1

Managing procurement and logistics of HIV/AIDS

Drugs and Related Supplies

Report of a Regional Training Workshop

Nicon Hilton, Abuja, Nigeria May 30- June 4 2005

Organized by the World Bank, Nigeria Office In collaboration with World Health Organisation (WHO), Global Fund, MSH, JSI/DELIIVER and ESTHER

With support from the National Action Committee on AIDS (NACA)

2

CONTENT

COLLABORATORS................................................................................. 3

EXECUTIVE SUMMARY ........ERROR! BOOKMARK NOT DEFINED.

ACKNOWLEDGEMENTS....... ERROR! BOOKMARK NOT DEFINED.

GLOSSARY OF TERMS ........... ERROR! BOOKMARK NOT DEFINED.

BACKGROUND ........................ ERROR! BOOKMARK NOT DEFINED.

THE CONSULTATION...........ERROR! BOOKMARK NOT DEFINED.

PRESENTATIONS................10ERROR! BOOKMARK NOT DEFINED.

CONCLUSIONS AND RECOMMENDATIONSERROR! BOOKMARK

NOT DEFINED.

PARTICIPANTS ....................... ERROR! BOOKMARK NOT DEFINED.

VIEWS ABOUT THE STANDARD AND QUALITY OF THE

MEETING..................................................................................................

3

PARTNERS

Wolrd Bank Institute Secretariat:

Tel: Email: Web:

National Action Committee on AIDS (NACA) The Presidency, Plot 823 Ralph Shodeinde Street

Central Business District, Abuja Website: www.naca.gov.ng

Global Funds Address: Website:

MSH Website: www.global-campaign.org

JSI/DELIVER

ESTHER

4

I EXECUTIVE SUMMARY Ninety eight participants representing a wide range of personnel involved with procurement of drugs from various countries in Africa met at the Nicon Hilton Hotel, Abuja on June 1 through to 4 2005, at a Regional training workshop on Managing procurement and logistics of HIV/AIDS Drugs and Related Supplies. The training workshop meeting was focused at improving country’s capacity to provide effective procurement and logistic systems for HIV/AIDS drugs and related supplies. The meeting was organized by the World Bank Institute in collaboration with the National Action Committee on AIDS (NACA), Global Funds, ESTHER, JSI/DELIVER and MSH. Key issues discussed by participants during the five and a half days programme which was divided in to 13 sessions include: intellectual property rights, financing and pricing, pharmaceutical systems, product selection and quantification, quality assurance, procurement planning and management, supply chain management and rational drug use. There were also sessions dedicated to sharing lessons learnt from countries experiences and country practices. The meeting was facilitated through a participatory learning approach with a lot of in session deliberations, brainstorming and group works At the end of the meeting, participants acknowledged that there was a lot of learning with respect to issues related to monitoring and evaluation, drug costs, planning for space management and stores safety for expanded programmes, human resources needed, local production of ARV, Federal and State government partnership on ART, nutrition and ART and how to address political challenges ART programmes may face. In addition, the World Bank Institute appreciated the positive effect of the multidisciplinary participation at the workshop as different experiences come to bear on learning thereby enriching discussions. Three countries developed their country procurement plans. All participants also agreed to facilitate further discussions on procurement planning and supplies through a created listserv while Global Fund representative gave his word that his organization would look into the possibility of facilitating open access to information on ARV drug cost o their website.

5

II ACKNOWLEDGEMENT

6

III GLOSSARY OF TERMS • AIDS Acquired Immune Deficiency Syndrome

• ARV Antiretroviral

• DELIVER

• DOHA

• ESTHER

• FDA Federal drug Agency

• GHAINS

• HIV Human Immunodeficiency Virus

• IPR Intellectual Property Rights

• JSI

• NACA National Action Committee on AIDS

• OI Opportunistic Infection

• PLWAs People Living with HIV/AIDS

• PSM Procurement and supply management

• SOC Standard of Care

• SOP Standard of Practice

• TRIPS

• WHO World Health Organisation

• WTO World Trade Organisation

7

IV BACKGROUND The sub-Saharan Africa is the most burdened by the HIV epidemic. It presently homes over 70% of the entire global HIV infection burden. Unfortunately, the region is also poorly equipped in terms of financial resources, to effectively handle the disease burden. One of the efforts taken by many African nations has been to roll out national programmes which provide drugs to HIV infected patients in addition to other efforts directed at ensure continuous prevention. These government efforts has also been supplemented by donor programmes and funding grants. Unfortunately, antiretroviral drugs are complicated to administer, require close medical monitoring, significant side effects and could lead to the emergence of resistant viruses. Not only are there patient level problems associated with ARV use, there are equally government level challenges with procurement of HIV medicines and related supplies. These problems range from financing and pricing to quality assurance, selection and quantification and human and infrastructure capacity. There is therefore an identified need for training programmes for relevant stakeholders in developing countries to improve the quality, efficiency and transparency of drug procurements for the treatment of HIV/AIDS. This could be achieved by increasing local capacity in key areas associated with the supply circle. In view of these, the World Bank Institute in collaboration with the National Action Committee on AIDS in Nigeria, WHO, Global Fund, MSI, MSF, JSI/DELVER and ESTHER organized a five and a half days workshop for relevant stakeholders involved with drug procurement in African states. The workshop tried to address some of these issues.

8

V CONSULTATION The consultative meeting themed Managing Procurement and Logistics of HIV/AIDS Drugs and related Supplies held at the Nicon Hilton Hotel, Abuja Nigeria on May 30-June 4 2005.The meeting which was organized by the World Bank, Nigeria in consultation with WHO, Global Fund, MSH, MSI, JIS/DELIVER, ESTHER with support from NACA, is part series of training by the World Bank Institute to help facilitate the establishment of an effective HIV/AIDS drugs and related supplies procurement and logistic system. Invitees to the meeting included all Procurement officers of all ARV centres in Nigeria, and personnel involved with HIV/AIDS drugs and related supplies. AIM: To improve countrys’ capacity to provide effective procurement and logistic systems for HIV/AIDS drugs and related supplies. OBJECTIVES: To enhance the capacity of program implementers in PSM, to provide a forum for sharing of experiences amongst participating countries and to address capacity building issues relating to PSM at country level PROCESS: Consultants discussed on various issues that would enhance the effectiveness of drug procurements within countries and within institutions. There were group discussions and deliberations on the various international, regional and intra-country mechanisms that need to be addressed to facilitate the procurement and supply mechanisms for ARV and related items. Case studies were taken to facilitate participants’ understanding of issues. The whole process took a problem based learning approach and was facilitated as a highly interactive process which allows for lesson sharing and networking. The five and a half days meeting was facilitated by a team of 10 consultants and 2 personnel from the World Bank Institute. There were 98 participants from various African countries in attendance. EXPECTED OUTCOMES: Revision of participants' country PSM plans where applicable, identification of capacity building and technical assistance needs of participating countries and possible formulation of practical solutions to address implementation challenges PARTICIPANTS’ EXPECTATIONS: Prioritization • Learn how to respond to political and social demand of ART in resource-poor settings. • Learn how to establish eligibility criteria for patients where there is a limited supply of

ARVs Capacity Building • Supply chain management • Procurement • Quality assurance

9

• Forecasting • Intellectual property rights • Training other implementers Access to Resources • To establish linkages that will assist in the provision of ARVs to the poor • Improve ability to access available funds for the management of PLWHA Comprehensive Care • Learn how to implement HIV testing literacy and ARV treatment literacy. • Discuss how to address stigmatization and discrimination against people on ARVs • Nutritional support Pricing • Sourcing quality HIV/AIDS drugs at affordable price. • Acquire knowledge about the best prices of HIV/AIDS drugs and related products and

their sources. Policy and Advocacy • How to educate policy makers in order to evolve favorable procurement and logistics

policies for medicines and supplies. • How to navigate beaurocracy Partnerships • How to form partnerships which use economies of scale for joint procurement of

medicines and supplies. • Share experiences on procurement successes from other countries. • To enhance public and private sector collaboration in the provision of ARVS. • Stakeholder collaboration • Networking Clinical/Therapeutic • Understand the selection of appropriate laboratory equipment for ART monitoring. • Share country experiences on monitoring the development of resistance to ARVs. • Management of resistant cases. • Learn about the rational use of ARVs Next Steps • Sustainability • Finalization of PSM plans • Determining what TA is needed for implementation OUTCOMES: At the end of the meeting, participants acknowledged that there was a lot of learning with respect to issues related to monitoring and evaluation, drug costs, planning for

10

space management and stores safety or expanded programmes, human resources needed, local production of ARV, Federal and State government partnership on ART, nutrition and ART and addresses political challenges to drug procurement. Three countries developed their country procurement plans. Finally, all participants agreed to facilitate further discussions on procurement planning and supplies through a created listserv while the Global Fund representative gave his words plans that his organization would look into the possibility of facilitating open access to information on ARV drug cost o their website.

