Author: team galvmed

Celebrating 2 years of achievements with PREVENT

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Poultry is an affordable and accessible asset for small-scale producers in Africa, but the effectiveness of vaccination has been limited and rural producers can have their flocks wiped out overnight due to preventable diseases.

PREVENT was launched in April 2021 as an initiative to establish an innovative and pragmatic veterinary health approach in Africa through medium-size hatchery vaccination. PREVENT comprises various workstreams and operations that are connecting the key pieces to achieve this endgame, and in this blog, we explore some of our achievements so far.

  • Hatchery vaccination: The initiative aims to equip 36 mid-size African hatcheries with the necessary equipment and expertise (vaccination techniques, maintenance, hatchery biosecurity practice, quality assurance, and vaccination monitoring) so that the hatcheries will be able to provide customers with large numbers of chicks vaccinated against the major infectious poultry diseases. Farmers and poultry producers buying these vaccinated chicks will have better chances at ensuring flock health, reducing risk of bird losses, securing income, and overall, running more successful businesses. PREVENT has launched activities in 8 countries (Tanzania, Nigeria, Ethiopia, South Africa, Rwanda, Ghana, Burkina Faso, Zimbabwe) and onboarded 24 hatcheries so far. This has allowed the initiative to administer 109 million doses of vaccines to 37 million day-old chicks (an average of 3 vaccine doses per chick). Diseases against which the chicks are vaccinated include Infectious bursal disease, Newcastle disease, Infectious bronchitis, and Marek’s disease.
  • Training and market development: Vaccination alone is not enough, and the lack of technical support and information about circulating infectious diseases is also a major constraint. To date, PREVENT has trained 100 Field Technicians in Tanzania, Nigeria, Ivory Coast, and Ethiopia to provide advice and technical support to small-scale poultry keepers. In serving as the link between the hatcheries and the poultry farmers, the field technicians will also foster demand for, and create markets for vaccinated day-old chicks. Since activities started in September 2022, these field technicians have visited 1,800 farms and held over 100 meetings with farmers.
  • Gender inclusion: The PREVENT initiative seeks to bring a pragmatic level of understanding of gender dynamics within the poultry sector with the goal of positively impacting women chicken producers through the hatchery intervention. To serve this purpose, a rapid gender landscaping analysis was conducted in 3 countries representing East, West, and Southern Africa (Tanzania, Nigeria and Zimbabwe).
  • Epidemiological studies: This is an integrated component of the initiative that aims to explore and describe the epidemiology of poultry diseases at the level of small-scale poultry producers. To date, activity has started in Tanzania, Nigeria and Cote d’Ivoire where 52 samples have been collected.

Introducing changes upstream, at the hatchery level, echoes the positive impact all the way down to the farmer level, and contributes to creating a sound and sustainable system that will lead to an improvement in poultry productivity and efficiency in the targeted African countries.

April 2023 marks the second anniversary of this 4-year initiative. Much has been achieved so far, and much is yet to come.

The PREVENT initiative (PRomoting and Enabling Vaccination Efficiently, Now and Tomorrow) is a partnership between Ceva Santé Animale (a global veterinary health company) and GALVmed, with the support of the Bill & Melinda Gates Foundation.

This blog was written by Patricia Valdeón Noya as part of the campaign “Celebrating 2 years of PREVENT”

The relation between gender inclusion and food security 

Posted on by team galvmed

Gender blindness in agriculture and in the livestock sector in particular, continues to limit production in many rural areas, and evidence shows that the more gender inequality there is in a country, the hungrier and more malnourished people are. But what is the relation between gender inclusion and food security? 

Socially constructed roles and cultural practices, rules and beliefs, are some of the reasons for food insecurity and poverty in many developing countries. Although society or community defined roles for members are not in themselves a bad thing, the issue comes when it leads to skewed or unfair allocation of resources and unequal power relations. Women are involved in raising livestock, but they normally do not have equal access to land, labour, feed, credit and capital, and veterinary services among others.  

In any increasingly populated society, there is a growing demand for food security and livestock source foods such milk, eggs and meat. Although women make up two-thirds of rural livestock keepers, they continue to face various constrains that limit them from achieving optimal livestock production and agricultural development. Addressing these constraints and providing access to the same level of resources as men, would increase agricultural productivity by up to 30%.

