Morocco’s Healthcare Industry:
Legal
Framework
Healthcare & Life Sciences Focus
In Morocco, there are three main sectors in the healthcare industry: pharmaceuticals, medical devices, and private medical establishments.
Law Update: Issue 364 - Healthcare & Life Sciences Focus
Safia Fassi Fihri Associate Counsel,Corporate Commercial
Located at the crossroads of Africa and Europe, Morocco offers a favourable environment for investment in the healthcare sector. In Morocco, there are three main sectors in the healthcare industry: pharmaceuticals, medical devices, and private medical establishments. This article examines the perspectives for healthcare investment in Morocco, focusing on the regulations that govern each of these areas, in addition to the obvious opportunities.
The pharmaceutical market in Morocco is governed by Dahir n°1-06-151 of 30 chaoual 1427 (November 22, 2006), implementing Law No. 17-04 on the drug and pharmacy code (“Drug Code”). This law defines a medicine as any substance or composition with curative or preventive properties against human or animal diseases, as well as any product that can be administered to humans or animals to establish a medical diagnosis or restore, correct, or modify their organic functions.
All aspects of medicines and pharmaceutical products are governed by the Drug Code, including marketing, authorization, manufacture, import, export, sale and distribution. It also lays down strict rules for the transport, storage, and destruction of medicines unfit for consumption.
It is important to point out that all medicines, whether locally manufactured, imported, or exported, including samples, must obtain authorization from the authorities before being marketed or distributed, whether wholesale or retail, in return for payment or free of charge. Authorization can take two forms: a marketing authorization for drugs intended for commercialization; or a specific authorization for product registration, for clinical trials, or in the case of drugs prescribed and not registered in Morocco, or in the case of temporary use of certain drugs intended to treat serious or rare diseases when no appropriate treatment exists in Morocco.
To obtain the above-mentioned authorizations, it is essential that the drug complies with current regulatory requirements. Compliance with these requirements is intended to guarantee the safety, quality, and efficacy of medicines, which is crucial to the protection of public health. Regulatory authorities ensure that medicines meet these standards before authorizing them to be marketed, distributed, or used.
Another important provision of the Drug Code is the regulation of drug imports. Under this law, all imports of medicines require a health visa issued by the relevant authorities. The main purpose of this visa is to guarantee traceability of imported medicines, particularly regarding their place of manufacture or origin. This measure aims to reinforce the safety and quality of medicines on the Moroccan market.
Where there's import, there's also export, which is why the Drug Code requires any industrial pharmaceutical establishment exporting a drug to apply to the authorities for a certificate of free sale. This certificate attests that the drug intended for export has been granted a marketing authorization, thus guaranteeing its compliance with current standards. This strengthens the credibility and traceability of exported medicines.
Moroccan legislation on pharmaceuticals attaches great importance to the storage and transport of medicines, requiring that these operations be carried out in such a way as to preserve their quality and prevent any deterioration. This requirement aims to maintain the integrity of medicines throughout their supply chain, from manufacture to use, to guarantee their efficacy and safety. These provisions reinforce the safety and quality of medicines on the Moroccan market.
Dahir n°1-13-90 of 22 chaoual 1434 (August 30, 2013) established Law No.84-12 on medical devices in Morocco (“Medical Devices Regulation”). This law defines a medical device as any instrument, apparatus, equipment, material, product, or other article intended for use in humans for medical or surgical purposes, including accessories and software involved in its operation. This medical device cannot achieve its main purpose by using pharmacological, immunological, or metabolic mechanisms, but it can help to accomplish its function.
Companies manufacturing, importing, exporting, and distributing medical devices are subject to the Medical Devices Regulation. It defines the requirements for the marketing and use of medical devices, including registration, traceability, and withdrawal of registrations in the event of non-compliance.
This legislation has allowed medical devices to be classified according to their uses, including the diagnosis, prevention, control, treatment, or alleviation of disease, as well as the diagnosis, control, treatment, alleviation, or compensation of injury or disability. It also includes medical devices used for the study, replacement, or modification of anatomy, as well as those used for the diagnosis, study, replacement, or modification of physiological processes, including those related to procreation.
Medical devices are classified according to various criteria, including their duration of use, their nature, their intended use, and the part of the body to which they are applied. A fundamental condition is that these medical devices must meet essential quality, safety, and performance requirements, guaranteeing a high level of safety.
As regards the importation, exportation, and distribution of these medical devices, it is imperative to submit a declaration to the competent administration. This declaration must be accompanied by a complete file containing all relevant documents relating to the device in question.
Accordingly, medical devices require a registration certificate before they can be placed on the market. However, there are exceptions to this rule, notably for medical devices not marketed in Morocco but prescribed for specific patients, custom-made medical devices, and samples imported for registration. These provisions are designed to guarantee the quality, safety, and efficacy of medical devices on the Moroccan market.
