Conference Documentation: Parallel Trade

Published by: SMI Publishing, Ltd

Published: Feb. 14, 2007

Table of Contents

Day 1

8.30 Registration & Coffee

9.00 Chairman's Opening Remarks

Boris Simkovich, President, Light Management Consulting LLC.

9.10 KEYNOTE ADDRESS

Past, present and future

How has industry’s strategy vis-à-vis parallel trade evolved over time?

· What strategies have fallen in - and out - of favour?

· What forces have influenced the evolution of industry strategy?

· What is the outlook for the future?

Boris Simkovich, President, Light Management Consulting LLC.

9.50 PARALLEL TRADE: DEBUNKING SOME COMMON MYTHS

Reviewing the beliefs of others

The EU gives the trade unqualified support

It's best left to our legal department to manage

· Pharmacists dispense parallel trade at every opportunity

· Now the "common origin" criterion for regulatory approval is gone our brands will have to compete with parallel-imported generics

· Every time the EU enlarges the situation gets worse

· High prices mean parallel importation into the US is inevitable

Donald Macarthur, Senior Consultant, PriceSpective .

10.30 Morning Coffee

11.00 HOW PREDICTABLE IS PARALLEL TRADE?

Looking at new products

What do people think are the key drivers of parallel trade?

· What are the actual key drivers?

· What is system dynamics and why is it the preferred route for PI forecasting?

· How can you validate a PI forecasting methodology when you cannot observe all the flows?

Gary Johnson, Managing Director, Inpharmation Ltd.

11.40 DOES PARALLEL TRADE BENEFIT THE PATIENT?

A global perspective

Does parallel trade benefit the poor?

· Parallel trade and counterfeit products

· Product diversion and access programmes

Eric Noehrenberg, Director, International Trade and Market Policy, International Federation Of Pharmaceutical Manufacturers Association (I F P M A).

12.20 Networking Lunch

1.50 PARALLEL TRADE

Accessibility of drugs by patients

Losses of margins

· Trends in distribution models

· Legal measures to deal with parallel trade issues

Stefan Rinn, Head, Corporate Division, Prescription Medicines Europe, Boehringer Ingelheim GmbH.

2.30 PHARMACEUTICAL PACKAGING AND TRACKING

Tactics and systems to combat counterfeiting in parallel trade

Repackaging issues

- Issues in counterfeiting

- Affect on safety and quality

- Tagging (RFID/2D Barcode)

- Considering standards

· The importance of drug tracking throughout the pharma supply chain

· Existing and planned pharma tracking regulations

· Retaining brand integrity and consumer confidence through packaging

· Overcoming pitfalls - from consumer clarity to label compliance

Andre Grigjanis, Managing Director, GCC Pharma.

3.10 Afternoon Tea

3.40 DRUG TRACKING

Strategies to track pharmaceutical products

The FDA guidance issued on June 9th 2006

· The benefits of tracking drugs on patient safety

· Is there a role for drug tracking in a parallel trade environment?

· Present and future drug tracking solutions

· How does drug tracking secure brand integrity to regain consumers' confidence with the healthcare industry?

Huda Midani, Vice President, Business Development, Authentix.

4.20 REGULATORY ISSUES AND INTELLECTUAL PROPERTY RIGHTS

Overcoming challenges facing the pharmaceutical industry

How the European courts are shaping the law on parallel trade

· Gaining and withdrawing market authorisations

· Eurogenerics - is there still a difference between generics and parallel imports?

· Invoking trade mark rights - the state of play

· Invoking patent rights - the exhaustion of rights rules and the Accession Treaty

· Withdrawal of reference products and competition law - is the EU importing US rules?

Maarten Meulenbelt, Partner, NautaDutilh.

Maarten Meulenbelt, Partner, Howrey LLP.

5.00 Chairman’s Closing Remarks and Close of Day One

Day 2

8.30 Registration & Coffee

9.00 Chairman's Opening Remarks

Thomas Zimmer, Corporate Senior Vice President, CD Safety, Quality & Environmental Protection, Boehringer-Ingelheim .

9.10 PARALLEL TRADE AND SUPPLY CHAIN TRANSPARENCY

Consequences for counterfeit penetration

· GMP issues

· Recall and complaint management

Thomas Zimmer, Corporate Senior Vice President, CD Safety, Quality & Environmental Protection, Boehringer-Ingelheim .

9.50 CROSS BORDER TRADE

The manufacturer's view

Manufacturer’s channel partners - friend or foe?

· Supply chain security - is the manufacturer in control?

· Practical considerations in monitoring cross border flows

· Minimising the impact of cross border flows on the quality of the demand plan

· Cross border trade - an easy win for sales management?

Peter Laurence, Director, scb consulting.

