NAIROBI METROPOLIS PROPERTIES: April 2012

AIDS
dependency
crisis
SOURCING
AFRICAN
SOLUTIONS
UNAIDS | ISSUES BRIEF

“If you want to go quickly, go alone.
If you want to go far, go together.”
African Proverb
Key messag es
• Getting to zero new HIV infections, zero
discrimination, and zero AIDS-related deaths will
require African solutions—innovative and responsive
to the needs of the African people. Building on
initiatives underway, solutions include: 1) exploring
more diversified funding sources for AIDS; 2) creating
an African Medicines Regulatory Agency for faster
roll-out of drugs and stronger quality assurance;
and 3) catalyzing local production of medicines.
• African dependency on external sources is
destabilizing the AIDS response. Two-thirds of
all AIDS expenditures in Africa come from external
sources. International investments for AIDS dropped
by 13% from 2009 to 2010.
• Africa can negotiate a new and balanced “shared
ownership-shared responsibility” agenda with
international partners.
• All high-income countries should invest more in the
AIDS response. There is a 139-fold difference in the
share of international HIV assistance between the most
and least generous.
• Africa can bridge the resource gap with strong political
leadership, leveraging the strong economic growth, and
by adopting innovative funding opportunities. These
include meeting the Abuja target of investing 15% of
government resources in health, allocating resources to
the AIDS response based on disease burden, exploring
the wider availability of ‘soft loans’ from the African
Development Bank and tapping new sources of revenue
such as taxing alcohol and tobacco consumption and
the use of mobile telephones, as well as taxing financial
institutions for commissions made on international
money transfers.
• Reducing African dependency on imports of
pharmaceuticals and developing a common drug
regulatory authority will ensure sustained access
to quality life saving medicines. Investing in local
manufacturing and simplifying market access to drugs
across the Continent will boost the economy, reduce
costs and ultimately save lives and money.
2
“There is no doubt in my mind that those of us in the developing world have to do
more and better to take charge of our destiny…I know that this is easier said than
implemented all the more so because much of the external assistance we get has in
practice been predicated on us towing the line of the donor community...The fact
remains, however, there is no possibility of us keeping our promise to our people unless
we do more and better to take charge of our destiny and depend on our own resources
as the primary means of achieving the MDGs.”
Meles Zenawi
Prime Minister of Ethiopia
AIDS DEPENDENCY CRISIS: Sourcing African Solutions 3
Introdu ctio n
The past decade has seen a remarkable transformation
across the African Continent—an expression of hardearned
progress and promise even in the midst of a
global financial crisis. This is an era of unprecedented
economic growth, socially sustainable gains and strong
African leadership. And today almost every country in
Africa has a success story to tell, a story of lives saved
through stopping new HIV infections and preventing
AIDS-related deaths.
Africa is on the move
Africa’s GDP is expected to grow by nearly 6% in
2012, about the same as Asia’s.I Africa’s economic
growth surge is widespread across countries and
sectors and is being fuelled not only by the global
commodity boom but also by pro-business policy
reforms and a marked improvement in peace and
security. More than half of all countries in Africa have
improved overall governance quality with a majority of
countries improving in areas of economic and human
development.II With a growing middle class, Africa is
creating new opportunities for both African and foreign
businesses. Together, these shifts have enabled the
beginning of a dynamic cycle of domestic growth.
Growth and stability has lifted millions of Africans
out of poverty over the last 10 years. The decade also
witnessed a decline in child mortality rates, an increase
in primary school enrolment, and increased access to
clean water.
Through growing unity, the voice of Africa is being
heard. African leaders are advancing a continental
vision for integration and accountability that includes
enhancing trade and transportation and promoting
stronger collaboration among Africa’s Regional
Economic Communities.
Partner paradigm shift
This changing landscape offers a new paradigm of
what collaboration can mean. China became Africa’s
number-one trading partner in 2009 and other emerging
economies such as Brazil and India now account for 37%
of Africa’s trade.III
Aid dependency is decreasing across the Continent as
growth strengthens domestic revenues. Currently, at
least one-third of African countries receive aid that is
equivalent to less than 10% of their tax revenue. Aid
exceeds taxes in only 12 extremely poor countries.IV
Traditional development cooperation, however, has not
kept pace with the accelerated changes in Africa. As the
international community surveys the implications of a
rapidly transforming world, there is a universal sense of
frustration with the fundamental failure to translate aid
into sustainable outcomes within a culture of country
ownership and accountability.
