Vaccine procurement in the Middle East and North Africa region: Challenges and ways of improving program efficiency and fiscal space.

Improving vaccine procurement performance has been a priority concern of national health authorities in the Middle East and North Africa (MENA) region for years particularly in terms of its role in accessing new vaccines and assuring a steady supply of quality vaccines at affordable prices. This article reviews the vaccine procurement mechanisms in the MENA region; analyzes the factors and drivers affecting demand for and supply of vaccines; discusses the main challenges; and suggests measures which can increase efficiency gains and generate the budgetary room to introduce life-saving vaccines. Based on in-depth analysis of available data and interviews with key informants at the regional and country level, this paper explains why most of the current strategies do not sufficiently recognize the specific characteristics of vaccine markets and best practices in procurement given these markets. The paper suggests potential efficiency gains for governments and global partners from pooling demand and moving from transaction-based purchasing to strategic purchasing in order to strengthen immunization services and introduce more life-saving vaccines.

Immunisation financing and programme performance in the Middle East and North Africa, 2010 to 2017.

Immunisation is a cornerstone to primary health care and is an exceptionally good value. The 14 low-income and middle-income countries in the Middle East and North Africa region make up 88% of the region's population and 92% of its births. Many of these countries have maintained high immunisation coverage even during periods of low or negative economic growth. However, coverage has sharply deteriorated in countries directly impacted by conflict and political unrest. Approximately 1.3 million children were not completely vaccinated in 2017, as measured by third dose of diphtheria-pertussis-tetanus vaccine. Most of the countries have been slow to adopt the newer, more expensive life-saving vaccines mainly because of financial constraints and the socioeconomic context. Apart from the three countries that have had long-standing assistance from Gavi, the Vaccine Alliance, most countries have not benefited appreciably from donor and partner activities in supporting their health sector and in achieving their national and subnational immunisation targets. Looking forward, development partners will have an important role in helping reconstruct health systems in conflict-affected countries. They can also help with generating evidence and strategic advocacy for high-priority and cost-effective services, including immunisation. Governments and ministries of health would ensure important benefits to their populations by investing further in their immunisation programmes. Where possible, the health system can create and expand fiscal space from efficiency gains in harmonising vaccine procurement mechanisms and service integration; broader revenue generation from economic growth; and reallocation of government budgets to health, and from within health, to immunization.

Overcoming challenges to sustainable immunization financing: early experiences from GAVI graduating countries.

Over the 5-year period ending in 2018, 16 countries with a combined birth cohort of over 6 million infants requiring life-saving immunizations are scheduled to transition (graduate) from outside financial and technical support for a number of their essential vaccines. This support has been provided over the past decade by the GAVI Alliance. Will these 16 countries be able to continue to sustain these vaccination efforts? To address this issue, GAVI and its partners are supporting transition planning, entailing country assessments of readiness to graduate and intensive dialogue with national officials to ensure a smooth transition process. This approach was piloted in Bhutan, Republic of Congo, Georgia, Moldova and Mongolia in 2012. The pilot showed that graduating countries are highly heterogeneous in their capacity to assume responsibility for their immunization programmes. Although all possess certain strengths, each country displayed weaknesses in some of the following areas: budgeting for vaccine purchase, national procurement practices, performance of national regulatory agencies, and technical capacity for vaccine planning and advocacy. The 2012 pilot experience further demonstrated the value of transition planning processes and tools. As a result, GAVI has decided to continue with transition planning in 2013 and beyond. As the graduation process advances, GAVI and graduating countries should continue to contribute to global collective thinking about how developing countries can successfully end their dependence on donor aid and achieve self-sufficiency.

Impact of BRICS' investment in vaccine development on the global vaccine market.

Brazil, the Russian Federation, India, China and South Africa--the countries known as BRICS--have made considerable progress in vaccine production, regulation and development over the past 20 years. In 1993, all five countries were producing vaccines but the processes used were outdated and non-standardized, there was little relevant research and there was negligible international recognition of the products. By 2014, all five countries had strong initiatives for the development of vaccine technology and had greatly improved their national regulatory capacity. South Africa was then the only BRICS country that was not completely producing vaccines. South Africa is now in the process of re-establishing its own vaccine production and passing beyond the stage of simply importing, formulating and filling vaccine bulks. Changes in the public sector's price per dose of selected vaccines, the global market share represented by products from specific manufacturers, and the attractiveness, for multinational companies, of partnership and investment opportunities in BRICS companies have all been analysed. The results indicate that the BRICS countries have had a major impact on vaccine price and availability, with much of that impact attributable to the output of Indian vaccine manufacturers. China is expected to have a greater impact soon, given the anticipated development of Chinese vaccine manufacturers in the near future. BRICS' accomplishments in the field of vaccine development are expected to reshape the global vaccine market and accelerate access to vaccines in the developing world. The challenge is to turn these expectations into strategic actions and practical outcomes.

