The Gambia National Medicines Policy 2022-2025

2.1. INFORMATION ............................................................................................................................................................11

2.2. OUTLOOK AND RISKS ...................................................................................................................................................11

2.3. FINANCING ISSUES AND OPTIONS ...................................................................................................................................11 3 - ORGANIZATION OF THE HEALTH SECTOR .............................................................................................................12 4 - ORGANIZATION OF PUBLIC PHARMACEUTICAL SECTOR .......................................................................................12 4.1. FUNCTIONS OF NATIONAL PHARMACEUTICAL SERVICES AND CENTRE MEDICAL STORES .........................................................12

4.2. FUNCTIONS OF THE MEDICINES CONTROL AGENCY ............................................................................................................13

4.3. FUNCTIONS OF THE PHARMACY COUNCIL........................................................................................................................14 5-GUIDING PRINCIPLES ............................................................................................................................................15

5.1. RIGHT TO HEALTH .....................................................................................................................................................15 5.2 RIGHT OF ACCESS TO QUALITY MEDICINES AND HEALTH TECHNOLOGIES ..................................................................................15

5.3 EVIDENCE-BASED HEALTH CARE .......................................................................................................................................15

5.4 HEALTH SYSTEM REFORMS ............................................................................................................................................15

5.6 SKILLED STAFF RETENTION AND CIRCULATION ....................................................................................................................15

5.7. PARTNERSHIPS ...........................................................................................................................................................15

5.8. EQUITY .....................................................................................................................................................................16

5.9 GENDER EQUITY..........................................................................................................................................................16

5.10 ETHICS AND STANDARDS .............................................................................................................................................16

5.11 CLIENT SATISFACTION .................................................................................................................................................16

5.12 CULTURAL IDENTITY ...................................................................................................................................................16

5.13 GOOD GOVERNANCE AND ACCOUNTABILITY ...............................................................................................................16

5.14 CLIMATE CHANGE & GREEN GROWTH ............................................................................................................................16

5.15 ONE HEALTH APPROACH.............................................................................................................................................16

5.16 PATIENT BILL OF RIGHTS ..............................................................................................................................................17 6. VISION AND MISSION...........................................................................................................................................18

6.1. GUIDING PRINCIPLES ...................................................................................................................................................18

6.2. VISION .....................................................................................................................................................................18

6.3. MISSION ...................................................................................................................................................................18 7. GOAL AND OBJECTIVES ........................................................................................................................................18

7.1. GOAL ......................................................................................................................................................................18

7.2. MAIN OBJECTIVES .......................................................................................................................................................18 8 – CHANGING FOCUS ..............................................................................................................................................19 9- TRANSFORMATIVE ACTION FOR CORE PHARMACEUTICAL SYSTEM.......................................................................20

9.1. LEGISLATION, BYLAWS, AND INSTITUTION BUILDING ...........................................................................................................20

9.6. REGULATION: .............................................................................................................................................................21

9.2. GOVERNANCE AND TRANSPARENCY................................................................................................................................21

9.3. PHARMACEUTICAL RISK MANAGEMENT ...........................................................................................................................22

9.4. HUMAN RESOURCE DEVELOPMENT .................................................................................................................................22

9.5. FINANCIAL RESOURCES.................................................................................................................................................23

9.7. REGISTRATION............................................................................................................................................................23 8 ti Gambia Na onal Medicines Policy 2022-2025

9.8. INSPECTION ...............................................................................................................................................................24

9.9. QUALITY CONTROL ...................................................................................................................................................24

9.10 QUALITY ASSURANCE OF PHARMACEUTICAL PRODUCTS .....................................................................................................25

9.11. PHARMACOVIGILANCE: ..............................................................................................................................................25

9.12. DRUG PRICING .........................................................................................................................................................26

9.13. ACCESS TO ESSENTIAL MEDICINES, ..............................................................................................................................26

9.14. PHARMACEUTICAL SUPPLY CHAIN IN PUBLIC HEALTH SECTOR .............................................................................................27

9.15. MEDICINES SELECTION ...............................................................................................................................................27

9.16. QUANTIFICATION ......................................................................................................................................................28

9.17. PROCUREMENT ........................................................................................................................................................28

9.18. STORAGE AND INVENTORY CONTROL ............................................................................................................................29

9.19. STOCK MANAGEMENT AND INVENTORY CONTROL ............................................................................................................30

9.20. DISTRIBUTION, SERVICE DELIVERY AND LOGISTICS ...........................................................................................................30

9.21. RATIONAL USE OF MEDICINES (RUM) ..........................................................................................................................30

9.22. HOSPITAL PHARMACY ................................................................................................................................................31

9.23. LOGISTIC MANAGEMENT INFORMATION SYSTEM (LMIS) ..................................................................................................31

9.24. INFORMATION MANAGEMENT SYSTEM ..........................................................................................................................32

9.25. WASTE MANAGEMENT ..............................................................................................................................................32

9.26. LOCAL PRODUCTION ..................................................................................................................................................33

9.27. TRADITIONAL MEDICINES ...........................................................................................................................................33

9.28. RESEARCH AND DEVELOPMENT ....................................................................................................................................34

9.29. INNOVATION ............................................................................................................................................................34

9.30. INTELLECTUAL PROPERTY ............................................................................................................................................35

9.31. INTERSECTORAL AND TECHNICAL COOPERATION ..............................................................................................................35

9.32. PANDEMIC HEALTH CRISIS MANAGEMENT .....................................................................................................................36 9.33.ONE HEALTH" APPROACH ............................................................................................................................................36

9.34. GREEN AND CLIMATE SMART PHARMACEUTICAL PRACTICES ...............................................................................................37

9.35. PUBLIC AND PRIVATE PARTNERSHIP (PPP) .................................................................................................................37

9.36. CIVIL SOCIETY ORGANIZATIONS (COMMUNITY PARTICIPATION) .........................................................................................37

9.37. DECENTRALIZATION ...................................................................................................................................................38

9.38. MONITORING AND EVALUATION ..................................................................................................................................38 10. IMPLEMENTATION OF THE NMP .........................................................................................................................38

10.1. COMMITMENT.....................................................................................................................................................38

10.2. MOBILIZATION OF STAKEHOLDERS: .....................................................................................................................38

10.3. MOBILIZATION OF RESOURCES: ...........................................................................................................................39

10.4. COMMUNICATION AND ADVOCACY: ...................................................................................................................39

10.5. MONITORING AND EVALUATION OF THE NATIONAL MEDICINES POLICY ............................................................39 9 ti Gambia Na onal Medicines Policy 2022-2025 1 –PREFACE TO THE NATIONAL MEDICINES POLICY 2022-2025 National Medicine Policy (NMP) 2022 is the third edition produced by the Ministry of Health of The Gambia. The revision has been informed by the National Health Policy “Quality Health Care for All” (2021-2030), the current state of the Pharmaceutical Structure and the need to strengthen the sector as a key component of the health system to meet the ever-changing health needs of the population. These reflect concerns raised regarding access to medicines for managing existing and emerging diseases of public health importance such COVID-19 pandemic which significantly affected availability of health products worldwide with consequences on health systems. The Gambian authorities, aware of these external challenges and in line with the National Health Policy "Quality Health Care for All" (2021-2030) have decided to adapt the national medicine policy. The various elements examined under the policy include but not limited to legislation, governance & transparency, human resources, financial resources, regulatory control, local manufacturing, traditional medicines, procurement and supply management functional areas, waste management, research & development, innovation, intellectual property, intersectoral and technical cooperation, pandemic health crises management, public- private partnership and decentralization, monitoring, and evaluation. In highlighting these areas, due cognizance has been given to available resources, potential of drugs in disease management and the socio-economic environment. The policy has also been formulated with an inherent flexibility to accommodate future developments and changes in the overall vision of attaining health for all including the introduction of the National Health Insurance Scheme. Focusing on access to quality essential medicines for the populace, it is the aim of the Government of The Gambia to foster stronger partnerships for better pharmaceutical service delivery and subsequently better health for all Gambians. The pillars of the revised version are to integrate all the actors of the chain (Manufacturers, Public Authorities, Patients Associations and Health Professionals) on the strategic intervention areas of the NMP. The NMP 2022 has been produced following consultation with various stakeholders of the health and pharmaceutical sectors to promote coherent endeavour required to achieve the objectives of the policy and bring about better health outcomes for the nation. In this light, each partner is expected to take responsibility and engage in a cooperative endeavour to contribute to the achievement of the objectives of the policy by tapping into their unique qualities and strengths. This document shall therefore remain the official policy to guide the pharmaceutical sector in The Gambia. I wish to express my sincere appreciation to World Health Organization for both technical and financial supports, and all other technical experts, the Directorate of Pharmaceutical Services and to the pharmaceutical sector as a whole for their immense contribution and support towards the review of this policy. ………………………………….. Dr. Ahmadou Lamin Samateh Hon. Minister of Health 10 ti Gambia Na onal Medicines Policy 2022-2025 2- RECENT MACROECONOMIC AND FINANCIAL DEVELOPMENTS

