[Ip-health] Presentation by Nigeria to WIPO Advisory Committee on Enforcement (Monday, 15 May 2006)

[Thiru Balasubramaniam]

WIPO/ACE/3/9
ORIGINAL: English
DATE: April 28, 2006
WORLD INTELLECTUAL PROPERTY ORGANIZATION
GENEVA

ADVISORY COMMITTEE ON ENFORCEMENT
Third Session
Geneva, May 15 to 17, 2006
CONSIDERATION OF INTELLECTUAL PROPERTY RIGHTS IN REGULATION
AND CONTROL: ACTIVITIES OF THE NATIONAL AGENCY FOR FOOD AND DRUG
ADMINISTRATION AND CONTROL (NAFDAC) *
Document prepared by Prof. D. N. Akunyili,
Director General, NAFDAC Nigeria




CONSIDERATION OF INTELLECTUAL PROPERTY RIGHTS IN REGULATION AND CONTROL:
ACTIVITIES OF THE NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND
CONTROL (NAFDAC)


INTRODUCTION

The topic "Consideration of intellectual property rights in regulation
and control activities of NAFDAC" will highlight the activities of the
National Agency for Food and Drug Administration & Control (NAFDAC) in
actualizing its mandate which is to regulate and control foods, drugs
and other regulated products with reference to intellectual property
rights. This is carried out in tandem with the federal government policy
of ensuring optimum public health alongside promotion of individual
private investment. NAFDAC is not oblivious of the provisions of
agreements on trade related aspects of intellectual property rights
(TRIPS) which has not been domesticated in legal system of Nigeria. Be
that as it may, the Agency has taken measures to ensure that its primary
focus which is safeguarding public health as mandated by its enabling
laws and consistent with national policy are effectively pursued.

The different forms of intellectual property namely, trademark and
patents are relevant to the regulatory and control function of the
Agency. While not primarily focused on enforcement of property rights,
the Agency=E2=80=99s concerns are on how claims and counterclaims on these
issues affect its primary responsibilities. Being that its regulatory
functions are product based, much attention is paid to trademark issues
because of product identity. The onus of proof however lies on the
claimants. From a regulatory standpoint, distinctiveness is the essence
of a valid trademark. Whatever that detracts from this, will be a pure
recipe for confusion and a negation of the right of a consumer to make
informed choice.

Patents which are mostly drug related are recognized in so far as they
are consistent with the national drug policy. The main objectives of the
national drug policy are to make effective, safe and low cost drugs
available and affordable to meet the needs of the entire population and
to ensure that drugs are of good quality and used rationally.

Misbranding or counterfeiting of regulated products is a direct
consequence of violation of intellectual property rights. The prevalence
of violations of these rights and the need for proper management of
intellectual property regime offer compelling reasons for enforcement
activities within a legal regulatory framework.


THE LEGAL REGULATORY FRAMEWORK

The National Agency for Food and Drug Administration and Control
(NAFDAC) is a body corporate established by the NAFDAC Act of 1993 now
listed in the Laws of the Federation of Nigeria 2004 as Cap NI.

NAFDAC is empowered under the enabling law to amongst other things:
regulate and control the importation, exportation, manufacture,
advertisement, distribution, sale and use of food, drugs, cosmetics,
medical devices, packaged water and chemicals, generally know as
regulated products.

The Agency is mandated to under take the registration of regulated
products. Related to this, is the recognition of intellectual property
rights in evaluation of data and products submitted for marketing
authorization.

Under the provisions of various regulations and related guidelines on
registration, the submission of evidence of ownership of trademark is a
condition precedent for the registration of branded regulated products.
Although, whenever any trademark right is in conflict with any
regulations or requirements of the Agency, the latter will supercede
(e.g. the issue of look alike and sound-alike). This is informed by the
need to ensure that the Agency's core mandate which essentially is the
protection of consumers by ensuring the use of only safe, wholesome,
quality and properly labeled regulated products is effectively adhered to.

Having recognized counterfeiting and circulation of fake products as a
health issue as well as an infringement of intellectual property rights,
the Agency has as part of its Enforcement Directorate, a police force
squad that is responsible for ensuring that its regulations and
guidelines are adhered to. They are to arrest any person suspected of
committing an offence under the national law on counterfeiting and
collation of files for prosecution by the Agency's legal team.


MEASURES TAKEN BY NAFDAC IN THE FIGHT AGAINST THE INCIDENCE OF
COUNTERFEIT REGULATED PRODUCTS AND TO PROTECT INTELLECTUAL PROPERTY RIGHTS.


