Lead Author: Mwelecele N. Malecela
Organization: National Institute for Medical Research (NIMR) Tanzania
Recent changes in the global health and development context – in particular the transition of low-income countries to middle-income status, declining levels of development assistance, and the adoption of the SDGs – are defining a ‘new context’ for access to medicines, vaccines and diagnostics. Developing countries need to allocate more domestic resources for public health, but also to exert greater control and ownership over health interventions.
There should also be a corresponding demand for donors and developed country governments to align their own policies, so that these do not act to prevent or hamper the achievement of national goals and global commitments. Global policy coherence will be of significance, particularly at the intersections of trade, health and human rights.
The consolidation of decision-making capacity, particularly in terms of effective priority-setting and policy coherence, should take place at the country level and in a bottom-up direction, in order that the determinants of access to medicines, diagnostics and vaccines are effectively and sustainably addressed. The Access and Delivery Partnership (ADP) has identified six ‘pathways’ towards an integrated approach for policy coherence that can have the most impact on access and delivery.
The implementation of an integrated approach towards access and delivery at the country level will provide an evidential basis of the key determinants of access and delivery, which should be taken into account in the efforts for policy coherence at the global level. On the basis of ADP’s implementation work, it may be said that the key determinants of access and delivery relate to the following: factors that ensure availability, affordability and accessibility of essential new health technologies, namely medicines, vaccines and diagnostics, as well as those that affect the effective introduction and integration of these technologies within the health system for use by target communities.
This contribution from the National Institute for Medical Research, Tanzania, highlights recent paradigm shifts in the global health and development arena, and argues for integrated approaches at the country and global levels to effectively address the major determinants of access to medicines, diagnostics and vaccines.
During the first 15 years of the 21st century – the MDGs era – the public health field was characterized by global forces that drove improvements in access and delivery of medicines, diagnostics and vaccines. These comprised supply-driven prioritization, global mechanisms for resource mobilization and bulk procurement, as well as price-setting determined by a combination of the open market and global activism.
A number of developments are now influencing changes in the global health arena. First, the adoption and commitment to the recently agreed Sustainable Development Goals (SDGs) have specified health targets that are influenced by the ideals of universal health access and equity, and which require comprehensive national measures by governments.
Secondly, the number of low-income countries has roughly halved in the past 15 years, through the emergence of mainly mineral exporting and transition economies. Although average incomes have increased in these countries, poverty has not fallen in absolute numbers, leaving three quarters of the world’s poorest people now living in middle-income countries. While many countries have experienced a shift in economic standing, this has occurred before their health systems have had the opportunity to undergo a similar process of graduation. The use of income thresholds to determine aid allocations will consequently leave many countries ineligible for continued support under global health funding and delivery mechanisms, including the GAVI Alliance, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the United States President's Emergency Plan for AIDS Relief/Malaria Initiative. These initiatives have played important roles in supporting the public health financing and delivery mechanisms in developing countries. In addition, the levels of development assistance have also leveled off, which will also have consequences for the level and degree of health funding and delivery for low-income countries.
These developments define a ‘new context’ for ensuring access to medicines, vaccines and diagnostics. It raises at least two urgent prerequisites for developing countries: the need for greater control and ownership over public health interventions; and the need to allocate a greater portion of domestic resources for public health spending. Due to the preliminary stage of institutionalized national responses to this new context, national capacities are lagging.
Policy coherence and the decision-making capacities to achieve such coherence at the national level remain critical requirements. In summary, it implies the need for country-level action to do the following:
• re-define national health priorities, based on country-specific needs, available evidence and resources, as well as to meet increasing demands for universal access to health;
• address the weaknesses or gaps at the country level, particularly with regard to capacities for multi-sectoral decision-making, sustainable resource allocation and efficient delivery systems; and
• identify alternative or new mechanisms for financing and delivery of public health needs, including effective South–South or regional collaboration between countries with similar national challenges and opportunities.
