The focus of our solutions is on supporting your European expansion. Europe provides very specific challenges and recent developments such as Covid 19 calls for a European local setup to support your European customers.  We provide you with a full set of integrated services to support your European customers

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EUROPE IS CHALLENGING

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Expanding your business to the European region involves a range of challenges. The European region is both diverse and complex. It has many cultures and languages, as well as a wide range of rules and regulations pertaining to registration, market access, customs, compliance, VAT, import-duties and

transport.

 

Recent development such as Article 13 of the EU MDR &IVDR require registration in the European region and require US company to get registered.  The Covid pandemic urged US companies to keep inventory in the European market to ensure short supply lines and the ability to supply the European customer anyway.

 

In the complex European region often characterized by “red tape” we provide you with guidance and European support so you can focus on your core business.  We distinguish ourselves in the market by offering an integrated package services in the fields of market access, logistics services including legal-, financial-, fiscal- and administrative services to offer a total solution for (complex) European expansion initiatives of US Companies.

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WE SIMPLIFY COMPLEXITY

 

The European market is a scattered and complicated market with various languages, cultures, legislations, VAT rules & regulations and so on. Operating in this market can be quite smooth if the right approach is chosen.

 

Scattered multi source solution:

 

• Multiple cont(r)acts

• Multiple partners

• Scattered solutions

• Complexity

• No transparency

• No accountability

• Multiple invoices

 

Our “single source” solution

• One contact

• One contract

• One window

• Pick ‘n choose

• Best in class solutions

• Multiple partners

• Coordinated solutions

• Transparency

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MARKET ACCESS, LEGAL & REIMBURSEMENT

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Market Access

Technological medical advances and demographic trends put pressure on healthcare budgets, forcing payers to take austerity measures and scrutinize budget allocation decisions. Payers increasingly want to see compelling and real-life evidence of a medical technology's superior value combined with pricing and payment schemes that will minimize the risk for a healthcare system. In addition, patients must be assured of appropriate access to new technologies at the right price.

Market Access is the complex and time consuming process that medtech companies have to go through in order to ensure that their technologies are made available in as many countries as possible, while ensuring that they are reimbursed and accessible to patients, who need them and payers to reimburse them. Other terms for  "market access" are: ‘Pricing and Reimbursement’ (P&R), ‘Health Economics and Outcomes Research’ (HEOR) and ‘Cost Effectiveness’.

 

Market Access has become increasingly important over the last two decades as more innovative medtech technologies have come to market, while at the same time there are cost pressures on governments and payers to contain the cost of healthcare. To gain market access is generally viewed as one of the key achievables for ultimate success of innovative medtech technologies and is a major driver of value of startup medtech companies.

 

In order to have their medtech products reimbursed at the best price possible, medtech companies have to go the extra mile, gathering lots of data around the health economic impact and cost effectiveness of their products, while presenting this data to reimbursement authorities in as convincing a form as possible.

 

 

Our solutions in the Market Access area are structured across four areas:

 

1. Strategy: develop compelling pricing, reimbursement and Market Access strategies.

2. Demonstrate value: support business case development demonstrating superior value.

3. Organization: organize for Market Access success.

4. Payer and stakeholder network: obtain timely and honest feedback via our payer and stakeholder network.

 

We offer the following detailed suite of activities to achieve market access for innovative medtech technologies:

 

• Economic modeling studies

• Cost-effectiveness research

• Clinical and quality of life research

• Multi-country clinical trial design

• Surveys among Key Opinion Leaders - Physicians and Patients

• Setting up consensus meetings according to Delphi method

• Preparation and writing of scientific publications in the clinical and economic field

• Price and reimbursement systems in the Netherlands and the EU

• Price and reimbursement strategy studies

• Price referencing and sequencing of global pricing and reimbursement

• Development of core value files

• Development of price and reimbursement dossiers

• Negotiations with pricing and reimbursement authorities

• Support on price reference systems

• Set up and implement multi-country price and reimbursement projects

• Consultation on general health political topics

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In case of questions with regards to Market Access & Reimbursement contact: Ron de Graaf

 

 

 

 

 

SUPPLY CHAIN, CUSTOMS & COMPLIANCE

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Medical Technology are a critical part of the life science & healthcare industry. Whether your products being shipped to pharmacies, hospitals, or other Healthcare Professionals, medical devices supply chains are vital, ensuring that products arrive in time, safely and securely. It’s important for distributors and manufacturers to work with logistics providers who understand and have in depth experience in this sector.