11

VII PRESENTATIONS Session1. Priority Setting and Effectiveness - Patrick Osewe Necessary considerations to be taken when prioritizing programme for care and support include issues related to ethics and human rights wherein there is a need to balance justice, equity and fairness; demand as a driving force for priority planning; biomedical needs; acceptability; political pressure as the driving force for setting up a national ARV agenda; and economic analysis. While ARV is important for improving the quality of lives of PLWA, equally important are palliative care, prophylaxis and treatment for opportunistic infections. These elements are equally expensive and therefore require prioritization in view of limited funding and also other pressing health and social needs. When setting priorities, it is important to determine the criteria for selecting populations that can access ARV in view of limited drug supplies relative to actual needs. The prioritizing criteria may vary from country to country – countries with low HIV prevalence may think about prioritizing access to people with high risk behaviour while countries with a generalized epidemic may think about ensuring access on a first come first serve basis. To ensure effectiveness of ARV programme, it is equally important to incorporate prevention into treatment programme so as to ensure the uninfected population stays uninfected and those on treatment do not indulge in risky behaviour. It is equally important to reduce the tendency for resistance development to drug, reduce side effects from drug use and over reliance on ARV as management option for HIV infection. While policies are important to guide ARV administration, the policies must address the level of treatment to be offered, the process to be followed in prioritization, those who will be prioritised for treatment, the potential adverse effects and how those side-effects can be mitigated against. Shared country experiences Nigeria – the country ARV programme was initially driven by political motives and interest. ARV drugs were imported from India and this was pilot tested in 25 centres in the country. While there were political considerations in site selection, patients’ access to drugs is based on medical criteria (upper and lower limits of CD4 count) as defined by the national guideline on ARV use. Stigma was an initial limiting factor for person to access service. This has improved over time. Uganda – the country treatment programme has evolved from a single regimen to a triple combination over the last 14 years. The programme ensures there are human and institutional capacities to faciliatate access by all those who can afford treatment. However, for the donor supported programmes which are free, priority is given to vulnerable orphans and their carers, pregnant women and destitute children Tanzania – the ARV programme started in 2004 with central harmonization of treatment programme. The national government decides on treatment sites with target been 4,200 patients and priority given to those who are ill. The programme is free with involvement of both the public and private sectors Zimbabwe – the ARV roll out programme started in 2002 following an assessment programme to determine which facilities have the right human and infrastructural facilities to implement programme. Five pilot sites were chosen and plans are on to scale up the sites to 20. The governmenr programme is presently subsidized though the donor programmes are offered free

12

GHAINS project Nigeria – there was an initial site assessment at the preparatory stage. There was a checklist to assess institutional capacity to implement ARV programming. This included laboratory capacity, pharmacy competency and provision of VCCT. The 12 facilities in 6 states selected for drug treatment were based on the competency of sites to implement programme. The programme offers treatment to 8,000 persons. Support to the programme comes from PEPFAR Gambia – clients place on the ARV treatment programme in the Gambia are selected by an eligibility committee which comprises of doctors, pharmacists, nurses, counselors, lawyers and lay community members. Clients are screened based on a list of criteria adapted from the WHO guideline Session2. Intellectual Property Rights - Aitangcho Akonumbo Intellectual property right is a fundamental human right just as the right to health. The WTO TRIPS is one of the international rules governing intellectual property rights (IPR). The IPR is an avenue by which governments and supply agencies can obtain quality low-priced, safe, and effective HIV/AIDS medicines lawfully and surmount obstacles created by patents. The TRIPS define the minimum standard of agreement for member states as well as issues related to patenting, obligation to disclose information, trademark/trade name and copyright. There were identified obstacles the IPR creates to drug access with respect to patenting, disclosure of information, trademarks and copyrights - for developing nations, government and supply agencies worry over the increase cost of products through patenting, prospect for monopoly and legitimate withholding of vital product related information - that IPR can create. The patent holders on the other hand worry about the ability of developing countries to enforce IPR systems and reduce piracy. Patenting may therefore create a barrier to public health for developing countries as this prevents the development of generics. In striking a balance, the flexibility of the TRIPS allow for parallel importation, compulsory licensing and a moratorium for enforcement of TRIPS agreement. The DOHA is a declaration which simply explained how the flexibilities of the TRIPS could be used effectively to ensure health for all. The document enhances the flexibility of the TRIPS for less developing countries. Question 1 - The USA used the compulsory licensing clause to produce drugs for the treatment of Anthrax and paid compensation to the Republic of Congo citing the state of emergency in the country as a basis for action. Answer – Yes, the USA did that in the face of a state of emergency. Ironically, the USA has been canvassing against the use of the compulsory licensing clause of the TRIPS and was therefore caught in the web of its own doing. USA was thereafter open to the development of the DOHA declaration. Question 2 – With the expiration of moratorium for developing countries, generics from India would reduce dramatically. Does this affect process or product or both? Answer – The IPR covers both. The moratorium would only affect generics produced after 2005. However, the TRIPS provide for mail box system thus allowing for patenting of drugs which were produced as generics before the expiration of the moratorium.

13

Questions 3 – With so much flexibility, why are countries not using the compulsory licensing clause of the TRIPS? Answer – There are a number of other political reasons why countries may not use the compulsory licensing clause of the TRIPS as a pressure tool for reduced pricing or for increasing country access. It is also more difficult to enforce when it involves a foreign firm. Question 4 – Can companies in India move their production plant to less developed countries to beat the moratorium on patenting? Answer – It is possible but that would be an unfair process. The TRIPS+ was also signed to attract investment into the signatory member nations. The process of such movements is quite cumbersome and may be unattractive economically. Question 5 – If a product is not patented in a country, are they bound by the TRIPS? Answer – No, they are not bound. However there are regional and cross country patent agreements that may enforce patenting agreements of drug in countries where such drugs are not patented directly. Question 6 – There are country differences in patent laws. For example in Kenya, generics can be used for trial but cannot be sold. Why these differences? Answer – This is a reflection of the agreements between the country and the manufacturers of the drugs. Extending the agreement beyond that stated is an infringement on the patent right. Session3. Group work: Brazil: A case study of the role of IPRs in the procurement of ARVs Case Study Question 1 (Group 1) What types of provisions should be built into the national legislative framework to take into account TRIPS flexibilities? Answer

- Declaration of a universal right to health - Enactment of a law declaring the treatment of HIV/AIDS and other pandemic

diseases a national emergency - Compulsory licensing and right to parallel importation

Case Study Question 2 (Group 2) Which of the TRIPS flexibilities has Brazil adopted in its national law? Answer

- Brazil guaranteed universal right to health through: - Use of compulsory licensing - Government domestication of the TRIPS - Regulatory review exception provision in the patent law

Case Study Question 3 Brazil has not adopted a rule authorizing parallel importation of medicines from abroad, except as a remedy for patent abuse or if the public interest requires it.

14

Answer - South Africa parallel import legislation authorises parallel importation - The South Africa had customised TRIPS to allow for parallel importation - The conditions imposed by South Africa are i. Duly approved by the Department of Health ii. Vendors of the drug must comply with the relevant laws on drugs in South

Africa iii. Get permit to use propriety name of drug iv. Adequate storage facilities v. Provision for recall procedure

Case Study Question 4 Compulsory licensing serves a number of functions. While the express purpose is to authorize a third party (other than the patent holder) to manufacture or import an invention (such as a medicine), it also serves other functions. Brazil has been very successful in using these other functions. What are they? Answer

- The country makes room for parallel importation - Eliminates the constraints of TRIPS to competition - Ensures affordability and accessibility of drugs - Cost saving measures were taken due to reduced hospitalisation - Ensures supply to domestic market

Session4. Financing and Pricing - Achal Prabhala The session focused on explaining the pricing and financing mechanisms for drug pricing especially with respect to ARV and how this affects supplies. There are tree types of market, three types of markets namely perfect competition, monopoly and monopolistic competition markets. There are also four key players in the market namely the manufactures, the wholesalers/distributors, the retailers and the Governmental & Non-Profit Sellers. Also in the market are the multinational innovative companies and the generic manufacturers. All these factors play a significant role in commodity pricing. Therefore the price of a commodity may vary within and across countries due to the roles these different factors play. There are however various instruments available to help countries derive the best pricing possible for commodities like ARV. These instruments include those related to international programmes like the Accelerated Access Initiative; legal remedies like compulsory licensing and voluntary licensing; and other remedies like bulk purchase, domestic production of ARVs and harvesting of donations. Question 1 – Why is it important to understand pricing and financing of ARV? Answers

– ARVs are costly – The main demand for ARVs are made by developing countries that cannot help

offset the cost of research and ensure profit which are necessary incentives for the pharmaceuticals

– ARV is for life and the cost implications for this has to be planned for

15

Question 2 - Why is pricing for ARV different from pricing of other drugs used for management of chronic diseases? Answers

- ARV is a palliative treatment and not cure - Management of ARV procurement and supplies entail a lot of ongoing logistics - There is a need to plan for sustainability of ARV drug supply to prevent

development of drug resistance, ensuring good pricing, and access by the poor. Question 3 – why the contrast in the pricing system of ARV and that of other drugs? Answers

- ARV is a new commodity and is not covered by patent laws presently allowing for relatively low pricing. However, years down the line when there would be increased demand for second line drugs, the patent laws would be applicable to ARVs and this has implications for pricing

- The cost of research is unknown to the consumers and so price determination by consumers is from a different perspective

- ARV is novel and in the present situation, only the rich can afford it to the detriment of the poor

Country experience with monopoly Nigeria – Novartis is the only company that produces AZT. The country had to go through WHO to secure reduced pricing otherwise the country would have had to purchase the drug at the high price in the open market. There was no place for competitive sourcing UNICEF – Monopolistic production also allow for stock outs as was the experience of UNICEF with stavudine. A single company produces stavudine and could therefore not cope with supply. Question 4 – Why is it important that ARVs and other HIV care packages are available in retail pharmacy? Answers

- This would ensure availability of the product at multiple points - It allows for alternative sourcing of the product by patients thereby preventing

possibility of stock out - It increases access of individuals to the drug through multiple sourcing options

(government vs private pharmacy) - The Public stocks are not available all nooks and crannys unlike the retail pharmacy.

Question 5 – Why is a strong public procurement framework important? Answers

- The public can buy in large quantity thereby reducing the price - The public has mechanisms to ensure quality control - The public sector handles most of the patients - There is a need for public/private sector partnership as this ensures that the two

sectors cater for the needs of different categories of patients. There would however be a need for coordination of activities of both sectors

- The public sector can cater for the needs of people who cannot afford the cost of drugs in the open market. The private sector can act to supplement the gap eg the

16

public sector cannot meet all the demands and they act as a fall back in case the public sector systems fail

Question 6 – Why should there be drug differential pricing between developed and developing countries? Answer - This allows for equity in pricing as prices should be determined by the country incomes. Presently, the pharmaceuticals are pressing for minimal differential pricing as this may affect their profits on branded in the developed countries in the long run. Strategies for ensuring price reductions for ARV include international programmes like the Accelerated Access Initiative; legal remedies like compulsory licensing and voluntary licencing; others like bulk purchase and drug donations.

Experience with Accelerated Access Initiative Usually the Access programmes ensure drugs are available at subsidized prices while with donor programmes, drugs are accessed free. Developing countries’ access to the initiative is usually difficult as benefiting countries are expected to provide documented evidence to ensure protection against product diversion/in country consumption. Developing countries often cannot meet up with the stringencies for such access and so often depend more on the public/private sector cooperations. In addition, the pricing of generics in the open market is less than that offered by the Accelerated Access Initiatives. Experience with drug donations

1. There is increasing demand on the need for countries to reflect donation programmes in the national budgets of governments. But how then do you determine the costs of these donations- at the pricing of the donor nation or the pricing of the recipients? How does this donation reflect in a national plan in the long term?