The empowerment of women in the livestock sector is fundamental to achieve gender inclusion and equality. This can be accomplished by, among others, creating opportunities and improving women’s access to resources including land, technical skills and capital. Women’s ownership, whether of land or livestock, and decision making (e.g. income from livestock) are some of the issues that should also be addressed.  

However, any gender initiative, whether targeted or transformative, that does not simultaneously aim at addressing the gender cultural norms and rules, will result in limited advances. Initiatives aimed at increasing access and/or providing opportunities for women and girls should include educational programs to change society’s entrenched gender beliefs and attitude systems, to avoid backlashes and unintended consequences that would reverse the gains.  

Women’s empowerment is not only beneficial to them but to society, as it has a positive impact on agricultural development and contributes to food security. 

Written by Thembinkosi Ramuthivheli, GALVmed’s Senior Manager, Commercial Development & Impact, Africa 

Working towards achieving gender inclusion in the livestock sector 

Posted on by team galvmed

Women around the world still face many challenges and disadvantages based on their sex/gender identity, and the agriculture and livestock sectors are no exception. 

Women continue to face challenges like unequal access to resources such as land, credit and capital, veterinary services, livestock ownership, or even knowledge and information. Although they are typically involved in caring and managing livestock, they tend to own fewer and smaller animals (small ruminants and poultry) and decision-making power and involvement normally decrease as the business grows. All these constraints continue to limit women’s access to opportunities.  

The International Women’s Day is celebrated annually on March 8. This year, the focus is on gender equity. At GALVmed, we have adapted this topic to the animal health and livestock context. What do we mean by gender equity in the livestock sector? While equality states that all individuals are equal in status, rights and opportunities, equity recognizes that individuals have different needs and power based on their sex or gender identity and/or expression, and that these differences should be identified and addressed in a manner that rectifies inequities. 

We asked some of our GALVmed colleagues why they think it is important to have gender inclusion in the livestock sector and how to achieve that inclusion. Here are their reflections: 

The importance of gender inclusion in the livestock sector  

It is estimated that Africa’s population will be over 2 billion by 2050. Given demographic predictions, there is an increasingly growing demand for food security and livestock-source foods such as milk, eggs, and meat. Facilitating women’s access to resources, land, capital, and education and training, while promoting their empowerment would increase livestock production, contributing to food security.  Thembinkosi Ramuthivheli, Senior Manager of Commercial Development & Impact in Africa, reflects on the relation between gender inclusion and food security.

 Dr Steve Wilson, Director of R&D highlights how inequality within the management of livestock and associated systems has a resultant impact on sustainability, productivity and health of families and the wider community.  

According to Katharine Tjasink, Senior Manager of Impact, Evaluation & Learning, evidence shows that women tend to reinvest most of their earnings from livestock back into nutrition, healthcare, school, and other household-benefitting activities, which contribute to improving livelihoods and breaking the cycle of inter-generational poverty. 

It is evident that women play a decisive role in the overall health and well-being of their families. To Gwynneth Clay, Project Leader of the Brucellosis Vaccine Initiative, this essentially mean they can play a vital role in the successful implementation of One Health strategies. 

Achieving gender inclusion in the livestock sector 

Acknowledging gender inequity and understanding its consequences is the first step, but addressing the constraints and designing effective solutions is not that simple. There are many structural and cultural factors that need to be taken into consideration. “There is clearly a need to find solutions that fit within a cultural context which ensure that woman and men have a more equal contribution to how their livestock and associated household decisions are made,” says Dr Steve Wilson. 

As stated by Katharine Tjasink, achieving gender equity at scale would require serious policy commitment backed by an implementable plan for shifting perceptions, changing behaviour, and addressing structural and other barriers. And Thembinkosi Ramuthivheli also weighs in that any gender initiative, whether targeted or transformative, not simultaneously aiming at cultural norms and rules, will result in limited advances. Initiatives aimed at increasing access and/or providing opportunities for women and girls, should include educational programs to change society’s entrenched gender beliefs and attitude systems. 

