Roundtable On Food And Drug Law 8th March, 2012

The Food and drug industry is a multi- billion dollar industry which makes food and drug administration one of the most vital sectors of the social system of most countries. The sector accounts for a significant share of the gross national product of many countries. This cannot be divorced from the fact that the combined socio-economic importance of food and drug as the essential and the most indispensable  commodities  of human consumption  accounts for over 25% of consumer spending.

The food and drug industry is a globalised  one and the cause of millions of shipments from many facilities across the world. Growth of the food and drug industry has been attributed to globalization in various segments of economy including production, trade, technology and regulation.
The sheer size of the industry and transactions that take place within it force global regulatory standards for making the products available worldwide necessary. As large as the sector is, it is not without its challenges, which touch on social, economic and health sphere of human endeavors, and occur on both the supply and consumption side of the chain. The problem  is  more  glaring  and  destructive  in  developing  countries  such  as  Nigeria.  They include the production and sale of fake and counterfeit drugs, tampering with sealed drugs, unwholesome food production, unlicensed and unqualified sale of drugs, sale of vaccines in the  open  market,  lack  of  proper  storage  and  transportation  facilities  for food  and  drugs, unavailability of drugs in the pharmacies of hospitals and illicit drug sale. The menace caused by drug related problems are compounded by poverty, ignorance, lack of options and access to genuine drugs, availability of fake or counterfeited drugs among others. This has led to deaths, injuries, incapacity, psychological trauma and more for consumers.
The  legal  regime  responsible  for  tackling  this  menace  in  Nigeria  has  its  own challenges to grapple with. These include lack of coordination among food and drug related regulatory  bodies,  multiplicity  of regulators,  multiple  legislations  and regulations,  lack of coherence in action by regulatory agencies, lack of capacity to discharge mandate as well as lack of equipment to carry out functions.

It is for the reasons mentioned above, the need to develop Food and Drug Law jurisprudence  in Nigeria  as well as the compulsion  to address  the lack of coherence  and coordination  in the Nigerian Food and Drug Administration  with the aim of mapping out strategy for a vibrant and more effective/ efficient regime that can reduce the menace caused by fake and counterfeit drugs and unwholesome food production, that the Nigerian Institute of Advanced legal Studies Held a Roundtable on Food and Drug Law on the 8th March 2012.


Some of the observations made at the roundtable include the following:

1     The menace of fake drugs has eroded the public’s confidence in the nation’s health care delivery system.
2          Fake drugs have led to a proliferation  of treatment failures,  organ dysfunctions  or damages, worsening of chronic disease conditions, and death of many Nigerians.
3          Out  of  the  130  existing  pharmaceutical  manufacturers  with  installed  capacity  to produce   between  50%  and  75%  of  the  nation’s  drug  needs,  only  60  are  in  active manufacturing.
4          Capacity utilization in pharmaceutical manufacturing in Nigeria is below 30%

5          A huge percentage of the drugs consumed in Nigeria are imported.

6          The legal and regulatory framework of NAFDAC’s work should not be punitive based

7          Media adverts concerning the dangers of the use of fake and counterfeit drugs are being preached to the converted as the majority of the counterfeit and fake drugs are being sold and used in the rural areas.
8          Drugs  are  still  regarded  as  commercial  merchandise  hence  the  large  number  of unlicensed and unqualified sellers and peddlers.
9. Sellers and peddlers in many cases are the first point of contact by consumers.

