The role of government in the achievement of medicines' security: A preliminary exploration of stakeholders' views and experience.

Medicines are essential commodities that form the cornerstone in majority of processes and interventions aimed at assuring optimal healthcare and wellbeing for any population. Apart from being saddled with the responsibility of providing medications for this purpose, the pharmaceutical industry has the potential to catalyse socioeconomic development such as job creation and revenue generation. This study aimed at assessing government's role in driving development in Nigeria's pharmaceutical sector. Questionnaires were administered to healthcare practitioners that participated in an event targeted at developing Nigerian pharmaceutical sector. Data collected were analysed using Statistical Package for Social Sciences. A total of 76 respondents participated in the study. Two-thirds of the study participants (69.7%) were males, slightly above a third of the study participants (38.2%) were aged 51 and above, and close to a quarter of the participants (21.1%) were doctorate degree holders. About half of the study participants (51.4%) indicated that Nigerian pharmaceutical sector was not adequately regulated, whilst almost all (97.4%) indicated that engaging the legislature was critical for the development of the sector. A strong majority of the study participants (87.5%) indicated that existing drug laws should be reviewed so as to protect the pharmaceutical sector. Also, majority of the participants (56.3%) were not satisfied with government's efforts in developing the pharmaceutical industry. Although this study explored a small cohort, its findings have revealed novel insights regarding factors limiting the requisite prioritisation of the Nigerian pharmaceutical sector. The emergent evidence can begin to underpin proactive policy and practice reforms aimed at achieving medicines' security in Nigeria. Further studies can build on these preliminary findings to enable robust and comprehensive sectoral interventions that improve access to healthcare, whilst also catalysing socioeconomic development.

Medicines prices in International (Geary-Khamis) Dollar. The comparison between regulated and deregulated markets.

BACKGROUND: Affordability of medicines is key for effective healthcare. Thus, we compared medicine prices using International Dollar (I$), which allows confronting the values of different currencies. Besides, we intended to verify if pharmaceutical market deregulation leads to lower medicines prices. MATERIALS AND METHODS: We conducted the study between December 2019 and September 2022 collecting data from 21 countries. From the preliminary sampling of 30 medicines, we selected 10 brand names (5 Rx and 5 OTC brands) for the analysis. In each country, we collected price information from 3 pharmacies and then converted them to the I$ using the rates published by the International Monetary Fund. RESULTS: There were differences between regulated and deregulated markets in prices presented in I$. For instance, Aspirin C® (10 soluble pills) was on average I$ 5.41 in Finland (regulated market) and I$ 13.25 in Brazil. The most expensive Xarelto® 20 x 28 pills (I$ 538.40) was in Romania, which in the case of other medicines, was in the group of cheaper countries. There was no statistical significance in price comparison between regulated and deregulated markets. In some cases, however, regulated markets offered lower prices of the same medicine than deregulated markets. CONCLUSION: The analysis revealed differences in I$ prices between countries. Pharmaceutical market regulation does not mean higher prices of medicines. There is a need for affordable medicines. Hence, decision-makers should work on the medicines prices and adjust them to the local economies. I$ could be important in creating pharmaceuticals prices, and the conducted study should encourage other researchers to present their results using this currency.

[Considering the Professionalism of Pharmacists from the Perspective of Pharmacists Working in Government and Industry].

Through many years' experience in pharmaceutical administration, we believe that when pharmacists active in various workplaces are involved in research and development (especially clinical development) and post-marketing (especially proper usage and safety measures), they can better meet patients' hopes and expectations based on actual conditions in clinical practice and other settings by means of mutual communication and collaboration. The International Pharmaceutical Federation believes that for the benefit of patients, pharmaceutical researchers and pharmacists should work together and that the three pillars of research, practice, and education are closely and inseparably integrated. In today's rapidly evolving society, it is necessary-and beneficial-for pharmacists working in both government and industry to be better connected toward achieving better health care.

Trends in financial payments from industry to US cancer centers, 2014-2021.

BACKGROUND: Industry payments to US cancer centers are poorly understood. METHODS: US National Cancer Institute (NCI)-designated comprehensive cancer centers were identified (n = 51). Industry payments to NCI-designated comprehensive cancer centers from 2014 to 2021 were obtained from Open Payments and National Institutes of Health (NIH) grant funding from NIH Research Portfolio Online Reporting Tools (RePORT). Given our focus on cancer centers, we measured the subset of industry payments related to cancer drugs specifically and the subset of NIH funding from the NCI. RESULTS: Despite a pandemic-related decline in 2020-2021, cancer-related industry payments to NCI-designated comprehensive cancer centers increased from $482 million in 2014 to $972 million in 2021. Over the same period, NCI research grant funding increased from $2 481  million to $2 724  million. The large majority of nonresearch payments were royalties and licensing payments. CONCLUSION: Industry payments to NCI-designated comprehensive cancer centers increased substantially more than NCI funding in recent years but were also more variable. These trends raise concerns regarding the influence and instability of industry payments.

The cost of influence: How gifts to physicians shape prescriptions and drug costs.

