Brexit boom ahead for Dutch clinical trials and human test subjects

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The arrival of the European Medicines Agency in Amsterdam next year will be a major boost for the Netherlands’ own drugs testing sector, and moves are already being made to make the most of the opportunities, writes Max Opray.

Amsterdam was announced as the new home for the EU regulatory body in November when the Dutch city’s name was effectively drawn out of a hat after tying with Milan in the final round of voting.

The announcement prompted a wave of concern from British experts such as John Hardy, professor of Neuroscience at UCL, who predicted the move of the EMA would extend beyond the regulatory body’s 900 employees and ‘be a magnet to Holland and Flanders (which already have strong pharma industries) for inward drug company investment and for divestment from the UK.’

Drugs testing firms and other pharmaceutical industry players are already jostling for position. After all, the Netherlands is in prime position to poach Britain’s lucrative clinical trials industry on the back of Brexit, says the new head of a leading Dutch drug-testing organisation.

Benefits

Koos Burggraaf, chief executive of the  Centre for Human Drug Research in Leiden, says he intends to ensure the centre is one of the Dutch organisations to enjoy the flow-on benefits expected to filter through to the entire Netherlands pharmaceutical sector.

‘The majority of people are talking about the non-primary process aspects of the move of EMA, the visitors, the impact on the housing market… but that is not the reason why professionals in the field are enthusiastic about this,’ he says.

Last year, Ruud Smits, a consultant with the law firm NautaDutilh, told the Financieele Dagblad the arrival of the EMA ‘fits in with the aim of creating a biotech-pharma hub in the Netherlands around Leiden, Amsterdam, Utrecht and Wageningen.’ There are, he said, already 24,000 people working on the development of medicines in the Netherlands.

Biotech firms

In particular, the EMA move is expected to provide a boost for the Netherlands’ own Medicines Evaluation Board. Its staff is being expanded and the Dutch government is pumping millions of euros into the organisation to boost staff training and generate extra capacity.

Burggraaf says he is already in discussions with biotech companies considering a move to the Netherlands in order to maintain close proximity to EMA headquarters, and that the centre has already established a consultancy to form strategic partnerships with biotech companies and provide advice to investors, regulatory bodies and governments.

He believes plans for a more centralised EU drug research process could dramatically add to the red tape for companies that keep trials in the UK.

Brexit

‘It depends on the outcome of Brexit negotiations – if as it looks now, Brits only want the benefit not the burden, it is likely they will not be considered eligible to participate in a harmonised trial system, and they become a so-called third country,’ he says.

‘That means an enormous admin burden for pharmaceutical companies. They don’t like to work twice… you can imagine companies with very big pockets don’t care too much, but that is not the case for smaller biotechs with limited capital and limited human resources.’

Even the major pharmaceutical companies are considering their options, with Japanese multinational Eisai, which employs 550 people in the UK, already starting to duplicate testing and approval procedures and urging the British government to remain under the jurisdiction of the EMA.

Trials

Burggraaf says another benefit of the EMA’s proximity will be that he can consult more closely with regulatory staff to improve the efficiency of clinical trials. He also anticipates significant growth in drug trials, but is reluctant to put a number to it until the final negotiations of Brexit have concluded.

The prospect of a boom in clinical trials presents opportunities not just for research professionals, but also those who participate in such experiments.

Isha (not her real name), a 52-year old Rotterdam masseuse who is not working for medical reasons, says she hopes the EMA arrival does deliver more clinical trials in the Netherlands.

She has participated in two trials with at the Leiden centre in hope of treating her sickle cell anemia, which she says causes pain in her joints.

Multicultural

‘I was just curious to know if there is finally a cure for what I have, it is still difficult to find a treatment because it is a bone marrow thing,’ she says.

‘it would be a good thing if more clinics are doing it because sickle cell anemia you see more with black people, and more and more the Netherlands is becoming a multicultural community.’

There can also be financial benefit for participants in experiments, with some trials offering in excess of €2,000 in compensation for time committed and travel expenses.

Kinderdijk-based mechanical fitter Bas van der Hoog says he was paid roughly €1500 for participating in a trial. ‘Last summer I was part of an investigation into the immune system, it went well and was financially reasonable,’ he says. ‘I haven’t noticed any difference in my health.’

Burggraaf says some trials do occasionally offer a prospect of treatment for patients, but stresses that due to ethical considerations the centre appeals to participants for altruistic reasons and not for motivations of personal health or financial benefits.