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Parallel Trade

SAE Media Group’s 16th Annual Conference

Parallel Trade

21-22 March, 2022 | Conference
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SAE Media Group presents its 16th annual Parallel Trade conference on the 21st and the 22nd March 2022. As the only parallel trade conference in Europe, this event provides the perfect platform for industry experts from both sides of the coin to come together and share perspectives on the practice of parallel trade.

The 2022 event will be more significant than ever before due to the transition period follow Brexit now also coming to an end. As such, the UK will no longer be part of the EU free market. This will mean increased medicines prices, reduced access to some specialist drugs and greater risk of supply chain shortages. In a post-Brexit environment, exhaustion of rights will cease to apply to the UK, making import and export a costly business and in a worst-case scenario could effectively kill parallel distribution.

This conference will bring together industry experts to discuss the challenges and drivers of the industry, including the EU regulatory landscape and the impact of the Brexit and the Pandemic together. The conference will also provide global insights on Parallel trade and will reflect on key takeaways for other member states.

pbaynham@SAE Media Group-online.co.uk

FEATURED SPEAKERS

Beatriz San Martin

Beatriz San Martin

Partner, Arnold & Porter
Christopher Stothers

Christopher Stothers

Partner, Freshfields Bruckhaus Deringer LLP
Eric Noehrenberg

Eric Noehrenberg

Vice President and Global Head of Market Access and Government Affairs, Corcym
Fabrizio Gianfrate

Fabrizio Gianfrate

Professor of Health Economics, University of Ferrara and Rome
Hynek Valerian

Hynek Valerian

Group Parallel Trade Manager, Dr.Max Group
Jackie Mulryne

Jackie Mulryne

Partner, Arnold & Porter
Jeroen Muyldermans

Jeroen Muyldermans

Partner, Fencer Law
Libby Amos-Stone

Libby Amos-Stone

Counsel, Arnold & Porter
Martin Howe QC

Martin Howe QC

Queens Counsel, 8 New Square
Martin Slegl

Martin Slegl

General Manager Czech Republic and Slovakia, IQVIA
Paul Maeyaert

Paul Maeyaert

Partner, Fencer Law
Peter Bogaert

Peter Bogaert

Managing Partner, Covington & Burling LLP
Robin Blaney

Robin Blaney

Partner, Covington & Burling
Shabnam Hanassab-Braude

Shabnam Hanassab-Braude

Engagement Manager, IQVIA
Shishu Chen

Shishu Chen

Senior Associate, Arnold & Porter
Stefan Enchelmaier

Stefan Enchelmaier

Professor of European and Comparative Law, Tutor in Jurisprudence, Lincoln College, GB-Oxford
Tushar Patel

Tushar Patel

Technical Director, Key Pharmaceuticals Ltd
Ulf Grundmann

Ulf Grundmann

Partner, King & Spalding LLP

Beatriz San Martin

Partner, Arnold & Porter
Beatriz San Martin

Beatriz focuses her intellectual property practice on the life sciences sector and innovative technologies, with niche SPC experience. She effectively manages and resolves disputes, assists clients on challenging technical legal issues and provides strategic IP advice.

Her disputes practice is varied with significant and high-profile experience handling cases before the UK Courts and the Court of Justice of the European Union, as well as assisting in multinational arbitrations. Besides her patent and SPC experience, she has also handled disputes and matters covering the full breadth of intellectual property rights including trademarks, database rights, copyright, design rights and trade secrets.
 

Christopher Stothers

Partner, Freshfields Bruckhaus Deringer LLP
Christopher Stothers

Christopher is a recognized expert in parallel trade, with a particular focus on the pharmaceutical sector - his 2007 textbook, “Parallel Trade in Europe: Intellectual Property, Competition and Regulatory Law,” has been cited by the UK Supreme Court. Christopher is also an experienced litigator on cross-border patent disputes, other types of intellectual property, antitrust, pharmaceutical regulation, EU law and commercial disputes. He has taken cases before the First Tier Tribunal, the Upper Tribunal, the Patents County Court, the High Court, the Court of Appeal, the House of Lords, the Supreme Court, the European Patent Office, the European Court of Justice and the European Court of Human Rights.

