Author: Benjamin Coovi DAKO, PhD
Doctor in Political Science, Public Policy Analyst
Expert in Health, Professor of Health Policy at the National School of Administration and the
and the Doctoral School of Legal, Political and Administrative Sciences from the University of Abomey-Calavi, Benin.
Since April 2016, Benin has experienced a new era in terms of protecting people’s health. Indeed, in accordance with pillar 3 “Improve the living conditions of the populations” of the Government’s Action Program, in its strategic axis 6: “Strengthening of basic social services and social protection”, a flagship action is planned (Action 22) consisting of “Reorganizing the health system for more effective health coverage”. To carry out this strategy, a technical commission has been set up in charge of reforms in the health sector, responsible for proposing solutions with a view to improving the performance of the system. In addition, a Committee for the Implementation of Health System Reforms, proposed by the said Commission, has been created and operationalized.
It therefore proved necessary, for the effective achievement of the strategic objectives mentioned above, to put in place an adequate legislative and regulatory framework. Hence the government’s initiative to draw up and submit to the National Assembly a bill on protection of the health of people in the Republic of Benin, in accordance with the provisions of article 8 of the Constitution of December 11, 1990 as amended by law 2019-40 of the November 07, 2019. This bill was adopted by Parliament on December 28, 2020. In the same vein, new legislation for the pharmaceutical sub-sector is being put in place to ensure the population adequate health safety of medicines and health products. health. This is specifically Law No. 2020-37 of February 3, 2021 on the protection of people’s health in the Republic of Benin and Law 2021-03 of February 1, 2021 on the organization of pharmaceutical activities in the Republic of Benin.
But the enthusiasm aroused by this vast legislative reform risks withering away in the medium or long term due to the congenital shortcomings brought about by the said reform. This article will be successively devoted to the presentation of each of the two key laws cited above law on the protection of the health of persons in the Republic of Benin, followed by an analysis aimed at highlighting their inadequacies within the framework of a comparative study in relation to the state of law at the international level.
I- Law n°2020-37 of February 03, 2021 on the protection of the health of persons in the Republic of Benin: a legislative innovation completed?
Law n°2020-37 of February 03, 2021 on the protection of the health of people in the Republic of Benin was adopted by the National Assembly on December 28, 2020 and promulgated on 03 February 2021. For the first time in this country, a law of this magnitude is put in place to supervise the entire health system with a view to the holistic protection of populations in matter of health.
Thus, under the terms of article 3, paragraph 1er of this law, “The organization of the protection of people’s health aims to guarantee the realization of the right to health for all and to contribute to the promotion of the strengthening of the capital human in a multisectoral approach. To this end, it guarantees in particular the principles of good morality, probity, ethics, fairness, dedication and responsibility, which are essential for the exercise of health professions with a view to to ensure the well-being of the people”.
The law, while specifically targeting the protection of the human person, also clarifies (article 3, paragraph 2) that it contributes to the strengthening of human capital through:
✓ the promotion of optimal conditions for a good quality of care;
✓ the efficiency of healthcare providers;
✓ the promotion of good practices in the health system;
✓ modernization of the technical platform of health facilities;
✓ the increase in health infrastructure;
✓ capacity building of system actors at all levels;
✓ environmental protection and promotion of basic hygiene and sanitation;
✓ training and recruitment of qualified health personnel;
✓ improvement of the drug supply and distribution system;
✓ the balanced and consistent distribution of health personnel throughout the territory;
✓ improvement of the framework and working conditions of health personnel;
✓ the responsibility of the medical and paramedical service;
✓ the prevention of emerging and re-emerging, communicable and non-communicable diseases.
As part of the strengthening of health protection, the law on the protection of the health of persons emphasizes the rights and duties of populations. It specifies in particular (art 5) that the right to health is a fundamental right and that the health system guarantees by all appropriate means, the protection of the health of the population, equal access to care, the right to adequate care and continuity of care.
