Brook K. Baker

Salaries and incomes of health workers in sub-Saharan Africa

Public-sector health workers are vital to the functioning of health systems. We aimed to investigate pay structures for health workers in the public sector in sub-Saharan Africa; the adequacy of incomes for health workers; the management of public-sector pay; and the fiscal and macroeconomic factors that impinge on pay policy for the public sector. Because salary differentials affect staff migration and retention, we also discuss pay in the private sector. We surveyed historical trends in the pay of civil servants in Africa over the past 40 years. We used some empirical data, but found that accurate and complete data were scarce. The available data suggested that pay structures vary across countries, and are often structured in complex ways. Health workers also commonly use other sources of income to supplement their formal pay. The pay and income of health workers varies widely, whether between countries, by comparison with cost of living, or between the public and private sectors. To optimise the distribution and mix of health workers, policy interventions to address their pay and incomes are needed. Fiscal constraints to increased salaries might need to be overcome in many countries, and non-financial incentives improved.

Ending drug registration apartheid: taming data exclusivity and patent/registration linkage.

I. INTRODUCTION: WHY REGISTRATION-RELATED DATA EXCLUSIVITY AND PATENT/REGISTRATION LINKAGE ARE SO IMPORTANT TO BIG PHARMA AND SO DANGEROUS FOR DEVELOPING COUNTRIES The pharmaceutical industrys dependence on intellectual property rights (IPRs), especially patents, to exclude competitors and thereby recoup past expenditures,1 incentivize future investments in research and development (R&D), and maximize profits2 is well known. Although initially content to solidify patent rights in the rich-country markets of North America, Europe, and Japan, in the last quarter of the 20th century the industry has increasingly turned its attention to emerging markets in Latin America, Asia, and even Africa as sites of future market expansion. Big middle-income countries like Brazil, India, China, and Indonesia have growing middle classes that increasingly favor allopathic medicine over the more traditional medicines of their elders. Obtaining monopoly rights in these growing markets could help the pharmaceutical industry weather the storm of increased consumer, business, and government blow-back against supra-competitive drug prices charged in rich country markets. Although patents are powerful weapons in the industrys IPR arsenal, they are an imperfect solution for its attempt to secure durable monopoly protections on a global scale. From the industrys perspective, the problems with patent-related monopolies are four-fold. First, the most innovative, truly revolutionary products involving new chemical entities ordinarily take a very long time to come to market because of extensive pre-marketing product development and clinical trials.3 Patent term extensions designed to compensate for product-development and regulatory delays4 help companies recapture some of their rights to exclude, but extension provisions are subject to stringent upper limits,5 meaning that patent terms are often too short to secure market exclusivity during the entire period of the medicines therapeutic advantage. Second, evergreening strategies6 - efforts to extend the period of patent protections through incremental modifications to the product - may help maintain monopolies, but many of these modifications may not meet patent criteria even under the lenient standards of novelty, nonobviousness, and utility applied in the U.S. Although overworked patent examiners might initially accept such patents, they are highly vulnerable to legal challenge from generic competitors eager to enter lucrative First World markets. Third, because patent applications on new chemical entities are usually filed very early in the process of drug candidate selection (and deselection) to ensure meeting novelty requirements and to establish priority, the patent holder must file multiple patents, many of them soon-to-bedoomed, early-stage prospects, and it must do so in each and every country where it wants patent protections. Since patent applications are costly in terms of legal, filing, and maintenance fees, and because patent specification and language requirements vary country-to-country, patent-holders must make shrewd cost-benefit assessments that typically involve deciding against filing patent applications in small-country and poor-country markets.7 Accordingly, patent claims are ordinarily perfected and maintained only in rich countries and big middle-income countries and in countries that have pharmaceutical manufacturing capacity.8 Fourth, bio-tech products are not always patentable, given permissible exceptions from patenting life forms in some countries.9 For these products, data exclusivity is the only way to ensure market exclusivity. Historically, pharmaceutical patent holders in the United States did not have to rely on patents alone to exclude competition. Until 1984, drug companies could treat undisclosed clinical trial and other data that that they submitted to the Food and Drug Administration [FDA] as trade secrets.10 The FDA in turn treated this information as confidential and refused to allow generic producers to rely on, or reference the information in order to obtain marketing approval for their therapeutically equivalent products. …

Using global health initiatives to strengthen health systems: a civil society perspective.

Abstract Research into the effects of global health initiatives (GHIs) on health systems has largely left out the viewpoints and contributions of civil society. This study details civil societys perspective regarding the effects of two GHIs, the US Presidents Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), on country health systems and the added value of civil society interacting with GHIs to strengthen health systems. The study employed qualitative data collection methods using semi-structured interviews administered during focus groups and key informant interviews. A range of health system stakeholders were interviewed in Kenya, Malawi, Uganda and Zambia. Data were coded and analysed for themes and sub-themes. In total, 2910 civil society participants provided information individually or in focus groups. Respondents reported that GHIs have contributed to dramatic health benefits within and outside of a disease-specific focus, including health systems strengthening efforts. However, opportunities for synergy between GHIs and health systems have been missed, and GHIs have not worked sufficiently to close capacity gaps of grassroots civil society organisations. Despite some governance innovations, civil societys opportunities to participate meaningfully in GHI priority setting efforts are limited. Recommendations are included on how to best use GHIs to strengthen health systems by partnering with civil society.

