Article

Commentary

Public health and the legal regulation of the

pharmaceutical industry in Algeria

Tareck Alsamara, Ghazi Farouk, Abbaci Adel

Corresponding author: Ghazi Farouk, Badji Mokhtar Annaba University, Annaba, Algeria. [email protected]

Received: 06 Sep 2021 - Accepted: 07 Jan 2022 - Published: 01 Feb 2022

Keywords: Pharmaceutical industry, public health, Algeria, legal framework

Copyright: Tareck Alsamara et al. Pan African Medical Journal (ISSN: 1937-8688). This is an Open Access article
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Cite this article: Tareck Alsamara et al. Public health and the legal regulation of the pharmaceutical industry in Algeria.
Pan African Medical Journal. 2022;41(86). 10.11604/pamj.2022.41.86.31524

Available online at: https://www.panafrican-med-journal.com//content/article/41/86/full

Public health and the legal regulation of the Abstract

pharmaceutical industry in Algeria
Through this commentary, we attempt to evaluate
Tareck Alsamara1, Ghazi Farouk2,&, Abbaci Adel2 the success of the Algerian legislature in developing
1 a legal framework for the pharmaceutical industry
Prince Sultan University, Riyadh, Kingdom of Saudi
that protects public health. The study is based on
Arabia, 2Badji Mokhtar Annaba University, Annaba,
Algeria's national legal framework for the
Algeria
pharmaceutical industry, namely, legislation on
& health law and regulations on pharmaceutical
Corresponding author
activity. The study focuses on legal texts and uses
Ghazi Farouk, Badji Mokhtar Annaba University,
the method of comparison whenever necessary.
Annaba, Algeria
Algeria has established an integrated system for
regulating the pharmaceutical industry at the
national level. Algeria reserves its right to intervene
in pharmaceutical economic activity through
national industrial institutions. At the same time,
 Article
Algeria allows private Algerian or foreign more expensive. It is not always necessary to find a
companies to become active in the pharmaceutical balance between social benefits and legal
industry. However, the pharmaceutical industry protection for companies. Pharmaceutical
sector has not freed the country from dependence companies need to be protected. Intellectual
on imports from abroad. Public authorities should property rights rules are not an obstacle to ensuring
provide continuous information about the support access of poor communities to essential
and facilities provided to pharmaceutical investors. medicines [7]. Therefore, international law tends to
strike a balance between intellectual property
Commentary rights and human rights norms relating to the right
to health and access to medicines [8]. For example,
Algeria is a developing country, suffering from the convention on the trade-related aspects of
economic problems including economic intellectual property rights imposes on countries
dependence on the production of fossil fuels, and the need to enact legislation to protect intellectual
thus the pharmaceutical industry becomes an property, which many experts see as an obstacle to
important alternative for the state to diversify its the availability of medicines in poor countries. But
economy. In Algeria, sales of the drug reached 3.8 the 2001 Doha declaration to the convention's
billion USD at the end of 2018 (Aissaoui 2020) [1]. member states eased restrictions for the benefit of
In 2020 the amount was 4 billion USD and the poor countries.
forecast for 2021 is for a level of 5 billion USD
(France business 2020) [2]. In 2021 the national The pharmaceutical industry also contributes to
production of drugs will have to exceed the value of ensuring the right to combat pain as a human right,
2.8 USD (APS 2021) [3]. The relationship between because article 11 of the 1966 International
the pharmaceutical industry and public health is Covenant on Economic, Social, and Cultural Rights
demonstrated by the fact that the pharmaceutical affirms that health is a human right. The committee
industry contributes to the achievement of public on economic, social, and cultural rights, the
health goals. However, this relationship is not monitoring body of the convention, decided that
always beneficial, and Bloor and Maynard have states should provide and facilitate access to
questioned whether legislation on the adequate quantities of public health, health care,
pharmaceutical industry protects health or protects goods, services, and programs [9]. Furthermore,
wealth [4]. the local pharmaceutical industries help countries
to control epidemics and pandemics because they
The pharmaceutical industry has public health provide countries with medicines and medical
benefits but can become an enemy if the law does supplies quickly and without the complications of
not define an exact relationship to protect society importing. This makes it easier for countries to deal
from scientifically harmful or unjustifiable with health emergencies quickly and effectively.
medicines [5]. We must point out that Algeria is aware of this, so Algeria is working to
pharmaceutical companies have contradictory develop the local pharmaceutical industry. The
obligations. This is because for they are obliged to COVID-19 pandemic has also had a profound
make profit on the one hand, and to protect society impact on the medical and pharmaceutical
from the rising costs of medicines on the other. industries. Because of it, governments now have to
Therefore, governments and non-governmental change their legislation to allow more effective
organizations play an important role in balancing treatments in health emergencies [10]. It has
these two contradictory commitments [6]. become necessary for governments to end foreign
Moreover, the pharmaceutical industry has a dependency in the pharmaceutical field by
positive impact on the availability of treatment and stimulating the national pharmaceutical economy.
medicine, especially in developing and poor There have been no previous studies published in
countries, but industrial companies tend to be English about this subject. There is an article by

