The role of compliance in pharmaceutical cross-border trade презентация

Trade Compliance Summit
Sheraton Hotel, Lagos (May 22,2014)
Presented by Remi ADESEUN, FPSN.

(Consumer) Angle
Best Practice
Summary

Remi ADESEUN

Economic, financial, Trade, and communications integration.
4 Basic Aspects according to IMF:
 trade and transactions, 
capital and investment movements, 
migration and movement of people
the dissemination of knowledge.[7]
Ref:International Monetary Fund . (2000). "Globalization: Threats or Opportunity." 12th April 2000: IMF Publications.

Globalization
process by which an increasing share of the economic activity in the world is taking place between people from different countries

transporting them to interested markets.

Remi ADESEUN

in one country and the buyer in the other country, for example, a company in the United States selling to a company in Canada. Or a company in Nigeria selling to a company in Ghana.

Africa is that African countries trade very little between themselves, 
only 10-12 percent of total trade, whereas regional trade accounts for 63% in EU, 40% in the US and 30% in Asean countries.”
Ref: http://kariobangi.com/2012/02/13/are-african-economies-too-similar/

& Customs Practices around the world
Deep understanding of
import and export laws and regulations,
The Global Supply Chain
Trade Processes and Controls
Extensive knowledge of Pharmaceutical Laws and Regulations
Forward-thinking attitude/Global Mindset
Harmonisation of Regulatory Requirements

driver for increased intra-regional trade
East Africa has made significant progress in this regard by making Product Registration in one Country acceptable for trade in another country
Leading to improved Compliance and enhanced Cross-Border Pharmaceutical Trade

a step-wise approach to harmonisation (e.g Start with Generics)
A need to invest in regulatory and industry capacity building,  
Acknowledgment that NMRAs must follow through on their mandate to promote and protect public health  
Sustainability, transparency and trust building  
Use of existing structures and broader REC strategies to advocate for AMRH
National sovereignty must be respected,  
Existing forums should be used to provide regulators with practical advocacy (African Medicines Regulators Conference (AFDRAC), International Conference for Drug Regulatory Authorities (ICDRA), International Conference on Harmonisation Global Cooperation Group (ICH-GCG)
Need for the Consortium to keep all stakeholders informed and involved  
Need to capitalise on strategic niche roles of key players including:WHO, NEPAD, DFID, etc.

Risk Issues concerning conducting cross-border business

enter into a Country in conformance with all laws and regulations of that Country.  
It should be the goal of the Customs Service to maximize trade compliance while facilitating the importation of legitimate cargo. 

international trade and transport,
the growing awareness of trans-national organized crime and, more recently,
the threat of terrorism.
increased awareness in Customs administrations that national and and international co-operation is essential

Laws
NAFDAC Act, Cap N1 LFN 2004 (formerly Decree 15 of 1993 as amended) + 14 Subsidiary Regulations
Drugs and Related Products (Registration, etc) Act Cap F33 LFN 2004 (Formerly Decree 19 of 1993 (as amended)
Pharmacists Council of Nigeria (PCN) Act 91 of 1992
Food and Drugs Act Cap 150 LFN (as amended)
National Drug Formulary and Essential Drugs List Act Cap 252 LFN 1990
Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Cap 34 LFN 2004 (formerly Decree 25 of 1999)
Poisons and Pharmacy Act (PPA) Cap 535 LFN 1990
Dangerous Drugs Act (DDA) Cap 91 LFN 1990
NDLEA Act of 1989

Drug Laws

Poisons and Pharmacy Act (PPA) Cap 535 LFN 1990
Dangerous Drugs Act (DDA) Cap 91 LFN 1990
NDLEA Act of 1989

Remi ADESEUN

NAFDAC Act CAP N1 LFN, 2004) to Regulate and Control the Importation, Exportation, manufacture, distribution, advertisement, sale and use of Foods, Drugs, Cosmetics, Medical Devices, Chemicals, Detergents and packaged water.
This mandate places on Ports Inspection Directorate (PID) the responsibility of carrying out the following functions and exercising powers as described in sections 5d,5e and 5g of the NAFDAC Act.

drugs, cosmetics, medical devices, bottled water and chemicals and establish relevant quality assurance systems, including certification of the production sites and of the regulated products;
5e) compile standard specifications and guidelines for the production, importation, exportation, sale and distribution of food, drugs, cosmetics, medical devices, bottled water and chemicals;
5g) control the exportation and issue quality certification of food, drugs, cosmetics, medical devices, bottled water and chemicals intended for export.

