FIRST AFRICAN MEDICINES REGULATORY AUTHORITIES CONFERENCE FINAL REPORT

FIRST AFRICAN MEDICINES REGULATORY AUTHORITIES CONFERENCE FINAL REPORT

WHO/AFRO/EDM/09.1 First African Medicines Regulatory Authorities Conference Final Report Addis Ababa, Ethiopia 31 October 3 November 2005 In collaboration with Department of Medicines Policy and Standards (PSM) Department of Technical Cooperation for Essential Medicines and Traditional Medicine (TCM)

AFRO Library Cataloguing-in-Publication Data First African Medicines Regulatory Authorities Conference: Final Report 1. Legislation, Drug 2. Drug Industry 3. Economics, Pharmaceutical 4. Public Health 5. Congresses as Topic 6. Africa ISBN : 978 929 023 1417 (NLM Classification: QV 33 ) WHO Regional Office for Africa, 2009 Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. All rights reserved. Copies of this publication may be obtained from the Publication and Language Services Unit, WHO Regional Office for Africa, P.O. Box 6, Brazzaville, Republic of Congo (Tel: +47 241 39100; Fax: +47 241 39507; E-mail: afrobooks@afro.who.int). Requests for permission to reproduce or translate this publication whether for sale or for non-commercial distribution should be sent to the same address. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization or its Regional Office for Africa be liable for damages arising from its use. Printed in India

CONTENTS Page ABBREVIATIONS...I EXECUTIVE SUMMARY...III 1. INTRODUCTION...1 1.1 Background...1 1.2 Participants...2 2. OPENING OF THE MEETING...2 2.1 Introduction to the conference...2 2.2 Welcome address...4 2.3 Official Opening of the Conference...4 2.4 Message from WHO/HQ...5 2.5 Administrative arrangements...5 3. METHOD OF WORK...6 4. MAIN TOPICS PRESENTED AND DISCUSSED AT PLENARY...6 4.1 Medicines regulation in sub-saharan Africa: an overview...6 4.2 Country initiatives to promote effective medicines regulation...8 4.3 Medicines regulation development path: concept for discussion...13 4.4 Revamping medicines regulation to respond to public health priorities...14 4.5 Medicines regulation harmonization in Africa...15 4.6 Effective law enforcement and regulation of distribution...22 4.7 Ethical practice, conflict of interest, code of conduct in medicines regulation...22 4.8 Rapid alert system on quality of medicines...23 4.9 Counterfeit medicines: framework convention...23 4.10 Current topics...24 5. DEVELOPMENT OF THE REGIONAL STRATEGIC PLAN...28 6. RECOMMENDATIONS...33 7. CLOSING CEREMONY...34 ANNEX: LIST OF PARTICIPANTS...35

ABBREVIATIONS ADR AFDRAN AIDS AMRAC ARFI ARV AU CEAC COMESA DACA DFID DRA DPM EAC EU ECOWAS EDM EML GCP GDP GMP GTN HIV ICDRA ICH IEC Adverse Drug Reaction African Drug Regulatory Authority Network Acquired Immunodeficiency Syndrome African Medicines Regulatory Authorities Conference Adverse Reactions Following Immunization Antiretroviral Medicines African Union Economic Community of Central Africa States Common Market of Eastern and Southern Africa Drug Administration and Control Authority Department for International Development (of United Kingdom) Drug Regulatory Agency/Authority Directorate of Pharmaceutical Services East African Community European Union Economic Community of West African States Essential Drugs and Medicines Policy Essential Medicines List Good Clinical Practices Good Distribution Practices Good Manufacturing Practices Global Training Network Human Immunodeficiency Virus International Conference of Drug Regulatory Authorities International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use Information, Education and Communication i

MDG MOH MRA NDA NDP NEPAD NMRA NPO PMS PSM QC QSM RAS RDU SADC TCM TRIPS UEMOA WAHO WCO WHO WR Millennium Development Goal Ministry of Health Medicines Regulatory Authority National Drug Authority National Drug Policy New Partnership for Africa's Development National Medicines Regulatory Authority National Professional Officer Post Marketing Surveillance Medicines Policy and Standards (Department of WHO) Quality Control (of Medicines) Quality and Safety of Medicines (Team of WHO/PSM) Rapid Alert System Rational Drug Use Southern African Development Community Technical Cooperation on Essential Drugs and Traditional Medicines (Department of WHO) Trade-Related Aspects of Intellectual Property Rights West African Monetary and Economic Union West African Health Organisation WHO Country Office World Health Organization WHO Country Representative ii

EXECUTIVE SUMMARY Currently, about 7% of the 46 sub-saharan African countries have a moderately developed medicine regulatory capacity. Of the remaining, about 63% have minimal capacities whereas 30% do not have a National Medicines Regulatory Authority (NMRA) in place. Over the years, the World Health Organization together with other international organizations and donor countries has been supporting African countries to establish and strengthen their medicine regulatory authorities. Despite the efforts made however situations have not changed much. Some of the reasons for this have been absence of government support, lack of adequate number of trained and qualified staff, high staff turn-over due to low salaries and lack of incentives, inadequate and unsustainable funding of the NMRAs, weak infrastructure. A conference of African Medicine Regulators held from 30 October 3 November 2005 in Addis Ababa, Ethiopia discussed the medicine regulatory situation in the subregion and came up with the following as the main characteristics: ineffective licensing system, weak product registration, poor inspection practices, inadequate access to quality control laboratories, inadequate market control, non existence of pharmacovigilance and control of promotion, lack of clinical trials, oversight, inadequate communication and information exchange system, lack of transparency and accountability and conflict of interest. The result is in many of sub-saharan African countries medicines are imported into the countries or manufactured locally without any appropriate quality assurance safeguards. In addition, in many of these countries medicines are smuggled across borders and sold in open market places and on streets, leading to a high prevalence of sub-standard and counterfeit medicines. Reports indicate that in sub-saharan Africa, on the average, as much as 30% of samples of medicines tested fail quality tests. The meeting also identified inadequate government and public support; law status given to NMRA; inadequate number of qualified and skilled staff; lack iii

of legislation, regulations, guidelines and procedures; inadequate and unsustainable resources; weak enforcement mechanisms and sanctions and corruption to be the main barriers to the improvement of medicine regulation in the subregion. The Conference recommended the following strategies to improve medicine regulation in the sub-region: Take gradual, feasible and realistic steps towards regulation Review and strengthen legislation Put in place an appropriate structure to support effective regulation Review and develop/strengthen regulations, guidelines and procedures to support regulation Establish mechanisms to ensure financial sustainability of MRAs Set up mechanisms to ensure recruitment, training and maintenance of adequate human resources Put in place advocacy strategies for effective drug regulation Improve IEC for the sensitization of stakeholders, civil societies and the general public to appreciate and support effective drug regulation Set up systems for managing and sharing of information Put in place mechanisms for monitoring and evaluation of implementation of drug regulation In conclusion, the Conference developed a five year plan for the development of medicine regulation in the sub-region and recommended that: National Medicine Regulatory authorities should: Develop and implement strategies to promote effective medicines regulation. Prepare and submit to WHO/AFRO a 2-year national plan indicating the priority activities to be undertaken in 2006 2007 to improve medicines regulation. Explore regional collaboration and support the creation of networks to share information on medicines regulation. iv

Government should: Support medicines regulation and provide adequate funds to NMRAs to perform their functions. Advocate for and support sub-regional and regional harmonization initiatives. Support human resources development for medicines regulation. Institutionalize the development and strengthening of autonomous NMRAs. WHO/AFRO should: Organize a conference for all African Medicines Regulatory Authorities at least once every two years to further the exchange of information and experiences of medicines regulation in the region. Ensure better coordination of medicines regulatory activities in the region. Advocate for countries to establish MRAs and adequately fund medicines regulation. Strengthen and expand MRA assessments to other countries in the region. Support capacity building and training of MRA staff. Ensure that all existing tools and documents are available in both English and French. Promote the exchange and use of technical expertise available in the region. v