10.30 Morning Coffee

11.00 THE IMPACT OF STATE AND FEDERAL GOVERNMENTS IN THE U.S.

Overview of state and federal government roles

State government basics

Medicare and Medicaid programs

Current public and political environments

The importation debate

The future and protecting innovation

Kipp Snider, Director, Amgen.

11.40 PROSPECTS FOR PARALLEL TRADE IN NORTH AMERICA

Outlook for importation, re-importation and internet pharmacy

Overview of parallel trade in North America

· Status of legislative initiatives to allow importation and re-importation

· Understanding how parallel trade in North America would differ from Europe

· Impact of Medicare Part D on North American parallel trade

· Trends in Canada and US internet pharmacy sales

· Factors affecting growth and decline in internet pharmacy

· Outlook and implications for parallel trade in North America

Neil Palmer, Vice President, RTI Health Solutions.

12.20 Networking Lunch

1.50 PATIENTS INGEST PHARMACEUTICAL TABLETS, NOT BOTTLE LABELS

How to protect the patient, not the package

Protecting and authenticating the package alone does not certify authentic content

· Counterfeiter, diverters and legitimate wholesalers switch units and repackage pharmaceutical drugs

· Unit dosage level protection and authentication is necessary to really ensure patients are getting the right medication

· Unit dosage level encryption with encrypted batch level data will combat illegal diversion

· Individual tablet encryptions can house data such as where the product was made, when it was made and where it is to be shipped to

Bruce Dudzik, Senior Director , Nanoink.

2.30 CHANGING THE BIO-PHARMACEUTICAL DISTRIBUTION MODEL

Development and implementation of Direct-to-Pharmacy (DTP) distribution strategies in Europe

Parallel trade as threat to industry and patients alike

· Development of pan-European wholesalers and impact on pharmaceutical distribution in Europe

· Direct-to-Pharmacy distribution as a way to increase supply chain visibility and control

· Implementing DTP models, Lessons learned

· The global picture and limitations of DTP strategies

Rolf Fricker, Senior Executive Advisor, Booz Allen Hamilton.

3.10 CONCEPT OF A SINGLE MARKET

Could this be a reality?

Considering the pharmaceutical markets for individual countries and the EU as a single state

· How feasible is a single market, EU or global?

· Why wouldn’t a single market work?

Jim Furniss, Director, Pricing & Reimbursement, Bridgehead International.

4.20 Chairman’s Closing Remarks followed by Afternoon Tea and Close of Conference

Abstract

With evidence suggesting that there are no direct benefits to patients through the application of parallel trade, is it time that policymakers re-evaluated current practices to protect the pharmaceutical industry? SMi’s conference ‘Parallel Trade’ will seek to uncover the true impact on drug manufacturers, patients and research and development. Discussing safety, regulatory policy, intellectual property and packaging, hear key leaders in the field provide advice on how to strategically combat this growing problem. Through case studies and plenary lectures, listen to aspects of parallel trade with a focus on pricing & reimbursement and wholesale & distribution.

Hear cutting edge contributions from leaders in the field, including:

• Dr Thomas Zimmer, Corporate Senior Vice President, CD Safety, Quality and Environmental Protection, Boehringer-Ingelheim
• Neil Palmer, Vice President, Pricing and Reimbursement, RTI Health Solutions
• Kipp Snider, Director, State Government Affairs, Global Government Affairs, Amgen
• Eric Noehrenberg, Director, International Trade and Market Policy, International Federation of Pharmaceutical Manufacturers Associations (IFPMA)
• Stefan Rinn, Head, Corporate Division, Prescriptions Medicines, Europe, Boehringer-Ingelheim
• Huda Midani, Vice President, Business Development, Healthcare & Life Sciences, Authentix
• Bruce Dudzik, Senior Director, Business Development, NanoInk
• Donald Macarthur, Senior Consultant, PriceSpective & Former Secretary General, European Association of Euro-Pharmaceutical Companies
• Boris Simovich, President, Light Management Consulting

Key issues that will be addressed at the conference include:

• The Effect of Parallel Trade: Hear global perspectives about the economic and socialistic impacts of parallel trade on patients, pharmaceutical manufacturers and traders in the EU and US
• Pricing and Reimbursement: Learn about the true impact of parallel trade and discover if the concept of a single market can ever be a reality
• Wholesale and Distribution: Hear how parallel trade has and will affect cross border trade and the pharmaceutical supply chain and practical considerations to overcome it
• Regulatory Affairs and Intellectual Property: Discuss effective strategies to overcome the challenges facing the industry and gain the knowledge of how to ensure product compliance
• Pharmaceutical Packaging and Tracking: Strategies and tactics to ensure product safety, brand integrity and consumer confidence
• Networking Opportunities: Meet the key leaders in the field, make valuable contacts and learn from their experience and expertise

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