A COMPARISON BETWEEN DIFFERENT TOBACCO PRODUCT INGREDIENT REPORTING SYSTEMS WORLD WIDE EXPERIENCES FROM PRACTICAL USE IN KEY COUNTRIES.

ABSTRACT

Over the last few years, debate and research has taken place on how to generate data in order to satisfy regulatory authorities´ requirements to disclose tobacco product information. Rather less attention has been paid to the mechanisms by which this data can be provided and trans-ferred to regulators in a reliable and accessible form. Furthermore, Article 10 of the WHO FCTC (Framework Convention on Tobacco Control) is likely to propose that regulators make tobacco product ingredient data available to the general public. This raises concerns about the misinter-pretation of the data provided and the risk of accidental publication of trade secrets and other confidential information. This poster contrasts and compares information transmission systems currently in use in selected jurisdictions worldwide: Canada, USA, Taiwan and the European Union. It focuses on the existing reporting requirements, usability and usefulness of a system for both regulators and the industry, and the protection of trade secrets and confidential infor-mation. Finally the EMTOC (Electronic Model for Tobacco Control) system is described, a system, which has already been implemented for use in several European countries. EMTOC allows the industry to satisfy its reporting obligations through secure and sustainable channels and provides the regulators with suitable formats for the public disclosure of information.

RESULTS & DISCUSSION

A paper based reporting regime, such as the one currently in place in Canada, results in a volu-minous submission document, which needs to be transferred to the regulators and requires in-tensive and time-consuming manual preparation for manufacturers. This approach offers only a low level of security with regard to data protection and does not allow direct publication of non-confidential data on authorities’ official websites, as the data are not provided in such a format,. Smoke chemistry data and toxicological data are provided on CDs. In the USA, tobacco product ingredient data are provided to the regulators through a gateway called “e-submitter”, whereas other product-related information needs to be submitted on paper. As such, this sub-mission process is semi-automated and requires further process steps to allow the publication of non-confidential information to the general public. Nevertheless, the system used in the USA provides a high level of security with respect to confidential data protection. The Taiwanese system, in contrast, offers only a low level of security, and continuous format changes allow only semi-automated use of the data. This involves a possible third party review of the submitted toxicological information and results in very slow updates of the information to be published for the general public. So far, the system is a challenge for both industry and regulators. The possi-bility exists that the Taiwanese Bureau of Health Promotion may outsource the responsibility for management of tobacco product ingredient submissions and public disclosure of the data to a third party in the future. The EMTOC system (Figure 3) is a SQL database with a web-based front end, accessed via a secure encrypted link, which offers a very high level of security for the protection of proprietary data. It allows automatic linkage to manufacturers´ in-house ingredient management systems, which significantly reduces the work-load for the preparation of tobacco product ingredient submissions. Non-confidential and confidential data are kept separately within the system, allowing a straightforward update of the information to be published for the general public. While user-fees are required to maintain the system, these are tolerable when set against the general usability and usefulness of the system.

CONCLUSIONS

The comparison of the different tobacco product reporting systems identified their strengths and weaknesses. From JTI´s experience, EMTOC has proved in practice to be the best model cur-rently available for the efficient, secure and sustainable reporting of tobacco product informa-tion. However, the best reporting system alone cannot overcome the deficiencies of the legisla-tive framework, in which it operates. The need to work towards guaranteed confidential data protection is crucial in order to meet the future demands of regulators, especially in relation to publication of information, and the expectations of the industry.

REFERENCES[1] http://ec.europa.eu/eahc/projects/database.html?prjno=2007312, Executive Agency for Health and Consumers

INTRODUCTION

Today, legislation in 50 countries around the world obliges manufacturers to disclose tobacco product information to the regulatory authorities on a regular basis. Reporting formats and ways (medium) of submitting information vary between jurisdictions and have diverged over time, whereas the basic submission requirements remain unchanged (Table 1). Regulators want to obtain information in a standardized form to allow data comparison, analysis and (in some countries) publication of non-confidential data on their official websites. Tobacco product manu-facturers prefer a harmonized submission format, as well as a robust, secure and sustainable reporting system for transfer of confidential product information.

