WG Life Sciences

The Working Group Life Sciences, co-chaired by Claudia Seitz and Patrick Wellens was launched on 18. February 2015 and aims at bringing together all practitioners and interested parties in the life sciences sector (e.g. pharmaceutical, food as well as agrochemical and chemical companies, authorities and courts, representatives from hospitals and insurance companies, advisors and academics) to discuss new developments on compliance in the Life Sciences sector.

The emphasis is put on specific questions for life sciences companies, especially for companies in a regulated environment.The WG organises regular lunch meetings, presentations and conference calls to exchange experiences, discuss key topics and to promote a Life Sciences Ethics and Compliance network.

 

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Next WG Event – February 22, 2019 from 2.30 pm till 4.30 pm (in the offices of Bayer Consumer care AG in Basel). The focus of the meeting is to discuss how compliance training can be made interesting and relevant for the various stakeholders. Both Kathy Tench from KPMG and Jan Wesiack from Roche will give a presentation and share their thoughts with the audience.  If you would like to register, please contact Patrick Wellens on Patrick.wellens@bayer.com.

On October 12, 2018 – Working Group Life Sciences met in the offices of Sonova and discussed the impact of the digital revolution on compliance.Moderated by Patrick Wellens, the audience discussed and agreed that the biggest compliance risks related to digital evolution are data privacy and IT security.  Whilst some of the respondents mentioned apps as their highest risk, others mentioned data breaches and cloud computing.

The group furthermore discussed the risk for loss of company secrets due to increased connectivity of systems and applications and the importance of effective technical and organizational measures to prevent this.

The group also had an interactive discussion on the challenges of monitoring activities on social media and the use of “bring your own device”. 

Friday June 8, 2018 – Working Group Event: Interplay between corporate and individual liability for compliance failures 15 members of the working group Life Sciences convened at the Baker & Mc Kenzie offices in Zurich to discuss the interplay between corporate and individual liability for compliance failures.

After an introduction of the speakers by Patrick Wellens, Lisa Griffiths gave an introduction on the US Department of Justice and Securities and Exchange Commission enforcement actions during 2005-2017 and enforcement actions taken by UK Serious fraud office. Afterwards Anne- Catherine Hahn talked about the legal framework for individual and corporate liability, the increasing importance of corporate criminal liability, the increasing trend of recourse claims against senior management for payment of damages in the wake of large compliance failures and the Yates Memorandum focusing on identifying individuals that caused corporate misconduct.

Compliance officers and companies are wisely advised to take into account the risks of corporate and individual liability in structuring an investigation and to have clear reporting lines and responsibilities regarding the compliance function defined so that the question “ how far down in the organization are management levels exposed to external liability” can easily be answered.

The members of the group also discussed the attorney client privilege in investigations and whether high fines for corporations, deferred prosecutions agreements and/or criminal sentences for individuals is the most powerful deterrent against corporate misconduct.

March 16, 2018 – Working Group Event. Our next meeting of the working group life sciences takes place on March 16 from 2.30 till 4.30 pm at the offices of KPMG, Badenerstrasse 172, 8004 Zurich.  In advance of the meeting each company can participate in a benchmarking survey where various components of the compliance management system are being evaluated. During the session the benchmarking study amongst life science companies will be presented (and each company has the possibility to see how they rank versus the total population) followed by an activity discussion.

September 29, 2017- Working Group Event. On Friday September 29 the working group convened at the offices of Novo Nordisk and discussed the topic “compliance risk assessment”. Patrick Wellens welcomed the group and introduced the speakers. Elvira Valverde from Baxter Healthcare gave us insight on the advantages and disadvantages of the various ways a risk assessment could be done (i.e. self-assessment, “audit type” assessment, survey questions, heat-map and Big Data), who participates and who conducts such a risk assessment.