This paper investigates the influence of gifts - monetary and in-kind payments - from drug firms to US physicians on prescription behavior and drug costs. Using causal models and machine learning, we estimate physicians' heterogeneous responses to payments on antidiabetic prescriptions. We find that payments lead to increased prescription of brand drugs, resulting in a cost rise of $23 per dollar value of transfer received. Paid physicians show higher responses when they treat higher proportions of patients receiving a government-funded low-income subsidy that lowers out-of-pocket drug costs. We estimate that introducing a national gift ban would reduce diabetes drug costs by 2%.

Legislating for Good Governance in the Pharmaceutical Sector through UN Convention Against Corruption (UNCAC) Compliance.

Pharmaceutical sector corruption undermines patient access to medicines by diverting public funds for private gain and exacerbating health inequities. This paper presents an analysis of UN Convention Against Corruption (UNCAC) compliance in seven countries and examines how full UNCAC adoption may reduce corruption risks within four key pharmaceutical decision-making points: product approval, formulary selection, procurement, and dispensing. Countries were selected based on their participation in the Medicines Transparency Alliance and the WHO Good Governance for Medicines Programme. Each country's domestic anti-corruption laws and policies were catalogued and analysed to evaluate their implementation of select UNCAC Articles relevant to the pharmaceutical sector. Countries displayed high compliance with UNCAC provisions on procurement and the recognition of most public sector corruption offences. However, several countries do not penalise private sector bribery or provide statutory protection to whistleblowers or witnesses in corruption proceedings, suggesting that private sector pharmaceutical dispensing may be a decision-making point particularly vulnerable to corruption. Fully implementing the UNCAC is a meaningful first step that countries can take reduce pharmaceutical sector corruption. However, without broader commitment to cultures of transparency and institutional integrity, corruption legislation alone is likely insufficient to ensure long-term, sustainable pharmaceutical sector good governance.

The politics and governance of drug production in public-private partnerships: Brazil's response to hepatitis C.

The local manufacture of advanced pharmaceutical products has been a long-standing objective of health and industry policy in many developing countries, including in Latin America. This strategy has been applied to fight epidemics such as HIV/AIDS, malaria, and the COVID-19 pandemic. However, we still know little about the politics and governance that enable such arrangements, especially when there is no consent from the originator company. This study focuses on the case of Brazil, a country that is well-known for its health-industry policy, which includes the local production of direct-acting antivirals (DAAs), a new treatment for hepatitis C. We seek to explain the factors that have contributed to Brazil's successful production of generic versions of DAAs, and, later, to the decision by the Ministry of Health (MoH) to procure drugs from multinational pharmaceutical companies rather than from local laboratories. A lack of support for domestic production by important stakeholders, the patent holder's attempt to block domestic production and the MoH's adoption of more modern treatment guidelines under a different procurement logic all created an unfavourable environment for local production and procurement of DAAs. Our study draws implications for middle-income countries that wish to produce drugs domestically without voluntary license agreements.

Exploring SureChEMBL from a drug discovery perspective.

In the pharmaceutical industry, the patent protection of drugs and medicines is accorded importance because of the high costs involved in the development of novel drugs. Over the years, researchers have analyzed patent documents to identify freedom-to-operate spaces for novel drug candidates. To assist this, several well-established public patent document data repositories have enabled automated methodologies for extracting information on therapeutic agents. In this study, we delve into one such publicly available patent database, SureChEMBL, which catalogues patent documents related to life sciences. Our exploration begins by identifying patent compounds across public chemical data resources, followed by pinpointing sections in patent documents where the chemical annotations were found. Next, we exhibit the potential of compounds to serve as drug candidates by evaluating their conformity to drug-likeness criteria. Lastly, we examine the drug development stage reported for these compounds to understand their clinical success. In summary, our investigation aims at providing a comprehensive overview of the patent compounds catalogued in SureChEMBL, assessing their relevance to pharmaceutical drug discovery.

How Labor Costs Affect Innovation Output in Pharmaceutical Companies: Evidence from China.

Existing literature generally suggests that rising labor costs lead to the substitution of capital for labor, prompting firms to save on labor costs through technological upgrades. However, as a typical human capital-intensive industry, the pharmaceutical sector finds it challenging to replace labor with capital through the introduction of advanced equipment. Therefore, compared to other industries, the pharmaceutical sector faces greater adverse impacts. Research on how pharmaceutical R&D behavior is influenced by labor costs is scarce. This paper analyzes the triple effects of rising labor costs on corporate innovation from the perspectives of human capital, physical capital, and financial capital. Based on empirical research using data from Chinese listed companies, we found that an increase in labor costs promotes innovation output in the pharmaceutical sector, but this effect is more pronounced in other sectors. Financing constraints play a negative role on corporate innovation in the pharmaceutical sector, while it is not significant in the other sectors. Factor substitution play a positive effect on corporate innovation in the other sectors, which is invalid in the pharmaceutical sector. This research contributes to a deeper understanding of the unique mechanisms by which labor costs impact innovation activities in the pharmaceutical industry.