Some specific rights of the patient are listed in art 6 which states that everyone has the right to be informed about one’s state of health. The specific rights of the sick person are also listed in this article in its paragraph 2 which provides that the sick person has the right:
✓ respect for his private life and dignity;
✓ information and respect for confidentiality;
✓ the expression of one’s wishes, in particular the choice of doctor, participation in medical decision-making, pain relief;
✓ to complain;
✓ the safety of care.
The law also establishes the freedom of choice of the patient with regard to his treatment, in his article 7 which states “Any patient has the right to accept or refuse a medical act or application of medical treatment“. However, she remains silent as to the choice of doctor treatment or health establishment, latitude widely granted to patients in the countries countries such as France and other countries, particularly those with health systems health insurance or liberal system. It is true that in Benin, which recently committed in a universal health insurance system through the Insurance for Strengthening the human capital (ARCH), private clinics occupy a considerable place in the supply of care and practice tariffs not regulated by the State, while private companies health insurance companies are establishing themselves as privileged players in the regulation of the supply and pricing of medical and surgical procedures. In such a context, the choice of doctor treating by the patient seems relatively possible but in a very limited proportion. The insured persons in the private sector can in fact make a choice of doctors or establishments in within a very limited set of health facilities or professionals called approved structures. Apart from these, treatments or medications are not or, for the best case, are only partially reimbursed, around 30% by companies benevolent. In such a context, the recently adopted Beninese law which, a priori, is bearer of hope for the optimal protection of patients, suffers from a lack of congenital disease in the enjoyment of one of the fundamental rights of patients, the free choice of healthcare facility and/or attending physician.
The same article 7 of the law emphasizes the necessary consent of the patient before the administration of any medical act or treatment by the doctor or any other practitioner. She adds that if the patient is unable to express his opinion in the event of a coma or for any other cause, the practitioner is required to obtain the opinion of a person trusted by the patient. The person of support can be a member of his family or another person he has previously designated. The parents consent to the care and treatment concerning their minor children. This provision is a significant step forward in terms of respect for the rights of the patient. However, in case of emergency or when the vital prognosis of the patient is engaged and in the cases provided for in articles 57 and 59 of the law, the practitioner is not required to obtain the consent the patient, a trusted person or the parents of the minor. On this point, Beninese law joins the French legislation which constitutes a reference on the matter.
The law opens up the possibility for the Beninese patient to be able to refuse a treatment or an act medical treatment proposed by his doctor or any other practitioner (Articles 7 to 8). She specifies that this The patient’s decision to accept or refuse care can be expressed at any time. He can, therefore, reconsider their decision to accept or refuse care. However, the decision, whatever it may be, must be respected by the practitioner, subject to the provisions of article 9 paragraph 4 of this law or of a court decision which may empower the practitioner to take a decision contrary to the protection of the patient himself or of society.
The law emphasizes the patient’s right to reliable information on his state of health (art 9) and on the care that is provided as well as the expected results. It’s the same layout. of art 9 which enshrines the patient’s access to his medical file. The law, in its title III, from art 20 to art 22, addresses the various actors involved in the organization of care offers to populations. These actors are both those from the public and private sectors. The focus is above all focused on the role of the State and decentralized communities in the supply and security of patient care. The law divides these actors into three chapters, in particular the resources human health (chapter one), health professional organizations (chapter second) and private providers and promoters of health services (chapter three).
The law on the protection of persons in health makes a point of honor on the sovereign role of the State in the definition, organization and operation of the health system. So she provides in its article 36 the following: “The State defines the national health policy. This one aims to promote healthy living conditions, improve the state of health of the population, the reduction of social and territorial inequalities as well as equality between women and men; it also aims to guarantee the best possible health safety and the population’s effective access to prevention and quality care. As such, he:
✓ promotes prevention against risks threatening health, health education, a healthy lifestyle, health control, the provision of curative or palliative preventive care and rehabilitation. These actions may concern individuals or groups of individuals and may be sectoral or intersectoral;
✓ sets up a stable, coherent and coordinated institutional intervention system that includes technical services located at the central, intermediate and peripheral levels;
✓ coordinates and ensures the consistency of public and private interventions in the system health ;
✓ organizes the deconcentration of technical services, of their human, material and financial resources necessary for the implementation of the health policy”.