10        The consumer’s inability to judge the quality of medicine they take becomes a huge public health challenge as such drugs can be ineffective and harmful.
11        Lack  of  knowledge  of  drug  quality  on  the  path  of  the  consumer  makes  them vulnerable to the business interest of drug sellers.
12        Patronising  peddlers  and unlicensed  sellers  are done  for several  reasons  including convenience, affordability, dependability of supply as well as poverty

13        Lack of access to medicine  in government  clinics and pharmacies  and where it is available,  the  prohibitive  cost  is  also  a  factor  that  leads  to  patronising  unqualified  drug peddlers and unlicensed drug sellers.
14        The prohibition of drugs, especially psychoactive substances is premised on the vast number of negative consequences that are thought to arise from their usage as well as the adverse reaction that characterizes the use of some of them.
15        Drug  prohibition  is also  due  to  the  social  problems  associated  with  psychoactive drugs. Drugs such as cocaine, heroin, Indian hemp are usually used by persons responsible for some incidences like murder, assault, suicide, drowning, spousal abuse and rape; most of which are against the criminal laws of states, hence the treatment of persons who commit offences in a psychoactive induced state as criminals.
16        The economic dimension to drug prohibition with respect to drug importation is to protect and encourage indigenous drug manufacturing companies in Nigeria.
17        In a study conducted in 2001, the cause of the preponderance of counterfeit drugs in Nigeria  included  ineffective  enforcement  of  existing  laws,  non-  professionals  in  drug business, loose control system, high cost of drugs, greed, ignorance and corruption.
18        Some of the awareness programmmes  lack impact and thrust and do not reflect or articulate the magnitude of the damage fake drugs can cause.
19        Fake drugs affect the entire community and not just a segment.

20        Some adverts give the wrong message as to the effect of certain drugs which in effect becomes misleading.
21        Law enforcement officers, especially those on the low income scale, are sometimes not convinced about the need to eradicate the menace of substandard drugs
22        The existence and effect of fake drugs may not be completely eradicated, but it can be minimized.
23        The percentage of imported drugs into Nigeria has reduced from the 90% range which it used to be around 2004
24        Herbal drugs consumption in itself is not a bad thing, but the problem lies with the lack of regulation of such drugs, that is not under the jurisdiction of NAFDAC as NAFDAC only regulate the product not the practice.
25        NAFDAC encourages the growth of drugs from alternative medicine. NAFDAC fully supports the National Institute of Pharmaceutical Research which is undergoing third stage test of a drug NIPRISAN, developed using herbs for the cure of Sickle Cell.

26        Illegal drug market structures have reared their heads in populated and busy areas such as Onitsha “Head Bridge”, in Anambra State, Ariaria Market in Abia State. Before these drug markets can be closed down, an alternative option in all the locations such as the Mega Drug Distribution  center in Ontisha, must be provided where only trained pharmacists  are allowed to operate
27        One  of  the  major  challenges   faced  by  all  drug  agencies   worldwide   is  drug counterfeiting which is a multi- billion dollar business
28        In wealthy economies, counterfeit drug amount to 10% of their sales, whereas about

50 % of such sale occurs online.

29        The most widely counterfeited drugs are anti- malaria, anti-biotics and analgesics.

30        Drug  counterfeiting  increases  loss  of  human  lives  and  reduces  confidence  in  the health sector
31        The  importance  of  the  sector  is  largely  due  to  the  combined  socio-  economic importance  of food and drug as the essential  and the most indispensable  commodities  of human consumption accounting for over 25% of consumer daily spending worldwide
32        The food and drug industry in Nigeria has grown from an unregulated to a regulated industry. There are regulations governing Food and Drug Administration in Nigeria
33         The legal regime governing the conduct of activities in the industry did not come to the fore until the recent national attention on the scourge of fake drugs and adulterated food substances which led to the emergence of a defined and more focused regulatory regime.
34        There   is  a  considerable   degree   of  consensus   that  regulation   has  become   an indispensable instrument of public governance of a modern economy.
35        The primary theory for regulation of food and drugs is founded on public health with sustained attention now focused on the institution of regulatory models and ‘character ‘ of governance beyond the precincts of private law.
36        Regulatory imperatives, reforms and overlaps are main challenges to food and drug law in Nigeria
37        Food and drug law has gradually  developed  into a body of law with statutes  and regulatory agencies, although it has not been fully developed in our jurisprudence.
38        The food and drug market has become completely riddled with fake, adulterated and counterfeit  products  that have undermined  the state of public health and safety, requiring urgent and more effective regulatory intervention.