The proceedings of the Fourth Summit on Aid
Effectiveness in Busan, South Korea in late 2011, gave
voice to this frustration. Busan was a catalytic moment for
initiating a new development cooperation paradigm. Now
is the time to build recipient ownership of development
finance, strengthening existing country resources and
capacities and utilizing aid in a way that contributes to
the end of aid dependency for Africa. Now is the time
to change the parameters of partnership—with Africa
setting the agenda.
4
Treatment gap in Africa is wide
and growing
Today almost every country in Africa has success stories
to tell: stories of lives saved through stopping new HIV
infections and preventing AIDS-related deaths. In
22 African countries the number of annual new HIV
infections declined by more than 25% between 2001
and 2009. This includes some of the world’s largest
epidemics in Ethiopia, Nigeria, South Africa, Zambia
and Zimbabwe. In 2010, more than 5 million people
in sub-Saharan Africa were receiving antiretroviral
therapy—up from just 50 000 in 2002.
Despite such progress, sub-Saharan Africa remains the
most heavily affected region in the world. The Continent
is home to two out of three people living with HIV but
only 10% of the world’s population. AIDS has claimed at
least 1 million African lives every year since 1998. Today,
only half of Africans living with HIV who are eligible for
treatment are able to access it.
AIDS dependency crisis: Threat
and opportunity
Overall, Africa’s prospects have never looked brighter.
The Continent is realising its potential and improving
the lives of its people.
However, the AIDS response presents a less certain
picture. The current global economic downturn and the
AIDS funding crisis expose the unsustainable nature of
the present model and the dependence of most responses
on a small number of international donors. This major
resource shortfall comes at a time when Member States
at the United Nations 2011 General Assembly High-
Level Meeting on AIDS committed to ambitious HIV
prevention targets, including placing 15 million people
on HIV treatment and eliminating new infections in
children by 2015.
Yet developments on the Continent also present an
enormous opportunity. Enhancing African ownership of
the AIDS response will further the health gains made in
the past decade and will also further enhance economic
growth. Africa imports the vast majority of antiretroviral
drugs it needs—meaning that the jobs and added value
stemming from their production accrue outside the
Continent. The story is similar in many other areas in the
health sector—products, equipment and even the delivery
of many high-end services come from external sources.
At the same time, the increasingly stable and promising
investment environment in Africa means investments in
AIDS can go further—making the AIDS response an even
more attractive opportunity.
“I do believe that a new Africa is unfolding before our eyes.
The African Renaissance is now at hand. It is within reach.
It is embedded within the honest and seeking minds of the young,
the professionals, the activists, the believers in our continent.”
Ellen Johnson Sirleaf
President of Liberia
AIDS DEPENDENCY CRISIS: Sourcing African Solutions 5
Sourcing African solutions
This issues brief presents African sourced solutions
to reduce external dependency in the HIV response,
including:
1. Strengthening African ownership of development
investments through utilizing more diversified
funding sources;
2. Creating an African Medicines Regulatory Agency
for faster roll out of drugs and stronger quality
assurance; and
3. Catalysing local production of medicines in
partnership with the BRICS group of countries
and other emerging economies.
Now is the perfect time to address these issues. Africa’s
expanding strength—economically, socially and
geopolitically—provides a solid footing to begin to diffuse
the dependency crisis and set a more socially sustainable
continental and international agenda for AIDS.
Building on existing African
processes and initiatives
Several African landmark agreements and initiatives lay
the foundation for the solutions herein proposed and also
provide political momentum, recommendations, guidance
and partners to accelerate actions. These include:
• The 2011 African Consensus and Position on
Development Effectiveness, Africa’s first-ever common
position on development effectiveness, which
acknowledges the critical role of aid, but stresses the
need for Africa to mobilise domestic resources
and build capacity to reduce external dependency.