1.INTRODUCTION 1.1 Background Currently it is estimated that about 30% of the 46 sub-saharan African countries do not have a National Medicines Regulatory Authority (NMRA) in place. About 7% of the remaining countries have a moderately developed capacity, and that a massive 63% have minimal capacities that hardly function. In most of these countries, NMRAs have an inadequate number of staff that are insufficiently trained and qualified. Staff turn over is high due to low salaries and lack of incentives. In addition, funding is inadequate and unsustainable, infrastructure is weak, and access to independent and objective medicine information is lacking. Consequently, in many of these countries medicines are imported without any quality assurance safeguards, while those manufactured locally are produced and distributed under deficient manufacturing and distribution conditions. Moreover, medicines are smuggled in and out of the countries and sold in open market places and on streets, leading to a high prevalence of sub-standard and counterfeit medicines. Reports indicate that in sub-saharan Africa, on the average, as much as 30% of samples of medicines tested fail quality tests. A recent study carried out by WHO showed that more than 50% of samples failed quality tests. In some countries, the prevalence of counterfeit medicines is estimated at 60% of the medicines found in market places. WHO has been supporting sub-saharan African countries to establish and strengthen their national medicine regulatory and quality assurance systems for a long time. More specifically, in the past 10 years, WHO in collaboration with other development partners, has organized several training courses and supported the participation of a large number of medicine regulatory officers in conferences and workshops. In addition, a number of initiatives were undertaken to stimulate regional and subregional collaboration in order to complement these activities. In 2003, WHO initiated a special scheme aimed at providing focused assistance to selected national medicine regulatory authorities, training regulatory officers in the different areas of medicine regulation, promoting subregional medicine regulation harmonization, and establishing centres of excellence for training medicines regulatory officers. For instance, in the last three years, under this 1

scheme, WHO assessed the regulatory systems of six countries in the subregion, identified gaps, developed action plans together with the respective NMRAs and provided financial and technical support to five of them. In addition, it supported existing and new harmonization initiatives and sent out circular letter to countries to express their interest to serve as training centres. The progress made so far under the scheme is encouraging, but a lot more needs to be done to make them operate effectively and efficiently. In order to discuss the status of medicine regulation in the subregion, identify the weaknesses, strengths and barriers, and to develop strategies that will help improve medicine regulation, a joint PSM-TCM-WHO/AFRO Conference of African Medicine Regulators was held from 30 October 3 November 2005 in Addis Ababa, Ethiopia. 1.2 Participants The conference participants were the heads of National Medicine Regulatory Authorities from 33 countries Angola, Benin, Botswana, Burkina Faso, Cameroon, Chad, Comoros, Republic of Congo, Côte d'ivoire, Ethiopia, Equatorial Guinea, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Madagascar, Malawi, Mali, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Tanzania, Togo, Uganda, Zambia and Zimbabwe. WHO was represented by staff from TCM/WHO, QSM/PSM, IVB/WHO, EDM/AFRO, WHO/AFRO and National Programme Officers (NPOs) of WHO Country Offices of Cameroon, Ethiopia, Senegal, Tanzania and Uganda. 2. OPENING OF THE MEETING 2.1 Introduction to the conference Mr Eshetu Wondemagegnehu, QSM/PSM, briefed participants on why the conference had been called and on the objectives and expected outcomes. He highlighted the current situation of medicines regulation in sub-saharan Africa, which is characterized by a weak regulation of medicines in the majority of countries, leading to unapproved/unregistered medicines circulating in the market, smuggling of medicines across borders, high prevalence of substandard 2

and counterfeit medicines and unapproved/unmonitored activities such as clinical trials, promotion and advertising of medicines as well as poor dispensing of medicines. Mr Wondemagegnehu also outlined some of the barriers to effective medicine regulation in the Region, which included, among other, weak political support and commitment to establish/strengthen medicine regulatory systems, inadequate numbers of appropriately trained and motivated staff, inadequate and non-sustainable financing, outdated legislation and guidelines, lack of transparency in the decision-making processes and conflict of interest. He outlined the objectives and expected outcomes of the conference as follows: Overall objective To promote effective medicines regulation in the subregion in order to ensure that medicines used by people in the subregion are safe, efficacious and of good quality. Specific objectives Discuss the medicines regulation situation in sub-saharan Africa and identify strengths and weaknesses, priority problems and solutions. Develop a five year strategic plan for the subregion to address the problems Identify priority activities to be undertaken during the plan period by the Region. Each country represented in the meeting was to develop a national strategic plan by identifying the strengths and weaknesses of its national medicines regulatory system, and solutions to address the problems and. Develop a strategic plan for 2006 2007. Expected outcomes Recommendations on how best to address the problems of medicines regulation in sub-saharan Africa to be formulated, discussed and agreed upon. A five-year Regional Strategic Plan be developed and main activities identified, discussed and adopted. Recommendations on how best to promote harmonization of medicine regulation in sub-saharan Africa to be formulated, discussed and adopted A two-year National Action Plan to be implemented by each National Medicines Regulatory Authority be developed and submitted. 3

2.2 Welcome address Following the introduction, Dr Nicholas Eseko, Acting WHO Representative, Ethiopia, welcomed participants to Ethiopia and thanked the organizers for choosing Ethiopia as the venue for this important conference. He reminded participants of the special nature of medicines which should not be treated as ordinary commodities and their crucial role in the delivery of health care. He commended WHO for the support it has rendered to many countries in sub- Saharan Africa to establish and strengthen NMRAs. He also noted that although a lot of progress has been made in the subregion with regard to medicines regulation and control, studies have shown that many MRAs in Africa have a low functional capacity and there are still some Member States with no MRAs. This has led to the circulation of sub-standard and counterfeit medicines in the subregion, which is a major public health concern to all Member States. Dr Eseko appreciated the relevance and timeliness of the conference, which he hoped would go a long way in promoting effective medicines regulation in the subregion. He expressed confidence that the objectives of the conference would be achieved and wished all the participants fruitful deliberations. 2.3 Official Opening of the Conference The meeting was officially opened by Mr Hailesellassie Bihon, General Manager of the Drug Administration and Control Authority (DACA) of Ethiopia on behalf of the Minister of Health of Ethiopia. In his speech, Mr Bihon, welcomed the participants to the conference and thanked WHO for choosing Ethiopia to host it. He noted that the provision of quality health services is not possible without availability and equitable access to safe, effective and quality medicines. He elaborated on the steps that Ethiopia has taken to implement the National Drug Policy and the special attention the Government of Ethiopia has given to strengthening the pharmaceutical sector, especially witnessed in the growth of the local manufacturing capacity, from one to more than a dozen local pharmaceutical manufacturers in a period of about 10 years. Mr Bihon told the participants that given the high burden of disease, the low manufacturing capacity and weak medicines regulatory systems in many African countries, MRAs must build strong partnerships among themselves and with their allies to reduce the consequences of the diseases prevalent in the continent and ensure sustainable development for the people. He noted that the lack of effective and strong medicines regulatory systems in Africa posed a challenge in 4

ensuring that medicines used by the health services are safe, effective, of good quality and rationally used. To achieve this would require that each country present in the meeting establish and sustain a strong and independent medicines regulatory body. Mr Bihon thanked WHO for the support given to strengthen the medicines regulatory capacity in Africa in general and to DACA in particular. He expressed hope that the meeting would yield useful results with the benefit of improving the regulatory situation, and therefore contribute to increasing the availability and access to safe, effective, and quality medicines in Africa. With these words, he wished the participants productive and successful deliberations and then declared the meeting officially open. 2.4 Message from WHO/HQ In her speech, Mrs Malebona Matsoso, Director of the Department of Technical Cooperation for Essential Drugs and Traditional Medicines, (TCM/WHO) noted that in spite of the progress made, the health status of the world's population, especially in Africa, remains a big challenge. The high burden of disease in Africa, with its weak and fragmented health systems continued to pose a serious challenge to the attainment of the Millennium Development Goals (MDGs). She highlighted the opportunities available through the support of international organizations/partners such as the WHO pre-qualification project and the focus by regional bodies such as the African Union (AU) and the New Partnership for Africa's Development (NEPAD) to strengthen health systems, including the regulation of medicines. Mrs Matsoso called upon the participants to do the right things first those that demonstrate added value and doing them right with available resources that can help to achieve the broad objectives of improved access to essential medicines. She reiterated WHO's commitment to provide guidance and technical support to Member States in this regard and wished the participants fruitful deliberations during the conference. 2.5 Administrative arrangements The opening ceremony was followed by administrative announcements, selfintroduction by participants, approval of the conference programme and election of officers. The following were elected for the different offices: 5