The role of regulator of the health sector is mentioned in articles 46 and 47 of this law. Thus, Article 46 provides that “there is established in the Republic of Benin, a Regulatory Authority of the health sector” and article 47 specifies that “the Regulatory Authority of the health sector has mission is to ensure the realization of the right to health for all by ensuring the improvement continuous supply and quality of care”.
One of the major innovations of this law is its holistic nature. Indeed, it addresses aspects of health linked to the region and which are the basis of what is known as traditional medicine. Thus, for the first time in its history, Benin recognizes and proclaims publicly the reality and the role of traditional medicine in the health system. Art 72 of this law provides: “the practice of traditional or natural medicine is authorized and this exercise is recognized for any natural or legal person, individually or in association, under the conditions set by the legislative and regulatory provisions in vigor”. The law went further by creating (art 73) a national order of practitioners of traditional and natural medicine. This umbrella body must in particular ensure compliance with the duties professionals, ethics and deontology in this profession.
As another major innovation, the law creates a national strategic framework for the universalization of health insurance for all. Indeed, the law n ° 2020 – 37 of February 03 2021, in its article 17, makes health insurance compulsory for all persons residing on the national territory. This obligation systematically becomes a legal debt for all employers, both public and private, who must now take out health insurance at all their employees, as provided for in article 18 of the law. Meanwhile, the state takes provisions for covering the health expenses of poor and poor people extremes living on the national territory. This measure of high social significance contrasts with those that took place under the previous regimes, in particular the regime for the insurance universal disease (RAMU), whose strategic and technical set-up constituted an obstacle congenital to its viability and functioning. But this provision lacks realism! Indeed, the experience of countries with a health insurance system shows that no scheme universal could not last long financially due to the rapid exhaustion of the sources of financing. The only countries that have been relatively successful in this type of care universal have set up innovative financing mechanisms based either on tax general or affected, or on the implementation of a contribution from the patient, empowering this last in the consumption of healthcare and health products. Benin, to win its bet, must therefore set up, without delay, a mechanism associating the financial contribution policyholders in order to guarantee the long-term financial sustainability of this protection system universal.
Like these provisions of the law, specifically protecting people in good health, the other parts are more devoted to those involved in the protection of people’s health (Title III), in particular health human resources (Chapter 1), organizations professionals (Chapter 2), private providers and promoters of health services health (chapter 3), to the State (chapter 4), to the local authorities (chapter 5), to the populations (chapter 6), to the Regulatory Authority for the health sector (chapter 7), to the ministry in charge of health (chapter 8), national councils (chapter 9), orders practitioners of health professions (Chapter 10). In title IV of the law, are dealt with issues relating to the prevention of diseases, the management of epidemics and death. It is in this title, in particular in chapter one, that the prevention and the fight against communicable and non-communicable diseases while chapter 2 organizes the management of epidemics. As for chapter 3, it is devoted to the management of deaths while Chapter 4 focuses on care for the elderly and people with disabilities. Other matters no less important, but outside the exclusive framework of medicine modern, are taken into account by this legislation. This is the alignment traditional and natural medicine (chapter 5), now considered one of the alternatives of choice in the therapeutic path of the populations if necessary. The title 5 of the law and specifically chapter 1 of the said title provides for a general system of sanctions coercive penalties in case of violation of the provisions of this law.
On analysis, Law 2020-37 of February 3, 2021 constitutes a legislative revolution in terms of protection of people’s health in the Republic of Benin. It is indeed the first time, since the independence of the country, that such legislation has been put in place, resembling political global long-term legal protection of populations against the unorthodox practices of health workers, the fatal imperfections of medical and galenic science and, above all, the systemic shortcomings of the technical platform in place. All actors, public as well as private, are henceforth constrained to respect the rights of the human person in terms of health.
