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European Pharmaceutical Pricing and Reimbursement
22 October - 23 October 2003
European Pharmaceutical Pricing and Reimbursement
National pharmaceutical pricing and reimbursement is a complex and ever-changing area. Despite increasingly coordinated trade activities within the European Union (EU), the five major European pharmaceutical markets (France, Germany, Italy, Spain, and the UK) retain unique approaches to setting reimbursement prices on pharmaceuticals. Country-specific systems based on differing sets of authorities, negotiation processes, and fundamental principles (including pharmacoeconomics) complicate the approval of pharmaceutical prices in these countries.

Meanwhile, the ongoing evolution of health care and pharmaceutical reimbursement systems in these countries provide further challenges for a pharmaceutical company considering a European product launch. In Europe, increasing economic pressures have led to a recent rise in efforts to curtail pharmaceutical spending by national health care authorities, despite the extensive medical advances of the past few decades. While France, Italy, and Spain tightly regulate drug prices and have historically kept them at relatively low levels, this practice has resulted in a burgeoning parallel trade to higher-priced markets such as Germany and the UK. While German and British authorities encourage this trade, they are also increasingly exploring alternative mechanisms for limiting pharmaceutical expenditures, such as mandated product substitution, the use of a 'positive list' of reimbursable pharmaceuticals, and regulated price setting for generics.

The conference will give an excellent insight into the methods used to control pharmaceutical products' prices in France, Germany, Italy, Spain, and the UK. It will give delegates a detailed insight into the pricing and reimbursement mechanisms in the major European markets.

Presentations will be from both the big Pharma companies and the key national authorities involved in pricing and regulation.

A unique opportunity to learn from leading industry experts including:
· Alfonso Rodriguez Alvarez, Deputy Director, Pharmaceutical Benefits, Ministry of Health & Consumer Affairs, Spain
· Sanjay Pande, Pricing Manager, AstraZeneca
· Dr Marion Bamberger, Senior Director, Economics & Government Affairs, Bristol-Myers Squibb
· Sue Sharpe, Chief Executive, Pharmacy Services Negotiating Committee (PSNC)
· Dr. Georges France, Director Economy & Regulatory Affairs, Wyeth
· Dr. Nick Schulze-Solce, Director Corporate Affairs, Lilly Pharma Holding
· Antoni Gilabert Perramon, Head of Division, Pharmaceutical Care & Complementary Benefits, Catalan Health Service
· Jim Furniss, Director, Pricing & Reimbursement, Bridgehead Technologies & Former Head, PPRS
· Trevor Leighton, Head, In-Market Pricing, Europe, Novartis
· Janice Haigh, Consultant, IMS Health

Benefits of Attending
· EUROPEAN PRICING ENVIRONMENTS: Learn from market reviews for the UK, France, Germany, Italy & Spain
· MEET THE DECISION-MAKERS: Meet the pricing and reimbursement regulators in Europe and take advantage of networking opportunities
· A COMPARISON TO THE USA: Discover current issues in pricing & reimbursement in the US
· NEW PRICING TECHNIQUES: Learn how to develop new and innovative pricing strategies for access to European markets
· REFINE PRICE APPROVAL TIMELINES: Expedite the price approval process

Conference agenda

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8:30

Registration and Coffee

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9:00

Chairperson's Opening Remarks

Janice Haigh

Janice Haigh, Consultant, IMS Global Consulting

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9:10

INTRODUCTION

Dr Jorge Mestre-Ferrandiz

Dr Jorge Mestre-Ferrandiz, Industrial Economist, Office of Health Economics

  • Key trends at - European level - national level - market level
  • Future options: what can we expect in the next five to ten years?
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    9:40

    EU ENLARGEMENT

    Trevor Leighton

    Trevor Leighton, Head, In-Market Pricing, Europe, Novartis

  • Enlargement of the European Union and possible effects on European pricing and reimbursement
  • Understanding the opportunities and challenges
  • The potential impact on parallel trade
  • EU enlargement in the context of current and emerging trends in European pricing and reimbursement regulation
  • Possible impact on future European pricing and reimbursement decision-making
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    10:20

    THE FUTURE FOR PRICING AND REIMBURSEMENT IN EUROPE

    Lucio D’Errico

    Lucio D’Errico, Corporate Price Control Manager, Serono International

  • Outlining the pressures of the future - pharmaceutical environment - at national levels - at a European level
  • The demands of cost and clinical effectiveness in the industry
  • The importance of pharmacoeconomics
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    11:00

    Morning Coffee

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    11:20

    PARALLEL TRADE & PRICING

    Janice Haigh

    Janice Haigh, Consultant, IMS Global Consulting

  • What is the relationship between price and parallel trade levels?
  • How can pricing strategies be used to manage parallel trade?
  • What other strategies are available to manufacturers?
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    12:00

    PRICING AND REIMBURSEMENT: AN IN-DEPTH COMPARISON WITH THE USA

  • Review of the healthcare system in the USA
  • Free pricing traditions in the USA
  • Impact of pharmacoeconomics
  • Parallel imports to the USA
  • Generic substitution in the USA
  • Future pricing and reimbursement issues: the next three years
  • Suzanne LoGalbo

    Suzanne LoGalbo, Vice President, Global Regulatory Affairs, Solvay

    Gregory Torre

    Gregory Torre, Vice President, Regulatory Affairs, Watson Pharmaceuticals

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    12:40

    Networking Lunch

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    14:00

    PRICING AND REIMBURSEMENT IN THE UK

    Jim Furniss

    Jim Furniss, Director, Pricing & Reimbursement, Bridgehead Technologies & Former Head, PPRS