• The Resolution of the 2011 Fourth Joint Annual
Meeting of the African Union Conference of
Ministers of Economy and Finance and United
Nations Economic Commission for Africa Conference
of Ministers of Finance, Planning and Economic
development which calls for an increase in health
financing and improved health outcomes for Africa.
• The on-going collaboration among the Harmonization
for Health in Africa, the African Union the United
Nations Economic Commission for Africa and the
African Development Bank to achieve better value for
money and accountability in the financing of health
in Africa as a key factor for economic growth and
sustainable development.
• The African Union Africa Health Strategy 2007-2015
which provides strategic direction to Africa’s efforts
in creating better health for all.
• The Pharmaceutical Manufacturing Plan for
Africa, adopted by the Summit of the African Union
in 2007, which is the basis for a more coordinated
approach to local medicines production – based
on countries’ needs.
• The Abuja Call for Accelerated Action towards
Universal Access to HIV and AIDS, Tuberculosis
and Malaria Services in Africa, 2006.
“Young people must take the leadership of the AIDS
response, and they must be given the space to lead.”
Amadou Toumani Touré
President of Mali
6
AIDS DEPENDENCY CRISIS: Sourcing African Solutions 7
AFRICAN
SOLUTIONS
The following analysis highlights the benefits of continent-wide
common positions and approaches to addressing the unsustainably
high levels of dependency of the AIDS response. There are a
number of solutions to this challenge.
“Africa’s leaders must be in a position to define clearly what they want from this new
South-South relationship. It certainly cannot be a replica of the traditional North-
South relationship – and that is for African leaders to decide- not China, Brazil, India
or Malaysia. African leaders must take a long-term view, which can form a basis for
engaging those partners.”
Donald Kaberuka
President, African Development Bank
8
Situatio n anal ysis
Aid dependency in the AIDS response: An
unsustainable and potentially volatile situation.
Estimates suggest that US$ 11-12 billion will be needed
annually by 2015 to prevent new HIV infections and scale
up treatment in Africa, if important gains in efficiency
and smart investments in effective programmes are made
simultaneously. While “more health for the money” is
critical, investment needs are US$ 3-4 billion more than
the current expenditure.
African governments invest less on AIDS than would be
expected. For the Continent as a whole, approximately
5% of health budgets are allocated to AIDS, despite AIDS
causing a median of more than 7% of the overall burden
of disease across countries.
External assistance dominates HIV investment in most
countries in Africa—to a much greater extent than for
the health sector as a whole. More than two-thirds of
overall health expenditure in Africa comes from domestic
sources, whereas international sources account for twothirds
of AIDS investments.
The procurement of antiretroviral drugs is highly
dependent on external funding. In 27 countries for
which accurate data is available, 84% of expenditures for
antiretroviral therapy in sub-Saharan Africa originated
from international sources.
OPTION 1.
Stren gthen Afri can owners hip
of de velopment in vest ments
through exploitin g more
di versified fundin g sour ces
Reliance higher for AIDS than health
Source: Country Progress Reports; WHO.
figure 1
Investment in AIDS in Africa
Investment in Health in Africa
Domestic
Domestic
International
International
63%
69%
37%
31%
AIDS DEPENDENCY CRISIS: Sourcing African Solutions 9
Percentage of care and treatment expenditure from international sources
Source: Country Progress Report; Ethiopia’s Fourth National Health Accounts, 2007-2008, April 2010.
figure 2
As a result, a high proportion of Africans on
antiretroviral therapy are directly dependent on donor
funding decisions for the drugs that keep them alive.
This dependency creates enormous risks, since external
aid remains unpredictable and can fluctuate considerably
from year to year.
The global economic crisis is exacerbating the African
AIDS resource gap. In 2010, for the first time in the
history of the response, international investments
for AIDS decreased by 13% from 2009 to 2010, from
US$ 8.7 billion to US$ 7.6 billion.
100
Cape Verde
30
Morocco
94
Mali
99
Niger
100
99 Samalia
Central African
Republic
97
Mozambique
98
Malawi
99
Eritrea
88
Ethiopia
85
Sierra Leone
81
Kenya
90
Nigeria
90
Côte d’Ivoire
78
Ghana
78
Togo
57
Benin
74
Cameron
48
Gabon
61
Senegal
45
Chad
75
Uganda
7
Egypt
9
Congo 100
Congo
Dem. Rep.