Chairs Mrs Margareth Ndomondo Sigonda, Director General, Tanzania Food and Drug Authority (TFDA), Tanzania Dr Maiga D. Minkaila, Director, Division of Medicine and Pharmacy (DMP), Mali Rapporteurs Dr Wynn Charles Chalira, Registrar, Pharmacy and Poisons Board, Malawi Dr Safiatou Ouattara, UEMOA, Burkina Faso Support group Mr Joseph, Serutoke, NPO, Uganda Ms Rose Shiga, NPO, Tanzania Dr Ngono Mballa Rose, NPO, Cameroon Dr Ngom Mamdou, NPO, Senegal. 3. METHOD OF WORK The conference was divided into morning and afternoon sessions consisting of plenary and workshop discussions. The plenary sessions entailed presentation of papers followed by discussions. The participants were divided into two working groups, French and English speaking, to discuss the workshop themes. Each theme was discussed by both groups separately. Findings of the group works were then presented at plenary session for discussion. Simultaneous French and English translations were provided during plenary sessions. A summary of the day's discussions was presented at the plenary meeting of the next day for discussion and agreement. 4. MAIN TOPICS PRESENTED AND DISCUSSED AT PLENARY 4.1 Medicine regulation in sub-saharan Africa: an overview (Dr Jean-Marie Trapsida, EDM/AFRO) Dr Jean-Marie Trapsida presented an overview of the medicines regulation situation in sub-saharan Africa. He outlined the functions of MRAs, which include licensing of persons and companies dealing in medicines, granting of marketing authorization, authorization of clinical trials, inspection of manufacturers and distribution outlets, monitoring the quality and safety of medicines and control of promotion and advertising of medicines. 6

He identified some of the major problems affecting medicines regulation in Africa as: lack of understanding by policy makers on the need to regulate medicines, leading to inadequate political support and commitment, inadequate legislation and regulations, inadequate structures and staff in terms of numbers, professional diversity and training, low salaries and lack of incentives, inadequate and non-sustainable funding. He said that these problems result in undesirable consequences such as: circulation of unregistered, sub-standard and counterfeit medicines in the market, non-gmp compliant manufacturing activities, unapproved/unmonitored activities such as clinical trials, promotions and advertising of medicines. Dr Trapsida listed the initiatives taken by WHO to strengthen medicine regulation in the Region and the positive outcomes from these interventions as follows: technical support to promote harmonization efforts in the SADC, UEMOA and EAC subregions, capacity building based on results of assessment of medicine regulatory systems, installation and use of SIAMED, conducting training courses for GMP inspectors and quality control laboratory staff, etc. He noted that improvements have been made in medicines regulation in some countries where interventions have been based on joint planned activities. He ended his presentation by calling upon the cooperation of all MRAs to improve the medicines regulation situation in Africa. 7

4.2 Country initiatives to promote effective medicine regulation Ethiopia (Mr Abraham G. Kahsay) Medicine regulation was first established legally in the late 1960s as Pharmacy Division under the Ministry of Health of Ethiopia. In 1999, a new structure was created as an independent authority under the name Drug Administration and Control Authority (DACA). It became operational in 2001. DACA reports to a Board. Fifty-five percent of the working budget comes from central treasury, 12% from fees collected for services and the rest comes from development partners. It has one branch office in the southern part of the country and others are to be opened in the near future. The workforce consists of 60 technical and 50 administrative staff. DACA's scope of activities as defined by Proclamation 176/1999 include the following: Setting standards of safety, efficacy, quality for drugs and traditional medicines as well as for competence of pharmaceutical organizations. Formulation of policy governing the sector. Preparation of list of drugs and categorization and revision of the list as necessary. Issuance of license to manufacturers, importers, wholesalers, retail outlets, etc. Registration of drugs for human and animal use, medical supplies, equipments, pesticides, etc. Licensing and inspection of pharmacy establishments. Investigation of the quality of drugs, medical equipment, supply, raw materials. Provision of current and unbiased drug information to professionals and the public. Control of drug advertisement and promotion. Issuance of license for clinical trials. Côte d'ivoire (Dr Assi-Gbonon Rosalie, Director, DPM) The Directorate of Pharmaceutical Services (DPM) was created in 1969 and has undergone several changes since then to an authority which is under the Directorate of Health Practices in the Ministry of Public Health and Population from 2002. It has a well-established structure and is fully dependent on financing from the Government. 8

The scope of work includes regulation and control of pharmacy practice, drug registration, manufacturing, import and export regulation, control of drug advertising, inspection of pharmaceutical firms, pharmacovigilance activities, control of narcotics and clinical trials. The organization has 11 technical staff and seven administrative staff. It has so far been able to develop various guidelines for the regulation of the pharmaceutical sector (manufacturing, inspections and registration), register all pharmaceutical products on the market, develop the essential drugs list (EDL), carry out inspections including good marketing practices (GMP) and the assessment of counterfeits which are impounded and destroyed. The Drugs Regulatory Agency (DRA) has several constraints mainly in the area of inadequate infrastructure, transport, human and financial resources. During the next five years, the Directorate of Pharmaceutical Services of Côte d'ivoire intends to concentrate on creating a legal framework to ensure independence of the DRA, training of staff in all aspects of regulation, pharmacovigilance, public education on the dangers of illicit (street) drug sales, adequately fighting counterfeits and creating a website for the agency. Democratic Republic of Congo (Mr Franck Biayi Kanumpepa, Director, Directorate of Pharmacy, Medicines and Medicinal Plants) The Drugs Regulatory Agency of the Democratic Republic\ of Congo was created in 1951. It has undergone several changes to attain its present status of the Directorate of Pharmacy, Medicines and Medicinal Plants, in 2002. It is fully dependent on Government for financing its activities and it operates as a department under the Ministry of Health. The DRA has a very limited budget that makes it very difficult to cover the entire country due to its vast size. It has a wellestablished structure with various departments (registration, drug control, quality control, cosmetics control and herbal medicines) consisting of a total of 35 technical staff and 37 administrative staff. The main activities include authorization of importation and exportation of medicines, market authorization for medicines, inspection of pharmaceutical outlets and manufacturers, licensing of premises and quality control of medicines. The DRA has so far managed to register all locally manufactured medicines, and those that are imported into the country. Twenty-five percent of the local manufacturers are compliant to good marketing practices. During the next five years, focus will be on mobilizing resources (both financial and human to carry 9

out their work effectively), training of staff in QC, GMP and GDP, and evaluation of the capacity of the Directorate. Mali (Dr M. Maiga, Director, DPM) The Directorate of Pharmacy and Medicines (DPM) was created in 2000 (before this, medicines regulatory functions were handled by the Health Inspectorate, the QC Laboratory and the Directorate of Health in the Ministry of Health) with the essential task of coordinating all activities in the pharmaceutical sector and to carry out medicines regulation. The DPM is fully dependent on Government financing but also receives funds for activities from technical partners. It has 11 technical staff and seven support staff and works together with other departments such as the QC Lab, GMP and clinical trials that are in the Ministry of Health. The DPM's scope of work includes drug registration (human, veterinary and herbal medicines), regulation and certification of pharmacy practice and licensing of premises and manufacturers. The regulatory functions of GMP inspections, clinical trials controls and QC of medicines are carried out by the Inspectorate, Clinical Trials and QC laboratory departments respectively. The DRA of Mali has been able to register all the products imported in the country, create a website (with support from WHO), install a computerized drug registration system (SIAMED), develop guidelines for registration and distribution of medicines, and set up a multisectoral committee for coordination of the fight against the illicit sale of medicines. They still face many challenges due to inadequate staffing, funding and failure to control imports and the illicit sale of medicines in markets/streets. Over the next five years the DRA of Mali will focus on training of inspectors, implementation of regular effective GMP inspections, regulation of medicines' advertisement, regulation of clinical trials and strengthening the National Health Laboratory for QC of biological and medical devices. Senegal (Dr M. Ngom EDM/NPO on behalf of Pr M. Badiane, Director, DML) The Drugs Regulatory Agency of Senegal was established as the Department of Pharmacy and Laboratories (DPL) in 2003 and is fully dependent on Government for financing. It has a well-established structure with various departments Registration, Administration, Narcotics and Psychotropic substances, Monitoring of ADRs, Registration of Pharmacy-related Businesses and Control/Release of vaccines. The DPL is charged with regulating the 10