However, it is important to point out that despite the will of the Beninese legislator to give new impetus to the health sector and especially to the protection of people in this domain, this seems incremental or all the same hemiplegic as a global policy health. Indeed, if the duties and obligations of patients are well identified and reinforced in this legislation, their rights are rather summarily addressed. At the same time, the duties and obligations of health professionals, are barely mentioned in the text. This verdict reveals unfair treatment between patients and healthcare professionals, in terms of of comparative policies for the protection of healthy people. The same is true for the healthcare establishments whose condition and functioning today matter for safety care provided to users. It is well known that the frequency of nosocomial infections is mainly due to the dilapidated and unsanitary condition of buildings, medical equipment and materials in service.
Furthermore, the question of the liability of health professionals and establishments is practically omitted. However, the recognition and codification of these responsibilities already constitute a preponderant guarantee of the protection of people in good health. This is why, the most Western countries have set up systems for listing, codifying and the fixing of various civil, administrative and penal sanctions for facts and acts constituting homicide or involuntary injury against professionals and health facilities. In France, for example, the legislator has provided for criminal liability for unintentional acts of health professionals in the event of harm suffered by patients when they are taken in for care1. This responsibility has evolved substantial in recent years, as described by A. Ponseille2 who specifies that, “since the reform of the penal code, the legal procedures for incurring criminal liability for this type of offenses have evolved in the direction of a legislative will tending to limit this type of responsibility “.
Notwithstanding this trend, in 1994, during the reform of the Penal Code, the will of the legislator French was more to refine the repression by creating a new non-intentional fault, willful misconduct, in order to more severely punish risk-taking behavior volunteers. In the same vein, article 121-3 had been created in the penal code which presents a gradation of faults by placing the deliberate fault between the intentional fault and the fault ordinary.
By voting law n°96-393 of May 13, 1996 relating to criminal liability for acts imprudence or negligence, the French legislator maintains the existing faults but envisages a less systematic repression. Until then, the judge traditionally resorted to an assessment in abstracto of the wrongful conduct, i.e. by comparing it with the behavior that a person observing diligence and prudence would have adopted. The legislator, in 1996, imposes a mode of appreciation in concreto of the faulty behavior in order to make less systematic repression of public and private health decision-makers. is required in fact, judges have greater motivation since they must demonstrate, in order to retain the criminal responsibility, that the defendant did not carry out “normal diligence” with regard to its skills, means, authority and powers, thus raising the threshold of incurring criminal liability. Thus, the judge cannot content himself with noting the faulty intervention of a person causing the damage to deduce his liability criminal. This method of assessing the fault was the one adopted with regard to the professionals of health, taking into account the particular nature of an activity in which the decisions likely to generate a risk are daily occurrences.
In practice and in general, this French legislative amendment did not have the expected effect since the trial judges easily demonstrated that if the fault at the origin of the damage had been committed, it was that normal diligence had not been observed.
Faced with the failure of this reform, French law n°2000-647 of July 10, 2000 tending to clarify the definition of non-intentional offences, proposes the creation of a new fault, the gross negligence, and a more radical solution consisting of a distinction between direct author and indirect author to which is added above all a decriminalization of the ordinary fault which causes a harmful consequence when it is attributable to an indirect author, Physical person.
This legislative trend aimed at limiting repression in this area has certainly found an echo favorable in case law. Because, the fate reserved for health professionals prosecuted for crimes of homicide or involuntary injuries is no different from other professionals prosecuted for similar facts. However, criminal liability for harmful acts involuntary presupposes, in order to be retained, as in matters of civil liability, a fault, damage and a causal link between the two.
