Cancer Patients and Research Could Suffer After Brexit

Liam Davenport

February 27, 2017

There could be serious consequences for cancer care and research in the United Kingdom when it leaves the European Union unless steps are taken to ensure that there is continuing collaboration with its neighbors, warn six leading academics.

In the absence of any clear plans over British exit from the EU ("Brexit"), there are a number of concerns about continued access to European funding and the Europe-wide regulatory environment, as well as the loss of the free movement of clinicians and researchers, they warn.

The authors include Nobel Prize winner Sir Paul Nurse, PhD, director and chief executive of the Francis Crick Institute, London. Their warning comes in an editorial published online February 24 in Ecancermedicalscience.

The editorial follows recent concerns that British patients could end up no longer being able to have access to modern medicines if the UK severs ties without making alternative arrangements, a possibility known as "hard Brexit."

In response, the pharmaceutical industry drew up a white paper setting out how the UK can continue to work closely with the European Medicines Agency (EMA), which oversees market authorization, to agree on drug approvals via reciprocal or mutual recognition.

The joint first author of the editorial, Mark Lawler, PhD, chair of translational cancer genomics, Center for Cancer Research and Cell Biology, Queen's University Belfast, UK, who is also vice president for research and innovation, European Cancer Concord, said in a release: "Research is no longer an ivory tower silo-type pursuit – collaboration is the key."

"UK scientists contribute enormously to the European research effort, while having scientists from different countries within our research institutions and hospitals greatly supports our battle against cancer," he said.

"Some reassurance has been offered," he added. "But will the UK Government continue to fund researchers who have previously been able to compete for European grants? That is the key question that needs to be answered."

Dr Lawler also expressed concern that EU regulations may not be replaced by the UK government, noting: "This particularly affects manufacturers of medical devices and tests, unless the EU and the UK are able to share regulatory frameworks to allow ready import and export of such devices/tests."

In their editorial, the authors point out that because the process of leaving the EU has not yet started and the terms of exit have not yet been established, it is difficult to estimate the "likely impact on cancer research and cancer patients with any confidence."

Nevertheless, they state that there are "widely held concerns among the cancer community" that EU support for cancer research in the UK would be lost, as would the UK's voice in setting the healthcare strategy in Europe.

One issue that the authors highlight is the "considerable" complexity of separating the UK from the EU in terms of cancer research. For example, EU regulations that are directly applied to member states would, in essence, disappear when the UK leaves the EU. Those regulations would have to be incorporated into UK law for the country to continue to abide by them.

Such regulations include the 2001 EU Clinical Trials Directive, which has been amended three times since it was adopted by the UK in 2004. The EU is currently developing a further update to the regulations, expected in 2018. The authors note that "careful design" will be required for the UK to develop its own compatible clinical trials regulatory environment.

Another example is the EU Good Manufacturing Practice Directive, which covers medical devices and medical tests. It was launched in 2003 and was amended in 2007 and 2008.

The UK's leaving the EU means that this directive would not longer apply, "which is of concern to the manufacturers of devices and tests unless the EU and the UK share regulatory frameworks in future to allow ready import and export of devices/tests," say the authors.

Furthermore, the EMA is currently headquartered in London. This would create a problem if the UK no longer had access to the centralized European authorization procedures. It has been suggested that the EMA might therefore wish to move its headquarters back into the EU.

To those ends, Danish Foreign Minister Anders Samuelsen recently announced that Denmark, in collaboration with Novo Nordisk, intends joining the list of countries campaigning to become the new host of the EMA.

Another, potentially major, issue is that of data protection. The proposed EU General Data Protection Regulation, which is expected to come into force in 2018, could apply to the UK for a certain time, but it is likely that there will be "considerable uncertainty" over moving personal research data between the EU and the UK.

Adding that "data protection regulations would influence UK companies wishing to trade in services to individuals within the EU," the authors say: "All of this is likely to be the subject of complex negotiations."

"It is important that the UK's cancer researchers and cancer care providers watch the 'Brexit space' very closely," Dr Lawler and colleagues write. "We need to take every opportunity to remind the UK government that cancer patients and cancer research could be significantly disadvantaged, unless great care is deployed in the negotiations of the legal and economic frameworks which will govern the UK's relationship with the EU beyond Brexit.

"When the Brexit negotiations are complete, the UK government may be prepared to step up to efficiently fill the gaps in law, regulation, resource allocation and strategic alliances that will probably ensue," the editorialists write, warning, "If they do not do so, cancer research and cancer patients will suffer."

Ecancermedicalscience. Published online February 24, 2017. Full text

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