The Challenge of Non-Communicable Diseases and Road Traffic ...

56 The Challenge of Non-communicable Diseases and Road Traffic Injuries in Sub-Saharan Africa
BOX 9: East African Community Medicines Regulatory Harmonization Project
Strengthening governance, regulations, and accountability in the pharmaceutical sector is an important challenge of
health systems. Improved regulatory policies and harmonization of efforts can lead to more competitive markets, economic
growth, improved access to new medicines, better quality of pharmaceuticals in circulation, and ultimately to better
health outcomes.
In 2009, a coalition of partners including the Pan African Parliament, NEPAD Coordinating and Planning Agency, WHO, the
Bill and Melinda Gates Foundation, UK Department for International Development, and the Clinton Health Access Initiative
came together to establish the African Medicines Regulatory Harmonization (AMRH) program. Working with African
regional economic communities, the program’s goal is to increase access to good quality, safe, and effective medicines
through harmonizing medicines regulations, and expediting the registration of essential medicines. With support from
the Bill and Melinda Gates Foundation, the Global Medicines Regulatory Harmonization Multi-Donor Trust Fund (GMRH)
was set up by the World Bank in 2011 to implement and scale-up AMRH activities. In 2012, the East African Community
(EAC) became the first regional economic community in Africa to receive GMRH funding.
The East African Community Medicines Regulatory Harmonization Project (US$5.5 million grant) is a five-year project that
will be implemented in two phases. GMRH provides support for Phase I which covers the first three years (2012-2015) of
the project. The project’s aims are: to harmonize medicine registration systems, to improve efficiency, and to enhance
transparency in medicines registration among EAC Partner States (Burundi, Kenya, Rwanda, Tanzania, and Uganda). The
results of this innovative partnership are expected to include: (1) EAC Partner States participating in harmonized medicine
registration; (2) National Medicine Regulatory Authorities (NMRAs) using common integrated Information Management
System; (2) NMRAs have a functioning quality management system in place; (4) regulatory capacity building in the region
institutionalized; and (5) government, industry, and civil society partnerships improved. As the project moves ahead, continuous
dialogue and collaboration with local industry and civil society groups will be emphasized to improve the quality
of technical standards being developed.
Source: [395]
made the situation worse, where vertical approaches
to planning and managing health systems crowded
out pre-existing, more-integrated approaches and
attention to NCDs.
Health-care infrastructure is insufficient across all
tiers of service delivery, not just in the case of facilities
but also laboratory and diagnostic systems and
capabilities. The WHO African Region as a whole
had the lowest ratio of hospital beds per 10,000 of
population of any region, which ranged from one
in Mali to 63 in Gabon (global average 30) [397].
Chronic NCDs may be over-represented in hospitals,
with patients lingering for weeks or months,
partly because of a lack of reliable outpatient facilities
for follow up; one study in Rwanda found that
these conditions accounted for 30-40 percent of
adult hospitalization time [56].
There is a growing sector of private health care
providers in some parts of Africa which already
treats a significant proportion of those covered by
private health care insurance and the well-to-do
[398].
The use of traditional medicine is widespread,
often in parallel to modern medicine: in some SSA
countries, 80 percent of the population rely on traditional
medicine for primary health care [399].
Payment is always out-of-pocket and can be substantial:
a national survey in South Africa in 2008
found that there was widespread use and that almost
three-quarters of the poorest quintile had spent
more than 10 percent of their household expenditure
in the previous month on traditional healers
[400-401].
Primary health care in much of SSA is dismal,
and prevention and promotion aspects are limited.
A study in Senegal and Tanzania found that on average
only 19 percent of primary health facilities in
Tanzania and 39 percent in Senegal had access to
basic infrastructure (electricity, water, sanitation)
[358]. Around half (47 percent) of clinics in Senegal
and one-fifth (22 percent) in Tanzania did not have
access to the most basic equipment (thermometer,
stethoscope, weighing scale) and around one-fifth
of clinics (22 percent Senegal; 24 percent Tanzania)