ISPP 2015

Career Opportunities in Pharmacy
Electronic pills can improve our health but create ethical and legal challenges

In the future, the medication you take will
not only be a matter between you and your doctor. Pills with built-in electronic sensors are
already a reality in both Europe and the US, and in the future, they will fill pharmacy
shelves. The new electronic pills can collect data,
for example, on the state of the stomach and intestines, and this creates new opportunities
for diagnosing diseases. The pills can also be used to monitor medication
e.g. in patients with mental disorders. In an article published in Nature Electronics,
a group of researchers point out that the use of the new electronic pills is not without
problems. The researchers point out that the new methods
of treatment create both ethical and legal challenges. The data that the pills collect constitutes
a data trail that reveals your state of health and your medicinal consumption. This is very sensitive data, which in the
hands of third parties may affect a person’s life insurance premiums or job opportunities. There is therefore a need for complete transparency
and clarity on how pharmaceutical manufacturers will use and handle this data. Electronic pills can be used, among other
things, to monitor whether patients with mental disorders are taking their medication. The information about when the pills are taken
is transferred to an app and the patient can choose to give family members or friends access
to data through the app. This can be a good option from a health point
of view, but it also presents legal challenges. Unlike doctors, relatives are not subject
to medical confidentiality and therefore the handling of such sensitive data by relatives
is not regulated legally, but must rely on general advice, which may prove insufficient
and put the patient in an uncertain position. The question of who owns the patient’s data
also generates a number of issues. It may be unclear how the pharmaceutical manufacturer
stores the data collected in the app, whether the manufacturer can use anonymised data for
its own analyses, how long the manufacturer may store data and if the patient can demand
the deletion of his data. The issue of safe data storage is particularly
relevant in view of the risk of the patient’s data in the app being hacked using software
viruses or spyware. All these ambiguities can help to create uncertainty
in patients. The consequence may be that patients opt out
of the new products, and thereby do not benefit from the new health options: It is important that the public have confidence
in the product. The manufacturers of electronic pills and
the treatment system must both win and earn the confidence of patients when it comes to
the handling and use of the collected data. In this process, the protection of privacy,
cybersecurity, accountability, transparency, fairness and robustness are essential. In the article, the researchers point out
that ethical and legal issues should be considered during the development of the product, rather
than tackling the problems once the product has been developed: Pharmaceutical companies are trying to meet
ethical and safety standards, but even though there are developments in the regulatory area
in both the EU and the US, there is still uncertainty as to exactly what these standards
involve. The consequence is that the industry is beginning
to ‘self-regulate’ and set up its own standards, and it is therefore important that pharmaceutical
companies in the future development of electronic pills are aware of and comply with the legislation
that the EU and the US are currently developing.

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