<html><body><P>American Enterprise Institute</P> <P>April 14, 2008</P> <P>[Edited transcript from audio tapes]</P> <P> <TABLE cellSpacing=1 cellPadding=1 width="100%" border=0> <TBODY> <TR> <TD> <DIV class=BodyText>9:00 a.m.&nbsp;</DIV></TD> <TD> <DIV class=BodyText>Registration and Breakfast</DIV></TD> <TD> <DIV class=BodyText>&nbsp;</DIV></TD></TR> <TR> <TD> <DIV class=BodyText>&nbsp;</DIV></TD> <TD> <DIV class=BodyText>&nbsp;</DIV></TD> <TD> <DIV class=BodyText>&nbsp;</DIV></TD></TR> <TR> <TD> <DIV class=BodyText>9:30&nbsp;&nbsp;</DIV></TD> <TD> <DIV class=BodyText><EM>Introduction</EM>:&nbsp;&nbsp;</DIV></TD> <TD> <DIV class=BodyText>Tom Woods, Heritage Foundation</DIV></TD></TR> <TR> <TD> <DIV class=BodyText>&nbsp;</DIV></TD> <TD> <DIV class=BodyText>&nbsp;</DIV></TD> <TD> <DIV class=BodyText>&nbsp;</DIV></TD></TR> <TR> <TD> <DIV class=BodyText>&nbsp;</DIV></TD> <TD> <DIV class=BodyText><EM>Presenter</EM>:&nbsp;&nbsp;&nbsp;&nbsp; </DIV></TD> <TD> <DIV class=BodyText>Dora Akunyili, NAFDAC, Nigeria</DIV></TD></TR> <TR> <TD> <DIV class=BodyText>&nbsp;</DIV></TD> <TD> <DIV class=BodyText>&nbsp;</DIV></TD> <TD> <DIV class=BodyText>&nbsp;</DIV></TD></TR> <TR> <TD> <DIV class=BodyText>&nbsp;</DIV></TD> <TD> <DIV class=BodyText><EM>Moderator</EM>:&nbsp;&nbsp;</DIV></TD> <TD> <DIV class=BodyText>Roger Bate, AEI</DIV></TD></TR> <TR> <TD> <DIV class=BodyText>&nbsp;</DIV></TD> <TD> <DIV class=BodyText>&nbsp;</DIV></TD> <TD> <DIV class=BodyText>&nbsp;</DIV></TD></TR> <TR> <TD> <DIV class=BodyText>11:00&nbsp;&nbsp;</DIV></TD> <TD> <DIV class=BodyText> <DIV class=BodyText>Adjournment</DIV></DIV></TD> <TD> <DIV class=BodyText>&nbsp;</DIV></TD></TR></TBODY></TABLE></P> <P><BR>Proceedings:</P> <P>Roger Bate [Moderator]:&nbsp; Well, good morning, ladies and gentlemen.&nbsp; We will begin in a few moments.&nbsp; My name is Roger Bate.&nbsp; I am a resident fellow at the American Enterprise Institute.&nbsp; And it is my pleasure to moderate the event today, and I m thrilled to do so.&nbsp; Counterfeit medicine is a topic that I have become interested in the last 12, 18 months.&nbsp; And hopefully, in your packets, you will see a flyer for a book that will be out within a few weeks, which I have written.&nbsp; It is called Making a Killing, and it is on the deadly implications of counterfeit trade.</P> <P>I m going to speak very briefly now.&nbsp; In fact, that is pretty much it because I m going to introduce our co-host today, Tom Woods of the Heritage Foundation.&nbsp; The Heritage Foundation is co-hosting the event today.&nbsp; And I d like to thank Tom very much for inviting Dora Akunyili here to speak today.&nbsp; For African watchers, Tom s name will be familiar.&nbsp; He has spoken here at least once, I think, when he was a representative of the U.S. government.&nbsp; And I made sure he had some very difficult questions to deal with about Zimbabwe, [speaks in French].&nbsp; He has moved on now to the Heritage Foundation and is going to be introducing our speaker today.&nbsp; So, Tom Woods, thank you very much.</P> <P>Thomas M. Woods:&nbsp; Thank you, Roger.&nbsp; Good morning.&nbsp; Let me start by echoing that welcome to American Enterprise Institute, and then, at the same time, thank AEI for hosting this event.&nbsp; Again, my name is Tom Woods.&nbsp; I m a senior associate fellow at the Heritage Foundation.&nbsp; And we are co-hosting this morning s program.</P> <P>Now, I have always found that it is a lot easier to introduce somebody who is already internationally known, a leader, widely acclaimed and an absolute pioneer in her field.&nbsp; Introductions become even easier when you get to use cool titles like the  Teflon Lady or the  Drug Lawyer. &nbsp; But I do want to make sure that everybody in the room understands the courageous role that our guest has played in the global war against counterfeit drugs.&nbsp; Since she took over as director general of Nigeria s National Agency for Food and Drug Administration and Control, or NAFDAC as we know it - since 2001 - Dr. Akunyili has distinguished herself as one of Africa s foremost health reformers.&nbsp; And Transparency International awarded her its International Integrity Award, and Time magazine named her one of its global health heroes.&nbsp; </P> <P>The awards are simply too numerous to mention.&nbsp; I could go on and on.&nbsp; You really need to see her office in Abuja: half the wall just coated with these plaques for all of her hard work.&nbsp; Suffice to say, Dr. Akunyili has been at the forefront of a lifesaving crackdown on counterfeit drugs, and that crackdown is having a global impact now.</P> <P>In case you have not noticed, there are two very important themes running here this morning.&nbsp; First, obviously, the need for continued inspired leadership in the fight against counterfeit drugs; but second, we are hearing from a powerful example of African leadership addressing global concerns.&nbsp; And importantly, this leadership is coming from an African woman.&nbsp; She has been shot at, threatened, harassed, but has never once backed down from the public health terrorists that she has so effectively combated.&nbsp; All this, of course, proves once and for all, that the best man for the job truly is a woman.&nbsp; Join me in welcoming Dora Akunyili to the podium.&nbsp; Thank you.</P> <P>Dora Nkem Akunyili:&nbsp; Thank you very much, Tom.&nbsp; I appreciate being invited to speak in this meeting.&nbsp; And I particularly thank Tom for inviting me.&nbsp; Let me start by talking about drug counterfeiting globally just for one minute.</P> <P>Drug counterfeiting is no longer a problem of developing countries.&nbsp; It is gradually rearing its ugly head in developed countries.&nbsp; And by 2003, WHO determined global sales of counterfeit medicine to be about US$32 billion, amounting to about 10 percent of drug sales globally, of course, costing pharmaceutical industry about US$46 billion and at the same time, endangering lives of millions of people.&nbsp; </P> <P>Recent findings actually show that in developed countries, we have less than one percent of drugs in circulation as fake, and in developing countries, over 10 percent, depending on geographical area.&nbsp; Even in United States of America, there is increasing trend in drug counterfeiting as you can see from the graph, nine in 1997, up to 58 by 2004; 2005 decreased a little and so on and so forth.&nbsp; And two most outstanding reports involve Lipitor and Serostim.&nbsp; The situation in U.K. is not better.&nbsp; In 2006, United Kingdom recorded 39 reports while Germany recorded 25 reports of counterfeit medicine. </P> <P>Background information on Nigeria - Nigeria is the most populous African country with a population of over 140 million people, a total area of 924,000 square kilometers, six geographical zones, 36 states.&nbsp; And the capital is Abuja, and Lagos is the commercial nerve center.&nbsp; And our lingua franca is English.</P> <P>NAFDAC is a parastatal of the Ministry of Health of Nigeria.&nbsp; We demanded to regulate and control the manufacture, the importation, the exportation, the distribution, the use and sale of drugs, medical devices, cosmetics, food, detergents and all drinks, including table water.&nbsp; This is our head office.&nbsp; </P> <P>And the question is:&nbsp; What is counterfeit medicine?&nbsp; Despite the global nature of counterfeit medicine, the international community has not given it the attention it deserves, evidenced by not having a harmonized definition of counterfeit medicine.&nbsp; U.S. FDA has their definition; WHO has their definition and so on and so forth, but NAFDAC has identified the following forms of counterfeit medicine.</P> <P>Drugs without any active ingredient:&nbsp; when these criminals find that a drug has no characteristic smell or taste, they add nothing.&nbsp; They compress excipients, compress chalk or add olive oil in capsules and call them multivitamin.&nbsp; And when they find that a drug has characteristic smell or taste, they add a little.&nbsp; For instance, chloroquine, an anti-malaria, which is intensely bitter -- we have never found more than 20 percent active.&nbsp; Some antibiotics that have characteristic smell, we have never found more than 25 percent active.&nbsp; And you know that when antibiotics contain little active, it is worse than when it does not contain any active because of development of resistant strains.</P> <P>We have expired drugs, drugs that expired then relabeled or drugs without expiry date.&nbsp; Clones of fast-moving drugs are another group.&nbsp; These are drugs that look very much like the original brand, containing the same quantity of active ingredient, but the efficacy can never be the same because the efficacy of a drug is not only dependent on the quantity of active but on the quality, particle size, excipients, formulation techniques and many other parameters.&nbsp; We have drugs with active ingredients totally different from what is stated on the [audio glitch] type of counterfeit.</P> <P>In 2004, Norvasc became [indiscernible] in Nigeria, which is an anti-hypertensive.&nbsp; These criminals, two different criminals went to India and produced Norvasc - one of them containing an anti-diabetic and one of them containing paracetamol, an anti-pyretic.&nbsp; And the one containing anti-diabetic actually killed many people.&nbsp; And it went on until a senator reported, who nearly died after taking it for two days.&nbsp; What that meant was that a hypertensive patient was taking an anti-diabetic drug.&nbsp; And we have too many other examples.</P> <P>Again, we have herbal preparations mixed with orthodox medicine.&nbsp; And this is not just peculiar to Nigeria.&nbsp; Even in WHO newsletter of February 2002, we read about how, in the state of California, a herbal medicine was mixed with chlordiaxepozide [sounds like].&nbsp; It is called Herbal Rest &amp; Relax until a whistleblower reported.&nbsp; </P> <P>Drugs without full name and address of manufacturer are also referred to as fake in Nigeria and drugs not registered by NAFDAC.</P> <P>What are the implications of fake drugs?&nbsp; Honestly, fake drug is bad news.&nbsp; Counterfeiting of medicines is one of the greatest atrocities of our time.&nbsp; Fake drug trade is the worst aspect of corruption because it affects life directly.&nbsp; Money can be regenerated, but life cannot be recreated.&nbsp; Fake drug trade is terrorism against public health as well as an act of economic sabotage.&nbsp; It is actually mass murder.&nbsp; Fake drugs violate the right to life of innocent victims.&nbsp; The evil of fake drugs is worse than the combined scourge of malaria, HIV, armed robbery and cocaine.&nbsp; </P> <P>Why do I say that?