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Me. TA Zambia Country Overview Public Sector Private Sector Civil Society 3/18/2018 Medicines Transparency Me. TA Zambia Country Overview Public Sector Private Sector Civil Society 3/18/2018 Medicines Transparency Alliance 1

Country Overview Violet Kabwe Me. TA Zambia Consultant 3/18/2018 Medicines Transparency Alliance 2 Country Overview Violet Kabwe Me. TA Zambia Consultant 3/18/2018 Medicines Transparency Alliance 2

Multi-stakeholder process What were the major milestones in the multi-stakeholder process? l Establishment of Multi-stakeholder process What were the major milestones in the multi-stakeholder process? l Establishment of the Me. TA Management Structure: Council, Forum and Sub – Committees l Establishment of National Secretariat l Developed Zambia Me. TA website l l Communication strategies implemented at both policy and community levels: motion in parliament, TV and radio live phone in progs, community sensitization road shows, development of fact sheets etc Orientation workshops for Me. TA Council members held in supply chain systems and regulatory issues/mandate l Have developed synergies with GGM l Conducted data disclosure tool l Drafted advocacy position papers on ‘ADDO’ system in Zambia and counterfeit and substandard drugs l Commissioned studies impinging on availability, affordability, and access to medicines l Provided technical support to CSO Coalition capacity building on supply chain systems 3/18/2018 Medicines Transparency Alliance 3

Major achievements and successes What where the main achievements and successes of Me. TA Major achievements and successes What where the main achievements and successes of Me. TA in your country? l Successful, well-attended Me. TA launch, opened by Minister of Health. l Effective capacity building of Council members in supply chain management and functions of PRA. l Successful mobilization of cross-party parliamentarians; moved motion in parliament which introduced Me. TA concept to august house. l Good buy-in from Cabinet Office –agreement to distribute Me. TA materials. l Establishment of national Me. TA Secretariat l Effective community mobilization efforts in rural pilot districts of North-Western Province –included 2 successful radio shows. l Live radio/TV programmes have become popular and made Me. TA ‘visible’ l Community radio station managers mobilized through sensitization workshop. l Mainstreaming of Me. TA in community programs have gained popularity l Me. TA included in national health reform processes l Reports commissioned for challenges of manufacturing sector, pricing structures in public/private sector, private sector mapping survey and data disclosure survey. l Me. TA Zambia website commissioned –impressive design. l Me. TA Forum meeting held 3/18/2018 Medicines Transparency Alliance 4

Overall challenges (1) What have been the main challenges during the Me. TA pilot Overall challenges (1) What have been the main challenges during the Me. TA pilot phase? l Creating trust and Commitment among stakeholders by striving to share joint Me. TA learning among all stakeholders common Me. TA benefits strategy or/and understanding that cuts across all sectors l Commitment by all stakeholders was a challenge l Me. TA Council/CSO Coalition synergies were not apparent l l l Felt need to set up sub – committees as implementation bodies of Me. TA Council Expected support from government and CPs did not fully materialize Used two pronged approach, targeting both policy and community levels as entry points for dialogue/sensitization concerning Me. TA core principles Capacity building of Me. TA Council members in pharmaceutical sector and health care delivery systems. Making private sector representatives, line ministry officers and members of parliament to become aware and gain knowledge on Me. TA issues 3/18/2018 Medicines Transparency Alliance 5