pharmaceutical sector and practice, registration of medicines, quality control of medicines, promoting rational use of medicines, and pharmacovigilance activities. Their major achievements have been recorded in the development of policies, training manuals, guidelines and procedures for the management of medicines, sensitization of health professionals and consumers on rational use of medicines, registration of all imported and locally produced medicines, inspection of pharmaceutical outlets, and development of a website (on-going). The DPL still has challenges resulting from inadequate funding, lack of personnel, technical equipment and logistics, and control of illicit sale of medicines in markets. Over the next five years, emphasis will be on training of DRA staff in pharmacovigilance, good marketing practices and good distribution practices, mobilizing financial resources, control of the illicit market, and strengthening the quality control and Inspection departments (see also Annex 3.2.6). Tanzania (Mrs Margareth Ndomondo Sigonda, Director General, TFDA) The Tanzania Food and Drugs Authority (TFDA) was established in 2003 from the former Pharmacy Board of Tanzania. It is an executive agency under the Ministry of Health, which is responsible for the regulation of food, drugs (including herbal medicines), cosmetics, medical devices and clinical trials. It has 83 staff responsible for control of food, drugs, cosmetics and medical devices in the departments for Inspection and Surveillance, Product Evaluation and Registration, Business Support Services and Laboratory Services. Their scope of work involves drug registration (including herbal drugs), registration and licensing of pharmaceutical manufacturers, importers, wholesalers and retailers, drug quality control, pharmacovigilance, control of medicines' promotion, advertising and clinical trials. TFDA has recorded some achievements in developing essential guidelines for drug regulation, a web site, using minilab centres which have been opened throughout the country for primary screening of drugs using GPHF Minilab Kits, establishment of interlinked databases for drug registration, inspection and quality control. The QC lab has been rated good in proficiency testing organized by WHO. Major gaps still exist in the lack of linkages to zonal offices, inadequate human and financial resources, insufficient laboratory equipment, reference standards and the capacity to carry out method validation and analysis of vaccines. Their 11

five-year plan focuses on conducting public education programmes, instituting a quality management system to attain ISO certification, strengthen inspectorate, pharmacovigilance and QC departments, develop in-house capacity to evaluate new chemical entities, develop specific guidelines for regulating vaccines and herbal medicines and combating counterfeit drugs. Uganda (M. Apollo Muhairwe, Executive Secretary/Registrar, NDA) Uganda's DRA, the National Drug Authority (NDA) was established to its present status in 1993. Hundred percent of its working budget comes from fees collected against the services it provides. It has four regional offices (two zonal offices are being set up) with a total of 42 technical staff and 30 administrative staff. The NDA is charged with the registration of drugs (includes herbal drugs, food supplements and public health chemicals), licensing of pharmaceutical premises including manufacturing, quality control of drugs, pharmacovigilance and vetting of pharmaceutical promotional materials and activities. The main achievements have been in the registration of locally produced products (81%) and those imported (94%). The remaining 6% are authorized for importation under a special provision of the law. Another achievement is in the licensing of premises for pharmaceutical operations (55%) of local manufacturers comply with GMP, 80% of importers and wholesalers comply with GDP and 76% of retail outlets comply with NDA regulations. The NDA's major gaps include post-marketing surveillance at the district level and the capacity of the National QC laboratory, which is limited. During the next five years, focus is set on training staff in QC, expanding the National QC laboratory to perform microbiological analysis, registration of medical devices and control of clinical trials. Zimbabwe (Mr M.N. Dauramanzi, MCAZ General Manager) The DRA of Zimbabwe is referred to as the Medicines Control Authority of Zimbabwe (MCAZ) and was established to its present status in 1997 from the Drugs Control Council, which was first established in 1969 under the Ministry of Health and Child Welfare. It is an autonomous body and it reports to the Minister of Health and Child Welfare through a Board. Hundred percent of its working budget is derived from fees collected for services. The MCAZ has one sub-office, 25 technical staff and 27 administrative staff. 12

It is charged with the licensing of manufacturers, wholesalers, retail outlets, industrial clinics, dispensing doctors and veterinary surgeons, registration of medicines, inspection of pharmaceutical premises and animal medicines, control of clinical trials and QC of drugs and medical devices. The MCAZ has been able to develop, print and distribute all the essential guidelines for medicines regulation (currently undergoing review). Furthermore, it has registered all locally produced products, and ensures that the majority of all those involved in pharmaceutical operations are GMP and GDP compliant. However the organ still experiences challenges due to inadequate human and financial resources, lack of legislation to control import and export of drugs, and a weak post-marketing surveillance system for medicines. Over the next five-year period, the MCAZ will focus on updating their legislation, developing capacity to control medical devices, control of complementary medicines, strengthening the information technology unit and post-marketing surveillance, expanding the laboratory services to include complementary medicines analysis, expanding the revenue base and will seek International Accreditation (ISO 17025). 4.3 Medicines regulation development path: concept for discussion (Mr Eshetu Wondemagegnehu, QSM/WHO) Mr Eshetu Wondemagegnehu presented a concept paper outlining the path that countries may have to follow in developing their national regulatory systems. He said building an effective medicine regulation is not an easy task since it involves issues that are political, legal and technical in nature. Implementation of medicine regulation requires scientific and technological knowledge and skills, which may not be easy to find in most countries, developing countries in particular. In many countries, problems and issues related to medicines are barely understood by governments and the general public. Consequently, government and public support is minimal. On the other hand, because the regulated firms are better organized, financially strong and have better scientific and technological knowledge and skills, they have better opportunities to apply pressure on politicians to change regulatory decisions. 13

Mr Wondemagegnehu recommended a phased (step-by-step) approach for countries starting to build a medicine regulatory system and outlined the following main phases: Preparatory phase establishing a medicine regulation taskforce to study the system and propose activites Consensus building phase Structure building phase - Establish a transitional medicine regulatory body step1 - Appoint leaders and create the authority by law step 2 Implementation phase (4 Steps) To ensure sustainable development in medicine regulation, countries are required to introduce a regular assessment system into their medicine regulation. Managers of medicine regulation should have a clear vision on which direction they would like to go and the level they would like to achieve within a given period. 4.4 Revamping medicines regulation to respond to public health priorities (Mrs Malebona Matsoso, Director, TCM/WHO) Mrs Malebona Matsoso, Director TCM/WHO outlined the different dimensions of medicines regulation, the regulatory barriers which impact on access to medicines, specific regulatory problems, and some possible solutions for improving medicines regulation. She pointed out some of the regulatory barriers affecting access to medicines. These were identified in a WHO survey of 11 African countries in 2005, and included lack of an enabling environment (legal framework), technical elements (lack of guidelines, registration delays and backlogs, lack of transparency in decision making) and lack of political commitment. According to Mrs Matsoso, these barriers are further compounded by submissions of poor quality and/or insufficient data, unsubstantiated claims and duplicitous marketing of medicines by the pharmaceutical industry in situations where the National Medicines Regulatory Authorities lack adequate numbers of skilled staff and funding to carry out their functions. 14

In conclusion, she recommended some regulatory frameworks and structures that can be developed and used as possible solutions to effective medicines regulation, emphasizing that each NMRA should perform self-assessments and develop an institutional development plan. This should take into account the available human and financial resources. She also proposed harmonization as one of the ways in which medicines regulation can be improved through collaboration and sharing of information between different NMRAs within the subregion. 4.5 Medicine regulation harmonization in Africa Experiences Southern Africa Development Community harmonization (Ms Gugu N. Mahlangu) Ms Gugu Mahlangu presented the experience of harmonization of medicines regulation within the Southern Africa Development Community (SADC). She outlined the historical development of harmonization within the SADC unto the point at which it was firmly placed on its (SADC's ) agenda in 1999. Two working groups one for the registration of medicines led by South Africa and the other on drugs control led by Zimbabwe were formed to carry out the work. She noted the political will and commitment availed to the working groups by the member states of SADC, which was mainly based on their need to improve access to medicines in the region. With external support from WHO and DFID, the SADC Member States, led by the Medicines Control Council of South Africa, shared the responsibilities of developing the various guidelines for the different regulatory functions. Ms Mahlangu highlighted the achievements made so far in drafting and adoption of harmonized application forms and guidelines for registration of medicines, bioequivalence and bioavailability, stability testing, GMP and clinical trials. However, she noted that there are still various challenges that need to be addressed by SADC, which include the publication and implementation of the guidelines, the creation of a sustainable and fully-funded structure to guide the process including appointing a focal person for pharmaceutical issues in the SADC secretariat and the development of regulatory capacity that is consistent with the available resources. 15

East African Community harmonization (Dr Nditonda Chukilizo) Dr Nditonda Chukilizo gave the experience of the East African Community (EAC) Member States. He outlined the composition of the EAC (Kenya, Uganda, Tanzania) and the conducive legal and institutional framework available through the EAC Treaty of 1999 that provides for areas of cooperation and establishes the organs of the community. The three Member States' Medicines Regulatory Authorities (MRAs) envision ending up with an EAC Food and Drug Regulatory Authority. He informed the participants that most of the guidelines that have been adopted by the EAC are based on WHO guidelines. The presence of a legally binding treaty between the three Member States of the community, a common language (Kiswahili) and the similar legislation and level of development of the MRAs are positive factors that are greatly enhancing the harmonization efforts of this subregion. Dr Chukilizo enumerated the gaps/challenges still faced by the EAC such as the inadequate capacity of the MRAs, absence of a focal person within the EAC secretariat, inadequate funding leading to limited contacts of technical committees, involvement of members of the EAC in other regional initiatives (SADC, COMESA) and the lumping together of medicines regulation with other activities in the EAC Charter. Monetary and Economic Union of West Africa harmonization (Dr Safiatou Ouattara) Dr Ouattara presented the experience of medicines regulation harmonization from the Economic and Monetary Union of West Africa (UEMOA). She listed the members as Benin, Burkina Faso, Côte d'ivoire, Guinea-Bissau, Mali, Niger, Senegal and Togo. She highlighted the factors that have been conducive in the harmonization efforts such as the strong political will in setting up the bloc, the common currency, languages and similar disease patterns across the union. With WHO support, UEMOA held the first technical meeting of drugs regulatory authorities in March 2003 and drafted a Memorandum of Understanding (MOU) on harmonization of drug regulations. A second technical meeting was called by the UEMOA, followed by the meeting of Ministers of Health who adopted the MOU in August 2004. In January 2005, the Ministers of Finance endorsed the MOU. 16