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Laouisset entitled “Algeria import constitution: the 1992, which contains the conditions to be met by
case of the pharmaceutical industry” [11], but it the institutions involved in the production or
concerns import activity and is not related to the distribution of pharmaceutical products. Because
local industry. In Arabic, there is a study entitled of the seriousness of public information and
“The role of industrial policies in the development publicity relating to pharmaceutical products, the
of the pharmaceutical industry in Algeria”. The Algerian public authorities have established legal
authors of the book, Ben Abdelrazzaq, and regulations for even this type of information and
Khanshur, have a study that focuses on the advertising, following executive Decree No. 92/286
economic aspects of Algerian national policy in the of 6th June 1992. According to the rules of this
field of the medical industry but does not discuss decree, pharmaceutical companies cannot make
the legal aspects. publicity without obtaining a visa from public
authorities. The decree prohibits publicity for any
The topic is particularly important because there is prescription drug, or for treatments for specific
a direct relationship between the pharmaceutical diseases such as cancer, tuberculosis, AIDS,
industry and economic development [12]. diabetes, infertility, blindness, or narcotic drugs.
Development of a national pharmaceutical industry
not only helps to break free from dependence on The limitations of the commentary relate to the
imports. It also contributes to job creation [13]. analytical method, which the study used in
Moreover, patents in the pharmaceutical industry analyzing the legal texts related to the subject. We
contribute to the development of economic should note that the commentary produced the
development and constitute an important source following findings: first, Algeria has established an
of wealth [14]. The need for a national integrated system for framing the pharmaceutical
pharmaceutical industry has also increased since industry at the national level. Algeria reserves its
the emergence of the COVID-19 pandemic, where right to intervene in pharmaceutical economic
the need for drugs to mitigate symptoms of the activity through national industrial institutions. At
disease and for supplies to reduce the spread of the the same time, Algeria allows private Algerian or
disease as well as its vaccine has increased [15]. foreign companies to become active in the
Through this study, we are trying to evaluate the pharmaceutical industry. Second, Algeria has
success of the Algerian legislature in developing a adopted institutions with considerable powers to
legal framework for the pharmaceutical industry regulate the pharmaceutical industry to maintain
that protects public health. public health, the aim of which is to protect society.
Third, under its legislative policy in the
Executive Decree No. 92/284 of 6th July 1992, pharmaceutical industry, Algeria has struck a
regulated the procedure for registering medicines balance between the need to protect health on the
and pharmaceutical products used in human one hand and the protection of wealth on the
medicine and subjected them to strict procedures. other. Fourth, Algeria still has several stages to
Article 23 of the above-mentioned decree states invest in all legislative and institutional capacities in
that it is possible to refuse to register a drug if it is the pharmaceutical industry. Fifth, Algeria has a
proven to be harmful or if its use does not achieve strong legal framework and institutions that allow
the expected therapeutic effect, or if it does not it to invest in the pharmaceutical industry,
include a qualitative and qualitative structure or its especially during the COVID-19 pandemic. Sixth,
contents, or if its production does not allow for Algeria responded positively to the situation in
quality control. We must point out that dealing with the COVID-19 pandemic and
pharmaceutical activity is not exclusive to public established the National Health Security Agency. It
enterprises but is also open to private companies, became the state adviser for strategic vigilance for
but that the practice of pharmaceutical products is future medical emergencies.
subject to the licensing system 92/285 of 6th July