Overall challenges (2) l Delayed funding due to local bureaucracy meant late start to Overall challenges (2) l Delayed funding due to local bureaucracy meant late start to implementation of national work plan l Delayed/disrupted recruitment and housing of Secretariat l Support of other Me. TA CPs to Initiative was not forthcoming l Need to maintain continuous buy-in of all sectors and stakeholders time-consuming. l l l l Operations of Council and Sub-Committees depend on voluntarism, and high levels of commitment and time. Most members in full-time work so regular participation challenging, very apparent in the Research & Survey sub - committee. Large Council makes convening meetings logistically challenging and expensive. –Large numbers with varied skills mix means decision-making is slow. Initially, a calendar of Council and Sub-Committee meetings was not published in advance, made planning and scheduling challenging. Lack of clarity on the log frame, delayed work plan approval, and disrupted timely funding/ implementation. Adhoc requests from Me. TA International for sudden activities a big challenge; especially with a tight work plan to implement Non – disclosure of pricing structures by most pharma industry Disclosure tool only made available in Sept 2009 –would have been useful as baseline data and for work plan development. 3/18/2018 Medicines Transparency Alliance 6

Lessons Learned What are the main lessons from Me. TA in your country? l Lessons Learned What are the main lessons from Me. TA in your country? l l Me. TA process is technical and complex, hence requires capacity for all members to move at the same pace. There are diverse interests among Me. TA members who continuously strive to have common understanding and expected outcomes from the Me. TA Process Establishing consensus requires constant lobbying for exchange of views Commitment of people important otherwise multi-stakeholder processes will not work l Me. TA members need medicines and management expertise l Me. TA can not operate in a political vacuum l l l Me. TA CSO needs to include members that are able to engage in dialogue at high profile level Two pronged approach in Me. TA process (sensitization/lobbying at grassroots and policy levels respectively), improved Me. TA ‘visibility” Non completion of desk review of data affected other dependent activities 3/18/2018 Medicines Transparency Alliance 7

Community Awareness l l l Community awareness activities – Me. TA roadshow in Mkushi Community Awareness l l l Community awareness activities – Me. TA roadshow in Mkushi Opportunity to create public awareness about Me. TA Positive response to Me. TA issues in rural communities 3/18/2018 Medicines Transparency Alliance 8

Thank you l Violet Kabwe l Email: kabwe. violet@gmail. com l Mobile number: +260976939364 Thank you l Violet Kabwe l Email: kabwe. [email protected] com l Mobile number: +260976939364 l Website: www. metazambia. org 3/18/2018 Medicines Transparency Alliance 9

Public Sector Mrs Bernice Mwale Director – Product Registration Pharmaceutical Regulatory Authority 3/18/2018 Medicines Public Sector Mrs Bernice Mwale Director – Product Registration Pharmaceutical Regulatory Authority 3/18/2018 Medicines Transparency Alliance 10

Summary Analysis at start of Me. TA What were the needs and issues in Summary Analysis at start of Me. TA What were the needs and issues in your specific sector at the start of Me. TA l l l Me. TA was initially to be housed within MOH, later agreed that Transparency International (Z) be host Me. TA very much linked to public sector; MOH key to success of Me. TA, even though not driving Me. TA provides big opportunity to have all different stakeholders on one roundtable to discuss issues that could influence policies/practices l Understanding core principles of Me. TA by members very key l Expected support from CPs l Me. TA members are volunteers, their time is at a premium l The size of Me. TA Council directly relates to Me. TA effectiveness l Targeting issues that directly impacts general public is measure of Me. TA success 3/18/2018 Medicines Transparency Alliance 11

Major milestones l l Government has shown support towards Me. TA as shown by Major milestones l l Government has shown support towards Me. TA as shown by the Minister of Health launching of Me. TA in Zambia and other activities Government has participated in the Me. TA live radio programs after some initial hitches Orientation workshop for Me. TA Council members in PRA mandate/functions Orientation of Me. TA Council members in the national supply chain systems (public and private) l Collaborative meeting held between PRA and its stake holders l Active participation of MOH and its institutions in Forum meeting l Co-chairing of Me. TA Council meetings 3/18/2018 Medicines Transparency Alliance 12

