International Pharmaceutical Companies Research Articles

Review on Ethical Approaches to Antimicrobial Resistance

The world is fast approaching a time whereby people will die from infections because there are no longer any effective drugs. This will change the face of medicine, as we know it, since many modern medical procedures are highly dependent upon antimicrobial protection. This might appear to be chiefly a problem for doctors and scientists but the nature of widespread AMR embodies a large number of ethical and moral issues, influencing every aspect of infection management and potentially affecting everyone. The objectives of this review is to introduce and discuss some of the most important ethical approaches associated with AMR and its control, including national and international responsibilities, pharmaceutical companies, prescribing, education, advertising, veterinary and agricultural practices, infection control and patient behaviour. Given the enormous importance of antimicrobial drugs for the functioning and delivery of modern health care, the progressive exhaustion of effective antibiotics presents health care professionals and policy makers with a distributive dilemma that raises complex moral questions of justice, especially how to fairly allocate antimicrobial resources.

Improving the quality of foreign language training of pharmaceutical specialists using digital technologies in the context of advanced professional education

The problem and the aim of the study. The main problems of employment for Russian specialists in international pharmaceutical companies and their representative offices in the Russian Federation are insufficient level of foreign language training and digital literacy. At the same time, a prerequisite for the admission of a pharmacist to work in the framework of continuing medical education is the completion of advanced training courses. The purpose of the article is to study possibilities of using digital technologies for the development of the foreign language communicative competence of pharmaceutical specialists in the context of advanced professional education. Research methods. Experimental and search work is carried out within the framework of the strategic partnership between the Vyatka State University and the NANOLEK company (Russian Federation). The experiment involves 52 pharmaceutical specialists. The use of digital technologies to enhance foreign language communication is implemented within the framework of the program "English in the field of professional communication" (144 academic hours, 4 months of training and 2 hours of final certification). MS Teams, LearningApps, eTreniki, Quizlet, etc. are used during foreign language activities. To determine the quality of preparation, the teachers developed testing which consists of 5 blocks: “Digital technologies when solving professional tasks”, “Project activity”, “Communication”, “Management”, “Analytics”. χ2 -Pearson criterion is used for statistical data processing. Results. The key feature of the program is that its structure and content are developed in close partnership between the university and specialists in the field of pharmaceutical production and engineering. The students of the experimental group use digital technologies (with official technical support) to activate foreign language professional communication, network collaboration and project activities. Statistically significant differences in the qualitative changes were identified (χ2 = 8.508; p < 0.05). In conclusion, the conditions which contribute to improving the quality of foreign language training: accumulation and analysis of the relevance of using digital technologies, expanding the knowledge of program participants, mastering the basic strategies of project work and reflection techniques are described.

OP48 Interactions Between Regulatory, Health Technology Assessment And Companies: Multi-Stakeholder Survey On The Current Experiences And Future Landscape Evolvement

IntroductionThe interactions between regulators, health technology assessment (HTA), and companies play a significant role in the process of getting medicine to patients. These have evolved at a product level as well as at a policy and cross-jurisdictional level; however, it is important these activities are adding value for stakeholders involved. A survey conducted in March 2021 assessed the current interactions from multi-stakeholders, and their perceptions on the added value these interactions bring to better decision-making.MethodsThree separate questionnaires containing nine questions were developed to assess the perceptions from pharmaceutical companies, regulators, and HTA agencies. The three questionnaires contained analogous questions where appropriate. The company questionnaire was sent to senior management at 19 international pharmaceutical companies, the agency survey was sent to 32 agencies (17 regulatory agencies and 15 HTA agencies) in Australia, Canada, Europe, and Asia.ResultsSeven regulators, seven HTA agencies, and nine companies responded to the survey. All regulators and HTAs indicated they have interactions with their peer agencies, as well as between regulators and HTA. The top areas of interactions for regulators were formal work-sharing between regulators during review (86% response) and regulatory strengthening (86%), whilst for HTAs, interactions between HTA on methodology/framework (83%) and HTA capacity building (67%). Regulatory-HTA interactions were seen to have fewer practical benefits, which may suggest areas for improvement. Both companies and agencies believed an effective engagement model should support evidence generation; agencies also viewed an aligned process and improved decision-making as important. Respondents believed that an ideal ecosystem for interactions should facilitate separate remits for stakeholders, converged requirements, aligned process and increased transparency and trust.ConclusionsThis survey provided a snapshot of the current landscape interactions between stakeholders during the life cycle of new medicines, identified the areas where value is added and improvement are needed. Suggested building blocks to improve future interactions included early scientific advice, alignment of evidence requirements, and a collaborative approach among all stakeholders.