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The national laboratory for the control of associations, and university professors. It also
pharmaceutical products: the National Laboratory contains five experts other than members of
for the Control of Pharmaceutical Products is one of specialized committees appointed by the minister
the oldest regulatory institutions in the of health based on their competence and
pharmaceutical industry, established by decree qualifications in areas relevant to the agency's
93/140 of 14th June 1993. It is a public institution of functions (article 21 of decree 1999/190). It is
an administrative nature with a legal character, necessary to note that the International Atomic
whose functions are focused on monitoring the Energy Agency (IAEA) scientific council is an
quality and quality of pharmaceuticals. It records advisory body, providing views and
medicines and studies the harmlessness, recommendations on matters relating to the
effectiveness, and quality of marketed medicines. agency's activity. It can make suggestions on
strategies for developing the pharmaceutical
The national pharmaceutical agency: it is sector, and can propose measures that would
important to point out that the National encourage production of pharmaceuticals and
Pharmaceutical Agency is a public institution with medical supplies. It might also express its opinion
moral, personal and financial independence (article on all matters relating to the scientific and
2 of decree 1999/190). It's not a pharmaceutical pharmaceutical fields relevant to the activity of the
company; it's a pharmaceutical industry control. agency including draft legislative and regulatory
The agency consists of a board of directors and a texts governing pharmaceuticals and medical
scientific board and is managed by a director. We supplies (article 20 of Decree No. 1999/190). It
note that issues relating to the agency's objectives must be made clear that the director of the agency
are decided by the governing council following the is appointed by presidential decree on the
legislation and organization in force. The governing recommendation of the minister in charge of
council determines the agency's annual and multi- health. Assisted in his duties by a secretary-general
year projects, plans and program of work, and the and sub-directors (article 16 of Decree 19/190), the
agency's estimated budget. The agency's accounts, director is responsible for implementing the
internal organization, and rules of procedure are decisions of the board of directors and the views of
also regulated. The council also examines draft the scientific board of the agency. It is necessary to
transactions, contracts, agreements, and emphasize that the National Pharmaceutical
conventions, appoints a governor, and establishes Agency has exclusive competence in the area of
regional attachments (article 10 of decree registration, medicines, and pharmaceuticals. The
1999/190). It should be noted that the board of agency is responsible for the registration,
directors of the agency consists of representatives validation, and control of pharmaceuticals and
of ministries of the state, such as the interior, as medical supplies and participates in the
well as representatives of the ministries of health, implementation of the national policy on
labor, social security, and higher education. Three pharmaceuticals and medical supplies used in
persons are appointed by the minister of health human medicine.
based on their competence and qualifications in
areas related to the agency's functions (article 9 of It is also responsible for the control of
decree 1999/190). pharmaceuticals and medical supplies and is
responsible for causing or requesting the
The scientific council of the agency differs from the competent authorities to take the necessary
board of directors. It is composed of measures aimed at maintaining public health in the
representatives of the National Council for Health event of a pharmaceutical substance or medical
Ethics, the National Council for Medical Ethics, requirement that constitutes or may pose a threat
pharmaceutical workers, pharmacy organizations, to human health (article 5 of Decree No. 19/190).
patient associations, scientific and pharmaceutical To achieve its objectives, the agency may express