Successes l Me. TA provided another forum for dissemination of information to wider circle Successes l Me. TA provided another forum for dissemination of information to wider circle of stake holders l Participation in live Me. TA radio programs l MOH representative is Vice Chairperson of Me. To. A Council l l Successful orientation of Me. TA Council members in the functions/mandate of PRA Successful collaboration by PRA with key stakeholders on various issues affecting them Successful orientation of Me. TA Council members by MOH/its institutions on the national supply chain system Active participation of MOH, PRA and MSL IN THE Me. TA Forum meeting 3/18/2018 Medicines Transparency Alliance 13

Challenges (1) l l l Big challenge for government employees to talk about transparency Challenges (1) l l l Big challenge for government employees to talk about transparency and accountability issues Finding time to attend to Me. TA activities given busy schedules Weakness in the tools that were used to carry-out some surveys; should have been field tested first The surveys were supposed to gather more evidence for advocacy and influencing change Ensuring quality verses spending more money in a short time (to beat financial deadline). It was a challenge for some government officials in the Me. TA sub -committees to follow tendering procedures rather than those followed in government (Comprehensive Tendering Procedures) 3/18/2018 Medicines Transparency Alliance 14

Challenges (2) l l l Balancing Me. TA activities and government duties was a Challenges (2) l l l Balancing Me. TA activities and government duties was a challenge, especially that Me. TA programs do not give sufficient notice The role of MOH in Me. TA is key, however, need to recognise that MOH is not the driver for Me. TA may be expected to address all kinds of issues, even if these are influencing access to affordable essential medicines Most CPs needed to be reminded about Me. TA can be seen as a tool with which to ‘punish’ or ‘expose’ the weaknesses in the public health sector 3/18/2018 Medicines Transparency Alliance 15

Challenges (3) l l l The challenge Me. TA presents is that all stakeholders Challenges (3) l l l The challenge Me. TA presents is that all stakeholders and concerned citizens want to be counted within Me. TA. This is clearly a difficult situation for Me. TA Council and admin team Me. TA is still in the formative stage and it may feel inadequate to tackle certain issues that impact on access to essential medicines Initial focus was on private sector from the regulatory point of view Misrepresentation of facts by consultant involved in desk review, delayed other Me. TA follow on activities Some of the tools used for data collection appeared to be deficient in certain critical information. 3/18/2018 Medicines Transparency Alliance 16

Lessons Learned (1) l l Me. TA should have an independent stand alone registered Lessons Learned (1) l l Me. TA should have an independent stand alone registered secretariat It was an opportunity for government to share information with the general public to discuss health issues, the forum can be used to share information dialogues with other stakeholders to introduce/withdraw new policies, schemes, fees and report illegal practices It was learnt that it is important to identify issues surrounding a survey before it is carried out. Difficult to fit in Me. TA activities 3/18/2018 Medicines Transparency Alliance 17

Lesson Learned (2) l l l There was need to have clear cut issues Lesson Learned (2) l l l There was need to have clear cut issues identified if a change was to be achieved it was a big opportunity for government to have all different stakeholders on one table hence a chance to raise awareness to other sectors. Awareness was also raised through the Me. TA radio programs Me. TA is very much linked to the public health sector. The MOH, even though not driving Me. TA, is key to the success of Me. TA There is a need to advocate for more infrastructure and health personnel to improve quality and accessibility of good quality medicines Focus on one or two issues was very necessary if tangible results were to be achieved The public health sector need not be seen as the only target for Me. TA 3/18/2018 Medicines Transparency Alliance l 18

Lessons Learned (3) l l Knowledge of the purpose and intentions of Me. TA Lessons Learned (3) l l Knowledge of the purpose and intentions of Me. TA by stakeholders. There is a need for all members and stakeholder to keep in mind the background that resulted in Me. TA The support from Cooperating Partners has been below expectation l Me. TA members are volunteers and their time is at a premium l The size of Me. TA Council directly relates to the effectiveness of Me. TA l l Targeting issues that directly impact the general public is a measure of Me. TA’s success Clearly the time- frame for Me. TA put pressure on members and the Me. TA administrative team. All parties want to succeed. 3/18/2018 Medicines Transparency Alliance 19

