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EU regulation may shut down vital research and cost lives

by Jennifer Boon | Analysis

6 December 2013

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The EU flag

Does smoking cause cancer? Is HIV sexually transmitted? Can the MMR vaccine cause autism?

What do these questions have in common?

They were all answered in large part by studying patient data. (The answers are yes, yes and no, in case of any doubt!)

Research into patient data has been saving lives for decades and it will continue to do so for many more. Or at least we hope it will.

Legislation currently going through the EU Parliament has the potential to make such studies illegal, shutting down research projects and, ultimately, costing lives.

What do we mean by patient data?

When you see your GP or have a hospital appointment, you’re frequently asked about your medical history, lifestyle, allergies, current treatments, etc. This kind of information is crucial in helping your doctors and nurses treat you most effectively. And it’s often collected and stored so that other healthcare professionals involved in your treatment have important facts about you to hand.

‘Patient data’ is simply this kind of information about you. It can be basic things like age, sex and postcode, or it might be details of your health conditions, your treatments and how you’ve responded to treatment. It can also cover information about your lifestyle and is routinely collected as part of everyday healthcare.

Everyday healthcare involves natural experiments. Each treatment is different because every patient is different. Data can tell us about the long term effects of treatment in different people, about what external factors affect the likelihood of people getting ill and what combinations of treatment are most effective.

Such information is a by product of the work the NHS would be doing anyway, but these ‘by products’ have the potential to address our most fundamental questions: what causes cancer, how do we spot it and how do we cure it?

There are answers in the data.

Health records are incredibly valuable and the lifeblood of research. Our National Health Service means that we have some of the most comprehensive, long term, high quality health data in the world.

What’s the problem?

In certain, limited circumstances researchers can currently access identifiable data, which still includes information such as NHS number, date of birth and postcode, without individual consent. In order to do this they must pass through a stringent ethical process and are subject to robust rules about how they handle the data. Individuals who do not want their data used in this way also have the right to object.

The European Data Protection Regulation in its current form will make all of this impossible.

Why would researchers need to access such data? Firstly,such access isn’t common. In the majority of cases, researchers ask for consent from patients or use anonymous data, which cannot be linked back to the original patient. But for certain types of research this isn’t enough. More information is needed to help reach a valid scientific conclusion.

Often a researcher will need to look at a large group of people over a long period of time – so seeking consent from each individual becomes impractical. The researcher will never meet or know the names of the patients whose records they’re looking at, but those patients are essential to the success of their research.

For example, the International Cancer Benchmarking Partnership (ICBP) is a unique international partnership which is looking at variation in cancer survival between countries. We know that the UK doesn’t have the best survival in the world, but we don’t completely know why. This is the key question which the ICBP is addressing.

The ICBP relies on high precision data because, in order to compare ourselves to other countries, we need a detailed understanding of what is going on here. The answers the ICBP is giving us will help decide approaches to cancer treatment and policy in the future so that we can save the most lives possible. But, the proposed regulation is threatening the data sources which are the foundation of studies like this.

Identifiable data is also used to find people who can be invited to take part in clinical trials. Often patients are told about trials by their doctor. But what about trials which require healthy patients, for example screening trials?

The UK Collaborative Trial of Ovarian Cancer Screening is investigating the possibility of screening for ovarian cancer. More than 4,000 women die from this disease each year and we know that the earlier cancer is diagnosed, the more likely treatment will be successful.

Researchers contacted women to invite them to take part having accessed their identifiable data to check that they were eligible. More than a million women were contacted – only 32 complained about being asked if they would like to participate in the study.

Preliminary results have already been published and it looks like ovarian screening could help detect the disease early, though we don’t yet know if it could reduce deaths.

Our hope is that this will be a life-saving piece of research – one that would have been hugely more difficult, if not impossible, had the proposed European regulation been in place.

Cancer registries – the jewel in the crown

In the UK we have lots of brilliant datasets, but for Cancer Research UK one of the most valuable is the National Cancer Registration Service. Cancer registration encompasses the whole of the UK and stretches back over 40 years.

This system provided the data needed to identify that there are at least ten different types of breast cancer, showed that mesothelioma is caused by asbestos exposure and gave us the evidence behind the new innovations in the bowel screening programme.

This is a life saving system, no question.

But cancer registration is also severely threatened by the new EU regulation. The registries collect data on patients automatically (although, as always, patients can object to their details being included) and seeking consent for this is impractical. There is no country in the world that operates effective registration that uses individual consent.

The Hamburg Cancer Registry was the oldest complete registry in the world until German requirements for informed consent led to its effective collapse. Its recovery has been slow and there are still large gaps in the data.

This was a terrible loss and we cannot allow something similar to happen here.

What next?

The European regulatory process is not over. The final decisions are being made over the next six months. The regulation is highly complex with lots of interested parties involved and many different issues, not least government spying allegations, to be considered.

Alongside all that, it’s easy for the needs of researchers to be forgotten. It’s our job to make sure that doesn’t happen. We’re working with other charities, scientists and patients to speak to UK and EU politicians, explaining why this is so important and why they must act.

Our data is precious and it is lifesaving – it is definitely worth fighting for.