Kingdom Of Morocco

Ministry Of Health

World Health Organization

Measuring Transparency in the Moroccan Public Pharmaceutical Sector

Dr. Mohamed Laghdaf RHAOUTI National assessor – Morocco

14 -18 NOVEMBER 2011 – ANTALYA TURKEY

ICIUMThird International Conference for Improving use of Medicines

Private sector : The 2nd industry of drugs in the African continent; 32 manufacturing units in conformity with the international standards; 70% of the requirements provided by the local production; More than 5000 specialties; 10% of the production intended for export; Good provisioning is ensured by a network of about 50 wholesalers and more than 9000 pharmacies. Public sector : 10% of the consumption of drugs in value, is not producer of drugs; Approximately 160 pharmacists; A national laboratory of control :

Accredited by the European Directorate of Quality of Medicines(EDQM) according to the Standard ISO 17025. Associate member of the European Pharmacopeia. Member of the European Network of official laboratories of medicines’ control;

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General data

The vulnerability assessment to corruption for the 8 functions of our study is summarized as follows : -- The vulnerability to corruption is marginal for 4 functions : registration, licensing, procurement and distribution, they constitute half of the functions studied. -- The vulnerability is moderate for 2 functions: inspection and clinical trials, they constitute a quarter of the 8 functions. -- On the other hand, this vulnerability is high for 2 functions: promotion and selection, they constitute a quarter of the 8 functions.

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General findings

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Function level Vulnerability

Registration 6.01 Marginal

licensing 6.79 Marginal

Inspection 5.70 Moderate

Promotion 3.82 High

Clinical trials 4.18 ModerateSelection 3.19 High

Procurements 6.54 Marginal

Distribution 7,20 Marginal

Scoring

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GovernmentOfficials

Private Sector

NGO Academia Total KI/Sectio

nRegistration 13 6 5 6 30

Licensing 11 7 8 4 30Inspection 12 7 8 4 31Promotion 11 7 5 6 29

Clinical trials 12 5 7 9 33

Selection 15 3 8 5 31Procurement 15 7 7 6 35

Distribution 13 7 9 4 33

• 55 KIs • Most of them answered several questionnaires at the same

time;• Almost 300 questionnaires were answered, i.e. :30 KIs per

function on average, higher than necessary;

KIs

Registration : Strengths (Marginal Vulnerability)

Existence of :• A specific legislative and regulatory frame;

• A National Laboratory of Control operational and accredited by EDQM;

• A Committee of ratification which meets regularly and keeps minutes of its meetings;

• A list of all the pharmaceutical products and an information system for the registration process;

• Written procedures accessible to the public on the way of presenting and evaluating the requests of registration of medicines.

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Absence of :• A written document

requiring a statement of (COI);

clarifying the mandate duration of the committee members;

describing clearly the required professional qualifications, the technical competencies and the practical experience of the members of this committee.

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Registraration : Weaknesses

(Marginal Vulnerability)

Licensing : Strengths (Marginal Vulnerability)

Existence of :• A specific legislative and regulatory frame; • An authorization to start a pharmaceutical establishment is legally

necessary;• A sworn inspectors' body of pharmacy, qualified and operational;• A procedure of approval of pharmaceutical establishments in strict

conformity with policies and procedures;• An official committee entirely operational and meeting regularly;• Written procedures and guidelines for the evaluation of

applications for licenses;• Guidelines on assessment of applications;• An inspection report obligatory prior to the obtention of license;• An up-to-date list of all licensed pharmaceutical establishments.

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Absence of : • A written document :

requiring a declaration of conflict of interest; specifying the mandate duration of the committee members,

and their role and responsibilities,

• A single counter to submit applications for licenses in order to reduce the number of parties involved in the licensing process.

• A frame of reference to govern these authorizations especially good manufacturing and distribution practices.

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Licensing : Weaknesses (Marginal Vulnerability)

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Existence of :

• A provision on the inspection of the pharmaceutical establishments in

the drug regulations;

• A sworn, qualified and operational body of inspectors of pharmacy;

• Standardized operating procedures (SOPs) written for the inspectors

on how to conduct inspections;

• The integrity of the inspectors is not influenced by personal profits such as gifts, material profits or other favors;

Inspection : Strengths (Moderate Vulnerability)

Absence of : • A department specific to the inspection of pharmacy within the Directorate of Medicines and Pharmacy (DMP);

• A specific set of laws that enable the inspectors to enjoy autonomy of work;

• A frame of reference related to the good practices, in particular good manufacturing, distribution and officinal practices;

• written guidelines on COI;

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Inspection : Weaknesses(Moderate Vulnerability)