2. How do you manage drug donations because of its long term implications? Presently, competition and regulations are forcing manufacturers to reduce drug prices to the point of minimal profit. With donations, that profit would be wiped out and production of drug stopped. At the expiration of donation period, how then is supply ensured?

3. Donations should also be properly managed to prevent dumping. National criteria should exist as to what forms of donations should be received in a country.

Session 5. Case study: procurement of antiretrovirals medicine in South Africa Question 1a – Could the government effect cost saving measures if it were to buy 200mg efavirenz from the generic manufacturer? Answer – Yes Question 1b – What are the possible reasons why the government is not procuring lopinavir/ritonavir from a generic manufacturer? Answers

- the generic may not be registered in the country

17

- the manufacturing company may not be registered with the WHO pre-requisition exercise

- may be due to customs and tax costs which may inevitably increase the price of the generic

- the country may have negotiated a long term contractual pricing and may not be able to reniche on purchase orders despite lower pricing

- the generic manufacturer may not be able to meet the country demand - the generic manufacturer may not be able to deliver products on time

Question 1c – What are the possible reasons why the government is not procuring lopinavir/ritonavir from a generic manufacture? Answers

- because it was almost 3 time more expensive - the brander also produces syrup form of the product thereby increasing range of

supply Question 1d – There are only two suppliers producing lopinavir/ritonavir: what does the price difference between the companies indicate? Answer - Monopolistic competition where a manufacturer has the upper hand in the market. Because there are few suppliers, the range of price choice is also poor

Question 2a – Imagine for the year 1 of the ARV rollout, government has limited the budget for ARV procurement to $3,000,000 – and also, that everyone needs only be treated with Regimen 1b. All other things being equal, how many additional people can be treated with ARV medicines if government was to procure at best world prices instead of at the price reported on the previous page? Answers

- the number of patients to be treated would be doubled - the cost of drug has impact on the number of people that would have access to

treatment and thus, impact on public health Question 2b – Next, assuming that ARV price information is easily available and that the SA Government is aware of the suppliers quoting the lowest prices reported in this case study, what are the possible reasons why it is unable to buy from the lowest-quote suppliers as mentioned in the MSF pricing guide? Answers

- country patent law may not allow for availability of generics - the drug may not be registered in the country - the drug may not be a WHO pre-qualification registered drug - the procurement criteria as determined by the sponsor for the purchase is often the

guide for ensuring quality assurance especially for countries that do not have the capacity to conduct in country quality assessment

Comments It is important to note from this example that generic drug supply does not ultimately translate to reduce pricing. Pricing would depend a lot on the forces of demand and supply whether generic or branded

18

Question 3a – What options does a government have with regards to correcting market anomalies in the pricing of an essential medicine? Answers

- negotiation - compulsory licensing - bulk purchase - donation harvest - pool procurement - domestic production

Question 3b – In your opinion, would the availability of legal options to correct market anomalies have played a role in the patent-owning pharmaceutical companies having decided not to enforce patent exclusively and/or voluntarily licence generic manufacturers? Answer - With no compulsory licensing in the national law, generic drug manufacturing could not occur. The domestication of compulsory licensing clause acts as a pressure tool for price conformity Comments

1. It is advisable for the government to domesticate the TRIPS so as to have a leverage in bargaining

2. Drug manufacturers focus on maximising profit and so where there are no challenges, the process of maximising profit continues

Question 4 – Based on your anwers to question 3, and from the sole perspective of access to ARV medicines, what advice would you give the government of South Africa? Answers

- The government should lift the ban - Government should negotiate based on domestication of the TRIPS - Encourage local manufacture of drugs by providing incentives for manufacturer. But

there should be a system in place to ensure cost recovery. The place of political factors as a determinant of process can however not be ruled out

- The law should protect drug pricing by ensuring parallel trading and compulsory licensing

Session 6. Pharmaceutical Systems - Jabulani Nyenwa Drugs are specialised health commodities accounting for 50-90% of non personnel health system costs. Pharmaceuticals are also the second highest public health budget expenditure in most countries. This makes pharmaceutical systems important though complex. Pharmaceutical commodities are special commodities that help to preserve life. There are needs for a functional logistic cycle to help ensure that these health products reach the end users. The system can ensure uninterrupted supply of commodities through a framework known as the logistic cycle. While the logistic cycle ensures that the products get to the consumers, various determinants of access to these pharmaceuticals are equally important. These include research and development and national regulatory systems. Access to drugs is usually limited by government failure, income failure and income gap. One major cause of government failure includes corruption. Differential pricing also facilitates access to drugs. However, the politics of the market needs to be understood to ensure maximal benefit.

19

Country level actions can help ensure drug access. This includes the development of a national ARV plan Question 1 – What are pharmaceutical systems? Answer – They are systems put in place to ensure commodities are available to the end users. Question 2 – What are the key features outside the system that creates a positive enabling environment? Answer – The policy environment, legal framework and regulatory frameworks Question 3 – How does research and development affect the availability of commodity? Answers

- R&D is the initial point for drug development and these development further drives R&D with the aim of improving on products

- R&D is key to the production of drugs - R&D affects drug availability - Consumer needs and the prospect for sales drive R&D

Question 4 – How does national regulatory systems affect drug availability? Answers

- Bureaucracy may be an impediment to drug availability. When the drug registration process is long, then this delays the time for drug availability in the market

- Waiver systems may facilitate drug availability Comments

- There is a need to balance emergency needs to the need for sacrificing quality. Quality should not be sacrificed under any circumstance. Thus waivers should not be synonymous to importation of low quality drugs

- While fast tracking drug registration processes, it is equally important to ensure that systems are in place to ensure quality. In Zimbabwe, while the drug waiver clause exists in the national drug regulatory system, quality is ensured through recourse to the WHO pre-qualification listing. There is also a time limit for waivers (6 months) during which the drug company must get registered within the country.

- It is equally important that relevant stakeholders are involved in the enlisting of drugs on the country’s essential drug list as good professional judgment ensures the compilation of comprehensive list.

Question 5 – How does corruption affect drug access? Answers

- In the Nigerian experience, corruption causes unaccountable depletion of stocks from stores, allows for drugs to get missing in transit and gives room for counterfeiting. Measures have since been put in place to reduce these tendencies such as ensuring professionals man these offices; bulk drug purchases are done following due process; all procurement process are transparent.

- In Sierra Leone, any drug to be procured must have been registered with the Pharmacy Board in the country. The Board in turn is saddled with the responsibility of ensuring the quality of the registered drugs

20

Experience of Uganda Initially at the beginning of the ARV programme, branded drugs were imported. It was later discovered that the cost of the branded drug was 10% higher than that of the generic in the market. Negotiation with the Brander based on this fact led to 9% reduction in price. Recently, with bidding invited by the national government for the Global Fund supported programme, the same brander quoted at a lower price than ongoing supply cost. Further negotiation was initiated based on this information and a further price decrease was obtained. Comments

- It is obvious that companies can give different prices for the same good supplied within the same country. Bargaining would depend on access to information

- How can a system be set up that would facilitate better country negotiation and possibly allowing for price harmonisation?

- It is important to ensure that information is disseminated on drug pricing as this information would facilitate bargaining

- It is important to note that big pharmaceuticals would rather bargain with individual countries and would kick against regional bargaining

Country experiences Tanzania – The national ARV plan is a reflection of the government’s plan of action for ARV treatment. It identifies the number of PLWA to be placed on ARV treatment, the number to be on management of opportunistic infections alone, cost and partnership mechanisms. The plan also highlights strategies for addressing these plans Sierra Leone – Presently, 50,000 persons have HIV infection. Only 20% need drugs. The developed guidelines for ART worked out criteria for PLWA qualification to access subsidized ARV. The country understudied the Eastern and Southern African countries and designed its programme to avoid the pitfalls of these other countries especially with reference to adherence an drug resistance development. Theurapeutic groups were constituted and human capacity built to ensure transparency in the enlistment process. Gambia – The country started its programme in September 2004 and plans to cater for 150 patients. Recruitment into the programme would be through screening by the eligibility committee which is a multidisciplinary committee. The patient is screen as a number not by name to reduce bias and possibility of stigma. The programme has presently enrolled 60 – 70 persons at its 3 sites. Two of these sites have comprehensive laboratory services. Nigeria – The country does not have a national ART plan. The government programme is providing for about 14,000 persons at 25 centres in 17 states. There are plans to scale this access up to the 36 states in the country. There is no compendium on the total number of persons on ART in the country. There is a planned mapping process to rectify this. Botswana – Stigma was a limiting factor to drug access despite the availability in the country. This was addressed by integrating HIV as part of the routine test of all patients that access health care facilities in the country. Uptake of drugs has since increased. Comments

- When there are many partners involved with ART in a country, the main challenge is coordination.

- While there may be the desirability to promote in country drug production, this may not necessary address drug pricing as was the case with South Africa. The increasing

21

cost of imported raw material may cause the cost of in-country produced drugs to exceed the cost of accessible generics.

