Where next? Geographic expansion: the regulatory perspective. Part 1: Benelux

In a new blog series, Kimty Bui-Van of ProductLife Group considers how increasing regulatory harmony between regions is improving the prospects for companies looking to grow their global opportunity

As global opportunities expand and barriers to market entry diminish in the form of increasingly consistent submissions requirements, we can expect to see more pharmaceutical organisations expand their international reach in and beyond 2018.

There are few geographic markets more strategically attractive than the European region of Benelux.

Market scope

The Benelux region (Belgium, the Netherlands, and Luxembourg) is an important European market for life sciences, not least because Brussels is home to the administrative HQ of the European Union. At the heart of Benelux, Belgium is an important regulatory hub too, an open environment that adheres closely to European legislation.

The ease of communication and the professionalism of the Belgian authorities have made Belgium a popular destination for clinical trials. According to pharma.be data, some 35,250 people were employed in the Belgian pharmaceutical sector in 2016. And thanks to a regulatory framework that supports research, 15 companies have headquarters in Belgium, and there are 14 R&D facilities, 32 production sites, 12 universities and research centres, 14 bioincubators, and 7 academic hospitals, according to 2016 figures.

Opportunities & challenges

One of Belgium’s defining features is its language diversity. Along with French, Dutch and German, English is spoken widely, making it easy to support all European countries from Belgium while maintaining strong communication with HQ. More often than not, Belgian teams manage regulatory filings on behalf of Luxembourg and the Netherlands.

The biggest difficulty companies face in Belgium is the need to have a single responsible person for pharmaceutical information about products marketed locally. The role is crucial—and demanding. It involves ensuring that all medicinal product advertising conform to laws and regulations. For every change in product information, the responsible person must sign a declaration confirming any translations are correct and consistent. The person is also responsible for medical sample management.

That individual must be a physician or pharmacist approved by the Ministry of Health, must have at least one year of experience in pharmaceutical information, and must fulfil local qualifications even if not based in Belgium. They also have to have official backup because if that person is away, the agency must be notified.

Since the requirement was introduced in 1984, just 1,100 people have been authorised in the role—typically those nearing retirement and comfortable with the role’s significant responsibility. Global companies sometimes delay consideration of the requirement for a local responsible person until late in the submission process, which can be a significant oversight given the scarcity of qualified people.

The verdict

Overall Belgium represents one of the most straightforward markets in which to base European operations. As a multilingual country that is strategically positioned geographically and with its well-established and transparent regulatory environment, Belgium serves as a progressive hub for European submission management.

Next time, Kimty Bui-Van evaluates the regulatory conditions and market growth prospects for life sciences in the Baltic countries of Lithuania, Latvia and Estonia.

Kimty Bui-Van is head of regulatory affairs and pharmaceutical services at ProductLife Group.