PUBLIC ENLIGHTENENT CAMPAIGNS

NAFDAC is empowered under section 14 of its enabling law to apply the
resources at its disposal to publicize and promote its activities. This
includes enlightenment campaign, which remains one of its most effective
strategies in combating product counterfeiting and ensuring effective
protection of intellectual property rights.

This is the Agency=E2=80=99s most effective strategy involving dialogue,
education and persuasion.

It is sustained by using:

=E2=88=92 Print and electronic media such as jingles, alert notices, erecti=
on of
billboards, publication of differences between identified fake and
genuine products in the national dailies, etc.

=E2=88=92 Production of many other publications, fliers, leaflets and poste=
rs,
both in English and Vernacular languages;

=E2=88=92 Workshops, seminars and meetings have been conducted for most
stakeholders.

=E2=88=92 Mobilization campaign for rural dwellers is on- going.

The campaign has also been extended to Nigerian High Schools in order to
catch them young, by organizing annual competitions and prize giving
ceremonies on their understanding of the ill effects of counterfeit
regulated products on the society. The Agency has established NAFDAC
Consumer Safety Clubs in most schools in Nigeria. These activities are
further geared towards educating the young ones on the dangers of
counterfeit regulated products, inculcating in them the value of genuine
products and encouraging them to join NAFDAC in this fight.

Enlightenment and the resultant change of heart are result-oriented and
complementary to prosecution, which the Agency had used over the years
with little success.

Above all, NAFDAC enlightenment campaigns have greatly empowered the
public to recognize and reject counterfeit regulated products, thereby
enhancing public awareness of intellectual property rights.

ADVOCACY AND COLLABORATION WITH RELEVANT STAKEHOLDERS

In line with one of the functions as contained in section 5 (r) of its
enabling law, which empowers the Agency to liaise with relevant
establishments within and outside Nigeria in pursuance of its mandate,
it has working relationship with the Police, Customs, the Ports
Authority, the National Drug Law Enforcement Agency, the Standards
Organization of Nigeria etc. This type of collaboration is to address
areas of overlapping functions, which counterfeiters are wont to
exploit. Good collaboration enhances effective enforcement. This
collaboration has resulted in the designation of exclusive ports of
entry for regulated products and release of cargo manifests from the
ports authority, shipper's council and all airlines to the Agency for
comprehensive inspection of cargo.

Moreover, there are various administrative bodies set up by the
government where stakeholders meet to formulate policies and review
strategies for combating the incidence of counterfeit products.

Also, one of the gains of the Advocacy and collaborative efforts is an
understanding between the Agency and Central Bank of Nigeria to require
clearance permit from NAFDAC prior to issuance of foreign exchange to
manufacturers and importers of pharmaceutical products to ensure that
they are genuine and authorized by NAFDAC.

The Agency has various understanding with relevant regulatory agencies
such as the United States Food and Drug Administration (USFDA) aimed at
pursuing areas of collaboration in the area of information exchange,
staff training and technical assistance.

PARTICIPATION AND COLLABORATION WITH THE LEGISLATURE

The Agency has had several meetings with members and relevant committees
of the two legislative houses of the National Assembly in Nigeria
namely: the House of Representative and the Senate in order to
strengthen the Agency's laws on counterfeiting of products and its
regulatory framework among other things. In this regard, a draft bill on
NAFDAC has been forwarded to the legislature which is currently
receiving attention. The Agency has made various contacts and hopes to
diligently follow-up the passage of the bills and its eventual assent by
the President of the Federal Republic of Nigeria.

COLLABORATION WITH THE BAR

NAFDAC has continued to collaborate with the Nigerian Bar Association
due to the strategic role they play in the administration of justice.
The Agency has honoured several invitations from them to address their
members on the need for effective fight against counterfeit regulated
products. For the most part, some of the frivolous and ill-motivated
applications for injunctions restraining the Agency from dealing with
counterfeiters are devised and pursued by lawyers on the prompting of
their unscrupulous clients. The Agency concedes the fact that a great
number of gentlemen of the bar may not be aware of the dangers of
counterfeit products, hence the Agency's desire to embark on advocacy drive=
.

Moreover, the Agency has called and keeps calling on the members of the
Bar Association to bring their tremendous influence and clout to bear on
the legislature to ensure that the laws particularly in the area of
sentencing of convicted counterfeiters, who get very minimal sentence
for the commission of this very dangerous class of offences, are reviewed.

COLLABORATION WITH THE JUDICIARY

Following the massive enlightenment campaign by the Agency, there is
sudden national awakening that the issue of counterfeiting, which is
tied to intellectual property rights, is a major public health issue.