&nbsp; Malaria can be prevented or treated.&nbsp; HIV can be avoided.&nbsp; And robbers may or may not kill.&nbsp; Cocaine and similar drugs are taken out of choice.&nbsp; But fake drugs are taken by all, and anybody can be a victim.&nbsp; Fake drugs embarrassed our healthcare providers and eroded the confidence of the public on our healthcare delivery system.&nbsp; It led to treatment failures, development of drug resistance and death of many people.</P> <P>In the area of drug resistance, it actually affected antibiotics and anti-malarias.&nbsp; In the  60s in Nigeria, malaria was regarded like flu because of efficacy of chloroquine.&nbsp; By early  90s, we started developing resistance to chloroquine because of previous intake of substandard chloroquine.&nbsp; And we moved up to a second-line drug, fancida, Halfan and so on.&nbsp; By late  90s, these criminals had again invaded us with substandard of those type of drugs, and we moved up to artemisinin derivatives.&nbsp; And as I speak, we are on LCT and we have been intercepting fake LCT.&nbsp; And what boggles my mind is, if these criminals succeed in making or develop resistance to LCT, where do we go from there?</P> <P>As people were dying, legitimate business were collapsing.&nbsp; Our local drug manufacturers were going out of business because it was on an uneven playing ground.&nbsp; How do you compete with somebody compressing chalk or re-labeling expired products, et cetera?&nbsp; Multinationals left Nigeria out of frustration.&nbsp; We used to have Merck, Boots, Boehringer, Lilly and all of them; they left.&nbsp; Made in Nigeria drugs were banned in other West African countries.</P> <P>What was the scope of the problem?&nbsp; In 2001, before the present management of NAFDAC came on board, fake drugs were first noticed in Nigeria in 1968.&nbsp; When crown agents divested as sole distributors of pharmaceuticals -- and the problem was not progressively until Nigeria became one of the countries with the highest incidence of fake drugs.&nbsp; By 2001, over 41 percent of drugs in Nigeria were counterfeit, conservative estimate.&nbsp; Poole, in 1989, found that 25 percent was fake, 25 percent genuine and 50 percent inconclusive.&nbsp; Lambo, in 1990, found that 54 percent of drugs in Lagos were fakes and that the figure could rise to 80 percent the following year.&nbsp; Ochekpe et al, in 1993, found the failure rate to be 41.4 percent.&nbsp; And Taylor et al found, in 2001, that 48 percent of drugs tested were counterfeits.&nbsp; NAFDAC study in 2002 showed that 68 percent of drugs in circulation were unregistered.&nbsp; Counterfeiters target cost and volume.</P> <P>What are the factors that encourage drug counterfeiting?&nbsp; Chief among the factors is corruption and conflict of interest.&nbsp; The first line of action by drug counterfeiters is actually to compromise regulators.&nbsp; When that failed, they resorted to harassment, intimidation, threats, blackmail, et cetera.&nbsp; And that resulted in deposition of fetish objects in my office like feathers with blood, African beads, and the highest was a tortoise.&nbsp; The day I saw that tortoise in my office, I ran and never stopped running.&nbsp; I forgot that a tortoise cannot run.&nbsp; And when that failed, they resorted to physical attack on us, against NAFDAC staff and facilities.</P> <P>In August 2001, six armed men invaded my residence at Abuja, ransacked everywhere and did not steal a pin.&nbsp; Fortunately, I traveled to Lagos, unplanned from the office because I got a report that I needed to see something.&nbsp; In August 2002, our laboratory in Lagos was totally destroyed.&nbsp; All the major equipment, the smaller equipment were carted away; the big ones were destroyed totally.&nbsp; In 2003, my son narrowly escaped being kidnapped.&nbsp; He was grabbed by two young men, and somehow it flashed in his head to tell them that,  This woman is not my mommy; she is my auntie. &nbsp; And they asked him whether he was sure.&nbsp; He swore that that I was his auntie.&nbsp; That pained me a lot.&nbsp; </P> <P>And these attacks culminated in a shooting attack on me on December 26, 2003.&nbsp; And during this near-death encounter, bullets shattered the back windscreen of my car, pierced through my headscarf, went out through the front windscreen, and a bus driver died on the spot.&nbsp; Three months after this shooting, all I had was just something like a hot water burn on my scalp, not significant.</P> <P>Three months later, there was synchronized burning of NAFDAC facilities across the country.&nbsp; From 7th March to 11th March 2004, every day, one place or the other was burning.&nbsp; And the fire started on five floors at the same time in Lagos - inside the office.&nbsp; Kaduna laboratory was also totally burned.&nbsp; Fire started at all corners at the same time.&nbsp; They went to burn Maiduguri but they were chased out by security agents.&nbsp; Surprisingly, the security agents did not catch anybody.&nbsp; They went to burn Benin and burned the office adjacent to NAFDAC office.&nbsp; </P> <P>Lack of awareness is also a factor that encourages drug counterfeiting.&nbsp; To a very large extent, drug counterfeiting was shrouded in secrecy for many years.&nbsp; And people died inexplicably after the right diagnosis and correct medication without being able to link that to the intake of fake drugs.&nbsp; My own younger sister continued having fake insulin pumped into her, and we watched her helplessly until she died because it did not occur to anybody that fake drugs were in circulation.&nbsp; And this was in the  80s.&nbsp; And yes, these criminals started since 1968.</P> <P>Another factor is discriminatory regulation by exporting countries.&nbsp; Some countries have strong regulations for drugs consumed internally and little or no regulations for drugs meant for export.&nbsp; And this fuels drug counterfeiting and is actually particularly critical in Nigeria because 60 percent of the drugs we use are imported.&nbsp; Most fake drugs in Nigeria actually are imported from India and China.&nbsp; Consequently, we have banned 30 Indian and Chinese companies from importing drugs into Nigeria, and one Pakistani company, and we are still compiling a new list that we do not announce until we are 100 percent sure.</P> <P>Another challenge is sophistication in copying technology.&nbsp; This has gone so high now that even original brand owners find it difficult to tell the difference between the original and counterfeit.&nbsp; In fact, sometimes, when they bring the counterfeit to my office for us to have them monitored [sounds like] from the system, I look at them and say,  Why is it that counterfeiters produce better packaging than you? because they spend more on packaging.&nbsp; This is not even a good example.&nbsp; </P> <P>I did not want to bring in non-drug products because we are talking specifically on drugs.&nbsp; Like toothpaste, when I saw the Close-Up toothpaste produced in China and the Close-Up toothpaste produced in Nigeria, I actually told the managing director,  Are you not ashamed that Chinese produced a better packaging than yours? &nbsp; The picture was sharper, crisp, beautiful, yet it was a copy.&nbsp; It is only when you place these drugs side by side that you will be able to tell where the one is different from the other.&nbsp; This is Cialis - two different counterfeiters brought in from different countries -- counterfeit one, counterfeit two [Editor s note: refer to PowerPoint reference.]</P> <P>Another big problem we have is false declaration by importers.&nbsp; Importers bring in counterfeit drugs and label that textile, candles and so on.&nbsp; Sometimes, these drugs are hidden inside containers - in the inner part of containers - or hidden inside dresses, shirts and so on, like these baby clothes.&nbsp; We had to actually open it to bring out the drugs.&nbsp; When you look at it in the containers that they came with, you would never suspect that they are drugs.&nbsp; In fact, the NAFDAC staff that started touching the clothes to find out why these shirts, these baby clothes were so fat.&nbsp; </P> <P>Of course, the boy got automatic promotion because I would not have started touching the shirts in the ports and these concealed in children s wear -- these children s wear -- the drugs -- this is Halfan.&nbsp; And this Halfan contained about 10 percent of active and that is second-line antibiotic.&nbsp; This is drugs concealed in men s clothes.&nbsp; We actually brought them for people to see.&nbsp; When you see the proper concealment, you would never suspect concealed in duvets, concealed in shoes.&nbsp; And this is the most classical - what we found in the container is what you can see on the left: DVD player.&nbsp; We never suspect that it is not DVD player, and this came in, in millions of cartons.&nbsp; But this is what it is -- is Zinnat.&nbsp; It is third-generation antibiotic.&nbsp; And when we tested it, it did not contain a single active.</P> <P>Inadequate legislation is a problem.&nbsp; All over the world, criminals are now shifting from gunrunning and cocaine pushing to drug counterfeiting because it is as lucrative but with relatively lower risk.&nbsp; In Nigeria, for dealing on fake drugs, you get imprisonment of three months to five years or a fine of US$70 to US$3,600.&nbsp; Abuse of judicial process is not helping matters.&nbsp; This is further hampered by granting of inordinate ambitions [sounds like], long delays of trials and other handicaps.&nbsp; And some cases linger for so long that the judge dies or the judge is transferred and started all over again.</P> <P>In one of the cases, our own lawyer, NAFDAC lawyer, claimed that he lost all documents - a high-profile case.&nbsp; In another case, a NAFDAC lawyer went and negotiated with a client out of court.&nbsp; I have tens and tons of examples, but I ll just give you three.&nbsp; One of them is Marcel Pharmaceuticals.&nbsp; Chief Marcel Nnakwe, the owner of Marcel Pharmaceuticals is the biggest drug counterfeiter in West Africa.&nbsp; You know, most drug counterfeiters in Nigeria are trained by him or people that he trained.&nbsp; He is based at Onitsha.&nbsp; Right now, he is at-large because government is looking for him to grab him in connection with the assassination attempt.&nbsp; </P> <P>This man, his counterfeit drugs were intercepted in 1997, two times in 1998, and in 1998, total of four times.&nbsp; Of course, you know that if one was intercepted, 10 must have passed because of his relationship with other law enforcement agencies.&nbsp; And NAFDAC took him to court and he got a high court injunction.&nbsp; And injunction says that NAFDAC was restrained from arresting, detaining, investigating, prosecuting or impounding on anything that belongs to Chief Marcel Nnakwe.