Food, Medicine and Health Care Administration and Control Authority (FMHACA) is considering lifting its restriction on importation of medicine and medical equipments which limits manufacturers abroad not to have more than three local agents.
This old practice by FMHACA, which has been there since 2014, is instituted to properly regulate the import of medicine and medial equipments in to the country.
The restriction was lifted following an intervention from the Ministry of Health (MoH), according to sources who spoke to The Reporter. The ministry intervened on the matter on the grounds that the guideline is distorting the pharmaceutical market in Ethiopia by encouraging the emergence of few big players with a considerable monopoly power, according to sources.
The maximum number of distributors a foreign manufacturer can have is limited to three, reads the guideline for the registration of medicines which was introduced in 2014.
Two weeks ago, officials of the Authority expressed their intention to lift the restriction at a conference with pharmaceutical importers held at Friendship Hotel.
The restriction was creating a huge problem on the supply of drugs and medicine, industry sources told The Reporter.
It has been problematic in a sense that it had paved the way for few importers, who have managed to procure local agency for big pharmaceutical manufactures, to monopolize the local market, sources said. This in turn resulted in unnaturally inflated prices of medicines and drugs.
According to the same sources, the restriction had allowed few big pharmaceutical importers “to hold 95 million people hostage”; the “public is at the mercy of these imports” when it comes to which medication, when and at what price will be available in the market.
The move by the Authority was received with a mixed emotion among industry players in the pharmaceutical industry.
This positive move, said another source, can improve bottleneck problems in terms of availability of medicines and price options for customers.
An immediate result of the lift may bring an overlap of drug supply in Ethiopia and excessive flooding of the market with pharmaceutical products. However, this is just a temporary case.
Another importer challenges the practicality of the new move by FMHACA.
Given a limited regulatory muscle, the FMHACA will have difficulties to regulate many drug and medicines related agencies.
According to the guideline, for registration the first agent of manufacturers should handle the medicine registration process. The appointed agent(s) is responsible for correspondence and complete compliance with regulatory requirements pertaining to the product distribution life cycle in the country.
If any fraud or unsuspected and unacceptable adverse event occurs to the consumer under normal utilization, all the party’s (local agents, manufacturer, and/or license holder) mentioned in the agreement will be responsible for collecting the product from the market and will be responsible for substantiating any related consequences.
It also stated that agents and manufactures should be responsible for post-marketing reporting of the product safety, quality, and efficacy follow-ups.
If the new amendment is going to be approved which agent is going to take the responsibility, questions an importer with decades of experience in the industry.
The Ethiopian local pharmaceutical market is growing at an annual rate of around 15 percent; it is currently valued at over USD 400 million, according to World Health Organization. The share of the domestic pharmaceutical market held by locally produced medicines is around 20 percent and the rest is filled by importation.
Back in 2015, Pharmaceuticals Fund and Supply Agency (PFSA) procured close to four billion birr’s worth of medical supplies and equipment.
Repeated attempts made by The Reporter to solicit comments from the FMHACA were not fruitful.