Patricia Valdeón Noya, Senior Communications Assistant, highlights the importance of facilitating education and training. “Education and training in animal health and husbandry practices is key for women small-scale producers’ success and empowerment, as it reinforces knowledge, builds confidence, and provides opportunities.” 

Overall, and according to Dr Lamyaa Al-Riyami, Senior Manager of Evaluation, Programme Planning, we must ensure that “support is tailored and appropriate to the needs of small-scale producers, leading to equal economic development and empowerment opportunities.” 

With all this in mind, what is GALVmed’s approach? Neil Gammon, Senior Director of Funder Relations & Development, shed some light on how GALVmed is addressing this matter. “We look at where women tend to be abundantly focused in small-scale livestock production and we make sure that we have very good and effective interventions that generate significant impact in those areas. Specifically, this would mean us implementing, at scale, vaccination programmes in small-scale poultry and small ruminant production. Vaccination rates in both these areas are currently very low and effecting a transformational change here would bring tangible benefits to millions of women small-scale producers.”  

There is a long way to achieving gender equity in the livestock sector. Animal Health and livestock strategies need to be designed minding and addressing gender issues and inequities. By encouraging women’s empowerment, they can fully achieve their potential and value as key players in One Health, livestock productivity and sustainability, and livelihoods. 

This blog has been written by Patricia Valdeón Noya as part of the International Women’s Day 2023 campaign on #EmbraceEquity  

What could gender inclusion in livestock health look like?  

Posted on by team galvmed

Inclusion, in its very definition, means to be open to everyone and not limited to certain people. In low-and-middle income countries, the focus for inclusion and equity has largely been about designing and implementing programmes that incorporate active participation of women and young people. In most of these countries, women especially face certain barriers and limitations that prevent them from actively participating in and benefiting from certain societal activities. Some of these barriers are due to socio-economic, cultural, and gender restrictions. Efforts to break the cycle of exclusion are being increased in all facets of economic and social development. But what would gender inclusion look like in animal health? 

Inclusion in animal health is especially crucial because women comprise most of the world’s 600 million poor livestock keepers. They do most of the day-to-day farm animal management, including the processing, marketing and selling of animal produce. But some gender norms mean women in this sector are still left behind. Throughout the livestock sector, there needs to be deliberate efforts to formulate strategies to help them contribute to and benefit from livestock health provisions as entrepreneurs, service and product providers, and livestock owners. Here are some areas where inclusion can make a big difference in animal health.  

Access to animal health information 

Some gender norms prevent women from accessing animal health related information e.g., vaccination campaigns. Stereotypes also affect the way women’s capabilities as farmers are viewed, so they are not directly targeted by information campaigns. And in some cases, women’s workload at home do not allow them to participate in information campaigns and trainings.  As a result, many women lack understanding around the availability and importance of animal health products.  To address this, animal health campaigns and information need to be deliberately targeted to women, taking into consideration their family and other commitments.  

Women as entrepreneurs  

Initiate and train women on livestock and animal health entrepreneurship. Women can fit in the livestock sector at different points. One, as livestock entrepreneurs with active roles in management and decision-making. Two, as product and service providers. In fact, there are cases where women vaccinators have been positively received by their communities and have been successful in conducting animal health campaigns and vaccinations.  

There is need to train and equip women as local animal health service providers and as livestock entrepreneurs. This can change their beliefs and behaviours that affect their decision-making regarding the use of animal health products, and the access to training and livestock management, and thus, continue to close the gender gap.  

Mind the (gender) gap 

Women representation in leadership roles decreases as we move to the upper echelons of animal health distribution and manufacturing. Across the industry, women comprise of 36% of leadership teams, with only 16% of senior corporate executives. Reading through literature, there are a number of contributing factors, including employment and pay gaps. Continued investment for example in educational opportunities needed to assume leadership roles can also make a huge difference. 

 A scholarship that has no age limit or that can accommodate family commitments can go along away in providing further training opportunities that will enable women to seek more leadership roles in animal health. Only by identifying and closing these gaps can we reach gender equity, which benefits women in the industry, the industry itself, customers, and the animals the industry strives to help. The glass ceiling needs to come down.  