A Comparative Pharmaceutical Evaluation of Amlodipine (5mg)

The objective of this study is to evaluate the pharmaceutical properties of three brands of Amlodipine (5mg) for local and international pharmaceutical companies. The main aim is to evaluate whether compliance with the United States Pharmacopeia (USP) is implemented for physical and chemical parameters including: assay, dissolution, hardness, thickness, length and disintegration. A HPLC device was used in the assay test to determine the percentage of the labeled amount of amlodipine (active ingredient) in the portion of tablets or capsules. Results of assay test showed that values for Norvasc, Myodipine and Nordip were 97.83%, 95.31%, and 93.64% respectively, which are within the acceptable range of 90-110% of the labeled amount of amlodipine. UV-VisibleSpectrometer was used in dissolution test to measure the percentage of dissolved amlodipine. Results of dissolution test showed that values for Norvasc, Myodipine and Nordip were 99.795%, 99.415% and 96.61 respectively, which are all within the acceptable range of not less than 75% of the labeled amount of dissolved amlodipine. Tablets andcapsules were subjected to various physical tests which included hardness, thickness, length and disintegration. Results were statistically analyzed as per USP official methods. The study concluded that all brands of Amlodipine Besylate showed satisfactory results for the chemical and physical tests.

Accelerating the integration of China into the global development of innovative anticancer drugs.

The aim of this Policy Review was to compare China's overall and synchronous participation in clinical trials for innovative anticancer drugs with that of the USA, the EU, Japan, and South Korea, and to assess changes in the participation rate trends in these five regions. Relevant data from the top 20 international pharmaceutical companies from 2011 to 2021 were systematically collected from the Trialtrove and Pharmaprojects databases. Among the 8260 trials for 954 new anticancer drugs identified, China was involved in 8·8% of the trials and with 20·4% of the drugs being trialled. These participation rates are significantly lower than those for South Korea (14·5% of trials and 36·3% of drugs), Japan (16·1% of trials and 38·7% of drugs), the EU (40·6% of trials and 67·7% of drugs), and the USA (65·7% of trials and 91·2% of drugs; p<0·0001 for all). Similar results were found for the synchronous participation rate, defined as the proportion of drugs or trials at the highest development stage internationally, for the 803 tested drugs, which ranged from 9·0% in China to 87·7% in the USA. China's participation rate in early phase trials (4·4%) and in synchronous trials (5·4%) was even lower, in stark contrast to that of the USA (66·1% for early phase trials and 89·1% for synchronous trials). The fastest growing annual rate of participation in trials was observed in China (15·7%), followed by South Korea (8·2%) and Japan (6·8%); no change was detected in the USA or the EU. This Policy Review shows that Chinese participation in the clinical development of innovative cancer drugs by international pharmaceutical companies has increased over the past decade, but an obvious gap persists in comparison with the USA, the EU, Japan, and South Korea, especially in its synchronous participation and early participation rates.

Research advances in treatment methods and drug development for rare diseases.

As the incidence of rare diseases increases each year, the total number of rare disease patients worldwide is nearly 400 million. Orphan medications are drugs used to treat rare diseases. Orphan drugs, however, are rare and patients often struggle to utilize them and expensive medications during treatment. Orphan drugs have been the focus of new drug research and development for both domestic and international pharmaceutical companies as a result of the substantial investment being made in the field of rare diseases. Clinical breakthroughs have been made in every field, from traditional antibodies and small molecule drugs to gene therapy, stem cell therapy and small nucleic acid drugs. We here review the therapeutic means of rare diseases and drug development of rare diseases to show the progress of treatment of rare diseases in order to provide a reference for clinical use and new drug development of rare diseases in China.

Clinical Trials of New Drugs for Vascular Cognitive Impairment and Vascular Dementia.

