Chapter 4: Reforming Drug... Chapter 4: Reforming Drug Registration Practices In the East African Community Chapter 6: Strengthening Rural... Chapter 6: Strengthening Rural Health Care in East Africa

   Chapter 5: East Africa's Essential Medicines' Distribution Chain

Nisha Patel, Alison Ross, and Mia Levi

This chapter differs from the others in this book.   Focusing on Uganda, Rwanda and Tanzanian experience, it abstracts and combines the relevant parts of research reports drafted by the authors to begin the process of conceptualizing legislation to help improve the distribution of essential medicines to all EAC inhabitants, especially those in remote rural areas.  All three authors underscore the importance of engaging knowledgeable country nationals in gathering additional facts to warrant – and, as necessary, to revise – their draft reports' initial hypotheses as to the nature and causes of the  problematic behaviors – the institutions – which proposed legislation must change to enable all the region's inhabitants to access efficient, affordable medicines.

This chapter does not repeat the three drafters' description of the larger, historically shaped EAC context, essentially summarized in Chapter One, above.  That constitutes larger context within which East Africans experience difficulties in obtaining affordable, effective medicines,   Instead, this chapter focuses on the three authors' analysis of the evidence relating to problem-solving's Step I, describing the country-specific role occupants' behaviors that contribute to those problems; Step II,  explaining the causes of each set of those role occupants' problematic behaviors; and, Step III, the range of logically possible, legislative solutions for eliminating those difficulties.  As required by problem-solving's Step IV, all three authors recommend that the proposed law incorporate a transparent, accountable and participatory monitoring and evaluation processes.  Those processes must ensure that those affected by the law can assess – and suggest improvements – in its implementation and its contribution to improving all East Africans' access to affordable medicines.

In reality, the social problems posed by difficulties in accessing effective drugs in the three countries do not appear to differ greatly.   Nevertheless, partially reflecting the countries' differing histories, the specific role occupants whose behaviors contribute to those problems (ie the 'institutions' responsible for distributing the medicines) do seem to differ significantly.    The EAC workshop participants should assess the evidence on which the authors ground their descriptions and explanations in light of their own deeper knowledge of their countries' unique realities.   In doing so, they should consider whether the apparent differences seem to require each member EAC state to enact national legislation to achieve a more equitable distribution of medicines to all their country's inhabitants; and or whether regional legislation might facilitate more effective, coordinated use of regional resources to improve the distribution of medicines throughout the region.

To facilitate the workshop participants' efforts to make that assessment, this chapter presents an abridged version of the three authors' research reports' Parts II, III, and IV – ie their four step analyses of the relevant problematic behaviors that still perpetuate the difficulties so many EAC residents still experience in accessing medicines essential to extend their life expectancy.

[ Provide a Map of Uganda, identifying the capitol and medicinal distribution networks: districts, hospitals, health centers, and pharmacies, and a box with a glossary of all the alphabet 'soup' (titles) of the health agencies described below) ]

A number of role occupants contribute to the problem of inadequate distribution of essential medicines in East Africa, as exemplified in the Ugandan case.²⁹⁷  The National Medical Stores (NMS) Management – including the Board of Directors, the General Manager, and the Staff – play a significant role.   Local health center personnel, responsible for drug procurement, stock management, and overall logistics of ensuring an adequate supply of drugs, and third party donor programs also contribute.   To ensure more equitable access to essential medicines for all Ugandans, the proposed bill's detailed provisions must change these primary role occupants' problematic behaviors.   Before designing or revising laws to change these behaviors, however, Ugandan law-makers together with Ugandan medical personnel will want to examine in greater depth the available evidence as to the role of the NMS, health center personnel, and third party donor programs which, currently, have primary responsibility of ensuring essential medicines reach all Ugandans.

Insert diagram of relationship between these institutions here.  The editors and authors have not yet found this information.

In the early 1990s, the Ugandan government decentralized its health care.  The Ministry of Health retained responsibility for policy formulation, standard setting, and resource mobilization.  Local governments (districts and delegated health sub-districts) assumed responsibility for implementing the policies, mobilizing additional resources at the local level, and planning and managing district health services.²⁹⁸ The Ministry of Health determines the country's National Health policies, which provide equitable delivery of health services, accessibility to health services, and improved health financing and development.²⁹⁹  The National Drug Authority (NDA) enforces the National Drug Policy (NDP) and sets the policy and principles under which the government can import drugs into Uganda, ensuring the availability, accessibility, and affordability of essential medicines of appropriate quality, safety and efficacy.³⁰⁰
 
In 1995/96 the Ministry of Health initiated a ten year National Health Policy (NHP) (launched in 1999/2000) and a five year Health Sector Strategic Plan (HSSP) (launched in 2000/2001).  These policies aimed to provide a package of services known as the Uganda Minimum Health care Package (UMHCP) designed to overcome, as cost-effectively as possible, the major causes of high mortality diseases.³⁰¹ The UMHCP focuses on control of diseases like malaria, HIV/AIDS, and TB along with childhood illness, sexual and reproductive rights, and school health.³⁰² Additionally, the MoH proposed a sustainable National Health Financing Strategy geared towards equitable national health,³⁰³  and a Health Care delivery system, with core functions at the central and district levels, to improve the alignment of structures and responsibilities.³⁰⁴ More recently, the MoH formulated a five-year National Pharmaceutical Sector Strategic Plan 2002/3 -2006/7 to facilitate ongoing health care reform, including access to essential medicines.³⁰⁵  

