General Report Ouagadougou Round Table-En

Round table on fake medicines – Ouagadougou (Burkina Faso) September 27 to 29, 2011

1

Round table

“A joint action against fake medicine in

West Africa”

October 2011


2

CONTENTS

CONTENTS ___________________________________________________________________ 2

ABREVIATIONS AND ACRONYMS _________________________________________________ 5

I.1. SUMMARY ________________________________________________________________ 8

I.2. RECOMMENDATIONS FROM CLOSING CEREMONY _______________________________ 11

I.3. OVERALL RECOMMENDATIONS FROM GROUP WORKS ___________________________ 11

II.1. OPENING CEREMONY______________________________________________________ 15

Presentation 1 : Cotonou Call and Montreux Resolution ___________________17

Presentation 2: ACP Group Countries Resolution____________________________18

Presentation 3: WHO Role and strategies to control counterfeit drugs_18

Presentation 4: ONUDC Strategy against counterfeit drugs_______________20

Synthesis of Session panel 1 _____________________________________________________21

Presentation7: Role of the Board of Pharmacists in counterfeit drugs

control _______________________________________________________________________________23

Presentation 8: Role of professional pharmaceutical organizations in

counterfeit drug control__________________________________________________________23

Synthesis of session 2 panel______________________________________________________24

II.5. SESSION 3: Supply sources and counterfeit drugs________________________________ 24

Presentation 9: Challenges in quality drug supply in Africa ______________24

Presentation 10: Interpol’s approach in counterfeit drug control _______25

Presentation 11: Traceability / Authentification of medecines___________25

Presentation 12: National Purchasing Agencies - Experience of the

ACAME________________________________________________________________________________26

Presentation 13: Medicine production in Africa- Experience of the

ECOWAS______________________________________________________________________________26

Presentation 14: Role of the national Pharmaceutical Regulations

Authorities __________________________________________________________________________27

Synthesis of session 3 panel______________________________________________________28

II.6. SESSION 4: Quality Certification of Medicines __________________________________ 28

Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 3

Presentation 15 : Study of the Quality of Antimalarial Drugs in Africa:

Results _______________________________________________________________________________28

Presentation 16: WANBL Project in West Africa _____________________________29

Presentation 17: Quality certification of medicines in Burkina Faso____29

Presentation 18: Procedure for setting up a quality control laboratory30

Synthesis of Session 4 panel:_____________________________________________________31

II.7 SESSION 5: Action Plan for the West African region ______________________________ 32

Presentation 19 : ECOWAS Experiences, WAHO Action Plan_______________32

Presentation 20: WAEMU Experiences – Advocacy _________________________32

Presentation 21: NEPAD Initiatives in harmonizing launching norms of

medicines in the ECOWAS area. _________________________________________________33

Presentation 22: Regional Integration, the Example of the OCEAC ______33

Synthesis of session 5 Panel _____________________________________________________34

II.8 SESSION 6 : Initiatives in Counterfeit Drug Control _______________________________ 35

Presentation 24: Presentation of the Medicrime Convention _____________36

Presentation 25: Presentation of the Franco-African Network of Quality

Control Laboratories of the AFSSAPS __________________________________________36

Presentation 26 : IRACM Initiative _____________________________________________36

Presentation 27: Initiatives and Support of the Customs in Counterfeit

Drug Control ________________________________________________________________________36

Presentation 28 : French Initiatives in Counterfeit Drug Control________37

Synthesis of Session 6 Panel_____________________________________________________37

II.9 SESSION 7: Some Private Enterprises Active in Counterfeit Drug Control _____________ 38

Presentation 29: Quality of Medicines in Africa _____________________________38

Presentation 30: Presentation by Sanofi-Aventis____________________________38

Presentation 31: Presentation by GSK _________________________________________38

Presentation 32: Presentation by MSD ________________________________________39

Presentation 33: SMS certification of medicines_____________________________39

Synthesis of Session 7 panel _____________________________________________________39

II.10. SESSIONS 8 and 9: Working groups__________________________________________ 40

II.11. CEREMONY CLOSING _____________________________________________________ 41


Sequences of the closing ceremony_____________________________________________41

III.1 STRATEGIC AND OPERATIONAL RECOMMENDATIONS ________________44 III.1.1. Strategic recommendations___________________________________________________________ 44 III.1.2. Operational recommendations ________________________________________________________ 46

III.2. CONCEPTUAL FRAMEWORK FOR THE IMPLEMENTATION OF THE

CONSOLIDATED LOGICAL INTERVENTION FRAMEWORK___________________50 III.2.1. Conceptual Framework ______________________________________________________________ 50 III.2.2. Functions and roles of the organs ______________________________________________________ 51

III.3. PERSPECTIVES _______________________________________________________________52

Appendixes _________________________________________________________________ 54

Appendix 1: Group work results ________________________________________________54

Group work I : Legislation / Regulation _______________________________________54

Group work II : Human resources ______________________________________________56

Group work III: Quality Certification and Technologies____________________59

Travaux du groupe IV : Politique / Leadership / Coordination /

Communication ____________________________________________________________________60

Appendix 2: List of participants_________________________________________________62


ABREVIATIONS AND ACRONYMS

ACAME : Association of Central Purchasing Agencies of Generic medicines

ACP : African, Caribbean and Pacific Group of States (group of beneficiary

countries set up in the framework of the EU development policy)

ACT : Artemisinine Combined Therapy

ACTA : Anti Counterfeit Trade Agreement

AFD : French Development Agency

AFSSAPS : French Food and Drug Agency

AMM : Lauching Certificate

AMRH : African Drugs Registration Harmonization

ANRP : National Pharmaceutical Regulation Authority

ARV : Antiretrovirals

BPF : Manufacture Good Practices

CAMEG : Central Purchasing Agency of Generic Drugss and Medical Consumables

ECOWAS: Economic Community of West African States

CEEAC: Economic Community of Central African States

CEMAC : Economic and Monetary Community of Central Africa

CEP : Certificate of Conformity of European Pharmacopeia

CHMP : Humanitarian Medico-Pharmaceutical Agency

CHRCP : Pharmaceutical Cooperation Harmonisation and Regulation Unit

CIARP Internationale ARP Conference

CIOPF : International Conference of the Board of Pharmacists

DCI : Common International Naming

DDS Department of social and cultural development

DEQM : European Directorate for Drug Quality

DGPML : General Directorate of Pharmacy, Drugs and Laboratories

DMF : Drug Master File

DPM : Directorate of Pharmacy and Drugs

ECOSOC : United Nations’ Social and Economic Council

EMACCOM ECOWAS Drug Anti-Counterfeit Committee

ESTHER : Together for a Hospital Therapeutic Solidarity Network

FIIM Drug Industries International Federation

FIP : International Pharmaceutical Federation

FM-STP : Global Funds to eradicate AIDS, Tuberculosis and Malaria

FNUAP : United Nations’ Population Funds

FSP : Priority Solidarity Funds (a French Cooperation programme)

GSK : GlaxoSmithKline

ICH : International Conference of Harmonisation

IPM : Interface Public Members

LEEM : The Drug Making Companies

MAEE : French European Ministry of Foreign Affairs

MSD Merck Sharp & Dohme Corporate

NAFDAC : National Agency for Food and Drug Administration and Control (Nigeria)

NAMCOL : African Drug Control Laboratories Network

NEPAD : New Partnership for Africa’s Development

OCEAC : Coordinating Organization for Endemics Control in Central Africa

OIF : Organisation Internationale de la Francophonie

OMD : World Customs Organisation


OMS: World Health Organisation

ONPB : National Board of Pharmacists - Benin

ONPBF : National Board of Pharmacists - Burkina Faso

ONU : United Nations Organisation

ONUDC : United Nations’ Office for Drug and Crime Control

WAHO : West African Health Organisation

PER : Regional Economic Programme

RAME : Generic Drugs Access Network

RAS : Rapid Alerte System

ReMeD : Drugs and Development Network

RESAOLAB : West African Network of Biomedical Analysis Laboratories

SWOT : Strengths, Weaknesses, Opportunities and Threats

UA: African Union

WAEMU : West African Economic and Monetary Union

UNICEF : United Nations Funds for Children

UNITAID : International facility for the Purchase of Drugs

UNTOC : Convention on organized transnational crime

USP : United States Pharmacopeia


Part 1:

SUMMARY AND OVERALL

RECOMMENDATIONS

Professor Adama Traore,

Burkinabe Minister of Health


I.1. SUMMARY

West Africa has become a turntable of all kinds of traffics, and more especially of counterfeit

drugs. The illicit trade of the drugs and of those of lower quality in addition to the

counterfeiting of the pharmaceutical products hinders seriously the sanitary progress of African

countries. This criminal traffic undermines the efforts to reach the Millennium Development

Goals (MDG) in the domain of health. At the economic and social levels, the losses of the legal

pharmaceutical industries, which are job providers, are estimated at billions of euros. At the

sanitary level, the therapeutic failures due to these counterfeit drugs, the appearance of

resistance to the treatments and the physical handicaps plus other reversible or irreversible

complications are a source of worry and represent a challenge.

The decision to organize this round table on fake medicine was taken in this context and also as

a follow up of the Cotonou Call against counterfeit drugs of October 12, 2009, the Montreux

Resolution of October 2010 of French speaking countries and the resolution of the member

states of the ACP group of November 2010. This round table is held under the very high

patronage of H.E.M. Blaise COMPAORE, President of Burkina Faso, Head of the Council of

ministers, and it is the product of a fruitful and exemplary collaboration between the French

Ministry of the Foreign and European Affairs, the Ministry of the Health of Burkina, the WAHO,

the WAEMU and many technical and financial partners.

The objective of this round table was to contribute to reinforce a sub regional strategy, thus

creating the necessary conditions for setting up of a coordination platform of the interventions

of the technical and financial partners in the struggle against the counterfeit drugs. To reach

this objective, experts from various horizons worked during for three days on different topics

related to counterfeit drug trafficking. Seven (7) plenary sessions were organized; they were all

followed by exchange panels. As a whole, 33 presentations were held. Two (2) other sessions

dedicated to group works, permitted to consolidate the WAHO action plan and the WAEMU

advocacy document, and also to set up a platform of technical and financial partners.

The opening and closing ceremonies were presided by the Minister of health, Representing H.E.

the President of Burkina Faso.

During the opening ceremony, four speeches and the opening speech of H.E.M. the President

of Burkina Faso read by the Minister of health permitted to evaluate the extent of the problem

of counterfeit drugs by focusing on the economic, social and political drawbacks. One after the

other the Representative of the Chirac Foundation, the ambassador of France to Burkina Faso,

the Representative of the President of the WAEMU commission and the French Minister with

special responsibility for Cooperation voiced their strong support to this initiative of the round

table and wished for convincing results for an efficient action against this phenomenon.

The message of the President of Burkina Faso raised the issue of the legitimate worry of

countries like Burkina Faso which depend almost completely on imported medicines, with

regards to the globalization of the problem of counterfeit drugs. While reaffirming his firm

commitment to fight against the phenomenon, the President recognizes the necessity for the


States and institutions to come together to solve this complex problem with transnational

strategies. That is why he praised this round table initiative and reaffirmed his commitment to

favor the implementation of its recommendations.

It has to be noted that the plenary sessions allowed the participants to better understand the

diversity of the issues related to the counterfeit drugs, and the necessity of a joint action from

administrations.

During the first session, a situation of the international political dynamics to fight against the

counterfeit drugs was presented through a recap of the Cotonou Call and the Montreux

Resolution, the resolution of the ACP group countries, the role and the strategy of the WHO in

the struggle against counterfeit drugs and the ONUDC strategy on fraudulent drugs. This

session permitted to bring out four key issues that must be combined in the struggle against

counterfeit drugs: political action and advocacy, institutional advocacy, preventive actions

and repressive actions.

The second session focused on the need for a strong and real implication of the civil society in

the struggle against counterfeit drugs. The network of access to essential drugs (RAME)

demonstrated the necessity to raise the level of sanitary awareness of the populations and to

work for the improvement of the availability and the financial accessibility to the drugs.

Training of health professionals, awareness raising in the population and sharing information

constitute efficient strategies that have been demonstrated by the Medicines and Development

Network (ReMeD). The Boards of the pharmacists evoked the necessity of taking into account

boards of professionals in the control strategies and the respect of the pharmaceutical

deontology by means of sanctions, and the safeguarding of the circuit of medicines through a

professionalization of all pharmaceutical acts.

The third session recalled that the supply sources are often the origin of the forgery. For that

purpose, the WHO through a mapping of the supply systems in 16 African countries pleaded for

a formalization of the supply sources with good practices, a clarification of the role of the actors

in the supply cycle and for a transparency in the policies of quality certification of the

international supply agencies. The WHO also shared a reflection in progress on the pre-

qualification of supply agencies. To confirm the arguments presented by the WHO, the CHMP

demonstrated in a practical way the importance of the traceability and authentification of

medicines.

The ACAME shared the experience of the central purchasing agencies in supplying with

pharmaceutical products, the WAHO described the experience of medicine production in the

ECOWAS area, and the NAFDAC focused on the role of the national regulation authorities by

giving specific details about Nigeria in the supply and control steps. Finally, Interpol brought

their contribution by describing their approach in the struggle against counterfeit drugs,

notably in training police officers on the specificity of the "pharmaceutical crime".

The fourth session was dedicated to the quality certification of medicines. The necessity to set

up simple systems of quality control was demonstrated by a survey conducted in Africa on the

quality of the anti-malarial drugs and the quality certification system in Burkina Faso. US

Pharmacopeia shared their experience of setting up of "sentry sites" equipped with Minilabs for


a first control, and presented the NAMCOL Network. The Pierre Fabre Foundation described

the procedure for setting up a quality control laboratory for pre-qualification, mainly the staff

training, material equipping and cost recovery aspects.