Embrace equity 

Progress is still needed to create equal opportunities and representation at all levels of the sector. There is an opportunity to ensure women’s capabilities are developed and strengthened to fully participate in the entire value chain. Because when women make decisions and take action to improve their livestock health, their own health and livelihoods, and those of their families and communities significantly improve. 

This blog has been written by Beatrice Ouma as part of International Women’s Day 2023 campaign on #EmbraceEquity

GALVmed provides updates on small ruminants’ vaccine development

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Livestock, including small ruminants, are an important asset for millions of people in low and middle-income countries and are a source of protein, income and wealth. However, animal diseases account for great losses in the livestock sector and seriously hamper animal production and small-scale producers’ livelihoods.

Numerous limitations hinder small ruminant production in the Global South. According to a deep-dive exercise conducted by GALVmed in 2019, feed scarcity and infectious animal diseases are major constraints to livestock production. Additionally, the availability of vaccines for small ruminants is very limited in Sub-Saharan Africa and South Asia.

In a Stakeholder Seminar series led by FAO, held in January, GALVmed presented its work on small ruminant vaccines with a focus on Peste des Petits Ruminants (PPR). GALVmed has considerable history working in the field of PPR and is currently working with commercial partners on different projects to develop and commercialise new mono and multivalent vaccines against different small ruminant diseases such as PPR, SGP, Contagious caprine pleuropneumonia (CCPP) and Brucellosis.

The presentation however noted that these products and solutions can only be sustainably provided and reach full potential if focus shifts from emergency interventions to comprehensive small ruminant health and productivity management. Stakeholders need to come together to develop 1) regional programs that foster small ruminants’ health, productivity and trade; 2) multidisciplinary public & private partnerships with shared mandate and accountability; and 3) a common strategy addressing animal health issues, resource and veterinary service limitations, infrastructure reliability, and other systemic weaknesses.

The full recording of this webinar on new vaccine & market development for small ruminants is available below:

GALVmed presenters:

Optimising procedure management for marketing authorisation of veterinary medicines in Eastern Africa

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Timely and effective marketing authorisation of veterinary medicines requires a combination of rigorous scientific evaluation and efficient management of procedures.  In line with GALVmed’s role in implementing the AgResults Foot and Mouth Disease (FMD) Vaccine Challenge Project in Eastern Africa, GALVmed has worked with the Secretariat of the East African Community (EAC) to support National Regulatory Authorities (NRA) in the region to build capability in marketing authorisation of FMD and other vaccines.  A first workshop was organised in November 2020 that focussed on the technical requirements for authorisation.  A second workshop took place in November 2022, looking at measures that NRA could take to optimise the management of marketing authorisation procedures so that authorisations are evaluated and issued in a timely manner.  The Veterinary Medicines Directorate in the United Kingdom (UKVMD) provided expertise to both workshops based on their experience as an NRA that has extensive knowledge in authorisation of FMD and other vaccines, both at national level in the UK and in cooperation with other NRA.

Key workshop outcomes

This workshop focused on optimising procedure management for marketing authorisation of veterinary medicines in Eastern Africa.  Although the main focus of the workshop was on marketing authorisation of veterinary vaccines, the same principles of effective procedure management apply to all types of veterinary medicines, and so the conclusions and recommendations apply equally to both veterinary pharmaceuticals and vaccines. 

National marketing authorisation procedures operate in all countries within Eastern Africa that have a functional regulatory authority.  Member countries of the EAC also operate a mutual recognition procedure (MRP).  Ultimately, MRP relies on national procedures for issuing a national marketing authorisation certificate following agreement on a harmonised summary of product characteristics (SPC). The workshop therefore examined procedure management of both national and MRP and the interface between them.

Approach

Participants in the workshop consisted of experts from NRA responsible for managing marketing authorisation procedures, particularly MRP, for veterinary products within their agency.  Over the course of two days experts explored, with the organisers and invited experts, those aspects of procedure management that worked well within and between agencies in the region and aspects that could be improved.  A representative of the global animal health industry association HealthforAnimals gave a presentation that summarised feedback from local industry on their perceptions of procedure management in the region.

