The great medicines scandal: next steps?
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Biomedical subjects
Publications and source records attributed to Warren A Kaplan.
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BACKGROUND: The ongoing policy debate about the value of communications technology in promoting development objectives is diverse. Some view computer/web/phone communications technology as insufficient to solve development problems while others view communications technology as assisting all sections of the population. This paper looks at evidence to support or refute the idea that fixed and mobile telephones is, or could be, an effective healthcare intervention in developing countries. METHODS: A Web-based and library database search was undertaken including the following databases: MEDLINE, CINAHL, (nursing & allied health), Evidence Based Medicine (EBM), POPLINE, BIOSIS, and Web of Science, AIDSearch (MEDLINE AIDS/HIV Subset, AIDSTRIALS & AIDSDRUGS) databases. RESULTS: Evidence can be found to both support and refute the proposition that fixed and mobile telephones is, or could be, an effective healthcare intervention in developing countries. It is difficult to generalize because of the different outcome measurements and the small number of controlled studies. There is almost no literature on using mobile telephones as a healthcare intervention for HIV, TB, malaria, and chronic conditions in developing countries. Clinical outcomes are rarely measured. Convincing evidence regarding the overall cost-effectiveness of mobile phone " telemedicine" is still limited and good-quality studies are rare. Evidence of the cost effectiveness of such interventions to improve adherence to medicines is also quite weak. CONCLUSION: The developed world model of personal ownership of a phone may not be appropriate to the developing world in which shared mobile telephone use is important. Sharing may be a serious drawback to use of mobile telephones as a healthcare intervention in terms of stigma and privacy, but its magnitude is unknown. One advantage, however, of telephones with respect to adherence to medicine in chronic care models is its ability to create a multi-way interaction between patient and provider(s) and thus facilitate the dynamic nature of this relationship. Regulatory reforms required for proper operation of basic and value-added telecommunications services are a priority if mobile telecommunications are to be used for healthcare initiatives.
Fees charged by drug regulatory authorities (DRAs) may be used as a policy instrument to speed up regulatory approval, to encourage retention of quality staff and to stimulate introduction of generics versus new chemical entities. Often, the cost recovery function of these registration fees is not related to the true cost of the pharmaceutical regulatory process. In this paper, we scaled new drug registration fees of various DRAs to indices of economic development - the GNP per capita and the total government health expenditure per capita. Based on our analyses of 34 countries, most DRA registration fees for new drug applications for developing/non-OECD countries are less than the current GNP/capita of that country or are about US dollars 5000 for each US dollars 1000 spent per capita on healthcare. At present, each US dollars 1000 new drug registration fee for the developing/non-OECD countries analyzed corresponds to a total pharmaceutical market share of about US dollars 85 million. Our analyses further suggest little relationship between DRA registration fees and drug approval times in developing countries. The situation is complex, however, as policy tradeoffs are important to consider. Differential registration fees, presumably designed to encourage locally produced versus imported products, may violate international trade regulations. Moreover, certain DRA registration fees may provide perverse incentives for the pharmaceutical industry. Developing countries should require that DRA registration fees be based on accurate accounting of the cost of services provided. At present levels, these fees could be increased without disincentive to the pharmaceutical industry. For new drug registration fees, our analyses suggest that developing countries could charge between 1-5 times their GNP per capita or between US dollars 17000 and US dollars 80000 for each US dollars 1000 spent per capita on healthcare.