Population aging has challenged the treatment of cognitive impairment or dementia. Vascular dementia is the second leading cause of dementia after Alzheimer’s disease. Cognitive consequences after ischemic brain injury have been recognized as a preferred target for therapeutic strategies, prompting the search for potential agents. The keyword “vascular dementia” was used to search ClinicalTrials.gov to determine agents represented in phases I, II, III, and IV. The agents were classified on the basis of their mechanisms. Of the 17 randomized controlled trials meeting our inclusion criteria, 9 were completed in the past 10 years, and 8 are ongoing or in the planning stages. We also identified one trial in phase I, nine in phase II, six in phase III, and one in phase IV. Fewer trials of new drugs for improving cognition or ameliorating the behavioral and psychological symptoms of dementia target vascular dementia than Alzheimer’s dementia. Drug trials on vascular dementia overlap with drug trials targeting functional outcomes in cerebrovascular disease. International pharmaceutical companies’ investment in new drugs targeting VCI and vascular dementia remains insufficient.

УХОД ИНОСТРАННОГО КАПИТАЛА ИЗ ФАРМАЦЕВТИЧЕСКОЙ ОТРАСЛИ РОССИИ

Abstract. Amid the aggravation of the geopolitical situation due to the situation around Ukraine, many international pharmaceutical companies announced the suspension of further investments in the Russian economy. There are not only political, but mainly economic reasons for this. In modern conditions, foreign investors do not see the point of deploying their business in Russia: to build factories, open new production lines, etc., because it is not possible to calculate and understand when their investments will be able to pay off. In addition to curtailing investment programs, due to the sanctions policy, clinical trials in Russia are suspended, which threatens that new drugs from foreign manufacturers will not be able to be registered in the country. The situation is not simple with the supply of standard samples from Europe and the USA to the country, used to determine compliance with the quality of medicines. Standard samples are not attributed to medicines, but to chemical industry goods, so they can get on the sanctions list. In addition, a number of European companies that previously supplied high-tech equipment, spare parts and components for the pharmaceutical industry to Russia have abruptly suspended their deliveries. Due to this, the domestic pharmaceutical sector faces a difficult task to independently solve issues related to the development of new medicines, their clinical trials and registration, the creation of a full-fledged production of standard samples for quality control of manufactured products, as well as the organization of the launch of production and the search for alternative suppliers of pharmaceutical equipment from India and China.

COMPARATIVE STUDY OF PATIENT PACKAGE INSERT OF MARKETED BRANDS OF ANTIBIOTIC EYE DROPS

Objective: In Indian scenario, there is a huge gap between the patient and health care workers leading to self-medication practices, antibiotic resistance, and adverse drug reactions. These emerging issues aggravate the need of providing a detailed package inserts (PI) in every drug formulations. Hence, this study was conducted with the objective to assess the completeness of a package insert and evaluate the content of information in PI among national and international pharmaceutical brands. Methods: A prospective, cross-sectional, and observational study was conducted over 50 PI belonging to different class of antibiotic eye drops and same antibiotic from different pharmaceutical companies. Medication belonged to both international and national pharmaceutical companies and they were evaluated according to standards laid down by Drugs and Cosmetic Act (1940) and Rules (1945) covered under the section 6.2 and 6.3. Results: The content of information was haphazard in both national and international PI but international PI was more valuable. International PI had clear information regarding warning and precautions and adverse effects. List of excipients, shelf life, storage indication, and handling were very well demarcated in both the level of pharmaceuticals. Conclusions: The study revealed major lacunae in the context of package insert with reference to prevailing guidelines. The most of the brands did not have PI and the quality of information in package insert of international brand was more superior to national brands.

Challenges and Opportunities for Companies to Build HTA/Payer Perspectives Into Drug Development Through the Use of a Dynamic Target Product Profile.

Background: The target product profile (TPP) outlines the desired profile of a target product aimed at a particular disease and is used by companies to plan clinical development. Considering the increasing importance of health technology assessment (HTA) in informing reimbursement decisions, a robust TPP needs to be built to address HTA needs, to guide an integrated evidence generation plan that will support HTA submissions. This study assessed current practices and experiences of companies in building HTA considerations into TPP development. Methods: An opinion survey was designed and conducted in 2019, as a cross-sectional questionnaire consisting of multiple-choice questions. The questionnaire provided a qualitative assessment of companies’ strategies and experiences in building HTA considerations into the TPP. Eligible survey participants were the senior management of Global HTA/Market Access Departments at 18 top international pharmaceutical companies. Results: 11 companies responded to the survey. All companies included HTA requirements in TPP development, but the timing and process varied. The key focus of HTA input related to health problems and treatment pathways, clinical efficacy/effectiveness, and safety. Variance of HTA methods and different value frameworks were identified as a challenge for development plans. Stakeholder engagement, such as HTA scientific advice, was used to pressure test the TPP. Conclusion: This research provides insight into current practice and potential opportunities for value-based drug development. It demonstrates the evolution of the TPP to encompass HTA requirements and suggests that the TPP could have a role as an iterative communication tool for use with HTA agencies to enhance an integrated evidence generation plan.

