Update from EU Commission on Competition Law Enforcement
- Recent updates in the EU pharmaceutical Law sector on competition law enforcement - Insight into abusive dominance through excessive pricing - Latest developments on reverse payment settlements
Dual Dialogue: Excessive Pricing in the Pharmaceutical Industry
- Update on abusive dominance through excessive pricing case law - Practical advice following decisions and developments in recent cases - What constitutes excessive: identifying appropriate value indicators for originator products and understanding value to whom and compared to what
Panel Discussion: Reverse Payment Patent Settlements
- Insight into the Lundbeck and Servier case: practical implications for patent settlements and market definition - Acquisitions of technology: can this be considered an abuse of a dominant position? - How do you define the relevant market from a competition law perspective to define dominance?
Update on Parallel Trade in a Post Brexit Era
- Recent competition law rulings and case law for parallel trade: update on dual pricing - Drivers of parallel trade across Europe, key risks and implications - Exploring the impact of Brexit on the EU market and parallel trade practices - Models and approaches for pharmaceutical companies: what opportunities and risks will Brexit offer?
Panel Discussion: Examining Product Hopping: Abusive Dominance or Product Innovation?
- Examining cases, rulings and review for product hopping as a lifecycle management strategy - Update on the expansion of antitrust scrutiny on product lifecycle strategies - Strategies to minimise competition law risks and protect your product
Panel Discussion: Assessing the Current Status of SPCs
- Update on the law of “protected by a basic patent force”: how is Gilead being applied by National Courts and Patent Offices? Royalty Pharma and Janssen references - The latest on SPCs based on 3rd party Mas: what is the direction of travel? - SPCs for novel and inventive formulations: the Abraxis decision - SPCs for medical devices and combined medical devices/medicinal products – the CJEU decision in Boston Scientific - Reform of SPC law - the Max Planck report and other initiatives: evaluating the proposed manufacturing exemption
Patent Relief: Injunctions, Arrow Declarations, Cross Border Declarations and Injunctions
- Examining recent trends in the granting of relief by the major European Patents Courts - Are final injunctions no longer to be the norm following a finding that a patent is valid and infringed? - What role could compulsory licences pay? - Cross-border relief - Update on Arrow declarations
Panel Discussion: Second Medical Use Patents
- Examining the UKSC decision in the pregabalin case and the implications for plausibility, amendment of patents and cross-label use - Practical steps to be taken when enforcing a second medical use patent - How much data needs to be included in a patent? How to find the sweet-spot in which to file an application
END OF MAIN CONFERENCE DAY 1 - Continue to the evening seminar
Competition Law for Biosimilars - Focus on competition authorities approach and enforcement for biologics and biosimilars - To what extent do the competition law principles developed for generic drugs apply to the biological space? - Status of abusive dominance: pricing practices and lifecycle market strategies
Intellectual Property Considerations for Biosimilars: Challenges and Opportunities - Practical guidance for Biosimilars and patent infringement - Strategies to delay the entry of biosimilar products when originator product patent expires
Regulatory Frameworks for Biosimilars - How are biosimilars defined and interpreted in Europe - What is the regulatory legal framework applicable to biosimilars? - Reviewing pricing and reimbursement considerations for biosimilars - Insight into the interchangeability of biosimilars and national substitution policies
EU Commission Keynote: Update on the Regulatory Landscape for Pharmaceuticals
- Update on the review into pharmaceutical incentives and rewards: views and timetable - Key areas for analysis and the potential implications for availability and accessibility - Areas of focus for potential legislative revision
Orphan Market Exclusivity: Regulatory Framework, Challenges and Opportunities
- Update on regulations, trends and case law - Insight into the EU Orphan Medicines Regulation review: consultation, analysis and industry view - Market access challenges for Orphans drugs
Challenges and Opportunities for Regulatory Data Exclusivity
- Scope and practical application of regulatory exclusivity - Practical implications of the Astellas case: impact on industry market strategies - Challenging the notion of global marketing authorisation: pitfalls and opportunities of different routes to approval - Examining the complexities of asserting rights to data exclusivity