2.1. INFORMATION Containment measures introduced to limit the COVID– 19 pandemic helped cause The Gambia’s GDP to contract by an es mated 2.4% in 2020, a er growing 6.2% in 2019. On the supply side, the tourism and trade sectors were the most a ected, while on the demand side, subdued domes c and external demand hurt the economy. The government responded with expansionary scal policy—health spending increased by 0.5% of GDP and food assistance increased by 0.7%. Monetary and nancial policies were also eased—the policy rate was cut by 200 basis points to 10% to boost liquidity. Subdued aggregate demand pushed down in a on to an expected 6% in 2020 from 7.1% in 2019. The scal de cit widened to 3.7% of GDP in 2020 from 2.4% in 2019 as a result of increased spending amid a shor all in revenue collec ons. The decline in remi ances and tourism receipts widened the current account de cit to 8.6% of GDP from 5.3% in 2019. Foreign exchange reserves expected to drop by $10 million in 2020 to $258 million (3.7 months of import cover) while the foreign exchange rate stabilized at GMD 51 to the US dollar throughout the year. Public debt increased to 83.1% of GDP in 2020 from 81% in 2019—because of large scal de cits and government e orts to prop up state-owned enterprises (SOEs). The nancial sector, although well capitalized and liquid, remains vulnerable to spillover e ects of the pandemic on the ability of rms in the tourism, trade, and real estate sectors to service their loans. These three sectors account for 54% of total credit and one-third of non-performing loans. The pandemic has hurt social indicators. An es mated 20,000 jobs were lost in 2020, the unemployment rate was about 40%, and the poverty level was es mated at 48.6%.

2.2. OUTLOOK AND RISKS The outlook is posi ve, if the economy reopens, good rains aid agriculture, global demand improves, structural reforms are ins tuted on non-performing SOEs, monetary policy is accommoda ve, and nego a ons to restructure public debt con nue as a complement to scal consolida on e orts. Real GDP is projected to pick up gradually growing by 3.2% in 2021 and 5.1% in 2022. In a on is projected to decline marginally to 5.9% in 2021 and 5.7% the following year. The scal de cit is projected to narrow to 3.2% of GDP in 2021 and 2.3% in 2022, while the current account de cit will widen to 10.4% of GDP in 2021 and 10.1% in 2022. Downside risks to the outlook emanate from possible spending pressures during the 2021 presiden al elec on. Failure to secure external assistance and a delay in reopening economies are other poten al downside risks.

2.3. FINANCING ISSUES AND OPTIONS The Gambia’s e orts to li growth to its precrisis level could be constrained by adherence to stricter scal rules under an Interna onal Monetary Fund program and Na onal Development Plan provisions for scal austerity. Therefore, The Gambia should explore external assistance to support its post-COVID–19 growth recovery. In this regard, The Gambia could capitalize on its past and ongoing debt restructuring and debt service deferment experiences. The G20 Debt Service Suspension Ini a ve, deferred payments, and debt restructuring of bilateral and mul lateral 11 fi ti ti tt fi fi ti ti ti fi ti fl ti ti ff fi ft ff ti tf fi ti ti fi ti ft ti ti ti ti ff ti ff ti ff fi fi ti fi ti fi fl ti ti fi ti fi fi fi Gambia Na onal Medicines Policy 2022-2025 credits have helped improve The Gambia’s debt distress ra ng to high risk from being in debt distress. The Gambia could also immediately introduce growth-friendly revenue enhancement measures—such as broadening the tax base, improving tax compliance, and streamlining exemp ons. In the short to medium-term, the country could pursue deepening the nancial sector to support private sector credit growth. Priority should be on obtaining new nancing on highly concessional terms, seeking other nancing op ons such as exchanging debt for development and mul creditor debt swaps, and exploring op ons for debt renego a on to bring public debt onto a sustainable path. 3 - ORGANIZATION OF THE HEALTH SECTOR Na onal government health sector leadership resides in the MOH. This ministry comprises 9 directorates. At the execu ve level, the ministry is led by a minister and a permanent secretary. Directors of each of the directorate’s report to the permanent secretary. Func onal responsibili es of the current MOH health directorates: • Directorate of Health Services • Directorate of Planning and Informa on • Directorate of Pharmaceu cal Services • Directorate of Nursing Services • Directorate of Public Health Services • Directorate of Na onal Public Health Laboratory Services • Directorate of Human Resources for Health • Directorate of Health Research • Directorate of Health Promo on and Educa on Regional health directorates (RHDs) are responsible for management and support of the seven regional health teams, which in turn are responsible for primary and secondary healthcare facili es and their sta in their respec ve regions. 4 - ORGANIZATION OF PUBLIC PHARMACEUTICAL SECTOR The Legal framework for regula on of medicines and related products is the Medicines and related products Act 2014 which established the Medicines Control Agency. For pharmacy prac ce, the legal framework is the Pharmacy Council Act 2014 which also established the Council for the regula on of personnel and prac ce premises.

4.1. FUNCTIONS OF NATIONAL PHARMACEUTICAL SERVICES AND CENTRE MEDICAL STORES • Coordinate Policy formula on and implementa on. 12 ti ti fi fi ti ti ti ti ti ti ti ti ti ti fi ti ti ti ti ti ti ff ti ti ti ti ti ti ti Gambia Na onal Medicines Policy 2022-2025 • Coordinate monitoring and evalua on of NMP Implementa on. • Coordinate dissemina on of monitoring and evalua on reports. • Coordinate pharmaceu cal human resources development. • Coordinate regular update of the Na onal Essen al Medicines List treatment guidelines and other gridlines. • Procurement and Supply Management of Medicines and other medical supplies for the public sector pharmaceu cal services delivery. • Ensure quality pharmaceu cal care to the populace.

4.2. FUNCTIONS OF THE MEDICINES CONTROL AGENCY • Regulate all ma ers rela ng to e cacy, quality and safety of medicines and related products. • Regulate in accordance with this Act, the importa on, manufacture, labelling, marking or iden ca on, storage, promo on, sale and distribu on of medicines and or any related product, materials or substances used in the manufacture of products regulated under this act. • Ensure that evidence of exis ng and new adverse events, interac ons and informa on about pharmacovigilance of products being monitored globally, are analyzed and acted upon. • Ensure that, clinical trials on medicines and related products, and herbal medicines are being conducted in accordance with prescribed standards. • Foster co-opera on between the Agency and other ins tu ons or organiza ons and other stakeholders. 13 ti ti ti ti ti ti ti ti ti ti ti ffi ti ti ti ti ti ti ti ti tt ti ti ti fi ti Gambia Na onal Medicines Policy 2022-2025 • Approve and register medicines and related products regulated under this Act, manufactured within or imported. • Examine, grant, issue, suspend, cancel and revoke cer cates and licenses or permits issued. • Appoint inspectors and order inspec on of any premises. • Promote the ra onal use of medicines and herbal medicines. • Establish and maintain the Gambia Na onal Formulary and Pharmacopoeia. • Provide the public with unbiased informa on on products regulated under this Act. • Control of adver sements of medicines and related products. • Prescribe standards of quality in respect of products regulated under this Act, Manufactured or intended to be manufactured or imported into or exported from the Gambia. • Maintain registers pertaining to regula on of medicines and related products prescribed. • Be responsible for its human resource management and development. • Promote, monitor and ensure successful implementa on of the provisions of this Act rela ng to medicines and related products. • A end to and where possible, take legal measures on complaints made by consumers against manufacturers of products regulated. • To ensure that all forms of medicines handling (importa on, exporta on, warehousing, distribu on, manufacturing) are appropriately regulated. • Provide the required human, technical, nancial, and logis cal capacity for the e ec ve applica on of the legisla on. • To ensure that the pharmaceu cal professional prac ces are e ec vely monitored and controlled.

