Category: Health Hits: 472So far, how has it been working with herbalists?
There has been the development of drug to manage sickle cell anaemia. NIPRD calls it Niprisan. This product was developed completely from bench work, to clinical trials, to patenting, to commercialisation by this institute.
Niprisan has a lot of history around it because it represents the success of Nigeria and this institute. It is the first drug of its class to have obtained US FBA drug status.
It is the first drug to be developed for a disease condition that is peculiar to blacks, especially Nigeria where we have a great number of sufferers of sickle cell anaemia. It has taught lessons on how to scale up drugs from bench work to pre-clinical and clinical trials and how to conduct field studies. Most importantly, it is the first experience where partnership with traditional healers and herbalists has been solidified.
The product was brought in by one Rev Ogunyele from Oyo State [late now]. Government drew our attention to it and asked NIPRD to liaise with the herbalist to find out if there is something we could do to promote the product. NIPRD linked with the herbalist and the relationship was beautiful. It was the first time that this institute would make a formal relation. So based on that experience, NIPRD developed an agreement form which is now used to relate with herbalists. This document was admitted at Conference of Parties of the Convention on Biological Diversity. The conference held in 1999 in Kenya received the document as a good example of good relationship between research and local community. It was circulated to about 170 countries.
The first publication on the drug was in the name of the late Rev Ogunyele. When the product was patented, it had Rev Ogunyele’s name on it. Based on that agreement, Ogunyele was paid royalties.
What is contained in the agreement?
It states the obligations of either party. When the product is developed, like the issue of patenting, joint patenting, joint ownership, joint development are spelt and this is what has guided the success of Niprisan which the company calls Nicosan.
Who drafts the MoU?
The institute’s lawyer drafted the template and the first test case was the Ogunyele’s case. When Ogunyele came with the sample, he met me and my boss then asked me to sit with him and get the information on the recipe that he was using.
When I sat down with him, he said he would disclose his product for two reasons: that he was aged and that he trusted the DG and by giving his product to this institute, being a public place, even if he did not benefit from it, he would feel fulfilled if at the end, the public benefits. He listed the things that were in that product. He didn’t know the English names. What I listed that time were Yoruba names.
The lawyers were drafting the terms that would be acceptable. After the draft was adopted, it was given to Rev Ogunyele. His lawyers have come here several times to look at the terms. Meanwhile, the study was going on, on the product. The man had submitted the product...anybody can submit product...like in his case, there was a publication and the ministry drew our attention to it. Once that happens, the practice is the person comes, we discuss. In his own case, we sent somebody to his place to say, “Oh government is interested in what you are doing. You did something we can work on together.” He was invited to this institute to talk to us in a seminar room. He explained how he had been using it and that felt honoured that a national institution was interested in the product he had.
One drama that happened was, the day he gave us the seminar, after the seminar, our fire service officer’s daughter was under crisis. He gave the drug to the officer to administer to his daughter. The next day, very early in the morning, the man was coming waving, excited saying, “My daughter is fine now!”
That gave us evidence that there was something in this. It strengthened the resolve of NIPRD to go on with that research.
He had two products, one was for maintenance and the other for crisis. We were actually attracted to the crisis product because that was the one that showed the drama. Eventually, we discovered that the one for crisis had alcohol and when we tested it in animals, the animals died. The safety margin was very low, so it was like a dangerous product in animals. What worked out to become Niprisan was the maintenance drug.
Based on this evidence, we invited the herbalist and say, “Government is ready to invest in the development of this product. The agreement is spelt out in simple terms. Are you going to cooperate? If you cooperate, we will give you some advantages. For instance, we will take the sample from you only. Although you have disclosed the material to us, NIPRD has the obligation to get back to you each time...we shall sample your material, say per kilogramme and pay you a fee for that as incentive. NIPRD also says you will be appointed a consultant to the institute so you will be paid an annual consultancy fee. Each time you come to the institute, NIPRD will accommodate you and pay your transport fare so long as it is on NIPRD’s invitation. Should this product be commercialised, you will be part of the patenting, publication and so on. Should it be commercialised and royalties accrue, you will share the royalties with NIPRD.” All this was spelt out in the agreement.
Except for the management problem that the company [that company that bought the licence] has which has made it to suspend production, each time NIPRD gets anything from that drug, even as he is no more now, the family gets royalties.
How much has been realised from this drug?
Rev Ogunyele had received N1.6 million in bits, in sample fees, honorarium or consultancy fee. To commercialise this drug was a herculean task. Because it is not a synthetic drug, it is not easy to say. As a matter of fact, NPRD signed an agreement with Xechem [International America] in 2002/3. Former President [Olusegun] Obasanjo launched the product in 2006. NIPRD received goodwill money of $15,000. Royalties, NIPRD has not received. In figures, I’m told is something in the neighbourhood of N25 million as calculated but it has not been released up to the time the company had this administrative difficulty.
What was the market response to the drug?
I don’t think I’m competent to give you technically how it was in terms of market rating. But I do know that the drug was in so much demand. The interesting thing was people called from the UK, US, Ghana, I received calls from people saying we need this product. Up till now, people still look for it.
Which comes first, sample test before agreement or vice versa?
No, you don’t sign agreement before you start. It is when you are ready to invest in that product and you are ready to include it in the budget line that you start to negotiate.
When a herbalist arrives with a product, discussions go on first. If it is herb, you would like to know the claim first. You first construct a test that is relevant to the claim. For instance, if the product is used for headache, you will construct analgesic study to show if there is element of truth in the claim. This quick test you do it and the person sees it.
We will call the person and say yes, this thing does this. How else can we...you used alcohol, alcohol is not very good in the tissue. We have other solvents—we can modify water to do this. You will show that the material really has value and you will show the result.
Once you do that, you will say it is time we go into agreement so that we can create budget line for this research so we give report and why management should approve that we enter agreement.