Blog: Focus On Regulation | 11 January 2019

EMA office in Amsterdam opened – Wooden shoes, orphan drugs and drug pricing in the context of Brexit

On 9 January 2019, the European Medicines Agency (EMA) opened its office in Amsterdam, the Netherlands. As the UK will leave the EU 29 March 2019 due to Brexit, the EMA is relocating from London to Amsterdam. The office has been opened, the true move to Amsterdam is expected to take place on 11 March 2019.

At the opening of EMA’s new temporary office in Amsterdam, the Dutch Minister of Medical Care, Mr. Bruno Bruins, offered traditional Dutch wooden shoes to EMA’s director Mr. Guido Rasi.

In a talk show on television later that day, Bruins noted that EMA’s move to Amsterdam is attracting more pharmaceutical activity including R&D in the Netherlands.

The Minister of Medical Care also touched upon excessive pricing for in particular certain orphan drugs. He stressed that:

• innovation and development of new drugs is important
• drug pricing should be reasonable
• pharmaceutical companies will be asked to explain high drug prices
• the EU regulation which provides for 10 years of market exclusivity for orphan drugs would need to be amended and this should be on the agenda of the new European Commission which will start later in 2019
• hospital pharmacies may offer cheaper alternatives by pharmacy compounding orphan drugs for their own patients.

The Minister also urged hospitals in the Netherlands to prepare for Brexit and to ensure that hospitals have access to alternatives for medical devices and other medical products currently obtained from the UK as those UK-originated products may no longer be available for patients in the EU after Brexit (29 March 2019).