NASIONALISME VAKSIN SEBAGAI PRAKTIK NEOMERKANTILISME: ANALISA STUDI EKONOMI POLITIK INTERNASIONAL

At first the health issue was the main task for each country to each of its people. But now the health issue has become part of a global issue whose dynamics have become the focus of various international collaborations. In this case, the Covid-19 pandemic, which has been running for more than a year in the world since the outbreak in China, has now found various innovations regarding vaccines to prevent the spread of Covid-19. This innovation in the production of the Covid-19 vaccine is controlled by various international pharmaceutical companies. However, in terms of the distribution of the Covid-19 vaccine globally, it appears that several developed countries have implemented protectionist approach with the aim of securing the availability of the Covid-19 vaccine for their domestic needs. In this study, the author would like to explain that the Vaccine Nationalism practices that occurred during the Covid 19 pandemic era were a policy development from the perspective of Neomercantilism in the study of international political economy. This article was written using a qualitative research method with a descriptive type of research. The results of this study explain that the practice of vaccine nationalism is the steps taken by developed countries in treating vaccines as a strategic commodity, not as a global public commodity. Developing and less developed countries have the potential to experience barriers to accessing the availability of vaccines in dealing with the Covid-19 pandemic.

A survey on the structure, organization, and functions of medical information departments in the pharmaceutical industry in Spain

The medical information (MI) function within the pharmaceutical industry plays a significant role in the provision of scientific answers for patients and healthcare professionals. The purpose of this study is to identify the current structure, organization, and functions of MI departments in Spain. Sixty local and international pharmaceutical companies based in Spain were invited to participate in this study between May and July 2019. An online 34–item questionnaire developed by the AMIFE MI Working Group was distributed to the companies. Data were analyzed through descriptive statistics using response frequencies. A total of 44 responses from 60 surveys (73%) were received. More than half of the respondents were employed in international companies based in Europe (57%, n = 25). Seventy-one percent (n = 31) of the companies had 100 to 1,000 employees in Spain. Most respondents declared that they had an MI department in their company (73%, n = 32), with most (53%) having two to five employees working on MI. Most MI (n = 50) specialists had a biomedical academic degree (predominantly pharmacy, biology, and medicine). MI departments were involved in many functions, the most common being answering enquiries (100%), handling drug information requests (97%), preparing written responses (94%), and literature services for external use (77%). The mean annual volume of MI enquiries was 2,301 (median 1,100). The results of this survey contribute to a better understanding of MI departments in Spanish pharmaceutical companies, as well as their functions and responsibilities, and could help identify opportunities and areas for improvement.

The Epidemic of Substandard and Falsified Medications in Iraq: Evaluating the Effectiveness of National Pharmacovigilance Alerts to Community Pharmacies.

