Last week, the Senate approved the appointment of Dr Emile Bienvenu as the new Director General of Rwanda Food and Drugs Authority (Rwanda FDA), after he was appointed by a Cabinet meeting of August 11. His appointment comes as Rwanda is making final preparations to start local manufacturing of drugs and vaccines, starting with the Covid-19 vaccine. The New Times’ ABRAHAM UWIMANA interviewed Bienvenu, who explained the tasks waiting for him and his plans to pursue all the duties he was called for, using the skills and experience he has acquired. Excerpts: What does it mean to you to be appointed to this position? It means a lot to me, that’s why I actually expressed my sincere gratitude to the Cabinet, but also I thanked His Excellency (the President) for having trust in me, and I pledge my unreserved commitment to serve and to contribute to the mission of this institution. First of all, I reflected on the mission of this institution, which is to regulate all pharmaceutical products, being those used for humans and those for veterinary purposes. The mission of this institution also covers regulation of human and veterinary vaccines, and it also covers the regulation of medical products and other veterinary devices. In which areas are you going to put in more effort during your tenure? There is no area that will be neglected, but we do have priorities. Previously, much emphasis was in regulating imported products but now it is going to be different. You can understand that if we want to produce drugs in the country, it is going to be a challenge for us, because we are familiar with handling products that are imported from outside without producing those products ourselves. Producing them will require Rwanda FDA to inspect to see how those products are produced and see if they meet the standards. Before authorising (production) you have first to inspect the facilities that are in place to produce vaccines, medical devices and other products, you have also to inspect the system they use, and their end products. That is something which is going to be prioritized because we need to train our staff to be able to do that. Our staff has knowledge to do that, what they lack is only the exposure, that’s why we will train them in doing it practically. Where does Rwanda stand in the area of manufacturing vaccines and other drugs locally? Anyone would like to see a pharmaceutical plant being established in Rwanda, you would like to see a drug produced from Rwanda, but before we have that end product, there are some preliminary activities that should be conducted. First of all, establish partnership with investors who are supposed to come and invest in that area. That is something that has been already done by the concerned ministries in the country. We already have investors who are willing to come and some of them are already in the country trying to establish themselves. I can tell you that real negotiations to start producing vaccines and other drugs are at an advanced level. We know who will be cooperating with us and when they can start, but so far there is no plant that is operating in Rwanda but all that is needed to start is being secured. What is the progress regarding production of Covid-19 vaccine and what is needed to make this a reality? We are in negotiations with partners who want to come to Rwanda to establish pharmaceutical plants in order to start manufacturing vaccines. When we talk about vaccine manufacturing, we are not saying Covid-19 vaccine only, because we will be manufacturing different vaccines, Covid vaccine being one of them. Because when you produce one vaccine and the outbreak disappears you will run into losses, and that is something we don’t want. First thing we need to do as a country for the process to be successful, is to speed up all the negotiations with business companies that are willing to establish pharmaceutical plants. Secondly, as Rwanda FDA, we need to meet international standards set by the World Health Organisation (WHO) to start regulating pharmaceutical plants. Here I mean that we need to meet what we call maturity level three. You can understand that there is level one, level two, level three and level four. Level three has a set of requirements allowing you to regulate pharmaceutical plants producing vaccines, without being at that level you can’t be accepted. So far, we have met maturity level 1, and we are doing everything possible to meet level 2 and level 3 at once. Next month WHO will be here to assess us and see if we have met all the requirements needed for level 2 and 3 and then later we will meet maturity level 4 separately. Another important thing in this process is capacity building, where we will bring some experts to come and train our staff to get used to this new venture because initially as you can guess we don’t have experienced staff in regulating pharmaceutical plants. Technically, what does it entail to start manufacturing vaccines? If you want to produce vaccines, first of all you need to have a pharmaceutical plant with all needed equipment, raw materials, and qualified staff because vaccines have specific characteristics unlike tablets, for they are injected directly into blood. Secondly, you will need to have a regulatory body like Rwanda FDA, qualified to inspect you, and technically we will need eligible staff to do that, you will also need some tools which you use to assess the concerned plants. We planned that there shall be a complex which we will call a Biotech industry which will also tackle vaccines. It is something that is being planned and we hope the production will start soon. There is a technology which is going to come to Rwanda soon, the one that will be used in manufacturing vaccines. We may start with Covid vaccine because it is the current serious issue which we are dealing with but in the entire plan it won’t only be one vaccine we may also produce different vaccines simultaneously, of course Covid vaccine being one of them. How will your skills and experience help you perform the duties you are called for? I am trained in the pharmaceutical area, I have been dealing with drugs in my education and training and I have experience in research in the same area, I have experience in management in the same area but also in other areas. The knowledge will help this institution because what technically this institution is dealing with is about drugs – human drugs and veterinary drugs. What they do is something which I understand very well because that was my field of training. Secondly, I have been managing Rwanda Medical Supply, the institution which was by then under RBC. It gave me exposure to at least know how the pharmaceutical field stands in the country and the challenges and opportunities in the field. I have experience in research in the pharmaceutical and medical field. Being a researcher I have been writing research proposals, I have been supervising PhD students, doing that help you to always be updated because the field is dynamic, to be able to attend to that you need a mind which is also dynamic. The pharmaceutical field also goes with innovation, the field which I have been trained in, intellectual property and innovation. Rwanda FDA will not get lost in this area of intellectual property because it is something I understand very well. Being the Acting Deputy Vice-Chancellor of the University of Rwanda part of my job was to negotiate partnerships, and that is something this institution is in need of and I will help in. As a pharmacist, what can you say about having cannabis as a medicinal plant in Rwanda? For me what is important is to know that it is a product that is abused and to set regulations to avoid that. Even most of the modern medicines that are used in hospitals and pharmacies are in the same pharmaceutical class as cannabis, and if you don’t regulate them people are going to abuse them in that way. We have to put in place strong regulations and allow this product to be in Rwanda. Having cannabis as a medicinal plant in Rwanda has several advantages, because if we are intending to start a pharmaceutical plant in Rwanda, why don’t we allow this rare medicinal plant to also get cultivated in Rwanda? Those pharmaceutical plants are going to be plants producing drugs, we will need to do the research on medicinal plants we have in Rwanda, taking a medicinal plant trying to isolate ingredients and if they are drug candidates, and they will start producing drugs using those active ingredients. That is why cannabis is a hot cake, because it can even help the country to generate a lot of money. What is your leisure time like? I like football and I used to be a good player and trained in coaching but now I don’t get enough time to play, I now go to the gym or I do some personal physical exercise at home. I also like to follow sports news, mostly Arsenal FC’s news which I am a fan of. In addition to that I spend time with my family, wife and three children.
