The pharmaceutical

sector:The problem
and accessibility of
medicines in
Senegal
OUTLINE
Introduction
• I. Context
• II. Problem
• III. National environment
• IV. The Senegalese pharmaceutical system
• V. Difficulties of access to medicines in Senegal
• VI. Solution
Conclusion
Submitted by Professor
Serigne Saliou Sarr Mr Cissé
Ramatoulaye Dieng
Mouhammadou Fallilou Kholle
Soukeyna Diaw
Introduction
Globalization has accentuated the gap between the rich and the poor.
This gap is felt much more, generally in the economic and social
spheres, and in particular in terms of health. Indeed, a state that wants
to achieve sustainable development must not lose sight of the health
situation of its populations. As a result, it needs to create quality
health infrastructures and have a health-care system,
effective supply and distribution of medicines without out-of-stock
and also training health personnel.
The health sector in Senegal offers interesting investment
opportunities in several areas, including the establishment of medical
clinics, pharmaceutical distribution companies and the development
of specialized services.
Senegal has set up a superb drug supply and distribution structure
composed of the PNA for the public sector and importing wholesalers
for the private sector. Despite the existence of this important
organization, which in principle aims to make medicines available at
lower cost to the population, the problem of accessibility is of concern
to the authorities. In view of the impact of the supply and distribution
system on the selling price of all goods, particularly medicines, it
would therefore be appropriate to study the system with a view to
improving it.
 Context
Access to quality, geographically, financially and properly used essential medicines is a
major challenge for national pharmaceutical policies. Some countries, such as Senegal,
have established national supply systems for essential drugs, mostly based on central
purchasing and distribution structures at central, regional and district levels. Unfortunately,
in some countries, the unreliability of the national public system makes it impossible to
ensure a regular supply of essential drugs. At the same time, there is a steady increase in
the number of partners involved in the supply of essential drugs. To achieve this objective,
Senegal has set up a national supply system (PNA) (Pharmacie National
D’approvisionnement) and its regional branches PRA (Pharmacie Régional
D’approvisionnement), district depots and health centre depots with drug cost recovery.
But the steady increase in the number of partners involved in the supply of essential drugs
and other health products has multiplied supply and distribution structures. It is in this
context, and in order to ensure a coherent and efficient supply that the Minister of Health
and Prevention (MSP) through the Directorate of Pharmacy and Drugs (DPM) has
requested the support of WHO to carry out a mapping of the supply and distribution of
essential drugs and other health products in Senegal, and to further develop the system.
public supply and distribution of essential drugs and other health products. With this in
mind, several countries have adopted a distribution system for different pharmaceutical
products, such as vaccines, depending on their situation and context.
 Issue
erSenegal, like other developing countries, has subscribed to these initiatives and,
through its National Pharmaceutical Policy, has committed itself to guaranteeing the
availability, quality and accessibility of these drugs to the entire population. Ensuring
a regular and constant supply of medicines and other medical products is a key factor
in improving access to treatment. It is with this in mind that Senegal has set up a
Venus Saturn
super structure for the supply and distribution of medicines composed of the PNA for
Has a beautiful Planet Saturn is
the public sector and the importing wholesalers for the
name, but it’s private sector.
the ringedDespite
one. It the
existence of this important organisation, which in principle
terribly hot aimsis to
a gasmake
giant medicines

available at lower cost to the population, these medicines have always remained
inaccessible to a large proportion of the population
 National environnement
Overview of the Geo-Demographic Situation

With regard to the demographic situation, reference was made to the approximate figure of 15 million
Senegalese, whereas the last census in 2013 had recorded 13,508,715 inhabitants, of whom 6,735,421
and 6,773,294 were women. The average density was 65 inhabitants per km2, however, the population
is unevenly distributed among the 14 in Senegal. The largest population is found in the regions of
Dakar, Thiès and Diourbel
 Overview of the socio-economic situation
Senegal is committed to a new development model through a strategy that aims to emerge in solidarity by 2035. This
strategy constitutes the framework for economic and social policy based on the Senegal Emergent Plan. It focuses on
creating wealth and jobs, strengthening governance, developing strategic sectors that have a significant impact on improving
people’s well-being, particularly by protecting vulnerable groups and ensuring access to essential services

Overview of the health situation:

