smi group's 11th annual parallel trade 2017 conference
TRANSCRIPT
WORKSHOP B | 13.30 – 17.30
Parallel Trade – Management Strategies Workshop Leader:
Janice Haigh, Practice Leader, Market Access, Quintiles
www.parallel-trade.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPSWednesday 8th February 2017, Holiday Inn Kensington Forum, London, UK
REGISTER BY 31ST OCTOBER AND SAVE £400REGISTER BY 30TH NOVEMBER AND SAVE £200REGISTER BY 16TH DECEMBER AND SAVE £100
@SMIPHARM
With Brexit and the new EU Falsifi ed Medicine Directive, what does the future hold for parallel trade? This event will discuss short term versus long term concerns of pharma manufacturers, regulators, as well as parallel traders. They will engage in an interactive debate and discuss how to keep abreast of the current trends and how to overcome all challenges. Discussion topics include:
• Parallel Trade 101 – Which factors determine the fl ow of pharmaceutical products in Europe?
• The European Commission’s Falsifi ed Medicines Directive – recent updates• Panel Debate – In the spotlight: Shortages• Parallel traders panel – challenges and opportunities• Beyond pharmaceutical products – parallel imports of medical devices• Panel Debate – In the spotlight: Technology and new trends• Regional and country focus – Scandinavia, UK and Eurasia
SMi Presents 11th Annual Conference & Exhibition on...
Parallel Trade The opportunities and challenges ahead – beyond FMD and Brexit
CONFERENCE: 6TH - 7TH
WORKSHOPS: 8TH
FEB 2017HOLIDAY INN KENSINGTON FORUM, LONDON, UK
CHAIRMAN: Eric Noehrenberg, Director, Regional Market Access Lead,
Latin America, Shire International GmbH
KEY SPEAKERS INCLUDE:• Heinz Kobelt, Director European Affairs, European Association of
Euro-Pharmaceutical Companies• Dr. Rick Greville, Director Wales and Director Distribution & Supply,
The Association of the British Pharmaceutical Industry• Tomasz Dzitko, President, Delfarma• Dr. Shabnam Hanassab, Senior Consultant, IMS Health• Dermot Glynn, Senior Advisor, Europe Economics• Katarzyna Kolasa, Science PhD, Warsaw Medical University• Mike Isles, Executive Director, European Alliance for Access to
Safe Medicines• Dr. Andrew Stainthorpe, Director Market Access and Managed
Entry, Research Health• Karoline Zwierzynska, Associate, Arnold & Porter (UK) LLP• Flemming Wagner, CEO, Abacus Medicine• Maarten Kamphuis, Business Development Director, Fisher Farma• Vladimir Zah, Health Economics Consultant, ISPOR
WORKSHOP A | 8.30 – 12.30
Understanding IP and competition law issues in parallel trade Workshop Leaders:
Kathy Osgerby, Associate, Arnold & Porter (UK) LLPKaroline Zwierzynska, Associate, Arnold & Porter (UK) LLP
MARKETING OPPORTUNITIESWant to know how you can get
involved? Interested in promoting your services to this market?