Regulations for eHealth, Mobile Apps and Artificial Intelligence
- Overview of the regulations and classification for digital offerings: AI, mobile apps, software, websites - What does the rise of AI mean for legal assessments and considerations? - Demystifying responsibility: practical scenarios which thing go wrong and who is responsible - Common pitfalls and challenges for compliance
Dual Dialogue: Pharmaceutical Marketing, Advertising and Promotional Activity
- Latest developments, and case law on Pharmaceutical promotional activity - Understanding liability when lines are crossed - The rise and challenges of social media, mobile apps and e-health tools for patient education
Flash Presentation: Obligations and Requirements of the Nagoya Protocol: Convention on Biological Diversity
- Understanding the international conventions and regulations implementing the Nagoya Protocol - Ensuring compliance: legal requirements and arrangements to ensure legitimate exploitation of genetic resources
Dual Dialogue: Legal Challenges for Off Label Use of Medicinal Products
- Latest developments: update on case law and market developments - Wider implications for the industry of recent rulings on off-label use of Avastin - Payers perspective: what are the opportunities for off-label use and when is it appropriate to use?
Panel Discussion: Market Access: The Convergence of Regulation, Pricing and Reimbursement
- Latest developments: examining levers utilised by healthcare authorities in price negotiations - The rise of compounding pharmaceuticals: challenges to authorised products and exclusivity in the Netherlands - Challenges for reimbursement for ATMPs and orphan medical products - How and to what extent are countries working together to create structures and forms of co-operation to prepare for market access negotiations?
Keynote Panel Discussion: The Evolving European Regulatory Landscape Post Brexit
- Unveiling MHRA’s plans and post Brexit guidelines o similarities and divergence from EU regulations o Practical insight into gaining marketing authorisation in the UK - Plans and priorities for 2019 and beyond o Practical implications of Brexit on EU pharmaceutical regulations: how has the approach evolved? o Update on plans, priorities and progress: practical focus on inspections, evaluations and certification o Practical impact on the pharmaceutical industry: what can we expect in the coming year?
END OF MAIN CONFERENCE DAY 2 - Continue to the evening seminar
New Regulations and Changes in Classifications
• MRD and IVDR readiness • Legal ramifications and practical implications of changes in classifications • Overview of the key areas likely to need upgrading to comply with the MDR/IVDR • Practical guidance on gaining CE Marking under the MDR/IVDR
Clarity for Combination, Complementary, Companion and Borderline Products
• Assessing your current preparedness for the transition • Demystifying what is covered under the MDR: practical scenarios around challenging areas • Common pitfalls and challenges for software and digital tools
Dual Dialogue: Data Privacy and Risk Management as a Business Enabler in the Pharmaceutical Industry
- Understand GDPR risk approach - Using GDPR as an opportunity to transform life science operations - Practical insight into how privacy can enable the strategy of a pharmaceutical business - Comparing the privacy risk-based approach of a global multinational to a small to medium size pharmaceutical organisation
Uncovering the Tensions Surrounding GDPR and Clinical Trials
- Understanding and evaluating the different legal grounds for processing personal data: experience in practice - Examining questions around the qualification of data controller and data processor - Exceptions and challenges for secondary use and scientific research - Managing data subject rights in clinical trials
Cross Stakeholder Conversation: New Data Protection Regulations and GDPR for Clinical Research
EMA perspective: new regulation on Data Protection applicable to EU institutions and bodies - Interpreting GDPR from and ethics committee perspective: varying approach to the legal basis for processing data - Practical challenges for the pharmaceutical industry - Data protection authorities approach and focus: identifying the challenges and opportunities - Health Authorities view on the application of GDPR for clinical trials
Future Scoping Digital Health: The Rise of AI and Big Data
- Digital health and its impact on the pharmaceutical industry, medical profession and patients from a privacy perspective - Responding to trends: equip your organization to respond to privacy challenges - Developments in AI and big data: key privacy questions and how to address them