Under Uganda's decentralized system, each of 56 districts has established a health care administrative structure consisting of five levels: health centers (HC I-IV, at village, parish, sub-county, county) and the district/general hospital.³⁰⁶  Additionally, eleven HC VIs act as referral hospitals at the district level, and two HC VIIs serve as national referral hospitals.³⁰⁷  NHP established health sub-districts as the operational zone in a district to take services closer to the population.³⁰⁸  The Ministry of Health reports that Uganda has 104 hospitals (57 government, 44 NGO, 3 private); 250 health centers (179 government, 68 NGO, and 2 private); 2 palliative care (1 government, 1 NGO); and 1,382 other (989 government, 352 NGO, and 41 private).³⁰⁹  Health center personnel dispense medicines from 2,939 public sector health facilities to 215 private pharmacies, and 2600 drug shops.³¹⁰ The Ministry of Health concentrates the delivery of UMHCP in HCs I-IV where the majority of the people live.³¹¹

Diagram the five levels ??

Private and missionary hospitals get their medicines from the Joint Medical Stores (JMS), while government and public hospitals obtain their drugs through the National Medical Stores (NMS), a government agency.³¹²   Under the National Medical Stores Statute, the NMS should ensure the continuous distribution of essential medicines to the population of Uganda, including the country's most remote regions.³¹³ The NMS specifically has responsibility for procuring, storing, and distributing essential medicines to the public sector.³¹⁴ 

The Ministry of Health set up the NMS as a corporation, with a Board of Directors, appointed by the Minister of Health, as its governing body.³¹⁵ The Board formulates and reviews the policy of the NMS regarding its procurement, storage, and distribution of medicines.³¹⁶The Board determines the NMS' organizational structure and staffing, and approves an Operations Manual for the NMS' internal operation.³¹⁷ The Minister of Health also appoints the General Manager, who oversees day-to-day NMS operations.³¹⁸

NMS manages a complex, unique, and highly integrated distribution network throughout the country.  NMS stores, distributes, and supplies goods in accordance with the NDP and NDA standards.³¹⁹ NMS stores and distributes imported drugs, including those donated by third parties.³²⁰ NMS runs its processes with Microsoft Navision 3.70, a tool that allows a business to streamline its internal processes, particularly in the areas of financial management, supply chain management, and customer relationship management.³²¹  The System used by NMS supports and facilitates its product distribution network, business processes and financial management, storage management and inventory control operations.³²²  

Under the decentralized system, district personnel use either a credit line, or directly purchase drugs for distribution.³²³ Under the credit line system, the Ministry of Health allocates funds to each health center's account with the NMS, and the NMS delivers drugs based on the health centers' requisition orders.³²⁴  NMS distributes these drugs to the districts from which HSDs collect and deliver them to local health centers.³²⁵ Under the direct purchases system, health centers must use at least 50% of public health care funds to purchase drugs.³²⁶ The districts must buy drugs from the NMS; only if the NMS issues a non-availability certificate³²⁷ may they purchase from another supplier.  The authority that purchases the drug must distribute it (i.e. if an HSD buys the drug, it must distribute it).   In a centralized book-keeping system, the districts distribute drugs to HSDs, which later distribute them to individual health centers.³²⁸  In a decentralized book keeping system, HSDs distribute the drugs.³²⁹  In the NMS "pull system" of drug procurement, a logical accounting system links all health facilities' credit lines.³³⁰  Districts and HSDs must place orders within specified ordering schedules, and receive orders within two months of the ordering date.³³¹  Delivery occurs every 8 weeks to each district and every 4 weeks for HIV treatment centers.³³²  In the pull system, each health facility estimates and places orders for its required quantities of medicines.³³³ NMS employs several distribution systems for: monthly supplies; quarterly schedule supplies; emergency supplies; flexible demand-based supplies; and door to door customer delivery.³³⁴  Government facilities most commonly use facility-managed vehicles (48%) or public transportation (48%) to transport drugs.³³⁵  Health center personnel perform inventory management at health centers and place orders for drugs.

Legislation to improve the implementation of this complex distribution system will have to alter or eliminate the causes of existing problematic behaviors of those who, at each level, manage it.  These include the managers and employees of the National Medical Stores; Health Center personnel at the District, HSD, and village level; and third-party donor personnel.