Contact – Anna Serazetdinova SMi Marketing on
+44 (0) 20 7827 6180 or email: [email protected]
Parallel Trade Day One | Monday 6th February 2017
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks Eric Noehrenberg, Director, Regional Market Access Lead,
Latin America, Shire International GmbH
OPENING ADDRESS9.10 Parallel Trade 101 – Which factors determine the fl ow of
pharmaceutical products in Europe? • Parallel exports and parallel imports – defi ning the terms • Beyond price differences and legal guidelines –
currency fl uctuations and much more • Parallel trade in the EU – key facts including value, key
import and source markets as well as key players • Impact on patients – shortages and quality • Current trends with parallel trade in pharmaceuticals in Europe Eric Noehrenberg, Director, Regional Market Access Lead,
Latin America, Shire International GmbH
9.50 The European Commission’s Falsifi ed Medicines Directive – recent updates
• Exploring the legal framework of the Falsifi ed Medicines Directive
• What progress has been made since February 2016? • Implementation of the Falsifi ed Medicines Directive - the
new rules on medicine verifi cation • All what you need to know about “product information
templates” • What are the regulatory requirements for nationally
authorised products? Dr Rick Greville, Director Wales and Director Distribution &
Supply, The Association of the British Pharmaceutical Industry
10.30 Morning Coffee
11.00 Initiatives of Parallel Distributors in the context of Falsifi ed Medicines Directive
• Good Parallel Distribution Guidelines • Early Warning Anti-CF Platform • Joint Audits Initiative • European Medicines Verifi cation Organization Tomasz Dzitko, President, Delfarma
11.40 European Medicines Verifi cation Organization – an update from Brussels
• Explaining the complexity behind the planning and design of a pan-European medicine verifi cation system
• Implementing national verifi cation systems that function at an equal level of effi cacy, are interoperable and cost effective
• The role of the European Hub and national data repositories
• EMVO and interactions with various supply chain stakeholders
Heinz Kobelt, Director European Affairs, European Association of Euro-Pharmaceutical Companies
12.10 Networking Lunch
PANEL DEBATE1.30 In the spotlight: Shortages • Shortages explained – manufacturing and
trade related shortages • The implications of parallel trade for low-price
countries • When Governments need to intervene
– Bulgaria’s case – oncology drugs • Examining an increased tendency to yield new
medicines’ availability in low income countries • Overcoming the challenges – on the road to a more
transparent and regulated distribution cycle • Will new potential trade barriers eliminate the shortages
problem? • Impact of possible import of products from outside the
EU into the EU Heinz Kobelt, Director European Affairs, European
Association of Euro-Pharmaceutical Companies Tomasz Dzitko, President, Delfarma
2.10 Which categories of pharmaceutical products offer highest margins for traders? What is a good profi t margin?
• Regional outlook – product range vs. product value for parallel trade in Europe
• The increasingly diversifi ed product portfolio for parallel distribution – challenges and opportunities
• Which categories of products are favoured by parallel distributors?
Vladimir Zah, Health Economics Consultant, ISPOR
2.50 Northern Europe – opportunities and challenges • An overview of latest developments in parallel trade in
Northern Europe (including Scandinavia) • Parallel trade – what does the future hold? • The benefi ts of parallel trade for the European society • Future threats to parallel trade Flemming Wagner, CEO, Abacus Medicine
3.30 Afternoon Tea
4.00 Region focus: Eurasia • Exploring regulatory aspects in Eurasia • Focus on Russia – reviewing the status after the recent
legalisation of parallel trade • Azerbaijan as a regional hub Alexey Savin, Principal Russia and CIS, IMS Health
4.40 Legal 101 - IP, competition and regulatory law • The impact of IP on parallel trade of pharmaceuticals • The competition restrictions on dual pricing, quota and
DTP models • How does the regulatory system deal with parallel
trade? Kathy Osgerby, Associate, Arnold & Porter (UK) LLP Karoline Zwierzynska, Associate, Arnold & Porter (UK) LLP
5.20 Chairman’s Closing Remarks and Close of Day One
REGIONAL FOCUS – FROM GERMANY TO EURASIA
PHARMACEUTICAL ANTI-COUNTERFEITING – COMBATING THE DANGER FROM FAKE DRUGS
LEGAL VIEW – INTELLECTUAL PROPERTY, COMPETITION AND REGULATORY CHALLENGES
Offi cial Publications
Register online at www.parallel-trade.com Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Offi cial Media Partners
HOT TOPIC – PANEL DEBATE
SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and branding
packages, uniquely tailored to complement your company’s marketing strategy. Prime networking opportunities exist
to entertain, enhance and expand your client base within the context of an independent discussion specifi c to your industry. Should you wish to join the increasing number of companies benefi ting from sponsoring our conferences
please call: Alia Malick on +44 (0) 20 7827 6168 or email: [email protected]
Parallel TradeDay Two | Tuesday 7th February 2017
Parallel Trade Day One | Monday 6th February 2017
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks Eric Noehrenberg, Director, Regional Market Access Lead,
Latin America, Shire International GmbH
OPENING PANEL DEBATE9.10 PANEL DEBATE: The big question – what will Brexit mean for
parallel trade to and from the UK? • Will a post-Brexit UK need a new trade deal with the
European Union? The impact of tariffs under a new trade deal
• How can wholesalers tackle the uncertainty until trading arrangements are fi nalised?