Eric Noehrenberg

Vice President and Global Head of Market Access and Government Affairs, Corcym
Eric Noehrenberg

Dr Eric Noehrenberg has a long history with SMi’s Parallel Trade Conferences, which he has Chaired several times over the past 16 years. Eric has worked in the parallel trade field since 1999 – in the last millennium!
Eric brings over 30 years experience and insights from the pharmaceutical, biotech and medical devices industries:

  • Eric is Vice President and Global Head of Market Access and Government Affairs at CORCYM, a leading multinational medical device company in the structural heart area, focusing on heart valve repair and replacement. In this role and reporting directly to the CEO, he is responsible for developing global market access and government affairs strategies for CORCYM and leading teams around the world in the adaptation and implementation of these strategies.
  • Eric was previously at Edwards Lifesciences, where he was responsible for developing international market access strategies for the leading products of Edwards’ Structural Surgical Heart and Critical Care Franchises, as well as collaborating with national and regional market access colleagues on the implementation of national-level strategies in the broad geographic region of Europe, EMEA, Latin America and Canada.
  • Eric came to Edwards from Shire Pharmaceuticals’ international HQ in Switzerland, where he was Director and Regional Lead for Market Access for Latin America. He had responsibility for pricing decisions for products across Shire’s portfolio for the region as well as creating launch strategies for major products from the Rare Diseases and Neurosciences franchises. Prior to this role, Eric was Director, Public Affairs for Market Access, for Shire’s Specialty Pharmaceutical Division, where he developed market access strategies for key neuroscience products for the European, Asian, and LATAM regions.
  • Eric has prior experience in global roles at the international trade federation for the pharmaceutical industry, IFPMA, and at the United Nations.
  • Eric has a Bachelor’s Degree from Princeton University, a Master of Public Policy Degree from Harvard University, and a Doctorate from the University of Tübingen, Germany, focusing on International Game Theory.

Fabrizio Gianfrate

Professor of Health Economics, University of Ferrara and Rome
Fabrizio Gianfrate

Bio of Fabrizio Gianfrate
PhD in Health Economics (1985), Masters in HE at Stockolm, York and Rome
-Current positions
Full Professor of Health Economics and Outcome Research
Market Access consultant
-Past roles
Ex payer (AIFA, Regions and Hospitals), formerly director at Ministry of Health,
Responsible of WHO Collaborative Centers.
In the past director of pharmaceutical Companies Foundations, Editorial director of
pharma magazines
Winner of the 2004 Award for Culture of Ministry of University
-Other
Actually board member of scientific societies and associations.
Author of more than 700 publications and 7 books on pharmaceutical economics and
policies

Hynek Valerian

Group Parallel Trade Manager, Dr.Max Group
Hynek Valerian

Hynek has spent more than 20 years in pharmaceutical and consumer health market research focusing on the Czech and Slovak markets. In 2020 he joined Dr.Max Group, a leading European pharmacy chain, as the Group Parallel Trade Manager.
Hynek holds MSc degree in Biophysics from Charles University in Prague, PhD degree in Physical Chemistry from the Academy of Sciences of the Czech Republic and MBA degree from Sheffield Hallam University.
 

Jackie Mulryne

Partner, Arnold & Porter
Jackie Mulryne

Jackie Mulryne advises clients in the life sciences and MedTech sectors, and has a broad practice providing regulatory compliance and public policy advice. She advises on UK and EU law, and has experience with a range of regulatory issues that arise throughout the product lifecycle. She regularly develops strategies to help bring innovative products to market, and has assisted a number of client in developing and implementing cross-border regulatory and compliance programmes.
Jackie also advises on contentious disputes in the sector, and has extensive experience in public and administrative law challenges to the decisions of regulatory bodies in the UK and EU.
 