Senegal ' s health policy takes into account the country ' s commitments to the standards established by international,
regional and subregional health institutions. This policy is part of the drive to achieve the SDGs (Sustainable Development
Goals) by 2030. It is based on a National Health Development Plan, the second phase of which was completed in 2018
(PNDS II 2009-20 018). The third phase 2019-2028 is currently being finalised. This health policy is based on the following
points:
- Guaranteed access to quality health care for all people regardless of socio-economic status;
- Greater decentralization and local health governance; - Promotion of health insurance coverage; - Protection of vulnerable
groups;
- Strengthening the public-private partnership;
- Promotion of a multisectoral approach;
- Alignment of external assistance with national health priorities;
- The culture of results-based management.
The organization of Senegal’s health system is based on a three-tier pyramid model: the Central Level, the Medical Region
and the Health District.
 The Senegalese pharmaceutical system
OVERVIEW OF PHARMACEUTICAL POLICY

The goal of Senegal’s national pharmaceutical policy is to ensure the availability and geographical and financial
accessibility of quality medicines to all sectors of the population throughout the country
Although there is no official document on the National Health and Social Development Plan (PNDSS, 1998-2007), the
activities carried out under the National Health and Social Development Plan (PNDSS, 1998-2007). This plan, of which the
11th PDIS (Integrated Health Development Programme) is the first phase, has identified the reform of the pharmaceutical
subsector as one of the priority actions. This reform of the pharmaceutical subsector incorporates the conclusions of the
various meetings of the African Ministers of Health of the countries of the CFA franc zone following the devaluation on:
(i) improving the availability and accessibility of essential drugs, (ii) strengthening the Pharmacy and Drug Directorates, (iii)
promoting generic essential drugs and rational use of drugs
Laws, decrees and decrees have laid down the conditions for granting marketing authorization (MA), price administration,
substitution of drugs, opening of pharmaceutical establishments, inspection, etc. NA, which has an autonomous status as a
Public Health Establishment (EPS) and which has decentralized structures at the regional level: the Regional Supply
Pharmacies (PRA). PNA purchases drugs through international tenders, and supplies are made on the basis of the National
Essential Drug List (NEDL). Supply to the private sector is ensured by the distributing wholesalers who are the importers.
Financing is not left out, the State first with the budgets allocated to the FSPs and organizations such as the IPM, the
Collectivities, etc. The system for recovering the costs of drugs is in force within the framework of the Bamako Initiative. (f)
The Traditional Pharmacopoeia is also under way with the forthcoming opening of clinical trials center's for herbal
medicinal products and the establishment of the regulatory framework for granting marketing authorizations to those drugs
 Presentation of the pharmaceutical sector
The Government’s objective is to ensure the availability, accessibility and rational use of medicines in the public and private
sectors. As a result, pharmaceutical policy is implemented on the one hand by the institutions responsible for regulating the
pharmaceutical system consisting of the Directorate of Pharmacy and Laboratories (DPL) and the National Laboratory for
Drug Control (LNCM) and on the other hand by the pharmaceutical market. Regulation The marketing of any drug product
is subject to obtaining a specialty pharmaceutical visa issued by the Ministry of Public Health. The regulations cover the
entire pharmaceutical sector: manufacture, distribution, control, pharmacy practice, registration of medicinal products, etc.
To this end, regulatory provisions have been adopted to implement pharmaceutical policy through the following institutions
and organizations:
• Directorate of Pharmacy and Laboratories: Decree No. 2004-104 of 4 November 2004 on the organization of the
Ministry of Health and Medical Prevention, the Directorate of Pharmacy and Laboratories is responsible for preparing
and monitoring the implementation of pharmaceutical policy. implementation of pharmaceutical policy and programmes
in the field of pharmacy and medical analysis
• Act No. 65-33 of 19 May 1965 amending the provisions of the Public Health Code relating to the preparation, sale and
advertising of proprietary medicinal products and the implementing decrees, in particular the decree of 4 January 1967
on the approval of proprietary medicinal products.
Act No. 73-62 of 19 December 1973 establishing the Association of Pharmacists. • Law 9457 of 26 June 1994 on the
definition of medicinal products
• Decree 96-395 of 15 May 1996 authorizing the substitution of pharmacists
• Order 4012 of 2 June 1998 organizing the national pharmacovigilance system Medicines and vaccines sometimes cause
undesirable effects or adverse reactions in some patients. In order to identify such side effects, the Government decided
to set up a more operational pharmacovigilance system and took further steps to strengthen the action of the national
supervisory authority, with the Order of 2 June 1998 on the organization of the national pharmacovigilance system.
 Financing and cost of drugs

The State of Senegal allocates a budget for the purchase of drugs. It also provides subsidies for the purchase of specific
drugs such as anti-tuberculosis drugs for $80 million a year; ARVs for $1 billion a year; vaccines for $850 million a year;
and insulin for $350 million. Development partners also participate in financing (ARVs, contraceptives) by USAID.
Medicines are also financed by the health and insurance companies, local authorities and NGOs, but still to a limited extent.
Cost recovery is also one of the main sources of drug financing in Senegal. There are also NGOs, associations, donations.
Despite the establishment of a system for licensing drug prices and procurement by tender, medicines remain relatively
expensive in public health facilities and in the private sector .
The pharmaceutical market