Le Brésil, la Fédération de Russie, l'Inde, la Chine et l'Afrique du Sud ­ les pays connus sous le nom de BRICS ­ ont fait des progrès considérables dans la production, la régulation et le développement des vaccins au cours des 20 dernières années. En 1993, les cinq pays fabriquaient des vaccins, mais les procédés utilisés étaient dépassés et non normalisés. Par ailleurs, peu de recherches pertinentes étaient menées et les produits ne recevaient qu'une reconnaissance internationale négligeable. En 2014, les cinq pays avaient pris des initiatives importantes en matière de développement technologique de vaccins et avaient largement amélioré leur capacité de régulation nationale. L'Afrique du Sud était alors le seul pays du groupe BRICS à ne pas produire complètement des vaccins. L'Afrique du Sud a maintenant amorcé le processus pour relancer sa production de vaccins et pour dépasser l'étape de la simple importation, formulation et conditionnement des vaccins en vrac. On a analysé les variations de prix du secteur public par dose des vaccins sélectionnés, la part du marché mondial représentée par les produits provenant de fabricants spécifiques et l'attractivité des opportunités de partenariat et d'investissement pour les multinationales dans les entreprises du groupe BRICS. Les résultats montrent que les pays du groupe BRICS ont eu un impact majeur sur le prix et la disponibilité des vaccins, et cet impact est attribuable, en grande partie, à la production des fabricants indiens de vaccins. La Chine devrait bientôt avoir un plus grand impact compte tenu du développement attendu des fabricants chinois de vaccins dans un avenir proche. Les réalisations du groupe BRICS dans le domaine du développement de vaccins devraient remodeler le marché mondial des vaccins et accélérer l'accès aux vaccins dans les pays en développement. Le défi est maintenant de transformer ces attentes en actions stratégiques et en résultats concrets.

Brasil, la Federación de Rusia, India, China y Sudáfrica, los países conocidos como BRICS, han hecho progresos considerables en la producción, regulación y desarrollo de vacunas en los últimos 20 años. En 1993, los cinco países ya producían vacunas, pero los procesos empleados para ello estaban anticuados y sin normalizar, había poca investigación relevante y un reconocimiento internacional mínimo de sus productos. En 2014, los cinco países contaban con iniciativas sólidas para el desarrollo de la tecnología relacionada con las vacunas y habían mejorado en gran medida su capacidad normativa nacional. Sudáfrica fue el único de los BRICS que no fabricaba vacunas en su totalidad. En la actualidad, dicho país se encuentra en proceso de restablecer su propia producción de vacunas e ir más allá de la simple importación, formulación y llenado de lotes de vacunas. Se han analizado los cambios en los precios por dosis de vacunas seleccionadas del sector público, la cuota de mercado mundial de productos de fabricantes específicos y el atractivo para las empresas multinacionales de la asociación y las oportunidades de inversión en empresas de los BRICS. Los resultados indican que los países BRICS han tenido un gran impacto en el precio y la disponibilidad de las vacunas, y que una gran parte de ese impacto se puede atribuir a la producción de vacunas de los fabricantes de India. Se confía en que China tenga pronto un impacto mayor, dada la evolución prevista de los fabricantes de vacunas chinos en el futuro cercano. Se espera que los logros de los BRICS en el campo del desarrollo de vacunas remodelen el mercado mundial de las vacunas y aceleren el acceso a las mismas en el mundo en desarrollo. El desafío consiste en convertir estas expectativas en actuaciones estratégicas y resultados prácticos.

Enhancing medicine price transparency through price information mechanisms.