In 2000, Canada enacted a law that required tobacco product manufacturers to disclose infor-mation on ingredients used in their tobacco products. The medium for submission was (and still is) in paper form. Soon after, in 2002, a mandatory reporting of tobacco product ingredients and their available toxicological information was implemented in the European Union. In the begin-ning, information was submitted on CDs or paper, but in 2008, as the limitations of the CD and paper based approach were more and more recognized, the European Commission decided to develop a secure and sustainable system [1], the Electronic Model for Tobacco Control (EMTOC), to be used as reporting platform for tobacco product information. The first official submission in the validated EMTOC system was in Austria in 2010.To date, nine European Union Member States offer reporting via this tool. The advantages of such an electronic data transfer system were also recognized in Asia, where in 2009 an electronic reporting tool was established in Taiwan. The USA followed in 2010 by implementing another electronic submis-sion system (Figure 1).

ANALYSIS

Based on JTI’s experience of different national reporting regimes over the past 12 years, we have contrasted and compared the key elements of the currently available electronic reporting tools and one selected paper based submission approach. Parameters for comparison are technical set-up of the reporting platforms, user friendliness, data security, costs for users, and the possibility to provide regulators with a set of non- confidential data for publication as infor-mation to the general public. These parameters were ranked for each system, using the scale “poor”, “average”, and “good”. A summary is provided in Table 2 and Figure 2.

Figure 1: Ingredient reporting overview (JTI’s understanding). Information transmission systems of the color-coded jurisdictions are used for comparison (Analysis, Table 2 & Figure 2).

Figure 3: Web page address for further information on the EMTOC system

Figure 2: Spider-net charts using the ranked evaluation parameters from Table 2.

Table 1: Reporting requirements in selected jurisdictions.

Reporting Requirements

Ingredients added to tobacco products required required required required

Frequency of ingredient data reporting quarterly on product change annually & on product change

annually

Canada USA Taiwan EU

Toxicological data on ingredients required not required required required

Smoke chemistry data 41 analytes 18 analytes 7 analytes 3 analytes

Frequency of smoke chemistry data reporting

annually and semi-annually (TNCO)

on product change annually & on product change

annually

Canada USA Taiwan EU

0123

0123

Ideal system

Ideal system Canada, USA, Taiwan & EUsystems comparison

Separate data setfor publication to

general public

Technical backgroundof systems

Usability data entry

Data securityCosts for using the system (user fees)

Separate data setfor publication to

general public

Technical backgroundof systems

Usability data entry

Data securityCosts for using the system (user fees)

History of Regulated Ingredients Reporting

Canada

Canada EU Taiwan USA

AustriaBelgium

DenmarkFinland

France

GermanyGreeceIrelandItalyLuxembourgNetherlands

PortugalSpainSwedenUnited Kingdom

Brazil

CyprusCuba

Czech RepublicEstoniaHungaryLatviaLithuania

Poland

Malta

SlovakiaSlovenia

KazakhstanMoldovaMontenegro

New Zealand

SwitzerlandUkraineTurkey

AlbaniaChile

Taiwan

Bulgaria

BoliviaMexicoRomania

RussiaCroatia

UAE

USA

2000Thailand1997

2002

2004 2005

IcelandNorway

2003

2007

2009

2010

2011

2012 Maldives

50 Countries have reporting requirement

Table 2: Ranking of evaluation parameters for the reporting systems used in Canada, USA, Taiwan and the EU, using a scale from “poor” (1) over “average” (2) to “good” (3). * = Data security of the system addresses, trasmission, systems stability and data storage.

Medium or platform for reporting

Paper FDA electronic gateway system(e-submitter)

BHP system EMTOC

Technical background of systems Paper sheets (1) SQL database (3) Access database (2) SQL database (3)Usability data entry Manual data entry (1) Semi-automated data entry (2) Semi-automated data entry (2) Automated data entry (3)

Data security* Low (1) High (3) Low (1) High (3)

Costs for using the system(user fees)

None (3) None (3) None (3) 200 € per country and submission (2)

Separate data set forpublication to general public

No (data needs to beadjusted) (1)

No (data needs to beadjusted) (1)

No (data needs to beadjusted) (1)

Yes (3)

Canada USA TaiwanParameters EU

J. Cheung , S. Krimmer-Quendler , J. Wolf JT International SA, 1 rue de la Gabelle, 1211 Geneva 26, Switzerland.

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