A.  National Medical Stores (Management and Employees)

Inadequate guidelines and supervision by the NMS managers, and NMS staff members' negligence and errors apparently contribute to life saving medicines' expiration on the shelves before reaching patients.³³⁶  In 2006, the Office of the Auditor General reported that 42,555 packs of anti-retrovirals (ARVs), valued at about $468,000, had expired at NMS.³³⁷  In 2007, the Parliamentary Social Services Committee discovered that, at NMS, Shs 1.2 billion (approximately $685,000) worth of already-expired ARVs and malaria drugs, and Shs1.65 billion (approximately $942,000) worth of other drugs about to expire.³³⁸ 

NMS staff members' non-compliance with specified drug-delivery procedures and schedules leads to late delivery of drugs to health centers, depriving patients of drugs they need immediately.³³⁹  As a result, some districts order from other sources without waiting for a certificate of non-availability from NMS.³⁴⁰  The higher the level of facility, the less time it takes to receive supplies: the majority of hospitals and HC IV level reported receiving supplies within one to two months, whereas the majority of HC III and HC II facilities reported that it took two to three months or more.³⁴¹  NMS delivers directly to most hospitals, and 73 percent of HC IV facilities stated that "they collect their supplies from the district, which allows for more control over timing."³⁴²  Only "25 percent of HC III and HC II facilities collect their own supplies; 50 percent rely on the HSD to deliver, and another 20 percent rely on the district to deliver their supplies."³⁴³ 

Lack of communication between the NMS staff, district, and HSD personnel concerning delivery dates aggravates local facilities' difficulties.   Not knowing the actual arrival date, district and HSD personnel cannot reserve vehicles in advance or plan for distribution to remote health centers.³⁴⁴The HSD often does not know that the District received an order, and sometimes discovers it only by chance.³⁴⁵ District level storekeepers and auditors may not know when to inspect and accept a delivery, causing more delays while the NMS District level staff waits for them to arrive.³⁴⁶ 

B.  Health Center Personnel (District, HSD, and village level)
 
Health center personnel's failure to keep adequate records as to drugs procured constitutes another seriously problematic behavior.   The 2006 Value for Money audit found that 19 out of 81 health centers did not have proper drug records.³⁴⁷  A 2002 survey indicated that 45% of facilities used stock cards³⁴⁸  for at least one of the contraceptives studied; 75% used stock cards for at least one of the essential drugs for treating OIs, malaria, and STIs; and 28% used stock cards for at least one of the TB medications studied.³⁴⁹  A comparison of the overall average percent discrepancy between the stock card and the physical count for all facilities surveyed revealed that a median discrepancy existed of 84% for contraceptives, 40% percent for OI/malaria/STI drugs, and 92% for TB drugs.³⁵⁰

A 2006 survey found improvements in the use of stock cards in some areas, finding that 80% of stock cards for selected essential drugs were up to date, however, in other areas, like HIV tests, only 50% of stock cards were up to date.³⁵¹ The lack of accurate data on levels of drugs makes health centers vulnerable to drug leakages and misappropriation by staff, especially when combined with very little segregation of duties.  Low levels of actual use of stock cards indicate that stock managers do not properly monitor their stock levels.  Not maintaining store records leads to delays in identification of drug stock outages and expired drugs.  In turn, this behavior tends to cause inadequate procurement and drug shortages that disrupt health service delivery.  A 2006 Value for Money audit showed that out of 81 health centers visited, 31 (38.3%) lacked essential drugs and sundries required by the medical personnel of the health centers in carrying out their duties.  Extrapolated, this indicates that 10,583 health centers nation-wide lack essential drugs.³⁵² Regular reporting of this information proves critical for making logistical decisions at each level of the supply chain.  The lack of these reports suggests that the Ministry of Health does not effectively draft, communicate, and enforce its guidelines regarding keeping accurate drug records at the health centers.

Health center inventory management personnel apparently neither maintain proper storage facilities nor comply with MOH and NDA handling procedures for proper storage to protect medicines from harmful conditions.  Inadequate storage at one out of three facilities storing medicines reportedly affected the medicines' quality.³⁵³  A 2002 survey found that about "half of government facilities were not maintaining their storage space" in clean conditions, with "all trash removed, sturdy shelves in place, and boxes organized."³⁵⁴ Similarly, approximately "half of the government facilities did not have sufficient space for the existing commodities."³⁵⁵  The 2006 Value for Money Audit found that 7 health centers out of 81 visited had improper drug stores, suggesting that, nationally, approximately 2,388 health centers might lack proper drug storage facilities.³⁵⁶ Some health centers had dusty and unventilated storage areas.   Other centers had no separate storage areas; their personnel stored medicines in the same areas from which they dispensed them to patients.³⁵⁷  Apparently, health center personnel did not separate expired from unexpired drugs.³⁵⁸ These inadequate storage conditions apparently contributed to deterioration of essential drugs' quality, destruction, and theft. 

C.  Third-Party Donor Programs

Third-Party Donor Programs, including Global fund, AIDS Control Programme, Clinton Foundation, and Malaria Control Programme, donate large amounts of medicines to Uganda.   No national or international authority, however, has responsibility for ensuring that third party donor programs efficiently store and adequately distribute their own donated drugs.   Although NMS did not engage in planning or procuring third party drugs supplies, it accepted all consignments, even on very short notice.³⁵⁹  Out of the 13,000 square meter-storage space at NMS, NMS drugs occupy only 2000 meters – i.e., 15 percent.³⁶⁰   The fact that NMS utilized over 80 percent of its available space to store donor drugs increased the number and value of medicines likely expire in NMS stores.  The NMS statute did not give NMS authority to distribute third party drugs, donated or otherwise.  Unless third party donors specify to whom and where the NMS should deliver their medicines, the NMS cannot send them out, even to national health centers.   The General Manager of NMS Apollo, Newton Mwesigye, indicated that third party programs procured big volumes of short-lived drugs (including some the NMS already has), and then stored them for long periods  with the NMS.³⁶¹Apparently as a result, some donated drugs, especially essential medicines with a short shelf life, expired.³⁶² The NMS often informed donors that their drugs would soon expire, but too often the donors failed to respond in time to save the drugs.³⁶³  The increased number and volume of redundant stock at NMS, such as condoms, homepaks for malaria, and ARV oral dosage syrups, also led to high inventory holding costs and inaccurate procurement planning by NMS.  These problematic behaviors apparently contributed to the failure of significant amounts of donated life-saving medicines to reach people who desperately needed them.³⁶⁴  