39        An important part of the development of the regulatory powers of NAFDAC is the exercise  of power  of the agency  to order the withdrawal  from  circulation  of a regulated product consequent upon suspension or cancellation of registration of the said product
40        The wide ranging powers, functions and activities of NAFDAC has enabled it to be proactive and to launch a holistic campaign against fake and adulterated regulated products thus bringing the entire food and drug market under tight regulatory oversight.
41        The  Nigerian  regulatory  model  through  NAFDAC  appears  to have  moved  from a mere registration system to an effective regulatory system in addressing the menace of fake and counterfeit food and drugs.
42        There is a need to settle the imperative of the Food and drug law regime

43        There is a need to examine the adequacy or otherwise of the existing regulation to meet up with international standard of governance.
44        The Nigerian regime for food and drug law is lying in an awkward position and needs to be repositioned and made more responsive to the nagging problem of drug counterfeiting, faking and unwholesome processed foods..
45        Food and drug administration in Nigeria is multi- statutory regulated based.

46        The statutes  were enacted to regulate the various aspects of the problems  of drug counterfeiting, fake and unwholesome processed food.
47        The multiplicity of statutes has not proved to be more advantageous in tackling the problems.
48        There are lacunas in the existing statutes and some of such lacunas prevent drug law administration  from compelling  drug  manufacturers  and handlers  to carry  out some  vital functions such as Drug Formulary under the NDFA which results in practitioners relying on British National Formulary (BNF) as opposed to Nigerian national Formulary (NNF).
49        Multiplicity of statutes has engendered uncoordinated enforcement in the regulation of food and drugs in Nigeria.
50        The National Drug Formulary and Essential Drugs List Act (NDFA), a vital statute in the Food and drug Administration in Nigeria is not administered by NAFDAC.
51        With the present state of Food and Drug Laws in Nigeria, the Federal Task Force on the Counterfeit  and Fake Drugs  Act (CFDA)  and the Unwholesome  Processed  Food Act (UPFA) can enforce the law.
52        NAFDAC is operating in a challenging environment, addressing a problem that has international dimensions with local regime.

53        No statute alludes to the need for international collaboration or grant seeking in our

Nigerian Food and Drug legal regime.

54        Appropriate  international  instruments  to  help  reduce  drug  counterfeiting  or  the dumping  of counterfeit  drugs  and unwholesome  processed  food  in Nigeria  are yet to be explored.
55        There is no reliable data on the mortality or morbidity arising from the consumption of adulterated food and counterfeit drugs in Nigeria.
56        Apart from drug counterfeiting, fake drugs and unwholesome processed food, another serious problem is tampering with original packages with drugs packed in large pack sizes.
57        NAFDAC is Nigeria’s lead food safety Authority responsible for the regulation of the manufacture,   importation,  exportation,   advertisement,   distribution,   sale  and  use  of  all processed packaged food, water and other beverages.
58       NAFDAC was established to control and regulate the manufacture, importation, exportation,  distribution,  advertisement,  sale  and  use  of  food,  drugs,  cosmetics,  medical devices and packaged water including all drinks.
59        NAFDAC’s  mandate  is  shared  by  other  government  Ministries,  Departments  and

Agencies (MDAs) across the different tiers of government.

60        There is over- regulation of the industry due to overlap of functions.

61        There is lack of effective collaboration and co-ordination of the MDAs as well as a lack of system for collection and dissemination of information.
62        There is lack of effective regulation of street food vending.

63        There is a prevalence of inadequate funding of hospitals pharmacies and the “out of stock syndrome” in Nigeria.
64        There are inadequate  storage facilities,  transportation  and distribution  of Food and

Drugs in Nigeria.