Jeroen Muyldermans

Partner, Fencer Law
Jeroen Muyldermans

Jeroen Muyldermans is a lawyer admitted to the bar of Brussels (2007) and has developed a particular interest and expertise in parallel trade matters, defending right owners in high stake cases before national courts and the EU Courts (Mitsubishi, case C-129/17 and Novartis, case C-253/20).
Jeroen is a member of different professional organisations (INTA; PTMG; ECTA, BMM) and regularly publishes articles and books on topics of intellectual property law, including “The Likelihood of Confusion – A practical guide to the case-law of EU Courts” (Kluwer Law International, 2019).

Libby Amos-Stone

Counsel, Arnold & Porter
Libby Amos-Stone

Libby Amos-Stone advises pharmaceutical and medical device clients on UK and EU regulatory matters, and on public and administrative law litigation before the UK and EU Courts. Libby assists companies on strategic issues arising during the life cycle management of pharmaceutical products and maximisation of IP regulatory rights including regulatory data protection, supplementary protection certificates, paediatric rewards, and orphan market exclusivity.

Martin Howe QC

Queens Counsel, 8 New Square
Martin Howe QC

Martin Howe QC is one of the leading practitioners in the field of parallel imports and their relationship to intellectual property law and regulatory law. Among the key cases in which he has appeared as counsel are C-403/08 FAPL v QC Leisure/Karen Murphy (Grand Chamber, 2011) on the parallel importation and use of satellite decoder cards, and C-267 Merck v Primecrown (Full Court, 1996) on patented drugs within the EU single market and from accession states.

He is also chairman of Lawyers for Britain, formed in 2016 as the lawyers’ group supporting Leave in the referendum campaign, which continues to work on legal issues where the UK can take advantage of its freedom of action in the post Brexit global environment.
 

Martin Slegl

General Manager Czech Republic and Slovakia, IQVIA
Martin Slegl

• Martin has over 9 years experience in the area of management consulting, he was leading South East Europe consulting with IQVIA (10 countries). His current role is General Manager for the Czech Republic and Slovakia
• His specialty is cross border trade and he has worked for a large number of HQs across Europe in different therapy areas
• He has proven project experience across a variety of industries through Europe as he worked with Roland Berger and A.T. Kearney
• Martin holds CEMS Master's in International Management and Master’s in Business Economics degrees from ESADE and University of Economics in Prague

 

Paul Maeyaert

Partner, Fencer Law
Paul Maeyaert

Paul Maeyaert is a founding partner at Fencer, an IP boutique law firm specializing in intellectual property, media & advertising, distribution as well as related practice areas. Paul’s intellectual property expertise has a particular focus on trademark, patent and copyright litigation, anti-counterfeiting, and parallel trade matters. He is a member of the Brussels bar and, over the past decades, Paul has built a vast experience as a litigator, not only before the Belgian courts, but also before the European courts.
Paul also lectures on European trademark law at the Université de Liège, as part of its LL.M program “Competition law and IP” and is a guest lecturer on advertisement law in Brussels at the VUB and the Université Saint-Louis. He also lectures at the yearly IP Summer School at Downing College, Cambridge. He is a frequent conference speaker and has authored several publications in the areas of intellectual property, distribution and advertising.
E-mail: paul.maeyaert@fencerlaw.eu

Peter Bogaert

Managing Partner, Covington & Burling LLP
Peter Bogaert

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the EU Courts in Luxembourg and in local litigation in Belgium. Peter's practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he represents numerous innovative life sciences companies, including start-ups, as well as several industry associations.


Chambers Global notes that a client said: “He is an extremely experienced professional with broad expertise and provides sensible and well-balanced solutions." He is consistently ranked by PLC as one of the leading life sciences lawyers globally and Legal 500 EMEA and Chambers Europe note Peter's prominent regulatory pharmaceutical and environmental practice. Legal 500 EME noted that he is "a superb lawyer who is very pleasant to work with." Peter regularly writes and speaks on life sciences issues. He is a founding member of the Brussels Pharma Law Group and also served for fifteen years as Managing Partner of the firm’s Brussels office.
 