Session 6. Product Selection and Quantification - Helen Tata/Vincent Habiyambere One crucial lesson is that every time one delays the implementation of a programme, there are many lives been sacrificed. It is important to develop an ART plan but it would be unwise to delay the process. It is important to identify the target group for ART programmes. This would then help to define the types of drugs to procure, the quantification and the procurement mechanism. It is equally important to stage disease diseases as this determines the prognosis as well as when to give treatment. Precondition for treatment include availability of adequate social support and patient care taker available, food supplies, existing nearby health facilities, appropriate education for the patient re: adherence and side effect issues and adequate testing and monitoring services. These treatment conditions and identified target population as identified in a country ART guideline helps guide product selection. On selection, there is also the need to quantify as this determines the quantity to be procured. There are different methods for quantification. These include the usage method, adjusted usage method and patient morbidity standard treatment method. The usage method cannot be used at the initiation of a programme because there is no reference baseline data for calculations. One could however use the adjusted usage method. When estimating consumption, use clinic records and stock cards for detailing. This helps to emphasis the need for documentation and good record keeping. It is also important to use 2 quantification methods to help validate estimates. Question 1 – What is the use of giving ARVs? Answers

- it helps to decrease the viral load - it helps to increase the CD4 count - it decreases morbidity and mortality - as a post exposure prophylaxis - for PMTCT programmes

Question 2 – Who can describe the WHO clinical staging? How many stages do we have? Answer – The WHO staging has four stages Comment – there is a need to be careful as to staging patients. The WHO staging can only be applied to patients who have been tested. One cannot just use the clinical symptoms to diagnose. It is extremely important to test before making a diagnosis. Question 3 – Can a centre with no CD4 facility initiate therapy? Answer – Yes. There are some centres which provide treatment but do not have facilities for CD4 count Comment – this question is important in the context of scaling up. In Africa, we cannot guarantee that all treatment centres should do a CD4 count before initiating ARV treatment. The WHO staging guidelines helps one identify clinical symptoms which would guide with

22

treatment initiation. Simple tests like a lymphocyte count can also be used as guides. Patients should not be denied treatment based on inability to do a CD4 count. Question 4 – Is there a country that started ARV therapy with no CD4 count facility? Answers Kenya – in Mao region of Kenya, PLWA were treated without any baseline tests and there was remarkable recovery in 24 weeks. Many of these patients were able to return to work and normal functions. CD4 tests were later done after receiving a donated equipment. Uganda – CD4 count of less than 200 is the baseline criteria for initiating therapy at the beginning of the ARV programme Tanzania – Treatment programmes were started in 96 sites with only 20 CD4 counting equipments. Sites with no equipment used clinical staging and all those at stage 4 of the WHO staging were started on treatment. Question 5 – Is there any country where ART can be initiated by non-medical persons? Answers Zambia – The national guideline indicate that treatment is initiated by doctors. However, there is so much staff attrition with few doctors. In the absence of the doctor, the laboratory scientists or nurse can initiate treatment. Tanzania – Medical assistants are also trained to initiate treatment Uganda – The clinical officers get extra training before they can administer ARV therapy. Comments

- In some countries, you have to be certified to manage HIV infected persons - Countries with huge HIV burden must consider expanding the pool of care

providers to include TRAINED paramedics (trained in HIV management and ART).

Question 6– Who are the usual members of a essential medicine selection committee? Answer – pharmacists, specialists like obstetricians, accountant, laboratory scientists, nurses, procurement officers, health planners. The selection committee should be a multidisciplinary committee Comment - It is important to develop a country standard treatment guideline before developing a drug list. This helps to ensure a comprehensive list Question 7 – What products do you select along with ARVs Answer –drugs for OIs, test kits, reagents. Comment - Condoms and contraceptives are expected to be on the country essential drug list. ARV are been selected because they are new Question 8 – How many are thinking about taking a HIV test? Comments

– It is a right of all healthcare workers to have HIV screening. – There should equally be guidelines for providing PEP included in the ARV guideline

23

Question 9 – What is quantification? Answer – Estimation of the required quantity of a product over a time period Question 10 - What do you consider when you are quantifying? Answers

- consider the number of people to be treated - the country human and infrastructural capacity to treat - budget - the dosage regimen - the tablet dosage - also consider the lead time and the rate of expansion of rate of expansion of the

ART programme. Question 11 – What are the advantages of adjusted consumption methods? Answers

- Easily calculated - Less complicated - Can be very accurate when based on accurate statistics and conformity to treatment

guidelines Comments

- it is important to identify the number of ARV on the essential drug list - it is also important for the drug selection committee to meet periodically to review

the drug list in view of evolving needs Selection and quantification exercise Question 2.1 - Propose a list of organizations and/or persons that you think should be part of the selection committee. Answer

- should consist of pharmacists, procurement officers, finance, PLWA, doctors, HIV specialist, nurses, TB programme representative, drug registration authority, nutritionist, policy maker, development partners, IPR lawyer, media practitioner, civil society representative

- the committee should be multidisciplinary in nature and should not be too large to be manageable

- it may also be equally important to look out for existing committees to do the job of a selection committee rather than constitute new committees

Question 2.2a -What criteria would you develop for making drug choice? Answers

- cost - WHO guidelines can be adapted to country situation to determine quality - Availability - Need for both 1st and 2nd line treatment choice - Registration status and requirements - Fixed dose combinations to address compliance - Ease of administration

24

- Dosage form - Factors that could affect compliance and adherence - Monitoring needs - Storage and shelf life - Availability of test kits - Efficacy

Question 2.2b -Is there a need to prioritize target groups and if so, could you from a moral and or social point of view prioritize? Answers - There is a need to prioritise according to vulnerable groups

a. children b. pregnant women c. Co-infection with TB patients d. CD4 count level e. WHO clinical classification f. People with high risk behaviour in countries with low prevalence

- Selection should not be biased by moal and social issues

Question 2.3 - Should second-line treatment be introduced at all considering the enormous backlog of people who are waiting for first-line treatment? Answers

- There is a need to make provision for a second line drug regimen but the quantity should be low. Based on research, the need for a second line regimen as a first line treatment option is just between 1-5%

- Second line regimen should be minimally stocked in the first year of treatment. This should not exceed 2% of budget. This can be stocked in the second year of treatment

- The stocking of second line drugs should be based on resistance prevalence in the country

Comments

- It is important to have a network system so as to avoid wastage especially with respect to mopping up of stocks. Unused stocks most often results most frequently with second line drugs.

- The use of second line drugs as a first line treatment regimen is only justified when there is clinical and immunological treatment failure in patients. Drug toxicity is not a basis for opting for second line regimen. Toxicity calls for drug switch.

Question 2.4 - One of the members of the selection committee argues that all medicines for the opportunistic infections have been part of the Zimbabwe Essential Drugs List since its introduction since all of the OIs existed before AIDS. No need therefore to discuss these OIs. Answers

25

- With the use of ARV, the need for management of OI would decrease due to improvement in the immunological status of the patient. However, this does not mean there would be no need to stock for management of OIs

- Also, not all patients would be on the ARV programme. These group of patients would need to be managed for OIs and they need to be planned for

- The quantification for drugs for managing OI in the existing essential drug list were based on disease rates in the general population. With the new HIV status and prevalence in country, there would be a need to revise the quantification of the old drug essential list.

Question 2.5 - One of the members of the selection committee insists that the minimum level of laboratory facilities and services as recommended by WHO should be in place before testing, and thus treatment, can start. What to do? Answer - One cannot wait for laboratory development before starting treatment. The clinicians can use WHO clinical criteria for treatment with a developed reference laboratory. Other laboratories at treatment sites could then be developed along side the treatment programme Question 2.6 - Use the following data to calculate the quantitative requirements according to the various methods: Answer

- assumptions include: a. The 10% of children b. The weight differences (70% below weight and 30% at appropriate weight) c. Took cognisance of the initial 14 days d. Calculation was based on quantification of need and not based on specific orders

been made - The patient morbidity standard treatment method was used for calculation

Session7. Quality Assurance - Ben Botwe Quality assurance is a process not an end point. The process is cycle which starts from research through proper documentation of processes to monitoring, feedback and follow up undertaken by certified persons. Assured good quality also becomes a parameter for product (ARV) selection - sustained, consistent and acceptable quality rather than high or better quality. To achieve this, the manufacturer must ensure good manufacturing practice which is an entire concept. This involves monitoring environmental conditions under which products are manufactured/stored, monitoring of air and water systems to prevent contamination, monitoring of humidity and personnel as well as ensuring feedback and follow-up. Identifying a product supplier with good manufacturing process and that would supply quality products entails a systematic approach. The WHO prequalification listing helps developing countries to fast track this process. Good quality medicine translates to successful treatment Comments

26

- It is important to ensure that the quality of procured drugs are high using in country capacity where they exist or using the WHO pre-qualification register. Quality assurance also entails monitoring of air and water systems to prevent contamination. Air systems when not in good functions could cause cross product contamination and this may not be detected through quality testing of product alone. Yet the contaminated product cause user reactions

- Quality assurance involves site inspection to ensure hygiene as this is critical to prevent contamination of products

Question 1 – how do you handle a situation where in a bid to ensure that supplies to the central stores are of the highest quality yet, your job is at stake due to conflict with political interests? Answer - For contractual supplies, it would be wise to check in such supplies. However, ensure that these supplies are assessed for quality by the national regulatory authority. That authority should legally adjudge the quality of supplied products and make appropriate statements as per the quality of products. The verdict of the national agency on the quality of such supplies cannot be faulted Question 2 – If generics are produced by companies having access to the details of the chemistry of a drug and understanding how to compound it, is there anything wrong with countries going ahead to produce such drugs with access to such information? Answer – No. But the process of accessing that information is tedious and an Herculean task that may not be accomplished. Question 3 – Is there a basis for forming an international low cost suppliers’ consortium? Answer – the WHO forms a basis for this Question 4 – In Paediatric AIDS, because of lack of formulations, adult dosage forms are used. The adult dose is broken. Is this appropriate? Answers

- How do you break these tablets? How do you ascertain they are equal? - Manufacturers can make flavoured granules for mother to mix with water or

chewable tablets if you know product is not stable in liquid medium - When you break a tablet, you loose a lot of powder and one may not have equal

amount of the active ingredient in each half of the tablet. Note that some drug companies do not produce tablets in breakable forms. The score may be for aesthetic purposes eg nevirapine.

Comment – In view of these it therefore becomes very important that paediatric preparations are made available in resource poor countries Question 5 – Resource poor countries rely on WHO pre-qualification lists for product selection. When there are new information on products, how can such information be sourced for decision making purposes? Answers

27

- Use the WHO guideline to help assess quality of drug in-house use of laboratories with international standards within the continent. There are a lot of such collaborative works within the region.

- Also, you could seek information from other countries about their experiences in respect to the use of such drugs

Question 6a – In a situation where FDC pre-qualified by WHO were ordered, delayed in arriving but there were single dose combination in stock, is interchangeability of drug regimen feasible? Answer – it is difficult to demonstrate interchangeability. There are lots of co-formulation and co-packaging. It is difficult to demonstrate bioequivalence between the two. Different things happen when the two drugs are put into one package. Question 6b – What should a clinician faced with this situation do? Answers

– Clinically, there is no problem switching from a FDC to single dose combinations. The problem is going from a single dose combination to FDC which is neither pre-qualified nor registered.

