HIV DRUG STOCK OUTS IN UGANDA

CABINET INFORMATION PAPER

1.0 Title: ADDRESSING CRITICAL FUNDING GAPS FOR HIV AND AIDS DRUGS FOR THE PUBLIC HEALTH RESPONSE TO THE HIV AND AIDS EPIDEMIC IN UGANDA

2.0 Author: THE HONOURABLE MINISTER OF HEALTH

3.0 Purpose: To Leverage additional Domestic Finances to support Procurement of HIV and AIDS drugs for the National Response

3.1 Objectives of the Memo

This cabinet information paper is intended to;

Provide information to Cabinet on the current funding gaps for HIV and AIDS drugs for the Public Health response to HIV/AIDS in Uganda.

Provide Information to Cabinet on the progress in the implementation of the Public Health Response to HIV/AIDS Epidemic in Uganda.

Seek for support from Cabinet for mobilization of additional domestic resources to support the funding gap for HIV and AIDS drugs for the implementation of priority interventions for the HIV and AIDS response in Uganda.

4.0 Epidemiology (Burden) of the HIV/AIDS Epidemic in Uganda

Uganda has been grappling with a severe generalized HIV/AIDS epidemic for over three decades. The 2011 AIDS Indicator Survey (AIS) revealed an increase in HIV prevalence among adults aged 15-49 years, from 6.4% in 2004/05 to 7.3% in 2011. This increase is attributed to incident HIV infections and improved survival due to increased access to HIV care and treatment services including antiretroviral therapy (ART).

The increase in prevalence was noted in several regions with doubling of prevalence in some regions such as West Nile. The HIV burden (number of people in the country living with HIV was estimated at 1,486,642 (Adults 1,339, 248 and pediatric 143, 312) in 2014 and will be 1,544,315 (1,406,789 adults and 137,526 children) at the end of 2015.

The data for Uganda indicate geographic and socio-demographic heterogeneities. Women are disproportionately more affected than men with an overall HIV prevalence of 8.3% among women compared with 6.1% among men. 

By geography, HIV prevalence ranges from 4.1% in Mid-Eastern region to 10.6% in Central 1 region. Mid-Eastern Uganda, with the highest population coverage of circumcision (53%) had the lowest HIV prevalence at 4.1% and registered a modest decline from 5.3% in 2004/05 . HIV prevalence was higher among uncircumcised men (6.7%) compared to circumcised men (4.5%).

Urban residents are more likely to be infected (8.7%) than their rural counterparts (7%); this picture is prominent among women with HIV prevalence among urban women estimated at 10.7% compared to 7.7% among rural women while the rates for urban and rural men are the same (6.1%). In the younger age groups 15-24 years, HIV prevalence is estimated at 3.7%; the female HIV prevalence for the age groups 20-24 is two to three fold that of males within the same age category.

The country continues to experience a high rate of new HIV infections. The number of new HIV infections was consistently higher than that of individuals initiated on treatment until 2013 when the tipping point was reached (ratio of new HIV infections to the net increase in ART was <1). It is estimated that approximately 99,000 new HIV infections occurred in 2014 - falling from 137,000 in 2013, 140,000 in 2012 and 147,000 in 2011. (MoH- Estimates and Projections, 2014).

Data from the MoH also indicates that high-risk behaviors remain prevalent in Uganda. Reported condom use in high-risk encounters is low. Comprehensive knowledge combining several knowledge measures remains low. In 2011, only 36% of women and 43% of men aged 15-49 had comprehensive knowledge about HIV/AIDS, with very modest increases from 2004/05 (less than 10% for both men and women). 

Overall, 25% of the men reported having two or more sexual partners in the previous year, compared with 3% of the women. Condom use among those engaging in higher risk sex declined from 47% in 2004/05 to 29% in 2011 among women and from 53% to 38% among men.