Indeed it has become a national issue. The Agency has also paid numerous
visits to members of the judiciary to ensure the mounting of a
conference for judges. This has resulted in the approval of a conference
on counterfeit pharmaceuticals and by extension other regulated product
by the National Judicial Institute, in association with the Agency, from
18th to 19th October 2006.

It is pertinent to mention that the National Judicial Institute is part
of the Nigeria Judicial system entrusted with the training and continued
education of judges. No doubt, this training, which will become a
regular feature in the Agency's regulatory calendar, will enrich judges'
knowledge of intellectual property rights and the scourge of counterfeit
products. The exemplary decision of Honourable Justice Adeniyi Ademola
sitting at the Federal High court in Kano Nigeria in the case of Federal
Republic of Nigeria Vs Nonye Iwunze involving the counterfeiting of some
drugs in the year 2005 wherein the Judge sentenced the offender on
conviction to 5yrs imprisonment or option of fine to the tune of
N500,000.00 on the two counts is worthy of mention.

BLUE PRINT ON ANTI-COUNTERFEITING

Realizing the complexity in the Intellectual property rights protection
and the anti-counterfeiting campaign; the Agency published a blueprint
to guide her in that regard. The blue print covers the year 2005-2010.

The strategy will address issues such as

=E2=80=A2 Sustained consumer awareness and education;
=E2=80=A2 Enhancement of partnership between the regulated product
manufacturer/importer and NAFDAC especially in the areas of policy
implementation, communication and introduction of modern security features;
=E2=80=A2 Provision of more effective legal framework for control and
prosecution of counterfeiters;
=E2=80=A2 Collaboration with other stakeholders both nationally and interna=
tionally;
=E2=80=A2 Effective monitoring, surveillance and enforcement.

STAFF RE-ORIENTATION AND MOTIVATION

At the inception of NAFDAC present administration, the need for staff
re-orientation was glaring. A total change of mindset and in fact, an
organizational cultural revolution were needed.

The following measures were undertaken to reposition staff for better
effectiveness:

=E2=88=92 Retrenchment of corrupt, redundant and incorrigible staff;
=E2=88=92 Induction training for new staff, specialized in-house and overse=
as
training and computer appreciation courses were organized;
=E2=88=92 Availability of information technology tools;
=E2=88=92 Effective delegation of duties and staff empowerment ;
=E2=88=92 Constant staff performance monitoring to ensure commitment and
effectiveness;
=E2=88=92 Hard work, dedication and integrity are adequately compensated to
encourage staff;
=E2=88=92 Leadership by example is highly emphasized;
=E2=88=92 Streamlining and Strict Enforcement of Registration Guidelines.

NAFDAC has strengthened its registration processes with some
administrative guidelines:

=E2=88=92 All drugs must comply with laboratory standards and inspection
requirements before they are registered;

=E2=88=92 Renewal of registration of drugs is every five years, while herba=
l
medicine is yearly;

=E2=88=92 NAFDAC insists on fixing of NAFDAC REGISTRATION NUMBER on the lab=
el of
all products to enable the public identify authorized drugs;

=E2=88=92 Drugs can be imported for only ten years, after which the importe=
r
must start producing locally.


STOPPING THE IMPORTATION OF COUNTERFEIT REGULATED PRODUCTS TO NIGERIA AT
SOURCE

To achieve this, NAFDAC has put in place some administrative guidelines
which include:

=E2=88=92 NAFDAC officials must inspect factories anywhere in the world bef=
ore
they register or renew registration for drugs, cosmetics, food and other
regulated products to ensure Good Manufacturing Practice (GMP) compliance;

=E2=88=92 NAFDAC has appointed analysts in India, China and Egypt who re-ce=
rtify
drugs before exportation to Nigeria;

=E2=88=92 NAFDAC requires mandatory pre-shipment information to be provided=
 by
all importers before the arrival of their drugs;

=E2=88=92 Nigerian banks insist on NAFDAC's clearance before processing
financial documents for drug importers.

BEEFING UP SURVEILLANCE AT ALL PORTS OF ENTRY

NAFDAC has re-enforced the two new directorates of Ports Inspection and
Enforcement for more effective surveillance at all ports of entry, and
better enforcement activities respectively.

Hitherto, land and sea borders were major routes of importation. The
Agency, having considerably intensified surveillance at these borders,
drug counterfeiters resorted to using airlines. Consequently, NAFDAC
issued a guideline that any aircraft that lifts drugs to Nigeria without
obtaining NAFDAC's authorization from their clients would be grounded.

=E2=80=A2 Mopping Up Counterfeit Drugs Already in Circulation

Cognizance of Nigeria=E2=80=99s many porous borders, NAFDAC embarks on plan=
ned,
continuous and sustained surveillance at all markets and retail outlets
for drugs.