– There might however be some psychological problems on the path of the client with respect to assuring the client that the different dosing of the regimens does not imply that the drugs are different

– Increasing bill burden may affect adherence and this need to be monitored – Another problem this may cause the central stores is the issue of multiple sourcing

and its implications Comment – For WHO pre-qualification listing, WHO controls how the bioequivalent studies are done as there are many tricks up the sleeve of the manufacturers which countries cannot monitor. The question during these bioequivalent studies is bioequivalent to what? In the WHO pre-requisition process, the reference standards are provided by the innovator. Question 7 – How should the issue of herbal cures be addressed in view of the strigent measures for quality assurance? Answer – The patent is often the problem encountered for registration. Also, there are no ways to ascertain the efficacy of the various claims on herbal medications. Request – Could WHO and World Bank help Zambia set up or upgrade their laboratories to enable them conduct quality assessment of drugs? The regional laboratory in Zimbabwe is not easily accessible and they are burdened with their routine duties Question 8 – Many drugs are being de-listed by WHO and the FDA. How much of this process is politically motivated? Answer – Product de-listing is more often than not a safety issue. Sometimes, the withdrawal may be due to seemingly trivial needs for improved labelling and packaging. There are no drugs (not aware) de-listed for economic or political reasons. However, a number have been withdrawn due to adverse side effects Question 9 – How can countries get protected from sharp practices of drug suppliers wherein they deliver poor quality drugs despite various precautionary measures taken and

28

then try to wrap the blame on the importer? This is moreso in view of past positive relationships with the supplier. Answer – this only highlights that quality assurance does not end until product get to the consumer and are consumed. There is a need for constant, regular short phased monitoring of suppliers/manufacturers. Case study: HIV/AIDS crisis in Fatakia- Getting the right medicine to the right patient at the right time Question A – Assuming you are a consultant contracted by WHO or World Bank to go into Fatakia, what are the problems you can identify with the country? Answers

- lack of a functional drug regulatory authority - dearth of qualified personnel - High HIV prevalence with high number of infected youths - Lack of infrastructure - Political/civil unrest - Unreliable infrastructure for distribution - Diversion of drugs - Counterfeit drugs - Very poor country - No protocols - Poor record keeping thus drugs not traceable - Pharmacists are not listed

Question B – If you have been asked to advice the government, what advice would you give? Answers

- the country should take advantage of international relationships such as that with international agencies, WHO, regional organisations

- the government should think of developing guidelines, policies, defining procedures including regulatory and procurement systems. The country could get help from agencies that could assist through identified processes at no cost.

- Build capacity at all levels and in all disciplines Session8. Lessons learned from East, Central and Southern Africa - Jabulani Nyenwa Panelists A. Stanley Mapiki (Botswana) B. Samson Kibende (Uganda) C. Emma Lekashingo Msuya (Tanzania) D. Loyce Lishimpi (Zambia) E. (Zambia)

29

Zambia experience - The ART programme was started in 2002 and was planned to be executed in phases. There were initial training of health providers - doctors, nurses, laboratory scientists, counsellors and pharmacists. The roll out started in 2002 at a university hospital and the Central hospital. In 2003, the programme was then phased to general hospitals. In 2004, it was phased to district hospitals. Presently, the country is continuing with the 2005 plan. ARV uptake was initially slow but has been steadily rising. The workload in the hospitals is equally increasing. There is presently a need to train more staff to cope with the workload. The WHO staging is use as patient eligibility criteria for initiating treatment. Treatment initiated after 4 weeks of post HIV counselling to allow for adjustment to the need for ART. The CD4 counts for patients were done only in the university hospital initially but now almost all general hospitals have CD4 count machines. The precise number of hospitals with CD4 machines cannot be given in view of the fact that we had no foreknowledge of this presentation. The Zambia population is predominantly females (52%) with rural to urban migration. ARV programmes had been initiated in the country through the private sector before the government roll out programme. The initial take off grant was $3million. There are donor funding for programme from Global Fund, PEPFAR, and USAID. Deterrents to the process include stigmatisation – more people accessed ARV from the private sector; discriminatory screening process; inadequate laboratory facilities for screening. The country is addressing the issue of stigma through the use of community partnership structures eg district AIDS task force and provincial AIDS task force which are multidisciplinary. The community chiefs are involved in this process because they are highly revered by the populace. The trained personnel use checklist which was developed based on the WHO clinical staging to help with determining patients’ prognosis and prospect for ARV eligibility. Between February and April 2005, a follow up assessment of trained personnel compliance to procedures was conducted. In one of these treatment sites, a system of using trained treatment supporters who meticulously followed up patients on treatment. No patient was lost to follow up through this mechanism in this site due to the efficiency of system. There was also a very high political will to address stigma even at the presidential level. Question – Why allow the clients to go away for 4 weeks to think about accessing ART? Answer – This gives time to allow for psychological adjustment to deal with various personal issues related to ARV use. The 4 weeks is not a strict rule for all patients. Any patient can start on the programme as soon as they are ready after post HIV counselling. Botswana experience – The country has a population of 1.5 to 1.6 million with an HIV prevalence rate of 34%. The prevalent HIV subtype is subtype C which is very virulent. The HIV situation in the country is considered a national emergency. The WHO guideline was used to proritise treatment. Prioritized populations are TB co-infection, pregnant women, children, persons with CD4 count of less than 200 and people with AIDS defining illness. The programme started in 2002 with ART provided at 4 sites - two referral hospitals and 2 district hospital - to 7,000 patients. This costed $10million. Presently, treatment is provided at 32 sites for 40,000 patients. The programme is been supported by government grants, efevirenz is free from Merck, concessional pricing from Roche, BI and BMS and MSD. There are plans to scale up the programme to 126 district hospitals; to involve private clinics and chemists through a public/private partnership initiative. To cover the 126 district clinics, the country would be using district resource such as pharmacy technicians and nurses. Procurement and drug distribution will still be done by the central medical stores. One of the main challenges to the programme is the reports of sudden deaths with the use of

30

branded drugs. The other is that of sustainability. The cause of this is still not yet know. Human capacity building is achieved through training using the KITSO package. Question – With 40,000 people on treatment in Botwana, what is the mortality rate? What is the HIV -1C prevalence? What is the experience with resistance? Answer – The mortality rate is under 3% for those on treatment. The death of patients on treatment could be attributed to a number of factors including patients choosing to go on alternative treatments such as CANOVA, a product from Cuba and other traditional remedies and stopping the ARV treatment prematurely. The report of these tests guides national drug selection process. The first line drugs are Combivir + NVP/EFV while the second line drug is D4T + DDI + NLF. Third line drugs are Ritonavir + Saquinavir(Indinavir) + 3TC or, depending on the sensitivity test,. There are a lot of Nelfinavir in the country store that has not been used for years because there were less patients on second line regimen than forcasted. The country also has a national reference laboratory where HIV resistance testing, HIV typing and drug sensitivity are conducted. Resistant is also under 5%. The strain common to southern Africa is the HIV-1C and so majority of the cases have these strain. Question – The country use only branded drugs and no generics. Why is the country not availing itself of country saving measures by using the WHO pre-qualification list? Answer – There has been an inter-government agency agreement between the innovators and the government of Botswana to get these drugs at subsidized prices. This saves problem of quality control and assurance which the country does not have the capacity to assess if the country were to get generics Uganda experience – The experienced shared is that of the Joint clinical research centre in the country. The ART programme started in 1991. this was funded project basically for research purposes and to provide clinical care and management. The programme started with the provision of only AZT and focus of research was to determine appropriate dosing. The initial dose was 800mg and this finally came down to 200mg as acceptable therapeutic dose. Through this research effort, the country developed capacity to treat. Treatment was only instituted for those who could afford it. Initially, Africans were to lose out on accessing treatment because it was conceived that the countries lacked the infrastructures to effective administer these drugs and that patients may not be drug compliant. One big lesson Uganda has come to learn is that bureaucracy slow down scale up processes. Tanzania experience - Tanzania has population of 35 million people with HIV prevalence of 7% and 85% of the population live in rural areas. In the year 2004, National AIDS Control Program developed Operational Plan for financial year 2004/05. The Operational Plan indicated major areas that were to be considered in the implementation of the Care and Treatment Programme and the total budget that is required for the programme implementation. Training of health care workers on management of HIV/AIDS was conducted in three phases. Assessment of the facilities that were to initiate the provision of ART took place concurrently with the training of Health Care workers. The government of Tanzania allocated in its budget a total of 2 million US Dollars in the financial year 2003/04 for the procurement of the first batch of ARVs. The funds procured drugs to cover 4,200 patients on treatment for one year. The government then allocated 3.5 million US Dollars

31

for the financial year 2004/05. The government of Canada supported the program by giving 3.5 million US Dollars for ARV procurement for more patients. Programme operational in 64 sites for 7,000. The PEPFAR programme would roll out in August 2005. There are plans to scale up to 100,000 patients by the end of the year 2006.The government has therefore identified new 102 sites. Currently, most country facilities are standardized. There is a need to build infrastructural capacity within the country especially with respect to laboratory facilities. General questions

a. Do countries who started their treatment programmes way back have experience with use of 2nd line drug? What ratio of patients are on 2nd line drugs?

b. What country mechanisms are put in place to reduce drug resistance and enhance communication? Answer – in Uganda, all the centres around the country are linked together by the internet. Through this system, feedbacks are received. In Tanzania, monitoring and evaluation tools are sent along with ARV supplies. Care providers are trained on how to fill these forms. In Botswana, the national ARV programme produce a monthly bulletin which reports on testings and patient care. There is also a national data base which keeps information on the number of patients on ARV, quantity of drug in circulation, number of patients on different drug combinations and number of new patients assessing treatment.

Comments

- programme monitoring is weak in most countries. Do the countries achieve their targets with respect to patient management and drug distribution?

- It is commendable to learn about African government committing funds to ART programmes

- Communication could also negatively affect a ART programme. Where the Ministry of Health appropriately budgets for ART, and then the Ministry of Finance insist on a ceiling budget, procurement is negatively affected

- Increased access to ARV has been related to increase in risky behaviour - Different countries have put a price on drugs to ensure cost sharing with patients.

While reports indict costs as one of the reasons for client drop out, evidence based research equally shows that free treatment does not necessarily increase patient retention.

- Studies in Uganda shows that dual therapy do not work maximally. Triple therapy is more effective with associated resistance being less than 1%.

