Pandemic preparedness and response: beyond the Access to COVID-19 Tools Accelerator.

Nationalism has trumped solidarity, resulting in unnecessary loss of life and inequitable access to vaccines and therapeutics. Existing intellectual property (IP) regimens, trade secrets and data rights, under which pharmaceutical firms operate, have also posed obstacles to increasing manufacturing capacity, and ensuring adequate supply, affordable pricing, and equitable access to COVID-19 vaccines and other health products in low-income and middle- income countries. We propose: (1) Implementing alternative incentive and funding mechanisms to develop new scientific innovations to address infectious diseases with pandemic potential; (2) Voluntary and involuntary initiatives to overcome IP barriers including pooling IP, sharing data and vesting licences for resulting products in a globally agreed entity; (3) Transparent and accountable collective procurement to enable equitable distribution; (4) Investments in regionally distributed research and development (R&D) capacity and manufacturing, basic health systems to expand equitable access to essential health technologies, and non-discriminatory national distribution; (5) Commitment to strengthen national (and regional) initiatives in the areas of health system development, health research, drug and vaccine manufacturing and regulatory oversight and (6) Good governance of the pandemic prevention, preparedness and response accord. It is important to articulate principles for deals that include reasonable access conditions and transparency in negotiations. We argue for an equitable, transparent, accountable new global agreement to provide rewards for R&D but only on the condition that pharmaceutical companies share the IP rights necessary to produce and distribute them globally. Moreover, if countries commit to collective procurement and fair pricing of resulting products, we argue that we can greatly improve our ability to prepare for and respond to pandemic threats.

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

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.

Trans-Pacific Partnership Provisions in Intellectual Property, Transparency, and Investment Chapters Threaten Access to Medicines in the US and Elsewhere.

Brook Baker describes the potential harms to global health from the Trans Pacific Partnership Agreement and its failure to balance the interests of patients and the public with those of industry.

Evolving Human Rights and the Science of Antiretroviral Medicine.

Recent years have seen significant advances in the science of using antiretroviral medicines (ARVs) to fight HIV. Where not long ago ARVs were used late in disease to prevent sick people from dying, today people living with HIV can use ARVs to achieve viral suppression early in the course of disease. This article reviews the mounting new scientific evidence of major clinical and prevention ARV benefits. This has changed the logic of the AIDS response, eliminating competition between "treatment" and "prevention" and encouraging early initiation of treatment for individual and public health benefit. These breakthroughs have implications for the health-related human rights duties of States. With medical advance, the "highest attainable standard" of health has taken a leap, and with it the rights obligations of States. We argue that access to early treatment for all is now a core State obligation and restricting access to, or failing to provide accurate information about, it violates both individual and collective rights. In a context of real political and technical challenges, however, in this article we review the policy implications of evolving human rights obligations given the new science. National and international legal standards require action on budget, health and intellectual property policy, which we outline.

Will the Modi government succumb to US and industry pressure to modify its pro-access pharmaceutical patent policy?

The US has persistently pressured India to adopt US-style patent protections on pharmaceuticals for many years. That pressure has intensified recently because of Indian rules that have blocked patents on medicines widely patented elsewhere and because India has issued a compulsory license. Under the leadership of its new Prime Minister (PM), Narendra Modi, India has already made several overtures to appease US pressure. The two countries have established a bilateral intellectual property (IP) Working Group that will meet regularly as part of their Trade Policy Forum. This allows the US fox in India's patent law chicken house. In addition, India has issued a Draft National IPR Policy that is highly pro-IP and that promises consensus-oriented negotiations with international partners. These signals have been reinforced by decisions to drop price controls on nonessential medicines, to appoint a pro-IP economic advisor, and to stall issuance of additional compulsory licenses. On the other hand, both PM Modi and the Draft IP Policy state the need for a balance in IP, including a balance that promotes public health and that avoids granting of secondary patents. The world will see other countries copying India's pro-access rules at the same time that India continues to be pressured by the US.

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

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 society's perspective regarding the effects of two GHIs, the US President's 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 society's 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.

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 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 'diagonal' approach to Global Fund financing: a cure for the broader malaise of health systems?

BACKGROUND: The potentially destructive polarisation between 'vertical' financing (aiming for disease-specific results) and 'horizontal' financing (aiming for improved health systems) of health services in developing countries has found its way to the pages of Foreign Affairs and the Financial Times. The opportunity offered by 'diagonal' financing (aiming for disease-specific results through improved health systems) seems to be obscured in this polarisation. In April 2007, the board of the Global Fund to fight AIDS, Tuberculosis and Malaria agreed to consider comprehensive country health programmes for financing. The new International Health Partnership Plus, launched in September 2007, will help low-income countries to develop such programmes. The combination could lead the Global Fund to fight AIDS, Tuberculosis and Malaria to a much broader financing scope. DISCUSSION: This evolution might be critical for the future of AIDS treatment in low-income countries, yet it is proposed at a time when the Global Fund to fight AIDS, Tuberculosis and Malaria is starved for resources. It might be unable to meet the needs of much broader and more expensive proposals. Furthermore, it might lose some of its exceptional features in the process: its aim for international sustainability, rather than in-country sustainability, and its capacity to circumvent spending restrictions imposed by the International Monetary Fund. SUMMARY: The authors believe that a transformation of the Global Fund to fight AIDS, Tuberculosis and Malaria into a Global Health Fund is feasible, but only if accompanied by a substantial increase of donor commitments to the Global Fund. The transformation of the Global Fund into a 'diagonal' and ultimately perhaps 'horizontal' financing approach should happen gradually and carefully, and be accompanied by measures to safeguard its exceptional features.

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.