&nbsp; And that injunction was never set aside until we came into office by late 2001.&nbsp; The injunction worked for him from 1998 to 2001.&nbsp; It means that for those years, he was bringing in fake drugs without anybody touching him.</P> <P>In fact, when we found five warehouses of his drugs containing 99 percent counterfeit in 2001, we could not do anything.&nbsp; We needed to do something crude.&nbsp; We went to the traders at Onitsha, the most notorious drug market in Nigeria.&nbsp; And the traders were convinced that they should call him to apologize.&nbsp; They actually called him.&nbsp; And we all got him intimidated to apologize to Nigerians that he would no longer deal on fake drugs.&nbsp; And he wrote a letter of forfeiture for us to destroy the fake drugs in his warehouses.&nbsp; That was how we destroyed them.</P> <P>Another case is that of Vipharm Industries from China.&nbsp; We have been in court with Vipharm since 1995 and the case is still on.&nbsp; You see cases involving big men never end; when I say big men - very rich.&nbsp; The cases never end.&nbsp; In fact, at a stage, Vipharm won the case, but NAFDAC refused to release the drugs.&nbsp; And from 1995 till now, your guess is as good as mine, whether the drugs are still in a good enough condition to be tendered as evidence.</P> <P>The assassination attempt is another classical one.&nbsp; I was shot, as I told you, in December 2003.&nbsp; Fortunately, before I was attacked, they boasted that I would never be alive to see 2004.&nbsp; In fact, whenever people went to the market to warn them about the problem they could have with NAFDAC, they say,  Do not worry.&nbsp; By the end of 2003, there will be no NAFDAC. &nbsp; And after the shooting, that gave a clue to get them arrested.&nbsp; And when they were arrested, they were tried to court.&nbsp; And after a year and a half of court proceedings, 58 exhibits, 19 witnesses - witnesses at every stage.&nbsp; </P> <P>Stage of planning - one of the people that shot me was caught and even testified.&nbsp; Stage after the shooting - when they even went to the hospital to make sure that I was dead, telling the doctor on duty that they were sent to take care of me from the security agency.&nbsp; The high court judge said he had no jurisdiction to hear the case, and it was taken to the appeal court.&nbsp; Appeal court told him,  You must hear the case.&nbsp; You have jurisdiction, and appeal court gave this instruction early last year.&nbsp; And we have been going to court at least twice a month and he kept adjourning it, and the adjournment is still on.&nbsp; We were in court last week, it has been adjourned for next week, and we are still hoping and praying.</P> <P>Chaotic drug distribution is a problem.&nbsp; In Nigeria, drug, for many, many years, have been marketed like any other commodity or trade.&nbsp; We worked out a system whereby drugs will be sold at wholesale basis in conducive environments and so on.&nbsp; But is so far the setback and we are still working on it with private companies and individuals.</P> <P>Lack of cooperation among regulatory agencies is a problem because when regulatory agencies - Custom, NAFDAC, standard organization and antinarcotics group and so on -- when they are not actually cooperating the way they should, that provides a fertile ground for drug counterfeiters. </P> <P>Poor database on health-related issues is also a problem because we need data.&nbsp; Most of the time, we do not have them.</P> <P>What are the strategies that NAFDAC employ to fight drug counterfeiting?&nbsp; We started with staff.&nbsp; We needed to reposition staff for better effectiveness by carrying our staff from the orientation, structure and motivation.&nbsp; First of all, corrupt, redundant and incorrigible staffs were retrenched.&nbsp; Staff employments were based mainly on merits.&nbsp; We had staff training and re-training because you cannot actually give what you do not have.&nbsp; </P> <P>Hard work is rewarded.&nbsp; Our reward is in form of recognition, commendation letter, promotion, oversea training or oversea inspection of facilities.&nbsp; Staff members who catch the 14 companies or report any staff that compromises with the 14 companies are similarly rewarded.&nbsp; Consequently, in NAFDAC, there is no friendship because your friend can use you to enhance his or her position.&nbsp; And our slogan is,  Watch me; I watch you, and it is working magic.</P> <P>Welfare packages like 13th-month salaries was initiated and has been sustained, and we find ways of putting food on your table, let me put it that way, because it is difficult to tell people not to be corrupt when they cannot feed.&nbsp; And when hard work is not rewarded, when transparency and honesty are not rewarded, corruption is promoted.&nbsp; Corruption is severely sanctioned.&nbsp; Staff members involved in abetting or aiding the 14 companies are outrightly dismissed, and I have always emphasized leadership by example.</P> <P>Restructuring and modernizing of our regulatory processes - NAFDAC got reorganized into eight directorates with huge state offices to cover the whole federation, zonal offices, four special offices in places with big drug markets.&nbsp; Old laboratories are upgraded; new ones are being constructed and equipped.&nbsp; We put in place standard operating procedures and guidelines so as to institutionalize our processes, and all our processes, of course, are automated and they are continuously upgraded.&nbsp; This is our organogram; it is too complex for us to discuss here.&nbsp; Just to show you, this is our vaccine laboratory in Yaba, Lagos.&nbsp; This is our food lab in Lagos.&nbsp; This is our Maiduguri Laboratory that was also nearly burnt down.&nbsp; And this is Port Harcourt Laboratory, the newest one.</P> <P>This is Kaduna Laboratory.&nbsp; There is a story behind Kaduna Laboratory.&nbsp; After the burning of the former Kaduna Laboratory, we converted our five staff houses into laboratories.&nbsp; We needed to do that because the war with drug counterfeiters is also psychological.&nbsp; We did not want them to defeat us psychologically; rather, we wanted to defeat them by telling them that even after burning our laboratories, we could still continue.&nbsp; The conversion of these staff houses to laboratories took less than two months.&nbsp; We had to mobilize what we had in some model laboratories to equip the laboratories and imported some by air, by sea, and so on.&nbsp; </P> <P>And we did the same thing for our NAFDAC offices.&nbsp; When they burned Lagos office, the next day after the burning, we put up canopies.&nbsp; Canopies - they are big plastics - and bought more chairs and sat under the canopies to work.&nbsp; I was very desperate for us to continue so that NAFDAC workers would not be dispirited so that these criminals would not rejoice.&nbsp; </P> <P>And that same day, on Monday - the burning was on Sunday - I asked them to produce stamps for the reports because our stamps were all burnt so that they would not seize that opportunity.&nbsp; In fact, from canopy, we brought back our cabins and something particularly happened when we are using the canopies - one of our staff got bitten by a very strange insect.&nbsp; I do not even want to give you the details and as I was talking, she walked in.&nbsp; I was in shock.&nbsp; I did not know she was in Washington.&nbsp; Hey Jelma [phonetic] -- she got bitten by an insect that we cannot understand and it formed maggots in her body because we were actually sitting on grass to operate.&nbsp; It was very disturbing.&nbsp; That same day, I was pretending to be bold but I was rattled.&nbsp; I needed to pretend because I knew that the staff was looking at me.&nbsp; </P> <P>And I called the director of Enforcement and I said,  Director, remember that we are moving to Idumuta on Wednesday.&nbsp; You should not stop.&nbsp; You should just go ahead.&nbsp; Mobilize the police. &nbsp; He was looking at me.&nbsp; I talked and talked and he said nothing.&nbsp; I said,  Are you not hearing me, Ejionueme? &nbsp; The smell of the smoke is still in the air and I could not say anything again.&nbsp; It now dawned on me that I was pushing too hard -- inside our laboratories, Lagos, Lagos, Maiduguri, Port Harcourt and so on.&nbsp; </P> <P>Public enlightenment campaign is our most effective strategy because it addresses the fundamental issue at stake, which is behavioral change.&nbsp; On the path of NAFDAC s staff and especially on the path of our clients - the stakeholders - it involved dialogue, education, persuasion, and so on.&nbsp; And it was sustained using print and electronic media like jingles, a lot notices, billboards, publications of the differences between fake and genuine products in Nigeria in newspapers, and translated to vernacular languages.&nbsp; We produce many other publications, some fliers and so on and workshops have been conducted for almost all stakeholders and mobilization campaign in rural areas is actually ongoing.&nbsp; </P> <P>And we have carried this campaign to Nigerian high schools.&nbsp; Since 2002, we started annual essay competition for Nigerian high schools and we give prizes to the best students -- first, second, and third at state levels, zonal levels, and national levels.&nbsp; What we give to them is actually very heavy - about one thousand dollars for the first prize, 750 second prize, and so on.&nbsp; The schools of the winning students -- we give computers, microscopes, encyclopedia, televisions, and so on, plus the positive publicity.&nbsp; And that actually made our Nigerian schools to be studying NAFDAC activities as if it is one of the high school final exam subjects.&nbsp; </P> <P>When we saw the success, we are recording these high schools.&nbsp; Catching these children young in the formative age, we put in place NAFDAC Consumer Safety Clubs in Nigerian high schools and the club is now about the most popular club in our high school.&nbsp; And this NAFDAC Consumer Safety Club is actually a platform for interacting with these students so as to inculcate in them the culture of quality consciousness.</P> <P>Another strategy is stopping the importation of counterfeit medicines from Nigeria from source.&nbsp; Remember I told you that most counterfeit drugs come from India and China.&nbsp; Consequently, we put in place independent analysts in these two countries to recertify drugs before they are imported to Nigeria.&nbsp; Without this recertification, the drugs will be collected and destroyed.&nbsp; And we started factory inspection of all NAFDAC-regulated products in any country.