The pharma industry in the Netherlands is a thriving sector, playing a crucial role in the country's economic landscape due to its innovative strides and steady growth. If you're thinking about how to start a pharma company in the Netherlands, this comprehensive guide will provide you with insights into the industry's potential, important regulations, and the steps required to establish a successful pharmaceutical business.
Overview of the Pharma Industry in the Netherlands
The Dutch pharmaceutical industry has a track record of impressive performance, showing moderate growth with a Compound Annual Growth Rate (CAGR) of 5.8% during the forecast period1. This robust growth rate can be attributed to various factors that make the Netherlands an appealing base for pharma operations.
The presence of top-tier research institutes, a highly educated workforce, a robust healthcare system, and an innovation-friendly government combined with a central location, make the country ideal for biopharmaceutical operations1. Moreover, the Dutch government is known for its good relations with businesses, making it an ideal environment for initiating a pharmaceutical venture.
However, it's also essential to understand the challenges that may arise. For instance, the high failure rate and developing cost of new products can potentially impede the growth of the market1.
The Impact of COVID-19 on the Dutch Pharma Industry
The COVID-19 pandemic has had a significant impact on the pharmaceutical market worldwide, and the Dutch market was no exception. Initially, the market saw a downturn due to various lockdown regulations that were imposed, leading to a reduction in pharmaceutical sales1.
However, the market is expected to stabilize post-pandemic, indicating a promising future for pharmaceutical ventures in the Netherlands1. This resilience of the industry in the face of the global crisis demonstrates the strength and potential of the Dutch pharma market.
The Role of Disease Burden in Market Growth
The increasing burden of various diseases is another factor that contributes to the steady growth of the pharma industry in the Netherlands. In 2021, cancer was the leading cause of death in the Netherlands1. Furthermore, the prevalence of diabetes as a percentage of the population aged between 20 and 79 was 4.5% in 20211.
With the increasing disease burden, the demand for innovative pharmaceutical solutions is expected to rise, paving the way for robust market growth.
Technological Advancements in the Pharma Industry
Technological advancements have revolutionized the pharmaceutical industry globally. The scenario is no different in the Netherlands. From precision medicine and gene therapies to artificial intelligence and big data analytics, innovative technologies are reshaping the way drugs are discovered, developed, and delivered2.
Staying updated with the latest technological trends and leveraging them effectively can help pharmaceutical professionals drive efficiency, enhance research and development capabilities, and deliver better patient outcomes2.
Regulatory Landscape in the Dutch Pharma Industry
The pharmaceutical industry, being subject to rigorous regulations aimed at ensuring patient safety and product quality, requires businesses to stay compliant with evolving regulatory requirements2.
Is a License Required for Pharma Related Activities?
Yes, medicine retailers and manufacturers must register and apply for appropriate permits, and get approval from the Dutch Medicines Evaluation Board before they can start operating3.
How to Import Medicines into Europe?
Importing medicines into Europe requires businesses to adhere to stringent regulations. For instance, if you intend to purchase medicines from outside the European Economic Area (EEA), you should read the manufacturer's license information3.
Regulations for Pricing in the Pharma Industry
The prices of medicine are regulated in the Netherlands, with a pre-determined maximum cap a business may charge for pharmaceutical products3. This is an important aspect to consider when planning your business model.
Starting a Pharmaceutical Business in the Netherlands
Starting a pharmaceutical business in the Netherlands involves several steps, including mandatory registration and obtaining the required permits3.
Registration and NACE Number
The first step is to register a company with the Dutch Trade Register. This registration must include the mandatory NACE (Nomenclature of Economic Activities) number. The NACE numbers for pharmaceutical businesses are as follows3:
Section C; Division 21; Group 21.1 - 21.2; Class 21.10, 21.20.
Section G; Division 46, 47; Group 46.4, 47.7; Class 46.46, 47.73
Good Manufacturing Practice Certification
Manufacturers are required to have Good Manufacturing Practice certification3. This certification ensures that the products are consistently produced and controlled according to quality standards.
Why Choose the Netherlands to Start a Pharmaceutical Company?
The Netherlands offers a prosperous and thriving health industry, making it an attractive destination for starting a pharmaceutical company. Here are some reasons why you should consider the Netherlands for your pharmaceutical venture3:
Prosperous and Thriving Health Industry: The industry is healthy and booming, and it's one of the best-performing sectors in the Dutch economy.
Lower VAT Rate: The Dutch government charges a substantially lower VAT rate on medicines than on most other goods and services.
Good Government-Business Relationship: The government maintains a good relationship with businesses, which is very crucial in a highly regulated industry.
Attractive for International Businesses: The Netherlands offers tax discounts for foreign employees, making it an attractive destination for international businesses.
Innovative Pharmaceutical R&D Schemes: The country is known for its innovative pharmaceutical research and development schemes.
Strong Protection of Intellectual Property Rights: The Netherlands offers strong protection of intellectual property rights, which is a crucial aspect for businesses in the pharma industry.
In conclusion, the pharma industry in the Netherlands offers immense opportunities for those who are prepared to adapt and innovate. With its robust growth, technological advancements, and regulatory landscape, it's a promising landscape for pharmaceutical entrepreneurs. Embrace the possibilities, drive positive change, and contribute to a healthier future for all.
Please note that this article is a general overview of the topic and should not be considered professional advice. For specific advice, please consult with a professional.
Which type of Dutch Business to Start?
There is no legal requirement to incorporate a local company such as the Dutch BV. Instead, you can also consider the registration of a branch in the Netherlands.