Session9. Procurement, Planning and Management - Helene Moller Procurement is a cyclical process which needs to be balanced. Procurement options also differ depending on the whether you are procuring health products, goods, services or works. It is important for procurement processes that everyone understands what is needed. Requirements (specifications) are defined as terms of reference when procuring services and as scope of works when procuring works. Procurement methods also differ depending on the bulk required, in-country financial regulations and options available. In procuring, options include direct contracting or waiver of competition for single sourcing, request for quotations or requests for proposals, international shopping or invitation to bid. Other

32

procurement methods include the use of specialized low cost international procurement suppliers or UN and the use of pooled procurement. These methods all have their indications, advantages and disadvantages. When planning for procurement, identify requirements to initiate and complete your procurement, schedule all task and schedule procurements. Also, identify and manage cost factors and critical path items. Finally expedite product availability for use. Whole planning for procurement, it is equally important to assess the capacity of a procuring agency as well as the robustness of a procurement plan. This all helps to prevent product stock out and or expiration. Question 1 – When there are stock outs or stock expiration, what needs to be done? Comment – this could always happen as 30 years of research and experience have shown. There is therefore a need to plan appropriately for this. Case study Scenario 1 In a market situation where the drug is on patent, available from originator supplier and in ACCESS initiative, what are the procurement options for small, medium or large size contracts? Answers

- one could consider doing a single sourcing for all cases - in view of the fact that there is ACCESS Initiative and thus concessional pricing,

then direct contracting may be appropriate for all thresholds - bidding in any form may not be appropriate since there is only a single source - international shopping may be appropriate for all thresholds so as ensure appropriate

price negotiation even within an ACCESS Initiative programme OR allow for parallel importation

Question – within the financial rules operational within countries, would direct contracting be feasible? Answer – this may not be feasible for all countries because of the peculiarities of procurement systems. Funding play a big role and there might be ceilings to available fund Comment – where there are restrictions on procurement mechanisms, one could write for permission to get a waiver in view of the limited option. Scenario 2 In a market situation where the drug is not on patent, available from originator supplier and generic manufacturers, what are the procurement options for small, medium or large size contracts? Answers Assumption A – where the drugs are available in country, then do a National shopping for the drug if the threshold is small, and limited international Bidding/national competitiveve bidding for medium threshold and an International Competitive bidding for large thresholds. Assumption B – where the drug is not available locally, do international shopping/limited international bidding for small thresholds; international shopping/limited international bidding for medium thresholds; and international competitive bidding for large thresholds Scenario 3

33

In a market situation where the drug is not on patent, available from originator ONLY or from generic manufacturers ONLY, what are the procurement options for small, medium or large size contracts? Answers

- For small thresholds, then do a direct contracting. However, an international shopping could help enhance price negotiation as there might be different pricing of the same product in different countries though only one manufacturer.

- For medium and large thresholds, do a direct contract since it is a single source. One may also do international shopping for price negotiation

Question 1- Is it possible to get a generic manufacturer without an originator? Answer – with FDC there are generic producers without originators Comments

- the urgency for supply may affect the procurement options - availability of product in country would also affect options - this process is about helping all persons think about how to maximize savings during

procurement procedures - It is obvious that there are a wide range of options for procuring. When there is only

one supplier, then one has to do direct contracting but try to negotiate. - When shopping for best prices it is important to note the need not to sacrifice

standards - When political interest apparently seems to override good judgment, it is important

to note that adherence to the principles of procurement is important Question 2– Is the capacity of country procurement agencies sufficient to conduct ARV procurement? Are there needed changes in procurement agencies operational framework that could be made to enhance procurement process? What are the 3 most important deficiencies that need to be address to make BEST PRACTICE EXAMPLE in the region? Answers

- there is need for a national agency and an ARV task force - need for a specific ARV procurement officer in Gambia who can focus and address

the ARV procurement issues - In Sierra Leone, there is a ARV procurement unit in place because the ministry of

Health does not have the capacity to handle the procurement mechanisms. Technical assistance is provided by the World Bank. There are efforts directed at building country human capacity with help from Uganda. Drug distribution is also decentralized with operational systems ensuring inland delivery services of procurements.

- In Ghana, ARV procurement is done within the unit of the Ministry of Health by a procurement unit. The central medical stores is a storage and distribution centre. Procurement is done in collaboration with the National HIV/AIDS agency. Procurement is done using the WHO pre-qualification lists to manage the 3,000 PLWA at 4 sites in the country. A HIV logistic focal person distributes drug to sites. The challenge there is is the need to scale up treatment to 12 sites by the end of 2005. Also there would be the need to re-address the present drug distribution mechanism. Thirdly, there would be a need to address how to sustain the

34

programme in the long run. Information derived from data generated from the treatment sites, using the LMIS forms, are used to plan for drug management.

- In Nigeria, procurement for ARV is managed by the tenders board which functions like a procurement agency. The tenders are reviewed by the ARV committee and recommendations sent to the tenders board which consist of representatives of multiple departments in the Federal Ministry of Health. The tenders board is saddled with other responsibility in addition to ARv procurement issues. Budgetary needs are then sent to the Federal Ministry of Finance for clearance through the ‘due process’ system depending on the availability of funds. Procured drugs are distributed centrally by the central medical stores to the 25 national ARV centres. The centres send representative to collect their consignments when notified. This notification goes out every 3 months. With the Global Funds project been managed by NACA, ARVs are distributed straight to the treatment sites. The national programme is planning to adopt this mechanism to address the present bottleneck with the centralized process. There is a need for physical and human infrastructures, training and retraining of staff, defining effective logistics as well as increased funding to enhance the quality of the national ARV programme.

- In Guinea Bissau, there is a major problem with human capacity. Presently, only one person is saddled with the responsibility of the national programme, PEPFAR programme and now the World Bank project.

Question 3 – Is the procurement of ARV something special? Why is ARV procurement special? List 3 things to be considered when one sets up an ARV unit? Answers

- yes ARV procurement is special - ARV is a life long continuous regimen that needs to be properly planned for and

managed to prevent resistance development - Because of the above, it is important to ensure continuous funding to ensure

sustainability through focused planning - ARV is a costly commodity - ARV procurement is done in an unpredictable environment - Its production is limited and so its procurement has to be specially addressed - ARV is new and the changes within the industry needs to be managed - Quantification is difficult due to absence of baseline information. ARV procurement

requires large multiple stocking of commodities which needs to be coordinated - There is a need to plan to ensure rural reach - Planners need to source for funds to sustain the programme which is essential in

view of the emergency nature of the epidemic Comments

- All these reasons can be categorized as technical issues, development and research issues, financial issues, political and social issues, product registration issues and legal issues.

- While ARV procurement has very special components that differ from the procurement of other drugs, yet they are not more special than other drugs. The stock out of antibiotics in Asia for a week would result in multiple children’s death

35

- Systems for ARV procurement may need to be developed if existing structures cannot cope with the additional responsibility. In most countries, existing structures more often than not, cannot cope

- The message is to be careful in scaling up. Most personnel have multiple tasks and not just ARV procurement. In scaling up, one may need to consider establishing a procurement unit to manage ARV procurement logistics

- All programmes should be assessed to ensure feedbacks which is needed to improve on the quality of on going programmes.

Question 4 – How do you address stock out or expiration of ARV drugs? Answer – it is important to ensure an effective system for monitoring. It is advisable for a country to have one system of monitoring and one distribution system. This way all issues can be adequately addressed. 10. Country Discussions: Sharing Experiences The Gambia – Preparations for the ARV programme started in the country in October/November 2003. In October 2004, the World Bank, through the Accelerated Results Implementation programme, helped with the establishment of the ART programme by getting the right person together with the right knowledge and commitment. 10 health professionals were trained and understudied other country ART programmes. The programme also needed to put in place policies, finalise treatment guidelines and validate the selection of ARVs for treatment guideline before patient recruitment. The programme is presently collaborative involving the NGO community and the private sector. Patient recruitment took a while. Presently, there are 60-70 patients on treatment in the 3 accredited centres (a teaching hospital, an NGO at facility level and the Medical Research Centre). The target for the first year is 150 patients. Monitoring tools have been developed and the country plans to collaborate with Ghana and other countries to help develop its LMIS. The country has a board of survey which monitors the disposal of. The country is working towards developing training programmes for its professionals. A present challenge is the plans to scale up. Another is the need to develop a national system of procurement, management and distribution. Ghana has a comprehensively detailed national ARV procurement plan drawn up in line with World Bank specifications. The ARV programme started in June 2001 and following a situation analysis, it was decided that ARV procurement should be handled by a separate unit from the general procurement unit of the Ministry of Health in view of the limited capacity. A strategic decision was also taken for procurement to be done by limited international bidding method. During the initial two years of the programme, focus was on building capacity while implementing the programme. Presently, procurement is now handled by open competition. The procurement procedure takes cognizance of national laws and is modeled after the Nigerian protocol. The country also has a scheduled delivery system which is flexible. The sites are given 2 months supplies. The country uses the pool system and gives 2 months notice to manufacturers for delivery. Patient literacy porgramme has just begun. The country is considering the feasibility for in country manufacture of ARV with support from DFID. However, it is difficult to get the appropriate information needed for such efforts even from other African countries.

