[{"bbox": [96, 178, 1133, 364], "category": "Text", "text": "The COVID 19 crisis, in addition to its heavy direct impact on the Zambian health systems, has also uncovered a number of structural weaknesses. Endemic corruption, poor planning, weak systems and heavy processes have led to a serious medicines availability crisis all over the country during these last years. Part of these problems have been recently reduced by the transfer of medical supplies and medicines procurement responsibility from the Ministry of Health to the autonomous Zambia Medicines and Medical Supplies Agency (ZAMMSA). Still, the country's quasi total dependency on imports of medicines is weighing heavily on the sector's already stretched budget."}, {"bbox": [96, 376, 1133, 589], "category": "Text", "text": "The solution proposed by the new Government was the launch of the Zambia Pharmaceutical Manufacturing Initiative, driven by both public and private sector, involving a dual approach of increasing private investments in local pharmaceutical production and creating a conducive environment for the industry, from a legal and regulatory perspective. The EU and some of its Member States have been the first cooperating partners to support this initiative – for the moment with technical assistance through MAV+. From a Global Gateway perspective, the EU Delegation has been active in prospecting for EU investments in the Zambian Pharma industry – efforts that materialised during the EU-Zambia Pharmaceutical Forum, beginning of March 2023, with the signature of a Memorandum of Understanding between a Spanish and a Zambian company."}, {"bbox": [96, 601, 1133, 787], "category": "Text", "text": "Even though this initiative is quite promising in the long run, there is much to do on the Government side to update old legislation, to improve the licensing and authorisation processes, and in general to create the necessary conducive environment for the development of a local pharmaceutical industry. The European Union has supported the Zambia Medicines Regulatory Authority (ZAMRA) under the Health Systems Strengthening Programme (HSSP), which is presently coming to an end. A mid-term evaluation of the HSSP has concluded that the “EU should consider continuing to be part of this pharmaceutical subsector partnership for a duration to be determined, as the situation is not yet consolidated or considered sustainable”."}, {"bbox": [96, 799, 1133, 879], "category": "Text", "text": "The objective of the support under the proposed action is to continue supporting the subsector, and particularly ZAMRA, in updating the critical legislation (e.g. the Medicines and Allied Substances Act no.3 of 2013) and to further support the Statutory Body to become a more performant and efficient regulatory authority."}, {"bbox": [96, 892, 1133, 945], "category": "Text", "text": "Identification of main stakeholders and corresponding institutional and/or organisational issues (mandates, potential roles, and capacities) to be covered by the action:"}, {"bbox": [96, 957, 1133, 1064], "category": "Text", "text": "The main stakeholders under this action are: 1) the Ministry of Health, holding the responsibility of the larger Health Sector and 2) ZAMRA which has as a mandate to regulate and control the manufacture, importation, storage, distribution, supply, sale and use of medicines and allied substances – and thus that the medicines and allied substances being made available on the local market meet the standards of quality, safety and efficacy."}, {"bbox": [96, 1076, 1133, 1210], "category": "Text", "text": "The policy dialogue will include as well ZAMMSA, in charge of procurement, storage and distribution of medicines and medical supplies to all public health facilities in the country. It will also include local level administration, involving the offices of the Provincial and District Health Directors (PHD&DHD), in charge of supervision of the Ministry's activities at local level, IT support to health facilities, training in the logistics systems, and overall management of the health sector at provincial and district levels."}, {"bbox": [96, 1223, 684, 1250], "category": "Section-header", "text": "### Priority Area 3 – Public Finance Management/Procurement"}, {"bbox": [96, 1275, 1133, 1329], "category": "Text", "text": "In a recent IMF Governance and corruption assessment (2022)¹¹, public procurement was identified as one of the key areas of governance inefficiency and vulnerability to corruption."}, {"bbox": [96, 1341, 1133, 1500], "category": "Text", "text": "In past budget support operations, the low credibility of the budget and the level of misuse of funds originated partly from a failure to follow procurement procedures. In the last decade corruption scandals in the social sectors, particularly recurrent in health, were related to large procurement transactions for the supply of goods and services to the administration. The 2021 report of the Auditor General (AG) identified several incidents of public procurement irregularities, questionable contract prices, and failure of suppliers to deliver goods and services as stipulated in the contracts¹²."}, {"bbox": [96, 1512, 1133, 1566], "category": "Text", "text": "The authorities recognize that public procurement is vulnerable to corruption due to the large amounts of funds involved in procurement transactions and space for discretionary decisions. The risks are particularly significant"}, {"bbox": [86, 1596, 1033, 1622], "category": "Footnote", "text": "¹¹ Zambia: Technical Assistance Report-Diagnostic Report on Governance and Corruption, IMF, 10 January 2023"}, {"bbox": [86, 1621, 477, 1644], "category": "Footnote", "text": "¹² Zambia Auditor General's Main Report 2021"}, {"bbox": [1037, 1680, 1142, 1704], "category": "Page-footer", "text": "Page 8 of 33"}]