&nbsp; Anywhere in the world, we must inspect the good manufacturing practice before we register the product.&nbsp; </P> <P>Again for drug, we insist on mandatory pre-shipment information.&nbsp; If we do not get information from the importer that this drug is coming in, this quantity, this conveyor vessel, et cetera, the drugs are not accepted.&nbsp; Again, Nigerian banks since 2002 -- had been insisting on NAFDAC clearance before they process financial import document for drug importers.&nbsp; In fact, landlords do not even allow people to keep drugs in their buildings without clearance with NAFDAC.&nbsp; We have come to that.&nbsp; </P> <P>Certificate of Free Sale - the Certificate of Free Sale is a certificate that says that this product, this drug, this cosmetics, this food is freely used in country of production.&nbsp; We insist on that.&nbsp; It was designed by Minister of Trade or Industry in that country and authenticated by Nigerian Embassy or any Commonwealth mission in any country without a Nigerian Embassy because any drug that is not used in that country cannot be used in our country.&nbsp; And in fact that is why we totally reject any product labeled  For export only. &nbsp; </P> <P>We have beefed up surveillance at all ports of entry.&nbsp; We have been successful with the new directorates and when we became too strong at the sea ports, this criminal diverted to use the airports and we issued a guideline that any aircraft that brings drugs to Nigeria that is not registered or found to be fake, would be grounded.&nbsp; And when we put out our guideline, communicated it to all the airlines, the first casualty would have been Ethiopian Airlines.&nbsp; They arrived in Nigeria and we had gotten information that they were coming and NAFDAC officers were all over the airport waiting for them.&nbsp; They discharged passengers and left without offloading the luggage to Ghana and unfortunately, by then, we had not instituted WADRAN.&nbsp; If we had I would have asked my colleague in Ghana to stop them.&nbsp; </P> <P>Another strategy is mopping up what is already in circulation because we had gone through over 30 years of dumping and our borders are porous, with corruption, and so on.&nbsp; We had a lot in the system, so we devised a planned, continuous and sustained surveillance of all markets and retail outlets for drugs and other regulated products.&nbsp; </P> <P>We have routine sampling, checking and testing of all the products we registered from time to time because these criminals, they also had their way of registering genuine products and going back to produce rubbish for our people.&nbsp; </P> <P>Third, drug dealers are also traced through reports from victims, health professionals and tip-off from the public.&nbsp; And in fact, we are very systematic in this process.&nbsp; When somebody reports about a particular eye drop that give a very terrible sensation in the eye, what is important to us is not that just one single eye drop.&nbsp; We collect it, go to the shop where it is purchased, get the receipts from where the person purchased it, get to the distributor, get to the importer, and most of the time, we are able to trace it to the factory.&nbsp; That was actually how we traced the companies that we blacklisted.&nbsp; </P> <P>In 2003, Nigerian journalists reported the death of three children in a teaching hospital after an open-heart surgery and we investigated and found that the adrenaline was fake, the muscle relaxant, the suxamethonium was fake - very substandard - and the infusions were contaminated.&nbsp; And when I personally went to interrogate the doctors, I was in shock.&nbsp; The anaesthesist told me that he had always been using suxamethonium that was substrength that he always made sure that he kept increasing the doses.&nbsp; So it means that they knew that the problem was there with most of the drugs, but they thought that they could get around it.&nbsp; </P> <P>In 2004, we had batches of four infusions heavily contaminated and this, we actually produced in Nigeria.&nbsp; In the same year, we found 147 out of 149 brands of water for injection being heavily contaminated; they were not sterile.&nbsp; </P> <P>Raids are carried out on regular basis on drug hawkers and the drugs are confiscated and destroyed.&nbsp; Most of the time, we cannot take such people to court because most of them do not have real names, they do not have addresses and drug hawkers lived under the bridges and if you lock them up in the cell, they can stay there and die.&nbsp; So we just confiscate the drugs and destroy.&nbsp; </P> <P>And when we got very strong about this, they started selling at night.&nbsp; And in one occasion, when we moved to sell at night, the criminals took over a lorry-load of drug from NAFDAC depot after the confiscation but the police eventually got them back from them.&nbsp; This continued surveillance has led to sealing up of many shops and big markets.&nbsp; Aba drug market was sealed off in 2002 for six months; Kano for three months; and Onitsha market for four months in 2007.&nbsp; </P> <P>And Onitsha market story is really an interesting one.&nbsp; Onitsha market traders are the worst of all.&nbsp; They are diehards.&nbsp; They are armed.&nbsp; They are prepared to die defending their fake drugs and because of that, we needed to find a special way of closing that market.&nbsp; That market was closed at 4 a.m. with 150 soldiers, 350 policemen, and 150 NAFDAC staff.&nbsp; So that by the time they came at 6 a.m. it was closed.&nbsp; If we went there between 6 and 7, there would have been bloodshed and we removed drugs worth almost 6.5 billion naira which we destroyed publicly.&nbsp; </P> <P>Then we run into trouble.&nbsp; Confiscating drugs, wanting to trace who produced it, who imported it, and we are given nontraceable receipts - fake receipts - then we put up a guideline.&nbsp; That is whenever we find that kind of receipts.&nbsp; All the drugs in that shop would be evacuated and destroyed and by the time we did it - two times, three times - we started getting proper receipts.&nbsp; </P> <P>Again, we had another problem of confiscating drugs in big warehouses, in densely populated streets, and nobody comes up to claim Onitsha.&nbsp; People will just come up in the street and be clapping,  Out NAFDAC, out NAFDAC, from morning till evening.&nbsp; And we put up a guideline that is, if we ever confiscate drugs and we do not find the owner, we arrest the landlord and when we arrested the landlord in Lagos at Ebute-Meta, the owner surfaced.&nbsp; That is why landlords would never allow any drug dealer to keep drugs in their buildings without coming to clear with NAFDAC.</P> <P>Typical drug destruction exercise - we monitor local manufacturers very strictly.&nbsp; Compliance directives are issued and enforced.&nbsp; Prosecution is a last resort as you can see what we are going through in the courts.&nbsp; </P> <P>We are streamlined.&nbsp; Our registration guidelines and there is very strict enforcement.&nbsp; All drugs must comply, of course, with laboratory standards and special requirements before registration.&nbsp; Drugs registration, they are renewed every five years; herbal medicine, every two years.&nbsp; NAFDAC Registration Number is affixed on every registered product as an authorization seal for Nigerians to know that this product is registered by NAFDAC.&nbsp; Criminals are faking that number, and we are now adopting serialized holographic labels in addition to the NAFDAC numbers so as to secure our product and it has return advantage.&nbsp; Drugs can only be imported into Nigeria for 10 years except for orphan drugs, after which importer must start local production.</P> <P>We have started regulation and control of clinical trials.&nbsp; We have established Clinical Trial Unit and develop regulations and guidelines for clinical trials.&nbsp; </P> <P>We have a National Pharmacovigilance Centre for monitoring adverse drug reactions.&nbsp; We have, since 2005, obtained over 620 reports and that has enabled us to ban some drugs or restrict the use of some drugs.&nbsp; Prescription requirement is being enforced because in the past, one did not need prescription to buy any drug in Nigeria.&nbsp; We started with sedatives and we are very strict with it and people are complying.&nbsp; We added injectables.&nbsp; We are moving into antibiotics.&nbsp; </P> <P>International collaboration - we are also working very hard on that.&nbsp; What happened was that when these crimi -- [audio glitch] Nigeria, they started relocating towards Western African countries and became a very big problem for them.&nbsp; And this led us, in 2005, to initiate WADRAN, West African Drug Regulation Authorities Network, for which I am the chairperson, for us to interact and share strategies and experiences with other drug regulators in the Sub-Saharan Africa so as to carry them along and also to ensure that these criminals do not find a safe haven anywhere in the region when they be chased out of Nigeria because they start moving down to the Congo area.&nbsp; </P> <P>One -- was it two years ago?&nbsp; I went for a meeting in South Africa and a drug regulator from Congo in his pidgin English, said -- he got up and said,  Nigeria problem.&nbsp; Nigeria big problem. &nbsp; And I said,  What is he saying? &nbsp; Said,  Nigeria had big problem. &nbsp; Then he started speaking in French and they translated.&nbsp; What happened was that Congo did not have much problem until they started running away from Nigeria, so it is just not West Africa.&nbsp; </P> <P>And from 2002, we have been proposing international convention for counterfeit pharmaceuticals and we propagated it and carried it to all conferences and eventually in 2006, WHO came up with the International Medicine Products Anti-Counterfeit and Task Force for which we are playing a major role - because I m the vice chair - and we believe that this is a step in the right direction that will eventually metamorphize into international convention because we still insist on that.&nbsp; If narcotics and psychotropic substance is good, get that as titles, why not fake drugs that we believe very strongly are worse than the other two?&nbsp; </P> <P>We have tremendous government support especially Nigerian press.&nbsp; These criminals are more afraid of the press than the courts because they know that the press can rubbish you and rubbish your money, but in the court you cannot actually get around.&nbsp; Government has also banned moving of drugs through land borders and we have designated sea ports for drug importation and 13 drugs that local manufacturers have capacity for have been banned.&nbsp; </P> <P>We have had cause to smile because we believe that we are winning in this fight.