Disclosure, transparency, and accountability: a qualitative survey of public sector pharmaceutical committee conflict of interest policies in the World Health Organization South-East Asia Region.

BACKGROUND: Weak governance over public sector pharmaceutical policy and practice limits access to essential medicines, inflates pharmaceutical prices, and wastes scarce health system resources. Pharmaceutical systems are technically complex and involve extensive interactions between the private and public sectors. For members of public sector pharmaceutical committees, relationships with the private sector can result in conflicts of interest, which may introduce commercial biases into decision-making, potentially compromising public health objectives and health system sustainability. We conducted a descriptive, qualitative study of conflict of interest policies and practices in the public pharmaceutical sector in ten countries in the World Health Organization (WHO) South-East Asia Region (SEAR) (Bangladesh, Bhutan, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand, and Timor-Leste) between September 2020 and March 2021. RESULTS: We identified 45 policy and regulatory documents and triangulated documentary data with 21 expert interviews. Key informants articulated very different governance priorities and conflict of interest concerns depending on the features of their country's pharmaceutical industry, market size, and national economic objectives related to the domestic pharmaceutical industry. Public sector pharmaceutical policies and regulations consistently contained provisions for pharmaceutical committee members to disclose relevant interests, but contained little detail about what should be declared, when, and how often, nor whether disclosures are evaluated and by whom. Processes for preventing or managing conflicts of interest were less well developed than those for disclosure except for a few key procurement processes. Where processes for managing conflicts of interest were specified, the dominant strategy was to recuse committee members with a conflict of interest from relevant work. Policies rarely specified that committee members should divest or otherwise be free from conflicts of interest. CONCLUSIONS: Robust processes for conflict of interest prevention and management could ensure the integrity of decision-making and build public trust in pharmaceutical processes to achieve public health objectives. Upstream approaches including supportive legislative frameworks, the creation of oversight bodies, and strengthening regulatory institutions can also contribute to building cultures of transparency, accountability, and trust.

A critical review of addressing cardiovascular and other non-communicable diseases through a primary health care approach in the South-East Asia Region.

Non-communicable diseases (NCDS) are responsible for almost two-thirds of all deaths in the WHO South-East Asia Region. Among the NCDs, reduction of CVD mortality, which accounts for almost half of all NCD mortality, must be considered as a priority. The eleven countries in the Region have committed to achieve the universal health and NCD health service access targets; its achievements will depend on the ability and the comprehensiveness of the primary health care systems to deliver the services. While most countries have made a solid beginning to integrate services for basic management of the four major NCD (CVDs, diabetes, chronic respiratory diseases and cancers) into primary health care services, a rapid consolidation and expansion should be undertaken along with the steps to improve access to essential medicines and diagnostics. Strengthening primary health care services in the Region has become ever more urgent to address the evolving NCD health care needs of populations and achieve the 25 by 25 NCD global voluntary targets and 2030 United Nation's sustainable development goals (SDGs).

Approaches to improving access to essential cancer medicines in the WHO South-East Asia Region.

The high cancer burden in the World Health Organization (WHO) South-East Asia Region represents not only a significant cause of death, disability and suffering but also a major threat to development. In 2015, the need for equitable access to cancer treatments was underscored by the addition of 16 cancer drugs to the 19th WHO model list of essential medicines, including three high-cost medicines. This paper explores strategies to improve access, including - but not limited to - managing costs through regional cooperation; coordinated procurement mechanisms; price controls; differential pricing; and licensing agreements. The composition of the region, with small and large pharmaceutical markets with a range of manufacturing capacities and supply-chain issues, offers a unique frame of comparison and consideration for access issues. Different approaches are needed that are tailored to specific country situations. However, in the absence of global collaborative funding mechanisms, the region can advocate now, with one voice, for regional action to improve the affordability and availability of essential cancer medicines and align national cancer-control strategies to leverage regional strengths. Delays will lead to more premature cancer deaths and more households in the WHO South-East Asia Region being impoverished through out-of-pocket payments for cancer medicines.