Robin Blaney

Partner, Covington & Burling
Robin Blaney

Robin Blaney is a partner in Covington & Burling’s Life Sciences practice. He advises pharmaceutical, biotechnology, medical device and cosmetic manufacturers and trade associations on a wide range of regulatory, compliance, transactional and legislative matters, as well as the full range of commercial agreements that span the product life-cycle in the life sciences sector. His expertise includes clinical trial agreements, manufacturing and supply agreements, distribution and other marketing agreements, regulatory services agreements, and tenders. He has particular experience structuring and documenting EU pharmaceutical distribution arrangements and transitional arrangements relating to product acquisitions. Robin writes and speaks regularly on subjects such as medical device regulation, pharmacovigilance and clinical trials.

Shabnam Hanassab-Braude

Engagement Manager, IQVIA
Shabnam Hanassab-Braude

IQVIA’s expert and thought leader in European Parallel Trade dynamics, supply chain and distribution with several years of experience working in this field. Shabnam has developed in-depth expertise in pharmaceutical market dynamics and the increasing complexities of the trading environment. Shabnam is highly experienced on IQVIA’s data types, coverage and various supply chain offerings available centrally as well as locally, working with network of people within and outside organization. She has led several European supply chain consulting projects in the past few years.

Shabnam holds BSc, MSc and PhD from University of London in Pharmaceutical and Computational Chemistry.

 

Shishu Chen

Senior Associate, Arnold & Porter
Shishu Chen

Shishu Chen focuses her practice on intellectual property matters. Her experience includes advising clients on enforcing and defending patents, trade marks, designs, copyright and confidential information, and this has included coordinating investigations on counterfeiting activities, assisting in pre-action counseling and negotiations, acting for clients in both civil infringement litigation and criminal prosecution, representing clients in applications for site-blocking orders, and initiating and defending trade mark opposition proceedings.
Ms. Chen also advises clients on IP-related issues arising from commercial transactions, and assists clients with the drafting of agreements for licensing, contract manufacturing, franchising, joint development, and supply of goods and services. She has experience in conducting full suite IP audits to support IP valuations, and regularly assists with IP due diligence exercises.
Ms. Chen acts for clients across a range of sectors and industries, including pharmaceutical, life sciences, fintech, education, food & nutrition and retail. She is qualified as a solicitor in England and Wales, and as an advocate and solicitor of Singapore. She is fluent in Mandarin.

 

Stefan Enchelmaier

Professor of European and Comparative Law, Tutor in Jurisprudence, Lincoln College, GB-Oxford
Stefan Enchelmaier

Professor Stefan Enchelmaier went to school in the Rhineland in Germany. Following National Service, he studied Law, Philosophy, and Latin at the universities of Cologne, Hamburg, and Edinburgh. Professor Enchelmaier is a fully qualified German lawyer, and has practiced mostly in private law. He obtained his doctorate from the University of Bonn with a thesis on European competition law, and his habilitation from the University of Munich with a thesis on comparative Anglo-German personal property law. Professor Enchelmaier also graduated LLM from the University of Edinburgh, and was conferred an MA by the University of Oxford. He held posts in Oxford (1997-2003); Max-Planck-Institute for Innovation and Competition, Munich (2003-2008); and York (2008-2013). Professor Enchelmaier returned to Oxford in 2013.

