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On eve of Brexit, Britain faces critical test to defend drug trial crown

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On eve of Brexit, Britain faces critical test to defend drug trial crown

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LONDON (Reuters) – It's 2023. Britain's brightest and best researchers are packing their bags when clinical trials start to slow, leaving a nation known as a global leader in pharmaceutical development to face a slow-moving future.

Petri dishes are shown in an unknown location in a Cancer Research UK laboratory on an unknown date. Cancer Research UK / Disclosure via REUTERS

This is the worst case scenario outlined by some scientists and industry experts following Brexit, which they said could deprive the country of its role as a European leader in early stage drug research, designing and hosting pan-EU trials.

Pamela Kearns, professor of pediatric oncology at the University of Birmingham, fears that, over time, Britain will get lost in the field of drugs that treat rare diseases and childhood cancer, where trials often need to collaborate and recruit across Europe to find enough patients. .

"It would be a real disadvantage for children in this country if we were not part of these networks," she told Reuters. "This is going to hurt us massively."

The University of Kearns sponsored the BEACON Neuroblastoma study, maintained as a model of cooperation and the type of project that may be at risk after Britain's departure from the EU on Friday and a transition period that runs until the end of 2020 .

The British clinical study designed is testing a combination of drugs to fight a rare aggressive cancer that affects children. It is partially funded by European groups and is being tested on patients across the continent.

Kearns said his team, among its Brexit contingency plans, selected a legal representative within the EU – in Dublin – who could allow them to continue to play a key role in the trials, as well as an EU distributor to provide medicines to patients.

It also added new legal provisions to the contracts, in case Britain is no longer covered by the bloc's GDPR laws for data exchange. However, all of these steps can only help in the long run if the UK remains closely aligned with EU research regulations.

Brussels is launching a new portal and database that will help coordinate the project, data collection and supervision of pan-EU tests, a system from which Britain is likely to be excluded after leaving the block altogether at the end of 2020.

Some company executives argue that Britain's fears of land loss are excessively pessimistic, and the country could indeed thrive under a more agile drug development and approval system, disassociated from 27 EU states.

"If you are a single approver compared to another with 28 people sitting around the table, you can probably get things done a little faster," said Hugo Fry, British head of French pharmaceutical Sanofi.

The divergence or alignment encapsulates the fundamental tension underlying Brexit: can Britain differentiate itself enough to succeed with the historic break and is the freedom to innovate with trump part of a larger group?

Launch a wide network

Kearns' concerns are echoed by the UK pharmaceutical industry body, ABPI, which warns of a brain drain from a sector that contributes about 2.7 billion pounds ($ 3.55 billion) to the economy and about 47,500 jobs.

"Without the ability to influence research program design, leading researchers are likely to leave the UK or not move to the UK, and this loss of world-renowned and highly qualified researchers will dramatically damage the UK's research base" , he stated.

It is not just the United Kingdom that faces risks; the European Union must lose the experience of a country that has accounted for an average of 28% of EU clinical trial requests over the past 10 years.

Britain leads Europe in studies at an early stage – phases I and II – with particular strength in cancer research.

Industry experts, from academics to executives, say the best way to limit possible damage from both sides is for Britain to stay in line with EU rules, so researchers can maintain collaborations and prevent cost duplication. and paperwork has two separate regulatory systems.

But the country's decision to leave the bloc was motivated by a desire to go its own way, establish its own rules and sign its own agreements. Britain said earlier that it will seek to align itself with the EU in clinical trials "where possible".

"After Brexit, clinical trials will continue to be approved at the national level, working with international standards and we are determined to maintain the UK's position as one of the best places in the world to run clinical trials," said the government.

Britain's leading role in drug development is underpinned by its research groups that bring together public hospitals, major universities like Oxford and Cambridge and companies like AstraZeneca and GSK.

However, domestic experience is often not enough.

A look at the work of the leading charity Cancer Research UK illustrates how closely Britain is intertwined with the continent; almost a third of the approximately 200 studies currently funded by the organization involve European collaboration.

Emlyn Samuel, its director of policy development, said that the emergence of drugs targeting tumors according to their genetic makeup, rather than the type of cancer, means that more studies would need to launch a wide network to find suitable patients.

"If we are outside, we can move forward more quickly in some areas, but I don't think that will outweigh the benefits of being part of a broader regulatory system," he said.

"IS THIS THE PLACE TO COME?"

Denmark's new Nordisk, a leader in diabetes medicines, has opened a research center in Britain. Although fully committed to the country, he is concerned about the broad impact of Brexit.

"If there are processes that mean this becomes more complex, companies look twice: & # 39; Is this the first place to conduct clinical trials or is it easier to recruit patients elsewhere? & # 39;" Reuters the head of the United Kingdom, Pinder Sahota.

Britain's Medicines and Health Products Regulatory Agency (MHRA) is looking at how being independent from the EU could give it a free hand to improve its systems, company sources said.

For example, it could reduce the time required to pass a test project or complete the initial phases. But some are cautious in a testing industry with little room for disagreement and risk.

When Britain leaves the EU completely after the transition period, the researchers in the BEACON study hope to be embarking on phase III tests.

On eve of Brexit, Britain faces critical test to defend drug trial crownSlide Show (4 Images)

Kearns has already had to reassure European partners that he can continue to lead these tests. But she is afraid of the future.

"We have fantastic researchers in the UK … we have a brilliant set of statisticians, methodologists and experts, so we are the trusted partner to lead," she said.

"We could find ourselves in a position to go back."

Kate Holton and Paul Sandle reporting; Editing by Pravin Char

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