In view of this gradual and successful evolution of the judicialization of health protection people, it seems obvious that Benin remains behind, despite the vote of law 2020-37, unprecedented and ambitious on the protection of people and that n ° 2018-16 of December 28, 2018 on the Penal Code in the Republic of Benin. This code, which marks bearing an evolution in the assessment of criminal offenses on the national territory, is deemed to be common law and has not provided specific provisions for offenses committed by professionals or attributable to health establishments on users. Consequently, it becomes uncertain, even impossible, in a Beninese context where the principle of obligation of means and a result of the attending physician is still in force and dominant in the minds, that the judge bases himself on common law offenses to convict professionals or health facilities allegedly responsible for homicides or injuries involuntary or intentional on patients. This weakness of criminal legislation in Republic of Benin has already emerged as one of the main causes of the notorious insufficiency of health case law in the judicial decisions noted during surveys we conducted for the writing of this article. This specific investigation took place from February to March 2020 in the three courts of first first-class instance of the first three major cities in the country, namely Cotonou, Porto- Novo and Parakou. The results show that of the 102 cases of appeal formulated, the five last years (2015 to 2019) preceding the survey, half, i.e. 51 of the offenses are category of offenses against medical property and the remaining 51 are in the category of offenses against persons.
These results seem marginal in view of the extent of recurrent medical errors, the phenomenon of nosocomial infections and iatrogenic conditions as well as their consequences for users of public health services. Most people interviewed say, when asked why they do not complain to the courts for damages suffered as a result of mistreatment, rely on the will of God. Beyond this resignation bordering on the collective unconsciousness of users of their rights, the stoic attitude of people who are victims of medical errors or malpractices, or even consequences related to the poor functioning of health infrastructures, is also explained by other factors analyzed below.
✓ The phenomenon still deeply rooted in Beninese culture, of “deference to the White blouse “. Health professionals in general and doctors in particular, still enjoy, within the majority illiterate3 population, almost all deification which would place them, from the point of view of human anatomy, “just after God “. For most illiterate populations, especially in rural areas, doctors are almost demi-gods because of their practice of the medical art which “saves human lives”. The medical failures which sometimes result in deaths, would rather fall under “the will of God” or simply attributed, for the most superstitious, to rather occult practices, bewitchments or witchcraft. Proof of the existence of the link between the medical error or malpractice and the cases harmful is established by the few rare specialists or approved experts, in the framework of the “principle of the obligation of means” and not that of the “obligation of results”, as in the French system for example (see the Health Policy in France, B. Bonnici, 2015).
✓ The reluctance of Beninese to complain to the courts for damages suffered on the medical level also reflects the fear of losing in advance any lawsuit brought. Indeed, the slowness of judicial or criminal investigations, especially for cases with uncertain outcomes for the plaintiffs, the lack of financial means to meet the expenses incurred by the advice of lawyers and travel expenses and sometimes accommodation (the courts are for the most part far from the homes of the complainants) and, above all, the fear of potential reprisals from professionals or the health establishment in question, are all factors that discourage and dissuade victims from initiating legal proceedings following bad medical care, even the most flagrant.
✓ Moreover, Benin has few truly independent medical experts and reliable, approved before the courts to clarify possible faults or errors having caused intentional or involuntary injuries or homicides or temporary or permanent disabilities, subject of complaints. Indeed, like most other African countries south of the Sahara, Benin does not have legislation specific specific on medical errors and malpractices and their apprehension by law criminal (see above). In the current state of Beninese positive law, it is the code of French medical ethics which remains applicable.
From the penal point of view, it is the general penal provisions contained in the new Criminal Code which apply to offenses or errors committed by professionals of health, with regard to the acts performed by them. With regard to health establishments, insufficiencies reproachable to them, which could cause damage to users, are also governed by the same Penal Code. However, the practice of modern medicine is a special art. And, the systemic delay in the assessment of professional responsibility on the medical plan is linked, among other things, to the maintenance of the retrograde principle of the “obligation of means” already replaced in France by the principle of “the obligation of results”4, in favor of numerous reforms aimed at increasingly stronger patient protection.