• How are the new circumstances affecting medicine supplies in the UK and the rest of Europe? The impact of currency fl uctuations and a weaker pound
• Short term concerns versus long term concerns • What can the UK learn from Switzerland and Norway? Dr Andrew Stainthorpe, Director Market Access and
Managed Entry, Research Health
9.50 European parallel trade – past, present and future • Key trends and dynamics in distribution and dispensing • Outlook and key factors likely to infl uence the market
going forward Dr. Shabnam Hanassab, Senior Consultant, IMS Health
10.30 Morning Coffee
11.00 The case against parallel trade in the EU – will the UK end parallel trade
• Patented pharmaceuticals are not like widgets • Parallel trade is wasteful and does no good • Parallel trade prevents poor people from being treated
with the best medicines Dermot Glynn, Senior Advisor, Europe Economics
11.40 Parallel traders panel – challenges and opportunities • How traders can work together to improve supply chain
safety – unleashing the potential of collaboration • Strategies for overcoming the threat to patients posed by
counterfeit drugs - the role of traders in ensuring product quality and safety
• An overview of initiatives in the context of Falsifi ed Medicines Directive
Flemming Wagner, CEO, Abacus Medicine Maarten Kamphuis, Business Development Director,
Fisher Farma
12.20 Networking Lunch
1.30 Beyond pharmaceutical products – parallel imports of
medical devices
• Benchmarking market conditions for medical devices with
pharmaceutical products
• Recent regulations and guidelines for parallel importers of
medical devices
• What pharmaceutical companies can learn from medical
devices manufacturers?
Katarzyna Kolasa, Science PhD, Warsaw Medical University
2.10 Fighting fakes by raising public awareness – how to
change consumer behaviours
• An overview of statistical trends and the rising threat
• What are the most effi cient ways to address the safety
and legitimacy of websites selling medicines
• The power of educational websites – convincing
results that raising consumer awareness can change
behaviours
• What organisations actively collaborate to enhance
patient safety and how can you get involved
Mike Isles, Executive Director, European Alliance for
Access to Safe Medicines
2.50 Managed entry schemes, HTA and parallel trade
• Managed entry arrangements are becoming the norm for
high cost drugs
• How schemes are tailored to each market - including
national, regional and local arrangements
• Exploring available mechanisms to address risks
Dr Andrew Stainthorpe, Director Market Access and
Managed Entry, Research Health
3.30 Afternoon Tea
4.00 Recap of the 2017 Meeting – Ask the Panel and Audience
Delegates will have the fi nal chance to ask speakers and
colleagues plus summing up what they’ve learnt over the
2-day meeting. It’ll be a recap for objectives set on Day 1
and sharing of key takeaways.
Eric Noehrenberg, Director, Regional Market Access Lead,
Latin America, Shire International GmbH
4.40 Chairman’s Closing Remarks and Close of Day Two
HOT TOPIC – PANEL DEBATE
NEW TRENDS AND THEIR IMPACT ON PARALLEL TRADE
Supported byOffi cial Publications
Register online at www.parallel-trade.com Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
THE FUTURE OF PARALLEL TRADE
Offi cial Media Partners
Understanding IP and competition law issues in parallel trade
Workshop Leader: Kathy Osgerby, Associate, Arnold & Porter (UK) LLP
Karoline Zwierzynska, Associate, Arnold & Porter (UK) LLP
HALF-DAY POST-CONFERENCE WORKSHOP AWednesday 8th February 2017
08.30 – 12.30Holiday Inn Kensington Forum, London, UK
Overview of Workshop:
This half day workshop will explore in depth how IP and competition law can affect parallel trade. Through interactive case studies, it will provide insight into the use of trade mark rights to prevent the sale of repackaged parallel imports, and the potential competition law issues raised by strategies to manage parallel trade.
