The Programme

Registration

Opening remarks from the Chair

 Assessing current issues in EU pharmaceutical regulation

• Improving clinical trials regulation
• Tightening controls over counterfeits
• Resolving borderline and combination product status
  

The Commission’s Sector Enquiry into pharma: latest developments and implications for the industry

• Why a Sector Enquiry and why now?
• What has happened so far?
• What is the Commission really interested in?
• Who should be involved in helping companies react and respond?
• What can we do to influence the Commission’s thinking?
• What happens next?

Morning refreshments

Philipp Saame
Senior Counsel
Baxter

International aspects of anti-corruption in the European healthcare sector

• The legal framework in major countries
• Particular issues in single jurisdictions
• Examining measures to prevent issues
• Discussing compliance programmes and reactive measures

Examining the legal framework for biosimilars

• Assessing the current legal framework concerning biosimilars
• Issues due to their entry into clinical practice
• Innovation in the biotech sector
• Pricing, reimbursement and cost containment in the biotech sector

Lunch

 The best strategies for extending your patent lifecycle

• Managing s patent filing strategy
• Identifying and implementing a regulatory and patent extension strategy
• Creating litigation support teams
• Assessing key territories and strategies appropriate to each potential competition
• Assessing potential competition
• Understanding evidential issues for litigation in each territory

 Supplementary Protection Certificates (SPCs) and data exclusivity in Europe

• Reviewing requirements for obtaining an SPC
• Analysing paediatric SPC extensions
• SPCs on combinations of old and new drugs and vaccines
• Multiple patentees and multiple SPCs
• Data exclusivity and significant new clinical indications

 The interface between intellectual property rights and competition law: where are we now?

• Existence versus exercise of IP rights
• Interests of the IP rights holder versus interests of society
• IP rights versus trade secrets
• Eliminating all competition versus eliminating workable competition
• Chilling innovation?
• Objective justification

Afternoon refreshments

IPR and competition law – friends or enemies and does it matter?

• Background to the relationship
• Is IP special under the EC rules?
• Where and when do clashes happen?
• How are tensions resolved?
• Recent developments and future prospects

Interactive panel discussion: developments in European pharmaceutical law

• Obtaining IP rights and other protections
• Data exclusivity
• Examining the new EU Paediatric Medicines Regulation
• Discussing legal issues surrounding clinical trials

Closing remarks from the Chair and close of Day One

Programme Day Two Wednesday 17 September 2008

Registration

Opening remarks from the Chair

Examining legal challenges in the context of market access

Legal issues arising due to linkage of cost of medicines to market access

• Legal frameworks for governmental policies on rationing medicines and healthcare services
• Appraisal processes for medicines to test cost-effectiveness and consequent legal issues
• Rights of patients, duties of healthcare professionals and decision-making by healthcare authorities
• Legal recourse for healthcare companies and patients
• Possible impact on M&A in the pharmaceutical industry

• Preparing for and co-ordinating the litigation
• Choosing when to sue
• Seeking interim relief
• The role of declaratory relief
• Settlements: what to consider

Morning refreshments

Multi jurisdictional and multi party product liability litigation: a practical approach

• Class actions and consolidated actions: a different approach
• Managing the aspects of various procedural litigation systems and avoiding conflicts in strategy
• Evidence proceedings and disclosure obligations: how to protect your company from cross border evidence production
• Issues affecting the defense strategy: regulatory and promotional issues, interaction between settlement strategies and ongoing litigation
• Cultural and linguistical challenges

Interactive panel discussion: Debating practical problems legal counsels have to face

• Issues surrounding settlement agreements in Pharma
• Discussing attorney-client privilege
• Trends and tendencies with respect to cost containment

Lunch

 Latest developments in licensing

• Issues surrounding settlement agreements in Pharma
• Identifying the latest developments in licensing
• Looking to the future: the changes arising in the pharma industry

 Distribution agreements in the pharmaceutical sector

• Negotiating the perfect agreement - points to look out for
• Possible legal and business issues which could arise during the lifetime of the agreement
• Involving the right business stakeholders, at the right time
• Parting company - how to successfully manage the termination of an agreement

Keep your license and alliance agreements trendy

• Early stage deals
• Reciprocal deals
• Complex deal structures
• How to respond in license and alliance agreements to these trends in licensing

Afternoon refreshments

• Recent European Commission and European Courts precedents on parallel restrictions in the pharmaceutical sector
• The Commission’s approach with regard to refusal to supply, dual-pricing and direct sales
• Change of policy? What can we expect from the Commission and the national competition authorities in the future?

 Corporate communication and marketing: what needs to be considered?

• The impact of corporate communication on pharma law professionls
• What we need to be aware of – looking at the current issues
• Identifying the responsibilities of legal professionals

Closing remarks from the Chair and end of conference