Thank you l Name of presenter : Mrs Bernice Mwale l Job Title: Director Thank you l Name of presenter : Mrs Bernice Mwale l Job Title: Director – Product Registration (PRA) l Email: [email protected] gov. zm l Mobile number: +260977804353 l Website: www. metazambia. org 3/18/2018 Medicines Transparency Alliance 20

Private Sector Presenter Name : Ruth Mudondo Job Title: Director – Unicare Pharmaceuticals. Chair Private Sector Presenter Name : Ruth Mudondo Job Title: Director – Unicare Pharmaceuticals. Chair person – Zambia Pharmaceutical Business Forum. 3/18/2018 Medicines Transparency Alliance 21

Summary Analysis at start of Me. TA What were the needs and issues in Summary Analysis at start of Me. TA What were the needs and issues in your specific sector at the start of Me. TA? Issues Ø Ø Ø Private sector was battling with the challenges & problems– alone. Though Zambia Pharmaceutical business Forum (ZPBF) was in place. Lack of transparency at MOH – One of the major concerns of the Private sector Lack of flow of information and very little consultation between Pharmaceutical regulatory authority – Private sector – PRA Private sector was not able to access some of the information at PRA. Lack of unity among the business community - drive to fight for the common cause. . . Needs Ø Wanted someone to represent the private sector in the Me. TA process 3/18/2018 Medicines Transparency Alliance 22

Major milestones What milestones have been achieved during the Me. TA pilot phase? Establishment Major milestones What milestones have been achieved during the Me. TA pilot phase? Establishment of Multi stake holders forum – Fantastic Ø Ø PRA (Pharmaceutical Regulatory Authority) heard the challenges of the Private sector from a neutral body like Me. TA MOH was more willing to respond to the queries raised by the Private sector. CSO and Media got to know the role of private sector in Health care. Private sector found it easy to express their challenges in the Me. TA meetings and most of the time private sector got the positive support from Me. TA. 3/18/2018 Medicines Transparency Alliance 23

Successes What were the successes for your sector during the Me. TA pilot phase? Successes What were the successes for your sector during the Me. TA pilot phase? Ø Ø Ø Zambia Pharmaceutical Business Forum – Recognition Issues pertaining to Local Pharmaceutical Manufacturers were taken up on FAST TRACK and are being addressed by relevant authorities. Media Campaigns: Ordinary citizens got to know more about distribution of medicines and the challenges that are faced by the Public & Private sector in delivering quality medicines. Radio program: Flow of information – Interactions – Public Participation Documentary: Public awareness about the role of Private industry in National Health care – Increased 3/18/2018 Medicines Transparency Alliance 24

Challenges What challenges has your sector endured during the Me. TA pilot phase? Ø Challenges What challenges has your sector endured during the Me. TA pilot phase? Ø Ø Ø Certain segment of Private sector is yet to appreciate Me. TA activities. Certain segment of private sector – Sceptical about Me. TA. Balancing the Me. TA activities with the routine business activities is a challenge. Getting co operation – conducting survey – is a real tough job Understanding the concept of disclosure – Cant visualize the benefits – hence it is difficult to get the support of private sector. 3/18/2018 Medicines Transparency Alliance 25

Lessons Learned What are the lessons that your sector has learned from Me. TA? Lessons Learned What are the lessons that your sector has learned from Me. TA? Ø Ø Importance of MULTISTAKE HOLDERS approach – well understood Strength and weaknesses of other government institutions, learnt others limitations and started appreciating their efforts to be more transparent and accountable. Ø Importance of Disclosure tools – Give and take policy. Ø Importance of lobbying 3/18/2018 Medicines Transparency Alliance 26

PHARMACEUTICAL PRIVATE SECTOR IN ZAMBIA 3/18/2018 Medicines Transparency Alliance 27 PHARMACEUTICAL PRIVATE SECTOR IN ZAMBIA 3/18/2018 Medicines Transparency Alliance 27