Tushar Patel

Technical Director, Key Pharmaceuticals Ltd
Tushar Patel

Tushar Patel An experienced team leader with broad experience of strategic, operational, and business management responsibilities. Have a proven history of successful pharma business start-up projects from conception to commercialisation within set timelines. Value creation by efficient use of business administration skills to grow a pharmaceutical company by strategically managed and tailored policies, training and development, HR, finance, supply chain management, research & development, marketing, and in/out licensing partnerships. A pharmacists with over twenty years working knowledge of Good Pharmaceutical Practices (GxP disciplines – Good Distribution &
Manufacturing Practice, GDMP, Good Pharmacovigilance Practice, GPvP, Good Clinical Practice, GcP), new product development R & D, pharmaceutical (Generics) product life cycle management. A trusted ability to resolve challenging problems, pharmaceutical strategies and engage at all management levels and regulatory authorities to overcome deficiencies and drive projects successfully to desired outcomes. Experience of QMS migration to a digital platform to improve data integrity, GxP compliance and remote workflow across global territories. Also experienced in use of artificial intelligence (AI) for
PV database modelling, literature searches and overall streamlining PV processes to improve drug benefit-risk management and risk evaluation. Understanding of Pharmacovigilance (PV) activities and processes for generic medicines attained by self-learning and developing from scratch a fully functional Quality Management System (QMS) for provision of PV in house to meet requirements for regulatory submissions and approval of manufacturing licences and marketing authorisations. As an experienced pharmacist have worked as a locum and owned and managed own pharmacies as a superintend and director. Together with my wife reached our heights of four pharmacies and forward integrated into provision of regulatory consultancy services where we self-trained and organically grew the company to provide full range of GxP services and attain its own marketing authorisations
and commercialised generics.

Ulf Grundmann

Partner, King & Spalding LLP
Ulf Grundmann

Ulf Grundmann is partner in King & Spalding’s FDA & Life Sciences practice group and is located in Frankfurt, Germany. With more than 25 years of experience, his practice focuses on the medical device, pharmaceutical, cosmetics and food industries. Ulf advises clients in all areas of EU regulatory, unfair competition and compliance law and represents clients before national and European authorities. Ulf is an experienced appellate litigator well known for representing his clients in litigation cases before German and European courts, including the General Court and the Court of Justice of the European Union.

Wes Lepla

Senior Associate, Covington & Burling
Wes Lepla

Wesley Lepla advises on all aspects of Belgian and European competition law, including merger control, cartels, anticompetitive agreements, abuse of a dominant position, and state aid law.
He has worked on a range of merger control cases before the European Commission and numerous national authorities and has gained extensive experience in coordinating multijurisdictional merger control notifications and proceedings. Mr. Lepla has represented clients in antitrust proceedings and regularly counsels on state aid, vertical agreements, and the licensing of intellectual property rights.
Mr. Lepla is also a research and teaching assistant at the law faculty of the Free University of Brussels (VUB).

 

Conference agenda

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8:30

Registration and Coffee

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9:00

Opening Remarks and Introductions

Tushar Patel

Tushar Patel, Technical Director, Key Pharmaceuticals Ltd

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9:10

Look back at Parallel Trade to understand the future

Tushar Patel

Tushar Patel, Technical Director, Key Pharmaceuticals Ltd

  • History of parallel imports.
  • What are parallel imports – some live examples to demonstrate the
  • complexities
  • How do PI work in the UK? What is a PI licence, manufacturing and processing and distribution of PI at wholesale, retail, and customer/patient level?
  • An introduction to the advantages and disadvantages of parallel trade
  • Understanding what has changed for Parallel trade over the past 12 months
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    9:50

    Parallel Trade and Brexit, where are we now?

    Tushar Patel

    Tushar Patel, Technical Director, Key Pharmaceuticals Ltd

  • Discussion on the changes that have happened due to Brexit over the past year
  • What strategies are currently being used?
  • Are these strategies of advantage to parallel traders?
  • Understanding what Brexit means for the long-term moving forward
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    10:30

    Morning Coffee

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    11:00

    Where are the limitations, if any, and what are they?