Access to pain relief and essential opioids in the WHO South-East Asia Region: challenges in implementing drug reforms.

It is a justifiable assumption that more than 15 million people in the World Health Organization South-East Asia Region are experiencing serious health-related suffering, much of it caused by persistent, severe pain. Despite this burden of suffering, overall access to pain relief and palliative care services is abysmal. The lack of access to controlled drugs for pain management is striking: the average morphine equivalence in the region in 2015 was just 1.7 mg per capita, while the global average was 61.5 mg per capita. Until recently, implementation of national legislation to facilitate medical and scientific use of opioids has proven to be very complex and difficult to achieve. The effects on the region of the exploitative British opium trade in previous centuries prompted countries to adopt draconian legislation on opioids, focused on restricting illicit use. In India, the Narcotic Drugs and Psychotropic Substances Act of 1985, for example, stipulated harsh custodial sentences for even minor clerical errors in hospitals stocking opioids. Decades of persistent efforts by civil society resulted in the landmark amendment of the Act in 2014 to improve medical access, but implementation remains highly protracted. Although some progress has been made in recent years in Bangladesh, India, Nepal, Sri Lanka and Thailand, pain is a symptom that is grossly undertreated in most parts of the region. On both human rights and public health grounds, there is an urgent need for well-formulated drug policies to increase access to opioid medications, coupled with capacity-building and comprehensive public health systems incorporating palliative care.

Addressing the threat of antibiotic resistance in Thailand: monitoring population knowledge and awareness.

The 2015 Global action plan on antimicrobial resistance (GAP-AMR) highlights the key importance of improving awareness and understanding of antimicrobial resistance among consumers. While low levels of awareness are not exclusive to consumers in low- and middle-income countries, the challenges to improving understanding are compounded in these settings, by factors such as higher rates of antibiotic self-medication and availability through informal suppliers. In 2016, Thailand set an ambitious target to increase, by 2021, public knowledge of antibiotic resistance and awareness of appropriate use of antibiotic by 20%. This involved first establishing baseline data by incorporating a module on antibiotic awareness into the 2017 national Health and Welfare Survey conducted by the National Statistical Office. The benefit of this approach is that the data from the antibiotic module are collected in parallel with data on socioeconomic, demographic and geospatial parameters that can inform targeted public communications. The module was developed by review of existing tools that have been used to measure public awareness of antibiotics, namely those of the Eurobarometer project of the European Union and a questionnaire developed by the World Health Organization. The Thai module was constructed in such a way that results could be benchmarked against those of the other survey tools, to allow international comparison. The Thai experience showed that close collaboration between the relevant national authorities allowed smooth integration of a module on antibiotic awareness into the national household survey. To date, evidence from the module has informed the content and strategy of public communications on antibiotic use and misuse. Work is under way to select the most robust indicators to use in monitoring progress. The other Member States of the World Health Organization South-East Asia Region can benefit from Thailand's experiences in improvement of monitoring population knowledge and awareness.

Essential cancer medicines in the national lists of countries of the WHO South-East Asia Region: a descriptive assessment.

Background: In 2015, the need for equitable access to cancer treatments in low- and middle income countries was underscored by the addition of 16 essential cancer medicines to the 19th World Health Organization (WHO) model list of essential medicines (WHO EML). This study assessed the degree to which this expanded WHO EML from 2015 has influenced inclusion of cancer medicines in the most recent national essential medicines lists of the countries of the WHO South-East Asia Region. Methods: The inclusion of a selected list of 38 essential cancer medicines in the 2015 WHO EML was assessed in the most recent national lists of essential medicines from the 11 countries of the WHO South-East Asia Region. Additionally, the availability of six essential cancer medicines common to the national lists of essential medicines from six countries of the WHO South-East Asia Region was explored. Results: Of the 38 selected essential cancer medicines included in the 19th WHO EML, a mean of 18.0 (range 2-33) were included in the national lists of countries of the WHO South-East Asia Region. Of the 25 essential cancer medicines included in the WHO EML prior to the 19th revision, a mean of 14.6 (range 2-21) were included in national lists; notably fewer of the 13 cancer medicines added in the 2015 revision were included: mean 3.4 (range 0-12). Conclusion: Compared with the WHO EML, there is a lag in the inclusion of essential cancer medicines in national lists of essential medicines in the WHO South-East Asia Region. Alignment of essential cancer medicines in national lists of essential medicines among the 11 countries in the region varies significantly. These differences may hinder regional strategies to improve access to essential cancer medicines, such as pooled procurement of selected high-cost medicines. The link between the availability and affordability of essential cancer medicines warrants further investigation, in the context of access to medicines for universal health coverage.