BackgroundAssessing Iraqi experience with the impact of substandard and falsified (S/F) medicines can help other countries deal comprehensively with the underlying causes of this multifactorial problem. The tools used in this study to assess strategies to prevent the use of S/F medications can be used in other developing countries. This study investigated the problem of S/F medications at three levels: the Ministry of Health (MOH), pharmaceutical company representatives, and community pharmacists.ObjectivesStudy objectives were to evaluate the effectiveness of alerts about S/F medications issued by the national Iraqi Pharmacovigilance Center (IqPhvc) to community pharmacies and to explore the reasons and potential solutions for this problem from the perspective of both pharmaceutical companies and pharmacists.MethodsThis was an exploratory mixed-method study. The qualitative phase comprised seven 1-h semi-structured interviews and one focus group conducted via Zoom. Thematic analysis was used to analyse the qualitative data. The findings of the qualitative phase were then used to develop the survey items. The quantitative phase included an electronic survey distributed among pharmacists via two professional Facebook groups between 23 April and 19 May 2020. The Kruskal–Wallis test was used to measure differences in pharmacists’ knowledge of and ability to detect S/F medications according to their years of experience in the private sector.ResultsOver the last 5 years (2016–2020), the IqPhvc received 183 reports about S/F medications from representatives of 25 international companies. Only 29 (15.8%) of the reports were about falsified medications; the majority were about substandard (parallel) medicines. We interviewed 12 pharmacists (11 male, 1 female) representing ten large international pharmaceutical companies. We also received surveys from 590 pharmacists, of whom 475 (80.9%) were women. Although 72% of the participants had not received any training in the identification of S/F medications, 59.4% of them easily identified S/F medications. Likewise, approximately three-quarters of the participating pharmacists recognized genuine registered medications through three means: medication price sticker, cost, and packaging features. Although 61% of the pharmacists followed-up alerts about S/F medications, only 25.6% were willing to report S/F medications.ConclusionsMost reports to the IqPhvc were about substandard medications. Participants of the two study phases agreed on several reasons for the problem of S/F medications, including their low prices, the unavailability of registered medications, the lengthy medicine registration process, and inadequate awareness of S/F medications among healthcare providers and the public. They also agreed that national alerts and price stickers are helpful in the identification of S/F medications. Community pharmacists can increase their efforts to report S/F medicines, but they need training, awareness, and tools. The study highlighted the need for a track-and-trace system to detect S/F medicines in the supply chain. In brief, the problem of S/F medication is multifaceted. Reducing it will require effective collaboration among different entities, including health officials, border agencies, healthcare providers, and registered pharmaceutical companies.

Detection of an appropriate pharmaceutical company to get a suitable vaccine against COVID-19 with minimum cost under the quality control process.

Some international pharmaceutical companies have succeeded in producing vaccines against COVID‐19. Countries all over the world have aimed to obtain these vaccines with minimum cost. We consider a set of K‐independent Markovian waiting lists. Each list contains a set of countries, where each one of them has an exponential service time and a Poisson arrival process. These companies differ in some characteristics such as the vaccine production cost and the speed of the required quantity delivery. We present a new detection model that helps in providing an appropriate decision to choose a suitable company. Moreover, the concept of balking and the retention of reneged countries is taken into consideration under the quality control process of each waiting list. Under steady state, we face an interesting and difficult discrete stochastic optimization problem. Its solution gives an optimal distribution of the searching effort, which is bounded by a known probability distribution. A simulation study has been derived to get the minimum value of the paid cost random values. The highest service rate, the total expected profit of each queuing system, and the optimum performance measures, which depend on this cost, have been obtained to show the effectiveness of this model.

Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey

BackgroundThe UK’s transition from the European Union creates both an urgent need and key opportunity for the UK and its global collaborators to consider new approaches to the regulation of emerging technologies, underpinned by regulatory science. This survey aimed to identify the most accurate definition of regulatory science, to define strategic areas of the regulation of healthcare innovation which can be informed through regulatory science and to explore the training and infrastructure needed to advance UK and international regulatory science.MethodsA survey was distributed to UK healthcare professionals, academics, patients, health technology assessment agencies, ethicists and trade associations, as well as international regulators, pharmaceutical companies and small or medium enterprises which have expertise in regulatory science and in developing or applying regulation in healthcare. Subsequently, a descriptive quantitative analyses of survey results and directed thematic analysis of free-text comments were applied.ResultsPriority areas for UK regulatory science identified by 145 participants included the following: flexibility: the capability of regulations to adapt to novel products and target patient outcomes; co-development: collaboration across sectors, e.g. patients, manufacturers, regulators, and educators working together to develop appropriate training for novel product deployment; responsiveness: the preparation of frameworks which enable timely innovation required by emerging events; speed: the rate at which new products can reach the market; reimbursement: developing effective tools to track and evaluate outcomes for “pay for performance” products; and education and professional development.ConclusionsThe UK has a time-critical opportunity to establish its national and international strategy for regulatory science leadership by harnessing broader academic input, developing strategic cross-sector collaborations, incorporating patients’ experiences and perspectives, and investing in a skilled workforce.

