Parallel Trade Day One | Tuesday 5th February 2019

08.30 Registration & Coffee

09.00 Chairman’s Opening Remarks Heinz Kobelt, Director European Affairs, European Association of Euro-Pharmaceutical Companies

PARALLEL TRADE AND PATIENT SAFETY

09.10 KEYNOTE SESSION: The fundamentals of parallel trade• The concepts behind the practice and specific ways of working• How a parallel trading business is run and the backing rational• Specialisation and regional considerationsEric Noehrenberg, Director Market Access, Edwards Life Sciences

09.50 The impact of parallel trade on patient safety• Parallel trade management to ensure patient safety• Case study presenting a case of patient safety issues• The creation of shortages through the parallel export of

medicines from states with lower costing medicines • Would there be any way to change the market dynamic to

reduce the level of shortages Nerea Blanque, Senior Global Market Access and Pricing Manager, Almirall

10.30 Morning Coffee

11.00 Patients First• Patients: Centre stage of everything we do / should do• Integrity of the Supply Chain• End-to-End supply chain: A MUS, not an optionFelipe Florez-Arango, CFO, Allergan

BRExIT’S IMPACT ON PARALLEL TRADE

11.40 The economic impact of parallel trade on consumers – will Brexit make a difference? • Effects of parallel trade on patients’ access to patented

medicines• Key risks and policy implications. • What opportunities and risks will Brexit offer?Deborah Drury, Senior Consultant, Europe Economics

12.20 Latest Trends of European Parallel Trade • Parallel import trends in year 2018• Drivers of parallel trade across Europe• Brexit and possible impacts on supply chainShabnam Hanassab, Engagement Manager, IQVIA

13.00 Networking Lunch

14.10 Entry deterrence, market shares and growth• Strategic and non-strategic reasons for introducing additional

drugs by a monopolist near the end of market exclusivity period for the original drug.

• Are these drugs introduced to deter generic entry, and if so, is it an effective strategy?

• Post-entry, do additional product and pack variations by an incumbent help with revenue growth of the business unit?

Farasat A.S. Bokhari, Senior Lecturer (Associate Professor), University of East Anglia

14.50 The impact of parallel trading on pharmaceutical companies who distribute products both nationally and internationally• The business and economic impact of parallel trading on

pharmaceutical companies and pharmaceutical manufacturers• The adjustment procedures which are put in place to avoid

adverse effects• The creation of competition within the market and the pricing

strategies that companies adopt• The assessment of demand based on the occurrence

of parallel tradingFlemming Wagner, CEO, ABACUS MEDICINE A/S

THE FALSIFIED MEDICINES DIRECTIVE

15.30 The European Medicines Verification System before the big bang! Are supply chain operators ready?• System readiness: rollout of repository system across EEA area –

experiences and last-minute obstacles• Company readiness: manufacturers, parallel distributors, wholesalers,

hospital pharmacies and community pharmacists all had to prepare for compliance with FMD obligations – Lessons learnt

• Funding of the EMVS and other remaining challenges• Implications on supply chain: is FDM disruptive? Are shortages to

be feared? And Brexit is around the corner! Heinz Kobelt, Director European Affairs, European Association of Euro-Pharmaceutical Companies

16.10 Afternoon Tea

16.40 PANEL DISCUSSION: The future of Parallel Trade and supply chain distribution:• The impact of parallel trade on the supply chain• The impact on pharmaceutical companies through the

economic actions as a result• Future regulations and implementations which will impact

existing models• The speculated effect of these changes within the market Moderator: Heinz Kobelt, Director European Affairs, European Association of Euro-Pharmaceutical Companies Felipe Florez-Arango, CFO, Allergan Nerea Blanque, Senior Global Market Access and Pricing Manager, Almirall Eric Noehrenberg, Director Market Access, Edwards Life Sciences Vimal Unewal, Senior Manager In Market Supply, Ferring Pharmaceuticals

17.20 The practical impact of FMD implementation on trade• A more practical outlook on the effect that the implementation of