This material delay in relation to the criminal apprehension of medical activity and its abuses in Benin, benefits professionals and health establishments whose various faults or errors causing damage to users, are difficult to establish before the courts. Even if the causal link between these faults or errors and the damage caused could be easily established, the spirit of solidarity between the medical expert (generally a doctor) approved before the courts and the health professionals presumed perpetrators of these faults or errors, can be another potential obstacle to the actual manifestation of the truth. This is yet another bottleneck to the effective application of criminal justice to acts damaging effects of modern medicine in Benin.
Following the example of the law protecting the health of people, the Beninese government has also put in place such an ambitious legal framework for the regulation of the activities pharmaceuticals and the safety of drugs and other health products. This is the law 2021-03 of February 1, 2021.
II- Law 2021-03 of February 1, 2021 on the organization of activities pharmaceutical companies in the Republic of Benin: the beginnings insufficient of a pharmacovigilance system.
Law 2021-03 of February 1, 2021 on the organization of pharmaceutical activities in Republic of Benin is part of the general policy of the State, relating to the improvement of basic social services. Its purpose, as specified in its article 2, is to organize activities related to medicine and other health products in the Republic of Benin. At this title, it aims in particular:
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- the availability and affordability of drugs and other health products;
- reorganization of the pharmaceutical sub-sector;
- traceability of the health product supply system;
- the quality of pharmaceutical products for consumption in Benin;
- improving health care;
- the reduction of cases of illnesses and deaths linked to the consumption of medicines from the illicit circuit and substandard and falsified medicines;
- the reorganization of the distribution system for more effective health coverage.
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This law also emphasizes the respect, by Benin, of its international commitments. compared to the African Union Model Law on the Regulation of Medical Products and the process of harmonization of pharmaceutical regulations within the Community Economy of West African States and the West Economic and Monetary Union- African, as part of the fight against the trafficking of drugs and other health products counterfeits in these areas of economic and monetary cooperation.
The law on the organization of pharmaceutical activities in the Republic of Benin introduces a consistency in the whole of the textual device relating to the pharmacy and the drug through the creation of a general legal anchoring which offers possibilities for improving the texts with a view to taking into account scientific, technological and social developments pharmacy and medicine.
It displays, in all respects, the fight against counterfeit medicines, a serious social scourge, to which Benin, like many African countries, is paying a heavy price. In this context, the law
introduces heavy penalties to punish traffickers of fake drugs on any the extent of the national territory. This legislative position confirms the political will of the government of Benin and parliament to scrupulously respect the commitments of the country in relation to the various conventions, in particular the Convention Medicrime, instrument of international criminal law to fight against the trafficking of counterfeit drugs. Through this law, the safety of medicines and other health products becomes a reality. Indeed, art 9 of the law provides that “The opening and operation of any establishment industrial pharmaceutical is subject to obtaining a license issued by the Minister in charge of health, on the proposal of the national regulatory body for the sector pharmaceutical, under the conditions and according to the methods defined by decree taken in Council Ministers, subject to the specific provisions of this Act”. In its articles 15, 16 and 18, the law reinforces this health security through a more elaborate mechanism of distribution of drugs, dispensing and advertising of drugs. The law 2021-03 of February 1, 2021 also sets up, for the first time in Benin, a body regulatory center for drugs and other health products. This layout is displayed in Articles 77, 78 and 79. In this case, Article 78 provides: “The regulatory functions pharmaceutical sector are exercised by the national regulatory body for the pharmaceutical sector, the organization and functioning of which are determined by decree issued by the Council of Ministers. The national regulatory body for the pharmaceutical sector is a structure endowed with the legal personality and financial autonomy”. Article 79 adds: “The organ regulatory authority for the pharmaceutical sector is vested with the prerogatives of proposing of texts governing the pharmaceutical sector, of decision, control, injunction and sanction allowing it to ensure the regulation of this sector”.
All in all, by putting in place such legislation, the Beninese government is instituting a legal framework for the traceability of the drug and other supply system health products and remediation of the pharmaceutical sub-sector, key elements of health care quality health to the people.