Key messages arising from the workshop

  • Companies that have used the MRP feel it generally works well and appreciate the ability to obtain marketing authorisation in multiple countries through a single procedure.  The role and activity of the MRP Coordinator was considered particularly helpful.
  • NRA are encouraged to make information on the technical and administrative requirements for marketing authorisation procedures more readily available to applicants, particularly in the case of the MRP.  It can be difficult for applicants to understand all of the requirements that apply in different countries, particularly where these differ between countries such as the arrangements for dossier submission, payment of fees and submitting samples for testing.  Where not already done, NRA should publish their requirements online and make use of the MRP ‘one-pager’ information sheet being prepared by the EAC Secretariat.
  • Adherence to timelines is frequently poor and delays may arise due to failure to adhere to deadlines by NRA, Local Technical Representatives (LTR), or applicants.  When accepting the role of Reference Country (RC) or Concerned Country (CC), NRA should ensure that they have sufficient resource to process applications in a timely manner.
  • Applicants currently find it difficult to obtain information on the previous experience, and performance, of NRA when performing the role of RC or CC.  NRA, possibly working the Coordination Group on Mutual Recognition (CGMR), should make this information public to allow applicants to make informed choices of NRA to act as RC or CC for their applications.
  • Communication with applicants on the progress of applications through the evaluation procedure is highly variable.  Some countries already have online systems allowing applicants to track their applications whilst applicants in other countries reported difficulty in monitoring progress of their applications.  NRA are encouraged to improve tracking of applications and communication with applicants.  NRA vary widely in the extent to which they rely on manual process or on IT solutions and on the resources available for management of procedures. Ways to promote exchange of experience and best practice between those agencies that already operate online tools and those that are developing them should be explored to accelerate the introduction of IT solutions and avoid unnecessary duplication of effort.
  • The LTR acts as the applicant’s representative with the NRA and plays a key role in the smooth functioning of the MRP.  The performance of LTR varies widely, and a poorly performing LTR can slow or halt an ongoing procedure.  Whilst managing LTR is the responsibility of the applicant, NRA need to consider ways to help applicants to improve or replace poorly performing LTR and to promote the use by applicants of LTR that are known to be effective.  Guidance from NRA on how LTR can best fulfil their role would be useful.
  • Participants were invited to explore the interest within their agency in trialling a self-assessment and evaluation tool developed by the UKVMD.  This tool provides a framework which agencies can use to evaluate the effectiveness of their regulatory functions and to develop action plans in areas identified for improvement.
  • Participants considered that a follow-up in-person workshop would help them develop action plans that address the areas for improvement identified by the current workshop.
  • The findings of the workshop should be brought to the attention of Heads of Agency to raise awareness of the benefits that the MRP is bringing to applicants and to agencies in the region, and of the areas that have been identified for further improvement.
  • The CGMR plays a key role in ensuring the smooth operation of MRP.  The group should be encouraged to play a greater role in fostering best practice among NRA by including process improvement as a standing item on their agenda and by promoting interchanges between agencies that increase sharing of work and knowledge.

This blog was written by the AgResults FMD Vaccine Challenge Project team.

Tackling small livestock diseases

Posted on by team galvmed

Almost every small-scale farming family in low- and middle-income countries owns small livestock – whether chickens, ducks, rabbits, sheep, goats or pigs. While small livestock provide nutrient-rich food, they are also considered a form of a savings account and often referred to as “ATMs” because they are a convenient source of cash.

Small livestock are also a pathway out of poverty and source of economic and gender empowerment for women and young people, especially in rural areas.

And yet for millions of small-scale producers, these very important assets are threatened by diseases. A chicken business can be decimated in a blink of an eye by Newcastle Disease (ND) which can kill up to 90% of the poultry. Similarly, Contagious Caprine pleuropneumonia (CCPP) is one of the most severe diseases of goats, and morbidity rate may reach 100% and the mortality rate can be as high as 80%. Peste des petits ruminants (PPR) can cause heavy losses, especially in naïve herds (up to 80%), and African Swine Fever, for which there is no vaccine, has a mortality rate which can be as high as 100%.

