From Asian innovation to European impact

Bringing an Asian life sciences innovation to Europe requires a connection between the company’s scientific expertise and the evidence, healthcare pathways and stakeholder questions of the intended European markets. A good local partner complements the company’s knowledge with that context.

For Taiwanese and other Asian companies considering European expansion, the starting point should be the product and its development stage. The route for a medicine differs from the route for a medical device or another healthcare technology. This article focuses on medicines, while the broader partnership principles also matter to other innovators.

Europe is not a single access decision

The EU centralised procedure provides a common authorisation route for eligible medicines: EMA conducts the scientific assessment and the European Commission issues the authorisation. Pricing and reimbursement decisions still take place at national and regional level. A European authorisation therefore does not by itself establish a funded route to patients in each country.

A market-entry plan needs to connect the regulatory pathway with evidence assessment, funding decisions and implementation in the selected markets. Country sequencing should reflect that work as well as commercial opportunity.

Consider how the evidence will travel

When clinical development has taken place mainly in another region, the question is how well the evidence supports the proposed use in Europe. ICH E5 provides a framework for considering intrinsic factors, such as physiological characteristics, and extrinsic factors, such as medical practice, when assessing the applicability of foreign clinical data.

This is not a judgement that evidence from Asia is weaker. It is a product-specific question about the relevance of the data to another population and setting. The guideline seeks to facilitate use of foreign data and avoid unnecessary duplication; additional studies are not an automatic requirement for every medicine.

Alongside regulatory applicability, a team should examine whether comparators, endpoints and care pathways address the questions likely to arise in its intended access discussions. Those questions are easier to address while the development strategy can still change.

Build a partnership around complementary knowledge

The innovator brings knowledge of the science, technology, clinical programme and home market. A European partner should add a specific understanding of the selected countries, their healthcare systems and the practical decisions required for entry.

That contribution should be visible in the work: a clear evidence-gap assessment, an explanation of local access pathways, a prioritised stakeholder map and recommendations linked to management decisions. A broad network is useful only when it helps the team ask the right questions and understand the answers.

Start with a focused feasibility discussion

• Which product, indication and patient population are being considered?
• Which evidence choices are still open, and which have already been fixed?
• What are the proposed European countries, and why have they been prioritised?
• Which regulatory, access and operational uncertainties need specialist assessment?
• What local capabilities are needed now, and which can wait until the next milestone?

The output should help the company decide what to investigate, what to change and what to resource next. For a Benelux entry, assess the relevant national requirements while coordinating the work across medical, access, regulatory and commercial functions.

Connect innovation with local implementation

Trust and mutual understanding take time. A productive partnership makes room for different perspectives, records assumptions explicitly and keeps the innovator involved in the decisions. Local expertise should strengthen the company’s strategy while respecting the knowledge that made the innovation possible.

Health Devotion supports international life sciences companies with senior experience and local stakeholder understanding. Explore our Market Exploration & Validation services or discuss your European market-entry questions.

About the author: Ivo Vink, Health Devotion.

Sources: EMA: authorisation of medicines; ICH E5(R1): acceptability of foreign clinical data.