65        One  of  the  major  challenges  being  faced  by  regulatory  agencies  especially  in developing countries is the counterfeiting of regulated drugs.
66        Counterfeiting has become a global problem that presents an enormous public health challenge
67        Counterfeiting, viewed from public health perspective is a major obstacle preventing access to safe, quality and efficacious medicines.
68        According  to  WHO,  over  270  million  people  in  Africa  lack  access  to  the  most essential medicines.

69        Counterfeiting  can  apply  to both  branded  and  generic  products,  and may  include products with the correct ingredients, without active ingredients or with fake packaging.
70        The  Pharmaceutical  Security  Institute  data  shows  that  most  counterfeiters  target developing countries of Asia, Africa and Latin America
71        It is also estimated that drug counterfeiting is S 750 billion business annually, while the World Customs Services estimate it as a S 200 billion business annually.
72        In emerging economies, counterfeits are estimated at 10% whilst in some parts of the developing world, counterfeits are put at about 30%.
73        According  to  a  study  conducted  by  NAFDAC  in  collaboration  with  WHO  and Department for International  Development  (DFID) in 2006, pharmaceutical  counterfeits in Nigeria stood at 16.7% as against 40% in 2001.
74        The WHO estimates that tens of thousands of people may be dying due to counterfeit of HIV/AIDS, diabetes and psychotropic medicines.
75        In an effort to reduce the negative public health impact, the burden on patients and to execute its mandate, NAFDAC has devised several strategies to improve access to safe and efficacious medicines.


The roundtable consequently came up with the following recommendations

1          There is a need to reintroduce health law into the curriculum of Nigerian Universities and other tertiary institutions
2          There is a need to have strong regulatory policy on herbal drugs

3     The  government   should  adequately  equip  and  also  have  training  facilities  for laboratory technicians in drug analysis.
4          NAFDAC  should  ensure  the registration  of all drug products  either  manufactured locally or imported.
5          The state task forces on counterfeit and fake drugs that are not in existence should be reconstituted and invigorated.
6          Pharmaceutical industries should have established drug surveillance units to monitor their products in the market to detect faking.
7          There should be stiffer penalties for those who contravene the prohibited drug laws.

8          The  various  agents  of  socialization  should  intensify  the  socialization  process  on societal reaction to deviance. The socialization should be extended to law and enforcement

agents who consume drugs illicitly and aid and abet those who are involved in the act of production.
9          There is a need for grass root enlightenment on the dangers of fake drugs.

10        There is a need for sustained public enlightenment on the dangers of fake drugs.

11        There  is  the  need  for  standard  and  regulation,  to  improve  the  quality  of  drugs circulating in the society.
12        There is a need to regulate and sensor advertisements in order to check the types and quality of products which circulate in Nigeria.
13        Sensitising the members of the public to the danger of fake drugs to health should be emphasized by NAFDAC, as opposed to the punishment for drug consumption.
14        There is a need to adopt the encouragement of attitudinal change by Nigerians to be able to tackle the menace of fake drugs
15        All drug regulatory agencies should also get involved in dealing with the challenges posed by fake drugs.
16        NAFDAC  should  create  special  zones  in  counterfeit  prone  areas  for  proper  and continuous surveillance to reduce to the barest minimum, if not eradicate the menace of the sale of counterfeit, adulterated, expired and improperly stored drugs.
17        Children should be encouraged to imbibe the culture of respect for the proper use of drugs as well as the right way to handle food from childhood
18        There should be collaboration with the appropriate international agencies for a more effective food and drug administration.
19        There should be an increase in capacity building and training of personnel involved in food and drug administration.
20        Compensation for victims of fake drugs by the sellers, should be encouraged

21        Cutting edge technology such as Truscan and use of infrared which gets the details of the drugs which can be used as evidence for prosecution should be encouraged and invested in.
22        The  provisions  of  the  Nigerian  law  must  be  distinguished  from  that  of  the  US, particularly in the area of prevention based regulation
23        The regulatory  regime  proceeding  upon specified  regulatory  policy or goal should define the regulatory practices and protocols that address the emergent nuances and mischief of the industry that the traditional legal regime or a mere regulatory coverage can no longer tackle.