4.3. FUNCTIONS OF THE PHARMACY COUNCIL • Determine the standard of knowledge and skill to be a ained by persons seeking to become members of the pharmacy profession and pharmacy support personnel and reviewing those standards from me to me. • Evaluate and monitor the standards of courses and training for registered persons. • Issue prac cing cer cates to persons and to cancel or suspend such cer cates in terms of this Act. • Prescribe and enforce prac ce standards, conduct, and discipline among registered persons; promote the highest standards of pharmacy prac ce. 14 ti ff fi ti ti ti ff ti tt ti fi ti ti ti ti fi ti ti ti ti ti ti ti ti ti fi ti ti ti ti ti ti ti ti tt Gambia Na onal Medicines Policy 2022-2025 • Maintain registers prescribed under this Act rela ng to pharmacy prac ce. • Promote, monitor and ensure successful implementa on of the provisions of this Act rela ng to pharmacy prac ce. • A end to and where possible, take disciplinary measures on complaints made by consumers. • Carry out such other func ons as may be conferred upon the Council by any wri en law or as are incidental to the performance of its func ons under this Act; establish standards and provide guidelines for con nuing professional development •and training of registered Pharmacists and pharmacy support personnel. • Register and maintain registers for pharmacists and pharmacy support personnel. • Advise the Minister on pharmacy prac ce and measures to protect the health and safety of consumers and the general public. • Encourage coopera on between the Council and other sister councils. • Advise the Minister on developing e ec ve regula ons for the implementa on of the Act; and do such acts or take such measures as are, in the opinion of the Council, necessary or expedient for the preven on of health hazards to consumers which may result from the prac ce of pharmacy as regulated under this Act. 5-GUIDING PRINCIPLES

5.1. RIGHT TO HEALTH The right to health includes mely to acceptable, quality, and a ordable health care.

5.2 RIGHT OF ACCESS TO QUALITY MEDICINES AND HEALTH TECHNOLOGIES Access to essen al medicines is a fundamental element of the right to health.

5.3 EVIDENCE-BASED HEALTH CARE Health planning, programming and service delivery shall be informed by evidence-based research.

5.4 HEALTH SYSTEM REFORMS Devolu on of poli cal and managerial responsibili es, resources and authority in line with the Government decentraliza on program; capacity building for the decentralized structures (ins tu ons).

5.6 SKILLED STAFF RETENTION AND CIRCULATION A rac ve service condi ons (package); job sa sfac on to encourage a net in ow of skills.

5.7. PARTNERSHIPS 15 tt fl ti ti ff ti ti ti ti ti ti ti ti ti ff ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti tt tt Gambia Na onal Medicines Policy 2022-2025 Community empowerment; ac ve involvement of the private sector, NGOs, local government authori es and civil society; e ec ve donor co-ordina on.

5.8. EQUITY Provision of health care shall be based on compara ve need. Accessibility and a ordability of quality services at point of demand for the marginalized and underserved, irrespec ve of poli cal na onal, ethnic or religious a lia ons.

5.9 GENDER EQUITY The planning and implementa on of all health programs should address gender sensi ve and responsive issues including equal involvement of men and women in decision-making; elimina ng obstacles (barriers) to services u liza on; preven on of gender-based violence.

5.10 ETHICS AND STANDARDS Respect for human dignity, rights, and con den ality; good management prac ces and quality assurance of service delivery.

5.11 CLIENT SATISFACTION Accessibility to twenty-four-hour quality essen al services care and blood transfusion services; reduced wai ng me; empathy in sta a tudes; a ordability and adequate sta ng in health facili es.

5.12 CULTURAL IDENTITY The recogni on of the importance of local values and tradi ons, and use of tradi onal structures such as Kabilos, ka os, tradi onal healers and religious leaders.

5.13 GOOD GOVERNANCE AND ACCOUNTABILITY Good governance is an essen al for improving the e ec veness of quality health services and mee ng the needs of the vulnerable people.

5.14 CLIMATE CHANGE & GREEN GROWTH Climate change is a long-term change in the average weather pa erns that have come to de ne Earth's local, regional, and global climates. These changes have a broad range of observed e ects that are synonymous with the term. ...

5.15 ONE HEALTH APPROACH One Health' is an approach to designing and implemen ng programs, policies, legisla on, and research in which mul ple sectors communicate and work together to achieve be er public health 16 ti ti ff ti ti ff ffi fi ti tt ti tt ti ti ti ff ti ff ti ti ti ti fi tti ff ti ti ti ti ti ti ti ff ffi ti ti ff ti ti ti ti ti ti ti ti ti Gambia Na onal Medicines Policy 2022-2025 outcomes. The ‘One Health’ approach is cri cal to addressing health threats in the animal, human and environment interface.

5.16 PATIENT BILL OF RIGHTS The Pa ent's Bill of Rights helps pa ents feel more con dent in the health care system. It assures that the health care system is fair, and it works to meet pa ents' needs; gives pa ents a way to address any problems they may have; and encourages pa ents to take an ac ve role in staying or ge ng healthy.

5.16.1 Informa on disclosure Pa ents have the right to accurate and easily understood informa on about his/her healthcare plan, health care professionals, and health care facili es. This must be done using a language understood by the pa ent so that he/she can make informed health care decisions.

5.16.2 Choice of providers and plans Where possible every pa ent shall have the right to choose health care providers who can give him/her high-quality health care when needed.

5.16.3 Access to emergency services In emergency health situa ons including severe pain, an injury, or sudden illness that makes a person believe that his/her health is in serious danger, he/she shall have the right to be screened and stabilized using emergency services. He/she should be able to use these services whenever and wherever needed without needing to wait for authoriza on and any nancial payment.

5.16.4 Par cipa on in treatment decisions Every pa ent shall have the right to know his/her treatment op ons and take part in decisions about his/her care. Parents, guardians, family members, or others that they iden fy can represent them if he/she cannot make his/her own decisions.

5.16.5 Respect and non-discrimina on Every pa ent must have a right to considerate, respec ul and non-discriminatory care from his/her health care provider (s).

5.16.6 Con den ality of health informa on All pa ents must have the right to talk privately with health care providers and to have his/her health care informa on protected. He/she shall have the right to read and copy his/her own medical record. He/she shall have the right to ask that his/her health care provider change his/her record if it is not correct, relevant, or complete.

5.16.7 Complaints and appeals Every pa ent shall have the right to a fair, fast, and objec ve review of any complaint he/she may have against any health plan, health care provider/personnel or health ins tu on. This includes 17 ti ti ti ti fi ti ti ti ti ti ti ti fi tf ti ti ti ti ti ti ti ti ti ti ti fi ti ti ti ti ti ti ti ti tti ti Gambia Na onal Medicines Policy 2022-2025 complaints about wai ng mes, opera ng hours, the ac ons of health care personnel, and the adequacy of health care facili es. 6. VISION AND MISSION

6.1. GUIDING PRINCIPLES Recognizing the basic human right of access to acceptable healthcare, the policy shall be guided by the principles of assuring equity in accessing safe and e cacious essen al medicines, focusing par cularly on the more vulnerable members of society.

6.2. VISION Ensure the quality and availability (including last miles) of all health product authorized in The Gambia throughout the pharmaceu cal chain (registra on, local manufacturing, importa on, recep on, storage, distribu on, ra onal use, pharmacovigilance) by decentralizing services.