FMD will have on parallel trade, from a parallel trader’s perspective• The impact on day-to-day processes of wholesalers, parallel

traders and pharmacies• The access of data generated towards member statesAntonio Mendonca Alves, CEO, MD Pharma

18.00 Fighting fakes by raising public awareness• The supply chains – legitimate and illegitimate• Demand side - fuelling the illegitimate Supply Chain• How can we monitor and manage the demand?• The role of the EU Commission and Member States in raising awareness Mike Isles, Executive Director, European Alliance for Access to Safe Medicines

18.40 Chairman’s Closing Remarks and Close of Day One

www.asdevents.com - www.asdevents.com/event.asp?id=19074

Parallel TradeDay Two | Wednesday 6th February 2019

08.30 Registration & Coffee

09.00 Chairman’s Opening Remarks Heinz Kobelt, Director European Affairs, European Association of Euro-Pharmaceutical Companies

THE SUPPLY CHAIN AND SHORTAGES

09.10 KEYNOTE SESSION: The supply chain and the importance of track and trace along with the combination of systems• The inclusion of track and trace along with a unique identifi er

system• How does this integration of systems cause hindrances when the

product travels through more complicated movements?• Are there any problem areas within the checking-in and out?Sigve Sivertsen, Head of Parallel Trade, Apotek Hjärtat AB

09.50 The impact of parallel trade within the lower cost states• Overview of Eastern European (EE) pharma markets • Key difference in supply chain regulation in EE• Data availability in EEMartin Slegl, Regional Principal of East Europe, IQVIA

10.30 Morning Coffee

11.00 Shortages of generic medicines: root causes and solutions• Drivers of medicines shortages in an off-patent, multi-source

sector• Pressure of costly regulatory/quality procedures and cost-

containment measures on generic medicines industry• Recommendations to prevent medicine shortages (addressing

the root causes)Maarten Van Baelen, Market Access Director, Medicines for Europe

11.40 PANEL DISCUSSION: Shortages - how and why do they occur?• The hypothesis behind where exactly within the

market the shortages within regions are caused• The potential implementation of incentives towards companies

to reduce this occurrence?• Would there be a way to track shortages in order to aid the

reduction of them?Moderator: Heinz Kobelt, Director European Affairs, EAEPC Kasper Ernest, Secretary General, European Association of Euro-Pharmaceutical Companies Maarten Van Baelen, Market Access Director, Medicines for Europe Martin Slegl, Regional Principal of East Europe, IQVIA

12.20 Review of recent excessive pricing and pay for delay cases and the implications for pricing• Current regulatory framework for prices of branded medicines • Relationship between prices of branded medicines and parallel

trade prices • Overview of recent branded pharma cases in UK and EC • Implications of recent cases for parallel trade pricesIona McCall, Senior Vice President, AlixPartners

13.00 Networking Lunch

THE LEGAL ASPECTS OF PARALLEL TRADE WITHIN IP, ANTI-TRUST AND COMPETITION LAW

14.10 KEYNOTE SESSION: How to co-exist but do not break anti-trust rules - the margins for movement within competition law in line with the best business practices• The best way to establish patient level demand for a particular

patient set, given the arguable changing goal-posts in the current landscape

• Meeting the basic obligation of domestic demand whilst not catering towards extra-ordinary demand in order to keep in line with business sense

• The strategy through which an interplay between bottom-bound capacity and a cap of supply is maintained

• Applied examples of treatments where the diffi culty of establishment of demand comes in i.e. with cancer treatments which could be used to treat multiple types of cancer and situations in which a company could be seen to be purposefully constraining a competitor’s behavior

Miranda Cole, Partner, Covington & Burling

14.50 Is there a harmonised approach of Parallel Trade by authorities and courts in the EU?• The implementation of historic ECJ case law in the member states• Differences in impact of the Kohlpharma-ruling in the member states• Views of EU authorities• What are the consequences for the business? John Lisman, Attorney, Consultant, Trainer, Lisman Legal Life sciences B.V.

