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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
Round table on fake medicines – Ouagadougou (Burkina Faso) September 27 to 29, 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
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 4
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
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 5
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
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 6
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
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 7
Part 1:
SUMMARY AND OVERALL
RECOMMENDATIONS
Professor Adama Traore,
Burkinabe Minister of Health
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 8
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
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 9
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
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 10
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
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 11
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:
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 12
- 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.
The following recommendations were made:
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
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 13
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.
The following recommendations were made:
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 …
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 14
Part 2:
SEQUENCES OF ROUND TABLE
WORKS
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 15
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)
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 16
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:
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 17
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.
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 18
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
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 19
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.
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 20
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,
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 21
- 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,
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 22
- 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
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 23
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
counterfeit drug control
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
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 24
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.
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 25
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
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 26
• 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
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 27
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
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 28
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®,
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 29
- 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.
Round Table on fake medicines – Ouagadougou, Burkina Faso. September 27 – 29, 2011 30
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.
Round table on fake medicines – Ouagadougou (Burkina Faso) September 27 to 29, 2011
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
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 33
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.
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 34
(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,
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 35
(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)
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 36
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
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 37
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.
The following recommendations were made:
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 38
- 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.
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 39
- 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;
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 40
- 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.
Round table on fake medicines – Ouagadougou (Burkina Faso) September 27 to 29, 2011
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.
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 42
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.
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 43
Part 3:
RESULTS AND PERSPECTIVES
Round table on fake medicines – Ouagadougou (Burkina Faso) September 27 to 29, 2011
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.
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 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.
The following recommendations were made:
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,
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 45
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.
The following recommendations were made:
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
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 46
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,
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 47
Strategic recommendations Operational recommendations
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,
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 48
Strategic recommendations Operational recommendations
• 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
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 49
Strategic recommendations Operational recommendations
• 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
counterfeit drug control
• 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...)
Round table on fake medicines – Ouagadougou (Burkina Faso) September 27 to 29, 2011
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
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 51
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…
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 52
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
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 53
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.
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 54
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)
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 55
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
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 56
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
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 57
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
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 58
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
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 59
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.
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 60
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
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 61
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
Round table on fake medicines – Ouagadougou (Burkina Faso) September 27 to 29, 2011
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
11 Public Health Association - Ouagadougou
YAKA-KOUDOUGOU
ALIANE FLAVINE Burkina Faso
12 Public Health Association - Ouagadougou
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
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 63
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
37 Delegation - Ouagadougou (Burkina Faso)
Traore Adama Burkina Faso
38 Delegation - Ouagadougou (Burkina Faso)
Souleymane Sanou Burkina Faso
39 Delegation - Ouagadougou (Burkina Faso)
Dipama Sylvain Burkina Faso
40 Delegation - Ouagadougou (Burkina Faso)
Nikiema Jean Baptiste Burkina Faso
41 Delegation - Ouagadougou (Burkina Faso)
DJIERRO épouse DAGBA
Kadidja Burkina Faso
42 Delegation - Ouagadougou (Burkina Faso)
OUEDRAOGO Arsène Burkina Faso
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 64
43 Delegation - Ouagadougou (Burkina Faso)
Toe Natacha Burkina Faso
44 Delegation - Ouagadougou (Burkina Faso)
OUEDRAOGO Charles Didier Burkina Faso
45 Delegation - Ouagadougou (Burkina Faso)
OUEDRAOGO R Eve Burkina Faso
46 Delegation - Ouagadougou (Burkina Faso)
Sebego Réné Burkina Faso
47 Delegation - Ouagadougou (Burkina Faso)
LAMIZANA/ Alade Djénébou Burkina Faso
48 Delegation - Ouagadougou (Burkina Faso)
Pare Jean-Laopan Burkina Faso
49 Delegation Board of pharmacists of Burkina Faso
MONE BRAHIMA Burkina Faso
50 Delegation Board of pharmacists of Burkina Faso
ZOUNGRANA EVANCE BRICE Burkina Faso
51 Delegation Board of pharmacists of Burkina Faso
ZONGO FRANCOIS Burkina Faso
52 Delegation Board of pharmacists of Burkina Faso
GUISSOU INNOCENT PIERRE Burkina Faso
53 Delegation Board of pharmacists of Burkina Faso
SANDOUIDI ALFRED Burkina Faso
54 Delegation Board of pharmacists of Burkina Faso
KABORE AMIDOU Burkina Faso
55 Delegation Board of pharmacists of Burkina Faso
KABORE CAMILLE Burkina Faso
56 Delegation Board of pharmacists of Burkina Faso
OUOBA BINDI Burkina Faso
57 Delegation Board of pharmacists of Burkina Faso
RYASSALATOU DIAWARA Burkina Faso
58 Delegation Board of pharmacists of Burkina Faso
HUGUET FRANCOIS PIERRE MAURICE
Burkina Faso
59 Delegation Board of pharmacists of Burkina Faso
SANON HAROUNA Burkina Faso
60 Delegation Board of pharmacists of Burkina Faso
SAWADOGO JACOB Burkina Faso
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 65
61 Delegation Board of pharmacists of Burkina Faso
KABORE PASCAL Burkina Faso
62 Delegation Board of pharmacists of Burkina Faso
KABORE KARIM Burkina Faso
63 Delegation Board of pharmacists of Burkina Faso
DESIRE NEZIEN Burkina Faso
64 Delegation Board of pharmacists of 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
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 66
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
Round Table on Counterfeit drugs – Ouagadougou, Burkina Faso. September 27 to 29, 2011 67
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