The National Agency for Food and Drug Administration and Control (NAFDAC), has made some giant strides recently in its bid to rid the country of fake drugs. In this interview with WINIFRED OGBEBO, the director-general, Dr Paul Orhii talks about the pharmaceutical manufacturing firms’ intervention fund and the challenges of funding.
Has the intervention fund for the indigenous pharmaceutical manufacturing firms taken off?
The federal government has not yet given me the money. What happened was that we determined that about 70 per cent of the essential medicines that are needed for this country are imported from other countries, so we looked at the situation and began to wonder that if for some reasons, medicines stop coming from these other countries, what would we do with about 150 million Nigerians? So I discussed the matter with the minister of health and the national security adviser, and the minister of health approved and opened doors to set up a committee to come up with a draft detailing measures to help pharmaceutical industries become self-sufficient, so that Nigeria can also become self-sufficient in the supply of essential medicines and a main exporter of medicines, instead of the current situation where we are the main importer of medicines from other countries.
What we did was to invite the World Health Organisation (WHO), realising that for us to be able to become a net exporter of medicine, we have to be WHO prequalified; have facilities that are WHO prequalified. WHO prequalification is needed because international donors buy medicines only from WHO prequalified companies. For example, the other year, Global Fund expended $4.7m acquiring medicines for donation to developing countries. Nigeria with a population of 150 million people is a major recipient of these donations and yet no single dollar was spent here, simply because we do not have a single company that is WHO prequalified. The only countries on the African continent that are prequalified are one in South Africa, one in Morocco and one in Uganda. In Nigeria or West Africa, there is no single company that has WHO prequalification. And so when we looked at the matter and at the fact that we import 70 per cent of medicines that are needed in this country, we did that analysis and came to the inescapable conclusion that the availability of these pharmaceutical products for Nigerians at affordable prices is a national security issue. We took some of the top companies that have made substantial investment in infrastructure and management. We selected about 11 of them and took them to Geneva for a workshop at the WHO, so that they will be trained and the prequalification programme extended to them. Surprisingly, when we arrived Geneva, we found that India and China had been there for the past six years as a deliberate policy of their government, to support the pharmaceutical industries in these countries. We were going there for the first time. The WHO experts conducted the workshop for our pharmaceutical industries. They looked at where we are and then this month, they have designated some experts to come to Nigeria, audit their factories and look at where we are and what they need to do to get to where they need to be and identify the gaps so that we can begin to work on them. But then, we realised that as the banking system currently is, industrialisation is not favoured for loans. There are no long-term loans; interest rates are too high. So we needed to come up with a pharmaceutical intervention fund that is a deliberate effort by the government to encourage ‘made in Nigeria’ medicines. That is why the minister of health got us to have a document with the Bank of Industry. We worked with the Central Bank of Nigeria and we came out with a document. In the document, we are requesting a N200 billion pharmaceutical intervention fund, so that single digit loans will be made available to pharmaceutical industries to help them and then there will be long-term loans to help them develop. The minister of health led the delegation to the president, along with the then minister of finance, the minister of state for commerce and industry and the managing director of the Bank of Industry. The president received the proposal very well, but the problem right now is that we have to source the resources, the money. That is what we are working on currently. The money has not yet been made available and the programme has not taken off, even though some industries are investing their own resources. Juhel pharmaceuticals, for example, last year built a state-of-the-art infusion manufacturing company – the biggest on the African continent – using German technology. It satisfies even WHO requirements and the president commissioned it last year. This year, May and Baker made a similar investment. They invested about N4 billion of their own money to build a giant manufacturing company that is of world standard and the president just commissioned it this month.
What are you doing about the activities of some Nigerian drug manufacturers who connive with foreigners to bring fake drugs into the country?
