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SMi’s 16th Annual Conference

Parallel Trade

21-22 March, 2022 | Conference
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SMi presents its 16th annual Parallel Trade virtual 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 after Brexit 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.


To register your interest, please contact: 

pbaynham@smi-online.co.uk

Vice President/ Heads of/General Managers:
• International Trade and Relations
• Supply Chain Development – Brexit
• Brexit Implementation
• Market Access
• Supply Chain Manager
• Parallel trade reporting
• Regulatory Affairs
• IP
• Purchasing
• Policy Patent Operations
• European Affairs
• Supply and Demand
• Attorney
• Distribution

 

AbbVie; AIFA - Agenzia Italiana Del Farmaco; Amgen Europe BV; Arnold & Porter; Baker & Mckenzie; bij CyTuVax b.v. ; Bristows LLC; Covington & Burling; Daiichi Sankyo Europe GmbH; Department of Health and Social Care; EAEPC; Erasmus University Rotterdam; Europe Economics; European Alliance for Access to Safe Medicines; European Association of Euro-Pharmaceutical Companies ; Ferring Pharmaceuticals; FERRING SA; Freshfields Bruckhaus Deringer LLP; Gilead Sciences Ltd; Hollister Europe Ltd; Intellectual Property Office; IQVIA; IQVIA Commercial GmbH & Co. OHG; Key Pharmaceuticals Ltd; Kopinke; LEO Pharma; Lisman Legal Life sciences B.V.; Medac GmbH; MHRA; MSD Animal Health ; Mundipharma; Novartis Pharma AG; Novartis Pharmaceuticals UK Ltd; Novo Nordisk Bioindustrie Sa; Novo Nordisk Ltd; SoftGroupáLtd.; UEA, University of East Anglia; White & Case LLP; Wiggin LLP; Windt Le Grand Leeuwenburgh;
 

Conference programme

8:30 Registration and Coffee

9:00 Chair's Opening Remarks

Eric Noehrenberg

Eric Noehrenberg, Director, Shire International GmbH

Christopher Stothers

Christopher Stothers, Partner, Freshfields Bruckhaus Deringer LLP

9:10 The trading of in-vitro-medical devices

Ulf Grundmann

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
 

9:50 Exhaustion of IP rights and Parallel Trade

Beatriz San Martin

Beatriz San Martin, Partner, Arnold & Porter

• 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
 

10:30 Morning Coffee

11:00 Key updates, including EU case law

Peter Bogaert

Peter Bogaert, 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?
 

11:40 An update on Parallel Trade in EE

Martin Slegl

Martin Slegl, General Manager Czech Republic and Slovakia, IQVIA

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

12:20 Networking Lunch

13:20 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
 

14:00 Regulatory, Economic and Market Evolution of PT

Fabrizio Gianfrate

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
 

14:40 Afternoon Tea

15:10 Intellectual property and free movement of goods: the internal market in pharmaceuticals

Stefan Enchelmaier

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

• 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
 

15:50 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

Eric Noehrenberg, Director, Shire International GmbH

Fabrizio Gianfrate

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

16:30 Chair's Closing Remarks and Close of Day One

Christopher Stothers

Christopher Stothers, Partner, Freshfields Bruckhaus Deringer LLP

Eric Noehrenberg

Eric Noehrenberg, Director, Shire International GmbH

8:30 Registration and Coffee

9:00 Chair's Opening Remarks

Eric Noehrenberg

Eric Noehrenberg, Director, Shire International GmbH

Christopher Stothers

Christopher Stothers, Partner, Freshfields Bruckhaus Deringer LLP

9:10 Parallel Trade post Brexit – Regulatory Insight

Jackie Mulryne

Jackie Mulryne, Partner, Arnold & Porter

• 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
 

9:50 Competition Law – An Update

Wes Lepla

Wes Lepla, Senior Associate, Covington & Burling

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

10:30 Morning Coffee

11:00 Parallel Trade after Brexit – from inside and outside the EEA

Martin Howe QC

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
 

11:40 Parallel Trade, Northern Ireland, and the UK

Robin Blaney

Robin Blaney, Covington & Burling, 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
 

12:20 Networking Lunch

13:20 Novartis – Case study: alchemizing generic medicines into branded products in parallel trade

Jeroen Muyldermans

Jeroen Muyldermans, Partner, Fencer

• 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.
 

14:00 Panel Discussion: Understanding the benefits of Parallel Trade

Eric Noehrenberg

Eric Noehrenberg, Director, Shire International GmbH

• 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
 

14:40 Afternoon Tea

15:10 Avoiding fake medicines by raising public awareness

Dermot Glynn

Dermot Glynn, Senior Advisor, Europe Economics

• How can pharmaceutical companies and parallel traders both ensure patients only received safe medications
• How can we improve the public understanding of active pharmaceutical ingredients
• The role of pharmacies and wholesalers in raising public awareness
• Can we really ensure that the public understand how to avoid fake medicines
 

15:50 Parallel Trade from the perspective of Dr.Max Group

Hynek Valerian

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

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

16:30 Chair's Closing Remarks and Close of Day Two

Eric Noehrenberg

Eric Noehrenberg, Director, Shire International GmbH

Christopher Stothers

Christopher Stothers, Partner, Freshfields Bruckhaus Deringer LLP

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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, SMI 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@smi-online.co.uk

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