The fifth session was an opportunity for the WAHO to present their action plan and for the

WAEMU to present their experience in the process of harmonization of the pharmaceutical

regulations and to present their advocacy document to reinforce counterfeit drug control. The

OCEAC shared the experience of Central Africa in the harmonization of Pharmaceutical Policies.

The NEPAD and the Gates Foundation gave details about their role and their financial support

to the different regional initiatives to harmonize medicine certification. During this session, the

Gates foundation also brought their contribution by demonstrating the mechanisms set up for

getting quality drugs to the patients. With regards to these contributions, it appears that

harmonizing pharmaceutical regulation policies will have a certain impact on the circulation of

the counterfeit drugs. The participants agreed on the necessity of a perfect coordination

between the institutions, particularly between the WAEMU and the WAHO, for efficient

interventions.

Session six dealt with counterfeit drugs control initiatives. Among these initiatives there is the

Medicrime Convention of the Council of Europe (adopted on December 8, 2010) that creates a

complete legal framework to criminalize the production and trade of counterfeit drugs and

medical products, and for international cooperation. It is good to notice that the Republic of

Guinea is the first non member country of the Council of Europe to wish to adhere to this

convention, thus raising awareness in the delegations of the other ECOWAS member states.

The Franco-African network of quality control laboratories was also set up of in partnership

with the AFSSAPS for sharing experience and capacity building; the IRACM presented the

initiative of a multidisciplinary training of the actors against counterfeit drugs, as well as the

French national action plan in the struggle against the falsified medicines, mainly in its

international aspect. Finally, the World Customs Organization (OMD) presented the importance

of the role of the customs and the limited legal means available for them to control counterfeit

drug trafficking. The OMD mostly insisted on the necessity to remove the obstacles between

technical services and the customs, and the emergency of having simple, efficient and

applicable legal texts for the customs services of the sub-region.

Session seven presented the enterprises of the sector that are contributing to the fight for

counterfeit drug control. Throughout advocacy and strategies, the LEEM are working to make

quality medicines available in the African supply circuit. They are proposing to carry out quality

control of imported drugs for pharmaceutical authorities with limited resources. At the end of

the presentation, Sanofi-Aventis, GSK and MSD described their strategy against the counterfeit

drugs and proposed their support to any country or institution that might call on them,

particularly for quality control of medicines. MPedigree, installed in Ghana, presented the

technology of authentification implemented with the collaboration of telephone companies as

well as the regulation authorities for the certification of medicines given to patients.

Sessions eight and nine were dedicated to group works. They permitted to make a SWOT

analysis (strengths, weaknesses, threats and opportunity) of the control strategies defined by

the WAHO action plan and the WAEMU advocacy document and to set the scene for the


creation of a platform of technical and financial partners. Four groups worked on the following

key issues: (i) Legislation and regulation, (ii) Human Resources, (iii) Quality Certification and the

technologies, and (iv) Policies, governance, coordination and communication. At the end of the

group work, all the participants were unanimous on a quick implementation of a consensual

action plan as a consolidation of the WAHO action plan and the WAEMU advocacy document.

However, a meeting of the WAHO focal points should permit the finalization of the

consolidated action plan while taking into account the results of the group works of the round

table. Then, a WAHO/WAEMU joint committee will be created for an efficient and coordinated

implementation of the activities in the action plan.

The closing ceremony’s highlight was the presentation of the prizes for the best journalistic

productions (radio, television, written press) on counterfeit drugs following the contest

organized by the ONPBF.

I.2. RECOMMENDATIONS FROM CLOSING CEREMONY

• Complete the strategic action plan for counterfeit drug control in West Africa on the

basis of the group works of the round table

• Set up a group of experts by the first term of 2012 to design a framework legislation for

counterfeit drug control

• Reinforce the capacities of all the actors (health professional, police officers, custom

officers, magistrates, MPs, journalists, etc.) intervening in the fight for counterfeit drug

control.

• Reinforce institutional and organizational capacities of the national authorities in

charge of pharmaceutical regulation as well as drug quality control laboratories.

• Create a steering committee or platform extended to the different partners (WAHO,

WAEMU, WAHO focal points, professional health boards and associations, customs,

police, industries, foundations, consumer associations, justice and international

organizations, international cooperation.

• Encourage countries to enter the Council of Europe Medicrime Convention.

I.3. OVERALL RECOMMENDATIONS FROM GROUP WORKS

The three days of work and discussion permitted the participants to make four strategic

recommendations:

a. Key issue # 1: Propose a regional strategic plan for counterfeit drug control and

ensure the implementation of operational action plans in the 15 ECOWAS countries:


- The WAHO action plan and WAEMU advocacy document served as work documents;

they have to be harmonized and enhanced.

- A Strategic regional plan will be consolidated and proposed according to 4 strategic

orientations: (i) political action and advocacy, (ii) institutional advocacy, (iii)

preventive actions, (iv) repressive actions.

The following recommendations were made:

1. Integrate both work documents to get to Regional Strategic Plan (RSP)

validated by the two regional institutions.

2. Also take into account the group work results to consolidate and enhance

the action plan.

3. Contribute to the elaboration of operational action plans at the country

level.

b. Key issue # 2: Create organs for the implementation and monitoring-evaluation of

the Regional Strategic Plan.

- The group of 15 focal points created by ECOWAS/WAHO and EMACCOM is identified

as essential for the appropriation of the RSP by the countries and its reproduction at

the national level.

- It is very important to make collaboration effective between the 2 regional

Institutions, i.e., WAEMU and WAHO/ECOWAS, mainly through dissemination of

information on counterfeit drug control in the joint WAEMU/ECOWAS secretariat.

- The synergy of the actions of the different TFPs should be a short term objective,

through the creation and promotion of a communication platform.


4. Formalize a protocol of agreement between the WAEMU and the

ECOWAS to integrate the major RSP orientations and the governance of

the system in charge of implementing and monitoring the RSP.

5. Imply the joint WAEMU/ECOWAS secretariat in the RSP implementation

by: 1) the validation of the protocol of agreement ; 2) mentioning the

issue in the meeting agendas,

6. Set up a steering committee made up of the Presidents of the

EMACCOM, of the WAHO/ECOWAS, of the CHRCP/WAEMU, of the MAEE,

of the Chirac Foundation, and of the NEPAD; the committee will be in

charge of (i) advocating in institutions to defend the issue of counterfeit

drug control, (ii) following the progress and evaluating the activities

implemented in the framework of the RSP and national operational

plans, and (iii) mobilizing the necessary human, technical and financial

resources.

7. Create a TFP platform which will be managed by the steering committee

and networked by the permanent secretariat. The objective of the


platform is the diffusion and sharing of information between all the

actors and partners, and mobilizing resources (e.g., diffusion list)

c. Key issue # 3: Reinforce juridical framework on counterfeit drug control at the

regional and national levels inside the ECOWAS

- National Authorities of Pharmaceutical Regulation are powerless and the counterfeit

drug control actions are too punctual and without a real strategy coordinated in the

long run between control organs (regulation, customs) and judicial organs.

- National legislations are not repressive enough to discourage traffickers.

- The definition of “counterfeit drugs” is not harmonized in the sub-region. There is no

specific incriminating element mentioned to start a legal action.

- Multidisciplinary and multisectoral control committees are not active enough and

the boards of professionals are not enough implicated in the struggle.


8. Propose a regional framework legislation which takes all the aspects of

the struggle into account, gives a juridical definition of counterfeit drugs,

allows collaboration and exchange of information between all actors, and

offers the competent services of the police, justice, customs, and health

(Multidisciplinary taskforce).

9. Encourage ECOWAS countries to enter in the MediCrime Convention

proposed by the Council of Europe.

10. Give assistance to Regional Institutions in assessing and enhancing their

ANRPs, or even in creating Medicine Agencies (which are more

operational structures).

d. Key issue # 4: Mobilize resources for implementing the RSP

- The financial resources allocated to the struggle are by far insufficient.

- Initiatives from TFPs are not coordinated, so they are not very efficient.

The following recommendation was made:

11. Look for funding opportunities throughout a large diffusion of the RSP

and the Round Table results to partners such as the European Union, the

MAEE, the NEPAD, the Council of Europe, the AFD, the ECOWAS, the

WAEMU, the WHO, the Bill and Melinda Gates Foundation, the private

sector …


Part 2:

SEQUENCES OF ROUND TABLE

WORKS


II.1. OPENING CEREMONY

The opening ceremony of the round table on fake medicine in

West Africa took place on Tuesday September 27 at 9 o'clock, in

the international conference room of Ouaga 2000 (Burkina Faso).

Placed under the very High Patronage of His Excellency Blaise

COMPAORE, President of Faso, this ceremony was heightened by

the presence of five members of the Burkinabè government 1.

The diplomatic representations, the national, regional and

international Institutions, the United Nations agencies, the WAEMU, the WAHO (West African

Health Organisation), a delegation of the French ministry of foreign affairs, a delegation of the

Chirac Foundation, a delegation of each country member of the ECOWAS2 and participants of

the international organizations attended that ceremony.

The opening ceremony included four addresses and a speech to launch the round table.

The first address by Mr. Jacques Godfrain, former French Minister of Cooperation was made on

behalf of the Chirac Foundation. He talked about the Cotonou Call (recalling the personal

involvement of Heads of State) that was an important international political act.

Returning to this round table, he stated that it was a logical continuation of the realization of

the commitments. He thinks that controlling counterfeit drug trafficking at the regional level

covers three dimensions: security, health and regional governance. While complaining about

the shortcomings of the administrative system and uncoordinated national or international

actions, Mr. Godfrain called for action to save the innocent victims of this criminal trade.

Besides, he reiterated former French President Jacques Chirac’s commitment to accompany the

implementation of the Action Plan which will be the consensus from the round table.

The second intervention was that of the Acting Commissioner, representing the President of

the WAEMU Commission. He welcomed the organization of this important meeting and

affirmed the full membership of the regional institution to this unifying initiative. Medicine, he

said, is a very vital and essential thing which has the special attention of governments and

institutions that ensure the populations’ health. It is in this sense that the President of the

WAEMU Commission has positively appreciated the patronage of Burkina Faso’s Head of State

and the fight led by the Chirac Foundation in controlling counterfeit drugs. He reaffirmed the

vision of the WAEMU which is to guarantee people's access to quality drugs. To do this, he

confirmed the total involvement of the WAEMU to future initiatives that will result from this

round table.

The third speech was delivered by H.E the Ambassador of France to Burkina Faso. He welcomed

the organization of the round table, particularly the commitment of the Burkinabe authorities

with the involvement of the head of state. The commitment of Cotonou in October 2009 is

noticed in almost all West African countries. Despite this strong political commitment, he noted

1 The Minister for Health representing HE the President of Burkina Faso, the Minister of Environment and

Sustainable Development, the Minister of Youth, vocational training and employment, the Minister of Territorial

Administration, Decentralization and security, the Minister of Agriculture, Water and Fisheries Resources. 2 ECOWAS : Economic Community of West African States (Benin, Burkina Faso, Cap-Verde, Côte d’Ivoire,

Gambia, Ghana, Guinea, Guinea-Bissau, Liberia, Mali, Niger, Nigeria, Senegal, Sierra-Leone, Togo)


that unfortunately West Africa is the area of the world which is the most flooded by counterfeit

drugs. The involvement of the French Republic through this round table is the pledge of

adherence to initiatives of fight. He stressed that his country, with good experience in the field

of drug, is ready to assist technically and financially African countries and international

organizations to improve access to low cost drugs and secure supply circuits and distribution of

pharmaceutical products. Finally, he said relied on the results of this round table that will

essentially help create an operational platform to coordinate and monitor actions.

The video speech of the French Ministerial Delegate for Cooperation, Henri de Raincourt, was

the fourth speech of the opening ceremony. The Minister came back on the involvement of

Burkinabe authorities, West African organizations and the WHO in organizing this round table.

Since September 7, 2011 France has adopted, a new strategy in the fight against fake drugs and

is currently working on obtaining a broad consensus from the WHO. In this vision, the French

minister would like this round table to lead to the development of a consensual action plan and

the creation of a platform of TFPs, which will ensure implementation. He mentioned the

availability of France to be part of this platform.

The opening ceremony speech was delivered by Professor Adama Traoré, Minister of Health,

representing his Excellency the President of Burkina Faso. In his speech, the Minister of Health

stressed that the President of Burkina Faso is pleased to host this high-level round table against

fake medicine. First, he welcomed all the participants to Burkina Faso. Then the Head of State

recalled that the proliferation of fake medical products is a phenomenon that dangerously

hinders development efforts of countries, especially in developing countries. He recalled that

the economic, social and institutional disaster caused by the development of counterfeit drug

trafficking is well established. That is why he is personally, along with his brother heads of

states, involved in controlling counterfeit drugs. He would not like the round table of

Ouagadougou to be just a meeting again. He would like some strong recommendations and

commitments from this historic meeting that is gathering leading figures of the pharmaceutical

sector and all stakeholders involved in the drug distribution chain. For his part, he said that he

is already the spokesman to the other Heads of States and Institutions for the implementation

of these recommendations. After the opening ceremony, the participants went to the

conference room of Laico Hotel Ouaga 2000 to begin their work.

