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.
June 2023 – Machine Learning /Artificial Intelligence in Pharma Compliance
On June 1 the working group life science met virtually to learn how machine learning and artificial intelligence could be applied to healthcare compliance. 20 participants attended the presentation of pour distinguished guest speaker Allana Rigby, Partner and regional head of data analytics for EMEA and Asia Pacific region from Control Risks. Allana has 12 years’ experience as a data scientist and fraud and compliance expert. Allanna specializes in the use of data to detect and prevent fraud and compliance risks.
Allana gave the audience an overview of what is machine learning (ML), what is Artificial intelligence (AI) and applications of machine learning in pharma compliance. Then she provided various real life examples and case studies on how ML/AI were applied. Afterwards Patrick wellens, co-chair of the working group moderated the questions and answers.
May 2023 – How do you measure Speak-up campaign?
On May 2 approximately 30 ECS members met at the offices of Meyer Lustenberger Lachenal Froriep in Zurich to discuss “ How do you measure the speak-up culture”. On Behalf of the WG Whistleblowing and Life Sciences, Patrick Wellens, vice-chair ECS welcomed the participants, thanked Renato Bucher and MLL for the hospitality and introduced Gerald Hucky as speaker. Gerald Hucky has been a head of compliance for Swiss listed companies and has over 16 years broad compliance experience gathered in the medical device and energy sector.
Gerald used ACFE Report to the Nation and Navex whistleblower benchmark report to provide some insights on the median percentage of allegation categories, reporting mechanisms used by whistle-blowers over time, statistics on the report volume per 1000 employees, retaliation reports and how a SpeakUp cockpit could look like.
After the presentation the WG actively discussed and concluded:
- Benchmarking with other companies or industry standards is good, but companies should be careful in comparing “speak-up statistics” with other companies as the definition of what is included in speak-up numbers might be different
- By looking at the median percentage of allegation categories HR, diversity and workplace respect constitutes between 50-60% of all cases. This is extremely high.
- Finding a right balance between “having employees speak-up” and obtaining many irrelevant whistleblower reports
- An analysis of numbers should ideally be done by Region/Division, by anonymous/non-anonymous, and percentages of confirmed allegations
- Numbers should be analyzed over time and analyzed by Region/Division/Country, by anonymous/non-anonymous, percentages of confirmed allegations vs non-confirmed allegations and type of allegations.
- Different Regions used different reporting channels so an analysis over time of reporting channels used by Region is recommended
- In addition to analysis of Speak-up Numbers, the evaluation of whether employees trust to speak-up can also be evaluated by including certain questions in employee surveys like “ how comfortable are you to report misconduct”
The Group then continued the discussion over an apero.
January 2023 – Supply Chain Visibility, Traceability and Compliance
To combat falsified medicine, in many countries pharmaceutical companies are required to have implemented “serialization” or “ track and trace” systems in their distribution network. The Working Group met virtually on January 18 where our distinguished speakers Andre Durrer, Head of Global Compliance Management System (CMS) at CordenPharma, Rob Leonard, Sales Director EMEA/APAC at RFxcel gave the audience an overview of the track and trace requirements in numerous markets and explained how track and trace dashboard is a powerful tool for companies to have insights in their logistic processes. The event was moderated by the WG Co-chair Patrick Wellens.
November 2022- Transparency and lobbying registers
Members of the WG met at Bayer Consumer care AG in Basel on November 16. The WG co-chairs Claudia Seitz and Patrick Wellens welcomed the participants and introduced Alexander Meier, Partner at Preu Bohlig law firm. Prior to joining the law he worked 11 years for Novartis in various functions amongst others as Head of Legal, Global and Pharma Drug Development for Novartis across all Divisions.
Dr. Meier set the stage by explaining that various laws/ regulations and or Codes focus on increased transparency. Pharma companies are well aware of the requirement to publish annually the transfer of value to healthcare organizations and healthcare professionals, but there is also EU Regulation 1049/2001 requiring to make clinical trial data transparent, the EU directive 89/105 on the transparency of pricing and reimbursement of pharma products and now newly the requirement to make lobbying activities transparent.
On a European level all activities carried out (e.g. the organization or participation in meetings, conferences or events; the contribution to or the participation in consultations, hearings or other similar initiatives; the organization of communication campaigns, platforms, networks and grassroots initiatives; the preparation or commissioning of policy and position papers, amendments, opinion polls and surveys ) by interest representatives with the objective of influencing the formulation or implementation of policy or legislation, or the decision-making processes of the signatory institutions or other Union institutions, bodies, offices and agencies (together ‘Union institutions’) means that such interest representatives have to be registered in an European lobbying register.