15.30 Exhaustion of Intellectual Property• Trademark law and the re-selling of products once it is within the

marketplace• Re-packaging methods used within the re-selling of

pharmaceutical products• The impact of new packaging requirements (i.e. safety features

according to FMD: unique identifi ers and anti-tampering devices) impact on re-packaging for parallel distribution

Christopher Stothers, Partner, Freshfi elds Bruckhaus Deringer

16.10 Afternoon Tea

16.40 The European Commission’s paper on the obligation of continuous supply• What the paper covers and the procedural practices for

companies within the industry that it outlines• The impact of these practices on the market and company

obligations towards the consumer• The rationale behind these policy choices and the potential

procedural terminations they include• The link to the obligatory supply considerations along with

tackling shortages Kasper Ernest, Secretary General, European Association of Euro-Pharmaceutical Companies

17.20 Evolution of Parallel trade: scenarios and strategies • Future impact of PT for manufacturer, wholesale

and pharmacist• Possible win-win solutions• The Amazon effect on PT• EU and UK Payer evolution on PT Fabrizio Gianfrate, Professor of Health Economics, University of Ferrara and Rome

18.00 Chairman’s Closing Remarks and Close of Day Two

www.asdevents.com - www.asdevents.com/event.asp?id=19074

HALF DAY PRE-CONFERENCE WORKSHOPMonday 4th February 2019

Holiday Inn Kensington Forum, London, UK8.30 - 12.30

Parallel Trade & Brexit. What to expect?Workshop Leader:

Tushar Patel MRPharmS, MBA, MTOPRA, PGDIP, Key Pharmaceuticals Ltd

Workshop Overview:This workshop will focus on Parallel Trade- its definition and what exactly is meant by parallel trade. What products are relevant to parallel trade and why. How parallel trade has evolved over the decade and the business models established in the UK. Explore the other side – rest of EU and see what parallel trade plays in everydaypharmaceutical trade. Stock shortages and FMD has recently been threats to Parallel Trade – what and how are these occurring and why are they important to the industry. Then Brexit was announced, and we can no go into different scenarios about Brexit and how the industry and pharma companies can prepare, plan and embrace this unknown encounter.

Why should you attend this workshop: A brief insight into the history, regulations and strategies employed to parallel trade. Then some case studies to explore different strategies pharma companies can adopt to plan ahead for Brexit. Also explore the impact of parallel trade on Pharma-covigilance, generics, parallel imports across EU boundaries.

Agenda8.30 Registration and coffee 9.00 Opening remarks and introductions 9.10 Session 1: Background on Parallel Trade

• Formation of EU and birth of PT• EU treaties and rules of PT• Industry models for parallel trade and products

of concern• Trading models adopted by Pharma companies.• The Grey market• Consequences and outcomes of PT

9.50 Session 2: Regulatory landscape current and for Brexit• What are the regulatory requirements for PT• Pro & Cons of Brexit on PT• Impact of pharma companies and products on

both sides

10.30 Morning Coffee 11.00 Session 3: Case studies to engage candidates to

explore scenarios for pharma industry to prepare for Brexit and its impact to product supplies and patients across EU.

11.40 Session 4: Recap and evaluate if workshop has met initial expectations. Q&A.

12.30 Closing Remarks and End of Workshop

About the Workshop Leader:Tushar Patel, MRPharmS, MBA, MTOPRA, PGDIPRegistered pharmacist in 1992 following a year training at Milton Keynes hospital. Worked as a community pharmacist for some years whilst also involved in regulatory projects for start-up of parallel import companies in the UK. Facilitated application for MHRA Manufacturing Licences and PL(PI) applications for various clients. Completed my MBA in 1996 and progressed along the community and wholesale of pharmaceuticals. Having established a group of four retail pharmacies I progressed with my initial passion for regulatory and generics. Currently fully engrossed with our formulation & development of generics and formed a fully encompassed pharma company with all regulatory disciplines in house with our own Marketing Authorisations. I am an EU QPPV leading our in house Pharmacovigilance department and also a trainee EU QP, having our own Manufacturing Licence. Our ambition has already been achieved to develop, manufacture and dispense our medicines to our own customer in our own pharmacies. Now we are looking ahead to better serve patients globally and improve where possible to safer medicines.