II.2. ROUND TABLE OBJECTIVES AND TERMS OF REFERENCE To introduce the sessions, the round table objectives were presented by Professor Jean-

Baptiste NIKIEMA, Director General of the pharmacy, medicine and laboratories (DGPML) of the

ministry of health of Burkina Faso. Professor Nikiéma first referred to the context of counterfeit

drug control, specifying the situation analysis that was done by the UNODC, mentioning health,

economic and social risks that led to decision awareness at all levels. From there, the response

was organized and today requires effective and active coordination.

Given this context, the main objective of this round table is to "contribute to the adoption of a sub-regional strategy, creating the conditions for the implementation of a platform to coordinate the technical and financial partners’ interventions in the counterfeit drugs control.” Specifically, this round table aims to:


1. Propose a logical framework of joint and consensual interventions to regional

institutions, technical and financial partners, and private sector.

2. Set up a platform involving technical and financial partners and the private sector for

a synergy of activities of different actors in controlling counterfeit drugs.

After the presentation of objectives, the agenda summary was presented as follows:

• Seven (7) plenary sessions with 33 presentations and one discussion panel for each

session.

• Two (2) group work sessions followed by plenary discussions and restitution, and the

adoption of the recommendations.

• A closing ceremony during which an award of excellence of the Board of Pharmacists

of Burkina Faso will be presented.

II.3. SESSION 1 : State of international dynamics to control counterfeit

drugs

Session chairman: M. Thierry Le Lay, MAEE, special representative for the fight against

counterfeit drugs

Reporters:

1) Dr. Magali BABALEY, from the WHO/Geneva

2) Dr. Céline ARNOLD, from ESTHER/Paris

This session was facilitated through four communications and a round table (or panel) that

examined the role of political commitment in counterfeit drugs control.

Presentation 1 : Cotonou Call and Montreux Resolution

Presenter : Pr. Marc Gentilini, general Delegate of the Chirac foundation

Professor M. Gentilini says that the

proliferation of counterfeit drugs is not a

new problem. He stresses, however, the

urgency to act now because counterfeit

drugs kill and even more in poor

countries. For this reason, he welcomes

the commitments made in the world to

fight against this scourge. He takes as example the IMPACT

initiative, involving the WHO and 20 other

partners. However, the initiative has not

had the necessary political support to

impose a consensus on the definition and

resolution of the problem.


Professor Gentilini also deplores the negotiation of the ACTA: anti-counterfeiting agreement

between rich countries since 2008. Part of the agreement is seen as an attempt of the rich

countries to obstruct to production of generic medicines produced in emerging countries. This

contributes to the confusion made between the protection of commercial rights and the

concern for patients’ health.

It is in this context that the Cotonou Call, signed today by 34 States, was launched on October

12, 2009. The objective of this launch was to politicize the issue of counterfeit drugs, to

improve public knowledge, to encourage political decision-making in countries that suffered

from this trafficking. This call has made the following recommendations:

1) Submit a consensual name such as "counterfeit drugs", taking into account aspects of

intellectual property and public health, instead of counterfeit medicines;

2) To distinguish the fake drugs from the counterfeit ones;

3) Organize cooperation between states to better intervene in the field;

4) Call for the development of a pragmatic policy of fight against organized trafficking in each

country.

The Francophonie resolution adopted by the member states in Montreux in October 2010,

supports the initiative of Cotonou, with 75 states committing to it and makes it possible to

think about an important diplomatic weight for the international advocacy campaign to be

carried out.

Presentation 2: ACP Group Countries Resolution

Presenter: Dr. John Kakule, from ACP Secretariat, Brussels, Belgium

The presenter mentioned that at the 92nd

session of the ACP member states in November 2010,

the Ministers reaffirmed their full commitment to strengthening the quality control of drugs,

controlling the importation and distribution of pharmaceutical products. The planned actions

are:

- Launch an international call for the fight against counterfeit drugs;

- Build capacity of countries to verify the quality of pharmaceutical products through a technical

partnership between control agencies;

- Harmonize drug regulation by a network of national drug regulatory authorities.

Presentation 3: WHO Role and strategies to control counterfeit drugs

Presenter : Dr Jean-Marie Trapsida, from WHO/AFRO, Brazzaville

The presenter began his speech by saying that every drug must meet the quality, safety and

efficiency standards. Counterfeit drugs lead to a treatment failure, toxicity, microbial resistance

and other public health problems. The WHO is aware of this danger and has undertaken several

actions for over 20 years. He recalled the various stages which are as follows:

1985: The involvement of the WHO in the fight against counterfeit medicines started in 1985,

specifically, after the recommendation of the Conference of Experts on the Rational Use of

drugs. The WHO and their partners have established an information center, responsible for

collecting data and informing member states on the nature and extent of the phenomenon.

Thus, the AMS 1988, in its resolution WHA41.16, requested the DG to initiate programs to

prevent and detect export, import and smuggling of falsely labeled, fake, counterfeited


pharmaceutical products or drugs that do not meet the standards and cooperate with the UN

Secretary General if international conventions were violated.

1992: In response to this resolution, the WHO and the MIIF (Medicine Industries International

Federation) jointly organized the first international meeting on counterfeit drugs in Geneva in

1992. The participants agreed to adopt the following definition, which later became the WHO

definition. Namely "A counterfeit drug is a drug which is deliberately and fraudulently

mislabeled, whose true identity and / or source are not mentioned. This may be a specialty or a

generic product.

Among the counterfeit products, there are some that contain good or bad or even not active

ingredients and there are others where the active ingredient is in short supply or with fake

packaging. "

1994: Because of the rapid spread of counterfeit drugs in the national distribution channels,

and following the adoption by the AMS of the resolution WHA47.13 in 1994, the WHO has

supported the efforts of the member States to ensure that available drugs are of good quality

and to fight against counterfeit drugs use.

1995: The WHO, with the Japanese Government’s financial support, launched the project on

counterfeit drugs. It was meant to support States to analyze the problem and to develop

measures to fight counterfeiting. A major outcome of these efforts is the development of the

WHO guidelines for the implementation of measures against counterfeit drugs.

2000 - 2006: The intensification of international trade in pharmaceuticals and Internet sales has

further helped the introduction of fake products in the market. Also, from 1994 to 2004, the

international ARP conferences asked the WHO, in their recommendations, to assist member

states to adopt measures against counterfeit drugs.

Specifically, in 2004, the CIARP (International ARP Conference) has considered the fight against

counterfeit drugs issue. Among the main recommendations, the Conference requested the

WHO to develop a policy paper for an international convention on counterfeit drugs and to call

a meeting of regulation authorities to which the document would be submitted. This meeting

and other explanatory work revealed the lack of a consensus among Member States regarding

the adoption of an international convention; so came out the idea of launching an expanded

international partnership and oriented toward practical action under WHO supervision.

2006: IMPACT Initiative with 193 member states and a secretariat held by the WHO.

2009: Circular Letter 25/2009 addressed to member states to document the problems

associated with counterfeit drugs. Only 55 states of the 193 States have responded. Among the

reports, the term counterfeit drug is not systematically integrated and this reveals the efforts

required to sensitize states about the notion of counterfeit drugs.

A guide was developed by the WHO to assess the problems of fake drugs containing the

following elements:

- An alert system that exists within the WHO to report a problem and a response

organized by the WHO through the mobilization of expertise.

- Promotion of the quality of drugs: in 5 years, standards and structures in charge

of quality control have been established.


2010: Concerns were expressed about the negative effects that the fight against counterfeit

drugs may have on generics. Indeed, some countries have made confusion between generic

and fake products, and have come to restrict free trade, competition and the promotion of

generics. The problem of defining resurfaced.

In the light of ongoing discussions on issues related to intellectual property rights, the use and

definition of "fake" has become controversial;

Hence the decision of the 63rd

AMS to talk about low quality / fake / falsely labeled / falsified /

counterfeit medicine (SSFFC)

The decision also requested the Secretariat to prepare an ad'hoc working group to discuss the

future work of the WHO in the fight against counterfeit drugs and its role in IMPACT to avoid

any conflict of interest related to the composition of IMPACT.

2011: From February 28 to March 2, 2011, a meeting of the Working Group to discuss (not of

commercial and intellectual property):

- The role of the WHO concerning the measures to ensure the availability of safe,

effective and affordable medical products,;

- The role of the WHO in the fight against uncertain quality, safety and efficiency medical

products such as SSFFCs;

- Relationship between the WHO and IMPACT.

The Working Group made the following recommendations in relation to future roles of the

WHO:

-Information and sensitization;

- Norms and standards development;

- Technical support to countries;

- Particular Monitoring of market perspectives and development of guidelines on the BPD for

Internet sales, importers and traders.

Presentation 4: ONUDC Strategy against counterfeit drugs

Presenter: Mr. Pierre Lapaque, from the ONUDC

The UNODC is one of the leading organizations fighting in the field against fraud related to

drugs. Its strategies were explained through this presentation, that is:

1) Research:

- Link between countries of production, transit and consumption

- Information about the financial, health, and economic impact on populations

2) Risk assessment

3) The writing of the MEDICRIME Convention in the Council of Europe

4) The creation of local and regional institutions

5) The operational support for law enforcement and maintenance of borders:

- Creation of specialized structures (police, customs, etc.).

6) The scientific and technical assistance:

- Collaboration between the WHO and pharmaceutical industry,


- Campaign (Interpol, civil society and competent authorities)

7) Increase awareness.

Synthesis of Session panel 1

Pr. Marc Gentilini General Delegate of the

Chirac Foundation

Dr. John Kakule ACP Secretariat, Brussels,

Belgium

Dr. Jean-Marie Trapsida WHO/AFRO, Brazzaville

M. Pierre Lapaque ONUDC

Panel Session 1

M. Alpha Amadou Diallo OIF

Considering the diversity of terminology used, the round table organizing committee wanted by

consensus to use the word counterfeit drugs that brings a broader view on the problem and

prevents discussions related to terminology. The discussion highlights the shortcomings regarding the dynamics of global fight against

counterfeit drugs. It is about:

- Insufficiency of cooperation between custom services and national regulatory

authorities or pharmaceutical regulation,

- Weak involvement of MPs in different fight strategies,

- The low involvement of professional boards in fight strategies,

- The inappropriate content of awareness campaigns,

- Poor financial accessibility to quality pharmaceutical products,

- Insufficiency of control of transits,

- The lack of consensus regulatory framework,

- Insufficiency of qualified resource persons in the supply circuit.

Considering these elements, several fight strategies have come out during the discussions. They

are :

(i) Action and political advocacy: It will be undertaken through political actions, the heads of

states and governments, with substantial contribution from the Chirac Foundation that has

been at the forefront since the Cotonou call. We already note that 30 Heads of State or Heads

of Government have signed this call.

(ii) Institutional advocacy: We can mention:

- Advocacy to ensure that instructions are given to legislative bodies,

- Advocacy with TFPs,

- Advocacy to reinforce the inter-service cooperation (customs – regulation authorities),

(iii) Preventive actions; among the preventive actions, some proposals were made:

- Prevention in which information / awareness needs to be targeted by health

professionals for the public,

- The role of the WHO in the harmonization of the attitudes of countries using drugs,


- Institutions must be provided with capacities to stimulate strong regulations that would

be applied to address the lack of control related to the manufacture, importation and

distribution of drugs,

- The need to secure the supply chain and propose corrective actions to reduce failures

of this chain,

- Limiting the number of registered importers and the number of entry points per country

to verify the actual control over the flow found.

(iv) Repressive actions: participants must agree to criminalize the counterfeit drugs

trafficking and take repressive actions because it can be noted that the criminal trafficking is

organized and sanctions are not sufficiently visible or real. It is necessary to promote

Coordination of the repressive response and give important capacity to investigation,

monitor the implementation of repressive measures and create adequate structures for

their implementation. All the participants agreed that counterfeit drugs trafficking must be criminalized. Professor

Gentilini concluded the session by giving the formula: « As long as drugs are too expensive for

a very poor population, the problem of counterfeit drug trafficking will always be a problem»

II.4. SESSION 2: Civil society and counterfeit drug control

Session chairman: Dr. Boniface Okouya, from ISPHARMA

Reporters:

3) Dr. Magali BABALEY, from the WHO/Geneva

4) Dr. Céline ARNOLD, from ESTHER/Paris

Presentation 5: Role of the consumer in counterfeit drug control Presenter: Simon KABORE, Chairman of Generic Drugs Access Network (RAME)

Mr. Simon KABORE noted that two (2) billion people worldwide lack access to drugs. As for him,

the causes that are behind the growth of counterfeit drugs are:

1) Political causes

• The inaccessibility due to medicine costs

• A significant proportion of household expenditures are devoted to health (WHO)

• The regulation of medicines is minimal in many countries

2) Causes from consumers

• Low level of health awareness.

The presenter recommends strengthening the quality control of medicines by reinforcing

medicine regulation, educating the public about their role, conducting awareness campaigns on

the rational use by emphasizing the consumer component, and promoting access and use of

generics

Presentation 6: Counterfeit drugs control: Point of view of the civil society

Presenter: Dr. Carinne Bruneton, General Delegate of ReMeD


She first described the network. The aim of the Network is to allow an exchange between

health care professionals for a promotion for the proper use of quality medicines. As for

counterfeit drugs, she said that Africa is sick of its drugs. Africa is facing many problems linked

to counterfeit drugs:

- Poor quality: counterfeits and sub standards

- Over-consumption: pressure everywhere (you have to sell medicines)

- Uncontrolled prescription: everyone is prescribing, including the patient himself,

- Uncontrolled use: the patient does not often know how to use the medicine (s)he has

received no information from the doctor

- Uncontrolled Supply: multi-channel, multiple partners, lack of coordination

To address these problems, the presenter has recommended the following actions:

- Increase the distribution sites managed by pharmaceutical professionals,

- Intensify training and supervision,

- Authorize reconditioning as part of pharmacy

- Use DCI (Common International Naming) in the prescriptions

- Publish the pharmaco-therapeutic information.