It is argued that a consolidation of decision-making, priority-setting and policy coherence will need to take place at the country level and in a bottom-up direction, in order that the key determinants of access to medicines, diagnostics and vaccines can be sustainably addressed. Policy coherence must be designed to address the intersections of public health with other sectors. This entails balancing and integrating the range of public health, trade, fiscal and other priorities within a country’s framework of laws and policies – at best, a medium- to long-term prospect. While comprehensive policy coherence may not be achieved immediately, it is very much a need and aspiration.
The Access and Delivery Partnership (ADP), a UNDP-led collaboration with TDR and PATH, has begun implementing an integrated approach in four countries: Ghana, Indonesia, Tanzania and Thailand. The ADP, in its implementation of an integrated approach to access and delivery, has identified six ‘pathways’ towards policy coherence that can have the most impact on equitable access and sustainable delivery, namely:
• an enabling national policy and legal framework;
• country-specific implementation research agenda for health;
• safety monitoring and pharmacovigilance system;
• evidence-based national resource allocation;
• effective delivery and supply chain systems; and
• strategic information and evidential base for decision-making.
The ADP approach is predicated on the belief that strengthening the country’s decision-making capacities and processes in these six pathways will result in positive health impacts. The focus on strengthening decision-making processes is based on two important judgments: First, building and strengthening mechanisms for effective decision-making is most amenable to long-term improvements to access and delivery; second, this approach allows lessons and best practices to be captured from the focus countries, which can then benefit other countries, enabling strategic South–South collaboration and learning. In our experience, the delineation of the ADP project activities into the six strategic, interrelated ‘pathways’ indeed helps strengthen capacity in decision-making processes along the entire value chain of access to and delivery of new health technologies.
These six pathways are further described in the accompanying illustration, and the case study of Tanzania below, provides a demonstration of how the integrated approach may be effected, in a country-specific manner.
With middle-income countries’ increased investment of domestic resources and ownership of national health priorities, there should be corresponding increased demand to ensure that donors align their own policies, such that they do not prevent or hamper developing countries’ efforts to meet national objectives, in line with agreed global health commitments, such as those of the SDGs.
It is argued here that as countries consolidate priority-setting and decision-making, this will create the demand for the existing global architecture to ensure better alignment with national priorities and aspirations. The components of the global health architecture, such as international procurement mechanisms, regulatory harmonization initiatives and normative policy guidance, will be in critical focus.
The World Trade Organization (WTO) Doha Declaration on the TRIPS Agreement and Public Health, adopted in 2001, may be regarded as one of few early examples of the demand and need for policy coherence at the global level. The Doha Declaration was the initiative of developing country members in the WTO to reach common understanding on the interpretation and implementation of the TRIPS Agreement; that “the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all”.
Such global ‘policy coherence’ at the intersections of trade, health and human rights, which directly influence the access to, and delivery of, medicines, vaccines and diagnostics, is necessary to address the determinants of access and delivery of medicines, vaccines and diagnostics.
The implementation of an integrated approach towards access and delivery at the country level will provide an evidential basis of the key determinants of access and delivery, which should be taken into account in the efforts for policy coherence at the global level. On the basis of ADP’s implementation work at the country level in its focus countries, it may be said that the key determinants of access and delivery relate to the following:
· factors promoting research and development, and innovation that will ensure the availability of needed and new health technologies.
· factors related to the affordability and accessibility of the new health technologies.
· processes for effective introduction and integration of new technologies within the health system for use by target communities.
Efforts to enable such coherence must however, take account of these three inter-linked elements. It is further argued that efforts to align global and national policy coherence must necessarily take account of how these public health objectives can be integrated within international human rights law and trade rules.
Implementing an integrated approach in Tanzania
The particularly adverse impacts of tuberculosis (TB), malaria, HIV and neglected tropical diseases (NTDs) on development outcomes has already resulted in the initiation of new approaches and partnerships to tackle the global deficiencies in research and development, as well as access to treatments.