Morocco has private medical clinics that are governed by the 2nd Title of Dahir n°1-15-26 of 29 rabii II 1436 (February 19, 2015), promulgating Law No. 131-13 concerning the practice of medicine. Clinics are private health establishments that provide diagnosis and care to the sick, injured, pregnant, or parturient women within the framework of hospitalization for the period necessary for their state of health, in accordance with this law. Furthermore, in accordance with current regulations, clinics can provide rehabilitation services and be part of the emergency medical assistance service (SAMU).
The law defines the operating rules for clinics and the procedures for obtaining authorizations to set up and operate the same. It also establishes standards for the practice of clinics, guaranteeing high standards of quality and safety in private-sector healthcare.
To set up a clinic, prior authorization must be obtained from the relevant government authority, after consultation with the National Council, even before construction work begins. Once construction work has been completed, the clinic can only begin operating once final authorization has been obtained from the competent authority. The authorities may ask the clinic's founders to provide additional documents to obtain this authorization. In addition, the plan to set up the clinic must be implemented within three years of the date of issue of the prior authorization.
In addition, the clinic must comply with the management rules laid down by law, particularly with regard to audit procedures and the roles of the medical director, the medical committee, and the ethics committee.
The conditions of ownership and management of private medical clinics are defined by different modalities. A clinic may be owned by an individual doctor registered with the Ordre in the category of private practitioners, who may set up a limited liability company with a single partner, assuming both the roles of medical director and manager. If the clinic is owned by a group of doctors, they must all be registered with the Order in the same category and may opt either for a form of association specified by the regulations, or for a commercial company. If the clinic is owned by a company made up of non-doctors, or doctors and non-doctors, medical management must be entrusted to a doctor registered with the Order.
Finally, if the clinic is owned by a non-profit legal entity, responsibility for medical management must be entrusted to a doctor registered with the Order. Owners and managers are strictly forbidden from interfering with the medical director's duties, or from imposing acts restricting his or her exercise.
Foreign investment in the medical sector depends to a large extent on the way healthcare services are reimbursed, notably through the Assurance Maladie Obligatoire (“AMO”) scheme managed by the Caisse Nationale de Sécurité Sociale (“CNSS”). Initially limited to specific treatments, the AMO care package has been progressively extended to include outpatient care, dental care, and facial orthodontics for children, thus covering a complete range of benefits. At the same time, patients can also benefit from reimbursement of certain medical services via private mutual insurance companies, subject to agreements between private clinics and insurers, and have the option of self-financing medical services without recourse to health insurance or public funds. In the latter case, reimbursement does not depend on a third-party payer, but is made directly by the patient himself, offering flexibility in healthcare financing options.
There are numerous investment opportunities for foreign investors in Morocco's healthcare sector. This includes not only medical tourism, which offers a variety of services such as cosmetic surgery, dental care, elective surgery, and fertility treatments, but also dental care and aesthetics in response to a growing demand for quality dental care. Aesthetic dental services, such as Hollywood smiles, dental implants, dental veneers, and dental crowns, also offer opportunities.
In addition, there are significant investment opportunities in the surgical sector. In Morocco, specializations such as cardiovascular, orthopaedic, ophthalmic, urological, neurosurgical, visceral and ENT surgery are being developed. In addition, due to growing demand for these procedures, cosmetic surgery of the face, figure, and breasts is also available.
And bariatric surgery, which includes procedures such as by-pass, sleeve/gastrectomy, and the use of gastic balloons, is a particularly attractive area for investment.
The Moroccan healthcare sector is evolving rapidly and offers numerous investment opportunities. Morocco's private healthcare sector is booming, with over 360 private clinics and more than 9,661 medical specialists. Morocco is also focusing on improving medical infrastructure by creating new university hospital centres (CHU), emergency units and mobile hospitals. Some of these projects offer a wide range of investment opportunities, including construction, the supply of medical equipment, and the provision of medical services, among others.
Morocco offers strategic advantages that make it an attractive destination for investors in the healthcare sector. First and foremost, its geographical position makes it a point of convergence between Africa, Europe, and the Middle East, offering access to international markets. In addition, the country boasts a skilled medical workforce, guaranteeing high-quality services. Labour costs are also competitive with Western countries, offering a significant economic advantage.
To ensure the success of their investments in Morocco's healthcare sector, investors can actively engage in managing the necessary procedures. In-depth knowledge of local regulations and meticulous research are essential. In addition, establishing partnerships with local players can facilitate market integration and ensure a thorough understanding of local needs and opportunities. In addition, establishing partnerships with local players can facilitate market integration and ensure a thorough understanding of local needs and opportunities. Morocco offers a favourable environment for investment in the healthcare industry, with a solid legal framework, strategic advantages, and rapid growth in the sector. Investors can become actively involved in managing procedures to ensure the success of their investments. Morocco is positioning itself as an attractive destination for investment in the healthcare industry, offering stability, growth, and opportunities for international companies.
For further information,please contact Safia Fassi Fihri.
Published in January 2024