    Tushar Patel

    Tushar Patel, Technical Director, Key Pharmaceuticals Ltd

    Current trading models and their successes
    The opportunities that are currently possible within the parallel trade industry
    Understanding the challenges within Parallel trade for -

  • A parallel import licences
  • wholesalers
  • NHS
  • Community pharmacy
  • Patients
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    11:40

    A future outlook and open discussion

    Tushar Patel

    Tushar Patel, Technical Director, Key Pharmaceuticals Ltd

    An interactive question and answer session

  • What is the future of Parallel Trade?
  • Has Brexit changed the role of Parallel Traders within wholesaling
  • Will things continue to change, how can we be prepared?
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    12:20

    Closing Remarks

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    12:30

    End of Workshop

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    13:00

    Registration and Coffee

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    13:30

    Opening Remarks and Introductions

    Stefan Enchelmaier

    Stefan Enchelmaier, Professor of European and Comparative Law, Tutor in Jurisprudence, Lincoln College

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    13:40

    Introductory session

    Stefan Enchelmaier

    Stefan Enchelmaier, Professor of European and Comparative Law, Tutor in Jurisprudence, Lincoln College

  • An overview of Intellectual property and free movement of goods
  • Territoriality of National IP Rights
  • When parallel trade is permissible, and when it is not an interactive discussion
  • clock

    14:20

    Case Study introductions and preliminary discussion

    Stefan Enchelmaier

    Stefan Enchelmaier, Professor of European and Comparative Law, Tutor in Jurisprudence, Lincoln College

  • Marketing of Pharmaceuticals – repackaging – parallel trade
  • COVID 19 and trade vaccines – international vs regional exhaustion
  • A glance at competition law
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    15:00

    Afternoon Tea

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    15:30

    An interactive look at the case studies

    Stefan Enchelmaier

    Stefan Enchelmaier, Professor of European and Comparative Law, Tutor in Jurisprudence, Lincoln College

  • Participants apply principles from previous session to scenarios
  • Participants work in small groups
  • Presentation to the whole group
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    16:10

    Open Q&A

    Stefan Enchelmaier

    Stefan Enchelmaier, Professor of European and Comparative Law, Tutor in Jurisprudence, Lincoln College

  • The impact that these case studies had on the real world
  • Open discussions of case studies brought by the audience
  • A discussion and future outlook for parallel trade
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    16:50

    Closing Remarks

    Stefan Enchelmaier

    Stefan Enchelmaier, Professor of European and Comparative Law, Tutor in Jurisprudence, Lincoln College

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    17:00

    End of Workshop

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    8:00

    Registration and Coffee

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    9:00

    Chair's Opening Remarks

    Eric Noehrenberg, Vice President and Global Head of Market Access and Government Affairs, Corcym

    Christopher Stothers, Partner, Freshfields Bruckhaus Deringer LLP

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    9:10

    The trading of in-vitro-medical devices

    Ulf Grundmann, Partner, King & Spalding LLP

    • An overview of the new EU regulation on medical devices
    • The additional requirements to be met by parallel traders moving forward
    • Case study related to the legal case of ‘Servoprax’
    • Next steps for traders and manufacturers ahead of the IVD regulation change
     

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    9:50

    Exhaustion of IP rights and Parallel Trade

    • Parallel exports from the UK to the EEA
    • Actions for parallel exporters of IP-protected goods
    • Actions for IP rights holders
    • Consultation on the UK’s future exhaustion of IP rights regime
     

    Beatriz San Martin, Partner, Arnold & Porter

    Shishu Chen, Senior Associate, Arnold & Porter

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    10:30

    Morning Coffee

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    11:00

    Key updates, including EU case law

    Peter Bogaert, Managing Partner, Covington & Burling LLP

    • Update on EU case law (including on safety features)
    • Lessons learnt from the new veterinary medicines Regulation (applies as from January 2022)
    • A general overview on the changes in regulations over the past year
    • The importance of safety within parallel trade and what can be done to improve it?
     