Well, the law is the same for everybody. If we catch you with counterfeit medicines, we don’t care whether you are a manufacturer, an importer or a distributor. Anybody that is involved in handling counterfeit medicines, from the manufacturer to the importer to the distributor, all of them along the chain will be penalised. What we have done is also to review the law. We want to give the law some bite, to impose stiffer penalties for people who engage in counterfeit medicines trade. I remember when we intercepted counterfeit medicines at the port here and we determined that they had originated from China. We took the matter up with the Chinese authorities and they arrested six of their citizens and sentenced them to death. We also took the matter up with the Indian authorities, because the medicines were labelled as ‘made in India’, even though they originated from China. The Indian government took it very seriously and their parliament passed a law that made it a criminal offence, punishable by lifetime jail and confiscation of assets of the culprits – the manufacturer and distributor of such products. In China now, it’s the death penalty, in India, it’s a life jail sentence and confiscation of assets. At the same time, we looked at our own law, which has been the most lenient paradoxically. Most of us who are on the receiving end, paradoxically have the most lenient laws when it comes to punishing counterfeiters of medicine. Our law currently is a 15 years’ jail term maximum, with an option of N500, 000, which is peanuts to all these billionaire counterfeiters. So we decided to review the law, and we brought in senior advocates of Nigeria, professors of law, and the Institute of Advanced Legal Studies helped us to draft a new law. In the new law, personally, I would have wanted the death penalty because as far as am concerned, drug counterfeiters are worse than armed robbers that we shoot here. Armed robbers are sentenced to death here but unfortunately, counterfeiters are not. When armed robbers a gun at your head, they usually give you an option; they say ’your money or your life’. Sometimes, when you give them your money, they let you go, but drug counterfeiters do not give you that option. They take the little money that sometimes poor, desperate people have to enrich themselves. They deserve death. But unfortunately, I have had to come to terms with civil rights activists who believe the death penalty is no longer fashionable. So just like in India, we’re asking for a new draft law for drug trafficking, that offenders should be jailed for life and their assets confiscated. And in situations where we can identify a victim and prove that the counterfeit products caused the death of or severe body injury for that victim, some of the assets that were confiscated should be used to compensate the victim. We are also asking for a whistle blower clause in that law, to enable us legally reward people who come forward with information that leads to the interception of these counterfeit medical products. Just like the arrangement we have with India now; if somebody comes and give us a tip that they found ‘made in India’ medicine and we intercept that medicine, the biggest catch of the month gets up to N300, 000 reward. This reward will be made available at the India High Commission.
We also want to make the offence a non-bailable one, but these people want to prolong the judicial process. Some cases last as long as eight years and they hope that we will lose steam and that public interest will die in the cases, And then it’s very expensive, we have to hire senior advocates of Nigeria to prosecute the matter. It’s not cheap getting a SAN to go to court, so with time, we begin to lose steam and that’s what they want, adjournment upon adjournment until we lose steam. We want the offence to be non-bailable as an incentive for the speedy trial of the accused while they are still in detention, so that they will have an incentive to finish the case quickly.
How can the average man in the village identify fake drugs?
The average man in the village cannot simply identify fake drugs, not even the average person in an urban setting can. Not even me as the DG of NAFDAC can! It is difficult with the current sophistication in printing technology. It used to be that the counterfeiter would just write something and you know that their English will be wrong, everything will be wrong and when you look at it, you would know that something is wrong with the medicine. At that time, we used to tell people that if they want to buy a product, they should look for the NAFDAC registration number. When you see it, then it’s a good one. But I cannot say that today, because these people are sophisticated now in printing technology. If somebody can go to the extent of making a fake tablet that looks exactly like the original, right down to the minute details of that tablet or capsule, what stops that person from maybe writing a fake NAFDAC registration number on the packaging? It’s so easy. In fact, NAFDAC registration number is the easiest thing to make for any printer in Nigeria now. They even improve on the original. We tried to use holograms to show the authenticity of products that we approve. We intercepted medicines that were counterfeits but had holograms when the originals did not have yet holograms. So you can see that counterfeiters are ahead in the game. That is why now, we have decided to give meaning to the NAFDAC registration number. For us at NAFDAC, we have equipment, the Truscan or the mobile laboratory, that allows us to immediately tell whether a drug is fake or genuine. But for the average person? Or course a Truscan costs about N50, 000; not even the pharmacy stores can buy them because they are too expensive. But we can identify them using the equipment. Forr the average Nigerian, we found out that about 70 million Nigerians use cell phones and they are conversant with texting, so we decided to put the power of detection of counterfeits in the hands of Nigerian consumers, the ultimate consumers who have the most stake in the product. You are the ones taking it, you should be able to check it yourself and see whether you want to take it or not. So we have put something like a scratch card on medicines. If you buy some of the most counterfeited medicines – like Ampiclox manufactured by GSK. This drug was very often counterfeited because it is a very popular, very good antibiotic, so the counterfeiters also wanted to get a share of the market and sometimes they were taking up to 40 per cent of the market share and destroying the brand, because if you buy Ampiclox once, twice and it doesn’t work, you may look for another drug next time. It could be very frustrating for the brand owners, so they decided to put this scratch card to help verify. If you go now and buy Ampiclox, you will see something like a scratch card on it. When you scratch it, it will reveal a pin number. You text that pin number to a short code, which is 35383 on all the GSM networks and within seconds, you will receive a message which will tell you what product you have in your hand, what NAFDAC registration number is supposed to be on that product, the manufacturer and will even give you the basic information on when it’s going to expire and information on the kind of drug you are taking, when and how to take it . This is one way of helping Nigerian consumers identify some fake products, but unfortunately, it’s not yet on all the products.
