Finances News Hebdo: How do you define a medical device and what differentiates it from a drug?
Abdelmadjid Belaïche : A medical device (MD) is any instrument, apparatus, equipment, material or other article, used alone or in combination, including accessories and software involved in its operation, intended by the manufacturer to be used in humans to diagnose, preventing, controlling, treating or mitigating disease, or compensating for injury or disability, studying, replacing or modifying anatomy or physiological process in order to control conception. The medical device is different from a drug by its function. Unlike drugs, the mode of action of a DM is physical. The DM arsenal is very rich in references. We are talking about 800,000 MD references for only nearly 7,000 drugs. The MD represents an essential link in the health environment, in the same way as the drug.
FNH: Medical devices are of economic and health importance. What exactly does it consist of?
A. B. : The medical device sector, despite its fundamental importance for health, has remained unknown to the general public and even to the media. The panThe Covid-19 pandemic has shown the importance of medical devices, whether medical consumables, biomedical equipment, laboratory products or associated services to secure our country’s supply of these essential products. to the health and even the lives of our patients. The economic place of the sector of DM is also important, both in terms of its turnover and the thousands of people it employs. One of the objectives of the Moroccan Federation of Health Industries (FMIS) is to make the medical device sector known to professionals as well as to the media and the general public.
FNH: Who are the main players in the medical device sector?
A. B. : The FMIS, created in 2019, is the most important professional association and the most representative of the medical device sector. It brings together operators (manufacturers, importers, distributors of consumables, equipment and medical services) totaling more than 60% of the sector’s turnover and capitalizing on more than 40 years’ experience in medical devices. The FMIS has 6 professional colleges, dedicated to implantable medical devices, medical consumables, the health products industry, biomedical equipment, laboratory equipment and products, and medical informatics technologies.
FNH: What is the turnover of the medical device sector and is there an informal medical device sector?
A. B. : The estimated turnover of the medical device sector is 5 billion dirhams, excluding the informal medical device sector. Indeed, the latter’s activity is difficult to pin down because his medical devices are often smuggled in, not declared to the guardianship and sold through a multitude of medical device businesses across the country. MDs in the informal sector have no traceability and offer no guarantee of effectiveness or safety.
FNH: Exactly, the law relating to this vital sector has been reviewed. Is this new regulation in favor of medical devices?
A. B. : Law 84-12 of 2014 poses problems for medical device operators in its application. Deadlines for obtaining authorizations are not respected. The law speaks of a period of 120 days, while in practice they are much longer. In addition, the exceptional import authorizations put in place by ministerial decision in times of health crisis are not issued within the required deadlines. In addition, expired registration certificates are not automatically renewed to allow business continuity for operators. This situation has caused many blockages that impact operators in the medical device sector. Furthermore, the application decrees relating to the maintenance of MDs have not yet been published. The FMIS adheres to this law, while hoping that certain regulatory provisions will be revisited, redesigned to adapt to the new environment and to optimize the process of registration and granting of authorizations. The Federation is also committed to enforcing ethical rules and good competition and to contributing to the fight against illegitimate or informal players who violate certain regulatory provisions and endanger the health or even the lives of patients or deprive hospitals equipment in good working order. To this end, the FMIS adopted an ethics charter in June 2022 that each new member must sign upon joining.
F.NH: Regarding the regulation of the medical devices sector, how is registration done, the type of authorizations and what about the reimbursement of MDs by the bodies managing the AMO?
A. B. : A MD can only be marketed after first obtaining a marketing authorization, and filing of a technical file mentioning the origin of the MD and its technical characteristics. According the law, this sesame is obtained in 120 days, but in practice, the operators complain that the authorizations requested for several months and even several years, have not been satisfied by the Directorate of Medicines and Pharmacy. They call for a streamlining of administrative procedures and an improvement in the awarding of public contracts, particularly in terms of tenders and collection. Moreover, and while the VAT on medicines is 0 to 7%, that of medical devices is still at 20%. This impacts the prices of medical devices despite their essential and strategic nature. Concerning the reimbursement of MDs by the organizations managing the AMO, some are not reimbursed and others are poorly reimbursed. This slows down patient access to many medical devices.
FNH: Who says medical device, says health sovereignty. Is this approach true?
A. B. : This approach is true insofar as local manufacturing of MDs is developed and sources of import supply are diversified. Regarding local manufacturing, some consumables (bibs, contact lenses, etc.) are already manufactured locally. For more complex MDs that integrate metallurgical, plastics, mechanical, electrical, electronic and software components for ners, ultrasound scanners etc.), manufacturing is currently difficult. Not only for technical reasons, but also and above all financial because it requires very heavy investments, which it is practically difficult, if not impossible to make profitable, by the sole demand of a very narrow national market. However, Africa with its enormous needs in health products and its privileged relations with Morocco can make the Kingdom a continental hub. This will allow European, American or Asian medical device manufacturers to enter into partnerships with local operators to conquer our continent. This also presupposes significant technological transfers to Morocco. In this context, FMIS already participates in the medical device cluster “Moroccan Medical Industry”, created in agreement with the Ministry of Industry and Trade, for better local integration of the Moroccan medical device industry.
This sector has largely contributed to our strategic stock of these essential products. The Covid-19 pandemic has shown its resilience. Supplying the local market with flank steaks at a time when many countries, including europians, lacked it, is the proof of it. The sector’s contribution to the anti-Covid-19 vaccination campaign was also notable through the supply of syringes. The supply of hospitals with resuscitation beds and artificial respirators has made it possible to meet the enormous demand from patients during this pandemic. This sector, which for decades was reduced to the simple role of importer, is about to begin a shift towards production local medical devices, and in particular consumables. Also, within the framework of the new development model, the FMIS has positioned itself as a major player in the project of national health sovereignty and in securing our country’s supply of medical devices. As for the development of local manufacturing, it requires, on the one hand, the support of the sector by the public authorities and, on the other hand, the reduction of approval times for locally manufactured products. It is abnormal that the time required to obtain a marketing authorization (MA) for an imported product is much shorter than that for a locally manufactured product.
FNH: Recently, importers sold faulty equipment to the Ministry of Health. A transaction that harms Moroccan citizens in the first place? How do you read it?
A. B. : Indeed, some operators are in the hands of justice. While respecting the presumption of innocence, I would say that any economic actor must take responsibility and respect the laws and regulations in force, because heavy penalties await those at fault. However, if some unscrupulous operators have defrauded, this does not justify accusing all operators in the sector.