Abstract PO-189: Precision medicine for African breast cancer: Bringing African researchers together to study African breast cancer

Abstract Introduction In sub-Saharan Africa, breast cancer (BC) is the leading cancer in women and the second cause of cancer mortality. In order to reduce the burden of BC in women with African ancestry there is a need for a structured, coordinated effort to address gaps in our understanding of the factors associated with the disease that influence tumor initiation, progression, and outcomes. To address this need ‘Precision Medicine for African Breast Cancer (PMABC)’ a comprehensive partnership housed at the Henry Ford Cancer Institute was created with the aim of bringing together African researchers to study African BC. We are currently composed of nine leading institutions spanning West and East Africa and two institutions in the United States. Objectives The broad aim of PMABC is to bring together researchers and institutions across sub-Saharan Africa to partner with foreign institutions and funding agencies to study and identify new and improved methods of screening, diagnosing, and treating BC in Africans to improve the overall outcome. Among the aims of PMABC are: • Registry: Create a national BC registry building on data from participating institutions which comprise at least 80% of all BC cases seen in the respective country • Standardization of pathology protocol and reporting: harmonize the pathology reporting scheme and ensure its conformity to international standards Standardization of treatment protocols: Study and compare treatment protocols with international standards and make recommendations • Biorepository: Create a national repository of patient samples to be used in genetic and biological studies • Study African tumor biology: Build the capacity to be able to study African tumors locally and participate in clinical trials • Patient follow up and survival studies: study and obtain data on patient outcomes Achievements We currently have ethical approval and have begun work in nine institutions across West and East Africa. • Creation of a national database in Ghana that currently consists of over 7000 patients. The data is being analyzed to determine risk factors and the distribution of BC by subtypes • We are setting up two research labs in Ghana to train local researchers for basic and translational research • We have a biorepository of over 2000 patient samples that is available for collaborative studies • We have developed tumor models from continental African breast tumors • Building partnership with international organizations, pharmaceutical companies, and funding agencies to study African BC Conclusion PMABC serves as an umbrella institution to coordinate the work between these researchers and to provide resources for the institutions to provide a high level of BC research and treatment. We are aiming to partner with countries across Africa to translate the model created by PMABC in order fulfill the need for further BC research and standardization of data collection and treatment. PMABC is made possible because of the dedication and passion of our collaborating researchers. Citation Format: Sabrina I. Fossi, Sylvester Antwi, Kwabena Agbedinu, Kafui Akakpo, Samuel Mensah, Nelson Affram, Mohammed Sheriff, Foster Amponsah, Jacqueline Asibey, Osei Collins, Alex Mremi, Livingstone Aduse-Poku, Kurt Fernando, Haythem Ali, Eleanor Walker, Jessica Bensenhaver, Evelyn M. Jiagge. Precision medicine for African breast cancer: Bringing African researchers together to study African breast cancer [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-189.

EU POLICY AGAINST FALSIFIED MEDICINES: OPTIONS FOR FURTHER DEVELOPMENT

The globalization of trade and internet access significantly increased the health risks associated with falsified medicines. International organizations, pharmaceutical companies and national governments developed a wide variety of measures to combat their pervasive penetration into the legal supply chains. However, the lack of harmonization, broad acceptance and legally bound enforcement obstructed their endeavours. The unsatisfying outcomes resulted in enhanced supranational cooperation focused on strengthening the pharmaceutical regulatory frameworks and the improvement of patient protection. 
 In 2011 the European Union joined the global fight with the adoption of Directive 2011/62/EU that became known as the Falsified Medicine Directive. It is legally binding for Member States and amends the fundamental for the pharmaceutical sector Directive 2001/83/EC. The objective of the present paper is to verify if it represents a comprehensive tool for effective prevention of the access of falsified medicines in the European legal pharmaceutical supply chains. The results revealed that although it is rather detailed, there are areas that could be further developed and improved when compared to analogical policies and initiatives.