UEMOA has since been able to standardize quality control standards, the registration of generics and other medicines and exchange of information within the Union. A planning meeting is scheduled for early 2006 to set up a secretariat that will coordinate: Validation of quality of medicines Value Added Tax (VAT) and other taxes on imported medicines and raw materials Harmonization of registration of pharmacies and pharmacists. A draft proposal has been prepared by the WHO in order to mobilize funds to enable UEMOA to set up the Secretariat which will handle the harmonization process. Economic Community of West African States harmonization (Mr Ben Botwe) Mr Botwe presented the harmonization initiative from the Economic Community of West African States (ECOWAS). He identified the challenges faced within ECOWAS as poor/outdated medicines legislation, uncontrolled distribution of medicines including traditional medicines, different languages and cultures, the existence of parallel initiatives within the same bloc (UEMOA) and inadequate funding. He noted that the bloc has agreed on a vision and mission and identified priority activities to be undertaken which include harmonizing the requirements for drug registration, labelling, inspections and licensing and pharmacovigilance. Support is needed in order to draft common agreements and a Memorandum of Understanding (MOU), perform an assessment of the MRAs, develop a training manual and design a website for the initiative. Mr Botwe ended his presentation by stating that ECOWAS is now seeking support from WHO and WAHO. The West African Pharmaceutical Manufacturers Association (WAPMA) has indicated interest in participating and supporting the initiative. 17

Economic Community of Central Africa States harmonization (Dr Peyou Ndi Marlyse) The presentation by Dr Peyou Ndi Marlyse was on the experiences of Communauté Economique des Etats de l'afrique Centrale (CEAC). She reported that harmonization was encouraged by efforts to control common diseases within the bloc. Activities included cover national drug policies, adoption of harmonized regulations, improvement of drugs procurement and price controls. The challenges faced by the group include the setting up of a technical working group to elaborate the priority areas for cooperation (human resource development, quality control, management of donations, improved exchange of information, regulatory and drug procurement procedures), training needs, a common legal framework for scheduling of medicines in particular and performing a baseline situational analysis. The initiative is progressing and the next meeting of CEAC is planned for early 2006. International Conference on Harmonization of Technical Requirements for Drug Registration (ICH) (Dr Lembit Rago, QSM/PSM) Dr Lembit Rago presented the set up of ICH, its members and the factors that have contributed to its success. These include ICH addressing primarily new pharmaceutical products, limiting its membership to six parties, and employing a consensus building activity based on the close relationship between the different working groups who review the differences in requirements among the three ICH regions and develop harmonized guidelines for adoption. ICH members represent the largest pharmaceutical trade block (76% of the world pharmaceutical market) and these countries are also the world leaders in producing innovator products through pharmaceutical research and development (R & D). ICH members benefit through considerable reduction in the duration of approval of products within Member States. Non-ICH members may be invited to ICH meetings as observers while WHO represents the interests of other Member States during ICH meetings. Dr Rago also outlined the different regulatory paths to assure quality, safety and efficacy of medicines for public health needs in the developing world. These 18

include the WHO pre-qualification project; United States Food and Drug Administration (FDA); tentative approval process for ARVs, the EU Article 58 and other legislative initiatives to approve generics under compulsory license for export (Canada and Norway). Article 58 of Regulation (European Commission) No 726/20041 establishes a mechanism whereby the European Medicines Agency (EMEA) may give a scientific opinion, in the context of cooperation with WHO, for the evaluation of certain medicinal products for human use intended exclusively for markets outside the Community. He concluded his presentation by reminding participants that the world is moving towards trusting one another based on transparency and understanding of regulations and procedures. This calls for carrying out activities that add value to the patient so as to enable the scarce resources to be of real value to medicines regulation. Working group discussions presented at plenary on harmonization of medicine regulation in Africa: Strengths and weaknesses Implementation Participants were divided into two working groups and discussed the strengths and weaknesses of MRAs in Africa with regard to harmonizing their medicines regulation. The groups also made proposals on the steps that should be followed to implement harmonization initiatives and the roles of the different stakeholders in the process. The working groups appreciated the need for harmonization of medicines regulation, which would lead to optimization of resources and expertise within a subregion, uniform implementation strategies with common requirements, guidelines and procedures for medicines regulation and quick access to medicines to support public health. Countries would take advantage of the economies of scale created through the free movement of medicines within larger markets. The following were identified as the major strengths, weaknesses and barriers for harmonization of medicines regulation within the region. Additionally, necessary steps to carry out the harmonization were proposed. 1. http://mednet3.who.int/prequal/ 2. http://www.fda.gov/bbs/topics/news/2005/new01152.html 3. http://www.emea.eu.int/pdfs/human/bwp/557904en.pdf 19

Working group findings Strengths and opportunities 1. Existence of regional economic blocks, EAC, SADC, ECOWAS, UEMOA, COMESA, etc. 2. Political will through the above-mentioned economic groups. 3. Existing initiatives to learn from e.g. ASEAN, EU, SADC. 4. Existing guidelines: WHO, ICH. Barriers 1. Lack of information exchange mechanisms e.g. IT shared websites/points. 2. Different legislations in different countries. 3. Different languages and cultures. 4. Different levels of development of countries and MRAs. Weaknesses 1. Weak MRAs with limited human and financial resources. 2. Parallel and overlapping harmonization initiatives. 3. Lack of structures to coordinate harmonization initiatives, e.g. Secretariat. 4. Inadequate exchange of information and experiences. 5. Lack of a common understanding of the true meaning and vision/goals of harmonization. 6. Lack of political commitment. 7. Lack of commitment from MRAs. 8. Lack of sustainable funding. Steps to carry out harmonization 1. Build trust and commitment among technical people towards harmonization. 2. Secure political commitment and support. 3. Carry out situation analysis and identify gaps. 4. Define the vision and goals of harmonization. 5. Set up administrative structures/secretariat. 6. Develop common strategies. 7. Develop common technical requirements, standard, guidelines, procedures. 8. Update legislations. 9. Exchange information. 20

The working groups proposed the following roles for the different stakeholders: Country Subregional group Partners Secure government political support and commitment. Secure the willingness and commitment of technical staff to the harmonization process. Discuss and adopt common r e q u i r e m e n t s a n d processes what can be done together, what can be shared. Coordination of member states. S e t u p a f u n c t i o n a l Secretariat. Sharing and exchange of information. Ressource mobilization. Advocacy. Technical and financial support. Advocacy. Set up an autonomous MRA with clear mandate for medicines regulation. Develop a capacity building plan. 21 WHO Technical support. Coordination of partners and processes. Support networking among MRAs and subregional groups. Disseminate information and best practices Set up systems to facilitate sharing of information (hared-points, websites).