The impact of the international monetary fund's macroeconomic policies on the aids pandemic.

Expansion of funding for HIV/AIDS, especially treatment, is under attack over concerns about cost effectiveness and financial constraints. The International Monetary Fund is deeply implicated in the history of the AIDS pandemic, the underlying weakness of health systems, and the ideology of constrained resources that underlies most attacks on AIDS funding. The IMF imposed structural violence on developing countries in the 1980s and 1990s through neoliberal and macroeconomic reforms that intensified individual and communal vulnerability to infection and dismantled already weak health systems. This same macroeconomic fundamentalism has recently been repackaged and renamed. IMF fundamentalist policies continue to prioritize low inflation, constricted government spending, robust foreign currency reserves, and prompt repayment of debt at the expense of investments in health and more expansionary, pro-growth and job-creation policies. Several recent surveys have concluded that the IMF reluctantly relaxed overly restrictive policy prescriptions in response to the global economic crisis, but this relaxation was temporary at best and only extended to countries previously acceding to IMF orthodoxy. AIDS activists are campaigning for billions of dollars to fulfill the promise of universal access. If IMF pressures persist, developing countries will continue to undermine the additionality of donor health financing by substituting donor for domestic financing, refusing to invest in recurrent costs for medicines and health workers, and neglecting needed investments in health infrastructure and health system strengthening.

The danger of in-kind drug donations to the Global Fund.

In-kind drug donations to the Global Fund to fi ght AIDS, tuberculosis, and malaria (GFATM) could greatly distort market incentives for entry of generic drugs, and thus delay the development of a more competitive market for priority drugs. Donations can be detrimental to market incentives for generic competition because they reduce the size of the residual market for a particular drug, create uncertainty about future market eff ects of donations of other drugs, change the risk–benefi t ratio with respect to patent-related issues, registration barriers, and costs of negotiating a distribution system, and reduce the market-pull advantage of an identifi able, sizeable, and sustained source of secure fi nancing. Similarly, drug donations can distort choices about best treatment options by deterring use of eff ective fi xed-dose combinations and other improved formulations, tying government treatment choices to particular so-called free drugs, delaying or undermining governments’ motivation to select or modify treatment guidelines, aff ecting regulatory decisions (such as registration of generic equivalents), and complicating procurement and supply systems. The issue of in-kind donations of drugs has been discussed within GFATM since 2002, mainly at the insistence of the private sector and certain donors. Recently a joint steering committee of GFATM has commissioned a policy paper analysing in-kind donations, including potential market and sovereignty eff ects, for consideration at the Board’s November, 2008, meeting. Civil society delegations have consistently and successfully opposed drug donations. We present key arguments against two underexplored aspects of drug donations to GFATM— namely, their distortion of market incentives and their adverse eff ects on therapeutic options. Drug donations to GFATM are tempting because they lower commodity costs and could increase the value of private-sector contributions. However, these apparent advantages are more than off set by the fact that drug donations might have serious adverse eff ects on market incentives for entry of generic drugs, and thus delay the development of a competitive and low-priced market for medicines. Similarly, drug donations can distort therapeutic options for best treatment. Up to now, analyses of drug donations—for example, WHO guidelines, and studies for tropical or neglected diseases and for disaster relief—have neglected market distortion eff ects. An early analysis showed that costs of donations were four times higher than other alternatives such as discount prices or cash donations, after taking taxes into account. WHO prefers cash donations in the aftermath of emergencies, and both AIDS-related and malaria-related donations have proven problematic because of transparency, market segmentation, and conditionality issues or cost-ineffi cient, but not on the basis of any thorough market analysis. In the absence of market studies, analysis of related evidence for entry of generic drugs is useful in general, and of antiretroviral medicines in particular. The main fi ndings of these studies are that the number of generic entrants: (1) aff ects the extent of price competition, and the presence of eight or more competitors is related to the greatest price reductions; (2) positively correlates with market size (volume of sales) and expected profi ts, and with time since generic entry; and (3) negatively correlates with the number of incumbent generic fi rms, the number of competing drugs in a therapeutic class, the duration of the exclusivity of a product’s brand name (which builds brand loyalty), the presence of an early-entry branded generic, and, paradoxically, of reference pricing in one study but not another. The fact that market size and expected profi ts are the main drivers of entry of generic drugs is not surprising. Similarly, if the brand-name company captures post-patent market share via a branded generic or low price drug, negative eff ects on entry of generic drugs and ultimately price, not surprisingly, take place. Both fi ndings show the probable eff ect of drug donations on the aggregated markets of GFATM recipients, because donations also capture market share, and thus demotivate generic entrants. The basic economic argument rests on the fact that generic companies assess market prospects, uncertainty, and risk on the basis of anticipated costs, expected returns, and a prediction about how many competitors will enter or remain in the market. In making economic forecasts about whether investment of scarce resources will be profi table, generic companies must address four key issues discussed below. How much aggregate market demand will there be and will it be possible to sell in diff erent markets or will the product be restricted to a few markets or market segments only? Aggregating demand from diff erent developing countries, including middle-income and low-income countries, and public, non-governmental and faith-based organisations, and private sectors makes the market attractive for generic entrants. If donations split the market or target specifi c sectors, generic entrants would be left with a small and diffi cult market niche and a disadvantageous cost–benefi t ratio. Alternatively, if the market is large, generic companies can produce at more-effi cient economies of scale; if the market is large enough, several companies will enter, promoting price competition. How will demand grow (or shrink) over time in relation to competition from other medicines and other generic producers? Lancet 2009; 373: 1218–21