100
Rwanda
76
Burundi
22
Botswana
17
Nambia
27
Lesotho
72
South Africa Swaziland
45
Angola
85
Burkina Faso
100
Gambia The
100
Sao Tome and
Principe
100
Equatorial Guinea
100
Madagascar
97
Guinea-Bissau
96
Guinea
0
Algeria
0
Seychelles
Comoros
Tunisia
Mauritania
Western
Sahara
Libya
Liberia
Sudan
Zambia
Tanzania
Zimbabwe
Mauritius
Djibouti
0-19
20-39
40-59
60-79
80-100
Missing Value
South Sudan
10
The lion’s share of international financing for AIDS
treatment comes from just two sources: the United States’
President’s Emergency Plan for AIDS Relief (PEPFAR)
and the Global Fund to Fight AIDS, Tuberculosis and
Malaria (Global Fund). In 2011, the Global Fund cancelled
its next round of new funding proposals due to financial
constraints arising largely from the failure of donors to
meet their financial commitments to the Global Fund.
The current funding decline may result in an increase
in new infections, due both to downturns in effective
prevention programming and a stagnation or decline
in treatment access. An increase in new infections and
decrease in treatment access has grave implications for
maternal and child mortality as well. At present, AIDS
is the leading cause of death and disease among women
aged 15 to 44 worldwide. In six hyper-endemic African
countries, AIDS is responsible for more than 40% of
child deaths.
Resources available for HIV in sub-Saharan Africa, 2002-2010 (US$ billions)
Source: UNAIDS.
figure 3
9.0
8.0
7.0
6.0
5.0
4.0
3.0
2.0
1.0
0
2002 2003 2004 2005 2006 2007 2008 2009 2010
US$ billions
AIDS DEPENDENCY CRISIS: Sourcing African Solutions 11
figure 4
Solutio ns
Africa can gain greater autonomy through the
pursuit of a more balanced partnership with
international partners in the AIDS response.
Such a balance could be achieved by negotiating
long-term, predictable investments from international
partners while decreasing dependency by growing
African investments and innovative financing.
Negotiate long-term, predictable investments
from international partners
Given these uncertain times, transparency around
financial commitments is more important than ever.
African countries can negotiate more multi-year visibility
into funding flows from international partners to be able
to plan effective and sustainable programs.
High-income countries can invest more in the AIDS
response: in 2009, among 14 of the wealthiest nations,
there was a 139-fold difference in the share of national
resources devoted to international HIV assistance
between the most and least generous. If all high-income
countries had met the 0.7% ODA/GDP target with
government revenue, the total value of ODA would have
more than doubled, from about US$ 127 billion to almost
US$ 280 billion in 2010, and the HIV funding gap could
have been filled.
More sustainable, long-term health financing could
also come from tapping innovative sources. There is
considerable potential in a proposed tax on financial
transactions. If this was adopted by the world’s largest
economies, and 50% of the new revenue was allocated
to development, some estimates indicate that it could
more than double ODA globally. The HIV funding gap
could be filled with a small fraction of these revenues.
A number of African leaders have backed this tax; a
common position would amplify the call.
$7
$6
$5
$4
$3
$2
$1
$0
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Minimum international investment needs for AIDS in
sub-Saharan Africa, US$ billions
International investments for AIDS in Africa
Significant and sustained international investments for AIDS in Africa will be required even if African countries
meet the Abuja target of allocating 15% of government revenue to health, and if allocation to AIDS is
proportionate to disease burden.
Source: UNAIDS.
“It is a critical time in the AIDS response and more important than
ever that we put the focus back on HIV… I am ready to open the
debate on AIDS dependency with colleagues to find local solutions.”
Ali Bongo Ondimba
President of Gabon
12
Decrease dependency by growing
African investments
Recent years have seen an increase in domestic investment
in AIDS in many countries, albeit often starting from a low
base. South Africa, for example, dramatically ramped up
its domestic funding of AIDS over the past two years—to
over US$ 1 billion annually. Building on these trends, as
well as prospects for sustained African economic growth,
countries have a number of options to assert greater
financial control over their national AIDS programmes.