MINI-CONCLUSION

Evidence that large numbers of people – lacking access to life saving drugs -- simply die from preventable diseases, underscored the inadequacy of Uganda's distribution chain for delivering essential medicines, the three most significant role occupants who contributed to this problem included: the NMS Staff and Management, health center personnel, and third party donor agencies. The NMS managers' and staff members' poor organization of procurement, storage and delivery of drugs contributed to stock outages at health centers, especially those in remote rural areas.  Health center personnel contributed by keeping inaccurate records of drug received and storing them in inappropriate facilities, aggravating stock outages and expiration of drugs before they reach patients who need them.   Finally, third party donor programs, while providing many essential drugs to Uganda, did not pay enough attention to their storage and distribution, so Ugandans too often receive them too late or not at all.

In the next Part, III, this report offers explanatory hypotheses, along with the limited evidence available, as to these three sets of role occupants' problematic behaviors' causes.  Ugandan experts, whose work experience makes them more familiar with Uganda realities, undoubtedly have access to more up-to-date relevant information.   That should enable them to revise and deepen the initial explanatory hypotheses provided here.

       
Alteration of the problematic behaviors of the NMS management and Staff, the health center personnel, and third party donor programs may require several specific bills.  To ensure those bills' design and drafting, this report proposes that the Ugandan Parliament enact a law to establish a Ugandan branch of the proposed EAC Health Commission.   The Ugandan branch should further analyze and design appropriate legislative solutions to transform the problematic behaviors of the NMS, local health centers, and third party programs for obtaining, storing and distributing affordable essential drugs.  While conducting research for evidence-based solutions to the problems of distributing medicines in Uganda, the proposed Ugandan Health Commission branch should simultaneously provide information for use in designing regional legislation to improve the distribution of medicines to those in need – especially the poor and vulnerable -- throughout the East African region.

This Part IV first reviews several logically possible alternative solutions for overcoming the difficulties of ensuring timely and efficient distribution of medicines; describes how its proposed solution, the establishment of a Ugandan branch of the proposed regional Agency on Health, will work; shows that the social and economic benefits of implementing it will likely outweigh the social and economic costs; and, finally, suggests a monitoring and evaluation mechanism to enable those whom the law affects – especially the poor and vulnerable – to participate in assessing its implementation and social impact.

A.    Alternative Potential Proposals

To determine the most appropriate legislative solution for the inadequate distribution of medicines, drafters should consider the range of logically possible alternatives.  As one alternative, they might decide not to draft a bill, leaving in tact the current state of affairs.  While this solution might save the cost of making changes now, in the long run it would likely aggravate the social costs, not only to many individual Ugandans, but to the nation as a whole, likely to result from the loss of essential medicines.  By apparently ignoring its responsibility for fulfilling the people's basic needs – in this case, access to essential life-saving medicines – the government itself may lose legitimacy.
   
As a second alternative, UA drafters might incorporate detailed provisions to alter the existing problematic behaviors of the NMS, health center personnel, and third party donors in an overarching new law. While separate national rules ultimately will probably prove necessary to deal with specific national problems in drugs distribution, however, experience suggests that any attempt to incorporate them into one huge bill will not likely help to improve the drug distribution chain.   For a law to prove effective, its detailed provisions should focus narrowly on changing one or two sets of behaviors that contribute to the targeted social problem.  An effort to draft a large bill, with multiple sections aimed at changing several sets of role occupants' behaviors will require a great deal of disparate kinds of evidence; and probably prove difficult – if not impossible – to design, enact, and implement. 

As a third alternative, Ugandan drafting teams could create an independent Ugandan Agency tasked with gathering evidence required to compile adequate research reports to justify the detailed provisions of separate laws (parliamentary acts, agency regulations, perhaps even municipal ordinances), designed to change the problematic behaviors of the NMS (managers and Staff), the health center personnel, and third party donor agency staff.  While an independent Agency might facilitate somewhat better use of Uganda's medical resources, it might lose the potential benefits of cooperation with its neighboring EAC countries made possible by participating in the proposed EAC Health Commission.   In key areas – like training of health and logistics workers, and taking advantage of economies of scale in the use of regional personnel and medical resources to improve all East Africans' access to efficient, effective medicines – Ugandans might reap greater benefits from cooperating closely with the proposed regional Health Agency.  Uganda and its neighbors might benefit significantly from cooperating to import, and eventually – given its significant regional market – to manufacture medicines, as well as improving communications technologies essential for efficient distribution and storage in remote rural areas.