5.0 The Public Health Response to HIV/AIDS in Uganda

The Government of Uganda has been addressing the HIV/AIDS epidemic through the implementation of the National Prevention Strategy, the National Strategic plan and the Health Sector Strategic and Investment Plan. In July 2014, these documents were re-inforced with the development of the HIV Investment Case which identified National core HIV/AIDS priorities. The response is premised on structural, behavioral and bio-medical interventions.

The priority interventions in the Feasible Maximum HIV Investment Case Scenario for Uganda will be scaled up over the first three years between 2015 and 2018 and thereafter maintained at the targeted levels through 2025. 

These priorities include the rapid scale up of ART coverage to 80%, with test and treat for MARPS, eMTCT coverage to 95%, annual HCT coverage of 50% of 15-49 years population, coverage of condoms use to 80%, coverage of SMC to 80% and expansion of BCC services to achieve a reduction in the number of sexual partners by 25%. The National Strategic Plan and Health Sector Strategic and Investment plan will also focus on the identified priorities in the HIV Investment Case.

It is envisaged that with the implementation of the priorities in the Investment Case, the country could avert 2,160,000 new HIV infections and 570,000 AIDS-related deaths between 2015 and 2025. Other integrated adjunctive interventions such as isoniazid preventive therapy, early detection of TB in HIV infected persons, and expanding ART coverage to all co-infected persons will be implemented because of their implications for the incidence, prevalence and mortality from the related TB epidemic.

6.0 Progress in the Public Health Response

The Ministry of health has a Health Sector HIV Strategic Plan (HSHASP 2010/11-2014/15) to guide the Public Health response to the HIV and AIDS epidemic. The health sector public health response focuses mainly on behavioral and bio-medical interventions. 

These include; BCC, Condom programming, HCT, STI management, Safe Male Circumcision, eMTCT, Care & Treatment and Strategic Information. The implementation of these interventions is tailored to focus on geographic and socio-demographic groups that are disproportionately affected by the epidemic. For the core programs that have been prioritized in the public health response, the following progress has been made;

6.1 Behavior change communication

Data from the NSP Mid Term Review indicate that many achievements have been registered in behavior interventions. These include the development of a BCC message book which was distributed to all districts; a pastoral letter distributed by the Inter-Religious Council of Uganda (IRCU); and interventions targeting cultural leaders. 

UAC also established a message clearing committee and launched a new campaign ‘Zip-up 256’. However, it is estimated that only 1,639,649 individuals were reached with BCC, representing 7.9% of the targeted number. Also, HIV risk behaviors persisted.

The Knowledge Management Communication- BCC review of 2013 indicates that consistent, targeted messages that are grounded in the realities of the communities, promoted by multiple sectors and multiple channels such as mass media and telecommunications are valuable but should be used strategically and targeted to communities. 

The review notes that the ABC campaign was previously successful but overlooked the influence of gender, coercion and socioeconomics of decision-making dynamics and did not target MARPs such as sex workers and fishermen as well as the risk compensation due to new technologies like SMC and ART . 

Inconsistencies in messages were also cited as a challenge (e.g. mixed messages around use and non-use of condoms). The current BCC models and messages are being adjusted to align with the current environment.

6.2 Condom Programs

The MoH is implementing a Comprehensive Condom Programming Strategy (CCPS) that is aimed at increasing demand for male and female condoms, improving access to and utilization of condoms, strengthening the condom supply chain management, and monitoring and evaluation. Both male and female condoms (FC2) are procured and distributed. 

The country has recently strengthened capacity for the Condom Post-shipment testing policy, and this has greatly improved the condom throughput. The number of condoms procured annually are significantly below the projected national need. 

 The Comprehensive Condom Programming strategy has been reviewed and a report is available. The review is the basis for the design of the next strategy that is being designed to refocus demand creation and condom distribution. 

With support from partners, a total of 172, 201,292 (56% of estimated national need) condoms were procured and distributed in the country in the last year. The capacity for post shipment testing at National Drug Authority (NDA) has continued to improve from 13 million in 2013 to 18 million per month in 2014. There is however a continued challenge of the lack of a budget line for this in the Ministry of Health budget.