36

Nigeria – the country has a multisectoral approach to addressing HIV/AIDS. the Federal Ministry of Education ensures HIV/AIDS education in schools. Professional organizations are also encouraged to ensure HIV/AIDS education before recertification. There are significant efforts been made with respect to developing training modules that could facilitate these trainings. Presently, efforts are geared towards institutionalizing these trainings. There are challenges to the ARV procurement in Nigeria. This includes the problem of forecasting, quantification, distribution and storage. There is presently a blanket custom waiver from paying custom duties for HIV/AIDS related drugs and test kits. Many states in the country have their ARV plans with their peculiar problems. States are however encouraged to liase with the Federal Ministry of Health when planning to roll out ARV programmes. The country has an ART programme with information on this disseminated to relevant stakeholders. The shortfall of the plan includes its failure to discuss access of ARV for the poor. Also, there are concerns about the sustainability of the programme especially after donor support is withdrawn though partnership with the World Bank and the MAP Project is for 20 years. The ARV programme in Abuja, Nigeria ran into a hitch based on poor assumptions. Drugs were procured based on the assumption that patients were above 60kg. However, on site the reality was that most patients were below 60kg. The Cross Rivers State in Nigeria presently has a load of expired drugs it plans to destroy with the involvement of the national drug regulatory agency, the Ministry of Health and the Ministry of environment. Sierra Leone – VCCT centres serve as entry point to the ART programme. This also help facilitate the development of a relationship between client and counselor that can be sustained while on ART. Adherence is enhance by encouraging PLWA disclosure of status to family members who can help ensure drug adherence. Peer support groups also help to conduct follow-up within the community. There is a national policy that ensures HIV and malaria drugs are duty free. World Bank purchases are duty free and clearance for the goods are received from the National revenue authority. The contractors for the World Bank goods mark the goods CIF Port free town and are distributed straight to the treatment sites. The government procurements are marked CIP and are taken to the central stores from where the distributed to treatment sites. Stigma remains a challenge in the country. Tanzania – the country conducts treatment literacy programmes including training on adherence counselling, and the use of IEC. The training is also designed for health care providers. The country is also making efforts at addressing community awareness about treatment issues Uganda – the country does drug quantification. Drugs are dispatched to the treatment sites using couriers. An assessment of the readiness of an ARV team is usually done by the training team after which training is conducted for the staff and then drugs procured and delivered to site. The country once had to procure and stock ARV for use in patients less than 60kg. With therapy, patients gained weight and then the drugs were no longer appropriate. Zimbabwe – the issue of managing expiry drugs are important. The idea of having a national de-junking exercise is been muted. This would entail all health institutions destroying all expired drugs in the stores after approval has been received for such destruction from the Federal Ministry of Health.

37

Botswana – there is a national research centre were resistant mutant viruses are typed and second line drugs prescribed. This information is sent to the national ART committee which then recommends appropriate actions. Capacity for resistance testing is yet to be fully developed. Comments 1. Budgeting

- Often, the issue of freight and insurances are forgotten in the budget. It is important to plan for cost of transportation from factory to the service point. Cost for procurement and distribution should also be budgeted

- Type of insurance would depend on the mode for good acquisition 2. Procurement plans

- With Global Fund, there must be a supply and procurement plan in place to access the fund. There appears to be many procurement plans which differ even within countries. This is because each drug donor have difference specification which needs to be met before funds are released

- In South Africa, procurement plans were based on drawn assumptions. A spread sheet was then drawn with the aid of JSI and used for forecasting

3. Monitoring - Once drugs are procured and consumed, there should be mechanisms in place to

facilitate data collection on consumption pattern. This data would serve as actual data which would help improve long term planning

- Countries may start running OI clinics before embarking on an ART. This helps with data collection which can enhance forecasting for ARV uptake as well as project for adherence.

- It is important to monitor for adverse drug reaction which will require drug substitution. The rate of such reactions would enhance the planning for drug substitute. Side effect to drugs may not have much programmatic effects. The possibility for side effects is further reduced when patients are properly screened for TB

4. Storage - Many systems have poor storage facilities and the drugs are referred to as fake due to poor storage 5. Managing expired drugs - It is amazing the quantity of expired drugs across the continent considering that several lives are lost daily on the continent which could otehrwise have been saved with the use of these drugs 6. PLWA management

- Nutrition is quite important in PLWA management. Research shows that when patients with debilitating disease take their drugs and have good nutrition, improvement rate doubles. Good nutrition should not be substituted for nutritional supplementation which could be more costly than ARV itself. There is a WHO guideline on nutritional requirements

- With the PMTCT programme, niverapine is given to mothers as single dose and hey then start on the triple drug regimen six months postpartum. This is not the best. WHO has a clear guideline of this?

- In West Africa, HIV 2 infections are resistant to first line ARV especially nevirapine and efaverenz. Suggested combination is AZT + 3TC with a PI. Therefore non response to therapy does not necessarily indicate resistance. Resistance is diagnosis after 24 weeks of therapy and there is no improvement in CD4 count and viral load

38

- Pre, post and ongoing counselling important as this ensures positive living. Many clients are not counseled before an HIV and this may be due to the fact that Doctors who prescribe the test do not have counselling skills. Group counselling can also be planned for pregnant women

General

- there is too much assumption that doctors and nurses are well informed on ARV management

- for every roll out training plan and programmes, it is important to define minimal training requirement for all staff managing the programmes at the various sites

- before starting an ARV programme, it is important to determine the number of people that would start the programme as this would help in planning for personnel need for both OI management and ART

- when conducting community awareness programmes, communicate issues in languages the layman can relate too and understand.

- Messages which try to address HIV issues could also promote stigma. There are many other disease other than HIV that does not have a cure. But just like those diseases, it can also be managed.

- Local capacity to produce ARV should be addressed especially with respect to long term planning. The continent should possibly start planning for this though it is important to note that there might be pitfalls with this approach. Locally produced products may end up been more expensive than importation due to cost of importation of raw materials.

- The public sector alone is not able to address entire country need. There are needs to rely on other mechanisms such as the private sector and NGO to reach areas not reached by the public sector

- WHO is planning to conduct ARV resistance surveillance and interested countries can indicate interest and could participate.

- Uptake of VCCT services is improved with community literacy efforts. The services can be promoted through the effective use of the media. Scale up of ART programmes would also imply scale up of VCCT services

Session11. Storage, LMIS, Inventory Management and Distribution - Timothy O’Hearn Critical decisions that need to be taken in respect to supplies include issues of full vs limited supply and the use of integrated vs vertical systems. While storage is important, key issues to consider about storage include the storage options for the various types of products including tests kits and ARVs. Equally important is the need to manage information about the ART programme. For HIV/AIDS commodities, the LMIS is a more appropriate management information system because it is timelier and consumption related. The HMIS on the other hand is more of a disease surveillance system. Essential data items that need to be collected include stock at hand, rate of consumption and losses/adjustment Question 1 – How do you maintain a cold chain? Answers

39

– In Nigeria where the electricity supply is erratic, alternative power supply like the use of solar panels are considered.

– Uganda developed their own solar system of keeping immunization coolers – Integration is critical because ownership of cold chains in immunization programmes

is by EPI and when other programmes need this service, a whole load of administrative discussions go on before getting support.

Comment – it is important that protocols on ARV management take cognizance of existing cold chain. Many countries are no longer procuring products that essentially need refrigeration. It is important to consider the storage needs of products procured in view of needed logistics. Question 2 – Why secure ARV commodities? Answer – their cost and life-saving value make them attractive for pilfering Question 3 – How does the storage requirement of test kits etc affect the efficacy of the test kit? Answer – poor staorage often results in false reports Question 4 – how do you deal with losses? Answer – you make adjustments. These adjustments should reflect in the logistic record. An adjustment could be a plus or subtraction Question 5 – why are expired products included in the adjustment? Answer – expired products are considered a loss Question 6 – how do you get the rate of consumption? Answer – by using ACTUAL consumption data to forecast Question 7 – what is the margin of error allowable in the system to make up for poor data retrieval from the facilities? Answer – Comment – it is important to use appropriate data collection forms for the appropriate levels of facilities they are designed for and used to collect the appropriate data. Question 8 – what is the minimum stock up level? The minimum is 7 months and the maximum is 10 months. Does it mean that orders are made every 3 months? Answers

- yes. There is a need to make the orders fit into this window. - In Nigeria, the facilities have a one month minimum stock level. New orders are

made every month. Question 9 –how do you estimate for the number of new patients that would be on the drug for the next month? Answer – TRENDS can be used – number from previous months, actual number presenting per month. One can also use an adjusted figure of 5% of actual current enrolled number of patients

40

Question 10 – what software has inventory prorgamme for clinical inventory control? Answer – Tim would source or information on this Session12. Rational Drug Use - Bannet Ndyanabangi Rational use of ARV requires that the patient receives medication appropriate to their clinical needs, in doses that meet their own individual requirements and for an adequate period of time at the lowest cost to them and their community. Irrational drug use would lead to treatment failure, rapid development of drug resistance, increase of toxicity risk and wastage of money. Many factors can lead to irrational drug use. These include inadequate communication with the client, under prescribing, incorrect prescription, extravagant prescription, over prescribing and multiple prescriptions. Various factors that culminate to poor dispensing prompt irrational drug use. Simple regulatory measures can help promote rationale drug use as adherence has implications for the individual, public health and the health economics. ART adherence is therefore best facilitated by a multidisciplinary approach, including the client’s family, with the objective been a minimum of 95% adherence for all patients. While ART is important, there are other complimentary issues that can affect ART and vice versa. One is nutrition. The other critical issues are pregnancy and children. Question 1 – Do you have guidelines for how to dispose expired product Answer – There are procedural methods. For Gambia, there is a board of survey which has on board Police, Auditor General, Finance, Ministry of Justice. They take decisions on disposal of expiration Question 2 – Why may there be different considerations for HIV/AIDS commodities as opposed to other essential drugs? Answer – there are basically no difference except for the need to plan for logistics. In Nigeria, the room temperature could go as high as 400c and there may be no refrigerators for storages. Where there are, the electricity supply is erratic. Thus storage needs to be adequately planned for in such as system Question 3 – If a woman on HAART gets pregnant, what do you do? Answer – change EFV and review the entire treatment combination in view of pregnancy Question 4 – If a child is born and is infected, what should be done? How is HIV infection detected in children? Answer – Do a PCR screening Question 5 – Are there countries that use nevirapine syringes in PMTCT programmes? Answer – Yes. Ghana received donations of 20mls and 50mls from BI. Comments

- One of the reasons for not treating paediatrics is the lack of paediatric counselors. We usually take it for granted that nay counselor can counsel the child but this is not so.

41

- In Zimbabwe, children are defined as below 12 years. When children are above 5 years, adult ARV can be used for treatment

- Country policy on testing for HIV infection in children is also critical as to determining how and whether it is done. This can very much affect how children are managed.

