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Parallel Trade

Pharmaceutical Parallel Trade in the European Union is a large and growing phenomenon.


Different regulatory regimes for pharmaceuticals result in significant differences in pharmaceutical prices across countries. These prices make it profitable for Parallel Trade to take place in addition to PT reaching a significant proportion of total national pharmaceutical expenditure in many European countries, particularly those with high pharmaceutical prices such as UK, Germany, the Netherlands and Sweden. But the issue of pharmaceutical Parallel Trade continues to generate controversy among stake holders and has become an issue of intense debate in the global trading system.
 

Europe’s leading Parallel Trade Conference will focus on assessing pricing strategies and the impact of parallel trade on the generics market and vice versa. In addition, there will be three open floor round table discussions drawing attention to the ongoing debate; is parallel trade justified? Stakeholder engagement and competition law effects will be discussed, in addition to a breakfast briefing on assessing data collection… and that’s just to start with.


Patient safety is first and foremost when it comes to the implementation of the Anti-Counterfeit Directive and this will be addressed. What will follow is assessing the repackaging and re-boxing of products. Further topics to be evaluated include case studies on the implementation of best practices and the outcomes to be reviewed on parallel trade, are they positive or negative?
 

The note to end on will be… What’s the future of Parallel Trade?
 

FEATURED SPEAKERS

Antonio Mendonca Alves

Antonio Mendonca Alves

CEO, MD Pharma SA
Bertram Häussler

Bertram Häussler

Chairman of the Board of Management, IGES Institut GmbH
Christopher Stothers

Christopher Stothers

Partner, Arnold and Porter
Dermot Glynn

Dermot Glynn

Senior Advisor, Europe Economics
Eric Noehrenberg

Eric Noehrenberg

Director, Regional Market Access lead, Shire GmbH
Janice Haigh

Janice Haigh

Practice Leader, Market Access, Quintiles (UK) Ltd
Matthias Heck

Matthias Heck

Attorney-at-law, Head of Brussels office, German Pharmaceutical Industry Association

Antonio Mendonca Alves

CEO, MD Pharma SA
Antonio Mendonca Alves

Bertram Häussler

Chairman of the Board of Management, IGES Institut GmbH
Bertram Häussler

Christopher Stothers

Partner, Arnold and Porter
Christopher Stothers

Dermot Glynn

Senior Advisor, Europe Economics
Dermot Glynn

Eric Noehrenberg

Director, Regional Market Access lead, Shire GmbH
Eric Noehrenberg

Heinz Kobelt

Director European Affairs, European Association of Euro-Pharmaceutical Companies
Heinz Kobelt

Janice Haigh

Practice Leader, Market Access, Quintiles (UK) Ltd
Janice Haigh

John Jolley

Director, Pharmaconsult Global Ltd
John Jolley

Leyla Hannbeck

Head of Pharmacy, The National Pharmaceutical Association Ltd
Leyla Hannbeck

Matthias Heck

Attorney-at-law, Head of Brussels office, German Pharmaceutical Industry Association
Matthias Heck

Mike Isles

Executive Director, European Alliance for Access to Safe Medicines
Mike Isles

Shabnam Hanassab

Consultant, IMS Health
Shabnam Hanassab

Suzanne Elvidge

Specialised writer in healthcare, pharmaceuticals and busines, None
Suzanne Elvidge

Tomasz Dzitko

Founder and CEO , Delfarma
Tomasz Dzitko

sponsors

Conference agenda

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13:30

Registration and Coffee

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14:00

Introduction and Overview - Interpretation of the Specific Mechanism

Martin Paltnoi

Martin Paltnoi, Managing Director, MPA Business Services Ltd

 

 

a) From the originators perspective

b) From the parallel traders view

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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14:30

How important is parallel trade from Accession States?