NAFDAC

by this Act at the Sea Ports, Airports and Land borders.
No NAFDAC regulated product shall be imported into and exported out of Nigeria unless it has been duly registered and/or issued a permit or certificate in accordance with the provisions of Act Cap F33 LFN 2004 and the accompanying guidelines.

NAFDAC

chemicals at ports of entry.
To control the export of food, drugs, cosmetics, medical devices, and chemicals and issue quality certification of the above products for export.
Duties also include compilation of guidelines & regulation for importation/exportation of regulated products.
Collaborate with other relevant Agencies, Organizations and the Private Sector at the Ports and Land Borders.
Sampling of relevant products for lab analysis before final release
Implementation of Government fiscal policy on the prohibition of imports of regulated products through the ports and land borders.

NAFDAC: Functions

for violative products and apprehension of culprits.
Operation of 24-hour surveillance at designated airports.
Organizing seminars, workshops and meetings to sensitize, update and create awareness on NAFDAC regulations as it concerns imports and exports.
Holding Consultative meetings with sectoral groups and stakeholders to encourage regulatory compliance.

NAFDAC: Functions

customs documents during importation.
The Ports (sea and Air) and Land border offices conduct physical inspection of goods, Hold assignments, fast track activities and final release of goods at the various ports and land borders.
Import Activities occur as:
Pre-clearance Activities
Clearance Activities
Post Clearance Activities

NAFDAC: Operations

are meant for export.
The following Certificates are issued on satisfying the requirements for export:
Combined Certificate of manufacture and free sale (for registered products)
Certificate of Pharmaceutical Products (COPP).
Free sale Certificates for products not manufactured in Nigeria but sold in Nigeria.
Export Certificate for goods transported through Land Borders for ECOWAS Market.

NAFDAC: Operations

and First Endorsement
Physical Inspection
Second Endorsement
Release of Goods to importers’ ware house

NAFDAC: Operations

Government Agencies including NAFDAC to regulate activities at the Ports.
In the light of this, the Federal Government in 2005 adopted the Destination Inspection (DI) Scheme.
The objectives of the Destination Inspection Scheme include:
To improve clearance of goods by using latest technology tools for documentary checks risk assessment and on the job training.
Facilitate trade through Risk Management and the use of non-intrusive inspection (x-ray scanners) of imports thereby minimizing the need for physical examination.
To enhance Government import revenue collection and the detection of illegal and false declaration of imports.

Ports Inspection Directorate

NAFDAC: Operations

documentary checking and Risk Assessment. These functions are performed by Nigeria Customs Service and Webbfontaine Nigeria Limited.
NAFDAC is connected with Nigeria Customs Service on the Nigeria Trade Hub at www.nigeriatradehub.gov.ng and http://trade.gov.ng for ports operations.
To facilitate legitimate trade, NCS in collaboration with regulatory agencies have listed all regulated products into HS Codes, clearing lanes as follows on the next slide:

NAFDAC: Operations

lane which is for physical inspection

X

X

X

X

port except for Lagos Ports and Airports

X
Drugs

ASYCUDA at Customs DTI (Direct Trader Input) Cafe

2. Costing for NAFDAC Charges NAFDAC eClearance Unit

3. First Endorsement of relevant documents

4. Physical Inspection of Products at ports and importer‘s warehouse

5. Submission of relevant documents for second endorsement and release

6. Final Release

of undertaking & Introduction (Original Copy)
Certificate of Analysis (Original Copy)
NAFDAC Certificate of Registration or Notification preferably 2013 – 2014
Electronic SGD
CRIA (Original) e.g
*India – QCS, Silis Labs, ACS
*China – NHU, Hanlin Shangai, Quangzhou Test Tech.
*Egypt - ITG

Photocopy of Payment Advice
Form C-30
Annual License to practice as a Pharmacist
Retention of Premises
NAFDAC receipt of payment
Permit to Import & Permit to Clear Controlled Substances
Packing list
Bill of lading/Airway bill
Invoice
Pre-Shipment Information for Finished Pharmaceutical Products
Form M

5/19/2014

Controlled Substances

Certificate of Analysis/CRIA
Invoice
Electronic SGD
Bill of Lading/Airway Bill
Form M
Packing List
PAAR (Pre-Arrival Assessment Report)
Physical Examination Sheet
NAFDAC Reg. Certificate
Permit to Import & Permit to Clear (Original where applicable)