&nbsp; We have sanitized the food and drug industry to a reasonable extent and created a well-regulated environment that have saved millions of lives of Nigerians, boosted our economy by encouraging local industries and genuine investors.&nbsp; Immense public awareness has resulted in the participation of all stakeholders in our regulatory process and has awakened international consciousness that Nigeria is no longer a dumping ground for fake drugs.&nbsp; Counterfeit drugs in circulation have dropped from over 41 percent in 2001 to 16.7 percent in 2006 and as I speak, it should be less than 10 percent.&nbsp; This was a study carried out by WHO two years ago.&nbsp; </P> <P>Drugs unregistered by NAFDAC stood at 19 percent in 2006 as against 68 percent in 2001.&nbsp; Production capacities of our local industries increased tremendously and the number of our local drug production outfits increased from 70 to 150.&nbsp; By 2001, we are producing less than 25 percent of our drug need; now, we are producing over 40 percent.&nbsp; There is continuous upward movement in the share prices of pharmaceutical companies posted in Nigeria s stock exchange.&nbsp; </P> <P>Multinationals that left Nigeria out of frustration; they are coming back in dozens because of improved regulatory environment.&nbsp; Ban on  Made in Nigeria drugs by other Western African countries have been lifted and in seven years, we have carried out 121 destruction exercises of counterfeit products worth over US$190 [in the PowerPoint reference, there should be million].&nbsp; We have had 45 people convicted.&nbsp; Sixty cases are pending in court but I m not actually excited about these convictions because the cases involving the very rich people never end.&nbsp; </P> <P>Old food and cosmetics industries are expanding; new ones are springing up.&nbsp; Sanitization of table water has greatly reduced the incidence of cholera and other water-borne diseases that used to be rampant in the past.&nbsp; And NAFDAC monitored salt iodization and in this regard, UNICEF has rated Nigeria as the first African country to achieve Universal Salt Iodization and you know that, here, you take it for granted but in developing countries, it is not.&nbsp; The iodization of salt actually prevents goiter and enhances brain formation in unborn babies and babies as they are growing up.&nbsp; And we used to have 20 percent goiter prevalence in the  60s and  70s and even  90s.&nbsp; </P> <P>The use of bromate by Nigerian bread bakers as bread enhancer has also reduced.&nbsp; It is also taken for granted here because they do not use it here.&nbsp; Bromate actually had been banned in the early  90s for causing cancer, kidney failure, loss of hearing, breakdown of vitamins in bread, and so on, but the Nigerian bakers continued using that.&nbsp; </P> <P>Well, I have enjoyed some moments of celebration and that is very encouraging -- very, very encouraging.&nbsp; In conclusion, drug counterfeiting has ceased to be a problem of only developing countries.&nbsp; It is rapidly rearing its ugly head in developed countries and this is actually fueled through buying of drugs via the Internet.&nbsp; The negative impact of counterfeit drugs knows no boundaries.&nbsp; Resistant strains of microorganisms do not need visa to travel from country-to-country.&nbsp; Drug counterfeiting involves transnational criminal network and can only be dismantled through international collaboration.&nbsp; </P> <P>We need an international convention on counterfeit pharmaceuticals just as we have for narcotics and so on.&nbsp; This will bring about harmonized regulation of drugs moving in international commerce and it should be treated at as an international health emergency program.&nbsp; Countries not yet invaded should be proactive because once drug counterfeiters get established in any country, uprooting them becomes a Herculean task.&nbsp; Regulators must work with confidence knowing that criminals have no power over them as long as they are not compromised.&nbsp; Anybody who pays you becomes your master and when you reject criminal s money, the criminal becomes as small as he should be.&nbsp; Counterfeiters can be overcome despite the daunting constraints as evidenced by our success in Nigeria.&nbsp; </P> <P>These are our contacts.&nbsp; Thank you very much.</P> <P>Roger Bate:&nbsp; Thank you very much.&nbsp; That was truly outstanding, a wonderful presentation, and I like the way that you began by saying that this is not a problem just of the developing world.&nbsp; It reminded me of the fantastic movie -- Orson Welles movie, The Third Man, which was the center thesis -- if you like -- of the movie was the dilution of penicillin after Second World War in Vienna which obviously is -- ever since therapeutic pharmaceuticals have been developed.&nbsp; They have been copied and faked and diluted.&nbsp; So absolutely, yes, it is absolutely outstanding presentation.&nbsp; </P> <P>I have numerous questions that I wanted to ask but I will not abuse my position as moderator and we will open it up to questions immediately; although, I do have one question to ask you.&nbsp; It has been rumored or I have seen it written, at least, in one place and this may be entirely unfair so I want you to respond that you do not employ men in senior positions because they are not trustworthy.&nbsp; Okay, how can you respond to that?&nbsp; </P> <P>Dora Nkem Akunyili:&nbsp; I hope the men will not feel bad.&nbsp; You see women have fear.&nbsp; Women have fear.&nbsp; Men, their heart is really strong.&nbsp; Women are less prone to corruption than men generally.&nbsp; That is why when a woman steals, it is big news.&nbsp; Like in Nigeria, when a woman steals, it is very big news.&nbsp; When a man steals, it is not very big news.&nbsp; So generally, there are places that -- it is not written down like registration.&nbsp; </P> <P>A criminal can pay $1 million to somebody in registration and the temptation is too much for the men.&nbsp; If criminal can pay $1 million at the port, the temptation is too much for them and in fact, it is a man, my director administration - he is still there - that came to me in 2002 and say,  Ma am, please stop posting men to the ports and registration.&nbsp; How can we be firing people every month?&nbsp; It is not a good image. &nbsp; So if it came for the men from the men that we should stop posting men to such places, I felt that he was honest and we stopped.&nbsp; So -- but men are good.&nbsp; </P> <P>Roger Bate:&nbsp; Thank you very much.&nbsp; That is a wonderful response.&nbsp; First question -- Paul Wolfowitz at the back.</P> <P>Paul Wolfowitz:&nbsp; Thank you.&nbsp; Paul Wolfowitz, AEI.&nbsp; First of all, thank you and congratulations.&nbsp; This is both a wonderful presentation and even more important, the work you have done is spectacular.&nbsp; My question concerns the support you get from the government more generally because, as you speak, it seems to be clear that while you have exercised extraordinary leadership.&nbsp; </P> <P>If you, for example, have 160 soldiers that come with you to close down the market, obviously, you are getting support from the government.&nbsp; And I guess some people would be surprised at that because they think of the government in Nigeria as extremely corrupt, and I would be interested in you talking about how you get the kind of support you need - more broadly -from the authorities especially in the security area.&nbsp; And the last part of this question would be:&nbsp; Does that vary depending on what state you are operating in because I know the variation among different states in Nigeria is very substantial; do you get enforcement uniformly or does it vary a lot from state to state?</P> <P>Dora Nkem Akunyili:&nbsp; Thank you very much.&nbsp; Let me start by states where we are operating because enforcement varies from state-to-state.&nbsp; This work is actually -- is -- we are able to remove politics from this job basically because the drug counterfeiters come from my area.&nbsp; Most drug counterfeiters are Ibos and I m an Ibo woman so that actually silenced critics though I would have said generally in Nigeria once any movement is started, it is called marginalization.&nbsp; Oh this tribe is marginalizing that tribe.&nbsp; And we even operate more in the Southeast, thus, from my place of origin.&nbsp; </P> <P>The only place that we can compare with Southeast is Kano.&nbsp; We are in 2007.&nbsp; They actually broke the leg of one of our staff during operation and they destroyed -- they always destroyed our cars and we needed 300 policemen, an armored tank to save their lives and so on.&nbsp; But we have very level even-handed and because of our even-handedness and because of our capacity to face people from my area, we have been able to buy into the minds of the public.&nbsp; So we have unparalleled public support in Nigeria and that public support has actually made it difficult for any political interference because the public is so much with NAFDAC that even if any politician wants to interfere, it would be suicidal to do so.&nbsp; </P> <P>And I can say that in Nigeria, we are lucky.&nbsp; I think it is because of how we started.&nbsp; Because if you start doing a job and you put in all you have in it and you are not partial, you do not get compromised, and people buy into what you are doing, government will be forced to support you.&nbsp; Because when we started WADRAN - this West African Drug Regulatory Authorities -- we had hair-raising stories.&nbsp; As example, the regulator from Mali told us that when they ceased drugs, politicians say,  Release. &nbsp; When they ceased drugs in Mali, politicians order for the release.&nbsp; </P> <P>But when a politician in Nigeria wants to plead for anybody, he starts by saying,  Please do not disgrace me in the press.&nbsp; I m not asking you to do anything.&nbsp; I m just asking a question. &nbsp; You see?&nbsp; The people do not even have the courage to interfere - if I can put it as bluntly as that.&nbsp; People do not have the courage to interfere in Nigeria.&nbsp; I think it depends on how we started.&nbsp; Companies, again, do not have the courage to come and tell us,  Why do you advertise that our drugs are fakes? &nbsp; They went to staff -- to order staff when we started showing the difference between fake and genuine products but they never had the courage to come to me.&nbsp; </P> <P>But, they have succeeded in doing that in other West African countries -- going to tell regulators,  Please do not advertise our drugs. &nbsp; So I think it all depends on the person at the head; how you start; your disposition; because people actually size you all before they do anything or say anything and the politicians know that.