These options are not mutually exclusive, and cumulatively
they can considerably close the investment gap in many
countries over the medium term.
Specifically, if government spending on health in Africa
were to increase at the same rate as economic growth,
an additional US$ 5 billion in public funds would be
available annually for health by 2015. A portion of these
new monies could be allocated to AIDS budgets, thereby
significantly reducing dependency on external sources.
Three different additive scenarios for increasing domestic
public funds for HIV are presented below:
1. If African budgets for HIV increased at the same
rate as projected economic growth in Africa, one
could expect an increase from US$ 2.5 billion today to
US$ 3.2 billion in 2015.
2. If all governments of African countries also increased
health spending to match the Abuja targets and
maintained the share of health spending allocated
to AIDS, public funds could rise further, to US$ 3.9
billion in 2015.
3. If African governments also raised the share of the
health budget devoted to AIDS to reflect the relative
burden of disease caused by AIDS compared with
other diseases, public funds to address HIV could
reach US$ 4.7 billion by 2015.
figure 5
Domestic resources for AIDS in Africa: Steady but slow increase
Source: UNAIDS.
US$ billions
International
Domestic Public
10
9
8
7
6
5
4
3
2
1
0
2002 2003 2004 2005 2006 2007 2008 2009 2010
AIDS DEPENDENCY CRISIS: Sourcing African Solutions 13
A compact for shared but differentiated
responsibilities
As part of a global compact on shared responsibility,
countries could agree on target levels for domestic
investment in the AIDS response that are specifically
adapted to the projected level of government revenue
and the size of the disease burden caused by AIDS. In
return for verifiable progress towards meeting these
financing goals within a five-year period, a consortium
of donor organizations could provide an assurance to
fund the remaining financing gap in line with an agreed
investment envelope that aims to meet the outcome
targets specified in the 2011 Political Declaration on
HIV/AIDS.
Three options for increasing domestic public HIV investment in Africa
Source: UNAIDS.
figure 6
In aggregate, changes in fiscal policies could come close
to meeting the HIV investment needs on the Continent.
However, the degree to which individual countries can
assume responsibility of their AIDS responses depends
upon their economic circumstances and the severity of
their epidemic. Very low-income countries might not
realistically be expected to assume an investment share
higher than 5% before 2015.
“The amount of resources dedicated to HIV prevention,
treatment and care has increased with each successive year. But it
is not enough. Much more needs to be done…We have no choice
but to deploy every effort, mobilise every resource, and utilise
every skill that our nation possesses, to ensure that we prevail in
this struggle for the health and prosperity of our nation.”
Jacob Zuma
President of the Republic of South Africa
Domestic public investment
in sub-Saharan Africa, US$ billions
5.0
4.5
4.0
3.5
3.0
2.5
2.0
1.5
1.0
0.5
0
2010 2015
with economic growth
2015
with economic growth
and 15% heath budget
2015
with growth, 15% heath
budget and allocation
by disease burden
2.5
3.2
3.9
4.7
14
Enhance equity, self-reliance and sustainability
through insurance innovations
Health insurance provides a mechanism to channel
health spending more efficiently and equitably. Only
3% of Africans currently enjoy health insurance coverage.
Expanding access to health insurance in Africa can
reduce high, and at times catastrophic, out-of-pocket
expenses that especially impact poor and marginalized
households. Rwanda introduced national health
insurance 11 years ago. Now, more than 90% of Rwandans
are covered, paying just US$ 2 annual premiums.
Extending health insurance
The PharmAccess Foundation, together with the Health
Insurance Fund—an initiative of a number of Dutch
insurance companies and Dutch multinationals with large
operations in Africa—has developed an insurance model
for low-income groups. This initiative is supported by
the Dutch Ministry of Development Cooperation with
a subsidy of US$ 100 million for six years.
The Health Insurance Fund concept is based on risk
pooling, donor support, co-payments and utilization of
public as well as private health care providers. The Fund
uses donor money to subsidize insurance premiums
for the previously uninsured poor. This is expected
to generate an increasing demand for prepaid health
schemes. The Fund is operating in Kenya, Nigeria
and Tanzania and has plans to expand. The schemes
cover basic health care and include treatment of HIV,
tuberculosis and malaria.