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    11:40

    An update on Parallel Trade in EE

    Martin Slegl, General Manager Czech Republic and Slovakia, IQVIA

    • Main trends to be understood
    • Access to innovation
    • Selected case studies about parallel trade
     

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    12:20

    Networking Lunch

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    13:20

    De-branding and re-branding without the consent of the IP-owner

    Paul Maeyaert, Partner, Fencer Law

    • Understanding the impact of de-branding and re-branding
    • Obtaining consent from an IP owner
    • The impact on IP rights holders from re-branding
    • How does this effect parallel trade and the import of medicines

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    14:00

    Latest key trends of Parallel Trade within Europe, Covid, Brexit and more…

    Shabnam Hanassab

    Shabnam Hanassab, Engagement Manager, IQVIA

    • Latest and historical overview of Parallel Trade sales trends across the EU
    • The impact of Brexit and COVID-19 on parallel trade
    • Exploring the key drivers of Parallel Trade across Europe and latest examples
     

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    14:40

    Regulatory, Economic and Market Evolution of PT

    Fabrizio Gianfrate, Professor of Health Economics, University of Ferrara and Rome

    • PT in a next unique EU HTA and assessment scenario development
    • Impact and response of PT on public healthcare services
    • Future scenarios of PT for manufacturer, wholesale, and pharmacists
    • Possible win-win solutions
     

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    15:20

    Afternoon Tea

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    15:50

    Intellectual property and free movement of goods: the internal market in pharmaceuticals

    Stefan Enchelmaier, Professor of European and Comparative Law, Tutor in Jurisprudence, Lincoln College, GB-Oxford

    • Territoriality of National IP Rights
    • Key provisions of the relevant Directives and Regulations, and their relationship with the Treaty
    • Exhaustion of the rights conferred by trademarks and patents
    • When parallel trade is permissible, and when it is not
     

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    16:30

    Panel Discussion: Understanding the impact of Parallel Trade, from production to sales

    • The impact on wholesalers and pharmacists
    • The working relationship between wholesalers and industry
    • Manufacturing requirements and how this impacts sales
    • What needs to change across the industry to improve customer safety
     

    Eric Noehrenberg, Vice President and Global Head of Market Access and Government Affairs, Corcym

    Fabrizio Gianfrate, Professor of Health Economics, University of Ferrara and Rome

    Tushar Patel, Technical Director, Key Pharmaceuticals Ltd

    clock

    17:10

    Chair's Closing Remarks and Close of Day One

    Christopher Stothers, Partner, Freshfields Bruckhaus Deringer LLP

    Eric Noehrenberg, Vice President and Global Head of Market Access and Government Affairs, Corcym

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    8:30

    Registration and Coffee

    clock

    9:00

    Chair's Opening Remarks

    Eric Noehrenberg, Vice President and Global Head of Market Access and Government Affairs, Corcym

    Christopher Stothers, Partner, Freshfields Bruckhaus Deringer LLP

    clock

    9:10

    Parallel Trade post Brexit – Regulatory Insight

    • Summary of the changes to the regulatory framework in the UK post Brexit and the position in Northern Ireland
    • The effect of Brexit on UK and EU regulations, what considerations should companies be aware of?
    • Overview of regulatory considerations and impact on EU case law on parallel trade in the UK
    • How to ensure your business model/supply chain is fit for purpose
     

    Jackie Mulryne, Partner, Arnold & Porter

    Libby Amos-Stone, Counsel, Arnold & Porter

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    9:50

    Competition Law – An Update

    Wes Lepla, Senior Associate, Covington & Burling

    • State of play in the EU
    • Implications of Brexit
    • Language in cooperation agreements
     

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    10:30

    Morning Coffee

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    11:00

    Parallel Trade after Brexit – from inside and outside the EEA

    Martin Howe QC, Queens Counsel, 8 New Square

    • Government consultation on Parallel Trade and Intellectual Property (govt response if available)
    • Special considerations in pharmaceutical sector, inc trademark substitution
    • Parallel imports and regulatory barriers – from EEA and from outside
    • Parallel importation and services
     

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    11:40

    Parallel Trade, Northern Ireland, and the UK

    Robin Blaney, Partner, Covington & Burling

    • Interpretation of the Northern Irish protocol
    • UK approach to parallel imports (into the UK).
    • Understanding the changes and challenges
    • The future of parallel trade within Northern Ireland and the UK
     

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    12:20

    Networking Lunch

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    13:20

    Novartis – Case study: alchemizing generic medicines into branded products in parallel trade