BACKGROUND: Medicine price information mechanisms provide an essential tool to countries that seek a better understanding of product availability, market prices and price compositions of individual medicines. To be effective and contribute to cost savings, these mechanisms need to consider prices in their particular contexts when comparing between countries. This article discusses in what ways medicine price information mechanisms can contribute to increased price transparency and how this may affect access to medicines for developing countries. METHODS: We used data collected during the course of a WHO project focusing on the development of a vaccine price and procurement information mechanism. The project collected information from six medicine price information mechanisms and interviewed data managers and technical experts on key aspects as well as observed market effects of these mechanisms.The reviewed mechanisms were broken down into categories including objective and target audience, as well as the sources, types and volumes of data included. Information provided by the mechanisms was reviewed according to data available on medicine prices, product characteristics, and procurement modalities. RESULTS: We found indications of positive effects on access to medicines resulting from the utilization of the reviewed mechanisms. These include the uptake of higher quality medicines, more favorable results from contract negotiations, changes in national pricing policies, and the decrease of prices in certain segments for countries participating in or deriving data from the various mechanisms. CONCLUSION: The reviewed mechanisms avoid the methodological challenges observed for medicine price comparisons that only use national price databases. They work with high quality data and display prices in the appropriate context of procurement modalities as well as the peculiarities of purchasing countries. Medicine price information mechanisms respond to the need for increased medicine price transparency and have the potential to contribute to improved access to medicines in developing countries.Additional research is required to explore more specific aspects. These include the market effects of dedicated donor funds for certain medicines to explain the driving force of user demands, and the effects of increased price transparency on different groups of medicines in context of the maturity of their markets.

EPIVAC International Conference on Financial Sustainability of Immunization Programs in sub-Saharan Africa, February 16-18, 2012, Ouidah, Benin.

The introduction of new vaccines with much higher prices than traditional vaccines results in increasing budgetary pressure on immunization programs in GAVI-eligible countries, increasing the need to ensure their financial sustainability. In this context, the third EPIVAC (Epidemiology and Vaccinology) technical conference was held from February 16 to 18, 2012 at the Regional Institute of Public Health in Ouidah, Benin. Managers of ministries of health and finance from 11 West African countries (GAVI eligible countries), as well as former EPIVAC students and European experts, shared their knowledge and best practices on immunization financing at district and country level. The conference concluded by stressing five major priorities for the financial sustainability of national immunization programs (NIPs) in GAVI-eligible countries. - Strengthen public financing by increasing resources and fiscal space, improving budget processes, increasing contribution of local governments and strengthen efficiency of budget spending. - Promote equitable community financing which was recognized as a significant and essential contribution to the continuity of EPI operations. - Widen private funding by exploring prospects offered by sponsorship through foundations dedicated to immunization and by corporate social responsibility programs. - Contain the potential crowding-out effect of GAVI co-financing and ensure that decisions on new vaccine introductions are evidence-based. - Seek out innovative financing mechanisms such as taxes on food products or a national solidarity fund.

Global support for new vaccine implementation in middle-income countries.

Middle-income countries (MICs) as a group are not only characterized by a wide range of gross national income (GNI) per capita (US $1026 to $12,475), but also by diversity in size, geography, governance, and infrastructure. They include the largest and smallest countries of the world-including 16 landlocked developing countries, 27 small island developing states, and 17 least developed countries-and have a significant diversity in burden of vaccine-preventable diseases. Given the growth in the number of MICs and their considerable domestic income disparities, they are now home to the greatest proportion of the world's poor, having more inhabitants below the poverty line than low-income countries (LICs). However, they have little or no access to external funding for the implementation of new vaccines, nor are they benefiting from an enabling global environment. The MICs are thus not sustainably introducing new life-saving vaccines at the same rate as donor-funded LICs or wealthier countries. The global community, through World Health Assembly resolutions and the inclusion of MIC issues in several recent studies and important documents-including the Global Vaccine Action Plan (GVAP) for the Decade of Vaccines-has acknowledged the sub-optimal situations in some MICs and is actively seeking to enhance the situation by expanding support to these countries. This report documents some of the activities already going on in a subset of MICs, including strengthening of national regulatory authorities and national immunization technical advisory groups, and development of comprehensive multi-year plans. However, some additional tools developed for LICs could prove useful to MICs and thus should be adapted for use by them. In addition, new approaches need to be developed to support MIC-specific needs. It is clear that no one solution will address the needs of this diverse group. We suggest tailored interventions in the four categories of evidence and capacity-building, policy and advocacy, financing, and procurement and supply chain. For MICs to have comparable rates of introduction as other wealthier countries and to contribute to the global fight against vaccine-preventable diseases, global partners must implement a coordinated and pragmatic intervention strategy in accord with their competitive advantage. This will require political will, joint planning, and additional modest funding.

New vaccine adoption in lower-middle-income countries.