6.3 HIV counseling and testing (HCT)

HIV Counseling and Testing is a critical entry point for HIV prevention and Care Programs. The number of people who tested for HIV in the last year was 10,273,927 out of a target of 7,421,024 people. Most of these tests were conducted in health facilities based on the Provider Initiated Testing and Counseling (PITC) approach. 

The population level proportion who know their HIV status were last determined in the 2011 AIS and was 45% for men and 66 % for women. The higher coverage among females is attributed to HCT opportunities during MCH and PMTCT services. 

HCT has expanded over the last three years with expansion of Provider Initiated Testing and Counseling (PITC), community models, and couples HIV counseling and testing. access to testing by some population groups (e.g. men) is still low. Couple testing is also low; only 5% of testers received couple HCT in 2014. A Population HIV Impact Assessment Survey will be conducted early next year and will help us determine the trend in this indicator.

6.4 Male circumcision

Data from UAIS 2011 indicate that the SMC prevalence was 26%. The annual target for the national SMC program is 1,001,875 circumcisions, to contribute to the NSP target of 4.2 million circumcisions by 2015. SMC scale-up was initially slow but has significantly increased due to improved capacity. 

The circumcision program has expanded and cumulatively a total of 2.4 million men have been circumcised since the program was initiated. In the last financial year, 688,313 men were circumcised. The program has developed a policy for tetanus immunization in response to the tetanus adverse events. In the new policy, there are proposals for booster immunization doses for target eligible males.

6.5 PMTCT and Early Infant Diagnosis (EID)

The implementation of the eMTCT program in Uganda is based on four prongs including:- 

a) Primary HIV prevention 

b) meeting the unmet need for family planning

c) lifelong ART-Option B+ and 

d) family centered treatment for children and adults infected with HIV. 

The new guidelines for Option B+ have been fully rolled out in the country and coverage of ART treatment to mothers receiving PMTCT in 2014-2015 was 112,909 (92%) against a need of 122,581 HIV infected pregnant women. The number of facilities implementing these new guidelines in the country has continued to increase and was 4,200 sites countrywide.

The PMTCT facility coverage has increased significantly over the past year; from 2,138 in 2013 to 3,248 facilities providing PMTCT services by June 2014. The proportion of pregnant women tested for HIV increased from 30% in 2008 to 95% in 2014. In 2013, EID facility coverage was 1,696 (76% of the facilities) including 100% of referral hospitals, 100% of district hospitals and 100% of HCIVs, 84% of HCIIIs, and 5.6% of HCIIs. 

Coverage of EID testing among infants (first DNA PCR) in 2013 was 60,437 (51%), a steady increase from 7% in 2007. However, the percentage of exposed infants who received the first PCR at two months has increased from 45.6% in 2011 to 59.8% by June 2014, against the NSP target of 50% by 2015. Prevalence of HIV among those tested was 9% in 2012 and 4.6% in 2013, a significant decline from 19% in 2007. Furthermore, data from MoH indicate that new pediatric infections reduced from 28,000 in 2009 to 15,000 in 2013 and were 9,500 in 2014

6.6 Care and Treatment

The objective of the Care and Treatment Program is to expand coverage so as to maximize individual patient benefit as well as the community prevention benefit. The Ministry of Health through the AIDS Control Program is implementing new guidelines for prevention and treatment that are focusing on enrolment of CD4<500 and test and treat for 

i) All TB/HIV and Hepatitis B/HIV co-infected individuals,

 ii) HIV infected children under 15 years, 

iii) HIV infected pregnant and lactating mothers, 

iv) All MARPS. This also includes a phased introduction of viral load monitoring of treatment in addition to the clinical and immunological markers.

The active ART enrollments grew by 28% during the 2014. The proportion of people who are on ARVs increased from 53% in 2009 to 750,896 (56%) by December 2014 of those in need (adults 694,627(58%) and children 56,269 (38%). 