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an opinion on provisional licenses for the use of requires that its functions be recognized. Regarding
unregistered medicines. It also contributes to the the above-mentioned decree, it enjoyed extensive
definition of good practice rules for the powers that overlapped with the functions of the
manufacture, storage, distribution, and National Agency for the Pharmaceutical Industry,
disbursement of pharmaceuticals. The agency's such as: it prepare and promote pharmaceutical
field inspection and inspection functions are carried industry policy, national production, and policies
out by inspectors including, in particular, the for the promotion and development of investment
monitoring of the application of rules of in the pharmaceutical industry. It also develops and
pharmaceutical good practice and standards of proposes measures and actions aimed at the
medical supplies following the legislation and abundance, quality, and availability of
regulations in force. It also conducts scientific pharmaceuticals and medical supplies. We should
assessments of the benefits, risks, and therapeutic note that it is body responsible for the accreditation
value of pharmaceuticals and medical supplies, as of pharmaceutical enterprises in the production,
well as their economic aspects. It must be noted import, export, exploitation, and distribution of
that its tasks include: the contribution to the pharmaceuticals and medical supplies, as well as
preparation and updating of pharmaceutical codes medical promotion companies and service
and medical supplies, the contribution to the providers.
preparation of the list of pharmaceuticals and
essential medical supplies, and the contribution to In the area of industrial policy, and in the
the preparation of the national pharmaceutical promotion of national production and investment,
registry and the pharmaceutical constitution. The it prepared the industrial policy of the
agency is also responsible for issuance of the drug pharmaceutical branch and assessed its impact,
price certificates upon registration as soon as it is proposing necessary adjustments, in liaison with
determined by the joint sectoral commission on the parties concerned. It also promoted and
medicines, and the licensing the promotion and harmonized the productive capacities of
publicity of registered pharmaceuticals for health pharmaceutical enterprises to produce
professionals. It gives opinions on the standards, pharmaceuticals and medical supplies following
rules of good practice, procedures, and methods specific objectives and national priorities. In
applicable to medical studies in relation to addition, every measure was taken to achieve the
pharmaceuticals and medical supplies. The agency objectives set by the pharmaceutical industry policy
undertake any study, research, or formative or and to follow up the implementation of its
information activities in the fields of its development programs. It also encouraged the
competence, and to contribute to the promotion of development of production inputs to create and
scientific research in the field of pharmaceuticals promote the industrial fabric of users necessary for
and medical supplies and the establishment of the integration of the pharmaceutical industry. It
databases relating thereto. It participates in the identified the mechanisms necessary to promote
preparation of the list of medicines compensable innovation and technological development in the
by social security bodies. pharmaceutical industry. All actions aimed at
developing training and rehabilitation capacities in
Discussion the professions of the sector could be proposed
and implemented in liaison with the parties
The ministry of the pharmaceutical industry: the concerned. All measures for investment promotion
most recent presidential Decree No. 20-163 of 23rd could be proposed, and whatever contributed to
June 2020 appointing members of the government improving the environment for the pharmaceutical
as the ministry of the pharmaceutical industry, industry.
under the auspices of the ministry of health, has
now been abandoned, but the scientific approach

