To give is better than to receive: compliance with WHO guidelines for drug donations during 2000-2008.

OBJECTIVE: to assess drug donations in terms of their adherence to the drug donation guidelines put forth by the World Health Organization (WHO). METHODS: in 2009 we searched the academic and lay literature - journal articles, media articles and industry and donor web sites - to identify reports about drug donations made from 2000 to 2008. Publications focusing on molecular mechanisms of drug action, general descriptions of guidelines or specific one-time drug donations before 2000 were excluded. For cases with sufficient information, we assessed compliance with each of the 12 articles of WHO's guidelines. FINDINGS: we found 95 articles describing 96 incidents of drug donations between 2000 and 2008. Of these, 50 were made in response to disaster situations, 43 involved the long-term donation of a drug to treat a specific disease and 3 were drug recycling cases. Disaster-related donations were less likely to comply with the guidelines, particularly in terms of meeting the recipient's needs, quality assurance and shelf-life, packaging and labelling, and information management. Recipient countries were burdened with the costs of destroying the drugs received through inappropriate donations. Although long-term donations were more likely to comply with WHO guidelines related to quality assurance and labelling, they did not consistently meet the needs of the recipients. Furthermore, they discouraged local drug production and development. CONCLUSION: drug donations can do more harm than good for the recipient countries. Strengthening the structures and systems for coordinating and monitoring drug donations and ensuring that these are driven by recipient needs will improve adherence to the drug donation guidelines set forth by WHO.

Living with Usher Syndrome: Patient and Physician Perspectives.

This commentary article is co-authored by a patient with Usher syndrome type 2A. The patient kindly shares her experience of living a life marked by the severe dual sensory loss associated with Usher syndrome. The experiences of the patient are put into perspective by two ophthalmologists associated with the Ophthalmological Department at Rigshospitalet, Denmark.

In this patient­physician perspective a patient with Usher syndrome shares her experience. Usher syndrome affects both hearing and vision. The patient describes how being deprived of these two important sensory functions have formed her life choices, from travelling the world while she still had vision to choosing not to have children due to fear of passing on the disease. Most importantly, the psychological impacts of the disease are shared and put into perspective by her ophthalmologists.

Essential medicines for reproductive health: developing evidence based interagency list.

OBJECTIVES: Although poor reproductive health constitutes a significant proportion of the disease burden in developing countries, essential medicines for reproductive health are often not available to the population. The objective was to analyze the guiding principles for developing national Essential Medicines Lists (EML). The second objective was to compare the reproductive health medicines included on these EMLs to the 2002 WHO/UNFPA list of essential drugs and commodities for reproductive health. Another objective was to compare the medicines included in existing international lists of medicines for reproductive health. METHODS: The authors calculated the average number of medicines per clinical groups included in 112 national EMLs and compared these average numbers with the number of medicines per clinical group included on the WHO/UNFPA List. Additionally, they compared the content of the lists of medicines for reproductive health developed by various international agencies. RESULTS: In 2003, the review of the 112 EMLs highlighted that medicines for reproductive health were not consistently included. The review of the international lists identified inconsistencies in their recommendations. The reviews' outcomes became the catalyst for collaboration among international agencies in the development of the first harmonized Interagency List of Essential Medicines for Reproductive Health. Additionally, WHO, UNFPA and PATH published guidelines to support the inclusion of essential medicines for reproductive health in national medicine policies and EMLs. The Interagency List became a key advocacy tool for countries to review their EMLs.In 2009, a UNFPA/WHO assessment on access to reproductive health medicines in six countries demonstrated that the major challenge was that the Interagency List had not been updated recently and was inconsistently used. CONCLUSION: The addition of cost-effective medicines for reproductive health to EMLs can result in enhanced equity in access to and cost containment of these medicines, and improve quality of care. Action is required to ensure their inclusion in national budget lines, supply chains, policies and programmatic guidance.

What strategies to boost production of affordable fixed-dose anti-retroviral drug combinations for children in the developing world?

BACKGROUND: No more than 8% of HIV positive children needing treatment in low- and middle-income countries have access to antiretroviral drugs (ARVs). Children presently account for about 4% of all treated patients, while for equitable access they should make up at least 13%. AIMS: This study explores key issues, implications and interaction dynamics to boost production of easy-to-use and affordable fixed-dose combination (FDC) ARVs for children in the developing world. Potentials for equitable solutions are examined including priority steps and actions, appropriate treatment options and reliable forecasting methods for paediatric ARVs, as well as combination incentives to generic companies against market unattractiveness and enforced intellectual property (IP) rights. Moreover, implementation strategies to enhance the development and production of affordable ARV paediatric formulations and appropriate supply systems to ensure availability are investigated. RESULTS: The current market for FDC paediatric ARVs is already substantial and will only grow with improved and scaled up diagnosis and monitoring of children. This provides an argument for immediate increase of production and development of FDC ARVs for children. These formulations must be low cost and included in the list of Essential Medicines to avoid children continuing to lag behind in access to treatment. Access-oriented, long-term drug policy strategies with the ability to pass muster of governments, the UN system, as well as generic and research-based enterprises are needed to let children gain expanded and sustained access to FDC ARVs. Under the requirements listed above, IP-bound Voluntary License (VL) flexibilities do appear, if coupled with substantial combination incentives to generic firms, as a fitting tool into the needs. Policies must consider enhancing human resource capacity in the area of caregivers and social and health workers aiming to spread correct information and awareness on effectiveness and rationale of FDC ARVs for children. Policies should urge that paediatric ARV treatment programmes entwine with extant interventions on prevention of mother-to-child transmission, as well as with HIV treatment initiatives focused on mothers and household members. Policies, again, should consider centralising functions and pooling resources to help overcome drug supply barriers. WHO's brokering role in VL-based agreements between wealthy and developing country industries, as well as its technical guidance in setting international standards should not be waived while looking for sustained access to optimised ARV treatments for children. Strategies discussed in this paper, while taking unavoidability of marketing and profit rules into account, look closely into the trade and drug policy directions of China and India according to frontier crossing implications of their IP management trends as well as their multi-faceted penetration strategies of both the wealthy and under-served markets the world over.