Presentation7: Role of the Board of Pharmacists in counterfeit drugs

control

Presenter: Dr. Toukourou Tidjani Moutiatou, President of ONPB

The observation also made is an increase in the illegal drug sale in African countries, and thus

the risk of counterfeit drug trafficking. In addition, insufficient means of control and some

health professionals’ lack of ethics are also stigmatized. For this reason, a strong involvement of

Professional Associations in controlling counterfeit drugs and a greater involvement of decision

makers with the professional boards are solicited.

Presentation 8: Role of professional pharmaceutical organizations in


Presenter: Dr. Isabelle Adenot, President of CIOPF and representative of the FIP

Dr. Adenot initially presented the International Pharmaceutical

Federation. FIP is composed of 127 organizations, 2 million

pharmacists in relation to the WHO and the UNESCO, it acts as

an alert in the fight against counterfeit drugs and the federation

gives its support for all information initiatives. www.fip.org.

The second entity is the International Conference of the Board

of Francophone Pharmacists (CIOPF).

It has 33 boards, 21 members from Africa. Its action is directed towards patients. It seeks to

ensure the legal framework tightness. Among its actions are: repression through discipline

rooms, training its members to fight against counterfeit drugs, public information, fight against

the illegal practice of medicine, repression via discipline rooms. She also offers as part of the

Round Table, to strengthen political, institutional and operational advocacy, establish


preventive and information measures and mobilize resources for financial and technical

support to professional boards.

Synthesis of session 2 panel

Simon KABORE Chairman Generic Medicines

Access Network (RAME)

Dr Carinne Bruneton General Delegate of ReMeD

Dr Toukourou Tidjani

Moutiatou

President of ONPB

Panel Session 2

Dr Isabelle Adenot CIOPF and FIP

The discussions during this session identified the following key points:

- The role of the civil society is to reinforce the population’s health awareness and to

make an advocacy in order to reinforce the rules and regulations and their effective

application,

- The states should improve the availability, the financial and geographical accessibility of

medicines,

- It is imperative that the actively involved parties work not to transform Africa into

“drugs garbage dump” and respect the regulations in force for the donation of

medicines,

- Awareness should be reinforced and the prescription and rational use should be

promoted through a well oriented training of health agents,

- There is a need to systematize the information via moderated platforms by health

professionals,

- The role of the professional boards is to sensitize and train pharmacists but also to

punish faulty people and finally collaborate more with the Authorities. The Boards

should discuss more and define common objectives to fight against cross-

bordercriminality related to unlawful trafficking of medicines,

- The Authorities should take disciplinary measures in order to compensate for the

professionals and traffickers’ feeling of impunity,

- The countries should install a committee which continuously discusses about the wide

range of the links and the institutional role of everyone in the control of medicines.

II.5. SESSION 3: Supply sources and counterfeit drugs

Session chairperson: Dr. John Kakule, from the ACP Group

Reporters :

1) Dr. Mathias SOME, from the African Federation of Public Health Associations

2) Dr. Michel MARQUIS, Regional Advisor of Health Cooperation and Social Development

(Burkina Faso, Guinea, Mali, Niger, Sierra-Leone)

Presentation 9: Challenges in quality drug supply in Africa

Presenter: Dr. Magali BABALEY, from the Department of Essential Medicines and

Pharmaceutical Policies (EMP), Unit of access to medicines and rational use (MAR), WHO,

Geneva.


This presentation permitted to define the concept of quality certification of pharmaceutical

products. Through this concept, it shows the actors, the processes and the tools which go with

the implementation. Surveys entitled “cartography of pharmaceutical supply systems”,

conducted in 16 African countries, and identified the strengths and weaknesses of the supply

circuit. To ensure security of the supply circuit of pharmaceutical products, it is necessary that:

- the role of each involved actor be clarified ,

- the supply agencies make their quality certification policy more transparent,

- the regulation authorities be reinforced,

- the imported drugs be exclusively those which are registered in their destination

countries,

- a system of pre-qualification of the agencies be proposed.

Presentation 10: Interpol’s approach in counterfeit drug control

Presenter: M. Thierry Tuina, from BCN Interpol

Mr. Tuina developed his presentation around four points : (i) a reminder of the approach used

by Interpol in the counterfeit drug control, (ii) the lawful supply sources, (iii) the unlawful

supply sources and (iv) the control of counterfeit drugs.

As far as the Interpol approach is concerned, counterfeiting is considered as an act of piracy

and which undermines the intellectual property and that pirating can be applied to generic

products as well as branded products. Thus, Interpol opted for the repressive way through

coordinated actions or selective actions of seizure. The strategies implemented are:

• the creation of a unit to fight against counterfeit medicines,

• the support of the States to control counterfeiting through (i) trainings and (ii) technical

and financial support to organize police operations (for example Operation Mamba in

Tanzania, Uganda and Kenya) and the Operation Harmattan which will take place in six

African countries

He ended up his presentation describing the lawful and unlawful ways of medicines trafficking.

Within this framework, he precised that the cross-border collaboration is very important to

control counterfeit drugs.

Presentation 11: Traceability / Authentification of medecines

Presenter: Dr. Alassane Ba, from the CHMP

For the traceability, it is necessary to have the transit documents: (i) the transportation letter,

(ii) the certificate of origin, (iii) the contract between the manufacturer and the distributor. In

the absence of these elements, there can be a strong suspicion of counterfeiting or product

misappropriation.

The presenter defined traceability which should be established from a codification that is

universal and impossible to forge. This method of codification permits to protect the anonymity

of people, to establish a link between the giver and/or the receivers. All in all, the traceability

permits to:

• Guarantee the quality of the product

• Locate a product at any time in a respectable period of time

• Follow the transfer of a product


• Identify a patient to whom a product has been implanted or a medicine has been

administered

• Protect patients and health actors

• Make sure of the compatibility of the medicine with the receiver

• Determine the use by date of a medicine

• Recall from the market a defective batch or a lot presenting risks of defectiveness

Finally, the traceability of medicines on the basis of the batch number, and taking into account

the use by date has become legal obligation. The traceability should be compulsory in all the

transactions. In these conditions, the CIP 13 digits codes and the Data Matrix which are efficient

and reliable codification methods are mentioned.

Presentation 12: National Purchasing Agencies - Experience of the ACAME

Presenter: Mr. Lazare Bansse, Permanent Secretary / ACAME

Mr. Bansse talked about the experience of essential medicines purchasing agencies, members

of the ACAME. To guarantee the traceability and the quality of medicines, a pre-qualification of

the suppliers is conducted by the agencies. For this pre-qualification, the supplier is asked to (i)

to fill in technical specifications clauses, (ii) give the list and the

technical specifications of the supplies, (iii) fill in a questionnaire

elaborated by the agency and (iv) provide information for the

administrative specifications. The short listing will take into

account:

� the letter of approval or the certificate of trade of each

manufacturer of the distributed products, testifying of

their quality of registered distributor of these products

(whose list is appended to the document)

� the certificate of manufacture good practices for each

site of manufacturing, of each manufacturer whose

products are proposed

� the certification CE or ISO 9000 of each site of production and distribution of medical

consumables proposed

� the analysis of the questionnaire in depth with a minimal grade of 70/100

For the WHO pre-qualified products, there should be: (i) the certificate of pre-qualification

delivered by the WHO, (ii) the product license in the country of origin of the manufacturer, (iii)

the certificate of analysis of the finished product, (iv) the certificate of pharmaceutical product.

For the products with a launching certificate ((AMM) in a ICH country, there should be: (i) the

product license in the ICH country, (ii) the certificate of pharmaceutical product, (iii) the

certificate of analysis of the finished product.

Presentation 13: Medicine production in Africa- Experience of the ECOWAS

Presenter: Dr. Sybil Ossei-Agyeman-Yeboah, WAHO

Through this presentation, Dr. Ossei-Agyeman-Yeboah from the

Department of medicines and vaccines of the West African

Health Organization (WAHO), pointed out the efforts of the

WAHO to support the African manufacturers. Advocacy meetings


are hold between the WAHO ruling team and the group of African manufacturers. The

Department of medicines and vaccines has for mission to:

- build the capacities of the units of production of health products

- build the capacities of laboratories to control quality

- establish the pre-qualification system and other types of accreditation for the West

African industries of medicine production

- advocate for the reinforcement of the capacities of the regulation authorities

- develop strategies and mechanisms of harmonization of the regulations policies and

pharmaceutical legislations

- support the countries in implementing strategies to fight against the unlawful market of

medicines

- reinforce the security of patients and improve the content of the awareness actions on

medicines,

- reinforce the stock of vaccines at the level of member countries in case of epidemics,

- promote and use coordinated information on the purchase of pharmaceutical products,

- elaborate and implement a sub-regional strategy on the commercial aspects and the

rights of intellectual property.

Therefore, through these missions, the WAHO supports the setting up of local production

industries but is watchful of good practices in the manufacturing through the promotion of the

WHO pre-qualification or other systems of certification. The presenter also mentioned the

challenges to take up. To do that, the paths to follow are:

- set up a regional certification system for the manufacturing of pharmaceutical products,

- get loans to support the local production,

- create a bio-availability and bio-equivalence center in the region,

- create a bio-technology and research center

- build the capacity of the quality control laboratories

- elaborate harmonized directives for the quality control laboratory and the systems of

health security in the region

- support the main manufacturers of raw materials

- continue the harmonization of the processes of drug registration

- engage more partners for the funding of the activities of the WAHO program of drugs

and vaccines

- organize purchases in bulk of raw materials to reduce the cost of the product for the

units of manufacturing in the region thanks to the creation of a working capital

Presentation 14: Role of the national Pharmaceutical Regulations

Authorities

Presenter: Mr. Yusufu Ubale Hashim, from the NAFDAC – Nigeria


The NAFDAC is the national pharmaceutical regulation authority. It regulates and controls the

manufacturing, importation, exportation, distribution, advertisement, selling and the use of

food, medicines, cosmetics, medical devices, chemical products, detergents and distilled water.

Next, the presenter showed the extent of the phenomenon of

counterfeit drugs and the risk factors in Nigeria. The control

strategies which essentially consist of sensitization and

repression have been efficient since 2001. We notice a strong

implication of the State in the funding of the activities and this

autonomy of the NAFDAC allows it to use new means of control.

Synthesis of session 3 panel

In this session, the time alloted to panel was used up by the presentations. Therefore it was not

possible to conduct debates on the themes evoked. This panel was delayed to session 4.

II.6. SESSION 4: Quality Certification of Medicines

Session chairperson: Professor Jean-Baptiste NIKIEMA, DGPML, Burkina Faso

Reporters:

1) Dr. Mathias SOME, from the African Federation of Public Health Associations

2) Dr. Michel MARQUIS, Regional Advisor of Health Cooperation and Social Development

(Burkina Faso, Guinea, Mali, Niger, Sierra Leone)

Presentation 15 : Study of the Quality of Antimalarial Drugs in Africa:

Results

Presenter: Mrs. Latifa El Hadri, from USP (USA)

The presenter first introduced her organization, US Pharmacopeia. The organization intervenes

in the domain of quality control. Its objectives are:

- To ensure the quality of the medicines by setting up (i) a supervision program of the

quality of the medicines and (ii) an African network of laboratories of medicine

control (NAMCOL).

- Setting up appropriate strategies to solve the problem of drug quality by (i) the

management of communication and awareness campaigns, (ii) implementing data

bases (MODB), and (iii) running a virtual forum.

On the occasion of this round table, the presenter gave the example of the program of quality

control of antimalarial drugs. The strategies of this program are:

- The support to national programs of fight against malaria,

- the carrying out of quality control at the level of sentry sites (sanitary districts) by

Minilab®,


- the evaluation of the quality of medicines by Minilab® , base tests and confirmation

tests according to the methods of the American pharmacopeia,

- the dissemination of the results and undertaking possible corrective actions

Within the framework of this program, the sentry sites are:

- 5 sites in each of these counties : Ghana, Kenya and Ethopia

- 9 sites in Senegal

- 7 sites in Mali

According to the QAMSA Survey (quality antimalarial study in Africa), the listed non

conformities in Senegal, Uganda and Madagascar were respectively de 44%, 26% and 30%.

Presentation 16: WANBL Project in West Africa

Presenter: Dr. Jean-Louis Machuron, from the Mérieux Foundation

The RESAOLAB project is a project of the Merieux Foundation which intervenes in the

reinforcement of biomedical analysis laboratories. The project intervenes through four lines: (i)

in service training of laboratory staff, (ii) reinforcing the quality certification system, (iii)

supporting the epidemiological supervision system and (iv) structuring a sub-regional network

of laboratories. The presenter laid emphasis on the importance of talking about this network

because he thinks the quality of the diagnosis (act) goes with the quality certification policies of

pharmaceutical products.

Presentation 17: Quality certification of medicines in Burkina Faso

Presenter: Dr. Arsène Ouédraogo, DGPML, Burkina Faso

The presenter initially defined the concept of quality certification of medicines which is a

concept including all the processes that can individually or collectively affect the quality of

pharmaceutical products. Quality certification is all the activities and responsibilities intended

to insure that the drugs which reach the patients are without danger, efficient and acceptable.

Domains of application: the pharmaceutical production, distribution, inspection and quality

control.

In the case of Burkina Faso, the pharmaceutical production is almost inexistent and importation

represents nearly 99% of all the products. So to set up a quality certification, the ministry of

health of Burkina Faso through the technical inspection of health services (ITSS) and the DGPML

has developed strategies to supervise the distribution, purchases, storage and dispensation. We

can notice a reinforcement of the supply system and pharmaceutical products management

through the affectation of pharmacists in all the health centers from the peripheral level to the

central level. The supply circuit is clearly defined and known by all.

