January 20, 2018
By Anne Kiruku
East African News Agency, Arusha
Good news from Burundi is usually hard to come by, but efforts to set up a pharmaceutical regulatory authority – with assistance by the East African Community Secretariat through facilitating a benchmarking visit by the country’s parliamentarians to Tanzania – is something to celebrate.
The parliamentarians’ visit to the Tanzania Food and Drug Authority (TFDA) goes a long way in enabling Burundian authorities to establish and fully operationalise their own regulatory body, known in French as Autorite’ Burundaise de Regulation des Medicaments et des Aliments (ABREMA).
Burundi is the only EAC partner state that has not enacted and implemented strong national pharmaceutical laws through its national Parliament. It is also the only country in the region that has not established a semi-autonomous national medicines regulatory authority.
Such authorities help promote public health and safety, in addition to facilitating cross-border trade in medicines, health technologies and other medical products, including enhancing local pharmaceutical manufacturing under the EAC Common Market Protocol.
Due to its failure to enact and implement pharmaceutical laws, Burundi is not currently benefiting from relevant instruments in place to encourage trade in medical products.
These include the harmonised EAC Regional Guidelines and Standards for Medicines Evaluation and Registration, Good Manufacturing Practices, Quality Management Systems and Information Management Systems, as well as the Mutual Reciprocal Recognition and Technical Cooperation with other partner states and with international medicine regulatory bodies and agencies.
This has denied the country the opportunity to trade with other EAC partner states in the field of pharmaceuticals. Indeed, the country needs to fast-track the enactment and implementation of the Burundi National Pharmaceuticals Regulation Law that is currently before its Parliament.
But even as the region tries to harmonise the pharmaceutical industry, authorities must fight the growing menace of counterfeit drugs that is threatening the lives of local citizens. Increased cases of deliberately and fraudulently mislabeled drugs are on the rise. It is sad that counterfeits of both branded and generic products have found their way into the market.
This means that the market is currently flooded with fake and poor quality drugs. It is no wonder that the global counterfeit drug trade is regarded as a billion-dollar industry that thrives mostly in Africa.
It is unfortunate that such illicit and counterfeit products, which are not sourced through established channels, end up in the market as unregulated imports under the very watch of law enforcers.
Counterfeit drugs have left millions sick and desperate in their wake, especially in Africa and South Asia. Although the problem is not confined to these two major regions, they bear the brunt of the problem.
The global counterfeit drug trade is a billion-dollar business. It is estimated that the counterfeit drug market in Africa is worth about $4 billion. In Kenya, for example, counterfeit drugs accounts for approximately Ksh9 billion ($90 million) in sales annually, according to the Kenya Association of Pharmaceutical Industry (KAPI).
It is unfortunate that in the very eyes of regulatory authorities, the global health entities estimate that about 100,000 deaths a year in Africa are linked to the counterfeit drug trade.
Even worse is the report by the International Policy Network (IPN) that 700,000 deaths a year are caused by fake malaria and tuberculosis drugs. Counterfeit drugs have compounded the fight against malaria and tuberculosis, which are some of the major causes of deaths in Africa.
IPN compares the death toll to the equivalent of four fully-laden jets crashing every day! This is unacceptable and unfortunate.
The region, through the health ministries, has a role to play in eliminating the counterfeit drug menace. The World Customs Organisation and the International Institute for Research Against Counterfeit Medicine have established that the number of illicit and potentially dangerous pharmaceutical product seizures have now reached dramatic proportions. The menace threatens the lives of millions of people.
Reports that most counterfeits drugs originate from China and India should be investigated and local leaders should work in collaboration with the two countries to bring an end to the menace.
EAC countries must be more vigilant at the region’s ports, which are major entry points of illicit products. Corrupt immigration officials allowing entry of the fake products should be made to face the full force of the law.
The port of Mombasa, which has been identified as a major entry point that oversees high levels of trafficking of fake essential pharmaceutical and veterinary drugs, should be put on high alert.
Consumer health and safety authorities cannot afford to compromise the health and lives of local populations in East Africa. The region has no choice but to fight the menace of counterfeit drugs.