6.3. MISSION To overcome stock-outs, overstocking and the risks of in ltra on of falsi ed health product into the supply chain; In general, to promote a holis c vision of access to quality medicines, taking into account gender equality and equitable access to health care for the di erent categories of the popula on, especially the most vulnerable, in the target geographical areas. 7. GOAL AND OBJECTIVES

7.1. GOAL The overall goal of the Na onal Medicines Policy 2021 is to contribute in its part to the a ainment of the highest possible health standards for the Gambian populace, through the *con nuous* availability, accessibility, a ordability and appropriate use of essen al medicines of appropriate quality, safety and e cacy.

7.2. MAIN OBJECTIVES • To provide a comprehensive legisla ve and regulatory framework that allows for the protec on and promo on of health for the Gambian populace, by ensuring compliance of pharmaceu cal products, personnel, premises and prac ces with the relevant legisla on. • To ins tute a sustainable nancing mechanism that ensures availability and equitable access to adequate quan es of the required essen al medicines. 18 ti tt ti ti ti ff ti ti ffi fi ti ti ti ti ti ti ti ti ti ti fi ff ti ti ti ti ti ti ti ffi ti ti ti ti ti ti ti fi Gambia Na onal Medicines Policy 2022-2025 • To ensure that all medicines selected are relevant to the priority needs of the populace and are procured in a manner that assures their quality, safety, e cacy and cost e ec veness. • To ensure that medicines are used by prescribers, dispensers and consumers in a manner that promotes maximum therapeu c bene t through con nuous educa on and health promo on. • To strengthen the human resource capacity in the pharmaceu cal cadre (both public and private). • To enhance research capacity at all levels. • To establish a robust Pharmaceu cals Management System that ensures availability and accessibility of informa on on pharmaceu cals and promotes the u liza on of such informa on for higher decision making. • To create an enabling environment to encourage local produc on of pharmaceu cals. • To maximize the bene ts of Tradi onal and Complementary Medicines (TCM) where possible and desirable and protect the public against their possible nega ve e ects. • To promote partnership through the ac ve par cipa on of all stakeholders, par cularly the private sector for the e ec ve implementa on of the policy. • To harness the synergies at regional (including community), na onal and interna onal levels to maximize the implementa on of the policy. • To establish a mechanism of coordina ng, monitoring and evalua ng the implementa on of the NMP, in close collabora on with all relevant stakeholders. 8 – CHANGING FOCUS From core func ons to outcome 19 ti ti ti ti ti ff ff ti ti ti ti ti ti ti ti ffi ti ti ti fi ti ti ti ti ti ti ti ti ti fi ti ff ti ti ti ti ti Gambia Na onal Medicines Policy 2022-2025 Outcome of NMP • Popula on coverage: Equity focused access to services for poor and marginalized. • Essen al services: capacity to deliver an essen al package of Hight quality services to those who needed it. • Financial Protec on: Cost of accessing services does not impoverish or curb necessary care. 9- TRANSFORMATIVE ACTION FOR CORE PHARMACEUTICAL SYSTEM

9.1. LEGISLATION, BYLAWS, AND INSTITUTION BUILDING Preamble The Medicines Act of 1984 established the Medicines Board under the ministry of Health to regulate medicines and related products, pharmaceu cal prac ce, and personnel in the pharmaceu cal sector. The ministry of Health in 2014 achieved a major reform with the separa on of regulatory func ons. The Medicines Act 1984 was repealed in 2014 with the enactment of the Medicines and Related Products Act, 2014 which established Medicines Control Agency and the Pharmacy Council 2014 which established the Pharmacy Council. The pharmaceu cal sector regulatory bodies are s ll fairly young, with limited nancial, human resources and exper se. This has meant that the inspectorate arms and the Quality Assurance Departments are s ll underdeveloped, and thus poten al ac vi es under-u lized. 20 ti fi ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti Gambia Na onal Medicines Policy 2022-2025 The regula on of Medical and Dental prac ces is enshrined in the Medical and Dental prac oners Act 1988 and for nursing prac ce, the Nurses, and Midwives Act 1990 for nursing. The Medical Services Act 1988 regulates medical services. However, most of these Acts are old and with their limited execu on. There is no AMR policy and weak governance structures at the regional levels coupled with weak coordina on with other agencies/ins tu ons. Non-separa on of the func ons of NPS and CMS are also major implementa on challenges. Current systems in place for control of imports are not resilient enough and most players in the industry expect this to be strengthened in order to improve the quality of medicines and related products in the country. Currently there are overlaps in some func ons s pulated in the Medicines and Related Products Act and the Pharmacy Council Act with respect to the Inspec on and Licensing of Pharmaceu cal Premises. However, this issue was recognized and resolved through a Memorandum of Understanding (MOU) between the Medicines. Illegal sale of medicines in the open market, Inadequate Human Resources for the MCA and Inadequate public educa on on the safe use of medicines and related products are others challenge for regula on. Policy Statement: Posi oning the pharmaceu cal sector to a successful system that can meet the current and future needs of the Gambian popula on. Policy Strategy: To review and revise current legisla ons and regula ons to align with best pharmaceu cal prac ces Provide the necessary nancial and human resources for the implementa on of the na onal pharmaceu cal policy.

9.6. REGULATION: Preamble Policy Statement: Improve legisla ve and regulatory framework to ensure that medicines are of acceptable safety and quality according to approved standards and speci ca ons. Policy strategy: Digitalize regulatory func ons to further strengthen its performance.

9.2. GOVERNANCE AND TRANSPARENCY Preamble 21 ti ti ti ti ti ti fi ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti fi ti ti ti ti ti ti ti ti ti ti Gambia Na onal Medicines Policy 2022-2025 The Na onal Medicines Policy 2007 is a na onal guide to pharmaceu cal governance and transparency. However, in order to address the current situa on, the policy needs to be updated. Policy Statement: A pharmaceu cal governance and transparency system in accordance with na onal and interna onal best prac ces. Policy Strategy: Develop and implement a na onal Guideline of Good Governance for pharmaceu cal sector implemen ng agencies

9.3. PHARMACEUTICAL RISK MANAGEMENT Preamble The country does not have a na onal guide for pharmaceu cal risk management. Policy Statement: A proac ve pharmaceu cal system with risk management strategies Policy Strategy: Develop and implement a na onal guideline for risk management in the pharmaceu cal sector.

9.4. HUMAN RESOURCE DEVELOPMENT Preamble The Pharmaceu cal sector comprises Pharmacists and Pharmacy support sta . The training of pharmacists is done abroad whilst pharmacy technicians and dispensing assistants are conducted locally at the University of The Gambia, and American Interna onal University, West Africa The overall ra o of skilled health workers per 1,000 popula on is 1.33, fewer than the WHO recommenda on of 2.25 health workers per 1,000 popula on. The ra o of pharmacists and pharmacy support sta stands at 0.029944 per 1000 popula on (HRH Assessment Report, July 2018). The limita on in numbers of pharmaceu cal sta means that, the management of pharmaceu cals is carried out by nursing sta in some health facili es. Policy Statement: Provide competent, mo vated, commi ed pharmaceu cal human resources, equitably distributed throughout the country. Policy strategy: Develop and implement a ve-year human resource development plan for the pharmaceu cal sector. Develop a digital pla orm for con nuing training on pharmaceu cal prac ces. 22 ti ti ti ti ff ff ti ti ti ti ti ti ff ti ti tt ti ti ff ti ti ti ti ti ti ti ti ti fi ti ti ti tf ti ti ti ti ti ti ti ti ti ti Gambia Na onal Medicines Policy 2022-2025