Patents, Pricing, and Access to Essential Medicines in Developing Countries

Steps are being taken by health activists worldwide to change patent and trade laws that have made essential medicines unavailable to so many for so long. Virtual Mentor is a monthly bioethics journal published by the American Medical Association.

Obstacles and Opportunities to Improve Antiretroviral Regimen Access in Low-Income Countries

Increasing evidence suggests that dramatically increasing access to effective and well-tolerated antiretroviral medications is key to reversing the HIV pandemic. Currently used first-line therapies in developing countries have multiple toxicities that cause significant morbidity and mortality. New World Health Organization HIV treatment guidelines support earlier treatment initiation and the use of less toxic first-line therapies. Adoption of these guidelines requires political and financial commitment from multiple stakeholders including country governments and donors. This review summarizes the major adverse effects associated with commonly used ARV regimens in low-income countries and also analyzes some of the barriers and potential solutions that affect the ability of low-income countries to implement the new World Health Organization guidelines.

The battle for access to medicines for all

In 2000, I returned to Durban, South Africa for the fourth time. For my fi rst visit, in 1997, I took a 6-month sabbatical at the faculty of law of the University of Durban-Westville (UDW). Although 1997 was the height of new HIV infections globally and in South Africa, public awareness of HIV was fairly muted—the Sarafi na 2 musical scandal was rocking the country amid half-hearted HIV-prevention efforts, but the science and reality of HIV treatment was far, far away. When I returned for a shorter visit in 1998, the science of HIV reached an even lower point, with the then Minister of Health promoting Virodene, which contained an industrial solvent, as an HIV treatment. A year later, I learned that 26% of the female students and 12% of the male students tested anonymously at the UDW health clinic were HIV positive. The rate was much higher for the black African, mainly Zulu, population than for students from Indian backgrounds. I knew that none of my students could afford the recently discovered triple antiretroviral therapy that was already producing a two-thirds reduction in deaths back home in the USA. I realised that more people would become infected, that those with HIV infection would die, and that the energy they might bring to the transformation of South Africa would be lost. In 2000, at the International AIDS Society’s International AIDS Conference in Durban, the convergence of the personal and the political turned me to AIDS activism. On a personal level, I couldn’t bear the idea of parents having children with treatable diseases being unable to afford medicines for their loved ones. My younger son is a cancer survivor, whose life had been saved 9 years earlier with expensive oncology drugs and HIV-free blood transfusions. It was a close call. Another father in the parents’ support group I attended had seen his son survive cancer, only to die of AIDS because of untestable blood transfusions. On a political level, at the outset of the 2000 Durban Conference, thousands of marchers, myself included, demanded that medicines costing US

Data exclusivity exceptions and compulsory licensing to promote generic medicines in the European Union: A proposal for greater coherence in European pharmaceutical legislation

10 439 per person per year be made affordable to the millions of sub-Saharan Africans living with and dying of HIV/AIDS. Marchers also denounced the bizarre AIDS denialism of the then President Thabo Mbeki.

Governance and transparency at PEPFAR

The challenge of providing access to high-priced patented medicines is a global problem affecting all countries. A decade and a half ago the use of flexibilities contained in the World Trade Organization Agreement on Trade Related Aspects of Intellectual Property Rights, in particular compulsory licensing, was seen as a mechanism to respond to high-price medicines for the treatment of HIV/AIDS in low- and middle-income countries. Today a number of upper-income European Union (EU) Member States are contemplating the use of compulsory licensing in their efforts to reduce expenditure on pharmaceutical products. EU regulation of clinical test data protection and the granting of market exclusivity interfere with the effective use of compulsory licensing by EU Member States and can even prevent access to off-patent medicines because they prohibit registration of generic equivalents.EU pharmaceutical legislation should be amended to allow waivers to data and market exclusivity in cases of public health need and when a compulsory or government use license has been issued. Such an amendment can be modelled after existing waivers in the EU Regulation on compulsory licensing of patents for the manufacture of pharmaceutical products for export to countries with public health problems outside the EU. Allowing a public health/compulsory license exception to data and market exclusivity would bring greater coherence between EC regulation of medicinal products and national provisions on compulsory licensing and ensure that Member States can take measures to protect public health and promote access to medicines for all.