&nbsp; If anybody interferes, I m prepared to announce this mess [sounds like] to the press.&nbsp; We effectively use the press and the public, so we do not have a problem.&nbsp; </P> <P>Yeah, it is a country where there is a lot of corruption and yet, people still love and encourage anybody who is not corrupt.&nbsp; So it is not that people do not know the corruption is bad.&nbsp; But when they see people that cannot help being corrupt, there is nothing they can do.&nbsp; But when they see people that are able to say,  No, and stand by it, you get a lot of admiration, support, and goodwill especially when they continuously sensitized that this is for their own health, for their life, for the lives of their children and generations unborn.&nbsp; </P> <P>&nbsp;Anthony Carroll:&nbsp; Yes, I m Tony Carroll of Manchester Trade.&nbsp; And a couple questions - one question and an observation.&nbsp; The first question is:&nbsp; Trying to interdict counterfeit drugs at point of manufacture you mentioned that most of these drugs originate either in India or China.&nbsp; I know in the issue of whether or not the Chinese, particularly authorities, have been helpful in being able to stem the export of these products because they are often made in venues that the Chinese know as well.&nbsp; So are they being cooperative in trying to help you thwart this from point of manufacture, acknowledging that Nigeria will always have a problem in enforcing its borders against shipments of small products?&nbsp; We have to acknowledge that will always be a challenge.&nbsp; </P> <P>The observation that I have to make is the one on industrial policy.&nbsp; Your work is terrific in the area of food safety and drug safety, but often, the extension into industrial policy is one that I get a little confused by.&nbsp; There has been a global trend in the last number of years to concentrate manufacturing in the pharmaceutical area, in part, because of the increasing sophistication of the manufacturing process.&nbsp; </P> <P>Many drugs, biologics, injectables, and so forth are never going to be established and manufactured in Nigeria just because it makes no economic sense for them to be so.&nbsp; So by forcing importers to manufacture locally - and that will never happen in the form of many drugs - you are, in effect, restricting your population from the availability of many life-saving products that could be made available had they not been barred from import by these restrictions on local manufacturer?</P> <P>&nbsp;Dora Nkem Akunyili:&nbsp; Thank you very much.&nbsp; Forcing importers to manufacture in Nigeria -- we can always identify what we cannot produce.&nbsp; When we cannot produce something, we cannot insist.&nbsp; In fact, we refer to those drugs as orphan drugs.&nbsp; We cannot produce them or they are produced in very little quantities, but with time, we are able to.&nbsp; Like infusions, we now have sufficient infusions produced in Nigeria and even exported to other West African countries.&nbsp; The one we have difficulties, we realize that.&nbsp; Laws are made for men, not men for the law.&nbsp; </P> <P>And when you come to China with the Chinese government, whether they are helpful, they are not helpful.&nbsp; In fact, Chinese are better copiers.&nbsp; They copy better than Indians, and they are not as cooperative as Indian government.&nbsp; Indian government, again, I do not even want to say they are cooperative.&nbsp; They are forced to cooperate.&nbsp; You see, Indians and Chinese, their government tacitly - I say it anywhere - they tacitly support these counterfeiters for economic reasons.&nbsp; And the execution of the food and drug boss in China, I think it was in response to the voice of Americans.&nbsp; When Americans rose up against the counterfeit products coming from China, they needed to do something to save their face.&nbsp; And as far as I m concerned, that is a face-saving measure.&nbsp; They have not gone to the root.&nbsp; </P> <P>And I have asked this in China, I have asked this in all conferences, if they executed the man, what of the people that are operating with him?&nbsp; We need to go in-depth because there is no way I can allow a substance not to be tested in Nigeria without using some people in the lab, without using some people down the ladder.&nbsp; So to just pick up the man and execute him, as far as I m concerned, is just to show that they are doing something.&nbsp; Because I have had meetings in China with these officials, they pretend not to understand a word of English.&nbsp; I never get any support from them.&nbsp; </P> <P>We imposed independent analyst on them.&nbsp; I even threatened that if they rejected our independent analyst, we would advise our government to ban their drugs.&nbsp; So it is very unfortunate.&nbsp; How can I say that Chinese government is not supporting counterfeiting when up to today, they have very strong regulation for drugs consumed in China and little or no regulation for those meant for exports?&nbsp; India is the same.&nbsp; </P> <P>So that is why I continue calling for international convention, because if there is international convention, there is a lot we can do.&nbsp; There is a lot we can do through a global body.&nbsp; There was a time NAFDAC officers went for inspection in China, and they found a very bad place.&nbsp; They got so frustrated.&nbsp; And not knowing what else to do, they used our normal sealing, whatever, and sealed the factory.&nbsp; And when they came back and told this story, I said,  This is useless.&nbsp; As soon as you left, they will open the seal. &nbsp; </P> <P>If we had an international convention, we have factories to report to the central body.&nbsp; But there is no central body to report to.&nbsp; BBC, Bad Medicine, a documentary -- I took them to India and I showed them some factories.&nbsp; They went there.&nbsp; Unknown to the owners of those factories that we are wearing secret cameras, they were asking them,  Whatever you want, we produce.&nbsp; If you want one-quarter strength, we do it -- anything, anything. &nbsp; Did you watch it?&nbsp;  We bought Bentley car for the minister.&nbsp; We pay off the officials and so on and so forth. &nbsp; What has Indian government done about it?&nbsp; Those factories are still on.&nbsp; The factories are still on as I speak, that we had evidence on with the secret camera by BBC.&nbsp; So I do not believe that if Indian and Chinese government, if they come all out to fight counterfeiting, I do not believe that the counterfeiters would be working with impunity.&nbsp; </P> <P>Before I forget, even that gentleman that was executed, I believe that he was executed not just as a face-saving measure because U.S. has started talking; the giant of the world had spoken.&nbsp; If it is the developing countries, they would not have killed that man.&nbsp; I also believe that it is because some Chinese children died.&nbsp; Remember, if those drugs were exported, nothing would have happened.&nbsp; So it is like the fake hits them in their own country.&nbsp; </P> <P>So these countries are not doing what they should do.&nbsp; They are still a tacit support, they pretend that something is happening, but nothing concrete is happening.&nbsp; And if you watch BBC, Bad Medicine, the man said  It is the business of those countries to do what -- </P> <P>&nbsp;Roger Bate:&nbsp; He said,  My country is my problem, your country is your problem. &nbsp; </P> <P>Dora Nkem Akunyili:&nbsp; Thank you.</P> <P>Roger Bate:&nbsp; Yes, indeed, it is a fantastic BBC program.&nbsp; If it was not breaching intellectual property rights, I would give everybody a copy of that.&nbsp; But do try and see it - Bad Medicine made by the BBC.&nbsp; </P> <P>The gentleman here, and then the lady at the front for the next two.</P> <P>&nbsp;Samuel Adeniyi-Jones:&nbsp; Samuel Adeniyi-Jones from U.S. Department of Health.&nbsp; Dora, I thought that for further clarification of Paul Wolfowitz s question, you could use the example of Oyo State.&nbsp; I do not know if you are ready to --</P> <P>&nbsp;Dora Nkem Akunyili:&nbsp; Thank you very much.&nbsp; In Nigeria, this fight sometimes can be resisted by some top politicians.&nbsp; They did not really succeed because I also face them headlong.&nbsp; We are not afraid of anybody.&nbsp; You see, when you are doing your work and you are doing it to your best of ability and you have no skeletons, you can face anybody.&nbsp; </P> <P>In Oyo State in Nigeria, we have one godfather called Adedibu.&nbsp; This godfather, he is the person that decides who should be governor; who should be senator; who should be anything; and he had done that for the past 20, 30 years successfully.&nbsp; So he now went and started preventing our officers from doing their work, threatening them to stop seizing products.&nbsp; And when they seized products, he would grant clean [indiscernible] them to release it.&nbsp; </P> <P>When we closed the fish factory, he ordered that the factory should be reopened.&nbsp; And when I got the information, I asked them to grant [sounds like], re-close the factory.&nbsp; It was re-closed.&nbsp; The people that actually opened the factory were arrested, taken to the police station, and the police people were too afraid to keep them.&nbsp; The police people reported that if they kept them, Adedibu men could come and burn the police post.&nbsp; They are as violent as that.&nbsp; </P> <P>So I went to Oyo State and reported to the governor.&nbsp; I told the governor that if nothing was done, we are going to close down the office in Oyo State.&nbsp; And I went to paramount traditional ruler and reported to him.&nbsp; This man was, for the first time in his life, harassed.&nbsp; And federal government tried him to court.&nbsp; He actually felt the pinch for the first time because he had always been like a small god.&nbsp; And thereafter, he has stopped disturbing our staff.&nbsp; </P> <P>So I can say that it was well-handled.&nbsp; And right now, our workers are doing their normal work in Oyo State.&nbsp; They closed down factories, they closed down shops, and Adedibu no longer interferes.&nbsp; I also suspect that people like the president of Nigeria must have also talked to him.&nbsp; But he is still a strong man.&nbsp; Until today, he will decide who will be governor.&nbsp; But as for NAFDAC activities, he has no power there.&nbsp; And it was a very big boost on NAFDAC that a man that is regarded as god did not have power over us.&nbsp; So it was a very good boost.</P> <P>&nbsp;Roger Bate:&nbsp; Yeah, in front here.&nbsp; Thank you.</P> <P>&nbsp;Carrie LaCrosse:&nbsp; Ms. Akunyili, thank you for coming today.