New Market Trends in the Pharmaceutical Industry: Impact on Licencing and M&A
- Outlook: examining the most significant changes occurring across the industry - Brexit: impact on existing and new licencing agreements - Are deals getting more complex? New models for M&A and partnering activity
Review of Commercial Litigation from the Pharmaceutical Sector: Lessons Learnt
- Examining litigation on commercial transactions: examining key areas of contention - Lessons learnt: rundown of the top pitfalls to avoid during commercial transitions
Duel Dialogue Examining Agreements for Multi-Partner Collaboration
- Aligning interests: how do you structure a deal to ensure all interests align? - Multiparty collaborations: format, structure, financial and sub-licence implications - Practical guidance and pitfalls to avoid when trying to align multi-party interests
Duel Dialogue: The Rise of Digital and Pharmaceutical Collaborative Models
- Examining the growth and opportunities of digital health - Exploring partnering models and deals structures - Practical guidance: managing partnerships, aligning diverse partner interests and culture and solving IP right challenges
Case Study: Maintaining Compliance When Partnering with a Digital Technology Provider
- How do technology providers and Pharma come together and what are the challenges? - Practical approach to safeguarding big data and anonymisation for big data analysis - Insight into the framework for legal, ethical and governance issues
Dual Dialogue: Walking the Fine Line Between Patient Education and Promotional Activity
- Latest developments, regulations, codes and recent case law on promotional activity - Optimising interactions in a highly regulated environment - How to mitigate risks for promotional activity: compliance standards and codes - Best practice for patient support programmes - The use of social media, mobile apps and e-health tools for patient education
Panel Discussion: Key Factors in Making your Collaboration a Success
- Evaluating different strategies and models for collaboration - What are partners looking for? Key driver’s strategic partners and investors - Where’s the value? Assessing your value across your assets, know-how and IP - What are the key aspects of an effective due diligence process - Getting due diligence right: starting the process early and taking a multi-functional approach
Dual Dialogue: Competition Law Considerations in Structuring Business Development Collaborations
- Implications of the DuPont Case: antitrust implications of licencing and collaboration deals - Understanding the thresholds for innovative space and the triggers for block exemptions - Practical guidance on how to define a market space and the redefinition of potential collaborators and competitors
Case Study: Collaboration and Compliance with HCPs
- Review of regulations and codes of conduct for transparency and collaborating with HCPs - Self-regulation vs. regulations: analysing the compliance gaps - Strategies for creating and maintaining successful HCP collaborations - Compensating healthcare professionals: establishing a fair market value
Whistleblowing and Anti-Bribery Protection: Setting up Safe Reporting Channels
- Overview of current whistleblowing protection in the EU and the proposal for EU Whistle-blower Protection Directive - Reviewing anti-bribery regulations across Europe: lessons learnt from recent cases - Best practice for implementing a successful compliance program - Examining competition law considerations around whistleblowing
Dual Dialogue: Negotiation Strategies Unveiled
- Use of term sheers and what to cover - How to ensure effective preparation - Exchanging of information and discussion - Negotiating towards a win-win outcome - Closing, commitment and course of action - Insight into managing a negotiation process that is heading towards failure
Expert Tax Advice: Tax Regimes for Innovation and Considerations when Structuring Deals
- Tax planning for collaboration and licencing agreements - Examining financial components of licencing agreements and their tax implications - Transfer pricing: intragroup and arm’s length arrangements - Comparison of tax regimes for innovation across Europe
Dual Dialogue: Implementing Effective Termination Provisions in Agreements
- The importance of early focus on termination and consequences of early termination - Best practice advice on handling conflict in licencing negotiations: termination clauses, identifying what you can claim and when damages need to be paid - Settling disputes: common pitfalls to avoid and best practice advice
END OF MAIN CONFERENCE DAY 3 AND CLOSE OF THE CONFERENCE