production of unregistered essential medicines.

Multinational pharmaceutical companies patent essential drugs routinely in developed countries. Patents grant a monopoly to manufacture and sell a particular drug to one pharmaceutical company. Drugs are therefore very expensive in developed countries as availability and pricing is dependent on one pharmaceutical company. In contrast with the absence of product patents, Indian pharmaceutical companies manufacture and sell generic drugs at a fraction of the price of patented drugs. In developing countries therefore affordable generic drugs from India are imported and used in the treatment of diseases and illnesses which are life threatening and chronic. AIDS, cancer, mental illness, asthma, and tuberculosis are some of the diseases for which generic drugs are sourced from India. All this is now set to change. The ability of generic pharmaceutical companies in India to manufacture and sell essential drugs at affordable prices to patients and governments in developing countries including in India is at risk due to the amendments in the Indian Patent Act. The impact of the legal amendments to the India Patent Act introduced in 2005 under the TRIPS agreement are going to be felt increasingly across the developing world. In the coming decade as product patents on essential drugs are granted in India to multinational pharmaceutical companies, many of these drugs will become either unavailable or very expensive. The article highlights the importance of generic drug manufacturing in India in the context of AIDS treatment. Legal options before the government of India to limit the impact of patents on generic manufacturing of affordable medicines are discussed with an emphasis on the political nature of the decisions involved.

Accessibility and availability of drugs has been a matter of great concern for health services all over the world, especially for less developed countries. The World Health Organization has devoted considerable time to this matter, as evidenced in several documents and policies, such as model lists of essential drugs and the strategy "Health for All by the Year 2000". The WHO policy for essential drugs has been widely accepted, and the WHO List of Essential Drugs is now in the ninth revised edition. Although the essential drug policy has been well-accepted by health agencies and NGOs, the pharmaceutical industry has not proven willing to produce essential drugs at affordable prices. The purpose of this study is to examine price levels of essential drugs in Mexico. The evaluation was performed through a comparison of international and national prices for leading drugs in the respective therapeutic categories and included in the WHO model list of essential drugs. The study shows clearly that prices of essential brand-name drugs in Mexico are very high. Per capita consumption has remained stable despite a sharp decrease in the Mexican GDP since 1995. The article discusses the reasons for this and proposes measures to deal with the problem.

Ghostwriters, Data Manipulation and Dollar Diplomacy: How Drug Companies Pull the Strings in Clinical Research

The purpose of the article is to substantiate global trends in the research and innovation activities of multinational pharmaceutical companies and to identify key directions of transformation in corporate innovation strategies in the context of increased international competition in the global pharmaceutical market. Methodology. The methodological basis of the work is the following methods of scientific research: dialectical, historical-logical, system-structural analysis of economic processes and phenomena, analysis and synthesis, the method of quantitative and qualitative comparisons. Results. One of the key global sustainable development goals of the United Nations for the period up to 2030 is to ensure the health and well-being of nations, which in global terms can be achieved primarily on the basis of the large-scale research activities of multinational pharmaceutical companies and the systematic commercialisation of the results of corporate research and development. In recent decades, under the influence of technoglobalisation processes, the innovatisation of pharmaceutical companies' activities has accelerated. It finds its concentrated expression in the steady increase of R&amp;D costs, diversification of their structure, mass commercialisation of innovative developments and strengthening of their transdisciplinarity, accelerated capitalisation of R&amp;D costs, etc. According to the world experience, the most effective innovative strategies of pharmaceutical companies today are such as mergers and acquisitions, strategic alliances of pharmaceutical and biotechnology companies, innovative outsourcing and insourcing, cointegration and pseudo-concentration, corporatisation of patent portfolios and research technologies, venture financing of R&amp;D of pharmaceutical companies. At the same time, mergers and acquisitions are increasing the capitalisation of the global pharmaceutical industry, strengthening its expansion into global markets, redistributing its regional segments and diversifying the sources of funding for pharmaceutical companies' research activities. Value/оriginality. Current trends and features of corporate strategy formation in multinational pharmaceutical companies are identified. Strategic orientations of research activities of pharmaceutical companies in specialised areas of clinical research in the context of therapeutic categories are determined. The process of capitalisation of pharmaceutical companies is analysed and the tendency to activate the use of corporate mergers and acquisitions (M&amp;A) strategy in the pharmaceutical business is revealed. It is proposed to create strategic alliances of multifunctional pharmaceutical companies with biotech companies using the M&amp;A strategy. It is recommended that pharmaceutical companies strengthen their innovation orientation in the design of their strategies by combining patent portfolios and research technologies, as well as jointly implementing large-scale innovation programmes and projects.

