Harmonising medicines’ regulation in West Africa

The West African Health Organisation (WAHO), Economic Community of West African States (ECOWAS) and the National Agency for Food and Drug Administration and Control (NAFDAC) have reiterated their commitment to promote health through improved integration as well as harmonised medicine registration in West Africa.

They made the commitment at the just concluded 5th Steering Committee Meeting of the West African Medicines Regulatory Harmonization Initiative, which has 15 West African countries and other bodies including New Partnership for Africa’s Development (NEPAD), World Bank, Melinda and Bill Gate Foundation, Swiss Medic, The World Association of Perinatal Medicine (WAPM) in attendance.

Director-General, WAHO, Prof. Stanley Okolo, said the main purpose is to appraise the Medicines Regulatory Harmonization (MRH) related activities in the region during the year 2018 and to recommend key actions and activities to be implemented in 2019 with the sole aim of strengthening the performance of the project.

He said, “Integration of national efforts to accelerate the well-being of the people is of great importance to the Authority of Heads of State and Government of ECOWAS.

“It is for this reason that WAHO has been mandated to promote better health through regional integration.

“The quality of health of over 350 million people in the region is paramount and it is a great honour for me to lead this steering committee to strategise and take decisions to ensure access to quality, safe, efficient and affordable medical products for the people.

Calling for support, he said, “We must all support the ongoing process to achieve our goal; as such, the diversity of capacities and efficiency of the National Medicines Regulatory Authorities are needed to manage the multifaceted approaches to pave the way for success. We may face challenges taking into consideration the limited human and financial resources.”

“These challenges could happen when building consensus due to our diversities and the level of communication.

“However, this should not deter us from achieving our common goal.

“And that is why we have agreed to jointly register and regulate medicines produced locally and imported into the region with the aim of reducing the time of registration and improving access to medicines as well as ensure better regulatory oversight.”

Okolo commended the West African Monetary and Economic Union (WAMEU) for being very instrumental in bringing the harmonised processes of medicines regulation so far into reality and we are very much grateful for the support.

He also expressed his profound gratitude to the Federal Minister of Health of Nigeria for accepting to host the gathering.

According to the WAHO director-general, this strongly indicates the commitment of the Federal Government of Nigeria to public health issues and the interventions of the WAHO in particular.

On influx of fake drugs, he said, “this is not peculiar to Nigeria, at least four ministers have also mentioned to me the difficulties they are having combating the influx of fake drugs into their country. What we are hoping to do is part of bringing the region together through promotion of integration in health policies and rationalization, regularization and harmonization of policies in terms of medicine and for this, we have a lot of technical support in terms of template from the WHO.

“The WHO is supporting us in West Africa region in addition, the initiative itself would not have taken off without the financial support of the World Bank so, it means for us access to high-quality, effective safe medicines, security in terms of having the drugs when we need them, not just drug but also vaccines.”

Lamenting the porosity of the Nigerian border, Director General of NAFDAC, Prof. Moji Christianah Adeyeye, said, “There are so many unregistered products in Nigeria because of the porosity of our border but more importantly is our port inspection directorate, we have our people stationed at different border, we are also partnering with customs to prevent substandard products from coming into the country.

We do a lot of raids, seize and destroy products that are not supposed to be in our country, our enforcement directorate is very active.

Adeyeye who represented the Minister of Health, Prof. Isaac Adewole, added: “Our goal is to have quality medicines for our people and to know that to get quality medicines, we have to bring quality into our local manufacturing facilities and that is why NAFDAC is doing a country wide or industry wide quality management system.

We are 15 countries and all countries are not the same but when it comes to challenges we have the same set of challenges but once we collaborate then we strengthen each other.

“The goal of course is to make sure that African have quality certification drugs and that substandard medicines don’t find their way into the continent and we do that with as much as possible to get rid of them.

Imports have significantly reduced by focusing more on our local manufacturers, improving their internal capacity and that is part of the our roadmap, we are also studying the capacity of each company to know whether we are making too many of a particular drug or we don’t have enough and also to see where the gaps are, in terms of therapeutics that we may have to either import or even through the joint registration go into the basket.

“Our goal is to make sure that when a drug is approved, it can easily be traded in every country within the continent but our ultimate goal is to make sure that our products are sold worldwide.”

Representative of WHO, Samvel Azatyan, said, “To maintain the health, you need to observe a healthy lifestyle, when you are sick you need medicine but in this context, medicines are considered as an instrument for public health and the national regulatory authorities in these countries are those who are responsible for ensuring that medicines that come to the West African countries are of good quality and safe. But of course, patients also have an important roles and they must be active not just passively taking what is given to them or what is available in the pharmacy but trying to be part of this process of ensuring that the medicines are of good quality, helping the other regulators by strong advocacy and support and this is also part of our engagement in this region.

“The WHO is working with all possible partners including with private organisations; The main role of the WHO here is to support national health systems and national regulatory authorities in building their capacity for them to be able to better regulate the medical products which are coming to the market and of course we strongly encourage individual countries to collaborate.

“ECOWAS is a good platform as other regional economic communities. We are trying to convince countries to collaborate, to share the workload, to accept the best practices available from elsewhere in the world and taking the harmonized guidelines, try to short the time essential medical products get to patients.”

Speaking on the project, Senior Health Specialist, World Bank, Dr. Aissatou Diack, said, “The project is a three years project that started in December 2018 and it’s a project of $3 million.

This project has two components, the first is a regional component where the ECOWAS mandated WAHO to perform the capacity from its team of technical experts and also fiduciary financial management and legal team to really find what challenges the countries are faced through brainstorming discussion and so, this original component is extremely important because we realised that the culture of the West Africans meeting challenges together is something that we are probably had for several centuries.

“In this region, you will find things like trade, economic development and commerce has been very successful. We are sharing a unique passport. Immunisation led by WAHO is really for us the most exciting part of the programme because it will lead to common technical document. She added,

“Before we have 15 documents, each from countries in the region but now we have one document. And another component, which is $1 million, is to support the countries.

“A lot of efforts have been done mostly through the country’s resources and the resources they get from ECOWAS so, as partner, Bill and Melinda Gate and United States Agency for International Development (USAID) to some extent found that maybe if we added a little bit of fund, it will accelerate the progress towards this result and complement the national budget and WAHO.”