Dr. Meier further explained the situation in Germany (“ Lobbyregistergesetz”) and France.
- The organization or participation in meetings, conferences or events; The contribution to or the participation in consultations, hearings or other similar initiatives; The organization of communication campaigns, platforms, networks and grassroots initiatives; The preparation or commissioning of policy and position papers, amendments, opinion polls and surveys
October 2022- Challenges and benefits of new compliance business models
Despite the ever increasing list of laws and regulations companies have to comply with (e.g. German Supply Chain Act, EU Whistleblowing Directive, EU Corporate Sustainability Reporting Directive, EU Corporate Sustainability Due Diligence Directive, EU Artificial Intelligence Act, Data Governance Act), studies show that budgets of (Ethics &) Compliance departments are not always increasing in line with these additional responsibilities. Some companies therefore start to look into new business models such as the creation of compliance shared service centers, compliance chatbots, outsourcing and/or automation of controls.
On both September 30 and October 17 the members of the working group Life Sciences came together at Bayer Consumer Care in Basel to exchange thoughts and discuss the benefits and challenges of these new compliance business models. Patrick Wellens, co-chair of the Working Group, gave some insights on the new compliance business models at Bayer after which the working group had a lively and interactive discussion.
May 2022 – Legal and Compliance Challenges when Collaborating to Develop and Offer Digital Medical Applications
The first post-Covid physical event of the Life Sciences Working Group took place in Basel on 20 May 2022. Jan Wesiack, Collaboration Lead, Roche, and Anne-Catherine Hahn, Partner, IPrime Legal, ran a workshop to discuss legal and compliance challenges when collaborating with partners to develop digital medical applications.
Relying on their own and the participants’ practical experience, the group looked at issues related to data governance, regulatory compliance, and HCP and HCO interactions, all of which are crucial for the success or failure of collaboration projects in the digital space. The group also exchanged best practices in relation to the role that legal and compliance professionals can play to help anticipate and address relevant issues, while taking account that digital collaboration projects typically bring together players from different backgrounds and organisations, creating a strong need for alignment, exchange and project management, both in relation to compliance needs and overall development objectives and roll-out.
The workshop was followed by drinks kindly sponsored by Deloitte in their new offices in Basel.
February 2022- Success factors of a speak-up culture
On February 28 the ECS working groups “Whistle-blowing” and “ Life Sciences” organized a joint event to talk about success factors of a Speak-up culture. Patrick Trepanier, director of Compliance from FIFA, gave an overview of the unique FIFA governance structure and Speak-up channels and emphasized as key success factors for a Speak up culture (called “ Raising Concerns” at FIFA) 1) communication of Compliance Handbook and “pocket guides” with short and concise content on numerous compliance topics 2) Reinforcing the importance of Compliance by organizing a Compliance Summit with key note speakers and members of top management 3) creating trust with the business and 4) measuring the speak-up culture across various channels.
Juliette Noto, as Head Analysis and Compliance of Swiss Federal Intelligence Services, gave an insight about the unique challenges of a Speak-up campaign at a Federal Intelligence department where by nature employees are dealing with sensitive information and are more inclined to work secretly rather than act openly and Speak-up. To make such Speak-up culture reality, a cultural transformation needs to happen.
Q&A was moderated by Patrick Wellens.
October 2021 – Conflict of interests at healthcare organizations (hospital)
Pharma companies often enter into sponsoring -, speaker -, consulting – or service agreements with healthcare professionals from hospitals.
When entering into such agreements, pharma companies often:
- Do not know the “conflict of interest “ policy of the hospital;
- Do not know whether the contracts entered into with healthcare professionals must be in the name of the hospital and/or whether the money paid to HCP must flow to the hospital or whether HCPs are allowed to enter into contracts in their own name;
- Do not always have the full transparency on how bank accounts are being managed by the hospitals and related foundations
Hospitals are not always aware of the services provided by individual HCP/employees to pharma companies.
Moderated by Patrick Wellens and Claudia Seitz, compliance officers from hospitals and pharma companies discussed in various virtual sessions during March- September 2021 what kind of conflict of interest might exist and how such conflict of interest might be remediated. The results of the discussions can be found in the attached document: ECS_WG life sciences_conflict of interest mitigating actions_20210713
September 2021 – Best practice document on sponsoring by Pharma companies of events organized by healthcare organization (hospitals)
Pharmaceutical companies in Switzerland often sponsor educational congresses or events organized by healthcare organizations.