The CAMEG is efficient and decentralized enough and all its purchases are made with

shortlisted suppliers on the basis of quality guarantee. All the boarded pharmaceutical products

can be imported through a visa after the checking of quality documents and regulation

elements. Nearly 22 pharmacists have been trained in the inspection but are not yet sworn in.

The post-marketing quality control is conducted but is still not efficient. Measures are taken for

the reinforcement of drugs registration committees.


Despite the progress noted, we can notice the following shortcomings:

• Insufficiency of the expertise to evaluate the AMM files

• Insufficiency of financial means for the pre-marketing control

• Non application of the approval of particular foodstuffs (dietary supplements, dietary

products)

• Lack of coordination and sustainable financing as far as pre-marketing and post-

marketing control of pharmaceutical products is concerned.

• Insufficiency of expertise as far as the inspection of Manufacture Good Practices (BPF)

is concerned

• Embryonic stage of the national system of supervision of the side effects of health

products

Presentation 18: Procedure for setting up a quality control laboratory

Presenter: Mr. Philippe Bernagou, from the Pierre Fabre Foundation

The Pierre Fabre Foundation is in 18 sub-Saharan French-speaking countries (comprising

countries from West Africa, Central Africa and the Indian Ocean)

One of the key strategic lines is to favor the “access to quality drugs”, through the training of

real drug professionals and the participation to the fight against the counterfeit drugs, including

the development of quality control structures.

The presenter recalled that drug quality control is both complex and political. It is not yet

“culturally” set in the mentalities of all health decision-makers. Among all the problematic of

access to medicines, it should be registered in the preoccupations, even in the priorities of

health ministers and medicine professionals in the broad sense of the word.

Finally the presenter ended up by precising that the control procedures are but only worth for

those who use them that is to say well-trained health agents. That’s why the Pierre Fabre

Foundation decided to focus on the training of health human resources.


31

Synthesis of Session 4 panel:

Dr. Magali BABALEY EMP/MAR Department,

WHO, Geneva

M. Thierry Tuina Interpol

Dr. Alassane Ba CHMP

M. Lazare Bansse, ACAME

Dr. Sybil Ossei-Agyeman-

Yeboah

WAHO

M. Yusufu Ubale Hashim NAFDAC – Nigeria

Professeur Jean-Baptiste

Nikiema

DGPML, Burkina Faso

Mme Latifa El Hadri USP (USA)

Dr. Jean-Louis Machuron Mérieux Foundation

Dr. Arsène Ouédraogo DGPML, Burkina Faso

Session 4Panel

Mr. Philippe Bernagou Pierre Fabre Foundation

The debates evolved around:

(i) The weaknesses of quality control laboratories : The quality control laboratories

at the level of the Africa zone do not have the necessary capacities to conduct

the quality control tests on all the drugs .They often lack reagents (reference

substances), equipments or qualified resource people. At last, when these

laboratories have the acceptable organizational and institutional capacities, they

are not accredited or certified according to the international norms or they are

not able to implement the recommended corrective actions, following the

detected non conformities. In accordance with all these elements, the

participants are unanimous on (a) the necessity to better coordinate the actions

of the regulations authorities and those of the quality control laboratories, (b)

the respect of the provisions allowing the application of the rules and regulations

in force, (c) the drafting of a reinforcement program of quality control

laboratories and (d) the networking of these laboratories.

(ii) The weakness of the national vigilance systems. Most African countries have an

embryonic or inexistent medicine monitoring system. However the medicine

monitoring system contributes to the reinforcement of the health watch and to

the detection of sub-standard or counterfeit medicines. It is therefore necessary

that this section be reinforced within the framework of setting up strategies to

fight against counterfeit drugs.

(iii) The absence from the profession of sworn in inspectors in most countries in sub

Saharan Africa. Generally pharmacists were trained and they practice routine

inspections or sponsored inspections without being sworn in. They have limits as

far as decision making is concerned and do not have any autonomy. The

participants agreed that there is a serious need to develop this profession and

grant the necessary independence within the context of carrying out their duties.

(iv) The non respect of regulatory measures, of which notably the importation of non

approved medicines in their destination countries. The special importation

Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 32

licenses delivered by the ANRP do not guarantee the quality of the imported

drugs. Registration is a proof of the respect of the principles of quality by the

manufacturer. Thus, it is imperative that the measures be reinforced and

harmonized at the level of the States for the registration of medicines.

(v) The lack of transparency in the quality certification policies of the international

supply agencies. On this point, it was pointed out that the supply agencies do not

have any quality certification policy or when it exists, it is insufficiently shared

with the actors. Measures should be taken to make all the structures conform to

the same regulatory conditions.

II.7 SESSION 5: Action Plan for the West African region

Session chairperson: Dr. René Adzodo, Health system Focal Point, WHO – Inter –country

technical support team for West Africa

Reporters:

1) Dr. Maryse Dugué, from the French Development Agency (Paris)

2) Dr. Caroline Damour, from the UNICEF WCARO, Regional Office for West and Central

Africa (Dakar)

Presentation 19 : ECOWAS Experiences, WAHO Action Plan

Presenter: Dr .Sybil Ossei-Agyeman-Yeboah, from the WAHO

The WAHO action plan is a multisectoral approach to fight against counterfeit drugs. A

committee of 15 focal points was set up to monitor and implement the action by countries. The

proposed action will be submitted to group works in sessions 8 and 9.

Presentation 20: WAEMU Experiences – Advocacy

Presenter: Dr. Safiatou Ouattara, from the WAEMU

Through this presentation, the problematic of counterfeit drug was

pointed out. The WAEMU has intervention lines which deal with the

pharmaceutical domain. They concern the reinforcement of the

pharmaceutical regulation and the support to the creation of mutual

benefit companies. The objective of the advocacy document is to

reinforce the capacities of WAEMU member states in the fight against

the unlawful market and counterfeiting of medicines

- Propose a glossary of definitions of terms and concepts which

are going to be used in this advocacy document and for a better

comprehension

- Make a situational analysis of the conducted actions within the

framework of the fight against the unlawful market and the counterfeiting of medicines

in the WAEMU States

- Identify the main intervention lines and propose a logical framework for the

implementation of the proposed actions

The WAEMU developed many strategies in the domain of protection. The one dealing with

drugs was developed in 2005 in collaboration with the WHO. It permitted to set up a structure

to harmonize pharmaceutical regulation (2007). This structure is organized through a


committee, a secretariat and technical groups of experts. The essential actions can be listed as

follows:

- Elaboration of an action plan with the main orientation of setting up a harmonized

regulation framework. This plan has three lines: (i) reinforcing the regulatory

framework, (ii) reinforcing the technical framework, (iii) development of exchanges and

technical cooperations.

- Elaboration of strategic documents: approval of medicines in the WAEMU zone,

inspection and pharmaceutical good practices, texts on advertisement and information

on medicines, non approved products etc.

- Implementing the approved documents reinforcing the structures in the countries

(Directorates of pharmacy)

Within the framework of the fight against counterfeit drugs, an advocacy document in the fight

against the unlawful market and counterfeits was elaborated. This document will be used for

the elaboration of a consolidated plan with that of the WAHO.

Presentation 21: NEPAD Initiatives in harmonizing launching norms of

medicines in the ECOWAS area.

Reporter : Dr. Margareth Ndomondo Sigonda, from the NEPAD

The presenter first talked about the current situation of the texts ruling the registration of

medicines in Africa. Then, she gave details about the issue of harmonization. Among the

insufficiencies, she mentioned the limited number of competent human resources at the level

of the States, the lack of transparency and the weakness of the regulation authorities. With

regard to these elements, the NEPAD has decided to support the WAHO as well as other sub

regional organisms for the harmonization of norms as far as medicine registration is concerned.

The harmonization should take out a quadruple challenge:

(i) Reduce the health risks while making quality drugs available,

(ii) Reinforce populations’ trust in the health system,

(iii) Enlarge the range of the registered pharmaceutical products

(iv) Make quality drugs financially accessible.

To achieve these objectives, the NEPAD committed itself in the initiative of harmonization and

works to a federation of financial partners to support the implementation of the activities

Presentation 22: Regional Integration, the Example of the OCEAC

Presenter: Dr. Hélène Degui, from the OCEAC

Dr. Degui first presented an inventory of the situation in Central Africa. Following the example

of the initiatives of harmonization and federation in West Africa, similar initiatives were

implemented in Central Africa. This region is also submitted to the existence of two organisms,

the CEEAC and the CEMAC, which extend only to the Zone Franc countries.

The coordinating organ for the public health sector in the CEMAC is the OCEAC. So far, the

following results were observed:

(i) The depiction of the situation and the drafting of a common pharmaceutical policy

document.


(ii) The setting up of a regional development program of the pharmaceutical sector by

the OCEAC. It is called “Regional economic program” and has for priority objective to

harmonize regulations and actions to control counterfeit drugs. For that purpose,

some activities have been scheduled, some legal texts written or in progress, and

some community directives have been written. Some monitoring indicators have

also been determined.

In order to reach these goals, an operational and coordinated roadmap has to be made and it is

necessary to look for technical and financial partners.

Presentation 23 : Role the Gates Foundation in the Field of medicine in

West Africa

Presenter: Mr. James Platts, from the Bill & Melinda Gates Foundation

In the framework of counterfeit drug control, the Foundation

sustains pharmaceutical regulation in Africa. They ensure the supply

of prevention programs in vaccines through clear and precise

circuits. Their main strategies are: (i) support to public/private

sectors partnership, (ii) development of global collaboration in the

field of health and improvement of coordination between the

different actors.

Concerning public health, the presenter has mentioned that the

Foundation sustains access to the medicines for control of serious

diseases in developing countries: HIV/AIDS, poliomyelitis, meningitis

in case of epidemic, malaria, etc.

For counterfeit drug control, the Foundation intends to (i) enhance ANRPs, (ii) contribute to the

improvement of the registration processes and (iii) support the regional approach.

Finally, the role of the Foundation is to improve public health by making quality medicines

available.

Synthesis of session 5 Panel

Dr. Sybil Ossei-Agyeman-

Yeboah

WAHO

Dr. Safiatou Ouattara WAEMU

Dr. Margareth Ndomondo

Sigonda

NEPAD

Dr. Hélène Degui OCEAC

Session 5 Panel

M. James Platts Bill & Melinda Gates

Foundation

During this panel, participants asked partners and countries to:

(i) improve the efficiency of aid through well targeted supports in the framework of

the capacity building of regulation structures,

(ii) promote harmonization of the regulations at the regional level,


(iii) ensure a better coordination of the activities of the institutions and to avoid

them conducting the same activities so that the financial resources can be used

for other priorities,

(iv) reinforce the ANRPs with qualified staff,

(v) ensure application of the decisions proposed during inspections

(vi) grant ANRPs the necessary means for the application of all regulatory functions

(vii) imply the boards of professionals in all strategies in order to develop a synergy

around the issue of counterfeit drugs.

To solve the problem of human resources, it has been proposed to create some regional

centers of excellence and to encourage exchanges between countries, in order to put together

the human resources available and to imply universities. Concerning harmonization, it has been

proposed that the countries establish collaboration and exchange conventions to use the

available capacities mutually. Also, it has been recommended to propose specialization

programs of pharmacists.

A strong recommendation has been made to regional organizations to assist the states in

enhancing the national regulation authorities. Some participants recommended the creation of

autonomous and independent drug agencies that will be able to take fair decisions. The

creation of agencies is not a miracle solution. Whatever the model, it is necessary that the

states give these agencies all the necessary prerogatives. For that purpose, it is necessary to

define the mission of the structures clearly and to provide them with the necessary tools and

means. A preliminary condition to counterfeit drug control is to reduce the poverty of the

population, or at least to make health services financially accessible, including medicines. More

strict and rigorous interventions are necessary, and regional initiatives have to be implemented

to obtain results. It would be good to put the means together and advance together. An organ

of management and coordination would be necessary to mobilize resources and to permit the

implementation of the integrated action plans of regional structures which would also be

evaluated.

II.8 SESSION 6 : Initiatives in Counterfeit Drug Control

Session chairperson: Dr. Nyango, Director of cabinet, DDS Commission, WAEMU

Reporters:

1) Dr. Maryse Dugué, French Development Agency

2) Dr. Caroline Damour, UNICEF WCARO (West and Central Africa regional Office, Dakar)


Presentation 24: Presentation of the Medicrime Convention

Presenter: Mrs. Caroline Larsen Le Tarnec, DEQM, Council of Europe

In the framework of counterfeit drug control, the

MEDICRIME Convention was adopted in December

2010. This convention creates a complete legal

framework for the international cooperation against

counterfeit drugs. The targets are the manufacture,

supply, falsification of document and the supply of

non authorized medical material. This convention is

open to non member states of the Council of

Europe, so all West African states willing to ratify it

are welcome.

Presentation 25: Presentation of the Franco-African Network of Quality

Control Laboratories of the AFSSAPS

Presenter: Pr. Alain Nicolas, from the AFSSAPS, represented by Mrs. Caroline Larsen Le Tarnec

The Franco-African network of LNCQs is composed of 11 laboratories and partners such as the

WHO, the AFD and the MAEE. The objective of the network is to get the pre-qualification of

laboratories, the conduction of the quality control of ARVs, the improvement of access to

reference substances, etc.

The means: collaborative studies, inventory of fixtures, sharing information, development of

network members’ QA system.

The perspectives: putting experiences together, improving communication, distance training,

improvement of the knowledge, possibility of collaboration with other laboratories or

networks.