Finally, the effective implementation of this law will undoubtedly contribute to the reorganization of the entire health system, for more secure health coverage and more efficient.
From any point of view, the institutional premises of a pharmacovigilance system are thus launched. But notwithstanding these legislative bases, conditions for a resilient system of pharmacovigilance must be fulfilled. Political, administrative provisions and social are necessary according to this declaration of the World Health Organization:
“Pharmacovigilance as a medical discipline is crucial in preventing the effects drug-related adverse events (AEs) in humans, promoting patient safety and the rational use of medicines. She has reached the maturity and stature of a discipline that has a significant impact on patient care and public health. A system effective pharmacovigilance system monitors drugs, their availability and safe use of these products5“.
Pharmacovigilance thus defined corresponds to the realities of countries with health systems efficient; countries with adequate health infrastructure and enjoying a sufficient medical density in relation to their populations. These countries also have a adequate social security and health insurance system. Also, funding systems of health in these countries meet the standards in this area, that is to say that the availability the minimum necessary to effectively cover the needs of the population. Such a system pharmacovigilance certainly seems chimerical for developing countries in general and especially for those located south of the Sahara such as Benin. The reasons that explain this situation are manifold.
Benin has a still fragile health system, notwithstanding the efforts made above all in recent years to improve its performance. To this health system corresponds a drug supply and distribution mechanism which remains to be perfected, especially in public health facilities where the distribution and storage circuits drugs, are still problematic. Indeed, in these health facilities, we still continues to notice here and there, offices or small shops sometimes completely dilapidated, in dust and heat, where medicines, solutes and other health products. These deplorable storage conditions for these products put a strain on test their quality. Their expiry date is also practically useless, because said storage conditions expose them to risks of premature expiry.
Faced with this situation, Benin deserves a particularly adapted pharmacovigilance system. to its context. Such a system must first take into account the need to improve the product supply and storage conditions. The country’s health system should adopt a program to modernize the management of medications in the public hospitals and health centers. The pharmaceutical depots of the said health facilities should be rehabilitated and provided with modern equipment, such as dispensaries specially designed, adequate cold rooms and healthy display shelves in order to preserve, according to the standards, the drugs and other health products that are supplied there. A Once the conservation infrastructure has been improved, the training of agents is essential. At this By the way, a study carried out in 2017 by doctors Habib GANFON and Giraud EKANMIAN, on behalf of the Pharmacotherapeutic Information Center of Benin (CIP-BENIN) and the Global Fund, and entitled Dispensing Practices for Uncomplicated Malaria in pharmacies in Cotonou, Abomey-Calavi and Porto-Novo (Benin), reveals this need for training of pharmaceutical product dispensers in pharmacies Beninese. This article offers below some key elements of this essential update of personnel assigned to the management of medicines in health facilities. public of Benin.
Human conditions: training and retraining of depot agents pharmaceuticals of health establishments
Currently, public hospitals in Benin have a shortage of trained staff to serve in depots6 (pharmacists, salespeople). However, in accordance with the texts in force, each hospital should in principle have in the workforce of its pharmaceutical depot, a pharmacist. In addition to the pharmacist who is also the head of the depot service, other well-trained agents (salespersons and cashiers) should be available in sufficient numbers to the optimal functioning of said depots. But today, in reality, the observation is alarming! Sometimes in the absence of any professional in the field, they are girls or boys room, without even on-the-job training, who are assigned to these positions. In addition to momentum very driven towards the corruption of these incompetent agents, users are sometimes served with inadequate or even counterfeit products that continue to circulate despite the fierce measures of repression put in place by the health authorities of the country. It would therefore be necessary for an optimal system of pharmacovigilance, to replace the current agents in post in the depots of health centers and hospitals by real professionals recruited and specially dedicated to this task. For those with the required training and skill, it is necessary to set up, for them, a program of continuous training or recycling, in order to familiarize them with technological developments in the field of pharmacy and transformation of certain molecules, in accordance with the aspirations of the new legislation on pharmaceutical regulation.