Programme:
8.30 Workshop Registration & Morning Coffee
9.00 Workshop Leader introduction
9.10 Case study 1: Responding to a repackaging notifi cation
• Legal principles - trade mark exhaustion and the BMS conditions for repackaging
• BMS conditions - when and how can goods be repackaged?
• Consent to sale of goods in the EEA - what about related and group companies?
• Other notifi cations - regulatory and specifi c mechanism
• Will things change post-Brexit?
10.30 Morning Coffee & Networking Break
11.00 Case study 2: Competition law and management strategies
• Legal principles - Articles 101/102 TFEU and case law
• Quota systems and potential risks • Agency (direct to pharmacy/hospital) systems
and potential risks • Other competition risks and red fl ags
12.00 Discussion – Q&A
12.30 Closing remarks from Workshop leader and end of morning workshop
About the Workshop Leaders:
Kathy Osgerby is an Associate in the IP team at Arnold & Porter in London. She advises clients on contentious intellectual property matters and has extensive experience in the life sciences industry. She
advises clients on the full range of IP issues including trade mark enforcement, parallel trade and exhaustion of rights. Kathy has a degree in Molecular Biology and Biochemistry, studied intellectual property law at a postgraduate level, and is a qualifi ed solicitor advocate.
Karoline Zwierzynska is an Associate in thecompetition team at Arnold & Porter in London. She has extensive experience of advising clients in the pharmaceutical sector and advises on a wide range
of transactional and conduct-related UK and EU competition law issues, including EU and multi-jurisdictional merger clearances and abuse of dominance investigations, including by dawn raid, commercial agreements and regulatory matters. In addition, she has also advised non-governmental organisations and has particular experience delivering training on UK and EU competition law compliance. Prior to joining Arnold & Porter, Karoline worked in the fi eld of academic research and has co-authored several peer-reviewed publications in developmental and clinical psychology. She holds a psychology degree from the University of Warwick.
About the Organisation:
Arnold & Porter LLP is an Am Law 100 fi rm focusing on the intersection of business, law, and public policy. The fi rm is known for:• Excellence of work in complex and challenging matters• More than 75 attorneys who have held senior positions in US
and European governments and international organizations• Ability to team effectively with clients and other outside
counsel and advisers• Broad reach across geographic, commercial, cultural, and
ideological borders• Interdisciplinary teams• Ability to assist clients with their international business needs• Chosen as outside counsel by 10 of the FORTUNE 25
companies, 43 of the FORTUNE 100 companies, and more than 2,500 other companies of all sizes
Supported by
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Understanding IP and competition law issues in parallel trade
Workshop Leader: Kathy Osgerby, Associate, Arnold & Porter (UK) LLP
Karoline Zwierzynska, Associate, Arnold & Porter (UK) LLP
HALF-DAY POST-CONFERENCE WORKSHOP AWednesday 8th February 2017
08.30 – 12.30Holiday Inn Kensington Forum, London, UK
Overview of Workshop:
This half day workshop will explore in depth how IP and competition law can affect parallel trade. Through interactive case studies, it will provide insight into the use of trade mark rights to prevent the sale of repackaged parallel imports, and the potential competition law issues raised by strategies to manage parallel trade.
Programme:
8.30 Workshop Registration & Morning Coffee
9.00 Workshop Leader introduction
9.10 Case study 1: Responding to a repackaging notifi cation
• Legal principles - trade mark exhaustion and the BMS conditions for repackaging
• BMS conditions - when and how can goods be repackaged?
• Consent to sale of goods in the EEA - what about related and group companies?
• Other notifi cations - regulatory and specifi c mechanism
• Will things change post-Brexit?