OBJECTIVES: Lower-middle-income countries (LMICs) are lagging behind both high-income and low-income countries in new vaccine adoption. Our study involved the following objectives: (1) understand the decision-making processes of LMICs on new vaccine adoption, (2) identify the factors influencing LMIC decisions, (3) obtain the views of vaccine manufacturers about LMIC markets for new vaccines, and (4) make recommendations concerning how to speed up and improve decision making, including proposing mechanisms for implementation of the recommendations. METHODS: Collect and analyse qualitative data from participants in decision making in 15 case study countries [12 LMICs and three upper-middle-income countries (UMICs)] and multinational and developing country vaccine manufacturers. FINDINGS: Interviews of actors in decision making indicate that the aspects deemed most important for adoption are: World Health Organization (WHO) recommendations, the existence of local epidemiological data and a set of factors comprising affordability, cost-effectiveness and overall cost of the new vaccine for the programme. National Immunization Technical Advisory Groups (NITAG) have a key role in advising decision-makers, although their resources and capacity vary. Country decision-makers and manufacturers both see advantages in pooled procurement mechanisms for vaccine purchasing. Recommendations for countries and the international community involve assisting with making epidemiological data and vaccine market information accessible to countries, building and reinforcing related analysis capacity, and assisting with purchasing mechanisms and practices such as pooled procurement.

Role of the private sector in the provision of immunization services in low- and middle-income countries.

The authors conducted a literature review on the role of the private sector in low- and middle-income countries. The review indicated that relatively few studies have researched the role of the private sector in immunization service delivery in these countries. The studies suggest that the private sector is playing different roles and functions according to economic development levels, the governance structure and the general presence of the private sector in the health sector. In some countries, generally low-income countries, the private for-profit sector is contributing to immunization service delivery and helping to improve access to traditional EPI vaccines. In other countries, particularly middle-income countries, the private for-profit sector often acts to facilitate early adoption of new vaccines and technologies before introduction and generalization by the public sector. The not-for-profit sector plays an important role in extending access to traditional EPI vaccines, particularly in low-income countries. Not-for-profit facilities are situated in rural as well as urban areas and are more likely to be coordinated with public services than the private for-profit sector. Although numerous studies on non-governmental organizations (NGOs) suggest that the extent of NGO provision of immunization services in low- and middle-income countries is substantial, the contribution of this sector is poorly documented, leading to a lack of recognition of its role at national and global levels. Studies on quality of immunization service provision at private health facilities suggest that it is sometimes inadequate and needs to be monitored. Although some articles on public-private collaboration exist, little was found on the extent to which governments are effectively interacting with and regulating the private sector. The review revealed many geographical and thematic gaps in the literature on the role and regulation of the private sector in the delivery of immunization services in low- and middle-income countries.

Sustaining GAVI-supported vaccine introductions in resource-poor countries.

Since 2000, GAVI provided essential support for an unprecedented increase in the use of hepatitis B (HepB) and Haemophilus influenzae (Hib) containing vaccines in resource poor countries. This increase was supported with significant funding from international donors, intended to be time-limited. To assess the sustainability of this important expansion of the global access to vaccines, we reviewed supply chains, financial resources for procurement and decision-making in countries that introduced hepatitis B or Hib vaccines with GAVI support. During the period studied, the types of vaccine products supplied fluctuated rapidly in relationship with the number of suppliers and availability of more combination products. The price of the cheaper vaccines decreased while that of pentavalent DTwP-HepB-Hib remained stable. In average, vaccine introduction was associated with an increase of national programs budget, with new vaccines representing more than half of that increase, while the part of GAVI contributions to the budget went from 25% to 46%. Less than 20% of the vaccine introductions were decided by a national advisory body. Strengthening supply chains, adjusting funding schemes and increasing national ownership will be key to the sustained use of hepatitis B and Hib vaccines and the eventual addition of other important vaccines where they are the most needed.

The role of emerging manufacturers in access to innovative vaccines of public health importance.

The role of developing country manufacturers in assuring global access to innovative vaccines was compared to the situation in 2005. These producers now supply over 60% of traditional vaccines doses globally and an increasing value (up to 15% in 2007) of innovative products. More suppliers are now strong players in global market, and an even larger group has potential to do so. These manufacturers are not a homogeneous group and most of them are now at a crossroads. Decisions made by their management and governments as well as by the international community will have a large impact on their existence and future and their ability to manufacture innovative vaccines at affordable prices.

[A mid-term review of the Millennium Development Goals: where are we with the goals on health?]. / A mi-parcours des Objectifs du millénaire pour le développement, où en sommes-nous avec les objectifs sur la santé?