Explore sustainable, innovative
funding sources
Given the increasing wealth on the Continent there
are a host of funding options that could be explored.
One potential source is the African Development
Bank, which puts a range of instruments at government
disposal. A united African approach could bring about
wider availability of “soft loans” that could begin to
reverse the external dependence of the AIDS response
as such resources are included in government budgets.
Leaders might also explore making use of the large
remittance flows from Africa’s diaspora. This could
involve a tax on financial and money transfer institutions
or by issuing bonds to the diaspora.
Another source derives from Africa’s new personal
and corporate wealth and the creation of public-private
partnerships to leverage private sector resources. There
are rich philanthropic opportunities to be explored with
the growth in African high-income households and from
Africa’s increasingly powerful companies. Currently,
20 African companies have annual revenues in excess
of US$ 3 billion.
There are additional options to tap emerging African
wealth to allow Africans to address African problems.
Many are already in practice. These include taxes on
tobacco and alcohol, levies on existing income or
value-added taxes and taxation reform to minimize
evasion. Some of these could be further extended, such
as the tax on airline flights and similar levies on mobile
telephone contracts.
Emerging development partners are becoming an
increasingly important source of funds. As countries like
India, China and Brazil have moved comfortably into
the middle-income space, they have begun to explore
how they can invest in international development. South
Africa is doing the same and other countries in Africa
may follow.
AIDS DEPENDENCY CRISIS: Sourcing African Solutions 15
16
SITUATION ANALYSIS
Weak drug regulatory capacity in Africa: Drug
lag, quality concerns and lives lost. In light of
existing resource constraints, it is critical to gain greater
efficiencies in the use of high cost medicines and to use
them as effectively as possible. Africa cannot afford less
effective, poor quality and counterfeit drugs—it wastes
resources and costs countless lives.
Novel health solutions in Africa suffer from significantly
slower uptake and limited coverage compared to the
rest of the world. The lengthy regulatory approval
cycle—caused by low regulatory capacity and inefficient
processes—contributes significantly to this “drug lag.”
A typical launch of a new drug in the U.S. requires about
eight years and will reach around 90% coverage. In
Africa, by contrast, the process is significantly slower,
and once approval takes place coverage remains low.
In these countries, slow uptake costs millions of lives—
unnecessarily.
The introduction and scale-up of antiretroviral therapy
has created a class of medications that have relatively high
cost value. As with the introduction of more expensive
anti-malarials, this has led to a greater risk for the
introduction of counterfeit versions of these drugs, with
limited or no efficacy. Stringent medicines regulatory
agencies, such as the European Medicines Agency
(EMEA) and the US Food and Drug Administration, use
pharmacovigilance measures that ensure post-marketing
surveillance of drug quality, adverse events, and other
concerns. Such regulatory agencies are sufficiently staffed
to investigate reports of counterfeit drugs in the market.
But in a number of African countries, resources and skills
for effective pharmaco-vigilance are lacking.
OPTION 2.
Get qua lit y assured medi cines
sooner to the people who need
them—the benefits of an Afri can
Medi cines Regulat ory Agen cy
figure 7
Drug Lag: Long regulatory approval cycle contributes to slow product uptake
Source: WHO; UNICEF; BCG analysis.
Percentage of coverage of intervention in low- and middle-income countries
100
50
0
25
75
0 4 8 12 16 20 24 28
Typical US Drug launch
(time peak sales)
ACT procured
Hep B vaccine
Hib vaccine
ARVs
ORT
Millions of lives could be saved
AIDS DEPENDENCY CRISIS: Sourcing African Solutions 17
SOLUTIONS
There is an urgent need for African countries
to adopt measures to ensure drug quality in
the response to HIV, and to maintain public
confidence in these drugs. Active surveillance of the
market, rapid response to reports of possible counterfeit
or tainted drugs and the ability to test suspect medication
batches are activities that benefit from a highly
specialized and centralized approach. Major economies
of scale can be reaped from adopting regional approaches
to pharmacovigilance—for example through an African
Medicines Regulatory Agency. Similar to the functions
that European countries have devolved to the EMEA, a
regional or full-continental African Medicines Regulatory
Agency could more efficiently take on pharmacovigilence
as well as a number of other specialized functions, to
complement and support African countries’ own drug
regulatory agencies.