This review of alternative possible solutions suggests that, as the best solution, Ugandan drafters might draft a bill's detailed provisions to create a Ugandan Agency (UA) as a branch of the proposed EAC Health Commission.   The UA could set up sub-committees tasked with researching and creating detailed regulations to change the problematic behaviors of each relevant set of actors: The NMS, health center personnel, and donor agencies' representatives.

B. Designing the details of a Ugandan Health Agency as a branch of the EAC Health Commission proposed by the EAC Summit in 2007

To establish a Ugandan Agency as a branch of the proposed EAC Health Commission, the proposed bill must detail the Agency (UA)'s structure, authority, and proposed objectives.  As the Ugandan legislature' policy-making body, the bill must grant the Agency specified powers, and impose rules that, as far as possible, insulate it from politics.  The bill must specify criteria and procedures by which the Agency conducts research and drafts proposed regulations which prove participatory, transparent, and accountable. The Agency must present each draft regulation, justified by a research report structured by legislative theory's problem-solving methodology.  The Agency should submit each regulation to the Ugandan Legislature for review.  The Agency should accompany each regulation with a research report, published through the media and available to stake holders and concerned non-government organizations.  That report should provide evidence to demonstrate that the proposed regulation will likely prove effectively implemented and help to resolve the targeted social problem.   Unless the Legislature, within a month, by majority vote, decides otherwise, the Agency will proceed to put the regulation into effect.  

The Agency governing board and drafting team members must represent interests of all those whom the proposed regulation will likely affect.  Taking into consideration nominees from other governmental agencies (including the NDA and NMS) and concerned civil society organizations, the Minister of Health will appoint a health professional, preferably from the MoH, as the Agency Director.  Subject to approval by the Ugandan Legislature, the Director will appoint members of the Agency's governing board, representing different interest groups, for a term of ___ years.  The Director will publish the reasons for each individual member's appointment   The Agency Board members will include at least one person each from the NDA and NMS since they comprise integral components of Uganda's distribution chain for medicines.  They will include:

• Representatives from both the NMS management and staff who have access to  information essential for drafting regulations that affect the storage and recording of medicines at national, district, and local health facilities.  
• Representatives from civil society groups which work on health issues on a  community level who will help to ensure that the distribution chain serves all Ugandans' interests, especially poor in rural areas. 
• Health professionals from Ugandan health institutions and universities who may coordinate, and, as necessary initiate new efforts, to conduct research and gather the relevant evidence required to justify specific UA draft regulations.
  [The next section of this report suggests the kinds of further research needed to design detailed regulations likely to help resolve problematic behaviors described in this report's first three parts.]  
• Representatives from the health districts, sub-districts, and health center levels  I-IV because many of the regulations the UA must draft will directly affect their procedures and current practices. 
• Representatives of third party donor programs, like the Global Fund and USAID who may provide useful suggestions relating to sources of funds and other developing countries' experiences with distributing medicines.⁴⁰³  

Agency board members will meet regularly to ensure efficient and appropriate implementation of the Agency's responsibilities.  Initially, the Agency board may have to meet once a week. Once the members have established its presence and decision-making procedures, however, they may meet less frequently.  The Agency will appoint drafting teams, composed of members with expertise in legislative drafting and knowledge of the problematic behaviors that hinder effective distribution of available medicines to all Ugandans.  Each team that drafts a regulation will accompany it by a research report that provides the facts, logically organized, to demonstrate the likelihood that the regulation's detailed provisions will prove effectively implemented and help to achieve the desired social impact.  The law establishing the Agency will require its board to appoint a subcommittee with responsibility for monitoring, evaluating, and publishing an annual written report for the legislature and civil society, describing how each drafting team completed its task of drafting regulations accompanied by well-designed research reports.

All decisions and actions of the Agency must prove transparent and accountable.  The Agency will make all decisions by a majority vote.   Only in specified instances, for specified reasons, may the director overrule their decisions.  The requirement of majority approval helps to ensure that no single member may exercise more power than any other.   More than that:  The proposed Agency establishment law's requirement that a research report justify each regulation's detailed provisions will serve as a quality control to ensure that each teams' members ground their decisions on reason informed by experience: the available evidence, logically organized. 

All members of the Agency will review all draft research reports and regulations before submitting them to the Ugandan Legislature.  In the interest of transparency, on request, the Agency will hold town hall meetings and open forums in easily accessible locations to discuss with all interested parties proposed regulations and associated research reports, as well as other Agency activities.  The Agency will publish annual reports that detail work done each year, including UA members appointed, decisions made, research performed, regulations drafted,  funds allocated, and the conclusions of UA monitoring and evaluation procedures.  The Minister of Health will appoint an independent auditor to review the UA's annual reports to ensure the use of appropriate criteria and procedures in making all decisions as specified in the law establishing the UA itself.

The UA Director will coordinate the UA's cooperation with the EAC Agency regarding the implications of research, drafting and implementing regulations specific to Uganda for possible formulation of regional level legislative projects. Training of NMS Staff and management, health center (all levels) personnel regarding logistics management, record keeping, storage procedures, and delivery schedules and timetables seem potentially important areas for UA-EAC Agency cooperation.     