Composed on the one hand of local manufacturers who cover only 10 to 15% of the drug needs. In order to deal with the
many public health problems, and in particular the demand for generic drugs, Senegal has set up a programme to promote
the use of generic drugs. Thus, the essential drugs and pharmaceutical products selected in Senegal are anti-parasitic drugs,
including anti-malaria drugs, anti-worm drugs and anti-worm drugs, intestinal, iron, antibiotics. On the other hand, this
market is also made up of imports. These are carried out by a public utility organization, the PNA, which is responsible for
supplying public health establishments and distributing wholesalers, of which there are 04, Laborex, Cophase, Sodipharm
and Sogen are responsible for supplying public health establishments to supply private pharmacies throughout the country.
95% of the drugs are imported; priority is given to generic drugs. Senegal imports almost 95% of its drug needs. The annual
turnover of the domestic pharmaceutical market is about 40 billion CFA francs. It is mainly carried out by the private sector.
In order to cope with the many public health problems, and in particular the demand for drugs, the State has launched a
program to promote generic drugs.
 The pharmaceutical industry in Senegal

The local production Senegal has three drug manufacturing units and one vaccine production unit (the Institut Pasteur in
Dakar). This local pharmaceutical industry meets only 10-15% of the country’s drug needs. These manufacturers are:

 Aventis-Médis: . It is Senegal’s main pharmaceutical industry with 20% of local production. Its turnover in
In 2000, it was estimated at 5. 3 billion CFA francs, of which 25 per cent was accounted for by exports to the other
countries of the subregion. This pharmaceutical industry manufactures under licence Aventis Bristol Meyers, Cooper,
Synthelabo, some 40 specialty pharmaceuticals (tablets, capsules, injectable ampoules, solid solute, ointments and syrups)
and about 90 generic products.
 Valdafrique: Subsidiary of Sosecaf achieved a turnover of 3. 5 billion in 2000 with 25% of exports in the sub-region,
particularly in Côte d’Ivoire. The company manufactures some specialty pharmaceuticals (powder and ointments),
parapharmaceuticals (valda pastille, mint alcohol, balms) as well as insecticides and household bactericides, which
account for 16%, 39% and 45% of the turnover on the local market. Only domestic insecticides and bactericides are
exported to the countries of the subregion
 Institut pasteur: It depends on the Paris Institute and is the only institute to produce vaccines in Black Africa. There are no
less than 22 Pasteur Institutes in the world linked to an international network. This structure has a capacity to produce
more than 16 million doses. It is financed to the tune of 30% of its annual budget by grants from the French Ministry of
Research and 2/3 by its activities.
 Distributing Importers

Imports of pharmaceuticals are carried out by a public sector composed of PNA and a private sector represented by
distributing importing wholesalers. The private sector accounts for 85% of the market value of the legal drug market and
distributes more than 3,500 references (excluding parapharmacies) through five distributors and more than 750 pharmacies.
 Public Sector: National Supply Pharmacy The National Supply Pharmacy (PNA) The PNA was created in 1954 to meet
the medical-pharmaceutical needs of French West Africa (AOF), then under French colonial domination. After
independence, it became a public service attached to the Ministry of Health. At present, the PNA is a non-hospital public
health institution under Act No. 98-12 of 2 March 1998 on hospital reform and its implementing decree 99-851 of 27
August 1999. Thus, the PNA has a board of directors and a directorate comprising five departments. The PNA’s mission
is to ensure the financial and geographical accessibility of quality essential medicines and products to the population.It is
decentralized in all 14 regions of Senegal. This organization is the wholesaler distributing the public and parapublic
sector. Its main clients are hospitals, districts and other government departments or private not-for-profit structures, and
sometimes even private distributors. With a staff of about 50 people, PNA achieves a turnover of about 7 billion CFA
francs per year, of which 90 per cent is generic and 10 per cent specialty pharmaceuticals. For its supply of medicinal
products, it proceeds through an international invitation to tender issued every eighteen (18) months. 70% of its imports
currently come from the countries of Central and Eastern Europe
 Private Sector: it’s constituted by four enterprises:
 Laborex Senegal: it’s an independent subsidiary of Continental Pharmaceutique France. It is the longest-established
wholesaler distributor in Senegal and is also the main importer of pharmaceutical products with almost 60% market
share. The structure has a stock of products covering approximately 3.5 months of sales and is estimated at 5 billion
CFA francs. Its products are distributed in Dakar by one agency and in the regions by four agencies in Kaolack, Saint
Louis, Thiès and Ziguinchor. 60% of its sales are in the Dakar region and 40% in regional agencies. Its turnover was
estimated at 32.4 billion CFA francs in 2005.
 Cophase The Senegalese pharmaceutical cooperation (Cophase) was created by a few pharmacists in 1992 to promote
the sale of generics. She’s here second private company importing medicinal products and has a stock corresponding to
3 months of distribution consisting of 2000 references of specialties. Distribution is ensured only from Dakar, 60% of
sales are made in Dakar. Its turnover in 2005 was 21.4 billion CFA francs. It imports almost all of the pharmaceutical
products listed on the national list of essential drugs through its parent company in France BAA (African Procurement
Office).
 SODIPHARM The Société de Distribution Pharmaceutique is the third wholesaler distributor created in 1986 with a
10% market share. It is a 100% Senegalese company with a turnover of Fcfa 5 billion in 2005. It sources direct from
France, but is moving towards a partnership with international laboratories (CERP) in order to increase its market share
and establish itself in the sub-region.
 SOGEN The Generic Society is a distributor of generics created in 2003.
 Illicit market :Alongside these two channels, there is an important illicit market. Drug trafficking, clandestine
distribution networks and the sale of counterfeit products are relatively common in Senegal. This contract is not
accounted for but represents substantial sums of CFAF 7 billion per year. It is fuelled by flows between the public and
private sectors, diversions, resale of expired, counterfeit or illegally imported products from neighboring countries, as
well as theft of medicines from donations. A national observatory to combat the illicit sale of medicines is being set up
by the DPM (Direction de la Pharmacie et des Médicaments) and the ONPS (National Order of Pharmacists of Senegal),
which has estimated the turnover of this market at 10 billion CFA francs. It is a market that, although illegal, is not
clandestine.It is a trade that is done in full view of all, with strong places such as the place called “keur serigne bi” in
Dakar.
 Analysis of the results of the pharmaceutical environment