These are some of the small livestock diseases that GALVmed and partners are currently tackling. For some of these diseases, there already exist control tools such as a vaccine; for others, not yet. But even for those with vaccines, there are still challenges that impede their wide usage by small-scale producers. Together with our partners, we are continuously researching appropriate technologies to increase their uptake. For example, GALVmed has been working with partners to explore co-administration of the ND-Fowlpox vaccines through a non-invasive, needle free route, using feather follicles for the Fowlpox (FP) and the Newcastle disease vaccine via eye. This research has demonstrated to be safe and to elicit immunity in two field studies, one in Tanzania the other in Nepal. These findings are important to appropriately trained small-scale backyard poultry farmers as well as to paraprofessionals and community health workers helping to increase vaccine uptake and the control of both FP and ND in low- to middle-income countries.

GALVmed is also working with a commercial partner to develop a Small Ruminant Systemic Multivalent Vaccine addressing several major small ruminant diseases (CCPP, SGP, PPR), in a single combination vaccine. The multi-valent approach has the advantage to maximise disease coverage through distribution networks operating effective cold chains.

GALVmed has also previously worked with MCI Sante Animale in Morocco to develop a multivalent vaccine for Peste des petits ruminants (PPR)  and Sheep and Goat Pox (SGP) in sheep and goats. The two diseases affect many of the same animals in the same regions, and are not, in fact, easy to distinguish. Many farmers vaccinate against the more frequently occurring SGP, but not against the less common, but more deadly, PPR.

It is clear that multi-valent vaccines offer pragmatic and cost-effective disease control tools for the small-scale livestock keeper.

Alongside our partners, GALVmed will continue to explore various technologies to address diseases that threaten small livestock, to improve their health, increase their productivity and reduce their mortality, so that small-scale producers can benefit from their small livestock investments.

 This blog was written by Beatrice Ouma as part of the campaign “The advantage of small livestock”

Small livestock, big opportunities

Posted on by team galvmed

Goats, sheep, pigs, chickens. These are some of the small livestock that are giving millions of people opportunities. Opportunities to build a house, buy clothes, secure their children’s education, or put food on the table. But the livestock are under threat from preventable diseases.

According to the Food and Agriculture Organization of the United Nations (FAO), smallholder farmers around the world produce about a third of the world’s food. With such an important role, it is essential that these farmers have access to affordable and high-quality veterinary products to keep their animals healthy and be able not only to address their basic needs, but also to help feed the world.

The value of small livestock, such as small ruminants or poultry, has been widely reported. Small stock provides small-scale producers with food, which contributes to nutrition security, creates employment opportunities, empowers women and young people (as they tend to care for and manage small animals), and overall bolsters households’ financials.

Binita is 18 years old and goat keeping is her family’s main support. “We do not have a farm, so goat keeping is our basic means of livelihood. All our household expenses are met with the money we earn from selling goats”.

At Malti’s house, she is responsible for the goats and sheep. Her husband is a casual labourer and the additional income gained from goat keeping helps them in “supporting their children’s education and other such expenses”.

Bitti, 21, takes care of the goats owned by the family. “The income is additional and helps us in taking care of additional expenses, such as the building of our house”, she claims.

Moses is a poultry business owner who was able to build a house for his family thanks to the benefits gained from his farm, which has grown from just a few chickens in 2013 to about 2,000. “My house is built with income from my chicken business. I am no longer renting. Even though I double a bit on crop farming, much of my income comes from my chicken business”, says Moses.

Read Moses’ full story here.

These are just a few of many stories by small-scale producers, who are experiencing the benefits of keeping small livestock.

At GALVmed, we understand the value of livestock, including small livestock. Through collaboration with different partners, we implement diverse programmes which ultimately aim at providing small-scale livestock producers with the medicines, tools as well as knowledge that they need to ensure their animals’ health and secure their livelihoods.

Some examples of these programmes are the Brucellosis vaccine prize, an initiative to develop a vaccine against Brucellosis in small ruminants, The GALVmed Hester South Asia Project, a programme supporting small-scale producers in Uttar Pradesh, Bihar and Nepal by making available the most needed veterinary products for their livestock and poultry,  and PREVENT, a project to boost poultry production in Africa through hatchery vaccination.

At least 1.3 billion people rely on animal agriculture for their livelihood and food security. By taking care of livestock, together with our partners, we are directly protecting humans, the environment, ensuring food safety and security, and contributing to improving the lives of the people who like Binita, Malti, Bitti or Moses, depend on livestock for their livelihoods.