&nbsp; Your story is very impressive, and we appreciate having you.&nbsp; My name is Carrie LaCrosse; I m with the State Department.&nbsp; And my question is, clearly, you have done an incredible amount of work, working within your country with your government, with the public, and the press.&nbsp; Are there things that your partner countries, such as the U.S. or other countries, could do to assist you?&nbsp; Are there things that we could do in the area of capacity building or resources or possibly helping other countries in the region or other countries in Africa in dealing with the same issue?&nbsp; </P> <P>&nbsp;Dora Nkem Akunyili:&nbsp; Thank you very much.&nbsp; Let me start by saying that USFDA under Dr. Adeniyi-Jones s section, U.S.--</P> <P>&nbsp;Roger Bate:&nbsp; Health and Human Services.</P> <P>&nbsp;Dora Nkem Akunyili:&nbsp; Health and Human Services.&nbsp; They have always helped us in area of capacity building.&nbsp; We do not mind being Oliver Twist.&nbsp; We need more help, especially in the area of clinical trials.&nbsp; In 2001 and 2002, we actually used to bring samples.&nbsp; When we had not updated our laboratories, we brought a lot of samples for USFDA laboratory to help us with.&nbsp; And they did help us.&nbsp; We brought down Coca-Cola drinks and all when we had a fight with Coca-Cola on the level of sugar and so on.&nbsp; </P> <P>But I think that we can get more help from U.S., especially in the area of capacity building.&nbsp; I do not know if Nigerian government will feel comfortable if I say that what you might call obsolete equipment, we can use.&nbsp; Because some of these equipment, you change after three years, and they may still be top of the range for us.&nbsp; We are not on the same level of development.&nbsp; There was a time I pleaded with USFDA to give us their used equipment.&nbsp; And I asked the ambassador to follow it up in 2002.&nbsp; And I got some promises, but I never got them because if we got them, we could pay for the freighting and clearing.&nbsp; I think we need help.</P> <P>&nbsp;Thomas Woods:&nbsp; That is a great question.&nbsp; Actually, I m aware of one bit of help that we have talked about, and that is to do a follow-up baseline study of the level of counterfeit drugs currently existing in Nigeria.&nbsp; NAFDAC had funding several years back for one study.&nbsp; And it would be, I think, very useful for the organization to know what their progress has been.&nbsp; So a follow-up study would be timely. </P> <P>Roger Bate:&nbsp; I m going to take some more questions in a second.&nbsp; But you mentioned clinical trials.&nbsp; And I m not asking you to discuss this specific ongoing fight that is going on between Pfizer and the Kano government, I think, the federal government.&nbsp; But that has sent, I think, a signal to Western pharmaceutical companies that conducting clinical trials in Nigeria may be difficult.&nbsp; I wondered if you, more generally - you can comment on that if you want to - but more generally, what are the associations, at least in Nigeria, potentially globally, between intellectual property protection and combating counterfeit drugs?&nbsp; Are there associations or do you think that they are largely irrelevant?</P> <P>&nbsp;Dora Nkem Akunyili:&nbsp; Somehow, combating drug counterfeiting is also a way of protecting intellectual property because the counterfeiters copy.&nbsp; They sound alike, look alike.&nbsp; So it is a way of stealing people s intellectual property.&nbsp; When we fight drug counterfeiting, we are fighting intellectual property rights.&nbsp; </P> <P>And that is why we insist in NAFDAC that before people register their drugs, they must, first of all go and get a trademark.&nbsp; And once there is a trademark existing, the people are not allowed to use the same name or any name that sounds like the same name.&nbsp; Intellectual property right protection --I can say fighting drug counterfeiting is an extension of that, because it is people s products that are generally copied.&nbsp; They do not produce anything new.&nbsp; They just as in the area of wristwatches, designer bags, and so on, it is just economic loss.&nbsp; But in the area of drugs, it is economic loss and health issues.&nbsp; </P> <P>&nbsp;Roger Bate:&nbsp; And the clinical trials, anything to add?</P> <P>&nbsp;Dora Nkem Akunyili:&nbsp; Sorry?</P> <P>&nbsp;Roger Bate:&nbsp; Clinical trials -- anything to add?</P> <P>&nbsp;Dora Nkem Akunyili:&nbsp; Well, on clinical trails.&nbsp; You see, I m never afraid to speak on any issue.&nbsp; I know that the case is in court, but the point is that Nigeria is open for clinical trials.&nbsp; We have put up guidelines and procedures that we did not have in the past.&nbsp; We have put up protocols and everything is so streamlined that anybody that wants to do clinical trial, we are asking that they should come.&nbsp; </P> <P>We have the population.&nbsp; In fact, Nigeria is a country that in Lagos alone you can get 20 million people.&nbsp; When somebody said he wanted to do clinical trial on pregnant women, I say,  If you want one million pregnant women in Lagos, give us one week. &nbsp; So yes, we have number.&nbsp; And because of that number, it should be attractive to investigators.&nbsp; We know that clinical trials will help us build capacity because they will help us train people in Nigeria; it is also an income-generating venture.&nbsp; </P> <P>The important thing is for it to be done properly.&nbsp; For NAFDAC to have responsibilities of putting down what is required and following it up, because sometimes, the problem is not always people that are coming to do it.&nbsp; It can also be partly the problem of the regulator not being able to monitor what who is doing.&nbsp; And right now, I can tell you that we are living up to our responsibility.&nbsp; We are appealing, actually, to companies to come and do clinical trials in Nigeria.</P> <P>&nbsp;Roger Bate:&nbsp; Great.&nbsp; Perfect answer.&nbsp; Thank very much.&nbsp; Lady over here.</P> <P>&nbsp;Meredith Wadman:&nbsp; Hi, I m Meredith Wadman.&nbsp; I m a reporter with Nature.&nbsp; I was curious about the -- you say that over 41 percent of counterfeit drugs in circulation in Nigeria in 2001 had dropped to 16.7 percent in 2006 and should be 10 percent as we speak, you said.&nbsp; Can you talk about which of those numbers is published and the methodology that you used to get to them, and then how do you get to the 10 percent today, which I take it as a guesstimate at this point?</P> <P>&nbsp;Dora Nkem Akunyili:&nbsp; Thank you very much.&nbsp; The over 41 percent we got were actually reports from different people, Lambo, Poole, Ochekpe, Taylor, et al.&nbsp; We actually took a conservative average because some of them were going up to 70-something percent and they were right.&nbsp; Because we had more counterfeit in the system than genuine, that we took a conservative average.&nbsp; The 16.7 that WHO got -- WHO/DFID carried out a study in 2005, 2006, and actually collected drugs from all over the country from markets, from hospitals, from shops at random and sent to WHO-certified laboratories in Thailand.&nbsp; They brought back results and their consultants analyzed, and found those ones that were counterfeit and they came to 16.7 percent.&nbsp; We also took samples of the same drug to our laboratories and checked with what they brought.&nbsp; And our laboratory and WHO laboratory in Thailand, the results actually agreed.&nbsp; </P> <P>Right now, from the sampling we do in the markets and shops, randomly, we have found that we have less than 10 percent.&nbsp; But the study is not an organized one.&nbsp; And that is why Tom was appealing to USFDA that this is an area where they can help us because we need to, at least once in two or three years, find out the level of incidence so that we can measure our progress.&nbsp; And when our progress is measured, the progress of Sub-Saharan Africa is actually measured because all these countries depend on Nigeria.&nbsp; What happens in Nigeria, generally, is what happens in Sub-Saharan Africa because they all buy from us.&nbsp; Nigeria is their big brother.&nbsp; </P> <P>&nbsp;Roger Bate:&nbsp; Question at the back.&nbsp; And if I can just add from, I think, as an outsider looking at the data I have done in the last 18 months.&nbsp; Nigeria s data are more accurate than most developing countries in the world.&nbsp; The figures, for example, coming out of the Indian government, albeit, it is about 0.4 percent of their products are spurious, i.e. counterfeit, and then something like 8 percent substandard.&nbsp; I would think the most of the analysts that I have spoken to in India - I was there recently - would say the figures are at least three or four times higher than that.&nbsp; So I think Nigeria s figures are probably more accurate than anywhere other than perhaps Europe and United States.&nbsp; Next question.</P> <P>&nbsp;Anthony Ikeme:&nbsp; My name is Anthony Ikeme.&nbsp; I m actually from Nigeria.&nbsp; I m just going back to the question on clinical trials.&nbsp; Prof. Akunyili, I must say it is always good to listen.&nbsp; It is not the first time I have done that, and I will always look forward to listening to you talk.&nbsp; It is very inspiring.&nbsp; </P> <P>But coming back to clinical trials, I actually run a CRO [sounds like] that has operations in Nigeria.&nbsp; I wanted to say that maybe, Prof. Akunyili, maybe what also letting them know that clinical trials in Nigeria is not just something government is pushing, but it is something the entire public is very receptive of, because this Pfizer issue may lead a lot of people to have a wrong impression of how clinical trial is perceived in Nigeria.&nbsp; The entire public in Nigeria is receptive of clinical trial.&nbsp; </P> <P>There is actually an organization called AGCPN who is actively involved in building capacity.&nbsp; We were involved in a training last October where we have a bunch of people coming to be trained on how to run clinical trials and conduct clinical trials.&nbsp; And I say, co-independently, we have also been training investigators in Nigeria.&nbsp; And I can tell you that enthusiasm for clinical trials is very high in Nigeria.&nbsp; So I think it is worth mentioning just so that people do not have a wrong impression about how Nigeria perceives clinical trials as a veritable part of the health strategy in Nigeria.&nbsp; Thank you.</P> <P>&nbsp;Dora Nkem Akunyili:&nbsp; Thank you very much.&nbsp; I also want to add that Nigerian public trusts NAFDAC so much that once they see authorization from NAFDAC for clinical trial, everybody will submit to that.&nbsp; </P> <P>&nbsp;Roger Bate:&nbsp; Great.&nbsp; Did you have a question?&nbsp; Yes, go ahead.