An African Medicines Regulatory Agency provides a
central plank to reduce the dependence of African health
on external factors. Further, a single Regulatory Agency,
built upon the experience and success of sub-regional
entities, will deliver a range of benefits:
• Faster. Expedite the introduction of new,
quality-assured medicines to African markets by
harmonizing and simplifying existing medicines
regulatory processes and procedures in all African
countries—thereby saving millions of lives and
boosting productivity.
• Cheaper. Provide a mechanism to pool national
resources and generate economies of scale in
registering medicines.
• Fairer. Promote a level playing field for African
and international companies wishing to compete
and market their products throughout Africa.
It would also remove barriers to entry of quality
assured products while yielding important
efficiencies for pharmaceutical producers—both
African and international.
18
The mobilization of African leadership for the creation
of a single African Medicines Regulatory Agency relies
on the presentation of a clear vision and roadmap to
African Heads of State. Under the aegis of the African
Union, an African Medicines Regulatory Agency would
bring together regional initiatives and provide a single
advocacy, regulatory and coordination platform for
availability of quality-assured medicines, including
antiretroviral therapy on the African Continent.
AIDS led the debate on patent protection with victories
on licensing and parallel imports. AIDS activism led to
tiered pricing and patent pooling. The AIDS response
can be leveraged to support Africa to develop its own
continental medicines agency.
Other regions have enjoyed the benefits of a harmonized
approach to generate more efficient and timely access
to medicines. Despite considerable national technical
capacity, European countries have pooled resources for
the EMEA. An African approach could benefit from the
experience gained there.
An African Medicines Regulatory Agency could
also provide the impetus and nucleus to establish a
complementary new African centre of excellence in
pharmacological research. Such a platform would
provide a mechanism for South-South partnerships
as envisioned by the BRICS and G77 and the African
Union’s Pharmaceutical Manufacturing Plan for
Africa. It could also provide African governments
with a platform to develop common positions to
negotiate as a bloc on pharmaceutical-related matters.
“So, we want aid directed at building capacity for
development—Africa’s exit from aid dependency hinges on
this…We want aid that supports a strong role for citizens,
parliaments and entrepreneurs. And we want an inclusive,
representative and accountable global system with strong
African participation to monitor progress on what has
already been agreed by Africa and its partners.”
Ibrahim Mayaki
Chief Executive Officer, NEPAD
AIDS DEPENDENCY CRISIS: Sourcing African Solutions 19
20
Situatio n anal ysis
Reversals in the AIDS response: Potential
risks and the cost of diminished action. Africa’s
dependence on foreign investments and foreign-made
drugs has put the AIDS response in a risky position.
Africa cannot afford to allow commitments to continued
progress to waver. The failure to scale up towards African
treatment targets (80% of people eligible) by 2015 will
result in an additional 2.5 million AIDS-related deaths
during the period. The number of AIDS-related deaths,
as well as the burden of ill health associated with HIV,
will be considerably higher if countries are not able
to maintain present levels of treatment coverage. A
failure to maintain treatment coverage will also result
in a resurgence of tuberculosis incidence and death.
Antiretroviral therapy can reduce the risk of TB incidence
by up to 90%. Timely access to HIV treatment can reduce
TB mortality by 60%.
The vast majority of HIV treatment drugs consumed in
Africa are imported from generic manufacturers. Over
80% come from one country: India. The viability of
this arrangement should be of grave concern to Africa’s
leaders, given the imminent changes to the market
incentives and regulations facing Indian manufacturers
which will likely result in a reduction in reliable low-cost
generic suppliers.
While quantities are still relatively small, the number of
African countries with local production of antiretroviral
therapy has been growing in the last several years.
However only one producer, in South Africa, has met
the standards for quality and good manufacturing
practices for pharmaceutical production by the WHO
Prequalification of Medicines Programme.
