The World Health Organisation (WHO) includes regulatory system functions as one of the six core building blocks of health systems: access to medical products, vaccines, and technologies of assured quality, safety, and efficacy. However, little attention has been focused on regulatory systems in low- and middle-income countries. They have not featured prominently in global health and development assistance programmes, according to this paper, and few strategic documents of major global health initiatives, including the United States Global Health Initiative, reference regulatory systems. The global activities that do involve regulatory systems typically involve high-income countries, such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which harmonises regulatory standards and processes for the pharmaceutical industry. ICH includes regulatory authorities from the European Union, Japan and the United States. The authors argue that lack of attention to medical product regulatory systems in low- and middle-income countries is a significant gap that needs to be bridged. They thus propose that strengthening regulatory systems in low- and middle-income countries must become a global health priority.
Public-Private Mix
This report points out that the private health sector is growing rapidly in low- and middle-income countries, while the debate about the purported advantages and drawbacks of the reliance on public, private not-for- profit and private for-profit providers has suffered from a distinct lack of factual documentation and evidence. It indicates a need for better empirical information, over a range of contexts, on the characteristics, extent, growth and consequences of unregulated commercial care provision. Such information should cover short- and long-term impact on safety, access, quality of care, health outcomes, health equity and social outcomes, as well as the level of trust in health systems and health authorities. An improved evidence base would also allow for a more productive exchange of experience between countries on best practices regarding constructive engagement with and regulation of different types of health-care providers. In many low- and middle-income countries reduced institutional capacity constrains constructive engagement with the wide range of actors involved in health-care provision. The World Health Organization aims to consolidate experience, document best practice and facilitate exchange and joint learning about ways to strengthen government capacity for constructive engagement and effective oversight of the full range of health-care providers.
This paper describes the context of health care provision in sub-Saharan Africa (SSA), analyses current mechanisms for public-private partnerships (PPP), and discusses emerging issues in strengthening partnerships to expand health coverage.
Global progress towards reducing undernutrition has been made through enlightened public policies, targeted development assistance, private sector actions and commitments from civil society. Yet every year, the deaths of more than 3.5 million children under the age of 5 can be attributed to undernutrition. This article argues that strong public-private sector partnerships can help to reduce undernutrition.
This paper by the AIDS Law Project calls for measures to address inequity in access to private health care services and to regulate costs in the private sector. For this reason regular and accurate information about health financing, service prices and business practices in the private sector is essential in determining both health policy as well as a fair and reasonable price for services and products.
ECDPM organised an informal multi-stakeholder meeting in Brussels in December 2012 to highlight and share the different views of the opportunities and challenges, as well as potential ways forward, in measuring the impact of the private sector on development. Participants included European Union (EU) officials, research institutes, development agencies, African, Caribbean and Pacific (ACP) and EU ambassadors, civil society organisations and private sector actors and confederations. Despite the private sector’s often-cited move beyond corporate social responsibility, delegates agreed that the focus for some still seems to be predominantly placed within the (often marginal) add-on projects on the side of the core business. By choosing to not address this, private sector actors are avoiding the fact that their main business activities most likely are their main development impact. The author recommends that partnerships between public-private and/or civil society actors should be balanced and in the interest of all partners, and that assessment of these partnerships should not only capture corporate social responsibility-type activities, but also core business impacts.
The United States Agency for International Development (USAID)/Tanzania
commissioned the SHOPS project and the IFC-World Bank Health in Africa
Initiative to conduct a private sector assessment of mainland Tanzania,
in response to a request from the Public-Private Partnership Technical
Working Group (PPP-TWG) in Tanzania. The assessment is intended
to assist the Ministry of Health and Social Welfare to develop a
prioritized agenda for more effectively engaging the private health sector
and building public-private partnerships focused on the country’s
key health challenges: HIV/AIDS, reproductive and child health, malaria,
and tuberculosis. It notes that although the private health sector in Tanzania is smaller than in some east African countries, it is sizable, diverse, and actively engaged throughout the health system
The Bill and Melinda Gates Foundation has pledged US$220 million over the next five years for the search for a tuberculosis (TB) vaccine. The money will be channeled via Aeras, a non-profit organisation developing vaccines to combat TB against the backdrop of a significant increase in drug-resistant strains. A large portion of their proposed TB vaccine work will take place in South Africa, where research partners have been promised they will benefit from the grant. The grant will allow Aeras to advance several vaccine candidates into pivotal large-scale efficacy trials in South Africa and elsewhere. Aeras estimates a total of $400-500 million will be needed over the next five years to fund activities. The Gates grant will provide approximately half of the estimated cost of meeting 2012 to 2016 milestone targets.
The UN post-2015 development agenda includes 17 Sustainable Development Goals (SDGs) and a “revitalized” Global Partnership to ensure their implementation. Formal inclusion of the private sector (in addition to governments, civil society, the UN system and other actors) is one of the defining features of this Global Partnership. Plenty of studies have shown how corporate actions can have significant impacts, positive and negative, for vulnerable people and for marginalised communities. However the author argues that it also raises an important question. How will the private sector be held accountable for its contribution to the Global Partnership? The latest draft of the 2030 Agenda for Sustainable Development provides that a High Level Political Forum (HLPF) under the auspices of the General Assembly and the Economic and Social Council will have the central role in overseeing follow-up and review at the global level. Interestingly, the HLPF will be tasked to carry out regular reviews that will include relevant stakeholders, including the private sector. The author argues that measuring businesses is as fundamental as measuring governments and that rigorous benchmarking of pharmaceutical companies will be crucial.
This report describes opportunities for engaging and supporting a well managed and effectively regulated private sector to improve the region’s health and complementary to traditional public sector approaches.