This blog was written by Patricia Valdeón Noya as part of the campaign ”The advantage of small livestock”

East African Community Mutual Recognition Procedure: What is it and why is it important?

Posted on by team galvmed

Obtaining approval to sell veterinary medicines in the market requires a marketing authorisation (licence) from the National Regulatory Authority in each country where the product is to be sold. In East Africa, this involves applying for a marketing authorisation separately in each country. This is often lengthy, resource-intensive, and unpredictable.

Since 2011, the East African Community (EAC) with support from GALVmed, AU-PANVAC (Pan African Veterinary Vaccine Centre of African Union) and HealthforAnimals (the global animal health industry association) has been implementing the EAC’s Mutual Recognition Procedure (MRP) system which allows applicants to apply simultaneously for licences in multiple countries. This saves time and allows countries and applicants to use their resources more efficiently. MRP increases the likelihood for the sustainable supply of quality registered veterinary medicines in the region.

The first licence under MRP was issued for a veterinary vaccine in October 2018. Since then, several applications, immunological and pharmaceutical, have been processed and are now authorised in multiple countries in the EAC. This has contributed to increased access to quality safe, efficacious veterinary medicines.

Numerous benefits

Apart from saving time and resources in the submission process, MRP has other benefits. For the National Regulatory Authorities (NRAs), some of the benefits include:

  • Increased efficiencies by avoiding duplication of effort
  • Increased likelihood of improved quality of dossier submitted
  • The approach builds trust between assessors and Good Manufacturing Practice (GMP) inspectors
  • Identical dossier is submitted to all   participating NRAs
  • Approved veterinary medicines have the same finished product specification and SPC across the region
  • For inexperienced and less resourced NRAs, have an opportunity to learn and benefit from the more experienced and resourced NRAs 

And benefits to the industry include:

  • One dossier format to all NRAs
  • One procedure with one set of questions agreed on by the Reference Country ant the Concerned Country/Countries and based on a specific time-line – a predictable process that enhances planning 
  • Harmonised release criteria
  • Harmonised label claims
  • Possibility of fewer field trials
  • Harmonised post marketing activities – variations and renewal times harmonised and granted/approved at the same time and hence rapid introduction of new veterinary medicines in the market

All these benefits translate to increased likelihood of sustainable supply of quality registered veterinary medicines to livestock producers in the region.

Current progress

Since being introduced, the MRP process has received submissions from seven (7) global and African companies. Several applications for immunological and pharmaceutical products have been processed and authorised in multiple countries in the EAC, and approval time has been reduced significantly to about 12 months.

The MRP initiative is set to expand to include veterinary pesticides and subsequently, veterinary medical devices. The goal of improving access to quality veterinary medicines in EAC region with limited regulatory capacity could be addressed through regulatory reliance.

Blog written by Adelaide Ayoyi

Using a Randomised Control Trial to study the impact of Newcastle Disease vaccine on poultry farmer welfare and livelihoods

Posted on by team galvmed

In 2020, Oxford Policy Management (OPM) was contracted by GALVmed to implement an intervention and conduct an associated impact study on the adoption of a Newcastle Disease Vaccine (NDV) by small-scale poultry farmers in rural Tanzania in the districts of Chemba and Mbozi. The objective of the study is to quantify the causal effects that the delivery of NDV has on the “production, productivity, and livelihoods of small-scale producers (SSPs)”. The study involves two main activities:

  1. The design and implementation of an NDV intervention in selected SSP farming areas of Tanzania.
  2. The design and implementation of an experimental study to quantify the causal effects of the NDV intervention.

The impact study was designed as a randomised controlled trial (RCT) where the study sample was randomly split into one treatment group and one control group. The treatment group was offered and will continue to be offered the NDV intervention package. This group will be compared with a control group, who did not and will not receive the intervention package during the study. The control group will receive one round of the intervention after the study’s endline survey.

A baseline study was conducted between September and November 2021 and the endline survey is scheduled for September to November 2023. Further details on the RCT and its findings will be made available upon publication of the results.

Blog written by Lamyaa Al-Riyami