Following the International Pharmacist Day, on the past 25th of September, we had the pleasure of interviewing Dr. Mahmoud Bach Hamba, a Tunisian pharmacist with a long experience of Maghreb’s international pharmaceutical industry. This article displays a detailed image of the sector, in the Maghreb, from the point view of the experience and know-how of our guest.
DR. BACH HAMBA – PATH AND PROFESSIONAL EXPERIENCE
In 1983, Dr. Bach Hamba started his professional career, as a pharmacist, for the Drug and Pharmacy Direction, at the Tunisian Ministry of Public Health. Then, in 1987, he was charged with the direction of the medicines import and distribution centre for the pharmacies sector, at the Central Tunisian Pharmacy, having been a part of its organization and digitalization. In 1991, he was nominated inspector of pharmaceutical industries and took part in the opening of thirteen pharmaceutical laboratories, where his role consisted in inspecting units previously to their licencing.
1996 was the year when he left the Ministry of Public Health, which gave place to a private sector career, as technical director in two laboratories. There, he was responsible for controlling the manufacture and commerce processes of the lab’s medicines. In 2003, Dr. Bach Hamba created two companies, Sophidis and IPC (International Pharmaceutical Consulting), companies specialized in pharmaceutical consulting, which are where he practices the skills for which, to this day, he is known both in Tunisia and internationally.
COMPONENTS OF TUNISIAN PHARMACEUTCAL ACTIVITY
From his deep knowledge of the pharmaceutical and parapharmaceutical Tunisian market, Dr. Bach Hamba revealed that the most sold pharmaceuticals in that market are, essentially, antibiotics, anti-inflammatory drugs and pain killers, as well as heart related and cancer products. As for parapharmacy, the most sold articles are plant based phytotherapy products, baby products, dermatology, cosmetics and hygiene products but accessories as well, such as syringes and band-aids.
MARKET DEMANDS: PHARMACEUTICALS
In Tunisia, the legislation ruling pharmaceuticals is very demanding. To be distributed, a market placement permit is needed (an AIM). Both local and foreign pharmaceutical laboratories wishing to market medicines in Tunisian territory must deliver the applications at the Medicine Pharmacy Direction, to get said AIM.
After a medicine achieves the AIM, this permit is valid for a period of five years, after which a renewal is needed. During distribution, medicines can be targets of non-systematic control, where they are subject to observation by the medicine control laboratory (LNCM), from the Public Health Ministry.
However, these medicines can be the object of control procedures by the LNCM, on the follow-up of a pharmacy complaint or one from a distributor. If this complaint has originated a sensory or visual aspect nonconformity it activates the control procedure. In these cases, the LNCM is called to control the returned medicine and justify its conformity near the Ministry of Public Health. The most usual consequences are the removal of the defective lot from the market, but, in extreme cases, the AIM can be removed and the laboratory must justify the process at the Ministry of Public Health, to be able to reintroduce the medicine on the market.
There is also specific legislation relative to narcotics, in particular for their storing and distribution. A dedicated accounting of those products is needed, with specific records at the Central Pharmacy, at the distributor and at the pharmacy which sells the product, as well as a sale process that strictly follows a prescription record from the prescribing doctor. Also, expired narcotics disposal is executed by a pharmaceutical inspector.
The remaining, non-narcotic, expired medicines, are also object of detailed procedure, since they cannot be sold. Specifically, these medicines are identified in a listing, which is submitted to the approval of a judicial officer, and an approval from the Environment Ministry is also needed, for the disposal. These products are destroyed by a specialized company, in the presence of an officer and a representative of the Finance Ministry, as to generate a refund process related to medicines purchased and not sold.
PHYTOPHARMACEUTICALS AND FOOD SUPLEMENTS
Phytopharmaceuticals and food supplements are not considered medicines and, therefore, do not need an AIM authorization. Instead, they must be approved by means of a consumption authorization (AMC). In these cases, product master files are delivered at the Ministry of Public Health to obtain the AMC. However, it must be noted that the main difference between medicines and these types of products, for the Tunisian law, is that the laboratories that produce phytopharmaceuticals and food supplements do not need to have a working permit emitted by the Ministry of Public Health.
Obtaining the consumption authorization (AMC) to be able to market phytotherapy products and food supplements obeys a systematic control of the products lots and samples. They are submitted to the Ministry of Public Health and transmitted to the medicine control laboratory (LNCM) for quality control to ensure their conformity, essential steps to receive the AMC.
SINGLE UNIT MEDICINE DOSES: JUST IN SPECIFIC CASES
By the law that governs it, the private Tunisian private sector cannot sell single unit medicine doses, because reconditioning is a pharmaceutical act, which must obey to Good Manufacturing Practices. Therefore, it is forbidden for pharmacies to recondition a medicine package to sell just the amount of the units prescribed by a doctor for a specific treatment. The only exception are narcotics, where the number of doses must match the number of daily medicine intakes for a treatment.
On the other hand, reconditioning is allowed in the hospitals, since the medicine conditioning for this sector is directed to high quantities, with boxes with 500 pills, for example. This type of distribution allows for the management of hospital services, who distribute medicines according to the internment period the treatments require.
UNDERSTANDING THE FUTURE OF THE PHARMACEUTICAL INDUSTRY
Dr. Bach Hamba believes the future of the pharmaceutical industry is connected to the development of biotechnology. According to him, “using biological, living organisms, either plants or micro-organisms, can provoke therapeutic effects equivalent to chemical products, with countless advantages for the environment, while reducing the pollution generated by synthesis and chemical waste”. According to him, the pharmaceutical industry might also have the capacity to adapt to different diseases and pandemics, and in that way, heal Humanity.
EDITOR’S NOTE
Tunisia is a unique market, mostly due to the Central Pharmacy state control over the import of medicines, as well as due to the state monopoly, but, on the other hand, Tunisia operates under a legislation similar to Europe and is high growth potential market and one which is very open to innovation.
To know how to introduce your products in this and other North African markets, contact RC REDOL, a company with ties to the pharmaceutical industry for over thirty years who is very present in Tunisia, Algeria, Morrocco and the GCC.