All in all, despite the implementation of law 2021-03 of February 1, 2021 on the organization pharmaceutical activities in the Republic of Benin which fortunately establishes the bases of a pharmacovigilance system for the country, appropriate measures should be taken to contextualize said on the institutional realities and the structure of the health system of <hr style=”width: 300px;” />the country.
The establishment in Benin of an effective pharmacovigilance system will ensure the monitoring of drugs, their availability at all levels of the health pyramid and safe use of these products. But the system, once in place, will have to comply with international standards with regard to the scope and indicators (to be developed) for objective measures of progress. Once pharmacovigilance is in place, the beneficiaries of the reform need coverage adequate financial support for equitable health care for citizens.
Finally, Benin, by setting up an efficient system of pharmacovigilance in accordance with to international standards, could take advantage of the international nets dedicated to it in order to obtain opinions and valuable assistance for the creation of departmental pharmacovigilance centres. This system would also make it possible to promote the training of specialized personnel as well as to organize exchanges of views and observations for the development of new techniques optimal medication management.
1In French legislation, before the intervention of the legislator with the law of March 4, 2002, both administrative and civil case law has attempted to create medical liability regimes favorable to the victims of injuries that occurred through no fault of the doctor. But since the Mercier judgment of May 20, 1936, of the Court of Cassation, a rigorous obligation of means was imposed on establishments and health professionals: the obligation of care arising from the medical contract and charged to the doctor is an obligation of means; the doctor cannot commit to curing, he undertakes to provide care that is not arbitrary, but conscientious, attentive and in accordance with the data acquired from science. As such, liability is based on the existence of a fault. But the administrative judge was the most innovative by admitting the responsibility of the practitioner or the public health establishment on the fault when the damage was due to a defect organization and operation of the service. BONNICI, Bernard, Health policy in France, opt-cit, p19-20.
2PONSEILLE, Anne, Professions, professionals and health establishments facing criminal law, September 2015.
3In 2018, the average adult literacy rate is 42.36% according to the results of the Demographic Survey and Health in Benin (EDSB) 2017-2018.
4Cf BONNICI, Bernard., op-cit, p20.
5WHO INDICATORS FOR PHARMACOVIGILANCE: A PRACTICAL HANDBOOK FOR THE EVALUATION OF PHARMACOVIGILANCE SYSTEMS PHARMACOVIGILANCE, World Health Organization, 2019, p.9.
6In order to avoid competition with licensed private pharmacies to sell specialty drugs to the public, hospitals and others public health facilities have drug depots specially dedicated to the on-site sale of generics to patents. Each deposit should in principle be managed by a professional pharmacist, assisted in his duties by sales and cashiers.
Bibliographic references
BONNICI, Bernard in Health policy in France. What do I know? PUF, 2015;
PALIER, Bruno, The reform of health systems, What do I know? 8th updated edition, February 2017;
PONSELLE, Anne, Professions, professionals and health establishments facing criminal law Ed LEH, September 2015;
SOSSOU, Gilles Armand et alii, Council for Economic Analysis (CAE), Parallel drug market in Benin, a report;
SOSSOU Gilles Armand, NOUKPO Homégnon and MOUNIROU Ichaou, Parallel drug market in Benin, a report produced at the Imprimerie Tropicale, Cotonou 2010
Code of medical ethics, November 2012 edition;
UEMOA, Council of Ministers, Directive No. 07/2006/CM/UEMOA relating to veterinary pharmacy, enacted and entered into force on March 23, 2006;
WHO indicators for pharmacovigilance: a practical manual for evaluating pharmacovigilance systems, World Health Organization, 2019, p.9;
Law No. 2020-37 of February 3, 2021 on the protection of human health in the Republic of Benin;
Law 2021-03 of February 1, 2021 on the organization of pharmaceutical activities in the Republic of Benin.