    Jeroen Muyldermans, Partner, Fencer Law

    • Re-branding of generic versions by parallel importers into branded originator medicines is one of the hot topics currently keeping the pharmaceutical industry busy.
    • Does the first affixing of the trade mark owner’s brand on the product constitute an act of use for which exhaustion does not apply, or does intra-community free movement of goods provides for a derogation to the exclusive right?
    • Is re-branding justified to ensure effective market access or rather to secure an economical advantage?
    • Case-law of national courts throughout the EU has been scarce and divergent
    • Two preliminary referrals involving Novartis are currently pending before the CJEU (joined cases C-253/20 and C-254/20) and merit an in-depth case study.
     

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    14:00

    Understanding the benefits of Parallel Trade

    Eric Noehrenberg, Vice President and Global Head of Market Access and Government Affairs, Corcym

    • Why is parallel trade needed? What are the benefits?
    • The challenges currently faced between parallel trade and industry
    • What does the future look like for Parallel Trade
     

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    14:30

    Afternoon Tea

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    15:00

    Parallel Trade from the perspective of Dr.Max Group

    Hynek Valerian, Group Parallel Trade Manager, Dr.Max Group

    • Dr.Max Group introduction
    • Perspective of the pharmacy chain
    • Implications for the Group’s wholesale
     

    clock

    15:40

    Chair's Closing Remarks and Close of Day Two

    Eric Noehrenberg, Vice President and Global Head of Market Access and Government Affairs, Corcym

    Christopher Stothers, Partner, Freshfields Bruckhaus Deringer LLP


    Partner
    Arnold & Porter
    Partner
    Freshfields Bruckhaus Deringer LLP
    Vice President and Global Head of Market Access and Government Affairs
    Corcym
    Professor of Health Economics
    University of Ferrara and Rome
    Group Parallel Trade Manager
    Dr.Max Group
    Partner
    Arnold & Porter
    Partner
    Fencer Law
    Counsel
    Arnold & Porter
    Queens Counsel
    8 New Square
    General Manager Czech Republic and Slovakia
    IQVIA
    Partner
    Fencer Law
    Managing Partner
    Covington & Burling LLP
    Partner
    Covington & Burling
    Engagement Manager
    IQVIA
    Senior Associate
    Arnold & Porter
    Professor of European and Comparative Law, Tutor in Jurisprudence
    Lincoln College, GB-Oxford
    Technical Director
    Key Pharmaceuticals Ltd
    Partner
    King & Spalding LLP
    Senior Associate
    Covington & Burling

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    Parallel Trade, let’s talk details
    Workshop

    Parallel Trade, let’s talk details

    Copthorne Tara Hotel
    23 March 2022
    London, United Kingdom

    The Case Law of Parallel Imports
    Workshop

    The Case Law of Parallel Imports

    Copthorne Tara Hotel
    23 March 2022
    London, United Kingdom

    VENUE

    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Interview with Christopher Stothers, Partner, Freshfields Bruckhaus Deringer LLP

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    Interview with Tushar Patel, Technical Director, Key Pharmaceuticals

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    Preliminary Attendees 2022

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    Speaker Interview - Peter Bogaert, Covington & Burling LLP

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    Interview with Peter Bogaert, Partner, Covington & Burling LLP

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    Conference Co-Chair Letter

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    Chair & Speaker Biographies

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    Workshop B Agenda

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    Workshop A Agenda

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    Past Attendees

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    Parallel Trade Brochure 2022

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    Past Presentation - Peter Bogaert, Covington

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    Past Presentation - Dr. Eric Noehrenberg, NIPC

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    Past Presentation - Jackie Mulryne, Arnold & Porter

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    Past Presentation - Dr Christopher Stothers, Freshfields Bruckhaus Deringer LLP

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    Media Partners


    World Pharma Today

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    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


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    PharmaVOICE magazine, and its supporting VIEW publications, provide commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE's more than 41,000 U.S.-based subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers.


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    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


    Drug Discovery Today

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    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    Mednous

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    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


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    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


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    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
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    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

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    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


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    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
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