4.6 Effective law enforcement and regulation of distribution (Mrs Malebona Matsoso) Mrs Malebona Matsoso gave a presentation on effective law enforcement and regulation of the distribution chain. She shared with the participants a short video film on the problem of street vendors in Burkina Faso, which highlighted the challenges and complexities of managing medicine distribution channels with respect to illegal/unlicensed premises, unregistered medicines, expired medicines and poor dispensing practices. Mrs Matsoso emphasized the need for countries to address this problem through a systematic approach and implement strategies, which would improve the procedures for distribution of medicines. Medicine vendors, who provide access to medicines critical in under-served areas, should be empowered through training and licensing so that they can provide good quality services. There is a need to improve coordination with other law enforcement agencies to control and close illegal medicines distribution outlets. She concluded by noting the need to strengthen post-marketing surveillance and sensitization of communities against the dangers of obtaining medicines from illegal/unlicensed outlets. 4.7 Ethical practice, conflict of interest, code of conduct in medicine regulation (Mr Eshetu Wondemagegnehu) Mr Eshetu Wondemagegnehu's presentation was on the code of conduct/ethical practices and conflict of interest in medicines regulation. He noted that the regulation of medicines is a key societal function that must be managed in the best interests of the public, emphasizing the need for transparency and accountability. He pointed out the two types of interaction that medicine regulators have with stakeholders as: (a) with the public, patients and consumers, which focuses on education, promotion of awareness and provision of advice and information and characterized by low potential for conflict of interest or corruption, and (b) with the regulated firms in the course of controlling private activities, provision of services and decision-making where the potential for conflict of interest and corruption is high. He enumerated several examples of situations where conflict of interest could arise in medicines regulation. These include acceptance of money by MRA staff 22

to write positive inspection reports, leakage of confidential information from drug registration dossiers to competitors and receipt of gifts to influence regulatory decisions. He cited some causes of this, which include the lack of guidelines and control measures, poor staff remuneration, and the weak rule of law. Corruption has negative effects on medicines regulation as it erodes institutional capacity. This is characterized by disregarding procedures, wasting resources, and hiring or promoting staff with no regard to performance. Mr Wondemagegnehu concluded his presentation by providing some strategies that can be set up to minimize corrupt practices. Among these would be guidelines on handling of confidential information. Ethical practices must be seen to be practiced in addition to use of external audits and peer review, which must be a part of institutional governance. 4.8 Rapid alert system on quality of medicines (Dr Jean-Marie Trapsida) Dr Trapsida gave a presentation on the rapid alert system on quality of medicines. He gave the historical background to the initiative, which started in 1997 when WHO convened a meeting of medicines regulation experts in 1997 in Harare, Zimbabwe. A plan of action for quality testing of medicines was developed and the results of these tests would be published and disseminated within the region. He noted that due to some technical difficulties the initiative did not take off as planned. He proposed areas of information exchange to include reports of counterfeit medicines, adverse drug reactions, registration status of products and manufacturers, and GMP inspection reports. The main requirement for this to take place would be MRAs' access to the Internet and creation of MRA web sites. Information would be collected from WHO, pharmaceutical industry, MRAs and drug quality control laboratories. Dr Trapsida concluded by calling upon all MRAs to develop web sites in order to facilitate the exchange of information and reiterated WHO's support in this regard. 4.9 Counterfeit medicines: framework convention (Dr Lembit Rago) Dr Rago presented the framework convention to combat counterfeit medicines. He noted the various aspects of counterfeit medicines that would include an 23

inadequate quantity or lack of active ingredients, and correct or wrong ingredients made with fraudulent intentions. Counterfeiting of medicines is now a major problem throughout the world and since 1985, WHO has taken the lead in addressing it. He revealed some of the contributing factors to proliferation of counterfeits, which are poorly developed distribution channels where the counterfeits bypass the official/licensed channels. Added to this is the evolution of the Internet and trade liberalization. Dr Rago emphasized that fighting counterfeits requires the joint efforts of MRA, industry, law enforcement agencies, national regional and global cooperation. An initiative being considered is the establishment of an international convention on counterfeit medicines control along similar lines of those controlling narcotic and psychotropic substances. 4.10 Current topics Vaccine regulation and monitoring of clinical trials vaccines (Mrs. Lilana Chocarro, IVB/WHO) Mrs Lilana Chocarro, IVB/WHO gave a presentation on the regulatory issues for vaccines and clinical trials evaluation. She emphasized the need to sensitize MRAs on the need to regulate the manufacturing and registration of vaccines, conduct post-marketing surveillance of vaccines including recording Adverse Reactions Following Immunization (ARFI) and clinical trials. She reviewed the procedures for evaluation of vaccines and the progress WHO has made in strengthening the regulatory capacity for vaccines in Africa. Mrs Choccaro informed the participants of the availability of tools and support to countries to improve vaccines regulation including vaccine clinical trials. These include training activities available through the Global Training Network (GTN) and support to develop institutional development plans that can be used for advocacy and resource mobilization for vaccine regulatory activities. WHO pre-qualification of priority medicines (Dr Lembit Rago) Dr Lembit Rago presented an overview of the WHO pre-qualification project including a demonstration on how to access information from the project web 24

site. He took the participants through the information on pre-qualified products, manufacturers, assessment and inspection reports, and training modules on GMP. This information is all available on the web site. He advised countries especially resource-poor MRAs which can consult the lists of pre-qualified medicines for priority diseases to make use of this information in making their regulatory decisions. Group work on regulatory gaps of MRAs in sub-saharan Africa and the development of a five-year regional plan with identified priority activities to promote effective medicines regulation. Dr Jean-Marie Trapsida then presented the results of an assessment of the medicines regulatory gaps that were identified from a WHO study of six MRAs in the African Region: Ethiopia, Ghana, Mali, Nigeria, Senegal and Tanzania. The purpose of the assessment was to review the existing legal framework as well as the regulatory and control systems. The assessments were carried out in collaboration with national authorities to identify gaps, make recommendations and develop a plan of action on how to address the gaps. He outlined the methodology used in the assessment, which included a data collection tool that was completed by the MRAs. The assessment team, comprising WHO/HQ, AFRO and an independent consultant reviewed and discussed the information provided with the staff of the MRA as well as with pharmaceutical manufacturers and importers and other stakeholders. The major gaps identified were an inadequate legal framework for medicines regulation, inadequate MRA structure, staff and office resources such as computers, vehicles, inadequate and non-sustainable financing of medicine regulation activities, weak infrastructure, lack of access to independent and objective information, and lack of management capacity. The lack of cooperation with other law enforcement agencies and no consultation with stakeholders, professional associations, consumer associations, industries and importers were also found to be major problems with the MRAs in the six countries. The two working groups then presented the results of their group work on the review of medicines regulatory gaps in sub-saharan Africa. The results are given in the following table. 4. http://mednet3.who.int/prequal/ 25

Strengths and opportunities Weaknesses Existence of some legislation for regulation. Existence of some regulatory structures of various strengths. Existence of some staff to perform some regulatory functions. Existence of references and norms from WHO (opportunity) Existence of harmonization initiatives and increasing cooperation between some countries. Ineffective licensing of premises and activities. Inadequate market control. Unregistered products on the market. Lack of transparency in registration systems/practices. Inadequate access to QC Labs to support registration. Poor inspection practices. Poor code of conduct corruption. Duplication and conflict between stakeholders.. Unethical promotion practices. Biased/inaccurate information to the public and health workers. Unregulated clinical trials and poor coordination among institutions involved in regulation of clinical trials. Non-existence/weak PMS/pharmacovigilance systems. Lack of/and inadequate communication strategy to support effective regulation and behavior change. Weak structures/status of MRA in the Government. Barriers Strategies to improve regulation Lack of/and inadequate legislation, regulations, guidelines, SOPs for all medicine regulatory functions. Inadequate status/structure of the MRA. Inadequate numbers of skilled staff. Inadequate resources and logistics: computers, finances, storage space for dossiers and samples, vehicles. Inadequate institutional link ages between the different regulatory functions. Lack of adequate prioritization/risk-based approach. Lack of code of conduct and transparency systems. Lack of cooperation between stakeholders. Inadequate enforcement mechanism and sanctions. Inadequate sensitization of the public and other stakeholders. Inadequate guidelines for pharmacovigilance. Inadequate appreciation of importance of effective medicine regulation. Take gradual, feasible and realistic steps towards regulation. Review and strengthen legislation. Put in place an appropriate structure to support effective regulation. Review and develop/strengthen regulations, guidelines and procedures to support regulation. Establish mechanisms to ensure financial sustainability of MRAs. Set up a mechanism to ensure recruitment, training and maintenance of adequate human resource (numbers and skills). Put in place advocacy strategies for effective drug regulation. Improve IEC/sensitization of stakeholders/public/civil societies to appreciate and support effective drug regulation. Set up systems for managing and mechanism for sharing information. Put in place mechanisms for monitoring and evaluation of implementation of drug regulation. 26

The groups also identified the roles for each partner in addressing the above-mentioned regulatory gaps: Government MRAs Government Put in place appropriate legislation. Set up and support appropriate structure of MRA. Establish and support sustainable financing mechanisms for the MRAs. Spearhead political support for drug regulation. Support harmonization and put in place a conducive environment for harmonization. Put in place mechanisms for monitoring and evaluation. Initiate process for reviewing and strengthening legislation with help of MOH and parliament. Propose to government/moh appropriate structures for the MRA. Review and create realistic strategic plans. Review/strengthen regulations, guidelines, SOPs. Put in mechanisms for financial sustainability. P r e p a r e h u m a n r e s o u r c e development policy and plan (recruitment, training, retention, remuneration). IEC/advocacy for appreciation of and support for drug regulation. Work towards harmonization of regulation. Support development of appropriate legislation and MRA structure. Support development of regulations, guidelines, SOPs. Support training of MRA staff. Advocate for adequate financing mechanisms for MRAs. Support MRAs/countries in resource mobilization mechanism to support medicine regulation. Provide technical assistance to facilitate strengthening of medicine regulation. Support mechanisms for exchange of information between countries: website, e-mail, and meetings. Support regional harmonization initiatives. 27