Presentation 26 : IRACM Initiative

Presenter: Mr. Wilfrid Roger, from the IRACM

The International Institute for Counterfeit Medicine Control (IRACM) is an institute-organism

essentially in charge of the training of the actors intervening in the struggle against counterfeit

drugs. Their main issues are: knowledge of the drug, the role of the health agents, traceability,

the problems at the borders, the notions related to intellectual property, the police

intervention, the distribution good practices, the problem of the Internet. The Institute intends

to be an alternative in the capacity building of actors in the struggle against counterfeiting. It

will soon be accessible online, by the end of October 2011.

Presentation 27: Initiatives and Support of the Customs in Counterfeit

Drug Control

Presenter: Mr. Christophe Zimmermann from the World Customs Organization

The presenter specified the context by mentioning that the fraud systems are better and better

organized, that the counterfeiting industries have increasing capacities of production, that


there are weaknesses of the transit controls in the because of the diversity of transportation,

and that counterfeiting is a means for laundering money.

Therefore, he proposed the following solutions : (i) reinforce cooperation, (ii) define the offense

of counterfeiting as a customs offense, (iii) conduct the customs checks since the external

border of the sub-region, (iv) widen the field of application of the community transit

regulations, (v) reinforce the capacities of the agents to risk analysis, (vi) create regional

observatories for counterfeit drug control, (vii) adopt a key tool for custom officers and other

first control line authorities (IPM).

Presentation 28 : French Initiatives in Counterfeit Drug Control

Presenter: M. Thierry Le Lay, from the MAEE, Paris

Counterfeit drug control has been decreed as a priority issue because it is related to public

health. It is necessary to have a factual database in order to reinforce advocacy. In view of the

importance of the phenomenon, a national plan to control counterfeiting and counterfeit drugs

was adopted on September 7, 2011. With this adoption, some perspectives are now offered for

the development of efficient strategies of struggle, mainly at the international level.

It should be noted that the French initiative sustains the IMPACT work group of the WHO in the

framework of counterfeit medicine control.

France supports advocacy actions from Heads of state, Governments and international

organizations, as well as of the initiatives at the international level in the preventive and

repressive domains. The country has appointed a special envoy, Mr. Thierry Le Lay, to

coordinate the French actions in this domain.

Synthesis of Session 6 Panel

Mrs. Caroline Larsen Le

Tarnec

DEQM, Council of Europe,

AFSSAPS

Mr. Thierry Le Lay MAEE Paris

Mr. Wilfrid Roger IRACM

M. Christophe Zimmermann World Customs Organization

Session 6 Panel

Mr. Thierry Le Lay MAEE

It is necessary to define a global strategy for the control of the ports of entry of the medicines

because counterfeiters constantly change methods (e.g.: factory ships)

The participants suggested the use of the shocking pictures by political and religious authorities

to raise awareness in the public.

The issue of counterfeit drug is a complex one, and it is necessary to think seriously about

developing joint strategies.



- Define strategies for a strong implication and/or collaboration of customs services

- Advocate for the reinforcement of HR capacities

- Ensure stricto sensu implementation of the pharmaceutical regulation and make it clear

that the pharmacist's monopoly is not a commercial monopoly.

- Think about financing health care through the creation of health insurance.

- Proceed with political advocacy to sensitize Heads of states and government of the most

affected countries.

II.9 SESSION 7: Some Private Enterprises Active in Counterfeit Drug

Control

Session chairperson: Mr. Lazare Bansse – ACAME

Reporters:

1) Dr. Margareth Sigonda from the NEPAD

2) Mr. Christian Abonnel, International Technical Expert from the Ministry of Health of

Benin

Presentation 29: Quality of Medicines in Africa

Presenter: Mr. Pierre Savart, from the LEEM

In the framework of LEEM advocacy and actions in counterfeit drug control, the following

objectives were designed:

- Reinforce awareness of high rank authorities,

- Favor exchanges between ANRMs and stakeholders,

- Contribute to creating a regulatory framework,

- Bring punctual support to quality control laboratories ,

- Promote a good use of drugs.

Presentation 30: Presentation by Sanofi-Aventis

Presenter: Mr. Wilfrid Roger, from Sanofi-Aventis

With this presentation, Sanofi-Aventis wished to share their experience in investigating to

identify counterfeiting. Checking the packaging, the color and the aspect of the products, the

lack of coherence of the importation documents, are elements which need a special attention.

It is as essential to verify the origin of all containers.

Presentation 31: Presentation by GSK

Presenter: Mrs. José-Mireille Aka, from GSK

The following information was shared by GSK:

- GSK products never have any plastic sachets; there is no transit by the port of Cotonou;

GSK products never come from the Asian countries,

- Some elements permit to certify the origin of GSK products: the logo, the method of

writing batch numbers, the insertion of hologram, etc.


- Some actions are undertaken by GSK: a project of verification of the origin of products

by SMS, subscription to the IPM database of the WHO…

Presentation 32: Presentation by MSD

Presenter: Mrs. Karen Bresard, from MSD

The presentation was around the following points:

- Presentation of MSD: This laboratory is represented in 149 countries. They invested a lot

in research and development. They make a wide range of products marketed in Africa.

They also developed some initiatives to improve access of patients to drugs.

- Proactive Approaches, notably by routine field investigations.

- Reactive Approaches: to react to the solicitations of pharmacists, regulation authorities,

police and customs officers….

- Strategy: protect the patient (securing supply circuit, detection of all counterfeiting

activities, sensitization of health professionals) and support ANRs.

Presentation 33: SMS certification of medicines

Presenter: Mr. Selorm Branttie, from MPedigree

It is a simple technology that exploits the possibilities offered by mobile telephony. The patient

sends an SMS with the code on code on the packaging of the medicine and receives

immediately an answer on the authenticity of the product. This is a very cheap technology

which comes in as a supplement to the use of holograms. It has permitted people in Ghana and

Nigeria (and soon in Kenya) to identify counterfeit drugs.

Synthesis of Session 7 panel

Mr. Pierre Savart LEEM

Mr. Wilfrid Rogé Sanofi-Aventis

Mrs. José-Mireille Aka GSK

Mrs. Karen Bresard MSD

Session 7Panel

Mr. Selorm Branttie MPedigree

In this session, discussion was focused on the following points:

- Controlling medicine-importing structures;

- Making practical and strong recommendations for this round table to boost again the

struggle against counterfeiting;

- Professionalizing progressively the actors of the supply chain in order to reduce the

impacts of its dysfunctions and make the detection of counterfeits proactive ;

- Reinforce collaboration between the LEEM and the Boards of professionals;


- Reinforce strategies in medicine-producing countries in order to reduce or eliminate

counterfeit products.

II.10. SESSIONS 8 and 9: Working groups

Sessions 8 and 9 were dedicated to working groups.

During session 8, participants were asked to make a SWOT analysis (Strengths, Weaknesses,

Opportunities, Threat) and propose corrective actions on the basis of three major weaknesses

in order to enrich the WAHO action plan and WAEMU advocacy document. For that purpose,

four work groups were made to ponder over the following topics:

- group 1 : Legislation / Regulation

- group 2 : Human resources

- group 3 : Quality certification and technologies

- group 4 : Leadership, policy, coordination and communication

-

The objective of session 9 was to make participants to think about the implementation of the

WAHO - WAEMU consensual action plan and about the creation of platform of technical and

financial partners. Concerning that point, all participants are unanimous on a quick

implementation of the consensual action plan to be derived from the consolidation of the

WAHO action plan and WAEMU advocacy document. First, it will be necessary to hold a

meeting on the WAHO focal points (EMACCOM) to finalize the consolidated action plan while

taking into account the contributions of the round table. Secondly, a structuring of the different

organs implied in the implementation of the action plan will have to be proposed.


41

II.11. CEREMONY CLOSING

Sequences of the closing ceremony

The end of the works of the round table on fake medicine

drugs was highlighted by an official closing ceremony

presided over by the Minister of Health, representing H.E. the

President of Burkina Faso. Three major events occurred

during the ceremony:

-the presentation of the prizes of the contest called “Best

journalistic productions on counterfeit drugs” organized by

the ONPBF;

- the reading of the final overall report, of the recommendations and the reading of the

motion of acknowledgement;

- the closing speech delivered by the Minister of Health.

The contest" Best journalistic productions on counterfeit drugs" was organized by the national Board

of pharmacists of Burkina (ONPBF). Dr. Jean L. PARE, President of the ONPBF, situated the context of

the contest which is an activity of the national awareness days on counterfeit drugs. He added that

the organization of the round table on the fake medicine in Burkina Faso honors all the pharmacists

of the country and representing a boosting factor in counterfeit drug control. Finally, mentioned the

ten-year fight of the ONPBF. After that, the prizes were presented to the winners.

Before the official closing speech of the round table, the general reporter made read the synthetic

report, mentioning the main events of these three days of meetings. Then, the representative of

Guinea (a WAHO focal point) presented the key recommendations of the round table. The

representative of Ghana, in the name of all the participants, finally addressed the motion of

acknowledgement to the Head of State of Burkina Faso, the members of the government for the

hospitality and the smoothness of all the activities, and also to all people, institutions and the

technical and financial partners who contributed to make the event successful.

In his closing speech, the Minister of Health expressed his satisfaction for the way this event went. He

reaffirmed the commitment of Burkina to control counterfeit drugs and guarantee quality drugs to

the populations. Therefore, Burkina Faso fully adheres to the results of the round table. Finally, he

thanked all the organizers and TFPs for their endless efforts which permitted to organize this round

table. While expressing the pride of his country to have hosted the event, the minister wished a safe

trip back to all the participants. The works of the round table ended at 4.30 PM and were followed by

a press conference.


The organisation committee would like to especially thank those who provided a financial support

to the event: the French Ministry of Foreign Affairs, the WAHO, the OIF, the Fondation Chirac, The

AFD, The IRACM, The Fondation Pierre Fabre, the LEEM and the Fondation GSK.

Motion of acknowledgement

We, the participants of the round table on the topic “A Joint Action against Counterfeit

Drugs in West Africa” held from September 27 to 29, 2011 in Ouagadougou,

Very sensitive to the warm reception and the hospitality that we enjoyed during our

stay in Burkina Faso;

Express our sincere gratitude to the President of Burkina Faso, His Excellency Mr. Blaise

COMPAORE, for the patronage of this round table and his personal commitment in the

struggle against counterfeit drugs

Thank the government and the people of Burkina Faso for the excellent facilities made

available to all the delegations;

Very happy after the organization of this round table and the opportunity that it gives

us to start a real struggle against counterfeit drugs in favor of our populations,

Sincerely thank the Ministry of the health of Burkina of Faso, the West African Health

Organization of (WAHO), the West African Economic and Monetary Union of (WAEMU),

the French ministry of foreign and European affairs, the Chirac foundation, for their

implication in the organization of these activities.

Thank the World Health Organization (WHO) for their technical support.

Congratulate the organizing committee and its members for their firm devotion and

their permanent availability.

Express our recognition to the financial partners for being with us all along this round

table.


Part 3:

RESULTS AND PERSPECTIVES


44

III.1 STRATEGIC AND OPERATIONAL RECOMMENDATIONS

III.1.1. Strategic recommendations

The three days of work and discussion permitted the participants to make four strategic

recommendations:

a. Key issue # 1: Propose a regional strategic for counterfeit drug control and ensure the

implementation of operational action plans in the 15 ECOWAS countries:

- The WAHO action plan and WAEMU advocacy documents served as work documents; they

have to be harmonized and enhanced.

- A regional strategic plan will be consolidated and proposed according to 4 strategic

orientations: (i) political action and advocacy, (ii) institutional advocacy, (iii) preventive

actions, (iv) repressive actions.


1. Integrate both work documents to get to Regional Strategic Plan (RSP)

validated by the two regional institutions.

2. Also take into account the group work results to consolidate and enhance the

action plan.

3. Contribute to the elaboration of operational action plans at the country level.

b. Key issue # 2 : Create organs for the implementation and monitoring-evaluation of the

Regional Strategic Plan.

- The group of 15 focal points created by ECOWAS/WAHO and EMACCOM is identified as

essential for the appropriation of the RSP by the countries and its reproduction at the

national level.

- It is very important to make rapprochement effective between the 2 regional Institutions,

i.e., WAEMU and WAHO/ECOWAS, mainly through dissemination of information on

counterfeit drug control in the joint WAEMU/ECOWAS secretariat.

- The synergy of the actions of the different TFPs should be a short term objective, through

the creation and promotion of a communication platform.


4. Formalize a protocol of agreement between the WAEMU and the ECOWAS to

integrate the major RSP orientations and the governance of the system in

charge of implementing and monitoring the RSP.

5. Imply the joint WAEMU/ECOWAS secretariat in the RSP implementation

through: 1) the validation of the protocol of agreement ; 2) putting the issue in

the meeting agendas,


6. Set up a steering committee made up of the Presidents of the EMACCOM, of

the WAHO/ECOWAS, of the CHRCP/WAEMU, of the MAEE, of the Chirac

Foundation, and of the NEPAD; the committee will be in charge of (i)

advocating in institutions to defend the issue of counterfeit drug control, (ii)

following the progress and evaluating the activities implemented in the

framework of the RSP and national operational plans, and (iii) mobilizing the

necessary human, technical and financial resources.

7. Create a TFP platform which will be managed by the steering committee and

networked by the permanent secretariat. The objective of the platform is to

share information between all the actors and partners, and to mobilize

resources (e.g., the diffusion list)

c. Key issue # 3: Reinforce juridical framework on counterfeit drug control at the regional

and national levels inside the ECOWAS

- National Authorities of Pharmaceutical Regulation are powerless and the counterfeit drug

control actions are too punctual and without a real strategy coordinated in the long run

between control organs (regulation, customs) and judicial organs.