This led to closure of 2 major drug markets for 3 -6 months. To achieve
high level of success with this mopping up exercise, NAFDAC has put in
place the following administrative guidelines:

=E2=88=92 Confiscation and subsequent destruction of drugs from sellers who=
 fail
to provide a proper invoice of purchase with full name and address, in
order to trace the big time importers and distributors of fake drugs.

Faced with the frustrations of evacuating many lorry loads of fake drugs
from warehouses on tip off without anybody accepting ownership, NAFDAC
notified the public that whenever the importer cannot be traced, the
landlord of the premises used for the storage of fake drugs would be
arrested, with a view to tracing the fake drug importer. In one occasion
in Lagos, it was only after the landlord of the warehouse was arrested
that the fake drugs' owner surfaced.

Raids are regularly carried out on drug hawkers, and their drugs are
confiscated and destroyed.

Fake drug dealers are also traced through reports from health
professionals or victims and constant tip-off from the public.

Routine sampling, checking and testing of all NAFDAC registered drugs in
circulation are routinely carried out.

MONITORING GMP OF LOCAL MANUFACTURERS

NAFDAC regularly monitors local manufacturers of drugs and other
regulated products. Compliance directives are issued and enforced to the
letter when lapses are observed. While prosecution is carried out when
counterfeit regulated products are manufactured.


SOME OF THE ACHIEVEMENTS AND GAINS RECORDED

=E2=88=92 Sanitized the food and drug industry and created a reasonably wel=
l
regulated environment which have saved the lives of millions of
Nigerians and boosted the economy by encouraging local industries,
genuine importers and foreign investors.

=E2=88=92 Immense public awareness resulted in the participation of all
stakeholders in the promotion of food and drug regulation in Nigeria,
and awakened the international consciousness that Nigeria is no longer a
dumping ground for fake drugs.

=E2=88=92 The level of incidence of fake/unregistered drugs has been reduce=
d by
about 90% from what it was in 2001.

=E2=88=92 The production capacities of local pharmaceutical industries have
increased tremendously, and 22 new drug manufacturing outfits were
established in the last 5 years.

=E2=88=92 The confidence of investors in the pharmaceutical industry has be=
en
reinforced as evidenced by the continuous upward movement in the share
prices of the pharmaceutical companies quoted in the Nigerian stock
exchange.

=E2=88=92 Ban on made-in-Nigeria drugs has been lifted by other West Africa=
n
countries.

=E2=88=92 Many Multinational Drug Companies are coming back to Nigeria due =
to
improved regulatory environment.

=E2=88=92 From April 2001 to January 2006, NAFDAC carried out over 100
destruction exercises of counterfeit and substandard products valued at
about US$100 million.

=E2=88=92 From 2001 to July 2005, over 1,000 raids were carried out on
distribution outlets of fake drugs.

=E2=88=92 45 convictions were secured in respect of counterfeit-drug relate=
d
cases, and over 56 cases are pending in courts.

=E2=88=92 Sanctions on erring manufacturers and importers are increasing
steadily. 2,226 in 2002; 3,178 in 2003; and 3,460 in 2004 and 4,132 in 2005=
.

=E2=88=92 By reason of NAFDAC requirements the Nigerian Patent and Trademar=
k
Office is enjoying increased patronage evidenced with upsurge in
application for Trademarks relating to NAFDAC regulated products.


CONCLUSION

There is no doubt that massive, sustained public enlightenment and
education of consumers, importers, distributors and retailers of
regulated products ensures willful compliance to regulatory requirements
and enables the regulator focus on primary responsibilities which is
safeguarding public health. While the responsibility for enforcement of
intellectual property right rests with the owner, the Agency has in
place, procedures to check such infringements, such as counterfeits, as
they impact on its regulatory functions.

There is need for the police, customs, the Patent and Trademark Office
and other relevant government bodies to ensure that counterfeiters are
not given any room to operate by exploiting any seeming overlap and
conflict. The realization that the consumers should be protected and
counterfeiters stopped from reaping the gains of their illegal and
dangerous enterprise will galvanize the various bodies into closing
ranks and forming a formidable force.

Finally, regional and international networking of stakeholders more
particularly, the regulatory bodies should be encouraged for the
exchange of information and adequate tracking and tracing of
counterfeiters and their loot for appropriate sanction. This has brought
to the fore the need for multilateral conventions on counterfeiting of
regulated products, particularly drugs, which have become a lethal
weapon of mass destruction in the hands of counterfeiters. This
obviously will lead to effective enforcement of intellectual property
rights and must be dealt with decisively.



[End of document]