9.5. FINANCIAL RESOURCES Preamble Government health expenditure as percentage of the Total Health Expenditure (THE) was 38.60% in 2016 and decreased to 30.6% in 2017. However, the 2016 and 2017 Na onal Health Accounts (NHA) results indicated that the health sector is mainly funded by external sources, 31.6% and 44.8% respec vely. Similarly, government contribu on to the procurement of medicines and related products is ranging from US$ 0.40 to US $ 1.04 per capita over the past ve years which is less than the recommended WHO threshold of US$2.00 per capita. (Public Expenditure Report, 2018). Although the Drug Revolving Fund (DRF) as a nancing strategy and later the Bamako Ini a ve (BI) were both introduced, access to and u liza on of these funds remains a challenge. The ministry has adopted Result-Based Financing (RBF) as a mechanism to be implemented country wide, following the implementa on of the RBF by the World Bank through NaNA and MoH. In addi on, the ministry has embarked on ins tu ng a Na onal Health Insurance Scheme as an addi onal nancing mechanism for the health sector towards the achievement of Universal Health Coverage. This will enhance equity in access to health care and availability of medicines and related products for the popula on par cularly the poor and the vulnerable. Policy Statement: Securing adequate nancing and payment mechanism for health products. Policy strategy: Government shall set up nancing mechanisms for sustainable nancing of health products. (cost recovery, domes c resource mobiliza on, Na onal Health Insurance Scheme) Promote op mal priori za on/use of investments using risk-based approaches

9.7. REGISTRATION Preamble There are products circula ng in the country without Marke ng Authoriza on. Addi onally, the country has very limited technical capacity to implement the Common Technical Documents (CTD) Guidelines and the assessment of the marke ng authoriza on request. Limited number of registered Medicines and Related Products and weakness of procedures and means dedicated to the evalua on of pharmaceu cal products (Procedures and means dedicated to the evalua on of Marke ng authoriza on applica ons are insu cient). Clinical trials conducted in The Gambia need more thorough follow-up. 23 ti fi ti ti ti ti ffi fi ti ti ti ti ti ti fi ti ti ti ti ti ti ti ti ti ti ti ti fi ti ti ti fi ti ti ti ti ti ti ti fi ti Gambia Na onal Medicines Policy 2022-2025 Policy Statement: The Gambia pharmaceu cal sector has a na onal technical capability that is transparent and in compliance with guidelines procedures to ensure that all products circula ng in Gambia have a Marke ng authoriza on. Policy strategy: To ensure an e ec ve and reliable medicines registra on system

9.8. INSPECTION Preamble The Prac ce of Pharmacy in The Gambia is regulated by The Pharmacy Council. Amongst other func ons, the PCG is responsible for inspec ng licensed premises to assess level of compliance relevant provisions of the Pharmacy Act. However, PCG has inadequate human resource and technical competence, as well as nancial and logis cs support to conduct regular inspec on. Policy Statement: protect the health and safety of the general public through safeguarding, maintaining, and enforcing the highest standards in the prac ce of Pharmacy. Policy strategy: Develop standards and guidelines for inspec on of manufacturing plants, warehouses, public and private pharmaceu cal premises as well as pharmaceu cal prac ce and personnel. Establish e ec ve mechanisms for inspec on of manufacturing plants, warehouses, public and private pharmaceu cal premises as well as pharmaceu cal prac ce and personnel. strengthen and maintain e ec ve inspectorate services PCG.

9.9. QUALITY CONTROL Preamble MCA is the Na onal Regulatory Body responsible to ensure the quality, safety and/or e cacy of medicines, and related products. Amongst other func ons, MCA is mandated to analyse the quality of medicines and related products to ensure that products meet quality standards. However, the QC services is outsourced due lack of a na onal medicines quality control tes ng laboratory and inadequate post marke ng surveillance system. Policy Statement: capacitate MCA to undertake QA and QC responsibili es/func ons Policy strategy: Undertake QA and QC to safeguard quality, safety and/or e cacy of imported health products. Set up a func oning Quality Control Laboratory in coopera on with African Vision and other partners. 24 ti ffi ti ti ti ti ti ti ti ti ffi ti ti ti ti ti ti ti ti ti ti ti ti fi ti ff ti ti ti ti ti ti ti ff ff ti ti ti ti Gambia Na onal Medicines Policy 2022-2025

9.10 QUALITY ASSURANCE OF PHARMACEUTICAL PRODUCTS Preamble MCA is the Na onal Regulatory Body responsible to ensure the quality, safety and/or e cacy of medicines, and related products. Amongst other func ons, MCA is mandated to analyse the quality of medicines and related products to ensure that products meet quality standards. Medicines Control Agency has been cer ed for Quality Management System with ISO 9001:2015 in 2019 and has embarked on web-based registra on of Medicines and Related Products. MAC developed and introduced a Pharmaceu cal Quality Assurance Plan including Procurement and Regulatory ac vi es e.g., Inspec on and Enforcement. In addi on, MCA provides oversight func on for Clinical Trials with approval from The Gambia Government- MRC Joint Ethics Commi ee. However, reinforcing current QA arrangements for imported health program remain a challenge as there are s ll substan al number of unregistered Medicines in the Gambian market. Policy Statement: All Medicines made available to the pa ents must be safe, e cacious, and meet the approved speci ca ons and standards Policy strategy: Improve governance for health product quality assurance system (Evidence -based health product quality assurance legisla on, regula on, and policies). Improve country regulatory system (Market authoriza on/ registra on, inspec on and licensing func ons).

9.11. PHARMACOVIGILANCE: Preamble The MCA is mandated to control the manufacture, importa on, exporta on, distribu on, use and adver sements of medicines and related products to ensuring their quality, safety, and e cacy. Amongst other func ons, MCA is responsible for monitoring, and analysing evidence of exis ng and new adverse events, interac ons, and informa on about pharmacovigilance of products and act upon. However, monitoring and repor ng on the safety of medicines and related products s ll a challenge, par cularly most healthcare prac oners. Other challenges include: • Implementa on of pharmacovigilance requires training and retraining of health prac oners. • There is no Poisons Centre to support the op mal func oning of the pharmacovigilance system. • Limited technical and nancial resources 25 ti ffi ffi ti ti ffi ti ti ti ti ti ti ti ti ti ti ti ti ti ti fi ti ti ti ti ti ti ti fi ti ti fi ti ti ti ti ti ti ti tt ti ti ti ti ti ti Gambia Na onal Medicines Policy 2022-2025 Policy statement: protect pa ents of the risks associated with the use of health products and having a clear picture of adverse events occurring throughout the country. Policy strategy: Migrate to or adopt an e-pharmacovigilance system Improve a pharmacovigilance risk management system Improve the capacity to undertake pharmacovigilance responsibili es

9.12. DRUG PRICING Preamble: The current budgetary alloca on is inadequate to meet actual health needs of the populace. Recently, the ins tu on of nominal registra on fees at RVH, BH and the Regional Clinics is orien ng the popula on to the concept of payment for services. Moreover, public drug prices are comparable private sector pricing scale, an industry that is quite visible in the greater Banjul area and drug supplies into private sector is somewhat more reliable than the government's acquisi ons. Despite the ins tu on of cost recovery program, drug pricing in public pharmaceu cal sector is not well de ned. There is no mechanism to monitor transparency in drug pricing. Factors that contribute to the in ated prices of medicines, such as taxes and tari s need to be removed. Policy Statement: A substan able health products pricing system, with regula on and reference pricing mechanisms that ensures that prices of essen al medicines are maintained at levels a ordable to the popula on. Policy strategy: Improve the health products pricing mechanism and promote medicines a ordability in Gambia Encourage government to exempt VAT on raw materials to promote local produc on of pharmaceu cals

9.13. ACCESS TO ESSENTIAL MEDICINES, Preamble: Government budgetary alloca on for health products has not increased signi cantly lately. There has been a major increase in demand due to popula on increase and coupled with the rapid expansion of health facili es. These factors contribute to the periodic shortages of medicines and other medical supplies. The bureaucra c process involves in the procurement of pharmaceu cals and other medical supply requires improvement. 26 ti ti ti ti fi ff ff ti ti ti ti ti ti ti ti ti ti ti ti ti ti fl ti ti ti ti ti fi ti ff Gambia Na onal Medicines Policy 2022-2025 Despite the implementa on of programs for the most vulnerable, access to products remains problema c in certain areas and for a certain category of popula on. Geographic and nancial access remains a challenge. Policy statement: Make access to products for all by the populace a priority, including the poorest and most vulnerable. Policy strategy: Leverage on Health Insurance Scheme to a ordability of health products by the community Innovate and sustainable distribu on model for last mile delivery of health commodi es to health facili es.