Pharma companies often struggle with:
- Obtaining budgets from hospitals when sponsoring request are being made
- Lack of transparency on co-sponsors (multi-sponsoring)
- Lack of transparency on how the sponsoring amount is being used
- Getting refund for unused sponsoring amounts (over-sponsoring).
Hospitals often struggle with:
- Different contractual clauses requested by different pharma companies
- Some pharma companies asking for budgets for all sponsoring events (regardless of amount), whereas other pharma companies apply a certain threshold
- Which cost positions are allowed in budgets by pharma companies.
Moderated by Patrick Wellens and Claudia Seitz, compliance officers from hospitals met with compliance officers from pharma companies and discussed in various virtual sessions during January- June 2021 best practice standards for sponsoring of events. The attached document provides best practice standards regarding the sponsoring request, in the sponsoring contract and after the completion of the sponsored event : 2021_ECS_Sponsoring standards_PWE_20210913
21 September 2021- Why are OECD’s global tax initiatives relevant for compliance officers?
On September 21, Martin Krivinskas, Tax Partner at Deloitte, gave an overview of the latest tax developments. Here the OECD BEPS, Country by Country reporting, minimum tax requirements (Pillar 1and 2), and Swiss Tax reform are worth mentioning.
In more and more countries companies are required by law to publish their tax strategies. This in combination with the country by country reporting – which requires companies over a certain threshold- to report by country on the nature of activities, the number of FTE, net turnover, profit before tax, income tax accrued, income tax paid, accumulated earnings, give the tax authorities a good overview whether global companies pay in each of the local markets a “fair share” of taxes. The increased transparency of the tax strategy and reporting data by country will also highly likely lead to increased media scrutiny and inquires and makes it increasingly difficult for companies to design tax strategies without a clear rationale.
Martin also discussed the Swiss Principal model and shared some transfer price risk indicators. At the end the group had an interactive discussion – moderated by Patrick Wellens- whether the increased reputational risk (by not abiding to tax laws, increased disclosure requirements, and potential inconsistencies between companies’ ESG requirements and tax planning) should be managed by Group Taxes only and/or whether the Compliance function should also be aware and/or be part of proactively managing such risk. Group Taxes might be experts in tax strategies but they might not be experts in responding to media inquiries. So here the audience felt that close cooperation between Group Tax department, Communication department and Compliance department is recommended.
21 April 2021- How to transform your compliance function through analytics
Allanna Rigby, Head of data analytics APAC, Control Risks explained the audience what kind of data analytics can be applied. Compared to traditional monitoring methods, focusing only on a sample of transactions, data analytics allows a review of the whole population of transactions and allows therefore a much more proactive and predictive approach to identify outliers and/or ethical misconduct.
Changes to the US Department of Justice compliance guidelines, cost pressure to the compliance function and the desire for compliance functions to analyze the data and provide value added insights to the business and becoming a business enabler are the key drivers for the use of data analytics by compliance departments.
Embarking on a data analytics journey takes time and budget(s). Therefore Allanna suggests to engage early on other stakeholders (risk management, internal audit etc.) that might be interested in data analytics as well and potentially share the costs. The speaker suggested to start small, pick a known issue and start with the data you already have and then continuously improve the data set- do not wait for perfect data. She also shared a number of case studies where data analytics applied and war stories on how data analytics should not be applied.
Patrick Wellens, co-chair WG Life Sciences, moderated the lively Q&A session.
9 April 2021- New Business Models in Pharma
Patrick Wellens , co-chair WG Life Sciences, introduced Esther van Weert, Head Ethics & Compliance of Arvelle Therapeutics and Kiki Meriakli, Head Ethics, Risk, Compliance Oncology Europe as key speakers.
Esther and Kiki explained that the last decade pharma companies had clear segregation between promotional (commercial roles) and non-promotional (scientific/medical ) roles. Because of the pressure on public spending, the increased patient empowerment, the changing product portfolios (from few blockbusters to many more targeted solutions), new organizational models and new roles (focusing on healthcare innovation, digital enablement, commercial partnerships etc.) were created.
The speakers suggest that any new role or business model proposed by the business must be evaluated how this new role will better serve patients, healthcare systems and industry. Iideally compliance works together with other business functions such as medical, legal to assess potential risks ( including ethics, reputation, legal, regulatory, pre- approval or off label / disguised promotion risks, perception risks, if KPIs and incentives may need to be adjusted, etc.) of the new role and define related risk mitigation plans
The objective and intent of each program/business model/initiative/engagement should be clear, legitimate, genuine and promotional activities should be clearly separated from non-promotional activities. Business models and activities should have the ultimate benefit to patients at their core, should be properly documented, and companies should refrain from starting any initiative that could put any party involved (HCO, payer, or company) in a real or perceived conflict of interest situation and that could be seen as an attempt to exercise undue influence.