In sum, the detailed provisions of the UA bill will focus on making sure that the Ugandan Agency functions efficiently, in a transparent, accountable, and participatory manner to draft regulations, justified by adequate research reports, to improve the distribution of essential medications to all Ugandans – including the poor and vulnerable majority, especially those living in rural areas.

C.  How the proposed bill addresses the causes of the behaviors that contribute to the specific problems that hinder efficient delivery of essential medicines to all Ugandans?

For the proposed UA bill to ensure the drafting of effectively implemented regulations to improve distribution of medicines in Uganda, its detailed provisions must alter or eliminate the causes of each set of role occupants' problematic behaviors.  Using the ROCCIPI agenda, this section suggests (1) additional research to gather evidence needed to analyze in more detail the interrelated causes of the problematic behaviors of the NMS managers and staff; local health facility personnel; and third party donor agency representatives; and (2) those analyses' implications for the criteria and procedures required to draft each one of a series of regulations' detailed provisions.  In that sense, this section suggests a research agenda for a Ugandan Health Agency drafting team to follow in drafting regulations, justified by a research report, to facilitate the distribution of efficient, effective medicines to all Ugandans.  

1.   NMS Staff and Management

NMS managers and staff must work closely with health facility personnel at all levels to ensure that they all carry out their responsibilities in distributing, recording, and storing medicines.  This section of this research report, IV-D, first reviews all the explanations suggested by the ROCCIPI categories in Part II; and then suggests possible regulatory measures to improve their work together.   It will then review possible additional causes of Health Center Personnel as a basis for suggesting regulations which UA teams might draft to alter or eliminate those causes.

Rule:   A UA drafting team needs to obtain and assess evidence to discover the influence of the stock management rules for NMS drug management policies and procedures on the NMS managers' and staff's problematic behaviors.  The NMS statute gives the NMS Management Committee authority to create an Operations Manual, but the drafting team may need to draft additional guidelines for monitoring and ensuring that NMS staff members, at every level, effectively implement their responsibilities.⁴⁰⁴  The team should obtain the NMS standard procedures and schedules for drug delivery, and assess whether they adequately specify who must do what to achieve the order and delivery date deadlines.  The team should update the 2003 DELIVER assessment⁴⁰⁵ of the cost of direct distribution to the health sub-districts (as opposed to delivering to the districts and requiring the HSDs to pick them up for distribution to the individual health centers)   Depending on the findings of the additional research, the team may need to rewrite the current delivery schedules and procedures.
                         
Opportunity:  Based on the new evidence as to the current NMS management's enforcement of the stock management guidelines, delivery schedules, and policies, the drafting team might consider drafting a regulation to establish a detailed mechanism for monitoring and punishing violators to ensure staff members follow the rules.

Capacity: The team needs additional information regarding the adequacy of the skill levels and current training procedures for NMS managers.  The team should gather evidence as to the existing staffs' skills and the adequacy of the current training procedures at all levels of the health facilities (i.e., district, HSD, village, etc.). The team should explore whether Uganda's NMS and health center personnel training in stock management and logistics might benefit if the UA cooperated with other EAC member states through the proposed EAC Health Agency.  The UA should join the EAC Health Agency in considering, given all the member countries' training needs, whether to establish a comprehensive regional training program to enable all the countries' distribution programs to benefit from (1) one or two member states' existing training staff and facilities; and (2) taking advantage of potential economies of scale by sharing personnel and financial costs to improve the regional training program and facilities.  Whether the UA establishes its own training program, or cooperates with other EAC members states through the EAC Health Agency, the drafting team might evaluate the potential benefits of Ugandan's DELIVER project's experiences.⁴⁰⁶  The drafting team should gather evidence about the existing distribution infrastructure (i.e., roads, trains, vehicles, etc.) and all storage facilities, especially at village health centers.  This could lay a basis in facts for designing a regulation to help to overcome further institutional obstacles to improving the distribution of medicines throughout Uganda.

Communication:  To determine whether the managers and staff personnel fully understand and attempt to follow the existing rules, the drafting team should examine the available evidence as to the extent and impact of NMS efforts to distribute information about the existing NMS Statute, the Operations Manual, and the staff delivery schedules and policies.  The team should also gather facts to assess utility of communicating the delivery schedules to the districts, HSDs, and village health centers.  If the evidence indicates that the existing means of communicating the relevant rules to NMS managers and staff personnel regarding stock management and delivery schedules prove insufficient, the team should design new regulations to ensure the district, HSD, and village health center personnel do understand the rules.  Only then can they prepare to accept, unload and safely store drugs as and when delivered.  If existing means of communication prove insufficient, the NMS managers might explore the potential cost-benefits of using solar powered Internet facilities, perhaps in coordination with other EAC member states' health officials.

Interest:  The drafting team should gather data on the actual salaries received by NMS managers and staff members as a basis for possible improvements to provide them with greater incentives to do their jobs properly.  If, as widely perceived, some NMS personnel consciously mismanage drugs in order to help conceal their own efforts to profit by selling them illegally, the team should design new regulations likely to increase the likelihood of detecting and punishing those kinds of corrupt behaviors.

