Breaking new ground in the regulatory environment: the EAC Mutual Recognition Procedure expands its product scope to include veterinary ectoparasiticides

In sub-Saharan Africa, obtaining approval to sell veterinary medicines in the market requires applying for a marketing authorisation separately in each country where the product is to be sold. This is often a lengthy, resource-intensive process that discourages private sector investment, hence limiting the sustainable supply of veterinary medicines.  

Since 2010, GALVmed and its partners, AU-PANVAC and HealthforAnimals, have been supporting the East African Community (EAC) to implement a mutual recognition procedure (MRP) in the EAC Partner States that allows for simultaneous application of marketing authorisations in multiple countries. This saves time and allows countries and applicants to use their resources more efficiently.

In 2022, GALVmed contracted a consultant to conduct a landscape analysis of veterinary ectoparasiticides (pesticides) regulation in six Partner States (Burundi, Kenya, Rwanda, south Sudan, Uganda, Rwanda and the United Republic of Tanzania). The analysis reported several areas of divergence in the region in the regulation of these products. This informed the need to harmonise the veterinary ectoparasiticides regulation and in order to implement the EAC Council of Ministers directive, EAC secretariat with support from GALVmed, TradeMark Africa (TMA)  and The United States Agency for International Development (USAID) developed working documents under the MRP initiative to harmonise regulation.

 As of June 2024, this novel initiative has been extended to also include registration of veterinary ectoparasiticides, thereby allowing companies to submit these products for registration through the MRP system. The draft guidelines and other key technical documents have been approved, and current efforts are aimed at capacity building related to initial training of veterinary ectoparasiticides dossier assessors.

An initial six days workshop took place in Dar Es Salaam, Tanzania on 18th-24th July to build institutional capacity and application of best practices for the evaluation and registration of veterinary ectoparasiticides to safeguard human health, animal health and the environment. This will enhance capacity of veterinary pesticides assessors on risk assessment and dossier evaluation to improve public trust in the MRP process, which will attract submission of safe, quality and efficacious veterinary pesticides in the region.

The meeting was attended by MRP members from veterinary medicine regulatory authorities drawn from Democratic Republic of Congo, Burundi, Kenya, Rwanda, Tanzania, Uganda and South Sudan. The training was conducted by representatives from Australian Pesticides and Veterinary Medicines Authority and EAC Secretariat.

MRP represents a key advancement in harmonising and strengthening veterinary product registration by reducing the time, costs, and resources needed to bring these medicines to market. By streamlining approvals and extending to new product categories like ectoparasiticides, this initiative enhances availability and access to essential animal health solutions, supporting animal health, livestock production, strengthening the livelihoods of farming communities, and contributing to sustainable development.

Stronger regulations would bolster food security and livelihoods in Africa

Originally published by S&P Global. Written by Lois Muraguri, Senior Director of Enabling Environment & Partner Engagement.

Across the African continent, livestock are one of the leading sources of food security and resilient livelihoods. Livestock production contributes 30-80% of the continent’s total agricultural gross domestic product (GDP) and provides jobs and nutrition for millions. Yet, Africa’s livestock sector faces several growing challenges – not least the spread of diseases, which threaten to disrupt the incomes and livelihoods of rural communities.

Diseases like foot-and-mouth disease, Newcastle disease and peste des petits ruminants cause widespread animal and productivity losses across the continent. In total, more than 20% of the world’s animal production is lost to animal diseases, with the burden exceptionally higher in regions like sub-Saharan Africa.

In most cases, veterinary medicines and vaccines are a vital solution to these challenges, helping to safeguard the livelihoods and food supply that livestock provide. Yet, across Africa, the regulatory frameworks by which new veterinary medicines can be registered and approved to address these challenges are either outdated, ineffective or simply non-existent.

In the last decade, great strides have been made to improve regulatory frameworks in sub-Saharan Africa. There have been various initiatives aimed at improving the regulation of veterinary medicines in sub-Saharan Africa. Most of these, such as initiatives under HealthforAnimals, have focused on improving capability of regulators through training and offering technical assistance on specific areas. Others, such as the UK’s Veterinary Medicines Directorate’s sub-Saharan Africa program, have looked at options for regulatory harmonization. These, plus efforts by the WOAH and others, have raised awareness and increased understanding of the need for improving regulatory frameworks in sub-Saharan Africa. 

With climate change and accelerating continental trade hastening the spread of livestock diseases, Africa needs a functioning regulatory environment for veterinary medicines. An efficient regulatory framework benefits all players – regulators, product manufacturers and ultimately, livestock producers and farmers. In the last decade, great strides have been made by regulators. A functioning regulatory framework will help to equip livestock producers with quality products, supporting them to protect their livelihoods and their vital contributions to continental food security.