5. DEVELOPMENT OF THE REGIONAL STRATEGIC PLAN The main objective of the conference was to prepare a five-year regional strategic plan. It was recommended that the two-year national plans be finalized later and submitted by each Medicines Regulatory Authority (MRA). Mr Eshetu Wondemagegnehu presented an overview of the WHO MRA evaluation tool. The tool collects information in six parts as follows: (a) the general information on the country and MRA, (b) organization of the MRA, (c) the legislation and regulatory system, (d) human resources management, (e) strategic plan for institutional development and (f) other regulatory functions. Dr Jean-Marie Trapsida then introduced the participants to the group work for the development of the regional strategic plan 2006 2010. Participants were also requested to identify priority activities to be undertaken during this period. The workplans developed by two groups were presented and discussed in a plenary session. The participants thereafter adopted one consolidated plan with priority activities as shown in the following table: 28

REGIONAL PLAN TO PROMOTE MEDCINES REGULATION IN WHO/AFRO REGION (2006 2010) Problem to be addressed Objective Main strategy/approach Main activity (ies)-who/afro Inappropriate legal status of national medicine regulatory authorities to carry out their regulatory functions. Inadequate human resources. To make national medicine regulatory authorities autonomous. To develop the capacity of human resources. Establish autonomous medicines regulatory authorities as a single structure for improved performance. Training of MRA staff. Assist countries in submitting a proposal to national governments for the creation of autonomous NMRA. Assist in the preparation documents that provide autonomy to the NMRA. Provide assistance to NMRA to make the regulatory function effective. Support in initiating consultative commissions. Provide training in: - product registration. - inspection-gmp. - quality control. - pharmacovigilance. - control of clinical trials. - GCP. - management (of MRAs). - effective communication. Promotion of exchange of expertise between countries and pooling of expertise in the Region. Use technical assistance from outside the Region. Create database on expertise within the Region. SWOT analysis for human resources. Organize training of trainers (TOT). Organize discussion fora. Arrange exchange of working visits. Identify technical assistance with a goal to develop national capacity. Inadequate legislation and regulations. To develop, revise and update legislation/ regulations. Advocacy for comprehensive, strong legislation and regulations. Conduct assessment of legislation. Provide model legislation. Provide technical and financial support to develop/revise/update legislation and regulations. 29

Problem to be addressed Objective Main strategy/approach Main activity (ies)-who/afro Weak information management system and lack of access to independent information. To build information management and exchange system. To improve access to independent information. Strengthen systems for information management and exchange. Create access to Internet. Create an information database: Regional shared points. Support exchange of information within the region. Develop model software and website design. Support countries to have website, databases and IT systems/hardware. Train countries in information management. Develop tools for IEC and behaviour change for effective drug regulation. Inadequate tools guidelines, procedures, SOPs not fully developed. To review, revise and develop tools. To translate WHO tools into other WHO languages and distribute them to countries. Provide technical assistance to develop tools. Provide model tools to countries to adopt or adapt them. Identify essential tools for good regulatory practice. Facilitate development, adoption, adaptation and implementation of model/harmonized tools (best practices within the Region). Translate existing tool into other WHO languages. Lack of technical cooperation networking between MRAs. To establish and strengthen regional and subregional harmonization and networking. To create a regional discussion forum. Support regional and subregional harmonization initiatives. Advocate for harmonization at the regional economic blocs. Create and support discussion fora. Foster harmonization by using WHO inter-regional structures and regional blocs. Inadequate funding To create adequate and sustainable funding system for MRAs. Encourage/advocate strategies for sustainable funding. Ensure that there is funding dedicated to medicines regulation/mras. Develop projects to mobilize funding. Advocate for dedicated funding from regional economic blocs for medicines regulation. Advise countries on mechanisms to generate funding for MRAs. 30

Problem to be addressed Objective Main strategy/approach Main activity (ies)-who/afro Inadequate import and export controls. To strengthen import and export controls. Promote/support cooperation and coordination between countries, MRAs, Customs, other agencies. Facilitate a forum for discussion between relevant agencies. Provide model certification systems. Support relevant training in controlling import and export of medicines. Strengthen legislation and regulations to facilitate effective control of import and export of medicines. Weak market control. To strengthen market control. Develop strategies for enforcement of good distribution practices (GDP) and market control. Strengthen post-marketing surveillance based on risk management. Help countries implement and enforce GDP. Provide support for innovative and alternative distribution systems without loosing sight of strengthening conventional systems. Support community mobilization activities to support effective market controls. Advocate for GDP and highlight dangers of poor market controls and practices. Existence of counterfeit products on national markets. To create effective systems for combating counterfeit medicines. Advocate and support strategies for combating counterfeit medicines. Training in detection and identification of counterfeit medicines. Create Rapid Alert System (RAS) for exchange of information. Put in place a system for detection and sharing of information on counterfeit medicines. Support the participation of countries in international meetings. Support the possibility of establishing a convention on counterfeit medicines. 31

Problem to be addressed Objective Main strategy/approach Main activity (ies)-who/afro Local production firms non-compliant with GMP (ARVs, anti-malarial and anti-tb medicines). To enhance GMP compliance by local manufacturers. Provide technical assistance to MRAs and industry on GMP. Assess domestic production capacity. Provide technical assistance training in GMP to MRA and industry staff. Advocate for GMP compliance among industry associations to promote self-regulation. Facilitate exchange of expertise between MRAs and industries. Develop a tool to assess feasibility of local production and facilitate strengthening of regulatory capacity in the Region. Weak quality control laboratories. To strengthen QC laboratories. Re-equipping laboratories. Strengthen QC management systems. Assist the re-equipment of QC labs and in acquiring reference standards. Assist QC labs to put in place quality management systems. Support ISO 17025 accreditation of QC labs. MRAs not regulating all categories of products subject to regulation (e.g. traditional and complementary medicine, biological products, medical devices etc.). To strengthen MRAs to enable them regulate all categories of products subject to regulation. Revise legislation to cover all products. Strengthen regulatory system to control all products. Provide technical support in revising legislation. Inadequate regulation of clinical trials. To strengthen regulation of clinical trials. Develop tools for regulation of clinical trials. Training MRAs staff. Provide support in the development of tools. Train MRA staff in clinical trial control and monitoring. 32

6. RECOMMENDATIONS Based on the various discussions during the meeting, the following recommendations were made: Recommendations to MRAs Develop and implement strategies to promote effective medicines regulation. Prepare and submit to WHO/AFRO a two-year national plan indicating the priority activities to be undertaken in 2006 2007 to improve medicines regulation. Explore regional collaboration and support the creation of networks to share information on medicines regulation. Recommendations to governments Support medicines regulation and provide adequate funds to MRAs to perform their functions. Advocate for and support subregional and regional harmonization initiatives. Support human resources development for medicines regulation. Institutionalize the development and strengthening of autonomous MRAs. Recommendations to WHO To further the exchange of information and experiences of medicines regulation in the region, it was recommended that WHO/AFRO organize a conference for all African Medicines Regulatory Authorities at least once every two years. Ensure better coordination of medicines regulatory activities in the region. Advocate for countries to establish MRAs and adequately fund medicines regulation. Strengthen and expand MRA assessments to other countries in the region. Support capacity building and training of MRA staff. Ensure that all existing tools and documents are available in both English and French. Promote the exchange and use of technical expertise available in the region. 33

7. CLOSING CEREMONY The conference was officially closed by Mrs Malebona Matsoso, Director of the Department of Technical Cooperation for Essential Drugs and Traditional Medicines, WHO (TCM/WHO). In her closing remarks, Mrs Matsoso thanked and congratulated the participants for a successful meeting, especially the conference chairpersons and rapporteurs for the excellent work done. She noted with satisfaction that the objectives of the conference had been achieved and hoped that this was the beginning of the process to strengthen medicines regulation in the region. Mrs Matsoso appreciated the enriching discussions and experiences that were shared by participants during the course of the meeting and was confident that these lessons would be taken back home to improve medicines regulation in their respective countries. She reiterated WHO's commitment and unwavering support to improve medicines regulation in the countries and continued advocacy. She informed participants that WHO would be celebrating 30 years of the Essential Medicines Concept in 2007. Her department intends to use the occasion to profile the exceptional work that has so far been done in this field through improving access to essential medicines, and medicines regulation. Mrs Matsoso thanked the participants once again for the work accomplished during the conference and wished them a safe journey home. After these remarks, the meeting was declared officially closed. Speaking earlier, the conference co-chair, Dr Maiga Minkaila thanked WHO for organizing the conference, and the Government of Ethiopia for hosting it. He noted with appreciation the enormous work that was accomplished during the four-day duration and was confident that when the recommendations are implemented, they will go a long way in improving the situation of medicines regulation in the region. On behalf of the conference chairs and the participants, he thanked the rapporteurs and interpreters for their admirable work. Dr Safiatou Ouattara offered a vote of thanks to the conference hosts, organizers, and participants. 34