Process:  The drafting team should gather additional information as to the actual decision making processes of the NMS Management, especially the extent to which that process appears non-transparent, unaccountable, and non-participatory.  The UA bill should require drafters to propose regulations likely to ensure open and transparent decision-making processes within all levels of NMS management, from the national NMS leadership to every district and village center.   In particular, those regulations should specify the criteria and procedures by which the managers of every NMS facility must provide the facts and reasons for their decisions about how to store and distribute medicines to their employees, the Ministry of Health, and the public in general – especially to the particular communities they serve. The regulations should encourage those affected by those decisions to make comments and suggestions for improvement.

Ideology:  The belief that corrupt behavior remains widespread affects not only health care, but many other sectors in Uganda and the developing world.  The UA bill should provide for a Corruption Unit within the Agency, itself.   That Unit should focus solely on gathering evidence as to the extent of corruption within the NMS and the drugs distribution chain as well as health centers at all levels; and formulating solutions likely to alter or eliminate the causes of MNS managers' and staff members' corrupt behaviors.⁴⁰⁷  In particular, the UA Corruption Unit should propose regulations for on-the job as well as formal training to reduce the factors likely to influence health center personnel's efforts to engage in corrupt activities: their opportunities, capacity, incentives, and ideological factors (i.e., their beliefs and values)    Training at national, district and local level should include components to help for NMS personnel understand the impact of corruption, not only on those needing medicines, but on the entire health care system – which impacts their own lives; and, through specific measures to encourage individual staff or community members to expose corrupt behaviors whatever form they take.  For this purpose, the UA bill should require that every regulation relating to the distribution and storage of medicines at the NMS and health centers:

• incorporate decision-making processes that remain open to public view, facilitating efforts of concerned citizens to expose corrupt behaviors;
• screening processes to select honest and capable employees;
• effective auditing systems to detect possible circumstances likely to facilitate corrupt behaviors;
• provide rewards for anyone (i.e. a 'whistle blower')  who exposes corruption; and
• increase penalties for corruption (larger financial fines, transfers, publicity, blackballing).⁴⁰⁸

2. Health Center Personnel

Since the section on NMS and Health Center Personnel suggests regulations that might help to alter or eliminate some causes of the Health Center personnel's problematic behaviors, this section will only discuss possible regulations likely to overcome additional causes suggested by the ROCCIPI categories, Rule, Interest, and Process.

Rule:  A team should further investigate the PPDA Act to determine whether the rule as written seems sufficiently clear to ensure that personnel at every health center throughout Uganda keep useful records of the drugs they receive, and store them in ways likely to ensure they remain effective as long as possible.  Depending on their findings, the drafting team could write regulations that prescribe in more detail what a center's personnel must do to keep accurate records; to establish a monitoring and feedback mechanism; and to ensure effective implementation of the entire system.  The drafting team may wish to review the DELIVER project's manual for ideas as to ways to improve drug stock management procedures.⁴⁰⁹ The team should review the existing NMS rules relating to minimum storage criteria and procedures to ensure they prove sufficiently clear and precise.  To reduce the instances of expired drugs, the team may draft regulations to encourage health centers to exchange drugs, as necessary, amongst themselves.⁴¹⁰ 

Interest: The drafting team should attempt to gather additional data regarding the extent to which most health center personnel seem interested in properly recording and storing drugs to ensure effective distribution.  The extent to which any health centers personnel seem to have an interest – as the relevant literature suggests – in maintaining inadequate records and improper storage to facilitate their efforts to profit misappropriating medicines.  To the extent that the evidence warrants it, the team may wish to draft regulations that make it more difficult to behave corruptly (see suggestions above relating to Ideology as a possible cause of corrupt behaviors of NMS and Health Center Personnel).⁴¹¹

Process:  The drafting team should conduct further research as to the processes of keeping records and implementation of drug storage rules to
determine the extent to which these seem transparent, accountable, and participatory.  The UA bill should include provisions for regulations to make sure that the health center personnel's decision-making processes require informing all the staff members, as well as community representatives,  of the facts and reasons that underpin their decisions. That should enable the center managers to draw on the experiences of those involved to design measures more likely to make record-keeping and storage measures more effective.

3. Third Party Donor Agency Officials

Rule:  A team needs to gather more information regarding the rules that govern the distribution of third party donated drugs.  That team may recommend a bill either (1) to amend the current NMS statute, giving the NMS authority to distribute third party donated drugs, or (2) to create a new statute that provides clear, detailed rules requiring third party donors to cooperate more closely with the NMS to ensure the timely distribution of donated drugs.

Opportunity:  Since third party donor agencies' behaviors do not in general fall under the Ugandan government's jurisdiction, the drafting team may simply have to gather information regarding this distribution problem which the NMS managers can present to third party donor agencies to request their cooperation in resolving the problem.  Perhaps the NMS can then reach an agreement with each agency's representatives to adjust their policies and procedures to help provide a mutually beneficial solution.

Capacity:  The research team should gather additional information regarding the capacity of third party donor agencies to effectively distribute donated drugs.  As a minimum, UA could present the results of the team's findings to the donor agency representatives, and suggest that they cooperate to improve their current practices, either by (1) storing and distributing the medicines themselves; or (2) explicitly requesting that the NMS not only store but also to disburse the medicines according to specified criteria and procedures.