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It also ensured the regulation of investment The ministry also has several powers in the area of
projects towards the production of high-value- strategic vigilance, in accordance with article 7 of
added essential pharmaceuticals. It facilitated the Decree No. 20/271, which ensures that it follows
establishment of industrial pharmaceutical the development and direction of the national,
enterprises and the promotion of contracts and regional, and international pharmaceutical markets
partnerships between the public sector and the and takes all measures to ensure their balance. It
national and foreign private sectors in the ensures that all technological security devices are
pharmaceutical industry, in particular through the developed in the field of pharmaceutical industry
development, monitoring, and evaluation of a activities. It also works on the establishment of a
partnership program for industrial public data bank and the preparation of periodic and
enterprises (article 3 of decree 2000/271). It should circumstantial reports on the evaluation of the
be noted that the ministry has powers in the area pharmaceutical industry. It promotes any measure
of the supply of pharmaceuticals and medical that facilitates and enables clients to access new
supplies. The ministry prepares the registration and technologies in the pharmaceutical industry. The
certification policy and ensures its development list of pharmaceuticals and essential medical
and implementation, particularly in its targeting of supplies, as well as the national pharmaceutical
high-value-added items from national production. registry, the pharmaceutical constitution, and the
The existing legislation and regulations on the national codes of pharmaceuticals and medical
quality, effectiveness, and security of supplies, are also prepared and updated.
pharmaceuticals and medical supplies are
respected. In addition, all measures are taken to The national agency for health security: following
ensure the availability of pharmaceuticals and the emergence of the COVID-19 pandemic, Algeria
medical supplies, particularly in the area of market established the National Agency for Health Security
control. by presidential Decree No. 20/158 of 13th June
2020. This agency serves as an advisory body for
Temporary licenses for the use of unregistered strategic vigilance in the service of Algeria's public
medicines are also received in accordance with the authority. It is both a private and a public institution
legislation and regulation in force. Such legislation with legal personality and financial independence.
ensures that import programs for pharmaceuticals It is an institution for monitoring, consultation, and
and medical supplies are carried out in integration oversight of the national health security strategy
with national production. Any measure aimed at and for ensuring its implementation. The agency's
controlling the national production of primary task is to prepare and implement the
pharmaceuticals and medical supplies is proposed national health security strategy. The agency is
through the national territory (article 4 of decree responsible for coordinating national programs for
2000/271). It is necessary to point out that the the prevention and control of threats and risks of
ministry assigned to the pharmaceutical industry health crises. The agency is the scientific adviser to
plays an important role in the area of promotion of the public authorities in the area of health security
studies, research, and development under article 8 and the reform of the national public health
of Decree No. 20/271, by promoting research and system. It is important to note that the agency has
development within producing pharmaceutical advisory, scientific guidance, and strategic vigilance
enterprises and by proposing all incentive bodies composed of scientific personalities,
measures for R & D activity in the pharmaceutical experts, and specialists recognized as competent in
industry. It also promotes innovation in the their fields.
pharmaceutical industry and ensures the
promotion and development of clinic studies and The role of private companies: in Algeria, the
the delivery of licenses. pharmaceutical industry is not only confined to
public institutions and agencies but to private

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institutions as well. Within this framework, the Conclusion
Algerian legislator, in article No. 184 of the law No.
08-13 relating to the protection and promotion of The aim of the study is to examine the capacity of
health, has exclusively designated the Algerian law in the field of the pharmaceutical
pharmaceutical public institutions and the industry. Algeria has shown interest in the
accredited private ones as producers, importers, pharmaceutical industry by preparing legal grounds
and exporters of the pharmaceutical products. In for the activity of public and private enterprises in
that context, the creation of a pharmaceutical the field. But the legal grounds are beset by
company to produce medicines requires prior economic and cognitive problems. In order to
approval for completion and another approval for strengthen the role of the private pharmaceutical
opening. These two approvals are exclusively companies, it is highly recommended that public
delivered by the minister in charge of the authorities should provide continuous information
pharmaceutical industry as stipulated in article No. about the support and facilities provided to
17 of the executive Decree No. 21-82 relating to the pharmaceutical investors. Public and private
pharmaceutical institutions and their accreditation partnerships should be given priority within the
requirements. pharmaceutical industry of the state. We should
note that startup pharmaceutical companies
Accordingly, many private actors like (Biopharm,
should be encouraged and accompanied by the
Hydrapharm-Beker, Inpha-Médis-Biocare, LDM,
public authorities. Finally pharmaceutical
Pharmalliance, etc.) play a significant role in the
incubators should also be given priority in order to
production, import, export, distribution of
contribute effectively to the development of
medicines in Algeria. However, the contribution of
pharmaceutical research.
these private players remains insufficient
compared to the needs of the local market and the
facilities provided by the public authorities in terms Competing interests
of legislation and real estate. Carrying out their
work, these private companies may sign The authors declare no competing interest.
agreements with foreign laboratories to create a
common project in Algeria. For example, the Authors' contributions
private pharmaceutical company Biopharm signed
an agreement worth 15 million USD with the Indian All the authors have read and agreed to the final
group Cipla in February 2015, to market and manuscript.
distributes medicines for respiratory diseases.
Biopharm also signed in the same year another Acknowledgments
agreement with the Anglo-Swedish AstraZeneca
laboratory of over 50 million USD for the All authors of this article would like to thank the
construction of a pharmaceutical manufacturing Governance and Policy Design Research Lab
plant in Algeria [16]. (GPDRL) of Prince Sultan University (PSU) for
financial and academic support to conduct this
It is noted that the Algerian authorities in the last research and publish it in sustainability journal.
years are working to reduce the bill of the medicinal
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