Progressive Applications of Dissolution, Its Impact, and Implications in the Pharmaceutical World

This chapter examines the possibilities of economic growth in Russia from the perspective of the development of organizational capability, namely through the study of best managerial practices of multinational companies (MNCs) doing business in Russia, and their use by Russian companies. With tightening competition, companies are forced to focus on the development of organizational capabilities. Our large-scale empirical research into the managerial capabilities and management practices of MNCs and Russian companies employs a comprehensive sample of 1,530 companies and 1,245 companies in 2016 and 2017, respectively, covering the 10 main sectors of economic activity in Moscow and the Moscow region. The analysis was performed across five managerial capabilities: communication, leadership, problem-solving and decision-making, conflict resolution, and motivation, each subdivided into five management practices. Using statistical methods, we identified the major statistically significant differences in and between the managerial practices of MNCs and Russian companies operating in the Russian market, and their dynamics from 2016 to 2017. Taking MNCs operating in the Russian market as a benchmark, we discover that Russian companies need to close the gap in 17 out of the 25 managerial practices in order to maintain competitiveness in the Russian market and be able to influence their economic growth in Russia.

Purpose : the purpose of this article is to study the current state of the pharmaceutical industry in Russia, to identify trends in Russian pharmaceutical market, and to provide preliminary analysis of the state support policy for pharmaceuticals in Russia, focusing on the federal target program "Pharma-2020". Methods: the study is based on a quantitative study of the characteristics and trends of the Russian pharmaceutical market. The emphasis was put on the period 2008–2017. The volume of the market, the structure of imports and exports are considered, and expenditures under the federal program "Pharma-2020" are studied. A qualitative comparative comparison with the tendencies of the global development of the industry is conducted and recommendations are made on further stimulating the growth of the pharma industry in Russia. Results: in the past 5 years, the pharmaceutical industry in Russia did receive special attention from the government, significant funds have been allocated for to support domestic producers, and import substitution policies have been launched. Financial results of the industry show slight improvement in a number of indicators: the market share of domestic medicines is growing, the generics production increased, production standards became tighter controlled. Nevertheless, Russia remains on the periphery of the world pharmaceutical science, import retains two thirds of the market share by value, while innovative novel drugs are now launched primarily by MNEs from the US and the EU. Conclusions and relevance : the challenges and development factors of Russia's pharmaceutical industry identified in this research require effective regulatory tools. First of all, it is necessary to reduce the gap between Russia and the developed countries in the R&amp;D standards and their market implementation. Statistical data has showed the progress in the production of drugs from the VED list (Vital and Essential Drugs), but it is necessary to emphasize the need to update this list, provide it with the latest and innovative drugs. Annual list actualization and its expansion can play an effective role in future. In general, the Russian pharmaceutical sector is currently at its best for the entire period under review, however, the rise in international competition and the role of developing countries pose new challenges. First of all, Russia might take the best from expanding the drugs market and supporting export activity. Trade agreements and union tendencies (EAES) on the scale of Eurasia can play a larger role – Russia's advantage is the fact that the countries of the former USSR have very limited own pharmaceutical industry, whilst the demand for quality products there is growing.

The WHO Model List of Essential Medicines (MLEM) has since 1977 helped prioritize and ensure availability of medicines especially in low- and middle-income countries. The MLEM consists mainly of generic medicines, though recent trends point towards listing expensive on-patent medicines and increasing global support for medicines against non-communicable diseases. However, the implications of such changes for national essential medicines list (NEML) updates for access to essential medicines has received relatively little attention. This study examined how government agencies and other actors in Kenya, Uganda and Tanzania participate in and influence the NEML update process and subsequent availability of prioritized medicines; and the alignment of these processes to WHO guidance. A mixed study design was used, with qualitative documentary review, key informant interviews and thematic data analysis. Results show that NEML updating processes were similar amongst the three countries and aligned to WHO guidelines, albeit conducted irregularly, with tendency to reprioritization during procurement stages, and were not always accompanied by revision of clinical guidelines. Variations were noted in the inclusion of medicines against cancer and hepatitis C, and the utilization of health technology assessment (HTA). For medicines against diseases with high global engagement, such as HIV/AIDS and TB, national stakeholders had more limited inputs in prioritization and funding. Furthermore, national actors were not influenced by the pharmaceutical industry during the NEML update process, nor were any conflicting agendas identified between health, trade and industrial policies. Hence, the study suggests that more attention should be paid to the combination of HTAs and NEMLs, particularly as countries work towards universal health coverage, in addition to heightened awareness of how global disease-specific initiatives may confound national implementation of the NEML. The study concludes with a call to strengthen country-level policy and procedural coherence around the process of prioritizing and ensuring availability of essential medicines.

PL03-05: International clinical research-Barriers and challenges: A vision from independent and publicly funded trials

The Role of the WFSA in Reaching the Goals of the Lancet Commission on Global Surgery.