One instructive example is Tanzania’s efforts to reduce the human and economic burden of TB, malaria and NTDs. While Tanzania has seen significant improvements in health outcomes, including reaching the MDG target related to child mortality, greater progress in other areas is needed. For instance, the annual NTDs incidence of around 5 million cases – in a country of 43 million people – exacts a huge social and economic toll. The annual spending of approximately US$183 million for NTD-related medicines alone also raises the issue of sustainability. To achieve the SDGs, an approach that combines smart policy development and improvement of health delivery systems will be needed. National strategic plans, including the Tanzania Development Vision 2025 and the Health Sector Strategic Plans (HSSP), have identified the need for a sustainable health delivery system as a national development priority. The Health Sector Strategic Plan (HSSP) III (2009-2015) has identified as a challenge, the “affordability of medicines and medical supplies, especially to the poor and vulnerable groups”. Accordingly, the HSSP III identified the need for strategies to ensure access; strengthen control of safety; enhance harmonization and coordination of procurement, stocking and distribution; as well as promote domestic production of pharmaceuticals.
In this context, the ADP is working with country stakeholders to design capacity-building interventions across six pathways towards an integrated approach for access and delivery, as noted above. The six pathways are the key components within the continuum of a health delivery system, and capacity-building efforts are focused on each key component to promote multisectoral decision-making processes to ensure an integrated approach for addressing access to, and delivery of, needed medicines, vaccines and diagnostics in the country.
Thus, in Tanzania, ADP focuses on building capacities for a national reform agenda to develop an enabling policy and legal framework. This framework will guide the implementation towards the policy goals of access and delivery, and addresses and minimizes the conflicts at the intersections of public health with other sectors. The policy and legal framework in Tanzania also operates within a broader context of the African continental and sub-regional initiatives and priorities. The policy focus on promoting local pharmaceutical production for greater access and security of supply is in line with the promotion of African-led solutions to respond to the changing global context of economic crises and shrinking development aid. African leaders have adopted Pharmaceutical Manufacturing Plan for Africa (PMPA) and a model law on medical product regulations that envisions African peoples’ access to essential, quality, safe and effective medical products and technologies, while facilitating the development of a competitive pharmaceutical industry in Africa to ensure self-reliance. These continental frameworks adapted at national and regional economic community (EAC) levels, thus provide strategic and policy guidance to policy-makers in Tanzania, on a range of cross-cutting issues from R&D,[i] intellectual property,[ii] drug regulation[iii] and local pharmaceutical production.[iv]
Secondly, there is a need for countries to identify the key barriers to the effective delivery and use of medicines, vaccines and diagnostics for priority diseases. In this regard, the role of implementation research in health is crucial, in pinpointing the country- and community-specific issues to be addressed. The development of the national agenda for health systems research will contribute to the priority-setting for the research questions and proposals (and the mobilization of funding) in order to address the major impediments, gaps and bottlenecks in the delivery and use of health technologies in the country.
In Tanzania, the “national agenda for health system research for tuberculosis, malaria and neglected tropical diseases”[v] has been spearheaded by the National Institute for Medical Research (NIMR) with the support of ADP through a series of consultations with a broad range of stakeholders. The agenda is in line with the fourth iteration of the National Health Research Priorities, 2015–2018.[vi] Consolidating inputs from the national control programmes for TB and leprosy, malaria control and neglected tropical diseases, scientists and researchers, as well as evidence from studies conducted among different groups, including marginalized and vulnerable populations and community-, district- and national-level stakeholders, the report sets out a list of key implementation research questions for Tanzania. As noted in the report, if the identified research questions are innovatively addressed, the health system shall be strengthened through improved implementation, policies and practice.
With the introduction of new health technologies, there should be corollary surveillance and safety monitoring systems. Hence, the ADP works on developing and building capacities of relevant health personnel. Efforts have focused on strengthening capacity for monitoring and responding to safety issues of newly introduced health technologies. This has been done in collaboration with the Tanzania Food and Drug Administration, including through national level training of appropriate personnel on pharmacovigilance, as well as through active engagement within regional and global pharmacovigilance networks, including collaborations with WHO Collaborating Centres and the WHO EMP Safety and Vigilance Group.
