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Rochelle Sampy speaks to Richard Bergström, Director General of the European Federation of Pharmaceutical Industries and Associations about the benefits Real World Evidence can bring to healthcare and how to alleviate very valid concerns about data privacy.

By Anonymous on Jan 31, 2013

Real world evidence (RWE) has the potential within the pharmaceutical industry to improve clinical and economic outcomes through real life clinical practice. In time, regulators could use RWE to reconsider product labels in light of safety concerns while payers may use this data to price drugs according to with the ‘real’ value of the medicine or to inform guidelines that drive clinical practice. However, the European healthcare industry cannot effectively capitalize on RWE without addressing data privacy concerns. These concerns can be minimized through educating the public on how, why and where their healthcare data will be used.

Last January, the European Commission proposed a new data protection framework in Europe which promised more effective protection of personal data in the EU, but there is additional clarification needed on a number of issues.

Despite these gaps, the Data Protection Framework does recognize the value of data minimization (only releasing a limited amount of relevant data into the public arena) and the need for clear consent when sharing personal data. Also, it places a compulsory obligation on organizations to develop a system of good data management.

Regulators in the US also recognize the need to balance consumer privacy concerns with big data usage through the HIPAA Privacy Rule and the HITECH act which looks at accurately anonymising health information through removing 18 different identification markers from the data.

“We the healthcare industry must collectively convince the general public that the collection and usage of health data is going to help the development of science.”

So, international regulators and health professionals understand the need to balance data privacy concerns and big data. However, are members of the public informed of the benefits of big data or RWE so as to lessen their privacy concerns?

EFPIA Director General Richard Bergström doesn’t think so. “We the healthcare industry must collectively convince the general public that the collection and usage of health data is going to help the development of science. There is a big difference between the healthcare industry and the commercial world using [personal] data.”

“For instance, a company like Facebook might sell your personal data to a shoe manufacturer in order to encourage you to buy more shoes without your permission. The healthcare industry will not do that even if accused of it. The purpose here is to develop science. If I acquire the health information of an individual, I cannot track it back to an individual nor do I have any interest in doing so. But, people will not believe this unless we can explain the benefits of it to the general public. I predict that data privacy will be one of the big debates going forward.”

Therefore, in order for privacy concerns to be minimized, the public needs to be informed or educated about the purpose and benefits of using personal health data.

Bergström adds: “RWE is not only useful for the regulators or payers but also for the science crisis. We possess various scientific research maps for diseases and conditions but we need to match these with real patients. Real patients can provide us with a DNA blueprint that we can use to adapt our way of thinking about a particular condition. RWE can help us figure out why an anti-depressant works in one patient and not the other and [helps us find] a mechanistic reason behind the diagnosis.”

RWE can enable a closer monitoring of patient adherence and outcomes as well as the delivery of a targeted communications and support strategy for individuals. For instance, a 2012 Health Research Institute survey states that 16% of payers have outcomes-based contracting agreements with pharmaceutical companies. A third of the remaining percentage of payers plan to execute this kind of arrangements within the next three years.

Similarly, the director of the Health Privacy Project at the Centre for Democracy and Technology, Deven McGraw, believes that that simply getting rid of the entities that harm people’s entitlement to data protection will not eliminate data privacy concerns. It is also about creating a healthcare system that people can trust so that they know that their confidential information will not be shared beyond the individuals that need the data, like health providers or insurance companies. Being transparent and open about the usage of health data is key.

“We haven’t put enough effort into trying different ways of educating people.”

He says: “We haven’t put enough effort into trying different ways of educating people. We, for too long, have assumed that, in a regulatory regime that provides permissive data sharing within the health care context, people will just trust their doctors.”

He continues to identify another difficulty with ensuring the correct balance between data privacy and health information: “Ideally, for people to be truly informed, you’d give them an exhaustive amount of information, right? But if you give them too much information, the chances that they’ll read it and understand it are really low. So then people end up saying ‘yes’ to things they don’t even realize they’re saying ‘yes’ to.”

This highlights the concept of data minimization which the European proposal for a data protection framework is aiming to tackle. Big data is only useful if managed well and at the moment, the technical, infrastructural and business-model connotations of this information has not been realized yet. Releasing more health information than necessary into the public arena can not only damage the reputation of the product but also the European healthcare industry as a whole.

Before, we start informing the public about how we are going to improve healthcare through RWE while still protecting privacy concerns, we need to establish a formula which decides which health data does become public and why. Bergström says: “There are several problems with releasing all [health] data. How are you going to interpret this data? How are you going to prevent people from re-analyzing the data? Someone might find out that a person died in a study and then put it down to the side effects of the treatment. However, this person could have died simply because of the disease itself. Regulators are trained to take a balanced view of clinical results but the public are not.” While this view indicates that we need to be careful about the health data released, it reinforces the need to accurately inform the public about RWE.

The public will continue to have data privacy concerns if we do not establish ways of educating them about the benefits of releasing relevant data. This type of education can only occur once regulators establish clear criteria on the types of health data should be released into the public domain. The healthcare industry must remember that privacy concerns cannot be eliminated altogether but they can reduce its effects through being more transparent and open with the public. Once, the public know why, how and where their health information will be used, they might be willing to share more which will greatly enhance the pharmaceutical industry’s understanding of medication. It is only then that RWE can help us develop into a learning healthcare system that seeks to control the wellbeing of their patients.

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Richard Bergström will be speaking at this year's Real World Data Europe summit on the value RWD can bring to future drug development. For more on his presentation and to find out who else will be speaking visit the official website.