9.14. PHARMACEUTICAL SUPPLY CHAIN IN PUBLIC HEALTH SECTOR Preamble: Despite these investments in the strengthening the health supply chain system in The Gambia, the system is yet to achieve essen al security for some of the required health commodi es, as there are s ll challenges in mee ng the required human resource needs; inadequate storage and distribu on capacity as well as challenges in ge ng quality logis cs data in me to inform decisions. Policy statement: Provide an uninterrupted supply of quality health product to end-users. Policy strategy: Provide CMS and decentralized structures the nancial, human, technical, organiza onal, resources to have a Capability and capacity according to interna onal guidelines and based on the principles of value for money. Provide Technical assistance to MCA for the implementa on of its strategic organiza on according to the WHO MQAS Guide.

9.15. MEDICINES SELECTION Preamble: The Gambia Essen al Medicines List (GEML) and Standard Treatment Guidelines (STG) were rst developed in 1984 and were last updated in 2017. There is no Medicines and Therapeu c Commi ee. The GEML and Standard Treatment Guidelines (STG) were rst developed in 1984 and were last updated in 2017. The GEML comprise of an es mated total of 391 essen al medicines. Between 2017 and 2018, the MoH procured only 36% of the products on the GEML. Of that, 47% and 38% 27 fi ti fi ti ti ti ti ti ti ti ti fi ti fi tti ti tt ff ti ti ti ti ti ti ti ti ti ti ti Gambia Na onal Medicines Policy 2022-2025 of procured items were those categorized for use at the primary and secondary care levels of the health system, respec vely. Importantly, it procured just 12% of GEML items categorized for use at the ter ary care level (HSSA report, 2020). The GEML and STG have not been updated regularly due to the non-existence of a Medicines and Therapeu c Commi ee. Policy statement: Use the principles of evidence-based essen al drug lists, with a focus on prevalence of prevalent diseases and health technology assessment mechanisms. Policy strategy: Apply economic evalua on strategy grounded in research and the scien c method to support evidence-based selec on and pricing decisions. Use GEML and STGs as a basis for procurement, prescribing and dispensing in the public health sector and promote its use in the private sector. Use health technology assessment to support evidence-based selec on, pricing and purchasing decisions.

9.16. QUANTIFICATION Preamble: Since 2017 the MoH established a Na onal Quan ca on Commi ee (NQC) responsible for the quan ca on of essen al medicines and other medical consumables required for the public sector. The Quan ca on process involves all stakeholders including those at periphery user end. However, the lack of reliable data, SOPs and guidelines on quan ca on and the required capacity hinder the quan ca on process. Given the data challenges faced currently in the quan ca on process, a mix method including u liza on of consump on, epidemiological and demographic data are applied. Policy statement: Coordinate all the needs of all the actors and that the data are reliable Policy strategy Improve data processing capacity and quan ca on at all levels Improve interoperability between medicine management informa on system and Health Management Informa on System to allow mely availability of reliable morbidity and consump on data.

9.17. PROCUREMENT Preamble: There is always a designated budget line for the procurement of essen al medicines and consumables for the public health sector. However, the budget allocated is always insu cient to meet the projected needs of public thus, crea ng shortage. The GEML comprise of an es mated total of 391 essen al medicines. Between 2017 and 2018, the MoH procured only 36% of the 28 fi ti ti ffi ti fi ti ti ti ti tt ti fi tt ti ti ti ti fi ti ti ti ti fi ti ti ti ti ti ti ti ti ti ti ti ti fi fi ti ti ti ti ti ti fi ti ti Gambia Na onal Medicines Policy 2022-2025 products on the GEML. Of that, 47% and 38% of procured items were those categorized for use at the primary and secondary care levels of the health system, respec vely. Importantly, it procured just 12% of GEML items categorized for use at the ter ary care level (HSSA report, 2020). There is no standard process to evaluate the executed procurement tasks. Furthermore, data tracking of procurement ac vi es, contracts, and suppliers is not always available. Thus, there is no clear performance system in place to monitor contracts or orders and working with suppliers. Policy statement: Improve the acquisi on process for essen al health products including during pandemics case (avoid stock outs and product losses due to expira on). Policy strategy Coordinate and collaborate on legal and regulatory requirements for ra ca on LTA with suppliers Coordinate and collaborate on possible joint procurement within ECOWAS member country or other individual countries

9.18. STORAGE AND INVENTORY CONTROL Preamble: Currently, there exists a CMS and earlier investments in the public sector led to the construc on of Regional Medical Stores which further enhanced the decentraliza on of the supply chain. The current arrangements are that the Central Medical Stores under the management of the Na onal Pharmaceu cal Services is responsible for the storage of essen al medicines and health consumables. Despite the existence of the Regional and Central Medical Stores, storage capacity remains a challenge. This coupled with ine cient security and the non-existences of a risk management plan, limited number of trained personnel (at the CMS and RMSs) con nue to a ect the performance of the supply chain system. The main challenges are the inadequate storage capacity, ine cient security and the non- existences of a risk management plan, limited number of trained personnel (at the CMS and RMSs). These con nue to a ect the performance of the supply chain system. At the central level, the CMS applies the mSupply licensed so ware while at the RMSs and some hospitals uses the CHANEL so ware. The CHANEL is not interoperable causing lack of visibility between CMS, RMSs and the hospitals. Policy statement: Provide suitable, compliant, and adequate storage facili es (to avoid degrada on of products due to non-compliant condi ons). Policy strategy: Improve warehousing capacity for the CMS to adequately accommodate growing needs for health products Upgrade health facili es storage capacity throughout the country to meet minimum standard storage condi ons 29 ff ti ti ti ti ti fi ti ti ti ti ffi ti ti ti ti ffi ft ti ti ff ti ti ti ti ft ti ti ti Gambia Na onal Medicines Policy 2022-2025

9.19. STOCK MANAGEMENT AND INVENTORY CONTROL Preamble: The management of the stocks is done by manual process genera ng much waste of me and defect of traceability. Policy statement: improve the performance and produc vity of health product logis c in CMS, regional warehouse, and pharmacy hospital. Policy strategy: Implement a na onal roadmap for the digitaliza on of stock management in CMS, Regional warehouse, and pharmacy hospital.

9.20. DISTRIBUTION, SERVICE DELIVERY AND LOGISTICS Preamble: The CMS have four trucks to facilitate the distribu on of essen al medicines and health consumables to the seven RMS and public hospitals. However, there is a lack of u lity vehicles at the CMS to support pick up of commodi es from the ports. RMS eet capacity to conduct the last mile distribu on is impacted by the lack of dedicated transporta on between the RMS and health facili es a ec ng availability of essen al medicine and consumables at the user end. Policy statement: A reliable and sustainable medicines distribu on system to achieve last mile delivery Policy: Strategy: Improve na onal system for distribu on with e ec ve monitoring and maintenance mechanisms

9.21. RATIONAL USE OF MEDICINES (RUM) Preamble: The existence of the Na onal Standard Treatment Guideline and the Essen al Medicines List in 2017 have contributed to the gains of RUM. However, there is weak regula on around the prescribing and use of medicines, especially an microbial agents. There exists no An microbial Resistance Policy (AMR) and no programme on Stewardship. There is inadequate quali ed health personnel, no Na onal Formulary, weak Pharmacovigilance structures,) and weak Laboratory Services, which have all nega vely impacted on ra onal use of medicines. 30 ti ti ti ti ti ti ti ti ti ti ti ff ti ti ti ti ti ff ti ti ti ti ti ti fi ti ti ti ti fl ti ti Gambia Na onal Medicines Policy 2022-2025 In addi on, there is no medicines informa on centers. Therefore, the need for the Review of Policies and Strategies to maximize the gains towards Ra onal Use of Medicines in The Gambia. Policy statement: improve ra onal use of medicines and vaccines to maximize their therapeu c bene t. Policy strategy: Regulate prescribing and dispensing prac ces and strengthen the regula on on promo onal ac vi es on medicines and vaccines. Promote informa on, educa on, and communica on on the use of medicines for the popula on.