ART enrollment increased to 823,050 (761,771 adults and 61,279 children) by September 2015. This coverage is based on the new HIV prevention and Treatment guidelines in which the number of people in need has gone up and is currently estimated at 1,345,872 (1,196,556 adults and 149,216 children) at the end of 2014 and is estimated to be 1,406,702 (1,269,176 adults and 137,526 children) by December 2015.

The total number of facilities providing ART in Uganda has increased from 1,552 at the end of 2013 to 1,658, of which 1,204 were concurrently providing ART to children by the end of 2014. These facilities include two national referral, 13 regional referral and 112 of 140 general/district hospitals (80%), 186 of 206 (90%) HCIVs, and 1084 out of 1309 (83%) HCIIIs, and 200 out of 2777 HCII as well as 31 specialized HIV clinics. The number of facilities providing pediatric ART increased from 869 in December 2013 to 1,204 sites (December 2014).

The Ministry of Health has introduced viral load monitoring through a centralized viral load laboratory at CPHL supported by the sample transport network. Since August 2014 to August 2015, a total of 132,000 viral load tests have been conducted. The Early Infant Diagnosis (EID) has continued to scale up services and last year over 98,000 tests were conducted and over 70,000 babies from 2239 health facilities.

7.0 Fundamental problem to be addressed in the Memo

In order to address the big challenge of the HIV/AIDS epidemic indicated in (4.0) and to sustain the achievements in (6.0) above, the MoH and Partners are implementing interventions that include the scaling up of priority behavioral and biomedical interventions in the National Strategic Plan, National Prevention Strategy, the Health Sector Strategic and Investment Plan and the HIV Investment Case. Other sectors are implementing Structural interventions and some behavioral interventions.

The Goal of the MoH and partners supporting the implementation of these interventions is to contribute to the following goals: (a) aversion of 2,160,000 new infections between 2015 and 2025- 77% reduction in new infections, (b) reduction of new infections in children from 14,200 to 4,040 between 2014 and 2025 (c) aversion of 570,000 deaths by 2025 and (d) saving lives of 42,620 children from AIDS related death by 2025.

The Care and Treatment program is an essential component of the interventions to achieve these targets. The Specific request in this Cabinet Memo therefore is for additional domestic financing to procure emergency drugs to fill out a critical public sector gap for the period November 2015 - June 206 and to request for the inclusion of additional resources in the budget for July 2015 - June 2016 to bridge a public Sector Funding gap. The ministry of Health aims to achieve the UNAIDS triple 90 targets in the scale up of the Care and Treatment program towards an AIDS Free generation.

8.0 Issues for Consideration by Cabinet

This Cabinet memorandum seeks to update Cabinet on the Status of the HIV and AIDS epidemic and to mobilize for funds to fill the gap for essential life saving ARVs. There are two major funding mechanisms in place for drugs: 

1) The Government of Uganda (GOU) budget support to the Health sector through the Ministry of Finance Planning and economic development; 

2) Support from AIDS Development partners; mainly PEPFAR and the Global Fund. The United States Government through PEPFAR supports the private sector ARV needs through the Joint Medical Stores and Medical Access Uganda Limited warehouses. The GOU and the Global Fund support the public Sector drug needs through the National Medical Stores (NMS).

The Government of Uganda has been increasing its contribution for public sector ARVS through NMS. There however remains a gap because the funds were insufficient for the patients currently enrolled on treatment, a situation which has been compounded by the depreciation of the shilling in recent months. 

There is therefore a stock out at the NMS and at the public health facilities. As a result of that, the Ministry of Health has asked the Global Fund to carry forward funds which were in their second year budget to fill the gap in the current first year. This therefore has a ripple effect in the second year which will also require to be offset to prevent a similar situation from recurring.

The focus for the resource mobilization in this memo therefore is to mobilize for funds for the procurement of anti-retroviral drugs to support the Care and Treatment Program in two categories namely; a) a subvention from the Ministry of Finance to the tune of USD 10,071, 638 for an emergency order for ARVs for November 2015 - June 2016 and b) funds to the tune of USD 92,281,641(excluding previous allocations to NMS budgets) for the July 2015 - June 2016 budget period.