Challenges of Pharmaceutical manufacturing in Zambia l Challenges of Pharmaceutical manufacturing in Zambia – Challenges of Pharmaceutical manufacturing in Zambia l Challenges of Pharmaceutical manufacturing in Zambia – Lack of modern equipment – Limited research and development expertise 3/18/2018 Medicines Transparency Alliance 28

Thank you l Ruth Mudondo l Director - Unicare Pharmaceuticals 3/18/2018 Medicines Transparency Alliance Thank you l Ruth Mudondo l Director - Unicare Pharmaceuticals 3/18/2018 Medicines Transparency Alliance 29

Civil Society Dimuna Phiri Paralegal Officer- Zambia AIDSLaw Research and Advocacy Network 3/18/2018 Medicines Civil Society Dimuna Phiri Paralegal Officer- Zambia AIDSLaw Research and Advocacy Network 3/18/2018 Medicines Transparency Alliance 30

Summary Analysis at start of Me. TA What were the needs and issues in Summary Analysis at start of Me. TA What were the needs and issues in your specific sector at the start of Me. TA? *To build capacity amongst CSO’s so as to enable them to engage and deliberate in the multi stakeholder process* l l To acquire advocacy skills To understand policy formulation and analysis as well as government structures and functions l To understand the drug supply chain in Zambia l To acquire research and budget tracking skills l To understand the Multi Stakeholder Process 3/18/2018 Medicines Transparency Alliance 31

Major milestones l Advocacy training was conducted l Drug supply chain training was conducted Major milestones l Advocacy training was conducted l Drug supply chain training was conducted l l l A training on policy formulation and analysis as well as the functions of government and it’s structures was conducted. 15 Civil society organization are fully committed in the coalition Me. TA CSO’s took part in the radio programs and television documentary. 3/18/2018 Medicines Transparency Alliance 32

Successes l Me. TA CSO secretariat is in operation l The Work-plan was successfully Successes l Me. TA CSO secretariat is in operation l The Work-plan was successfully developed and approved l An advocacy strategy has been developed l l Increased knowledge amongst CSO’s on medicine issues to participate in various opportunities and forums. Developed networks with the private government and similar campaigns such as the Stop Stock Out Campaign. Me. TA CSO has legitimacy because it has representation from the community. Multi-dimension civil society participation. (e. g. governance, faith based, media and human rights organisations. ) 3/18/2018 Medicines Transparency Alliance 33

Challenges l l l The implementation period of the work-plan was too constraining. Dividing Challenges l l l The implementation period of the work-plan was too constraining. Dividing time between respective organisational duties and Me. TA activities was a challenge Delay in the disbursement of funds Health issues are complex and time is needed to build adequate capacity to understand them. Co-opting organisations in the Me. TA CSO process was a challenge on inception 3/18/2018 Medicines Transparency Alliance 34

Lessons Learned l The work plan was over ambitious (time-frame) l Some trainings were Lessons Learned l The work plan was over ambitious (time-frame) l Some trainings were too technical. l Fluctuation in exchange rates affected the budget l Harmonizing Me. TA Zambia and Me. TA CSO work-plan was a challenge l There was under budgeting during the budget planning process l There is so much that Me. TA CSO’s can do as regards to issues on health in Zambia. (evidenced from the trainings) l There is a need to share and link with other similar campaigns. l CSO’s became aware that they had a role to play in the pharmaceutical sector 3/18/2018 Medicines Transparency Alliance 35

Thank you l l Name of presenter : Dimuna Phiri Job Title: Paralegal Officer- Thank you l l Name of presenter : Dimuna Phiri Job Title: Paralegal Officer- Zambia AIDSLaw Research and Advocacy Network l Email: [email protected] com l Mobile number: +260979092885 l Website: www. metazambia. org 3/18/2018 Medicines Transparency Alliance 36