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Discovery & Development Business Practice, Standards & Regulation, Clinical Trials, Trends & Forecasts

Trials and Tribulations

On June 23, 2016, Britain will decide whether or not it wants remain a member of the European Union. The pharma industry in the EU is regulated by the European Medicines Agency (EMA), and many in the industry see the EMA’s harmonized regulation across the different EU nations as an advantage because companies don’t have to adhere to multiple regulatory systems to sell to different EU nations. But Angus Dalgleish believes that the benefits of EU membership are outweighed by burdensome overregulation.

Angus is a Professor of Oncology at St George’s University of London, and his work on human retroviruses led to him being a co-discoverer of the fact that HIV used CD4 as a receptor. Angus has firsthand experience working with the EU as he currently sits on the European Commission Cancer Board. He is member of Scientists for Britain – a group set up to counter the political narrative that a vote to leave would cause undue hardship to UK science – and the UK independence Party (UKIP) for whom he stood in the 2015 UK general election. Here, he shares his experience with EU regulation – and why he thinks Britain should leave the EU.

What has your experience with the EU Clinical Trials Directive been like?

Some years ago Immodulon, a private biopharma company in the UK, resurrected a vaccine I had been working on and hired me as chief investigator. We took the drug though a couple of clinical trials, and in one, we found a survival advantage in patients with prostate cancer – which is quite significant. We went to the EMA for approval and were told that two large-scale, randomized clinical trials were needed. It would have cost us over £2 million to carry out the studies, so we had no choice but to stop. In fact, if we had continued we would have been committing a crime…

Prior to the Clinical Trials Directive we could have carried out the studies for around £100,000. Consequently, it is now extremely difficult to make any progress without the backing of the big drug corporations, stunting innovation and preventing treatments – such as those for pancreatic cancer developed by my team – from being brought to market.

Does EU regulation also impact big pharma?

Funnily enough, when I spoke to the House of Commons Select Committee (a committee in the UK that are largely concerned with examining the work of government departments) about my experiences with the directive, a representative from Novartis spoke up. I braced myself, assuming she was going to put up a fight, but she told the committee that costs of clinical trials are so high now that “even we in the pharmaceutical industry can't afford to do all the ones we'd like to do”. Even people in big pharma find that barriers are too high to do their studies.

By making it much more expensive and time consuming to carry out a clinical trial, the directive has made it impossible for people like myself to do the trials I’d like to, and pushed big pharma towards large scale studies aimed at finding the next blockbuster. This means they're not going for the kinds of smaller studies they used to go for, such as for less common cancers, because it’s just not worth it – they’re too expensive.

This is evidenced by the massive reduction in the proportion of the world’s clinical trials the UK conducted before and after the Clinical Trials Directive was introduced – from 6 percent in 2000, to 2 percent in 2006.

Is there a problem with the EU as a whole?

The primary problem is that Brussels vomits out directives at such an alarming rate. Appointed commissioners propose the legislation and they pass it through the European Parliament to stamp some form of democracy on it. I’ve actually watched MEPs pass dozens and dozens of directives at a time and at times I can't believe when they put their hands up to wave them through that anybody has actually read them. And yet the unintended consequences of these laws are horrendous. I’ve read that the cost of EU directives and red tape on small businesses and medium sized enterprises is over £33 billion a year. And it's impacting 90 percent of the companies in the UK that don't even trade with the EU, which means that their hands are tied behind their back trading with other partners in the US, for example.

Leaving the EU would allow the UK to free researchers from harmful regulations like the Clinical Trials Directive, and allow the UK government to reinvest a substantial portion of the funding we currently hand over to Brussels into our own health service and research councils.

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About the Author
Angus Dalgleish

Angus Dalgleish is a Professor of Oncology at St George’s University of London, Institute of Infection and Immunity.

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