- National legislations are not repressive enough to discourage traffickers.

- The definition of « counterfeit drugs » is not harmonized in the sub-region. There is no

specific incriminating element mentioned to start a legal action.

- Multidisciplinary and multisectoral control committees are not active enough and the

Boards of professionals are not enough implicated in the struggle.


8. Propose a regional framework legislation which takes all the aspects of the

struggle into account, gives a juridical definition of counterfeit drugs, allows

collaboration and exchange of information between all actors, and offers the

competent services of the police, justice, customs, and health (Multidisciplinary

taskforce).

9. Encourage ECOWAS countries to enter in the MediCrime Convention proposed

by the Council of Europe.

10. Give assistance to Regional Institutions in assessing and enhancing their ANRPs,

or even in creating Medicine Agencies (which are more operational structures).

d. Key issue # 4: Mobilize resources for implementing the RSP

- The financial resources allocated to the struggle are by far insufficient.

- Initiatives from TFPs are not coordinated, so they are not very efficient.

The following recommendation was made:

11. Look for funding opportunities throughout a large diffusion of the RSP and the

Round Table results to partners such as the European Union, the MAEE, the


NEPAD, the Council of Europe, the AFD, the ECOWAS, the WAEMU, the WHO,

the Bill and Melinda Gates Foundation, the private sector …

III.1.2. Operational recommendations

The Operational recommendations presented hereby were made during the group works; the results

of the latter are presented in the appendix to this document .

Strategic recommendations Operational recommendations

Propose a regional

strategic for counterfeit

drug control and ensure

the implementation of

operational action plans

in the countries:

(i) action and political advocacy:

• Share the recommendations of this round table with the African

Union and the regional institutions, ECOWAS and WAEMU

• Inform national political and legislative authorities about the

issue of counterfeit drugs and the recommendations of this

round table;

• Plead with the institutions (ECOWAS/WAHO and WAEMU) for

the creation of a steering committee dependent on the Joint

Secretariat and reinforcing the EMACCOM

• Advocate with national authorities for the ECOWAS countries to

enter the MediCrime Convention

(ii) Institutional advocacy:

• Write an advocacy document for decision makers

• Adopt a specific procedure for awareness in the Regional

Directorates of the Customs, Police and Justice.

• Propose a regional framework legislation to allow collaboration

and exchange of information between the police, justice,

custom services and health regulators (multi-disciplinary

Taskforce) and determine the procedure for elaborating this

legislation.

• Establish an annual discussion framework between ANRPs in

ECOWAS countries.

• Associate the Boards of pharmacists to the decisions and actions

to control counterfeit drugs

• Enhance the authority of the Boards of pharmacists

• Consult technical and financial partners for good practices and

definitions

• Reinforce multi-disciplinary collaboration between customs,

trade, justice, police, and health services

(iii) Preventive actions:

Concerning Human Resources:

• Reinforce HR training and take into account Health Boards,



politicians, MPs, trade unions, professional associations, civil

society (NOGs, consumer associations, private sector, religious

leaders, journalists…)

• Identify training institutions

• Make technical expertise available for training

• Create an information and training platform

• Train pharmacists to assessing files to be registered

• Build capacities of officers (mainly in the customs) in risk

analysis

• Include trainings modules on counterfeit drugs in the curricula

at health faculties and schools, police academies, custom and

magistrate training schools.

Concerning access to medicines

• Favor a better geographical and financial access to quality

medicines through the multiplication of pharmaceutical stores

and real pricing policy ,

• Proceed with the development of the lists of essential generic

medicines. Avoid granting AMMs (launching certificates) to non

essential medicines.

• Favor a reasonable use of medicines

• Develop protection mechanisms for health risks (social security,

health insurance...)

Concerning Quality Certification and Technologies

• Proceed with the harmonization of pharmaceutical and AMM

regulations at the regional level (AMRH),

• Build the capacities of the staff in the LNCQs.

• Train pharmacists to assessing files to be registered

• Create a few top rank regional quality control laboratories to

collaborate with national LCQMs,

• Set up a corps of pharmacist inspectors with a full autonomy.

• Promote a strategy with three control levels : decentralized

(sentrysites) national, regional (with precise role of each one)

• Reinforce relations between central purchasing agencies and

LNCQs to test products purchased.

• Set up a pre-qualification procedure of supply agencies

• Study the feasibility of a group pre-qualification of suppliers by a

sub-regional structure

• Develop and reinforce medicine monitoring systems

Concerning Communication :

• Launch awareness and information campaigns for health

professionals, public opinion, political and religious authorities,



• Improve information on medicines and take social obstacles into

account

(iv) repressive actions:

• Reinforce the authority of the Boards of Pharmacists, in order to

punish any breach of deontology,

• Reinforce the disciplinary cells of the Boards of pharmacists,

• Adopt the IPM data base at the level of the customs services

(OMS/OMD),

• Restrict importation of medicines to well determined points of

entry (good practice from Nigeria),

• Upgrade the offense of counterfeiting to custom offense in the

national custom codes

• Extend the field of application of the WAEMU common customs

regulations to goods in transit

• Allow the controls of goods at entry in the territory of the

Regional economic community, before diffusion inside the

Community

• Write and distribute circulars for actors of the justice to

sensitize and to focus the action of the courts on the issue of

counterfeit medicines

Set up organs for the

implementation and

monitoring-evaluation of the

consolidated and harmonized

Regional strategic plan

• Create a yearly discussion framework between ANRPs,

throughout the committee of experts from the 15 ECOWAS

countries (EMACCOM)

• Reinforce the EMACCOM committee created by the WAHO

• Share information with the joint ECOWAS (WAHO)/WAEMU

joint secretariat for matters related to counterfeit drug control

• Create a steering committee for counterfeit drug control in West

Africa

• Propose a platform of TFPs (WAHO, WAEMU, Boards and

associations of health professionals, customs, police, justice,

industries, foundations, consumer associations, development

agencies, WAHO focal points, international organizations …)

• Create a permanent secretariat to implement the activities of

the steering committee and platform of the TFPs

Reinforce the cadre juridical

framework regulating

counterfeit drug control at the

regional level as well as in the

15 ECOWAS member countries

• Promote the initiative of a regional framework legislation

allowing collaboration and exchange of information between

police, justice, customs and health services (Multidisciplinary

taskforce)

• Extend the field of application of the WAEMU common customs

regulations to goods in transit



• Assist countries which are willing to sign the Council of Europe

Medicrime Convention

Mobilize resources to

implement the regional

strategic plan

• Create the platform of technical and financial partners for


• Diffuse the general report of the Round Table and the logical

intervention consolidated framework

• Advocate with funders such as the European Union, the MAEE,

the AFD, the Council of Europe, the Bill and Melinda Gates

Foundation, the private sector to subsidize (1) the regional

process and (2) some of its activities (customs reforms, training,

AMRH...)


50

III.2. CONCEPTUAL FRAMEWORK FOR THE IMPLEMENTATION OF THE CONSOLIDATED LOGICAL INTERVENTION

FRAMEWORK

III.2.1. Conceptual Framework

PLATFORM OF

TFP

STEERING

COMMITTEE

Regional

Strategic Plan

(RSP)

Draft and signature of an

agreement protocol

OPERATIONAL ACTION PLAN – (COUNTRIES)

EMACCOM

ECOWAS WAEMU

ECOWAS Commission

DDS

JOINT

SECRETARIAT OOAS CHRP

ACRONYMS

OOAS: West African health

organization

CHRP Pharmaceutical regulation

harmonizing cell

EMACCOM: Ecowas Medicine

Anti-counterfeit Committee

DDS: Department of social and

cultural development


III.2.2. Functions and roles of the organs

Organs Members Roles, functions Meeting Frequency

Joint ECOWAS/WAEMU

Secretariat

President/ECOWHAS;

President/UEMOA,

Political advocacy

Appoint a Permanent Secretariat

(WAHO/ECOWAS, CHARCP/UEMOA) to

report on the implementation of the

regional strategic plan to the joint

ECOWAS/UEMOA secretariat and the

steering committee.

WAHO / ECOWAS Define the strategies;

Monitor the implementation of the

regional strategic plan ;

CHRCP / WAEMU Define the strategies

Monitor the implementation of the

regional strategic plan ;

EMACCOM 15 focal points, WAHO/ ECOWAS Implement national operational action

plans;

Reconcile the WAHO action and UEMOA

advocacy document

Bimonthly (teleconferencing)

Steering committtee WAHO/ ECOWAS,

CHRCP/WAEMU, WHO, NEPAD,

MAEE, Chirac Foundation,

EMACCOM (2 co-presidents)

Follow the progress of the implementation

of the regional strategic plan ;

Evaluate the results achieved;

Mobilize resources

Quarterly (teleconferencing)

Platform of TFPs All Share information among members of the

platform on ongoing projects. Additional

funding for the regional strategic plan ;.

Virtual network, discussion

forum…


III.3. PERSPECTIVES

Dates Round table follow up action Important similar events

10/25-28/11 Meeting of the intergovernmental group: “Low quality/ fake/ wrongly

labeled/ counterfeit medical products”. The round table will be

presented as a model for taking into account the issue in a crosscutting

and regional way.

10/28/11 Ceremony of ratification of Medicrime in Moscow. Representatives

from Guinea will be present.

10/28/11 Finalization and diffusion of the overall report of the round table

(French and English versions)

10/29/11 Diffusion by the MAEE of the overall report to all the future

members of the platform.

11/02/11 XVIIIth

CIOPF General Assembly – Presentation of the results of the

round table during the conference entitled “Two years after the

Cotonou Call, at what point is the struggle for counterfeit drug control”

11/07-10/11 WAHO workshop: "Harmonization of the Legislation on counterfeiting

and the illegal market"

11/30/11 Validation of the revised version of the West African Consensual

action plan after the recommendations of the round table. This

will be done by a taskforce of four people representing the WAHO


Dates Round table follow up action Important similar events

focal points of Burkina-Faso, Nigeria, Sierra-Leone and Togo

12/31/11 Sensitization of the ECOWAS/WAEMU on the project of regional

strategic plan and the mentioning of the issue on the agenda of

the next meeting of the joint secretariat.

12/31/11 Sensitization of the MAEE to mobilize resources

12/31/11 Sensitization of the NEPAD and the AU to mobilize resources

12/31/11 Sensitization of the EU delegation in Burkina-Faso (+ the DG

DevCo in Brussels) to mobilize resources

12/31/11 Study of the possibility of a technical assistance from the Council

of Europe for countries which are willing to ratify and integrate

MEDICRIME in their legislation.

12/31/11 Study of the possibility of obtaining funds for West African in the

framework of the AMRH (African Medicines Registration

Harmonization) project, from the AFD for the WAEMU region, and

from the Gates Foundation for the ECOWAS/WAHO region.


Appendixes

Appendix 1: Group work results

Group work I : Legislation / Regulation

Weakness Deadline / Cost Opportunities Menaces Solutions identified

Lack or inadequacy of

national legislation

Lack of harmonization in the

definition of counterfeit

drugs (criminal and public

health approaches)

Lack or weakness of penalties

and of law enforcement

1. Discussion with

partners

Deadline: Q1 2012

Cost: 1 meeting

2. Agenda : definition,

harmonization of

penalties, Capacity

building, inter-agency

cooperation

3. Develop an advocacy

document

Deadline: Q2 2012

Cost : consultants at

national and international

levels + 1 meeting to

approve document

Develop a framework law at

the regional level

Deadline: � Q3 2012

Cost: � 4 meetings +

Good will

Existence on regional

structures

Existence of texts and

regulations

Strong legitimacy to act :

political calls,

international resolution,

guidelines, SOP…

Funding

The active participation of

each member to the

process

Efficient collaboration and

coordination

Heterogeneous national

legislations in the area,

which will require

harmonization

Lack of capacities

Legislative procedures are

slow

Write an advocacy document

for decision makers

Discussion with technical and

financial partners for good

practices and definitions.

Discussion with members

Necessity of a regional

framework legislation to allow

collaboration and exchange of

information between the

police, justice, custom

services and health regulators

(multi-disciplinary Taskforce)


consultants at national and

international levels

Amend et promulgate

national legislation with the

regional framework law

considered

Deadline: � Q2 2013

Concerns all the actors :

legislative, justice, police,

customs, regulators, MPs

Cost � 3 meetings

Recommendations of group I

• The platform of TFPs should make sure not to initiate a similar action to this process of legislative and regulatory reinforcement

• There a need for efficient coordination and collaboration between TFPs, with the help of the WAHO


Group work II : Human resources

Weaknesses Corrective actions Responsibles

The document does not take human resources

into account enough

Take into account boards of health

professionals, politicians, unions, professional

organs, civil society (NGOs, consumer

associations, private sector, religious leaders),

repressive administrations, justice

WAHO and WAEMU in collaboration with

national authorities in a joint action plan

If there is any, reinforcement of human

resources as scheduled is limited and does not

take all the actors into account

Identification of training organisms

Capacity building through:

- training according to types of professionals

(include specific sessions on counterfeit

drugs in training)

- the creation of an information and training

platform

- the availability of a technical expertise

Train journalists, opinion leaders and civil

society

WAHO and WAEMU: give guidelines

Creation by national Authorities in collaboration

with professional organizations

There is no definition of competence profile for

actors/operators

Writing index: identification of actors,

competences, missions and roles, and the

means made available to them

WAHO and WAEMU in collaboration with

national authorities

Menaces to the implementation of an action plan Corrective measures

Existence of two structures (WAEMU and WAHO) with different

action plans

Harmonize the two action plans


Common secretariat for the implementation of a joint action plan

Uncertainty about resources to fund action plan Quantify the financial needs for HR

Identify TFs

Advocate for the mobilization of resources

Creation of a common fund

Lack of political will Advocate with political leaders for human resources

Administrative dysfunction: insufficient collaboration between

the different structures in the struggle for counterfeit drug

control

Reinforce process of joining competences


Opportunities How to take advantage of these opportunities

International mobilisation Keep this mobilization alive for a long time

Existence networks of professionals Reinforce the activities of these organizations

Analysis criteria for set up up a platform of technical and financial partners

Advantages, Drawbacks, Federation of leadership

Putting means together

Relevance, Strong

Set up procedures : participants, juridical aspects…, Joint secretariat for counterfeit drug control

Role and Objectives, Mandate, Objective: function of platform

Mandate : mobilization of resources

Port (identification of institution or proposal of alternative ways) Joint secretariat


Group work III: Quality Certification and Technologies

Weaknesses Opportunities Menaces

Weak institutional and organizational capacities of

laboratories (LNCQ) (pre-AMM control and post-

marketing)

1) Reinforce technical capacity of LNCQ staffs. 2)

Need for a regional reference LNCQ at WAHO level.

