Navigating Licensing, Trade & Distribution in Life Sciences — What 2025’s Data Tell Us About the Road Ahead

The journey from molecule to market has never been more complex—or more intriguing. DCOPI’s 2025 “Licensing, Trade & Distribution” white paper offers a rare, policy-first lens on the forces shaping life-science market access on both sides of the Atlantic. Below is a practitioner-friendly digest of its key insights and what they mean for corporate strategy.

DCOPI White Paper, Trade, Licensing and Distribution 2025.pdf

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1. Two Continents, Two Regulatory Rhythms

• Speed vs. Sequencing. In 2024 the FDA cleared 50 novel therapies, 56 % under Priority Review (six-month clock) and 14 % via the Accelerated Approval pathway. Median review times held at ~11 months for small molecules.

• EMA’s single licence, multi-country launch. A centralised authorisation unlocks all 27 EU markets, yet pricing/reimbursement remain national, extending the commercial timeline. Even with EMA’s Accelerated Assessment (150 active days), country-level HTA and price talks commonly add 9-18 months.

Strategic takeaway: Treat “approval” and “access” as two distinct critical paths when forecasting EU revenues; align clinical, market-access and supply-chain teams early.

2. The Hidden Layer of HTA

EU HTA is an eight-step process—scoping, evidence synthesis, clinical and economic appraisal, ELSI review, stakeholder input, decision, dissemination, implementation. EUnetHTA is slowly harmonising methods, but thresholds and timelines still diverge country by country.

Strategic takeaway: Build a modular value dossier that can survive different cost-utility thresholds and evidence preferences (e.g., QALYs vs. budget impact).

3. Parallel Trade — Europe’s Quiet €6 Billion Market

Price gaps of up to 300 % among EU states fuel a €6.366 billion parallel-import trade; Germany alone absorbs 47 % of that volume.

• Arbitrage can shrink manufacturer margins and aggravate shortages in lower-priced “source” countries such as Spain and Italy.

• Upcoming UK-wide Parallel Import Licences (PLPIs) under the Windsor Agreement (Jan 2025) will further change flow patterns.

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Strategic takeaway: Monitor inventory movements daily; consider differential pack design or launch sequencing to dampen arbitrage risk.

4. Distribution Resilience in an Era of Shortages

Roughly one-third of a medicine’s EU retail price is still absorbed by supply-chain margins and VAT—rates range from 0 % (Sweden, Ireland, Malta) to 25 % (Denmark).

• VAT differentials alone can swing ex-factory demand and trigger “export waves.”

• EU discussions on stock-monitoring and emergency quotas are intensifying.

  
  

Strategic takeaway: Tax policy is becoming a supply-chain variable; embed finance and public-affairs leads in shortage-prevention playbooks.

Navigating Licensing, Trade & Distribution in Life Sciences

5. Five Signals Every Board Should Track to 2030

1. Medicare price negotiations under the U.S. Inflation Reduction Act and their knock-on effect on global reference pricing.

2. Convergence of EU HTA methods post-EUnetHTA 21.

3. Digital traceability mandates aimed at curbing falsified medicines.

4. Rise of value-based VAT relief (zero-rating for essential therapies).

5. New IP harmonisation talks that may compress biologic exclusivity windows.

Bottom Line

The next five years will reward companies that can synchronise regulatory science, market-access economics and supply-chain telemetry in real time. Use the insights above as a checklist for quarterly risk reviews—and as a springboard for bold, forward-back strategy.