[Application of process analysis technology in traditional Chinese medicine manufacturing industry].

In the traditional Chinese medicine(TCM) manufacturing industry, quality control determines the safety, effectiveness, and quality stability of the final product. The traditional quality control method generally carries out sampling off-line testing of drugs after the end of the batch production, which is incomprehensive, and it fails to find the problems in the production process in time. Process analysis technology(PAT) uses process testing, mathematical modeling, data analysis, and other technologies to collect, analyze, feedback, control, and continuously improve the critical quality attributes(CQA) in all aspects of the production of TCM preparations in real time. The application of PAT in the TCM manufacturing industry is one of the research hotspots in recent years, which has the advantages of real-time, systematic, non-destructive, green, and rapid detection for the production quality control of TCM preparations. It can effectively ensure the stability of the quality of TCM preparations, improve production efficiency, and play a key role in the study of the quantity and quality transfer law of TCM. Commonly used PAT includes near-infrared spectroscopy, Raman spectroscopy, online microwave, etc. In addition, the establishment of an online detection model by PAT is the key basic work to realize intelligent manufacturing in TCM production. Obtaining real-time online detection data through PAT and establishing a closed-loop control model on this basis are a key common technical difficulty in the industry. This paper adopted systematic literature analysis to summarize the relevant Chinese and foreign literature, policies and regulations, and production applications, and it introduced the development trend and practical application of PAT, so as to provide references for accelerating the application of PAT in the TCM manufacturing industry, the intelligent transformation and upgrading, and high-quality development of the TCM industry.

Physician's perceptions regarding the pharmaceutical industry: a Brazilian national study.

OBJECTIVE: The objective of this study was to investigate the newly graduated physicians' attitudes and perceptions regarding the medical relationship with the pharmaceutical industry and identify the sociodemographic patterns related to such thinking. METHODS: A structured questionnaire was administered to 4,601 participants selected from a pool of 16,323 physicians who were registered with one of the 27 Regional Medical Councils of Brazil in 2015. Answers were analyzed using two stratification variables: type of medical school (public vs. private) and the sex of the respondents. RESULTS: Out of the participants, 61.8% believed that industry funding could support medical conferences and education, and 48.4% felt that small gifts and conference travel funding were acceptable. Conversely, 64.7% disagreed with industry-sponsored social events. Views on whether pharmaceutical representatives' visits influenced prescriptions were divided. Statistically significant differences were observed between genders and medical school types, with men and private school graduates being more accepting of certain industry interactions. CONCLUSION: The study highlights the nuanced attitudes of new doctors toward industry relationships, indicating the need for clearer ethical guidelines and education in medical schools to align practice with evolving societal values.

The pharmaceutical company-healthcare relationship: much ado about something.

The relationship between the pharmaceutical companies and the healthcare profession, especially doctors, has always been fraught with conflicts of interest (COI). The publication of the influential The Diagnostic and Statistical Manual for Mental Disorders, Fifth edition, Text Revision (DSM-5-TR), by the American Psychiatric Society (APA) raised concerns that the financial relationships between pharma and members responsible for DSM could result in bias. This resulted in calls for stricter enforcement of controls on financial conflict of interest (FCOI) [1, 2], which could influence the formulation of diagnostic criteria (resulting in more people being "diagnosable as mentally ill"), creating a larger pool of "patients" who "need" pharmaceutical drugs. Knowingly or unknowingly, they would end up serving the pharmaceutical companies' agenda to sell more drugs and drive up profits [2] .

Trends in Industry-Sponsored Research Payments to Physician Principal Investigators.

This cohort study investigates trends in total and per-physician industry-sponsored research payments to physician principal investigators from 2015 to 2022.

Opioid promotion in Canada: A narrative review.

Studies based on the United States Open Payment database have demonstrated an association between the promotion and prescribing of opioids. An equivalent database does not exist in Canada; therefore, I undertook a narrative review of the literature. In 2015, Purdue spent over CAN$4 million promoting a single product and generated over 160 pages of journal advertising. In the current review, I describe each of the six different forms of promotion that companies used to try and influence prescribing behaviour: messages from sales representatives, journal advertisements, company involvement in undergraduate medical education, key opinion leaders, clinical practice guidelines, and the funding of patient groups. Recent regulatory changes have decreased the volume of opioid promotion, but it would be incorrect to assume that it does not continue to influence the prescribing of this class of drugs.

How successful are AI-discovered drugs in clinical trials? A first analysis and emerging lessons.

AI techniques are making inroads into the field of drug discovery. As a result, a growing number of drugs and vaccines have been discovered using AI. However, questions remain about the success of these molecules in clinical trials. To address these questions, we conducted a first analysis of the clinical pipelines of AI-native Biotech companies. In Phase I we find AI-discovered molecules have an 80-90% success rate, substantially higher than historic industry averages. This suggests, we argue, that AI is highly capable of designing or identifying molecules with drug-like properties. In Phase II the success rate is ∼40%, albeit on a limited sample size, comparable to historic industry averages. Our findings highlight early signs of the clinical potential of AI-discovered molecules.