24         The retention of NAFDAC among the remaining agencies at the ports of inspection will help in consolidating the gains of the current regulatory practice.
25        An effective regulatory regime beyond a mere legal regime or regulatory coverage is crucial to effective governance which constitutes the established and the primary legal regime for food and drug administration.
26        There should be an avenue by which foreign manufacturers of counterfeit drugs and unwholesome processed food who conspire with Nigerians will be made liable even where such foreigners do not come into the Nigerian territory.
27        Express provisions are needed in the FDA, NDFA and CFDA to vest the power of enforcement of Food and Drug laws on NAFDAC.
28        There is a need to domesticate  appropriate  international  instruments  with which to string  the  regime  on  Food  and  Drug  Administration  for  better  efficiency  and  effective tackling of the international  dimension of drug counterfeiting  and unwholesome  processed food.
29      The Palermo Convention under which counterfeiting, manufacture and sale of unwholesome processed food should be domesticated and applied to individuals.
30        Bilateral  treaties  should  be  used  to  clearly  and  in  detail  define  the  rights  and obligations of parties under each subject.
31        There  should  be  a  provision  in  the  NDFA  mandating  the  NAFDAC  to  annually publish NNF for guidance of medical practitioners, pharmacists and other users of the information specified in the Second Schedule to the Act.
32        The power of NAFDAC  to appoint inspection officers and their powers under the FDA and the powers  of its officers  under  the NAFDAC  Act, being essentially  the same should be streamlined to avoid the unnecessary repetition in our statutes.
33        The  provision  of  the  FDA,  CFDA  and  the  NAFDAC  Act  vesting  jurisdiction  to Federal High Court (FHC) should be amended  to give concurrent  jurisdiction  as in other criminal  matters  granted  to  the  Court  under  the  Constitution  of  the  Federal  republic  of Nigeria 1999.
34        The provision of the NAFDAC ACT on the conduct of proceedings which makes the Criminal Procedure Code applicable,  being in conflict with the provision of the FHC Act should be amended.
35        Upon the proper identification of foreign manufacturers as major actors in dumping counterfeit  drugs and unwholesome  processed  food in Nigeria,  the offence  of conspiracy should be included in the statutes governing Food and Drug Administration.

36        The  FDRA  provides  for  the  conduct  of  clinical  trials  in  accordance  with  the provisions of regulation in force. In the absence of any, there is a need to make regulations for clinical trials.
37        There is a need for overhaul and consolidation  of the legislations that make up the legal regime for Food and Drug administration in Nigeria to enable NAFDAC discharge its mandate effectively and efficiently.
38        Government  subsidized  drugs  should  be  made  available  to the public  and private health care delivery system.
39        There should be well developed distribution network of food and drugs in Nigeria.

40        There is a need to consolidate drug related laws in Nigeria.

41        There  is a need  to create  a National  Policy  on E- Medicine  and licensing  online pharmacies.
42        There is a need for improved cooperation and collaboration of MDAs with roles in

Food Safety or create a Food Safety Authority.

43        Enhanced regional co-operation, collaboration  and information sharing on food and drug safety issues should be encouraged.
44        Patient protection and affordable care to provide for the protection of sick persons and to  make  sure  consumers  have  access  to  accurate,  science-  based  information  about  the products they need and rely on every day to improve their health and well- being.
45        There should be Increase in the nation’s preparedness to address threats as a result of bioterrorism pandemic and emerging infectious diseases to ensure organisational excellence, transparency and accountability.

Professor Epiphany Azinge, SAN Director General