Martin Paltnoi

Martin Paltnoi, Managing Director, MPA Business Services Ltd

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15:00

What is the view of parallel trade from Accession States in the post- Specific Mechanism

Martin Paltnoi

Martin Paltnoi, Managing Director, MPA Business Services Ltd

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15:30

Coffee Break

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16:00

Review of the Specific Mechanism as it appears in the Accession Treaty and as a result of subsequent court action

Martin Paltnoi

Martin Paltnoi, Managing Director, MPA Business Services Ltd

 

What are the differences in the different Accession States likely to influence the Specific Mechanism and Parallel Trade from those states.

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17:00

Discussion & Q&A

Martin Paltnoi

Martin Paltnoi, Managing Director, MPA Business Services Ltd

Other matters likely to effect the parallel trade from Accession States, i.e. the need to upgrade MAs filed prior to 2008 (Croatia) (Appendix to Annex V – Accession Treaty).

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17:30

End of Workshop

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Eric Noehrenberg

Eric Noehrenberg , Director, Regional Market Access lead, Shire GmbH

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9:10

Overview of Parallel Trade and its impact

Eric Noehrenberg

Eric Noehrenberg , Director, Regional Market Access lead, Shire GmbH

  • What is parallel trade?
  • Who benefits from parallel trade? Where are negative impacts of parallel trade?
  • Key players in parallel trade and their respective strategies
  • Meeting the challenges of parallel trade
  • clock

    9:50

    Parallel distribution - a view from the top

    Heinz Kobelt

    Heinz Kobelt, Director European Affairs, European Association of Euro-Pharmaceutical Companies

    The European medicines supply chain under stress - and PT taken as its scapegoat

  • Economics in distribution - the legitimate role of wholesaling
  • Ideal profile for a functioning supply chain 
  • In hindsight: what could have worked better in the recent case of medicines stolen in Italy, and ending up via parallel import in Germany?
  • How we see the call from the German MoH to the EU Commission to examine the legal framework for parallel distribution
    clock

    10:30

    Morning Coffee

    clock

    11:00

    Assessing pricing strategies for parallel trade

    Janice Haigh

    Janice Haigh, Practice Leader, Market Access, Quintiles (UK) Ltd

  • Price strategy, price competition and equity – defending differential pricing
  • Understanding the role of price strategy in parallel trade management
  • What are the other options?
  • clock

    11:40

    KEYNOTE ADDRESS: Initiatives of Parallel Distributors in the context of Falsified Medicines Directive

    Tomasz Dzitko

    Tomasz Dzitko, Founder and CEO , Delfarma

  • Good Parallel Distribution Guidelines                                                                                                                                                                                                                                                                             
  • Early Warning Anti-CF Platform
  • Joint Audits Initiative    
  • European Medicines Verification Organization
  •  

    clock

    12:20

    Networking Lunch

    clock

    13:30

    Parallel Trade in Germany – Situation and perspective

    Bertram Häussler

    Bertram Häussler, Chairman of the Board of Management, IGES Institut GmbH

  • Parallel importation dynamics – assessing the impact
  • The evaluation of new drugs in Germany – new paradigm for Parallel Trade?
  • Political and regulatory environment: What`s changed, what is to be expected
  • clock

    14:10

    Case Study 1: The role of the pharmacists in parallel trade defined

    Leyla Hannbeck

    Leyla Hannbeck, Head of Pharmacy, The National Pharmaceutical Association Ltd

  • Distribution and supportive programme with the pharmacists as the central person
  • Channels and factors with regulations, market access and other factors
  • Sourcing parallel trade when they’re cheaper and how it’s impacting the pharmacists
  • clock

    14:50

    Afternoon Tea

    clock

    15:20

    EU perspective for Parallel Trade

    • Current trends and drivers of PI
    • Legal framework
    • Developments in EU-memberstates

    Matthias Heck

    Matthias Heck, Attorney-at-law, Head of Brussels office, German Pharmaceutical Industry Association

    clock

    16:00

    Chairman’s Closing Remarks and Close of Day One

    Eric Noehrenberg

    Eric Noehrenberg , Director, Regional Market Access lead, Shire GmbH

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    Eric Noehrenberg

    Eric Noehrenberg , Director, Regional Market Access lead, Shire GmbH

    clock

    9:10

    EU perspective for Parallel Trade

    Suzanne Elvidge

    Suzanne Elvidge, Specialised writer in healthcare, pharmaceuticals and busines, None