Analysis of the situation revealed the following strengths:

• Existence of basic regulations;
• Existence of a Pharmaceutical Regulatory Authority (DPL) and pharmaceutical structures, organized with clearly defined
tasks;
• Implementation of core regulatory functions
• Existence of a well-organized and decentralized drug import system;
• Existence of quality drug manufacturing units;
• Existence of documents required for rational use (therapeutic dictionary in IND index, guide to therapeutic equivalencies,
list of essential drugs and products, training module for prescribers and dispensers);
• Political will on the part of the State to subsidize certain drugs (diabetes, AIDS, tuberculosis);
• Existence of a State budget for medicines;
• Existence of a cost recovery system (IB);
• Existence of skills and research institutions.
The presence of many private partners, including local drug manufacturers and wholesale importers/distributors, ensures
good coverage of the national market. Public health structures also face many difficulties in supplying drugs because of the
existence of a single partner (the ANP). This body is the wholesaler distributing the public and parapublic sector. PNA is
often unable to obtain cash from clients who are struggling to collect their debts. This most often leads to stock-outs of the
structure.
. Difficulties of
Access to
Medicines in
Senegal
 SOLUTIONS
 Strengthen the capacity of the Directorate of Pharmacy and Laboratories
 Establish mechanisms to monitor the performance of health personnel with tools to monitor the availability and
rational use of medicines
 Put in place an appropriate legislative and regulatory framework for the implementation of the national
pharmaceutical policy
 Ensure regular supply of and access to quality medicines, including improved traditional medicines, at the lowest
cost at all levels of the health pyramid.
  Promote generic essential drugs to health workers and the public to make drugs more accessible to the population
 Promote the rational use of medicines by health professionals and consumers.
  Increase public funding for health in general, and for drugs in particular
 Combating the illicit market in medicines.
   Promote local industrial production of medicines
  Promoting research

 Ensure the affordability of drugs. (Price control and access policy)

 Effective supervision and control of outlets: particularly for prices, management tools, storage conditions, etc.

(supervision and training)

 Ensure availability of EM lists and prescribing guides at the field level.

 Training drug managers and dispensers.

 Training prescribing staff for better management of essential pathologies. This capacity-building is needed to rationalize

prescriptions, as misdiagnostics lead to irrational use of drugs.

 Make available ORS and Retinol capsules at private pharmacies.

 Ultimately develop a National Pharmaceutical Policy Document to make all activities concerning the sector visible and

coherent.
The use of ineffective, poor quality and harmful
drugs can lead to treatment failure, exacerbation of
disease, drug resistance and, in some cases, death.
It also undermines confidence in the health care
system, health care professionals, pharmaceutical
companies and distributors.
Governments must therefore establish strong
pharmaceutical regulatory authorities for the
manufacture, trade and use of drugs to protect and
promote public health
Research Resources

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