9.0 Timing

This Cabinet Memorandum needs urgent action by Cabinet to bridge the Funding gap for essential drugs to ensure patients that are currently on treatment continue to receive essential life saving treatments. The Ministry of Health has notified AIDS Development partners including the Global Fund and the United States Government of Government of Uganda's intentions to increase domestic financing for the HIV and AIDS response and the processes it will take to mobilize them that includes the development of this Memorandum for Cabinet.

10.0 Policy analysis

The Ministry of Health concurs with the proposed procurement of essential life saving drugs to contribute to a reduction in new HIV infections and avert AIDS related deaths in a quest for an AIDS free generation. 

This will in turn save costs and contribute to socio-economic development. These interventions are in line with the Global UNAIDS triple 90 targets, the goal of the National Development Plan, the HIV Investment Case, the National HIV Prevention Strategy, the National Strategic Plan and the Health Sector Strategic and Investment Plan.

11.0 Implications of the Cabinet Memorandum

The Ministry of Health has conducted a Financial Gap analysis to determine the funds currently available from GoU and from AIDS Development Partners in order to determine the existing Funding Gap for essential drugs for the HIV and AIDS response. The focus for this Cabinet Memo will be on the procurement of essential life saving drugs for the Care and Treatment Program. 

Because of the current stock outs for ARVs in the Public Sector, the Ministry of health has requested the Global Fund to carry forward the funds in the 2nd year period of the HIV Grant that is currently being implemented to ameliorate the current deficit in drugs. The Global Fund have agreed to that request; that however will bridge but not completely close the first year gap. More importantly however, this front load will now result in a bigger public Sector Gap for the second year of the Global Fund Grant.

The request in this Memo is therefore for additional domestic funding for a) bridging the emergency requirements for ARVs for the period November 2015 - June 2016 for patients currently on treatment and b) bridging the gap for ARVs for the period July2016 - June 2017 Based on the programmatic and Financial gap analysis for the Care and Treatment Program for the public sector, the funding requirements for essential life saving drugs for the Emergency order for November 2015 - June 2016 and for the intermediate period July 2016 - June 2017 are summarized in table 1 and table 2 below.

This Cabinet Memo aims to mobilize for funds for the procurement of anti-retroviral drugs to support the Care and Treatment Program in two categories namely a) a subvention from Ministry of Finance to the tune of USD 10,071, 638 for an emergency order for ARVs for November 2015 - June 2016 and b) funds to the tune of USD 92,281,641(excluding what was previously in the NMS budget) for July 2015 - June 2016 budget period.

12.0 Recommendations

The Ministry of Health and Partners have proposed a plan to scale up the HIV and AIDS response that aims at an AIDS free generation by 2030. To implement that plan, there are significant resource gaps. The Ministry of Health proposes to Cabinet that GOU leverages for a subvention from Ministry of Finance for USD 10,071, 638 for an emergency order to support the procurement of essential life saving ARVs to support the current public sector gap at NMS. The Memo also seeks for USD 92,281,641 in the budget period July 2016- June 2017.

13.0 Conclusion

The implementation of the proposed priority interventions in the HIV Investment Case, the National HIV Strategic Plan, National Prevention Strategy and Health Sector Strategic and Investment Plan has the potential to significantly reduce the number of new HIV infections and AIDS related death in Uganda. Care and Treatment is an essential component in these plans. It is essential that Government prioritizes HIV and AIDS commodities particularly ARVs that will have impacts on the AIDS epidemic by cutting AIDS related deaths and contributing to a reduction in new infections. In the long term, this will also save costs of care and contribute to enhanced socio-economic development.

14.0 Attachments and References

This Memorandum needs a Certificate of Financial implication from Ministry of Finance Planning and Economic Development

15. Address of Author and Date of Initiation

THE HONORABLE MINISTER OF HEALTH

MINISTRY OF HEALTH, 6 LOURDEL ROAD, P.O. BOX 7272

KAMPALA, UGANDA

16th November, 2015.