Question 6 – Is there any country with palliative care plan for children? Answer – There are short and long term training courses on programmes for children in Uganda. There is also a published book on this Question 7 – Do children on ARV survive till after 5years? Answer – There is evidence to support that they live long enough to get married and have their own children Question 8 – Any experimental evidence of possible interaction between the new generation nutritional supplements and ARV? Some clients go off ARV to use these products because of the way the products are promoted. Answer – Clients should be advised to continue with use of ART despite the use of the nutritional supplements Question 9 - How do know patients are adhering? Answers

– Self report could be used but this is not reliable enough. Pill counts can be used as a more effective monitoring tool. Others are use of pharmacy records, provider estimate, pill identification test, biological markers, use of electronic devices and measuring drug levels

– It is critical for clients to understand the importance of adherence. Therefore, clients should be a part of planning for their treatment to enhance adherence

Question 10 – What factors could cause irrational drug use? Answers

– These factors include prescribers/dispenser contributory factors. Their workload can cause them to be overworked which may affect efficiency.

– The knowledge and understanding of the precribers/dispensers may also be a limiting factor

– Ineffective communication can be another limiting factor. Barriers to ineffective communication include language. This can be addressed by utilizing the counselor to enhance communication though comprehensive communication may also be limited through this alternative. This is because the counselor may not appropriately communicate pharmaceutical issues about the drug which is of great importance to the client.

Session13. Drug Logistic Management: the PEPFAR Funded GHAIN/ACTION project in Nigeria - Deo Kimera

42

With the GHAINS/ACTION project in Nigeria, the government placed a great role in determining the site of implementation of programme. Some of the 6 sites of the project were selected based on site needs rather than capacity. Experiences gained on the job also helped with the development of simple monitoring tools which helps enhance the efficiency of procurement and reduce wastage. One of the challenges on the job is the need to integrate the project LMIS into site computation systems, the need to facilitate the integration of the national ARV programme with the PEPFAR and other donor driven programmes. Question 1 – Then why did Lagos and Abuja qualify for enlistment on the programme in view of the fact that they have 11 treatment sites between the two? Answer – These sites were chosen as they had waiting patients from their implemented VCCT projects. Comments

- The project is managed by a consortium of 7 organisations. And this emphasizes the role of networking at all levels of HIV programme.

- There are needs for buffer stocking so as to take cognizance of delayed funding of programme and thus prevent stock out. Buffer stocks are best made for 3 months. Ordering buffer stock with first order helps in cases of unpredicted increase in demand or sudden changes in lead time

- Long term forecasting helps to plan and takes cognizance of lead time. This lead time has been increasing over the years as manufacturers now have increased demand

- Stocking up a year supply though may reduce the tendency for stock out, increases stock holding cost as budgets have to be made for storage space, pilfering etc. it also increases tendency for drug deterioration. Where there is a need ensure funding for drug stock are not diverted, the contract for the procurement and supply of the drug could be secured by contractor asked to do scheduled delivery

- For logisticians, the clinicians are important in forecasting. As they can help with giving more appropriate figures from experience as this impacts on forecasting. The national policy also impacts on treatment projections as the target population affects population focus.

- LMIS is a new system and for many, the introduction of new data collection tools which would feed into the LMIS often appears as apparently increasing work load. However discussions on the need for the data, how the data generated helps to facilitate management and communicating the impact of the ‘new’ system helps motivate staff to change documentation and poor reporting culture.

- Cold chain management is a major challenge for the project. The EPI delivers bulk consignments while the ARV needs small delivery yet there are no small delivery vans. There are presently no adequate infrastructure for ARV delivery for those that need cold chains

Question 2 - What does general orientation entail with capacity building? Answer – It is important to help people understand about the project and understand the procedures involved with the logistics. This is general knowledge/sensitization process. Facility based training is now more specific and helps address the issue of storage and logistic management. Centralised training helps to address the policy issues.

43

Question 3 – What is the possibility of bringing the prescribers and procurement officers together to training? How does the system integrate the private sector into public health system planning so as to ensure one national system? Answers

– In Nigeria, the Federal Government is focused on ensuring private sector integration into the national health plan. There are many efforts in that respect especially with respect to trainings, networking and facilitating communication. This would ensue the same standard of are in both sectors

– In Ghana, there is an existing public-private sector relationship which enhances public – private sector distribution. However, the bottleneck to this is how to manage and ensure that ARVs distributed from the public sector to the private sector are prescribe at the subsidized cost

– In Botswana, the private sector utilizes ARV drugs procured by the public sector. Question 4 – What percentage of procurement cost could be factored in as distribution cost? Answers

- This would vary with country peculiarity. In Nigeria, it is cheaper to distribute ARV by air in view of all the insurance and land freight cost. All, the use of courier services for distribution does not work. This Nigerian model is peculiar impressing the importance of country peculiarity

- The cost would depend on the distribution pipeline, type of product distributed and volume

- Experiences with donated contraceptives shows that distribution cost is about 10-13% of cost of product. In Uganda, it was 18%. With ARV this cost may vary.

- In Botswana, the distribution is done by the manufacturers from whom procurements are made. They often have in country distribution mechanisms. However, these manufacturers are reluctant to take on the procurements made by the local contractors on their distribution pipeline. The Botswana laws allows only for local contracting for shortfalls from bulk supplies thereby encouraging public private sector partnership in drug distribution.

- There are no one ways of doing things. There is however a need to do specific country assessment to be able to do good specific budgeting for distribution of ARV

Suggestion – Various countries should come up with policies that address effective distribution of ARVs including storage and supplies

44

VIII . CONCLUSIONS AND RECOMMENDATIONS Discussion Addressing critical issues During the workshop, the focal critical issues related to monitoring and evaluation, drug costs, planning for space management and stores safety or expanded programmes, human resources needed, local production of ARV, Federal and State government partnership on ART, nutrition and ART and political challenges Question 1 - What are the best ways to share tools? Answer – It is agreed that tools would be collated and distributed to all persons through identified contact persons. Shared information would not only be limited to M&E tools but also with respect to SOP, SOC, and other relevant instruments for ARV programming Question 2 - How much are countries paying for ARV drugs ex manufacturer prices? Answers

– The countries vary from countries and may be as much as 30 – 50% for same drug supplied by the same innovator within the same country irrespective of volume. This needs to be addressed by an identified information sharing mechanism which can thereby enhance country ability to bargain.

– The Global Fund has a website which shares for hosts such information but access to these information is limited to countries accessing the Global fund. Efforts would be made to review this in view of the outcomes of the various World Bank facilitated workshops

– Prices of ARV vary from $280/patient/year from Ghana to $25/patient/year in Nigeria, $26/patient/year in Sierra Leone, $16/patient/year in Tanzania, $32/patient/year in Botswana, $15/patient per year in Uganda

Question 3 – How do you initiate progamme following the skills and knowledge gained from the programme? Answer – Most discussion around sharing lessons learnt and challenges from different country level programmes help address this. Technical details of how to go about this would be addressed when tools are shared as idenitified. For Nigeria however, state programmes should not be initiated as stand alone programmes which run parallel with Federal Givenrment programmes. Effort should be made to link programmes with the Federal Government programmes. The Federal Government would provide technical assistant to states on this matter Addressing hanging issues The issues related to determining beneficiaries from the ARV programme, role of politics and polity in ARV programming were also addressed. However, the issue of providing technical assistance for ART programme initiation was left hanging Suggestions

– WHO presently plays a leading role in providing technical assistance on procurement management for sites interested in initiating programme.

45

– Establishment of a listserv for workshop participants to help facilitate continued discussion. This discussions would be structured quarterly so as to ensure indepth discussion of focal issues that arise

Achievements 1. A multidisciplinary participatory approach to the workshop planning enriched the

discussion and this also help enrich outcomes 2. In an unusual way, the involvement of a number of organizations as collaborators for

this World Bank facilitated training has helped expedite the development of procurement plans for a large number of countries. This was done within a week, a process that would normally take 4 weeks. Though the commitment and hard work of all parties are acknowledged.

The meeting closed with messages from the Federal Government of Nigeria and the World Bank.

46

ASSESSMENT OF MEETING BY PARTICIPANTS

47

LIST OF PARTICIPANTS

PARTICIPANTS ANALYSIS

Total number of participants……………………. 98

Number of Programme Coordinators……………

Number of Procurements officers………………

Number of Pharmacists …………………………

Number of Physicians ……………………………

Number from International agencies…………….

Others (Lawyers, economists, politicians) ……….

COUNTRY DISTRIBUTION

Percentage of Nigerian…………………… 72.45%

48

Percentage of Gambians………………………. 3.06%

Percentage from Sierra Leone………………… 5.10%

Percentage from Guinea Bissau……………… 2.04%

Percentage from Liberia……………………… 2.04%

Percentage from Senegal……………………… 3.06%

Percentage from Tanzania……………………. 3.06%

Percentage from Uganda……….…………….. 2.04%

Percentage from Switzerland……….…………2.04%

Percentage from Zambia …..……….……….…4.08%

Percentage from Botswana ...……….…………1.02%

GENDER DISTRIBUTION

Percentage of females…………………………… 26.53%

Percentage of Males………………………………82.05%

Percentage of Undisclosed……………………… 8.16%

49

PROGRAMME Managing Procurement and Logistics of HIV/AIDS Drugs and Related Supplies

May 30 - June 4 2005, Abuja, Nigeria

Time

Monday May 30

Tuesday Wednesday Thursday Friday Saturday June 4

8.30-10.30 Introduction

WBI

Financing and Pricing

Achal Prabhala

Product Selection and Quantification

Helen Tata/Vincent Habiyambere

Procurement Planning and Management

Helene Moller

Supply Chain Management

Timothy O’Hearn

Lessons Learned in

Implementation: The Nigeria Experience Deo Kimera

10.30-10.45 TEA BREAK 10.45-12.30 Priority Setting

and Effectiveness Patrick Osewe

Financing and Pricing

Achal Prabhala

Quality Assurance

Ben Botwe

Procurement Planning and Management

Helene Moller

Supply Chain Management

Timothy O’Hearn

Conclusion and Summary

WBI

12.30-13.30 LUNCH 13.30-15.30

Intellectual Property Rights

Atangcho Akonumbo

Pharmaceutical Systems

Jabulani Nyenwa

Quality Assurance

Ben Botwe

Country Discussions:

Sharing Experiences

Rational Drug Use

Bannet Ndyanabangi

15.30-15.45 TEA BREAK 15.45-17.30 Intellectual

Property Rights Atangcho Akonumbo

Product Selection and Quantification

Helen Tata/Vincent Habiyambere

Lessons learned from East, Central

and Southern Africa

Jabulani Nyenwa

Country Discussions:

Sharing Experiences

Sharing Experiences in

Rational Drug Use

50