  • Assessing the impact of parallel trade on certain countries
  • Concerns about medicines shortages to lower priced countries
  • Competition law – an overview of what’s likely to happen over the next five years to impact parallel trade
  • clock

    9:50

    Supply chain protection and patient safety

    John Jolley

    John Jolley, Director, Pharmaconsult Global Ltd

  • Assessing the security of supply chain to enhance patient safety
  • Evaluating the complexity of European supply chain
  • Reviewing what the hurdles ahead may be
  • clock

    10:30

    Morning Coffee

    clock

    11:00

    Market Outlook and Macro Dynamics

    Shabnam Hanassab

    Shabnam Hanassab, Consultant, IMS Health

  • Developments in last decade
  • Impact on patient and manufacturer
  • clock

    11:40

    Effects of parallel trade on affordable access to medicines in the EU

    Dermot Glynn

    Dermot Glynn, Senior Advisor, Europe Economics

  • Effects on prices
  • Effects on timing of launch
  • Effects on reliability of supply
  • Effects on innovation
  •  

    clock

    12:20

    Networking Lunch

    clock

    13:30

    KEYNOTE ADDRESS - Intellectual Property Update

    Christopher Stothers

    Christopher Stothers, Partner, Arnold and Porter

  • Can brand names be changed in parallel trade? Recent case law
  • Specific Mechanism - the Advocate General’s Opinion?
  • Other recent developments
  • Practical implications
  • clock

    14:10

    Patient Safety – Fighting the Fakes

    Mike Isles

    Mike Isles, Executive Director, European Alliance for Access to Safe Medicines

  •  The evolving internet rogue pharmacy environment
  • Law enforcement and collaborative voluntary actions 
  •  Addressing the issue of online demand by patients  
  • clock

    14:50

    Afternoon Tea

    clock

    15:20

    Government intervention in exporting countries, a new trend?

    Antonio Mendonca Alves

    Antonio Mendonca Alves, CEO, MD Pharma SA

  •  Examples of government intervention is exporting countries
  • Are governments trying to restrict exports? Is this legitimate?
  • Are there alternatives?
  • clock

    16:00

    ROUND TABLE DISCUSSION - A clear divide still stands - The Big Debate!

    Antonio Mendonca Alves

    Antonio Mendonca Alves, CEO, MD Pharma SA

  • Ethics of Parallel Trade and the Originators
  • Input and perspective on what the ethics of parallel trade and the originators are
  • Greece as a target – is ring fencing in place or will it be?
  • Is parallel trade justified – different perspectives  
     
  • clock

    16:40

    Chairman’s Closing Remarks and Close of Day Two

    Eric Noehrenberg

    Eric Noehrenberg , Director, Regional Market Access lead, Shire GmbH


    CEO
    MD Pharma SA
    Chairman of the Board of Management
    IGES Institut GmbH
    Partner
    Arnold and Porter
    Senior Advisor
    Europe Economics
    Director, Regional Market Access lead
    Shire GmbH
    Director European Affairs
    European Association of Euro-Pharmaceutical Companies
    Practice Leader, Market Access
    Quintiles (UK) Ltd
    Director
    Pharmaconsult Global Ltd
    Head of Pharmacy
    The National Pharmaceutical Association Ltd
    Attorney-at-law, Head of Brussels office
    German Pharmaceutical Industry Association
    Executive Director
    European Alliance for Access to Safe Medicines
    Consultant
    IMS Health
    Specialised writer in healthcare, pharmaceuticals and busines
    None
    Founder and CEO
    Delfarma

    Sponsors and Exhibitors

    Supporters

    Workshops

    Parallel Trade for Accession States

    Parallel Trade for Accession States

    Holiday Inn Regents Park
    11 February 2015
    London, United Kingdom

    Parallel Trade Event Attendees 2015

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