3) Strategy with 3 control levels: decentralized

(sentry sites), national, regional (need to precise the

role of each one)

1) Experience of the Franco-African Network of LNCQs of

the AFSSAPS. 2) Experience of the NAMCOL. 3) Experience

of the Pierre Fabre Foundation. Exchange of experience

between LNCQs of the WAHO. 4) WAHO and WAEMU

Project of reinforcement to accredit LNCQs

1) Lack of human and financial resources 2)

Political and national divisions about

becoming the regional LNCQ

Low capacities for evaluating manufacturers’ files

while registering medicines in DPMs and in the pre-

selection of manufacturers/suppliers by the central

purchasing agencies

Training pharmacists in file evaluation. Good

relationships between central purchasing agencies

and the LNCQ to test purchased products. Feasibility

of a grouped PQ of suppliers by a regional structure

National registration documents.

WHO blue "Registration of multi-source medicines ".

WAEMU reference document on registration. ACAME

harmonized pre-selection files

1) Lack of human and financial resources. 2)

Lack of funds to train actors in using these

tools

Poorly developed medicine monitoring system

(integrated medicine monitoring system)

Integrate existing medicine monitoring activities in the

programs of control of major diseases at the national

level. Integrate medicine monitoring activities when

designing Global Funds/Gavi programs. Share the

experience the member countries of the WHO – MM.

Existence of the Vigiflow tool

1) Vertical aspect of current medicine

monitoring. 2) Lack of trained personnel

dedicated to MM.


Travaux du groupe IV : Politique / Leadership / Coordination / Communication

Weaknesses of the WAHO

Action Plan

Corrective actions Analysis and amendments to the WAHO Action Plan

Absence of elements

related to:

• Governance

• Coordination

• Leadership

• Formalize the WAHO committee

into a steering committee

extended to the different partners

(WAEMU, WHO, Professional

Boards and Association of health,

Customs, Police, Industries,

Foundations, Associations,

Consumer Organizations, etc.)

• Integrate the platform of

technical and financial partners

• Reinforce the WAHO-WAEMU

Joint secretariat

• Define juridical status,

prerogatives, competences and

composition

A: Cooperation framework

Suppress activities A5 and A6

Create an WAHO/IMPACT committee

Participate in the activities of the committee

Add a point A7: Reinforce international cooperation by encouraging countries

to enter international conventions on counterfeiting such as Medicrime

C : Identify and propose appropriate and efficient technologies to detect

counterfeit medicines

C1 : Integrate the database of technology suppliers into the situational analysis

D : Mobilize resources to reinforce ANRMs and LNCQs to ensure the quality of

medicine and control counterfeiting

Reformulate the title of point D as follows: “Reinforcement ANRPs and LNCQs to

ensure the quality of medicines and control counterfeiting”

F : Propose an advocacy document to reinforce political will at the national level

• Reinforce political will at the national, sub-regional and international

levels

• Take into account the advocacy document produced by the WAEMU

• Enrich the chapter on the context and justification of the advocacy

document with accurate data and reference studies already conducted in

West Africa

• Advocate with countries, sub-regional organizations (WAEMU, WAHO)

and TFPs

• Evaluate the cost of the actions proposed in the WAEMU advocacy

document

• Give priority to actions and integrate them in the WAHO Action plan


Weaknesses of the WAHO

Action Plan

Corrective actions Analysis and amendments to the WAHO Action Plan

against counterfeiting and counterfeit drugs for a perfect coherence

• Establish precise deadlines for implementing the actions in the definite

integrate action plan


62

Appendix 2: List of participants

N° Institution Last Name First Name Country

1 ACAME - Ouagadougou Bansse Lazare Burkina Faso

2 ACAME - Ouagadougou Barjot Yves Burkina Faso

3 AFD - Ouagadougou Tranchant Patrice Burkina Faso

4 Ouagadougou City Hall Nardone Jessica Burkina Faso

5 AFD - Paris Dugué Maryse France

6 Preventive Medicine Agency (AMP)

Aplogan Aristide Burkina Faso

7 Preventive Medicine Agency (AMP)

Tall Haoua Burkina Faso

8 African Federation of Public Health Associations

(FAASP)

Some Mathias Burkina Faso

9 Public Health Association- Ouagadougou

BATIONO BOUBIE GERARD Burkina Faso

10 Public Health Association - Ouagadougou

BIO RENE BIENVENU Burkina Faso


YAKA-KOUDOUGOU

ALIANE FLAVINE Burkina Faso


TRAORE SALIMATA Burkina Faso

13 Public Health Association -Ouagadougou

FOFANA LAMOUSSA Burkina Faso

14 Bill & Melinda Gates Foundation Platts James Not confirmed

15 OCEAC Degui Hélène Cameroun

16 OCEAC Pola Yissibi Emilienne Cameroun

17 CHMP - Clermont-Ferrand Ba Alassane France

18 Coalition of Private Enterprises - Benin

Tozo Christophe Benin

19 Coalition of Private Enterprises - Benin

Biaou Judicaël Benin

20 Council of Europe (European committee for criminal issues)

Larsen Le Tarnec Caroline France


21 International Council of Francophone Boards of

Pharmacists

Adenot Isabelle France

22 Delegation - Cotonou (Benin) Loko Christian Frédéric S Benin

23 Delegation - Ouagadougou (Burkina Faso)

Sawadogo Casimir W. Burkina Faso

24 Delegation - Abidjan (Côte d'Ivoire)

Allali Justin Leopold Côte d'Ivoire

25 Delegation - Abidjan (Côte d'Ivoire)

Kouassi Parfait Côte d'Ivoire

26 Delegation - Banjul (Gambia) Janneh Kaira Markieu Gambia

27 Delegation - Accra (Ghana) Amedzro Thomas Ghana

28 Delegation - Conakry (Guinée) Sidiki Diakité Aboubacar Guinea

29 Delegation - Bissau (Guinée Bissau)

Gomes Da Costa Zeferina Guinea-Bisau

30 Delegation - Monrovia (Liberia) Tijli Tarty Tyee, Sr Liberia

31 Delegation - Bamako (Mali) Maiga Ababacar Mali

32 Delegation - Niamey (Niger) Sambo Mariama Oumarou Niger

33 Delegation - Abuja (Nigeria) Hashim Yusufu Ubale Nigeria

34 Delegation - Dakar (Senegal) Diop Papa Amadou Senegal

35 Delegation - Freetown (Sierra Leone)

Komeh James Peter Sierra Leone

36 Delegation - Lomé (Togo) Bignandi Aklesso Togo


Traore Adama Burkina Faso


Souleymane Sanou Burkina Faso


Dipama Sylvain Burkina Faso


Nikiema Jean Baptiste Burkina Faso


DJIERRO épouse DAGBA

Kadidja Burkina Faso


OUEDRAOGO Arsène Burkina Faso



Toe Natacha Burkina Faso


OUEDRAOGO Charles Didier Burkina Faso


OUEDRAOGO R Eve Burkina Faso


Sebego Réné Burkina Faso


LAMIZANA/ Alade Djénébou Burkina Faso


Pare Jean-Laopan Burkina Faso

49 Delegation Board of pharmacists of Burkina Faso

MONE BRAHIMA Burkina Faso


ZOUNGRANA EVANCE BRICE Burkina Faso


ZONGO FRANCOIS Burkina Faso


GUISSOU INNOCENT PIERRE Burkina Faso


SANDOUIDI ALFRED Burkina Faso


KABORE AMIDOU Burkina Faso


KABORE CAMILLE Burkina Faso


OUOBA BINDI Burkina Faso


RYASSALATOU DIAWARA Burkina Faso


HUGUET FRANCOIS PIERRE MAURICE

Burkina Faso


SANON HAROUNA Burkina Faso


SAWADOGO JACOB Burkina Faso



KABORE PASCAL Burkina Faso


KABORE KARIM Burkina Faso


DESIRE NEZIEN Burkina Faso


SANOU DO MALICK SOUFIANE

Burkina Faso

65 ReMeD - Ouagadougou Benao Victoire Burkina Faso

66 ESTHER Arnold Céline France

67 Chirac Foundation - Paris Gentilini Marc France

68 Chirac Foundation - Paris Catalan Pierre France

69 Chirac Foundation - Paris Godfrain Jacques France

70 GSK Foundation Beauvais-Remigereau Laurianne France

71 GSK AKA José-Mireille France

72 Mérieux Foundation Machuron Jean-Louis France

73 Pierre Fabre Foundation - Paris Bernagou Pierre France

74 Gilead Calles Brigitte France

75 Group of ACP countries - Bruxelles

Kakule John Belgique

76 IRACM - Paris Roge Wilfrid France

77 Interpol Ouagadougou Tuina Thierry Burkina Faso

78 Inter-Board of African Pharmacists (IOPA)

Ingani Hyacinthe Brazzaville

79 JSI/DELIVER - Ouagadougou Edah Parfait Burkina Faso

80 Laborex / Eurapharma - Paris Roy Jean François France

81 Laborex - Niger Marou Mehaou Issifi Niger

82 LEEM - Paris Savart Pierre France

83 MAEE - Paris Le Lay Thierry France

84 MAEE - Paris Renaudin Stéphane France

85 MAEE Lecrivain Nicolas Burkina Faso

86 MAEE Torrano Jean-Pierre Burkina Faso

87 MAEE - Paris Marquis Michel Mali

88 MAEE - Paris Abonnel Christian Bénin

89 MAEE - Paris Spery Christophe Burkina Faso

90 Ministry of Justice France Valette-Valla Guillaume France

91 MPEDIGREE Branttie Selorm Ghana


92 MSD Bresard Karen France

93 NEPAD Sigonda Margareth N. South Africa

94 International Organization of the Francophonie - Paris (OIF)

Diallo Alpha Amadou Togo

95 WHO - AFRO - Brazzaville Trapsida Jean Marie Congo

96 WHO - EIP AO - Ouagadougou Toure Bokar Burkina Faso

97 WHO - EIP AO - Ouagadougou Rochigneux Christophe Burkina Faso

98 WHO - EIP AC - Libreville Aubry Loic Gabon

99 OMS - Genève Babaley Magali Suisse

100 OMS-WCO-Ouagadougou Zombre Sosthène Burkina Faso

101 ONUDC Lapaque Pierre ONUDC

102 ONUSIDA - Ouagadougou Faye Mame Awa Burkina Faso

103 WAHO - Bobo-Dioulasso Ossei-Agyeman-Yeboah

Sybil Burkina Faso

104 WAHO - Bobo-Dioulasso Diallo Ely Noel Burkina Faso

105 World Customs Organization - Bruxelles

Zimmermann Christophe Belgique

106 PHARMACTION - Cotonou Toukourou Tidjani Moutiatou Benin

107 RAME - Ouagadougou Kabore Simon Burkina Faso

108 RBM - Genève Van Erps Jan Suisse

109 ReMeD - Paris Bruneton Carinne France

110 Pharmacy Union - Brazzaville - ISPHARMA

Okouya Boniface Congo

111 ISPHARMA Dia CHEICKOU OUMAR

ISPHARMA MALI

112 ISPHARMA Sarr Aboubakrine Senegal

113 National Board of Pharmacists Congo

Malonga André Congo

114 Union of Pharmacists of the Congo

Ngoma Victor Congo

115 Faculty of Medecine and Pharmacy – Owendo University

of Health Sciences Gabon

GASSITA Laurence Gabon

116 WAEMU - Ouagadougou Nyango Burkina Faso


117 WAEMU - Ouagadougou Ouattara Safiatou Burkina Faso

118 UNICEF - Dakar Damour Caroline Senegal

119 US Pharmacopeia El Hadri Latifa

120 USAID - Ouagadougou Trucker Janet Marie Burkina Faso

121 LANSPEX - Niger Bonkaney Oumarou Niger

122 RFI Strauss Igor France

123 RFI Elzas Sarah France

124 ISPHARMA DIA Cheikou Oumar Senegal

125 Delegation Abuja (Nigeria) ARILESERE Afolabi Nigeria

126 ATN DIA Mamadou Senegal

127 DGPM/BF TIENDREBEOGO Hubert Burkina Faso

128 ATN KONE Christian Burkina Faso

129 Douanes Papazian Alexis Niger

130 ITP.E Traoré Edmond Burkina Faso

131 Bitibaly Celestin Burkina Faso

Documents

General Report Ouagadougou Round Table-En