Development, validation and application of tandem mass spectrometry for screening of inborn metabolic disorders in Kuwaiti infants.

OBJECTIVE: The aim of this work was to develop a specific and validated tandem mass spectrometric (MS/MS) method for screening of amino acidopathies, organic acidurias, urea cycle disorders and fatty acid oxidation defects in Kuwaiti newborns and sick infants. MATERIALS AND METHODS: A total of 1,520 blood samples were tested for inborn metabolic disorders in Kuwaiti newborns and sick infants. Positive electrospray MS/MS was used to measure diagnostic acylcarnitines and amino acids in blood spots after simple extraction and derivatization procedures. Validation and stability studies were conducted using control blood samples supplemented with known concentrations of the diagnostic amino acids or acylcarnitines. Reference and cutoff levels of the diagnostic metabolites were determined in a group of 500 normal Kuwaiti babies for quantitative evaluation. RESULTS: Of the 1,520 samples, 32 were positive newborn cases and 27 positive symptomatic infants. For the validation studies, the range of relative standard deviation was 2.6-14.7%, whereas the range of the percent deviation from nominal concentrations was -23.0 to +25.0 of the diagnostic metabolites. Stability studies indicated appropriate stability of the diagnostic amino acids and acylcarnitines in dried blood spots stored at 22 +/- 1 degrees C and relative humidity of 50-60%. CONCLUSIONS: Tandem mass spectrometry can significantly contribute to a newborn screening program as a fast and highly specific diagnostic technique for screening of a broad range of inborn metabolic disorders.

Advertising and disclosure of funding on patient organisation websites: a cross-sectional survey.

BACKGROUND: Patient organisations may be exposed to conflicts of interest and undue influence through pharmaceutical industry (Pharma) donations. We examined advertising and disclosure of financial support by pharmaceutical companies on the websites of major patient organisations. METHOD: Sixty-nine national and international patient organisations covering 10 disease states were identified using a defined Google search strategy. These were assessed for indicators of transparency, advertising, and disclosure of Pharma funding using an abstraction tool and inspection of annual reports. Data were analysed by simple tally, with medians calculated for financial data. RESULTS: Patient organisations websites were clear about their identity, target audience and intention but only a third were clear on how they derived their funds. Only 4/69 websites stated advertising and conflict of interest policies. Advertising was generally absent. 54% of sites included an annual report, but financial reporting and disclosure of donors varied substantially. Corporate donations were itemised in only 7/37 reports and none gave enough information to show the proportion of funding from Pharma. 45% of organisations declared Pharma funding on their website but the annual reports named more Pharma donors than did the websites (median 6 vs. 1). One third of websites showed one or more company logos and/or had links to Pharma websites. Pharma companies' introductions were present on 10% of websites, some of them mentioning specific products. Two patient organisations had obvious close ties to Pharma. CONCLUSION: Patient organisation websites do not provide enough information for visitors to assess whether a conflict of interest with Pharma exists. While advertising of products is generally absent, display of logos and corporate advertisements is relatively common. Display of clear editorial and advertising policies and disclosure of the nature and degree of corporate donations is needed on patient organisations' websites. An ethical code to guide patient organisations and their staff members on how to collaborate with Pharma is also necessary, if patient organisations are to remain independent and truly represent the interests and views of patients. As many organizations rely on Pharma donations, self-regulation may not suffice and independent oversight bodies should take the lead in requiring this.