What I require is that by September 1, all the often counterfeited medicines, especially the antibiotics, antimalarial drugs, diabetes and hypertension drugs will be on that programme so that Nigerians can begin to scratch and verify their authenticity.
What are the challenges facing the agency?
We need money. For example, we need lots and lots of modern computers. With a population of over 150 million Nigerians, we have less than 2,000 people on our staff. The border is big, vast and porous; poorly manned, yet, we don’t even have vehicles. We have an office in a state like Kano with 44 LGAs with two office vehicles. One is an old 504 station wagon that breaks down all the time. Ideally, we should have 44 vehicles for a state like Kano, one for each LGA, to be fully covered. We cannot emphasise money enough. For the Truscan I am talking to you about, we don’t have up to 10 yet. We need as a minimum, one Truscan for every state, so that we can verify products and check them. Most pharmacists should have it to verify their products. We are one of the 18 top medicine regulatory agencies in the world. We belong to the elite group that includes the US, Canada, Britain and Japan. On the African continent, we are the only such agency. If you compare their funding and their populations to our funding and our population, it is nothing to write home about. Let me give you an example. In the US, like Nigeria, it has a centre for drugs’ evaluation and research and then a centre for food evaluation and research; that is a directorate in NAFDAC. For the centre for drugs’ evaluation and research alone, they have 133 PhD level statisticians, who evaluate every policy, impact analysis and feed you the effects. In NAFDAC as a whole, when I came in, the entire directorate combined had six staff and none of them was a statistician. So what can you do with six people and none of them a statistician in the planning and research department? That is why if you look at the advertisement that I did recently, we advertised for a director of planning, research and statistics who should be either a statistician or an economist, and then we need to hire people in that area, who will help us analyse what we are doing. They should be the ones telling us the impact of any major policy we take, on Nigerians. Right now, we are just groping in the dark.
NAFDAC has been indicted by ICPC for spending its internal generated revenue (IGR). What is your comment on that?
The issue of IGR is very complicated. The NAFDAC law that established it allows us to generate money and spend it for activities. At the same time, the constitution of Nigeria Section 80, sub section 1 says all money generated should be deposited in the consolidation account to be budgeted. The question is whether our law contradicts the constitution and the answer is no, because sub section 3 of that section 80 of the constitution further says that unless the issue of that money has been approved by an act of the National Assembly. My argument is that the act that created NAFDAC is an act of the National Assembly. The National Assembly says, here are the functions of NAFDAC, and it says any law that runs contrary to the constitution is a nullity and in this case, our law does not contradict the constitution. It is the constitutional expression that allows us to generate money and spend it. But we are not just generating money and spending it. For example, to register a drug, somebody comes from India or China, I tell them to pay two million naira. People counting IGR will say we’ve gotten two million naira. But what am I doing with the money? With that money, I am required, before I give you the registration, to send at least three senior inspectors to go to the source and inspect the factory where the drugs are being manufactured. They spend at least three days, checking the quality of the source, and then we use some of the money to do some laboratory analyses of some of those drugs, to make sure that they conform to quality standards. I’m meant to pay estacode for their trip to the country concerned and then they come back, you do the analysis of that product. Tell me, what is left from that two million naira? Is that IGR? Am I now going to pay that two million naira into the consolidated account and then be waiting for the budget? What will I tell the people who paid for their product to be registered, that they should wait for my country’s budget?
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