In order to ensure efficient allocation of national resources and improve access to new health technologies, ADP works with the government to develop capacities for priority-setting through the implementation of a health technology assessment (HTA) mechanism, and a national strategy for local production. The focus is on the use of the HTA approach to inform the revision of the National Essential Medicines List. In addition, the Pharmaceutical Services Section (PSS) of the Tanzania Ministry of Health is conducting research on the local and regional market competition of the pharmaceutical sector, to identify competitiveness issues for the pharmaceutical industry at both the national and regional levels, as well as issues related to further expansion capacity, future diversification, and quality of products. The focus is on the East African region, with a view to evaluate capacities, quality, strengths and weaknesses in the region. The findings will inform implementation planning and strategy development of Government of Tanzania’s Pharmaceutical Sector Action Plan 2014–2020, as well as the plan for the roll out of the African Union Pharmaceutical Manufacturing Plan for Africa (PMPA).
Finally, the supply chain and delivery systems are also addressed. As new health technologies come onto the market, more choices are created and additional decisions need to be made across supply chain disciplines. The key steps required within a functional supply chain fall under the areas of planning, procurement and distribution. In Tanzania, efforts have focused on developing training and guidance materials for key actors in the procurement and distribution of medicines – including central-level decision makers (PSS, the Medical Stores Department, Neglected Disease Control Programme, MOHSW) and health professionals from the district, facility and community level (pharmacists and frontline community-based health workers and drug distributors). These guidelines will help to reduce wastage and increase efficiency of the supply chain management of NTD medicines for mass drug administration (MDA).
The strategic integrated approach adopted in Tanzania across the access and delivery value chain is predicated on the assumption that strengthening country’s decision-making process and structures will improve the uptake and sustainable use of health technologies. Building and strengthening processes and structures for effective decision-making ensures sustainable change and impact.
The strength of an integrated approach lies within the inter-linkages between the different pathways, and the implementation of each pathway supports the others. In many ways, the implementation and capacity-building process across each pathway is an illustration of how an implementation research agenda is affected: through the identification and prioritizing of the gaps and/or bottlenecks that can mitigate efforts for access and delivery of medicines, vaccines and diagnostics. The integrated approach thus provides a means of enhancing the capacity for the range of stakeholders, from policy-makers, technical experts and other actors or implementers of various health interventions to be able to identify implementation gaps that limit access and delivery of health interventions and to be able to develop strategies to address them.
In Tanzania, the integrated approach should also ideally lead to the establishment or creation of a platform to institutionalize the linkages between the different actors, within and beyond the health system, so as to create the longitudinal interaction among programmes, agencies and institutions that will help speed up the processes of access and delivery of new health technologies across the country. Furthermore, this will also provide the evidential basis on the key determinants of access and delivery: What are the specific issues and factors that will have impact on the availability, affordability and accessibility of needed medicines, vaccines and diagnostics, as well as those that affect the effective introduction and integration of these technologies within the health system for use by target communities?
This evidential and empirical foundation should provide the basis for efforts to achieve policy coherence at the global level.
Bibliography and References
Global poverty, middle income countries and the future of development aid
COHRED-NEPAD Strengthening Pharmaceutical Innovation in Africa, 2010 (COHRED-NEPAD Pharmaceutical Innovation)
The EAC Regional Intellectual Property Policy on Utilization of Public Health-Related WTO-TRIPS Flexibilities and the Approximation of National Intellectual Property Legislation, 2013
African Medicines Regulatory Harmonization Programme (AMRH). The East African Community Regional PMPA 2012-2016 (EAC RPMPA); the Pharmaceutical Manufacturing Plan of Action, 2007, and Business Plan, 2012.
Setting a national agenda for health systems research for tuberculosis, malaria and
neglected tropical diseases in the United Republic of Tanzania, National Institute of Medical Research (NIMR), 2015
Fourth National Health Research Priorities 2013-2018.