ANNEX: LIST OF PARTICIPANTS ANGOLA Mr Daniel Antonio Tel: +244-222-320030 Fax: + 244-222-328166 e-mail: dnmedicamentos@ebonet.net BENIN Dansou Alfred Tel: +229-90903298 Fax: +229-330882 e-mail: dansoube@yahoo.fr BOTSWANA Dr Sinah Selelo Tel: +267-3-632064 Fax: +267-3-180870 e-mail: sselelo@gov.bw BURKINA FASO Dr Amadou Koumare Tel: +226-50324660 / 70250915 Fax: -+226-50314476 e-mail: akoumare2002 @yahoo.fr Dr. Ouattara Safiatou Tel: +226-50324660 Fax: +226-50314476 e-mail: Safiatou_bf@yahoo.fr CAMEROON Dr Ngono Mballa Rose Tel: +237-221-0259 Fax: +237-221-1077 e-mail: mgonor@cm.afro.who.int OCEAC Dr Peyou Ndi Marlyse Tel: +237-616-4932 Fax: +237-223-0061 e-mail: Iry-palu@oceac.org CHAD Dr Ahmat Ali Hissein Tel: +235-517566 Fax: +235-517566 e-mail: dpml@intnet..td or aalihisseir@yahoo.fr COMOROS Dr Said Omar Said Hamidou Tel: +269-731-264 / 269-330-480 Fax: +269-731-724 e-mail: Hamidovitch2005@yahoo.fr REPUBLIC OF CONGO Dr Gondzia Guy Patrick Tel: +242-810-542 / 662-3525 Fax: +242-810-543 e-mail: dimpharmcongo@yahoo.fr CÔTE D'IVOIRE Dr Rosalie Assi Gbonon Tel: +225-213-57313 Fax: +225-213-56958 e-mail: assirnosalyn@yahoo.fr EQUATORIAL GUINEA Mr Mocong Mate Rafael Tel: +240-2-51305 e-mail: rmocong@yahoo.es ETHIOPIA Mr Abraham G. Giorgis Kahsay Tel: + 251-115-524116 Fax: +251-111-5521392 e-mail: abrahamkahsay05@yahoo.com GAMBIA Mrs Fatoumata I.N Jah Tel: +220-4-225374 Fax: +220-4-225873 e-mail: fatisj@ganet.gm 35

GHANA Mr E. Kyeremateng Agyarko Tel: +233-2-1660489 Fax: +233-2-1660389 e-mail: fbd@ghana.com Mr Benjamin Kwame Botwe Tel: +233-2-1910760 Fax: +233-2-1660389 e-mail: benbotwe@hotmail.com GUINEA Dr Bah Harirata Tel: +244-4-52028 / 297071 Fax: +224-4-52050 e-mail: harinata@yahoo.fr GUINEA-BISSAU Mr Pepas Vincente Natak Tel: +245-7-206617 Fax: +245-7-201188 e-mail: pevnatak@yahoo.com.br KENYA Ms Sarah Akoth Chuchu Tel: +254-227-21937 Fax: +254-227-13431 chuchu@wananchi.com MADAGASCAR Dr Rasoanaivo Nivo Hanitra Tel: +261-22-32300 minsandpl@wanadoo.mg MALAWI Dr Wynn Charles Chalira Tel: + 265-1-752652 Fax: +265-1-755204 e-mail: wychalira@globemw.net MALI Dr Maiga Minkaila D. Tel: +223-222-6570 Fax: +233-223-2463 e-mail: mmaiga@dirpharma.org MOZAMBIQUE Dr Suraia Mussa Nanla Tel:+258-21-326547 Fax: +258-21-303473 e-mail: msuraia@hotmail.com Dr Tania Vuyeya Sitoi Tel:+258-213-26547 Fax: +258-213-03473 e-mail: Vuyeya78@yahoo.com NAMIBIA Ms. Dinah Jorokee Tjiho Tel: +264-61-2032391 Fax: +264-61-234462 e-mail: dtjiho@mhss.gov.na or jorokeetjiho@yahoo.co.uk NIGER Elhadj Maty Maman Tel: +227-722450 Fax: +227-733570 e-mail: dphl@int.net.ne NIGERIA Mr Hashim Ubale Yusufu Tel: +234-9-6709894 Fax: +234-9-5241106 e-mail: hashimyusufu@yahoo.com RWANDA Mr Munyankinde Vedaste Tel: +250-5-11270 e-mail: dirpharmacie@yahoo.fr SAO TOME AND PRINCIPE Dr Marcelina Quaresma J. Costa Tel: +239-225942 Fax: +239-221306 e-mail: marcelinacosta65@hotmail.com SENEGAL Dr Ngom Mamadou Tel: +221-8695937 Fax: +221-8204314 e-mail: mgomm@sn.afro.who.int 36

SEYCHELLES Mrs Aimie Totin Tel: +248-388333 Fax: +248-323618 e-mail: druginformation@moh.gov.sc SIERRA LEONE Mr Michael Jack Lansana Tel: +232-22-229346 / 228497 Fax: +232-22-224526 e-mail: pharmbdsi@hotmail.com or mikelansana@yahoo.com TANZANIA Mr Hiiti Baran Sillo Tel: +255-744-307179 Fax: +255-222-450793 e-mail: hiiti@yahoo.com; info@tfda.or.tz Ms. Margareth Ndomondo Sigonda Tel: +255-22-2450 979 Fax: +255-22-2450793 e-mail: mnsigonda@yahoo.co.uk or info@tfda.or.tz Dr. Nditonda Benno Chukilizo Tel: +255-22-2450512 Fax: +255-22-2450793 e-mail: nchukilizo@yahoo.com or info@tfda.or.tz Ms. Rose Shija Tel: +255-22-2111718 Fax: +255-22-2113180 e-mail: shijar@tz.afro.who.int TOGO Dr Atany Nyansa (Bernardin) Tel: +228-22-20799 / +228-09-206221 Fax:+228-22-20799 e-mail: bnyansa@yahoo.fr UGANDA Mr Apollo Muhairwe Tel: +256-41-255665 Fax: +256-41-255758 e-mail: ndaug@nda.or.ug Mr Deusdedit Mubangizi Tel: +256-41-347391 / 2 Fax: +256-41-255758 deuskm@yahoo.co.uk Mr Joseph Serutoke Tel: +256-41-335500 Fax: +256-41-335569 e-mail: serutokej@ug.afro.who.int ZAMBIA Mr Felix Peter Chizu Tel: +261-1-220429 Fax: +261-1-238458 e-mail: pharmacy@coppernet.zm ZIMBABWE Ms Gugu Nolwandle Mahlangu Tel: +263-4-736981 / 5 Fax: +263-4-736980 e-mail: mcaz@africaonline.co.zw Mr Mafios Dauramanzi Tel: +263-736981 5 Fax: +263-4-736980 e-mail: mcaz@africaonline.co.zw WHO SECRETARIAT Mrs. Malebona Matsoso TCM/WHO Tel: +41-22-791-1452 e-mail: matsosom@who.int Dr. Lembit Rago QSM/PSM Tel: +41-22-791-4420 Fax: 41-22-791-4730 e-mail: ragol@who.int Mrs. Lilana Chocarro IVB/ WHO Tel: +41-22-791-1883 Fax: chocarrol@who.int 37

Mr. Eshetu Wondemagegnehu QSM/PSM Tel: +41-22-791-3473 Fax: +41-22-791-4730 e-mail: wondemagegnehue@who.int Mr Tefera Bekele NPO/WCO, Ethiopia Tel: +251-115-44-44-53 e-mail: bekelet@et.afro.who.int Dr Modibo Dicko WHO/AFRO Tel: +47-241-38200 / +263-11412488 e-mail: dickom@afro.who.int Dr Jean-Marie Trapsida EDM/AFRO Tel: +47 241 39258 Fax: +47 241 39511 e-mail: trapsidaj@afro.who.int 38