10.30 Morning Coffee & Networking Break
11.00 Case study 2: Competition law and management strategies
• Legal principles - Articles 101/102 TFEU and case law
• Quota systems and potential risks • Agency (direct to pharmacy/hospital) systems
and potential risks • Other competition risks and red fl ags
12.00 Discussion – Q&A
12.30 Closing remarks from Workshop leader and end of morning workshop
About the Workshop Leaders:
Kathy Osgerby is an Associate in the IP team at Arnold & Porter in London. She advises clients on contentious intellectual property matters and has extensive experience in the life sciences industry. She
advises clients on the full range of IP issues including trade mark enforcement, parallel trade and exhaustion of rights. Kathy has a degree in Molecular Biology and Biochemistry, studied intellectual property law at a postgraduate level, and is a qualifi ed solicitor advocate.
Karoline Zwierzynska is an Associate in thecompetition team at Arnold & Porter in London. She has extensive experience of advising clients in the pharmaceutical sector and advises on a wide range
of transactional and conduct-related UK and EU competition law issues, including EU and multi-jurisdictional merger clearances and abuse of dominance investigations, including by dawn raid, commercial agreements and regulatory matters. In addition, she has also advised non-governmental organisations and has particular experience delivering training on UK and EU competition law compliance. Prior to joining Arnold & Porter, Karoline worked in the fi eld of academic research and has co-authored several peer-reviewed publications in developmental and clinical psychology. She holds a psychology degree from the University of Warwick.
About the Organisation:
Arnold & Porter LLP is an Am Law 100 fi rm focusing on the intersection of business, law, and public policy. The fi rm is known for:• Excellence of work in complex and challenging matters• More than 75 attorneys who have held senior positions in US
and European governments and international organizations• Ability to team effectively with clients and other outside
counsel and advisers• Broad reach across geographic, commercial, cultural, and
ideological borders• Interdisciplinary teams• Ability to assist clients with their international business needs• Chosen as outside counsel by 10 of the FORTUNE 25
companies, 43 of the FORTUNE 100 companies, and more than 2,500 other companies of all sizes
Parallel Trade – Management Strategies
Workshop Leader: Janice Haigh, Practice Leader, Market Access, Quintiles
Overview of Workshop:With a volatile macro-economic and evolving regulatory environment, parallel trade activities have introduced new dynamics to pharmaceutical market in 2015. Pharmaceutical manufacturers now recognise it is a cross departmental effort to ensure business integrity. This workshop educate attendees on the following:
• Challenges of logistics and supply• Importance of accurate measurement and affi liate
partnerships in import and export markets• Revenue and profi t• Ensuring patient supply
Programme:
13.30 Workshop Registration and Coffee
14.00 Workshop leader introduction
14.15 Background to Parallel Trade (PT)
14.25 PT Management Options
15.00 An Overview of Supply Management
15.30 Afternoon Tea
16.00 Critical Success Factors
16.30 Review of Tactical Details
17.00 Discussion and Q&A
17.30 End of Workshop
About the Workshop Leader: Janice joined Quintiles Consulting in January 2012. Janice has 25 years pricing and market access strategy experience gained through a variety of consulting roles and in pharma.
She was with IMS/Cambridge Pharma for almost 10 years before joining Astellas Pharma Europe as senior director of pricing and market access in 2006.
About the Organisation:Quintiles (NYSE: Q) helps biopharma and other healthcare companies improve their probability of success by connecting insights from our deep scientifi c, therapeutic and analytics expertise with superior delivery for better outcomes. From advisory through operations, Quintiles is the world’s largest provider of product development and integrated healthcare services.
HALF-DAY POST-CONFERENCE WORKSHOP BWednesday 8th February 2017
13.30 – 17.30Holiday Inn Kensington Forum, London, UK
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VENUE Holiday Inn Kensington Forum, 97 Cromwell Rd, London SW7 4DN, UK
PARALLEL TRADEConference: Monday 6th & Tuesday 7th February 2017, Holiday Inn Kensington Forum, London, UK
Workshop: Wednesday 8th February 2017, London, UK
4 WAYS TO REGISTERwww.parallel-trade.com
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POST your booking form to: Events Team, SMi Group Ltd, Ground & First Floor, 1 Westminster Bridge Road London, SE1 7XW, UK