To begin with, a functioning and harmonized regulatory environment for veterinary medicines can unlock further private-sector investment, which has been constrained across the continent. At present, animal health companies are discouraged from registering their products in some countries across sub-Saharan Africa. Global and local companies alike face significant regulatory and commercial barriers. This is in part because of unclear and unpredictable regulatory frameworks, which are often driven by limited capacity to assess the safety and efficacy of veterinary medicines.

Creating a functioning environment for regulating veterinary medicines will begin to address private sector concerns, enabling animal health companies and manufacturers to invest and register new products that are subsequently adopted by Africa’s livestock keepers.

Regulation of novel and cutting-edge technologies requires experienced regulators to assess the next generation of innovations. Africa’s regulatory agencies often lack the necessary expertise and resources to efficiently regulate novel, innovative veterinary products thereby reducing the likelihood of these products’ availability in African markets. Similarly, for emerging diseases, the lack of a long-term market and clear regulatory pathway inhibits the development of vaccines.

Void for vet meds

The lack of safe, quality, effective veterinary products creates a void that is currently being filled by poor-quality counterfeit products, which do not offer benefits to livestock producers and whose ineffectiveness may instead undermine confidence in the effects and benefits of livestock vaccination. Similarly, regulators in sub-Saharan Africa facing inefficient regulatory systems encounter numerous challenges that affect various aspects of public health, animal welfare and the economy. The prevalence of substandard, counterfeit products is not an issue for livestock producers and private sector only – these products hamper regulators’ disease control efforts. Inefficient systems discourage private sector investment which leads to potential loss of revenues from registration fees and taxes. Ineffective regulation can adversely affect livestock health leading to lower productivity, higher mortality rates and economic losses for farmers ultimately resulting in lower national productivity.

By unlocking greater investment from animal health companies through a functioning regulatory environment, we can also deliver multiple benefits for the African continent’s millions of livestock producers. Due to the inadequate existing regulatory framework, Africa’s livestock producers typically do not have adequate access to medicines or cannot be sure of their quality, with many therefore choosing not to vaccinate their animals.

Yet we know losses from livestock diseases can be preventable – if only farmers can be made aware and assured of the quality of these medicines. A more predictable and clear registration process for new veterinary medicines can therefore improve the availability of quality veterinary medicines, whose use can prevent livestock disease, improve livestock production and boost producers’ incomes.

A well-functioning regulatory system provides immense benefits to regulators as well. It ensures only safe and effective veterinary medicines reach the market, protecting both animal health and public health, thereby preventing zoonotic diseases. It ensures medicines are manufactured to high standards reducing the risk of substandard or counterfeit products. The economic benefits that flow from a functioning regulatory framework, such as improved market access, increased investment and trade facilitation, are compounded at national level contributing to rural economies and GDP. Regulators also have a stake in improved disease control; effective regulation ensures timely availability of veterinary medicines for the prevention and control of animal diseases directly contributing to countries’ disease control efforts.  

Ultimately, facing evolving disease threats because of climate change and global trade, the animal health private sector and livestock producers need a greater say in the development of Africa’s regulatory system in order to deliver much-needed improvements to its efficiency. Improving regulatory frameworks requires regulators, the private sector and livestock producers to come together to develop an accessible and time- and cost-effective regulatory system for veterinary medicines.

GALVmed work

Parties like GALVmed, for example, can be an invaluable convener. GALVmed is already supporting the implementation of the East African Community Mutual Recognition Procedure project, which is helping to harmonize registration requirements for veterinary medicines across eight countries in East Africa. By allowing companies to seek approval for multiple countries simultaneously, rather than bilateral applications at a national level, this project incentivises animal health companies to seek licences in multiple countries, thereby increasing their market.

This creates more choice and support for livestock producers and offers a model for harmonizing regulations for veterinary medicines across the continent, working hand-in-hand with the private animal health sector.

GALVmed is also working in collaboration with WOAH, the Veterinary Medicines Directorate and the East African Community on a new project called Improving Access to Quality Veterinary Products via Better Regulation. This will support regulatory agencies across Africa to identify their capacity-building needs and how they could be addressed, helping to improve the regulation of veterinary medicines at scale.

Ultimately, the inadequate and inefficient regulatory system for veterinary medicines that prevails across most of Africa causes negative impacts throughout the value chain – for regulators, animal health companies, livestock farmers and the continent’s food security at large. The momentum from past and current efforts by various parties must be accelerated. Well-functioning regulatory frameworks will lead to increased investment, confidence in the system, resulting in availability of more safe and effective veterinary medicines in the market. 

Achieving this goal will help ensure Africa’s livestock producers have quality veterinary medicines that address the rising disease challenges they face while safeguarding their contribution to the future of food security in Africa.