Philipp Luettmann from BDO shared a three step methodology for risk assessment. In the preparation phase internal/external information sources, relevant policies & procedures, industry regulations, applicable laws are reviewed, compliance risk areas and risk models are defined. In the discussion phase in a moderated workshop risks are identified, ranked according to criteria (e.g. likelihood and impact) as well as mitigation measures are defined. In the last phase compliance risks are prioritized and measures and controls are defined to mitigate results.

After hearing how a pharma company and a consulting firm conduct risk assessments the participants further discussed whether such risk assessment are conducted by the compliance department and/or whether these are part of an overall Enterprise Risk Management concept. Furthermore it was discussed that risk criteria such as low, medium and high might be OK for a risk assessment at an individual subsidiary level however as soon as a company-wide risk assessment is done then criteria such a low, medium and high needs to be quantified.

May 12, 2017 – Working Group Event. On May 12 the working group Life Sciences gathered at Roche (Basel) to discuss how EFPIA figures can be used by the Compliance department in discussions with Country and Regional management and how compliance departments can measure their effectiveness.

Our host, Esther van Weert,  Pharma Healthcare Compliance Leader Europe for Roche, provided us insight how the EFPIA figures that were first published in June 2016 are used internally in discussions with local management teams. Whereas the reporting of transfer of value (“TOV”) is an external obligation, the compliance department is adding value by analyzing the R&D, consultancy, sponsorship and event costs, sharing these data with local management and initiating discussions to reflect on this data and where needed change business practices.

By analyzing the consent rates and the amounts of TOV spend per category, each pharma company can compare how they are performing against their peers. Additionally the compliance department can analyze the most significant TOV data to HCP or HCO sales volumes to understand whether there is any relationship between them.

In a second part, Patrick Wellens, compliance business partner Bayer, presented some thoughts on how to measure the effectiveness of a compliance department. Whereas various guidance exist on the components of an effective compliance management system, few guidance exist on how to measure the effectiveness of a compliance department. Any KPIs developed to measure such effectiveness should be easy measurable, should be consistently measures over time, should focus on the outcome and not of activities conducted and is dependent on the stakeholders that are interested in such effectiveness analysis. Patrick then opened and moderated the discussion.

February 3, 2017 – Working Group Event. On February 3 the working group Life Sciences gathered at PriceWaterhouseCoopers (Zurich) and further discussed challenges in interactions with patients and patient organizations. As on October 14,2016 there was not enough time to continue with the highly interactive discussions on patient organization, it was decided to do so in a separate meeting.

All participants welcomed the involvement of patients in providing input and sharing information about diseases to better understand their medical needs. Where patient programs are initiated by the marketing department and/or funded by marketing department cost centers, the compliance department must be critically analyzing such program(s). The working group also discussed the difficulties  and compliance challenges in working with various type of patients (normal patients that might not be so educated about their disease and some other patients that are very well educated ) and various degrees of compensation for participation in events.

October 14, 2016 – Compliance aspects in market research and patient associations.
On October 14, 2016 the Working Group Life Sciences will meet at Johnson & Johnson in Zug and will discuss the regulatory framework and compliance challenges when working with market research organizations and additionally will discuss the impact on compliance processes when pharma organizations change to become a more patient centric organization. Efstathia Gkika (Baxter) will explain the regulatory framework and compliance areas of concern when conduction market research activities. Additionally, Sophie Beaumont (Baxalta/Shire) will give insight into working with patient organizations and the changing role of compliance when companies want to be perceived as patient centric organizations. The meeting of the Working Group Life Sciences is open to all interested and registered parties. If you whish to participate please confirm your attendance to the co-chairs of the Working Group Life Sciences (Claudia Seitz/Patrick Wellens) one week in advance of the meeting the latest.

June 10, 2016 – Third party due diligence.
The working group consisting of 24 persons met on the Novartis campus. Philipp Luettmann (BDO) and Oscar Perdomo (PwC) presented to the working group the importance of screening/monitoring third parties, gave examples of risk assessment criteria and a methodology that can be used to identify third parties. They also touched upon the possibilities of using external parties to do more detailed screen as the risk level goes up. After this 20 minute presentation Patrick Wellens moderated the intense discussion between participants and more particularly the frequency of screening third parties and when to conduct/not conduct audits of third parties.