 

Based on you profile Tesseract Europe designs the most suitable supply chain for the European Region based on the type of products, type of customers and your logistics footprint. In this solution we integrate warehousing-, transport-, customs- and compliance solutions.

 

Tesseract Europe offers a wide range of supply chain services for medical devices manufacturers. From Global Transport, customs handling, temperature-controlled and humidity-regulated storage to European distribution, our supply chain & control tower services ensure that your products reach their destination in time, right quantity and in the right condition.

 

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CONTROL TOWER

 

Our Control Tower is not your typical transport related Control tower, that provides visibility only. Our Control Tower monitors, manages, and controls decisions and execution across functions and across companies to optimize your entire network. With the development of multi-party, customer-driven networks, our control towers now provide real-time visibility, collaboration, and powerful capabilities to move beyond decision-support to decision-making and value chain control. The control tower manages:

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• (European) Transport

• Warehousing & value-added logistics 

• Customs services

• Compliance (import, export &GDP)

 

And based on our customers need and position we define our KPI Dashboard.

In case of questions with regards to Supply Chain contact: Rene de Koning 

TAX & ACCOUNTING

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Tax

 

Tesseract EU can assist you with setting up a local company in The Netherlands which will be taxed at corporate income rates varying between 15% and 25%. The taxable base itself is often significantly mitigated by the circumstance that the added value within in the group of companies allows for a smaller attribution of profit to the limited scope of activities performed in The Netherlands.

 

Non-resident companies are only taxed on their Dutch-sourced income. There are no special tax rates for foreign companies.

 

Business expenses are generally tax-deductible, including costs incurred in setting up a business; reserves kept for certain types of future spending and book profits; rents, royalties and interest payments on corporate debt; remuneration of members of the managing and supervisory boards; bad debts; capital losses; pension plan contributions; commissions; bonuses paid to employees through an internal profit-sharing plan and many types of taxes, including foreign taxes if not already benefiting from a tax treaty (but not corporate income tax). An additional standard allowance is provided for investment in fixed assets. Certain expenses such as fines are non-deductible.

 

A Participation Exemption is provided for qualifying dividends and capital gains from the sale of shares in a company. The firm investing in a subsidiary must meet the following requirements: (a) maintain a minimum 5% ownership of the subsidiary; (b) the subsidiary is not held as a portfolio investment or the subsidiary is subject to a reasonable corporate tax rate in its country of residence; or (c) the share of "dormant" assets (such as portfolio investment) of the subsidiary does not exceed 50% of the total.

 

Accounting

 

International Financial Reporting Standards (IFRS) as adopted by the EU apply to all domestic and foreign public companies. Small entities must choose between Book 2 of the Dutch Civil Code combined with fiscal valuations, Dutch Accounting Standards for small entities, Dutch Accounting Standards for medium sized and large entities and IFRS Standards as adopted by the EU combined with a part of the Dutch Accounting Standards for medium-sized and large entities. Medium sized entities must choose between Dutch Accounting Standards for medium-sized and large entities and IFRS Standards as adopted by the EU combined with a part of the Dutch Accounting Standards for medium sized and large legal entities.

 

Private companies, cooperatives, mutual insurance companies and general partnerships have to publish their accounts.
To be published, the annual report must be submitted to the trade register. Statements must be filled annually.
For large BVs and NVs, annual reports containing a balance sheet and a profit and loss statement that compare results from previous years must be presented to shareholders and published within eight days of adoption.
Specified “closed” NVs (whose shares are 100% privately owned) that are subsidiaries may be exempt from publishing annual reports if the results of their activities are included in a consolidated report issued by the parent company, which is expected to assume full responsibility for their accounts.

 

In case of questions with regards to Market Access & Reimbursement contact: Marc Dunnewijk