Least Developed Countries (LDCs) have received a
waiver from the World Trade Organization’s Trade
Related Aspects of Intellectual Property Rights (TRIPS)
Agreement granting an extension of the transition period
before pharmaceutical patents need to be enforced in
January 2016. Beyond that date, the patenting situation
of HIV-related medicines, particularly second- and thirdline
treatments as well as diagnostics, will be even more
complex than it was when the Doha Declaration
was adopted.
Optio n 3.
Estab lish centres of excellen ce
for local produ cti on of medi cines
in Afri ca
figure 8
AIDS deaths in sub-Saharan Africa: The consequences of failure to meet African targets
Source: UNAIDS.
1 800 000
1 600 000
1 400 000
1 200 000
1 000 000
800 000
600 000
400 000
200 000
0
2010 2011 2012 2013 2014 2015
Estimated number of AIDS deaths if ART coverage
remains constant at 2010 numbers
Estimated number of AIDS deaths if 80% ART coverage
is achieved by 2015
AIDS deaths, sub-Saharan Africa
2.5 million deaths
AIDS DEPENDENCY CRISIS: Sourcing African Solutions 21
Solutio ns
Local production of high-quality
pharmaceuticals provides an opportunity to
ensure sustainability of the AIDS response and
put products nearer to those who need them.
Local pharmaceutical production both catalyses and
relies on building Africa’s knowledge-based economy.
Local production of high-quality pharmaceutical
products will play a major role in not only ensuring
long-term access to HIV medicines but in developing an
industry manufacturing other medicines particularly
suited to the African context.
Joint ventures, technology transfers, and direct
investment provide new opportunities for production
of both generic and patented medicines. African leaders
should be supported to further explore and implement
industrial policies that will favour a new industry of
local pharmaceutical production. Through a supportive
policy environment, governments can incentivize
the development of local competencies to produce
medicines efficiently including through the promotion
of greater collaboration among external pharmaceutical
companies and local manufacturers.
Ensuring the extension of the TRIPS Agreement
beyond 2016 will further enable favourable market
conditions for production of generic antiretroviral
therapy and other essential medicines and will provide
the necessary window to consolidate production on the
African continent.
The region also needs to forge new industrial policies
that can support local pharmaceutical industries—policies
that address increased technical capacity in production,
quality control and intellectual property rights issues.
South-South cooperation may be a way to address technical
barriers, but the policy barriers need African solutions.
North-South and South-South technology transfer
will play a fundamental role in establishing centres of
excellence for local production of antiretroviral therapy
and other commodities on the Continent. BRICS
countries are playing an increasingly pivotal role in
delivering solutions for advancing equitable access to
public health goods—by significantly expanding scientific
cooperation and innovation and creating a market for
technology transfer, overcoming trade barriers and
advancing innovative financing solutions.
22
African avenues for collaboration for technology and
innovation transfer could include:
• Institutional collaboration (universities and hospitals)
including through health staff exchanges.
• Research and development, which has been a proven
area for technology transfer in other development
areas, such as agriculture, and could be expanded.
• Strategic planning technical assistance / technical
cooperation between China and the African Union
to support expansion from project-based models to a
broader, more sustainable programme-based approach.
As mandated by AU Heads of State in 2005, a business
plan is currently under development for implementation
of the Pharmaceutical Manufacturing Plan for Africa.
Renewed political engagement from the AU is required
for continued progress in this area.
“In a cynical world we have become an inspiration to
many. We signal that good can be achieved amongst
human beings who are prepared to trust, prepared to
believe in the goodness of people.”
Nelson Mandela
I. World economic outlook: April 2011. Washington DC, International Monetary Fund, 2011.
II. 2011 Ibrahim index of African governance. Mo Ibrahim Foundation, 2011.
III. African economic outlook 2011. African Development Bank, Development Centre of the Organization
for Economic Co-operation and Development, United Nations Development Programme, United Nations
Economic Commission for Africa, 2011.
IV. African economic outlook 2011. African Development Bank, Development Centre of the Organization
for Economic Co-operation and Development, United Nations Development Programme, United Nations
Economic Commission for Africa, 2011.
Notes
Notes
Notes
UNAIDS / JC2286E (English original, January 2012)
ISBN 978-92-9173-928-8
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