9.22. HOSPITAL PHARMACY Preamble: The are many challenges in pharmacy hospital as out of stock, the limited capacity warehouse (and conformity), and the so ware management system for traceability of dispensing. Policy statement: provide for good health product management provisions in hospital se ngs Policy strategy: Improve quality and access to essen al medicines in district and general hospital

9.23. LOGISTIC MANAGEMENT INFORMATION SYSTEM (LMIS) Preamble: The current LMIS requires facili es to collect and report logis cs data every month. All health facili es collect and report logis c data to the Regional Medical Stores where data is aggregated for onward submission to the central level. The CMS aggregates informa on from all RMS to generate na onal stock report that is later shared with key stakeholders. There are SOPs and Job Aid to guide supply chain workforce on procedures for collec ng, repor ng and sharing logis cs data. The logis cs management informa on system uses a mix of both paper- based and electronic inventory control tools. At the central level, the CMS applies the mSupply licensed so ware while at the RMSs and some hospitals use the CHANEL so ware. The CHANEL is a stand-alone so ware causing lack of visibility between CMS, RMSs and the hospitals. Policy statements: Timely and high-quality logis cs informa on is available for decision making and resource alloca on. Policy strategy: Assess and develop the IT requirements and speci ca ons for an eLMIS system 31 ti ti ti ti tti ft ti ti ti ti ti ti ti ti ft fi ti ti ti ti ti ti ti ti ti ti ft ti ti ti ti ti ti fi ti ti ti ft Gambia Na onal Medicines Policy 2022-2025

9.24. INFORMATION MANAGEMENT SYSTEM Preamble: The current Na onal Health Informa on System in The Gambia uses both paper-based in the form of registers and monthly returns at the facility level and electronic systems at the RHDs and central level. The electronic system includes District Health Informa on System (DHIS2), Human Resources Informa on System (HRIS), the Logis cs Management Informa on System (LMIS), and the Integrated Diseases Surveillance and Response (IDSR). There is an ICT Unit within the MOH under the DPI however, there is absence of an ICT Policy and Guidelines for the sector to guide on data management and protec on. Generally, there need for guidelines, skilled sta , and improved ICT infrastructure to facilitate a transi on from paper-based to electronic base health informa on System. Policy statement: improve availability of reliable and adequately protected data. Policy strategy: Regulate medicines related promo ons and adver sement

9.25. WASTE MANAGEMENT Preamble: Health-care waste (HCW) is waste generated during the cause of delivering health care services. Health-care wastes include sharps, infec ous non-sharps materials, blood, body parts and uids, chemicals, pharmaceu cals, radioac ve materials. One of the Medicine policies is to ensure that all medical waste are disposed of promptly, e ciently, and safely. The policy mandates the MCA to ensure suitable methods of disposal of unwanted or pharmaceu cal waste, medical and surgical items are in opera on across the country. However, despite this policy being in place health facili es seem to have a serious problem of appropriately disposing of medical waste such as expired drugs. The WB nanced Project is suppor ng the MOH to establish healthcare waste management across the country that is environmentally friendly: • Two state-of-the-art health care waste treatment machines, which are automated and employ microwave technology have been procured • Construc on of two clinical waste treatment centres, one located at Farato and the other at the Edward Francis Small Teaching Hospital for the Ecosteryl machines. • Seven containerized environmentally friendly and energy e cient dual chamber incinerators; one for each region can be moved from one place to another for waste treatment. • Four refrigerated waste collec on trucks and 120 wheelie bins that will collect and transport healthcare waste from various health facili es to the waste treatment centres. 32 fl ti ti ti ffi ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ff ti ti ti fi ti ffi Gambia Na onal Medicines Policy 2022-2025 • Addi onally, orders have been placed for 40 dual chamber incinerators to be installed at health centres and hospitals across the country. Policy statement: Improve the current waste management prac ces to ensure is environmentally friendly, protects the populace and prevents redistribu on of unwanted pharmaceu cals. Iprove the current prac ces to achieve the goals set out in their plan and develop policies and internal regula ons that will guide them to successful implanta on of the plan Policy strategy: Promote public awareness of HCW impact to the environmental Prevent, regulate, and monitor the disposal HCW

9.26. LOCAL PRODUCTION Preamble: Gambia currently imports 100% of its medicines and there are approximately 10 importers ac ve in the country. A signi cant propor on of its medicines are imported from India which accounts for approximately 90% of products by volume. There is one pharmaceu cal project in the Gambia, Toskani Pharmaceu cals, which is in development but has not been granted a full manufacturing and marke ng license as the company is currently s ll in its set up phase and therefore not ac vely manufacturing products cer ed for distribu on (Gambia GMP roadmap 2019) Policy statement: lessen The Gambia's dependence on importa on of health products Policy strategy: Provide guidance on op mizing local produc on and opera onaliza on in accordance with standard interna onal prac ces Coordinate and cooperate with neighboring countries to explore possibility of joint manufacturing units

9.27. TRADITIONAL MEDICINES Preamble: There are currently weak legisla ve and regulatory systems on tradi onal, herbal and homeopathic medicines, prac ce, as well as other alterna ve medicines. Tradi onal medicines are not included on the Essen al Medicines List. E orts to streamline ac vi es rela ng to tradi onal medicines had resulted to the establishment of the Na onal Tradi onal Medicine Program in the MoH. However, TM is not integrated in the na onal health system and no policy exists. In addi on 33 ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ff ti ti ti ti ti ti ti ti fi ti ti ti ti ti fi ti ti ti ti ti ti ti Gambia Na onal Medicines Policy 2022-2025 there is lack of development of botanical garden and no capacity to analyse the e cacy and toxicity of TM products in country. Policy statement: Maximize the bene ts and minimize the risk/hazard associated with the use of tradi onal medicines Policy strategy: Improve tradi onal medicine regulatory system for safe and e ec ve tradi onal medicines Support the development of a tradi onal medicines policy

9.28. RESEARCH AND DEVELOPMENT Preamble: Research on pharmaceu cals within the health sector is limited in func on due to inadequate human resources, funding and other logis cs such as equipment and legal / regulatory framework. Governance for health research is weak and there is no na onal Ethics Commi ee. Research outcomes are not fully u lized to guide decisions in the sector. The poten al for further opera onal, clinical and tradi onal medicine research exists, but limited research has so far been conducted mainly due to human and nancial resources constraints. There has never been any research conducted on consumer behavior in terms of medicines. Policy statement: Improve research and u lize the outcomes to guide decision in pharmaceu cal sector Policy strategy • Support technology transfer and collabora on. • Leverage MRCG and other exis ng private partnerships to expand drug research and development. • Build drug development capacity at universi es and other stakeholders (pharmaceu cal, toxicology, clinical trials, etc.) supported by an incen ve system within the industry. • Promote inter-university collabora on in drug research and development. • To organize opera onal and implementa on research on access to medicines, quality and ra onal use.