Promotion Control : Strengths

(High Vulnerability)

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• Existence of a shy legislation on the promotion of drugs;

• Pre-approval of promotion is officially required;

Promotion Control : Weaknesses

(High Vulnerability)

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• Absence of an ethical charter for promotion;

• The materials of promotion are not always approved before being exposed to the public;

• The civil society/NGOs do not have an influence on the improvement of

the control of drugs promotion;

• Absence of a formal procedure of complaint to denounce unethical

promotional practices;

• There exists a service responsible for the monitoring and application of

the provisions concerning drugs promotion but :

the members of this service are not designated on the basis of clear criteria;

there is absence of a written document indicating the composition and the terms of reference of this service;

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KIs approve that the regulation authority of medicines tries to ensure that the clinical trials are in accordance with :

• The regulations;

• The principles of the GCP;

Clinical Trials : Strengths

(Moderate Vulnerability)

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Absence of :

• A legislative provision imposing the regulation of clinical trials;• Regulations allowing to set up officially :

A National Ethics Committee with attributions and a multidisciplinary composition involving(academics, lawyers, scholars, sociologists, civil society,…)

An independent Ethics Committee that operates under the supervision of the National Committee.

• The members of the IEC and of the Review Committee belonging to the

MRA, are not always designated in accordance with the written selection criteria;• Provisions allowing to specify relations between all parties

involved in CT (IEC members, MRA review committee members, investigators, sponsors, trial subjects, etc …..)

Clinical Trials : Weaknesses

(Moderate Vulnerability)

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Existence of :• A List of the Essential Medicines;

• A committee responsible to select the medicines that should be registered in the EML;

Selection : Strengths(High Vulnerability)

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• EML was not established in consultation with all concerned

parties and using an evidence-based approach;• KIs disapprove that the committee responsible for the selection

of national EML is operating under no external influence;• Absence of Clear written guidelines, accessible to the public on

the process of selection of the medicines to be included into, deleted or rejected from the national EML;• The nomination of the selection committee members is not

subject to clear criteria; • Absence of Guidelines on COI with regard to the selection of

essential medicines;• The role and responsibilities of the selection committee are not stipulated in their global mission.

Selection : Weaknesses(High Vulnerability)

Existence of :• Transparent and explicit procurement procedures of

pharmaceutical products ;• Written guidance for procurement staff to use according to types

of products; • Procurement is made according to an objective method of

quantification;• A procurement office and a tender committee with clearly

separated functions; • An efficient post-tender system to monitor and report to the

tender committee on suppliers’ performance.

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Procurement : Strengths(Marginal Vulnerability)

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• The procurement department does not function like an autonomous

structure specialized only in the procurement of medicines and medical goods;

• The requirements in medicines in the public structures are not established

on rigorous scientific foundations and the budgets to meet these needs are not consequently sufficient;

• The process of grouped procurement does not integrate the medicines of

the national medical programs;

• Absence of written guidelines on the conflicts of interests.

Procurement : Weaknesses(Marginal Vulnerability)

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Existence of :

• A system of customs clearance at the borders;

• A system of security management to supervise storage and distribution;

• An appropriate form to request medicines;

• Appropriate procedures to dispose of expired or spoiled medicines;

Distribution : Strengths(Marginal Vulnerability)

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• The majority of informants do not think that pharmaceutical products are

easily cleared through customs and that it is not necessary to give presents to speed up the process;

• Absence of an assessment and monitoring project of the quality of the

medicines distribution system;

• Only ½ of the informants think that leakages in the medicine distribution

system are very rare;

• Elaboration of a national project for essential medicines allowing to

level up hospital pharmacies;

• Combat the lack of regional pharmacies to bring medicines closer to the

consumer;• Generalize outsourcing of deliveries by private conveyors;

Distribution : Weaknesses(Marginal Vulnerability)

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• On the organizational level: Organize a national workshop; Set up a National Piloting Committee;

• On the legislative and regulatory level : Set and publish specific regulations in different domains by taking into account

specific recommendations listed in the report;

• On the ethical level : Require statements of conflict of interest for the members of all committees of

different functions and specify the duration of the mission of these members;

• On the level of human resources: The MRA should recruit, train and motivate a sufficient number of

multidisciplinary, qualified and experimented personnel;

The MOH should sensitize other Ministries and Departments to recruit pharmacists;

• On the level of information, education and communication: Launch a campaign of sensitization; Make explicit, in written documents accessible to the public, notably via Internet,

all procedures; guidelines, and documents relating to all functions as well as members of committees and their statements of conflict of interest.

Key Recommendations

KINGDOM OF MOROCCO1