About the Organisation:Key Pharmaceuticals Ltd Our consultancy services have been established for over 15 years. Our professional services are delivered with extensive experience, knowledge and skill in formulation and development, manufacture, distribution, retail and marketing of pharmaceuticals in Europe. • Proficient in all GxP disciplines. GDP, GMP, PV, GCP.• Formulation & Development• Project Management and product life cycle strategies.• Regulatory Affairs and representation to MHRA

www.asdevents.com - www.asdevents.com/event.asp?id=19074

HALF DAY PRE-CONFERENCE WORKSHOP B Monday 4th February 2019

Holiday Inn Kensington Forum, London, UK13.30 - 17.00

Understanding IP, regulatory and competition law issues in

pharmaceutical parallel trade Workshop Leaders:

John Schmidt, Partner, Arnold & Porter LLPKathy Harford, Professional Support Lawyer, Arnold & Porter LLP

Workshop Overview: This workshop will explore in depth how IP, regulatory and competition law can affect parallel trade in the pharmaceutical industry. Through interactive case studies, it will provide insight into the potential competition law issues raised by strategies to manage parallel trade, the use of trade mark and patent rights to prevent the sale of repackaged parallel imports, and how regulatory notifications can be monitored to assess risk.

Why should you attend? • Understand the legal framework regulating parallel trade

of pharmaceuticals• Participate in interactive case studies considering common

competition law and IP issues• Analyse the risks of parallel trade management strategies

Agenda

13.30 Registration and coffee

14.00 Opening remarks and introductions

14.10 Case Study 1: 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 flags

14.50 Case Study 2: Trade mark exhaustion and repackaging• Legal principles - trade mark exhaustion• BMS conditions - when and how can goods be

repackaged?• Consent to sale of goods in the EEA - what about

related and group companies?

15.20 Afternoon Tea

15.50 Case Study 3: Regulatory and patent notifications• The Specific Mechanism - patent protection and

parallel trade• Monitoring notifications for risk

16.30 Q&A

17.00 Closing Remarks and End of Workshop

About the Workshop Leader: Kathy Harford, Professional Support Lawyer, Arnold & Porter. Kathy Harford is a Professional Support Lawyer in Arnold & Porter’s London office, supporting the IP and litigation practices. She has a particular focus on IP disputes, with experience of patent, trade mark and trade secrets actions in the English courts, opposition proceedings at the European Patent Office, and coordinating IP litigation in multiple jurisdictions across Europe.

John Schmidt, Partner, Arnold and Porter. John Schmidt leads the UK Competition team in London. He has more than two decades of experience dealing with competition authorities and courts in the UK and the EU and regularly advises on complex competition conduct issues, investigations, litigation, and merger cases. He is dual-qualified in the UK and Germany and has a particular focus on the life sciences, consumer goods, finance, and infrastructure sectors.Mr. Schmidt has extensive experience advising pharmaceutical and medical device companies on pricing matters, including a number of reverse payment patent settlement cases both at the EU and UK level. A significant recent success involved a no grounds for action case closure for Teva Pharmaceuticals in the CMA’s investigation into paroxetine after a statement of objections, a supplemental statement of objections, and two oral hearings. He is currently involved in a number of CMA investigations in the pharma sector.

About the Organisation: Arnold & Porter’s Competition, IP and Life Sciences Regulatory practices are recognized worldwide for their breadth, depth, and excellence. With a unique, fully integrated regulatory practice, competition experience covering the full range of US and EU antitrust issues, and prominent IP litigation and transactional practices, Arnold & Porter is able to advise a huge range of life sciences clients on complex cross-practice issues such as parallel trade.

www.asdevents.com - www.asdevents.com/event.asp?id=19074