  • The PPRS, generics and price control
  • The impact of NICE on reimbursement
  • Local decision-making – the role of PCTs
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    14:40

    SETTING AN OPTIMAL EUROPEAN PRICING STRATEGY

    Sanjay Pande

    Sanjay Pande, Pricing Manager, AstraZeneca

  • Importance of 'Big Five' European markets
  • Key issues in developing a European pricing strategy: - Consideration of national pricing and reimbursement systems - Pricing, reimbursement and market access trends - Uniform versus differential pricing - International reference pricing - Parallel trade - Launch sequencing - Modelling impact of alternative strategies
  • Implementation of pricing strategy: - Organisational issues - Monitoring launch prices
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    15:20

    Afternoon Tea

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    15:40

    PRICE NEGOTIATION

    Sue Sharpe

    Sue Sharpe, Chief Executive, Pharmaceutical Services Negotiating Committee (PSNC)

  • New arrangements for pharmacy remuneration
  • Reimbursement mechanisms
  • Making the market work
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    16:20

    REIMBURSEMENT IN SPAIN

    Dr Antoni Gilabert Perramon

    Dr Antoni Gilabert Perramon, Head of Division, Pharmaceutical Care & Complementary Benefits, Catalan Health Service

  • The role of autonomous administration
  • Cost containment policies: sustainability
  • Sharing responsibilities
  • Setting budgets for pharmaceuticals
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    17:00

    Chairperson's Closing Remarks followed by Afternoon Tea.
    Close of Day One

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    8:30

    Re-registration and Coffee

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    9:00

    Chairperson's Opening Remarks

    Jim Furniss

    Jim Furniss, Director, Pricing & Reimbursement, Bridgehead Technologies & Former Head, PPRS

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    9:10

    PHARMACEUTICAL PRICING AND REIMBURSEMENT IN GERMANY

    Dr Stefan Kramer

    Dr Stefan Kramer, Head of Affairs, Economics & Statistics, BPI, Germany

  • Pharmaceutical pricing policy in Germany
  • Aut Idem and reference pricing
  • Pharmacy price regulation
  • Parallel import under German healthcare legislation
  • Pharmaceutical reimbursement policy in Germany
  • Future regulatory proposals for the German pharmaceutical industry
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    9:40

    HEALTHCARE REFORM

    Dr Nick Schulze-Solce

    Dr Nick Schulze-Solce, Director Corporate Affairs, Lilly Pharma

  • The 4th Hurdle - methodological issues and general implications
  • Rebates for payers - new customers for the industry?
  • Deregulation of distribution – impact of changes
  • Reference pricing – more or less of it?
  • The Positive List – update of experiences
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    10:20

    HIGH PRICES AND PARALLEL IMPORTATION

    Dr Ann-Katrin Gonschior

    Dr Ann-Katrin Gonschior, International Product Manager, Corporate Marketing Health Economics, ALTANA Pharma

  • The current situation: the regulation with regards to encouraging the purchase parallel imports in Germany
  • The impact of Aut Idem on parallel trade in Germany
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    11:00

    Morning Coffee

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    11:20

    IDENTIFYING NEW GROWTH LEVERS IN A CONTEXT OF COST CONTAINMENT

    Dr Marion Bamberger

    Dr Marion Bamberger, Senior Director, Economic & Government Affairs, Bristol-Myers Squibb

  • Different market potentials
  • Towards the right equilibrium in health care budgets
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    12:00

    OPPORTUNITY AND THREAT OF RECENT CHANGES IN THE PRICING SYSTEM

    Dr Georges France

    Dr Georges France, Director, Economy & Regulatory Affairs, Wyeth

  • The system in France – introduction to reference pricing
  • Opportunity of free price for new innovative products: a reality?
  • Maximising reimbursed price (R&D)
  • Negotiation under reference pricing constraints
  • Launching a medicine outside reimbursement
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    12:40

    Networking Lunch

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    14:00

    THE KEY ISSUE IN PRICING AND REIMBURSEMENT IN SPAIN: DECENTRALISATION

    Alfonso Rodriguez Alvarez

    Alfonso Rodriguez Alvarez, Deputy Director, Pharmaceutical Benefits, Ministry of Health & Consumer Affairs, Spain

  • Reimbursement policy in Spain
  • Pharmaceutical pricing policy in Spain: a critical review
  • Health system structure in Spain (the devolution of responsibility to the 17 regions)
  • Patient satisfaction in Spain
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    14:20

    TOWARDS A NEW REGULATORY FRAMEWORK

    Fabrizio Gianfrate

    Fabrizio Gianfrate, Professor of Health Economics / Vice President & General Manager, University of Ferrara / SmithKline Foundation, Italy

  • Pharmaceutical pricing policy in Italy
  • Demographics based co-payment exemptions
  • Increased regional control in the Italian pharmaceutical industry
  • International reference pricing
  • Therapeutic reference pricing
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    14:40

    PRICING AND REIMBURSEMENT IN SPAIN: AN INCREASINGLY CHALLENGING TASK

    Stefan Holmstrom

    Stefan Holmstrom, Pricing Manager, Europe, Allergan

  • Impact of new directives on pricing dossiers
  • Decentralisation, what does it mean for the industry?
  • What is the role of health economics?
  • The dynamics of the Spanish reference pricing system (RPS)
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    16:20

    Chairperson's Closing Remarks and Close of Conference

    Workshops

    Pricing in the USA
    Workshop

    Pricing in the USA

    The Hatton, at etc. venues
    24 October 2003
    London, United Kingdom

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