February 12, 2016 – ISO 19600.
The working group consisting of 12 persons met in the offices of Acino Pharma in Zurich. Daniel Buhr (Lalive) presented to the audience the principles of the ISO 19600 standard on “compliance management system” after which the audience debated on the usefulness of such standard and how this ISO standard needs to be seen against other standards (US Sentencing Guidelines, German public accountants standards etc.)

October 16, 2015 – Fair Market Value.
The working group consisting of 14 persons met in the offices of Novo Nordisk in Zurich and discussed how the fair market value (FMV) for reimbursement to healthcare professional is determined. Topics that were discussed intensively are how to define FMV for retired HCPs, how to compensate for “travel time” (only time spend in flights or also trains), how to document and define if a healthcare professional is a general practitioner or specialist, how to handle FMV in clinical trials and how to deal with HCPs licensed in one country but living in another country.

Basel, 26 June 2015.
On 5 June 2015 the Working Group Life Sciences met in the offices of BDO in Basel and discussed the topic “EFPIA transparency reporting”. The participants discussed and exchanged practices around the scope of EPFIA, consent management, attestation process, implementation solutions and challenges, systems and sources used to track transfers of values.

It was agreed that the next meeting will take place on October 16th in the offices of Novo Nordisk in Zurich. The meeting will focus on “ fair market value” for interactions with healthcare professionals, healthcare organizations and CROs. To register for this event please contact Patrick Wellens, Co-Chair WG Life Sciences.

Basel, 30 April 2015.
On 17 April 2015 the Working Group Life Sciences started with their first face to face meeting in Basel.

Claudia Seitz and Patrick Wellens welcomed the participants at the premises of Bayer in Basel. Claudia Seitz explained at the beginning of the meeting that according to the by-laws and the spirit of ECS it is to be seen as an association which promotes ethical leadership and integrity in all organizations and which is open to all who share an interest in integrity and compliance. The Working Group Life Sciences is open to all interested parties, whether they are coming from government, courts, authorities, life science companies, law firms, consulting companies and academia. According to 4.4 of the ECS by-laws it is the duty of all participants to abstain from any marketing and lobbying in the frame of ECS’ activities.

Patrick Wellens showed the participants the topics of interests that were mentioned in an initial mailing. After discussion it was agreed that for the next meeting (to be held in June) the focus of interest should be transparency reporting (EFPIA) and the meeting afterwards (end of September) the focus should be on R&D/clinical trials.

The next meeting will be scheduled for June in Basel. Patrick Wellens will circulate a doodle amongst the participants.

Basel, 26. March 2015.
During the first Working Group Life Science kick off call beginning March we had an animated discussion whether consultants, advisors, government officials, authorities etc. should be included or excluded from the Working Group. It was then agreed that this discussion could not take place in our working Group but needs to happen at the Board of ECS.

At its meeting of 9 March 2015 the Board of ECS discussed this topic in detail and came to the conclusion that we must stick to the by-laws and spirit of ECS as an association which promotes ethical leadership and integrity in all organizations and is open to all who share an interest in integrity and compliance management, indiscriminately of whether a member works in-house or not. Hence we must not exclude anyone who is interested in participating in the Life Sciences Working Group.

In order to address the concerns expressed by some members, the Board decided to issue a guideline specifying Article 4.4 of the by-laws, i.e. the members’ duty to abstain from marketing and lobbying in the frame of ECS’ activities. The Board confirmed that members must not market their services and must refrain from lobbying third party interests in the frame of ECS’ activities.

Feedback was obtained from all participants with regards to future topics of interest for our Life Science Working Group and this will be further discussed in the next meeting on April 17 at the premises of Bayer.

Contact

Prof. Dr. iur. Claudia Seitz, M.A. (London), AttorneyCo-Chair Working Group Life Sciences
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Patrick WellensCo-Chair Working Group Life Sciences
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