&nbsp; I ignored you.&nbsp; I apologize for that. </P> <P>&nbsp;Rachel Nugent:&nbsp; Rachel Nugent&nbsp; from the Center for Global Development.&nbsp; We have a project that is underway on the issue of global drug resistance.&nbsp; As you pointed out, resistant micro-organisms do not need visas, so it really is a global problem.&nbsp; </P> <P>I m interested in your telling us that you have asked people in India and China -- you hired people to do inspections to try to look at the situation there.&nbsp; That would seem certainly to be something of interest to your neighbor countries, as well as other countries that are experiencing this problem of defective and low quality imports.&nbsp; Do you see some potential for joining together, perhaps along the lines that you have already done with WADRAN?&nbsp; And what are some lessons from the WADRAN experience that might indicate a broader possibility of countries who are importers bonding together to try to address the problem at the source?&nbsp; Thank you.</P> <P>&nbsp;Dora Nkem Akunyili:&nbsp; Thank you very much.&nbsp; You started with global drug resistance.&nbsp; You are right.&nbsp; Resistant strains, they do not need visa.&nbsp; If I have a resistant tuberculosis strain, you would not know by looking at my face and the embassy would not have detected it.&nbsp; That is why the global community should look at it very seriously and you see this resistance to antibodies and anti-malaria.&nbsp; </P> <P>When I m talking to the public in Nigeria, I break it down to common language.&nbsp; The way you are given small, small chemical for which the big quantity can kill an organism to the patient, the organisms get used to that chemical.&nbsp; So when you now give enough of the anti-malaria or the antibiotic, that organism has gotten used to the food we are given to eat.&nbsp; Because it would become food, part of it.&nbsp; So that was why we actually got into trouble with anti-malaria, antibiotics, and so on.&nbsp; </P> <P>As far as I m concerned, it is better for a criminal not to put anything in an anti-malaria than to put 10 milligram; not to put anything in Zinnat - the one we found - not to put 10 milligram or 20 milligram of Zinnat.&nbsp; So that is one of the pointers that actually tell us that we need to work in concert, not just in Africa but globally.&nbsp; </P> <P>In India and China, yes, we have put up independent analysis, and we have asked other West African countries to do the same.&nbsp; But you see they have to follow at their own pace.&nbsp; We can only advise and urge them.&nbsp; Some of them do not have the capacity.&nbsp; They do not have the human capacity.&nbsp; They are poor.&nbsp; We have even talked with our former president to give us resources to help them.&nbsp; If government gives us resources to help them, they would not have been able to grow more.&nbsp; </P> <P>But if we can get resources from the international community to strengthen WADRAN, Sub-Saharan Africa would be better off for it.&nbsp; Some of the country will not commit except if we pay for them.&nbsp; And WADRAN is actually, right now, making enough progress to attract East African countries.&nbsp; They are joining us.&nbsp; We are also working hard to strengthen the African region, because the more we work together, the more we are able to frustrate the counterfeiters.&nbsp; </P> <P>For instance, when we banned companies in Nigeria and I insist that other WADRAN countries will ban the companies, it teaches them more.&nbsp; Because it is not just Nigeria, it is 14, 16 other countries.&nbsp; And we are now getting East Africa.&nbsp; We are working with south and northern part of Africa.&nbsp; The coalition, we are looking at it to grow enough for impact - for us to have a global coalition, a global coalition that will speak for everybody.&nbsp; A global coalition that can make a statement on India, and the Indian government will listen.&nbsp; That can make a statement to Chinese government, and they will listen.&nbsp; And for me, my dream is to work in that kind of coalition.&nbsp; Maybe I m talking too much.&nbsp; I think I have answered your question.</P> <P>&nbsp;Roger Bate:&nbsp; Indeed, yes.&nbsp; I m going to take one more question.</P> <P>&nbsp;Richard Tren:&nbsp; Thanks very much.&nbsp; My name is Richard Tren from Africa Fighting Malaria.&nbsp; I m from South Africa, and I have many conversations with drug manufacturers there.&nbsp; Their frustration is registering the legitimate medicines, good medicines through the South African Pharmaceutical, the equivalent of the FDA there.&nbsp; And many years ago, the southern African region was supposed to harmonize their drug regulation process.&nbsp; I think, to my knowledge, if anything, it has gone backwards.&nbsp; It is less harmonized.&nbsp; </P> <P>My question is how do you work to ensure that the good, legitimate manufacturers that have registered their medicines in the U.S. and Europe, in Japan, that it is easier for them to register their drugs that you concentrate on the bad drugs?&nbsp; And is there any way of incentivizing the good drugs in that way?&nbsp; Thanks.</P> <P>&nbsp;Dora Nkem Akunyili:&nbsp; Thank you very much.&nbsp; Actually, we give fast track to any company that has registered in U.S. or registered in Britain or in some of those countries that we call green line countries, not red line countries.&nbsp; Then when the drugs are only registered in Asian countries, we give it at least three months.&nbsp; We are about the fastest in the whole world.&nbsp; We register in three months when all documentation is complete.&nbsp; If you bring Certificate of Free Sale, analysis and everything we need, and the drug, give it three months.&nbsp; </P> <P>If your drug is not registered, then you have a right to report that your drug is being delayed.&nbsp; But I have heard that in some countries, it stays for two, three years.&nbsp; It is not the same in Nigeria.&nbsp; If you bring genuine drugs, especially when they are already registered by FDA, because we know that we do not even have the capacity of FDA.&nbsp; We do not have to pretend about it.&nbsp; So if a drug is registered by FDA, it should have fast, fast track - may not be up to those three months.&nbsp; But three months is the maximum that we have told Nigerians and foreigners that after three months,  You have the right to complain that your drugs have not been registered.&nbsp; What is going on? &nbsp; Thank you.</P> <P>&nbsp;Roger Bate:&nbsp; I actually lied.&nbsp; We can have time for one more question.&nbsp; So if there is another question.&nbsp; We have one question in the front.</P> <P>&nbsp;Jeff Green:&nbsp; I m Jeff Green from the U.S. Department of Commerce.&nbsp; And first of all, I cannot agree more with your comment about the need for international global cooperation to get a handle on this problem.&nbsp; I know that you have been active in the World Health Organization, International Medical Products Anti-Counterfeit Task Force.&nbsp; Now, I just want to get your opinions on how you feel about this organization having the impact on the global problem?</P> <P>&nbsp;Dora Nkem Akunyili:&nbsp; What is IMPACT?</P> <P>&nbsp;Jeff Green:&nbsp; Yes.</P> <P>&nbsp;Dora Nkem Akunyili:&nbsp; I m the vice chair of IMPACT and IMPACT has its secretariat in WHO.&nbsp; IMPACT is making a lot of effort, but honestly, IMPACT would have moved faster if it is based in the country that is bearing the brunt.&nbsp; WHO is housing the secretariat because they have the resources.&nbsp; We do not have the resources, but we have the problem.&nbsp; And if I say it is not moving as fast as I want it, then another question would be what have you done?&nbsp; Are you not part of it?&nbsp; </P> <P>Yes, I m part of it, but we are limited because what we are doing is administrative.&nbsp; We are not backed by international law.&nbsp; That is why we are talking about international convention because international convention we give all the teeth to bite.&nbsp; Right now, we do not have the teeth to bite.&nbsp; We have IMPACT, but we have not been able to, through IMPACT, tell China that they have not done enough.&nbsp; </P> <P>Who are those people that were working with the man?&nbsp; He was working with some people.&nbsp; And really, I always feel very bad about that situation.&nbsp; Who are those people?&nbsp; Can IMPACT go to China today and investigate?&nbsp; Do they have the legal backing?&nbsp; You see, that is the problem.&nbsp; The problems are fundamental.&nbsp; </P> <P>But I believe that IMPACT has started; we have started talking, but we have not started enforcement.&nbsp; And the enforcement is not going to be too easy, especially when it is not backed by a convention.&nbsp; IMPACT knows that we have identified some counterfeit drug producing factories in India.&nbsp; I can locate some of them, the ones that BBC visited.&nbsp; What has IMPACT done?&nbsp; They are not backed by law, so it is a problem.&nbsp; We are working on the legal framework, but it may not be as strong as we want it because it is still administrative.&nbsp; We need something stronger.&nbsp; I think that is very simple.</P> <P>&nbsp;Roger Bate:&nbsp; Well, thank you very much.&nbsp; I would like everybody to put their hands together for - I have one more question.&nbsp; She wants the questions.&nbsp; And who am I to deny it?</P> <P>Judith Okator:&nbsp; Hi, my name is Judith Okator.&nbsp; And my question is what are the pharmacists in Nigeria doing to help out?&nbsp; Is there a task force inviting them to be a part of this fight?&nbsp; Because being that they are out there in the community, they might be able to be really good resource for you to help move this forward.</P> <P>Dora Nkem Akunyili:&nbsp; Thank you very much.&nbsp; We have the support of most pharmacists in Nigeria, but we also do not have the support of some pharmacists, because in every bad situation, somebody is gaining.&nbsp; Those pharmacists that are gaining from the confusion, they give us a lot of trouble.&nbsp; When we wanted to set up wholesale distribution outfits, it was those few pharmacists that made sure that scheme was frustrated.&nbsp; The majority of the pharmacists appreciate, as major stakeholders in drugs, that this should be their problem, especially the drug manufacturers.&nbsp; We always try to carry them along, but we are not getting the level of assistance we need from the pharmacists, unfortunately.&nbsp; </P> <P>Roger Bate:&nbsp; Well, thank you all very much indeed for coming.&nbsp; And I would like you all to thank our speaker today who has done a fantastic job, Dora Akunyili.</P> <P>[End of file]</P> <P>[End of transcript]</P> <P>&nbsp;</P> <P><BR>&nbsp;</P></body></html>