Managing life science compliance & risks in the digital age

 

By Fleming.| 08/01/2019

 

The Fleming team sits down with Michael de Villiers, Healthcare Compliance Lawyer, Roche, Switzerland , Caroline Kelly, Head of Compliance, former Grunenthal, UK and Antonis Roussos, Senior Director Ethics & Compliance, Privacy Lead for EMEA, Astellas, Greece to discuss:

 

 

What risks does the digital world present for life sciences companies?

 

 

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Michael de Villiers
Healthcare Compliance Lawyer

Roche, Switzerland

Reputational risks.

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Caroline Kelly
Head of Compliance

former Grunenthal, UK

Cyber-attack challenges all parts of all businesses. The weakest link is company employees, which is why companies need to train their staff not just to a superficial level, but to really understand what they ought to be alert to. Done well, this will also benefit them in their personal lives, which will encourage their engagement, rather than just positioning to protect company interests.

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Antonis Roussos
Senior Director Ethics & Compliance, Privace Lead for EMEA

Astellas, Greece

Our business models in life sciences sector are increasingly employing some truly remarkable data-driven innovations, applications and decision-support tools, which are also increasingly using sophisticated and intelligent algorithms. We are witnessing advancements in artificial intelligence techniques, which present a great opportunity to gain new insights and improve massively operational efficiency ultimately serving patients’ interests and their access to new, innovative treatments. However, at the same time, those great opportunities of this new, digitalized world present a great risk: they constitute techniques, which are materially reliant on the use of a vast amount of data. The new digital world is data-driven and all stakeholders, including life science companies, have a strong duty to use data in a safe and transparent way. Having said that, it becomes self-evident that one of the greatest challenges is how we will ensure that, while employing such new technologies, we will engage with healthcare professionals, patients and the public in a way that maintains trust and gives them the confidence that we are transparent, protective and respectful as we use and process their personal data.

As patients, physicians and pharma companies increasingly rely on e-channels for information and communication, how should life sciences companies identify and monitor digital content and e-channel risks?

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Michael de Villiers
Healthcare Compliance Lawyer

Roche, Switzerland

 

Companies should design processes and SOPs to monitor these channels. This is as expected by law and regulation but it is also moral expectations.

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Caroline Kelly
Head of Compliance

former Grunenthal, UK

Before engaging in any e-channel activities, companies need to have a well-thought out (and tested) monitoring plan. It should consider numerous different challenges, and outline coherently how these challenges will be managed should they arise. This needs to be maintained in a version controlled, easy to access reference document so that it can be consulted in haste if necessary.

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Antonis Roussos
Senior Director Ethics & Compliance, Privace Lead for EMEA

Astellas, Greece

Using digital channels for disseminating information in the life sciences sector is not only promising increased productivity; the current challenge in our digital world is how companies will manage by using digital marketing techniques to deliver more personalized interaction material to stakeholders (healthcare professionals, patients, payers). That presents a great challenge since it creates a need for developing a new ability: how to design and use fast-changing digital marketing tools for promotion while meeting regulatory compliance in a timely manner and especially in a globalized world. Addressing this challenge requires an organization culture whereby regulatory review will be integrated in a single governance model for coordinated review and execution among Brands, Regions, Agencies, and IT teams and that marketers will engage early on the medical, legal and compliance colleagues. It is also important to ensure that vendors used for digital marketing channels are informed of the company’s compliance standards and avoid producing non standardized material which then increases the risk of non-compliance.

Which steps and approaches does your company undertake to achieve compliance and the highest ethical standards in the use of digital interactions, AI and other disruptive technologies?

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Michael de Villiers
Healthcare Compliance Lawyer

Roche, Switzerland

We dedicate resource and we state it clearly in our Code of Conduct.

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Antonis Roussos
Senior Director Ethics & Compliance, Privace Lead for EMEA

Astellas, Greece

Working on a cross-functional governance model, which includes people from all departments and functions (business, regulatory, compliance, privacy, legal, IT, etc.), ensures a business model whereby digital-related decisions are not taken in isolation but in a manner that ensures a comprehensive approach taking into account all risks and challenges before decisions are being made. It is also important to conduct privacy impact assessments before introducing any technology or other solution which may present a high risk to individuals in our industry.