Theoretical Problems of Legal Regulation of Innovations in the Medical Field: Experience in Counteracting Covid-19

The work is devoted to identifying the main problems of legal regulation of innovations in the medical field and developing the best options for solving them in the context of the Covid-19 pandemic. Thus, the research methodology is based on general and special scientific methods, in particular: formal legal, historical and legal, comparative analysis, and modeling. So, the procedure and issues to be considered are as follows. In the introduction, we will briefly highlight the origins of intellectual property rights issues in the medical field and the overall state of the pharmaceutical industry. In the first subsection of the third section, we will consider the positions of the main players in the pharmaceutical industry and the contradictions between them. In the second subsection, we will highlight the international obligations under TRIPS. In the third subsection, we will consider the consequences of their direct violation. In the fourth subsection, the impact of Covid-19 and the methods of legal regulation of medical innovations and patents under the TRIPS agreement will be discussed. In the fifth subsection, we will propose a way out and a compromise according to the Indian scenario. As a result of the study, contradictions were identified in the aspect of maintaining the balance of private and public interests between states and international pharmaceutical companies in the context of a pandemic and proposed ways to resolve them within the existing legal methods under the TRIPS agreement to achieve an acceptable compromise.

Publication rate and characteristics of cancer clinical trials in India

BackgroundNon-publication of clinical trials gives rise to publication bias which distorts data available in medical literature. Prior research indicates that a large number of clinical trials remain unpublished. We conducted a study to determine the publication rate of clinical trials related to cancer which were registered in the Clinical Trials Registry-India (CTRI), the clinical trials registry of India. MethodsWe performed a cross-sectional analysis of CTRI to determine publication rates. We searched CTRI for completed interventional clinical trials related to cancer. A comprehensive search for publications of the registered trials was performed by three different investigators. We considered a trial to be published if the study or any outcome data pertaining to the study was accepted for publication in a peer-reviewed journal. Results73 of the 133 trials (54.9 %) included in our study were published. Randomized controlled trials were more likely to be published than non-randomized trials (61 % vs 34 %, p 0.007). Trials funded by international pharmaceutical companies were more likely to be published than the ones by Indian pharmaceutical companies (72 % vs 24 %, p < 0.00001). Trials conducted at a multinational level were more likely to be published than the ones conducted only in India (84 vs 37 %, p < 0.00001). ConclusionLarge number of cancer clinical trials remain unpublished. This could be due to reluctance on the part of the investigator to publish statistically non-significant results, and sometimes to protect intellectual property. There is much scope for improvement in the rates of trial publication and information dissemination.

Striving as a nation to become an academic leader in the COVID-19 crisis.

In December 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged from the city of Wuhan. As of 6 March 2020, the virus had spread to more than 80 countries, infecting 98,192 people and causing 3,380 deaths in less than five months.(1) Since the 2003 SARS-CoV epidemic, Singapore’s infrastructure has rapidly improved to allow the conduct of high-quality biomedical research. Research facilities such as the Agency for Science, Technology and Research (A*STAR) and Duke-NUS Medical School have been established. The research capabilities of academic hospitals and tertiary institutes have also improved. This has led to the emergence of many local biomedical start-ups and collaborations with international medical device and pharmaceutical companies. With increased capabilities, Singapore’s ability to produce high-quality research on time-sensitive issues, such as those related to the coronavirus disease 2019 (COVID-19), has also improved. Clinical groups from Singapore have recently published in The Lancet and JAMA during the COVID-19 crisis.(2,3) However, more can be done to develop Singapore’s attractiveness as a research hub for novel diagnostic and therapeutic technologies for such emerging diseases. This article will first describe the response of Singapore to the COVID-19 crisis. It will then focus on the various research domains in epidemic settings and highlight the speed at which research is being pursued today. Finally, the article will discuss the current research initiatives and capabilities in Singapore for such research before expounding on the potential improvements that can be implemented. Singapore’s response to the COVID-19 crisis On the 23 January 2020, the first case of SARS-CoV-2 in Singapore was reported.(4) As of 6 March, a total of 117 confirmed cases were reported in Singapore with local transmission established.(1) Singapore’s early response has been effective at identifying the infected and preventing widespread community transmission. To curb the external sources of infection, bans to entry have been put in place on travellers from Mainland China, Iran, North Italy and South Korea.(5) Local cases were quickly identified with extensive contact tracing, leading to the quarantine of clusters. The infected were given appropriate medical care in tertiary centres. As of 6 March 2020, 82 patients have recovered from the infection.(6) Singapore’s response to the epidemic has received praise from international organisations and academics.(7) Most importantly, as of 6 March 2020, there was no mortality among the infected in Singapore.(1) Such evidence highlights Singapore’s capability in managing the epidemic.