9.29. INNOVATION Preamble: The concept of pharmaceu cal innova on encompasses discovery, development, produc on, and delivery process that enhance the availability of health products and people’s access to them. The complex and dynamic trends in the global pharmaceu cal market and global trade rules highlight the need to strengthen capacity on two fronts: for research, development, and local 34 ti ti ti ffi tt ti ti ti ti ti ff ti ti ti ti ti ti ti fi ti fi ti ti ti ti ti ti ti ti ti ti ti ti ti Gambia Na onal Medicines Policy 2022-2025 pharmaceu cal produc on; and the ability to engage construc vely in delibera ons that a ect the health of the populace. Due to limited scope, budget and me, the pharmaceu cal innova on ini a ves in the pharmaceu cal sector of The Gambia is not well mapped out and developed Policy statement: Introduce innova ve technological solu ons to create more resilient UpToDate pharmaceu cal system Policy strategy: Use new technologies to op mize the pharmaceu cal system while working on environmental protec on. Leverage private sector resources and forge stronger collabora ons

9.30. INTELLECTUAL PROPERTY Preamble: Intellectual property an essen al element for pharmaceu cal Research and Development (R&D) that required to be addressed. The challenge is to work within intellectual property rules to provide incen ves for pharmaceu cal R&D based on pro-public health and pro-access principles. The Gambia is yet to adopt na onal intellectual property measures that protect popula ons health interests o en due to lack of skills in intellectual property management and di cul es nego a ng patent condi ons and exis ng agreements to ensure procurement of the most cost-e ec ve and high-quality drugs to meet country speci c disease needs. As a country, there is a need to balance between high price of innovator medicines poses a major barrier to access to essen al and life-saving medicines vs protec on and reinforcement of intellectual property as a necessary incen ve for innova on and for returns on the investments made to bring new products to market. The pharmaceutical system is not sufficiently documented in the national intellectual property policy. For example, the potential application of ADPICS is not documented. Policy statement: Nurture intellectual property rights protec on Policy strategy: Foster partnership with OAPI and states to implement TRIPS provisions and exibili es to facilitate access to medicines.

9.31. INTERSECTORAL AND TECHNICAL COOPERATION Preamble: There has been increasing support/collabora on with development partners. However there needs to be streamlined coordina on both with the external partners and within the MoH between the various departments to maximize the poten al of the resources whilst avoiding duplica on of e orts, wastage of resources. 35 ti ffi ff ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti fi ti ti ti ti ti ti ti ti ti ti ff ti ti ti ti ti ft ti ti ti ti ti fl ff Gambia Na onal Medicines Policy 2022-2025 Policy statement: Foster, maintain and e ec vely u lize of Technical Coopera on, na onally and interna onally, to ensure the full implementa on of the Medicines Policy. Policy strategy: Bring on board common administra ve and regulatory measures to combat the illicit sale of medicines, vaccines and other medical products in conjunc on with other countries. Incorporate the guidelines of the African Medicines Agency (AMA) into harmoniza on procedures. Domes ca on of the African Union's pharmaceu cal policy, regula ons and guidelines.

9.32. PANDEMIC HEALTH CRISIS MANAGEMENT Preamble: Lessons learned from the health system’s response to emergence of epidemics and pandemics such as, Coronavirus disease (COVID-19), Ebola, Severe Acute Respiratory Syndrome (SARS) and situa ons of disasters with acute sudden increases in injury and loss of lives have raised ques ons about the health system’s preparedness and capacity to manage such and similar emergency situa ons. The Gambia has limited capacity to detect and respond to emerging and re-emerging outbreaks. It has also face lack of resources to opera onalize the Public Health Emergency Opera on Centers in wake of disease outbreaks and Pandemics. Policy statement: Ins tu onalize an emergency response system that adequately respond to emergency situa ons Policy strategy: improve surveillance and response system at all levels to prevent, detect, inves gate, protect against, control, and provide a public health response to the emergencies 9.33.ONE HEALTH" APPROACH Preamble: There is no framework for consulta on between the di erent health actors according to the one health approach. Policy statement: improve collabora on between the human health, animal health, agriculture, and environment sectors to op mize the ght against an microbial resistance. Policy strategy: • Promote the ra onal use of medicines and other health products in human health, animal health, agriculture, and the environment within the framework of the "One Health" approach. • Regulate and promote the use of new technologies in the health sector. 36 ti ti ti ti ti ti ti ti ti ff ti ti ti ti fi ff ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti Gambia Na onal Medicines Policy 2022-2025

9.34. GREEN AND CLIMATE SMART PHARMACEUTICAL PRACTICES Preamble: Waste is an endless problem to dealt with, through the ages, humankind necessi es have escalated, and with the escala on of humankind necessi es, the waste produced by humankind has also escalated. Digitaliza on is one of the e orts to reduce excessive paper waste. The digitaliza on processes have posi vely impacted environment especially in case of waste reduc on. The pharmaceu cal sector is increasingly a culprit with several types of paper-based-waste, such as primary and secondary packaging materials, the waste that is harmful and di cult to dissolved by natural processes. Despite these uncertain es, a global widening range of purposes and goals have been ascribed to the digital transforma on in pharmaceu cal industry, however no situa onal assessment of the climate impact to the industry in the Gambia. Policy statement: The Gambia has a supply chain that is climate resilient with a low carbon footprint Policy strategy: Promote digital transforma on and environment sustainability

9.35. PUBLIC AND PRIVATE PARTNERSHIP (PPP) Preamble: A Directorate of Public-Private Partnership (PPP) has been established to leverage public and private sector resources and exper se to close the infrastructure gap and deliver e cient services to the popula on (h ps://mofea.gm/ppp). Principles governing PPP arrangements are in place and implemented. The current PPP is an arrangement for the procurement of a public service and applies to all sectors and levels of government. As the result, the policy does not speci cally ar culate the level of private pharmaceu cal sector engagement in bring the value added to the public sector. Policy statement: engage the pharmaceutical private sector in optimizing PPP arrangements Policy strategy: improve pharmaceu cal sector PPP including the op mal use of available resources and exper se

9.36. CIVIL SOCIETY ORGANIZATIONS (COMMUNITY PARTICIPATION) Preamble: civil society is not very involved in the management of the pharmaceu cal system. 37 ti fi ti ffi ti ti ti ti ti ffi ti ti ti ti ti ti ti ff ti ti tt ti ti ti ti ti ti Gambia Na onal Medicines Policy 2022-2025 Policy statement: involve civil society as an observer in the improvement and governance of the pharmaceu cal system. Policy strategy: set up a ci zen observatory of pharmaceu cal prac ces.

9.37. DECENTRALIZATION Preamble: Insu cient decentraliza on of the ac vi es of the pharmaceu cal sector in par cular MCA. Policy statement: provide quality services in all areas, including the most remote ones. Policy strategy: incorporate decentraliza on strategy and roadmap for the transfer of responsibili es and resources.

9.38. MONITORING AND EVALUATION Preamble: There is limited collabora on amongst MoH and these ins tu ons. There is also limited human resource capacity. Since there is limited capacity at the M&E Unit, there is need to out-source the M&E ac vi es to independent minds to ensure accuracy and adequate coverage. Since there is limited capacity, there is need to out-source the M&E ac vi es to independent minds to ensure accuracy and adequate coverage. Policy statement: Improve coordina on and collabora on to plan correc ve and preven ve ac on and capitalize on good prac ces. Policy strategy: Improve M&E capacity to collaborate with stakeholders, and to undertake external assemment and Strengthen the capacity for M&E at all levels. Establish the mechanism for external assessment. Strengthen collabora on with key stake holders. 10. IMPLEMENTATION OF THE NMP

10.1. COMMITMENT The Ministry of Health is commi ed to the adop on and implementa on of this Na onal Medicine Policy: • A budgeted implementa on plan will be developed for a 5-year period along with annual or biennial priority ac on plans. • The NPS will be responsible for the implementa on of this policy.

10.2. MOBILIZATION OF STAKEHOLDERS: 38 ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti ti tt ti ti ti ti ti ti ti ti ti ti ti ffi ti Gambia Na onal Medicines Policy 2022-2025 For the implementa on of this policy, the Ministry of Health will ensure the mobiliza on of all stakeholders.

10.3. MOBILIZATION OF RESOURCES: The Ministry of Health is commi ed to developing and implemen ng a plan to mobilize internal and external resources to make this policy opera onal.

10.4. COMMUNICATION AND ADVOCACY: The NPS commits to developing and implemen ng a communica on and advocacy plan to opera onalize this policy.

10.5. MONITORING AND EVALUATION OF THE NATIONAL MEDICINES POLICY The Ministry of Health will create a na onal mul disciplinary and mul sectoral group to monitor and evaluate the implementa on of the Na onal Medicines Policy. The group will be provided with opera ng resources to carry out the tasks allocated to it 39 ti ti ti ti ti ti ti ti ti tt ti ti ti ti ti Gambia Na onal Medicines Policy 2022-2025 5 ti Gambia Na onal Medicines Policy 2022-2025 6 ti