5/19/2014

Excise Management Act, Cap 84 Laws of the Federation [CEMA, Section 4], LFN.1990 – power to control and manage administration of the Customs & Excise Laws. Collects and account for revenue.
[ii] Anti – smuggling operations Applicable at: Borders, sea and airports – checks contrabands, hazardous goods, national security interest.
Physical interception, examination of goods and documents.

performs inter-agency functions on behalf of other government agencies, namely;
Nigeria Police Force – seizure of arms and ammunitions.
National Agency for Food and Drug Administration and Control [NAFDAC] – prevents illegal importation of foods, drugs and chemicals.
National Drug Law Enforcement Agency [NDLEA] – prevents importation and exportation of hard drugs.

at the core of Customs operations due to the following
Developments in the WTO with emphasis on trade liberalization and facilitation.
Development of Free Trade Areas across the regions of the world – removing tariff and non-tariff barriers to speed up economic development .
NCS strategic positions at the entry and exit points of Nigerian borders; lead agency role

and reduce transactions cost between business and government.
To attract Foreign Direct Investment (FDI).
To make Nigeria’s borders competitive by un-impeded flow of goods, services and investment funds through the borders.

of NCS modernization agenda.
II. Revised Kyoto Convention (RKC) on the simplification and harmonization of Customs procedures- Pre-lodgement and Pre-registration.
III. WCO guidelines on immediate release of consignment - PreArrival processing.
IV. Facilitation of trade through provision of adequate & accurate information in the Nigeria Trade Hub Portal (NTH).

NCS New PAAR Policy

allows importer/Agents to submit import Documents for assessment and issuance of PAAR (for Clearance) before the arrival of the cargo

Customs processes.

(& NAFDAC) laws.
Risk analysis: Systematic use of available information to determine how often defined risks may occur and the magnitude of their likely consequences.
Risk areas: Those Customs procedures and categories of international traffic which present a risk.

management priorities by evaluating and comparing the level of risk against predetermined standards, target risk levels or other criteria.
Risk indicators: Specific criteria which, when taken together, serve as a practical tool to select and target movements for their potential for non-compliance with Customs law.

identifying, analyzing and managing risks. Risk management can be associated with any activity, function or process within the organization and will enable the organization to take advantage of opportunities and minimize potential losses.

combination of characteristics or risk indicators, based on information which has been gathered, analyzed and categorized.

put risk management into practice. It replaces random examination of documents and goods with planned and targeted working methods that use profiles as a basis.
Standardized Risk Assessments (SRAs): These Assessments produce risk indicator products for use by Customs officials for the purpose of targeting goods and conveyances in their daily work.

that are beyond the control of Companies
Dispute Resolution Mechanism
No Agency must be allowed to be Prosecutor, Judge and Jury

the company's internal controls for Customs transactions coupled with an audit of selected import transactions.
Goal: determine the company's current level of compliance, and whether or not there are sufficient systems in place to ensure a high level of compliance with Customs laws and regulations for future transactions.
Outcome: Compliant or Non-Compliant.   
If Non-Compliant, the company will be required to formulate a compliance improvement plan (CIP), and tender any revenue found to be owing. 

fortunes for developed nations and increased opportunities for smart developing nations
Developing nations need to take advantage of Globalisation for prosperity while avoiding inequalities of wealth distribution
All need to be aware of the risks that have come with Globalisation and mitigate against them
Cross-Border Trade:
Essentialy between Neighbours
Regional Cooperation is enlightened self-interest and should be encouraged
Inventory the relevant National laws/regulations and harmonise across the region
Keep all stakeholders actively informed and involved

Compliance Issues/Breaches to Industry with a view to aiding improvement
Goal should be facilitation of Trade not encumbrance
Policy implementation must be customer-centric and culture must be to protect consumer rights while pursuing National Interest
Dispute Resolution Systems and Structure must be established
Cross-Border Pharmaceutical Trade (CBPT):
Deference should be given to the difference between Professionally Regulated Pharmaceutical Trade and Trade in General Goods
There should be greater inter-agency collaboration especially between Customs and NAFDAC given the key role the latter plays in regulating CBPT
Companies need to establish Compliance Management Desks and give it appropriate Executive Oversight