The eight Millennium Development Goals (MDGs) are the expressed commitment by world leaders to combat the most obvious forms of social inequality in the world: poverty, illiteracy and disease. The MDGs set health priorities and serve as markers of the most fundamental problems to solve: the maternal and child health high mortality, and the fight against major endemic diseases. Thus, health appears in three of the eight goals, and plays a decisive role in achieving the other MDGs such as the eradication of poverty and hunger, promotion of education and gender equality. While progress has been made in various domains and in numerous countries, enormous gaps and lack of funding remain. This is the case for infant mortality and HIV/AIDS, and even more so in the area of maternal mortality reduction especially in sub-Saharan Africa and Southeast Asia. The recent proliferation of forums and international partnerships for health have put at the forefront the targeted health-related MDG, increased financial resources for the benefit of poor countries but have made the architecture of global health even more fragmented and complex. Attempts to align on country priorities, needs and national health plans, and also to harmonize donors and partners' actions and funding according to the 2005 Paris Declaration principles, were difficult to actually materialize. The revitalization of primary health care and the strengthening of health systems are now back on the international and national health agenda.

Access to vaccine technologies in developing countries: Brazil and India.

This study, conducted by visits, interviews, and literature search, analyzes how vaccine manufacturers in Brazil and India access technologies for innovative vaccines: through collaborations with academia and research institutions, technology transfer agreements with multinational corporations, public sector, or developing country organizations, or by importation and finishing of bulk products. Each has advantages and disadvantages in terms of speed, market, and ability to independently produce the product. Most manufacturers visited are very concerned about avoiding patent infringement, which might result in undeveloped or delayed products because of a lack of mastery of the patent landscape. Disregarding the patent picture could also threaten the market of a potential product. Although it is too soon to assess the effects of TRIPS on vaccine technology access in Brazil and India, a good understanding of intellectual property management will be useful. A case study on development of a new combination vaccine illustrates these findings.

The impact of globalization on vaccine development and availability.

Globalization is likely to affect many aspects of public health, one of which is vaccine-preventable communicable diseases. Important forces include increased funding initiatives supporting immunization at the global level; regulatory harmonization; widespread intellectual property rights provisions through the World Trade Organization agreements; the emergence of developing-country manufacturers as major players in vaccine supply; and the appearance of new communicable disease threats, including those potentially linked to bioterrorism. All of these forces can affect, either positively and negatively, the development and availability of vaccines. Harnessing these will be a challenge for policymakers and immunization stakeholders.

Managing the effect of TRIPS on availability of priority vaccines.

The stated purpose of intellectual property protection is to stimulate innovation. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires all Members of the World Trade Organization (WTO) to enact national laws conferring minimum standards of intellectual property protection by certain deadlines. Critics of the Agreement fear that such action is inconsistent with ensuring access to medicines in the developing world. A WHO convened meeting on intellectual property rights and vaccines in developing countries, on which this paper is based, found no evidence that TRIPS has stimulated innovation in developing market vaccine development (where markets are weak) or that protection of intellectual property rights has had a negative effect on access to vaccines. However, access to future vaccines in the developing world could be threatened by compliance with TRIPS. The management of such threats requires adherence of all countries to the Doha Declaration on TRIPS, and the protections guaranteed by the Agreement itself, vigilance on TRIPS-plus elements of free trade agreements, developing frameworks for licensing and technology transfer, and promoting innovative vaccine development in developing countries. The role of international organizations in defining best practices, dissemination of information, and monitoring TRIPS impact will be crucial to ensuring optimal access to priority new vaccines for the developing world.

Regional group purchasing of vaccines: review of the Pan American Health Organization EPI revolving fund and the Gulf Cooperation Council group purchasing program.

This paper reviews the key design features, accomplishments of and lessons learned from two regional group procurement mechanisms dealing with vaccines that have been in operation for more than 25 years. The Pan American Health Organization (PAHO) EPI Revolving Fund purchases vaccines and immunization supplies on behalf of more than 35 countries in the Latin American and Caribbean region. Based on a 'central contracting' model, the program handles most aspects of procurement-from tendering to contracting with and paying producers--using a common fund to pay producers before being reimbursed by countries once goods are received in-country. The Gulf Cooperation Council (GCC) Group Purchasing Program among seven Persian Gulf States issues joint tenders for vaccines, as well as drugs and other medical goods. Through this 'group contracting' program, countries are responsible for contracting with and paying producers on their own, once the group has selected winning bids. Both programs have experienced substantial growth in the past two decades and are considered to have contributed to or accelerated achievements of immunization programs in both regions, including the introduction of new vaccines. The paper identifies several features of both programs--both those designed to attract country participation and those designed to ensure the programs' financial viability--which help explain their success and longevity.