Communication:  The relevant UA drafting team needs to gather additional evidence and data regarding the existing forms of communication between the NMS and third party donor agency representatives.  On that basis, the team might develop a regulation to facilitate ongoing communication between the relevant NMS and third party donor personnel to ensure more timely distribution leading to fewer expired drugs.  The UA might present the regulation, accompanied by a well-constructed research report, to third party donor representatives, requesting their willingness to help ensure their staffs would contribute to its effective implementation.  The UA might request donor agency assistance in financing solar-power Internet facilities to improve communication with the NMS and the local drugs stores and health centers.

Interest:  Donor agency officials have expressed interest in ensuring developing country inhabitants have adequate access to medicines.  Some donor agency officials, however, seem to have an interest in publicizing their role in getting medicines to the countries, rather than in ensuring their effective distribution and use. Some have little interest in the actual distribution of those medicines equitably to all the countries' inhabitants.  The drafting team might suggest that UA and donor agency representatives meet to discuss possible UA regulations likely to increase donor agency staff's interest in cooperating with the NMS and health care centers to improve the timely distribution of donated medicines to all who need them.

Process:  The drafting team might work with third party donor agency officials to change the current rules that prohibit the NMS from disbursing donated drugs without the donor agency instructions.  If third party donors want to retain control of where, when and how donated drugs get distributed, then perhaps joint NMS-donor agencies discussions could agree on regulations to improve the current procedures and make donor agency representatives accountable for the consequences of failures to distribute drugs.  The current decision-making process does not appear participatory.   Not even the NMS managers, far less either health center personnel or civil society organizations concerned with patient access to medicines, seem to have participated in making the existing distribution rules.  That suggests the necessity, as a minimum, of providing for a new decision-making process that ensures direct inputs from the NMS and local health center and drug store managers.  In addition, the UA bill might require inputs into the relevant decision-making processes from representatives of the employees engaged in record-keeping and storing medicines, as well as the civil society organizations which seek to improve all Ugandans' access to essential medicines.

Ideology:  Donor agency representatives probably do believe their agency should contribute to making medicines available to country nationals although a UA team might undertake further investigation of the relevant evidence.  Nevertheless, donor representatives may differ about the role of country nationals and civil society organizations (public or private) in distributing and providing feedback about the medicines they provide.

In sum, a review of the existing causes of the problematic behaviors of the three relevant sets of role occupants – the NMS mangers and staff, the health center personnel, and the donor representatives – suggests that a bill to establish a Ugandan Agency could contribute significantly to improving the present status of law as it affects the existing system of drug distribution.

D.  Weighing the bill's costs and benefits

1.   Estimating the economic costs and benefits

The actual economic costs and benefits of the proposed UA bill remain difficult to determine.  Little relevant quantitative data exists.   Creating the UA seems like to prove costly, especially in terms of conducting the necessary research and drafting detailed regulations.  To mitigate the economic costs, the Ugandan government could solicit funds from donor agencies like USAID and the Global Fund.
 
Over time, the UA's role in improving the distribution of medicines should provide significant economic benefits.   A more efficient distribution system will save money in the form of reduced expired and redundant procurement of drugs.  The limited delivery resources (i.e. vehicles and personnel) will prove more efficiently used, lowering the costs of fuel and salaries.  As the distribution system grows more transparent, donor agencies' growing confidence in Uganda's improved distribution and use of donated drugs may increase may lead to greater contributions. 

2.  Non-Quantifiable social costs and benefits

The non-quantifiable social benefits of creating the UA to improve the distribution of medicine to the Ugandan population will likely prove significant, justifying the economic costs.  The UA will ensure better distribution of essential medicines to all Ugandans, a human right justifiably claimed for every individual.   No social costs seem likely to result.  Some critics may fear that this bill may reduce wealthy urban dwellers' access to medicines, but, in reality, the UA should improve the efficiency in the distribution of drugs to both rural and urban Ugandans.  Beyond that, the Ugandan Agency's success could foster improved health care, not only in Uganda, but also in East Africa.

3.  Social impact statement: the UA's potential impact on different social groups, especially the valued but poorly represented majority

The proposed UA, however, will likely impact the lives of rural Ugandans – the poorest sector of the population – the most.   The UA will improve distribution of essential drugs overall, but especially in rural areas which are often times remote and hard to reach, reducing the poor majority's physical and financial costs in accessing effective, efficient medicines.  Basic health care should not remain a luxury for the wealthy few, but a human right to which every Ugandan citizen has access.

E.Monitoring Performance

To ensure adequate monitoring and evaluation of the proposed Ugandan branch of the EAC Agency, the UA bill should require monthly status reports of the drafting teams' progress to all UA board members.   Board meetings should schedule regular meetings to give the drafting teams' representatives an opportunity to report on what their teams have accomplished, the problems encountered, and the anticipated timeline for completion of their tasks.  In addition, each proposed regulation must include a monitoring and evaluation mechanism to ensure the bill's effective implementation and desired social impact.

Chapter 4: Reforming Drug... Chapter 4: Reforming Drug Registration Practices In the East African Community Chapter 6: Strengthening Rural... Chapter 6: Strengthening Rural Health Care in East Africa