After the presentation, a lively discussion took place.
17 September 2020 – Working with a Monitor
Patrick Wellens, co-chair Working Group Life Science, opened the webinar and introduced both speakers:
- Kaisa Karvonen heads up the Forensic Risk Alliance practice in Switzerland and assists her clients in both private and public sectors with cross-border and cross-sector regulatory and internal investigations, commercial disputes and claims, as well as fraud prevention, detection and related compliance program remediation.
- Babila Gapponi is the Head of Ethics and Compliance Europe at Getinge. He previously was in charge of the compliance program in Europe for Zimmer Biomet
Kaisa gave insight in the Compliance Monitor workplan and timelines to get certified, what factors to consider preparing for a monitor and how to best manage a monitor. Balila Gapponi the continued and gave first hand experience during the Zimmer Biomet monitorship and challenges in each phase of the Monitorship.
14 September 2020 – From FMCG to Life-Science – E&C challenge, contribution, and learnings
Charles Pare, Ethics and Compliance Head EU West PMI
Charles provided background information on the biggest shift in history of PMI- namely replace cigarettes with smoke-free products as soon as possible. As a result the company started a massive recruitment of scientists, engineers to develop less harmful alternatives to cigarettes and transformed the company from a pure fast moving consumer goods company to a life science company that had comply with medical device regulations.
He provided the audience with deep insight in the risk assessment phase of the journey into a life science company, how behavorial science was used to obtain ethics and compliance support from management and the results achieved through this new approach. Patrick Wellens, co-chair Working Group Life Science, moderated the Q&A.
12 June 2020 – Social Credit System in China – a different perspective on third party management
Patrick Wellens, as co-chair of the working group, welcomed the participants and introduced the key speaker Ralf Rehfuss. Contrary to the widespread knowledge on the social credit system impacting individuals, Ralf Rehfuss explained how the social credit system for companies is working. Data from different sources (supplier management, environmental protection, corruption, tax payments, tax avoidance, compliance with China Cyber Security Law, National Export Control -to name a few- are all consolidated in a central database). Possible sanctions and/or implication for companies with a poor company social credit score could be the increased examination and verification of import/export cargo documents, restrictions on access to loans and/or financing, capital market (stock and bond), restrictions or ban of participation in public tender biddings, legal representatives of such companies and/or its directors would not be allowed to serve in leadership roles at either private or state-owned companies, legal representatives of such companies can’t leave the country, public blaming and shaming of the company etc.
Ralf then provided the participants a number of tips for how companies can prepare for the new legislation:
- Understand exactly what the social credit system requires from your company.
- Conduct a risk assessment where your company stands regarding the requirements, review internal processes and design and implement effective adjustments, where needed.
- Pay attention to local databases (individual SCS)
- Define how frequent the SCS of Third Parties is monitored.
05 June 2020 – Ordinance on Integrity and Transparency in the field of medicinal products
Patrick Wellens, as co-chair of the working group, welcomed the participants and introduced the key speaker Alex Fuchs (Biogen). Alex Fuchs explained the scope and content of the new legislation (by highlighting the new requirements in articles 55 and 56 of Therapeutic Act) and showed the audience how Biogen conducted a risk assessment to evaluate what areas would be affected by the new legislation. Alex Fuchs then went into greater detail to explain that free of charge deliveries (logistic costs) to customers are considered rebates that must be shown on invoices and the challenges his company had with implementation. Afterwards a lively question and answer discussion with participants took place.
05 May 2020 – Third Party Management
After thanking Deloitte for hosting this webinar, Patrick Wellens as co-chair of the working group handed over to Philipp Luettmann, partner with Deloitte. Philipp showed us that a typical company has thousands , if not ten thousands of third parties (sales agents, distributors, clinical research organisations, contract manufacturers, toll manufacturers, in and out-licensing partners, customs brokers, advertising agencies, IT technology partners etc.), each coming with different third party risks. Key findings from the Deloitte Extended Enterprise risk Management survey (2019) were that although 53% of respondents mentioned that they have a high or critical dependence on third parties, 94% of respondents mentioned that they have a low to moderate level of confidence in the ability to manage third parties. Philipp then gave an overview of the numerous regulations (GDPR, UK bribery Act, ISO 37001, ISO 19600, Brazil Clean Companies Act, Swiss Responsible business initiative) affecting companies managing third parties.
In order to have an effective third party risk management program in place it was recommended that companies:
- Define a clear business case for third party risk management
- Be clear in defining the framework (risk domains and third party types)
- Define in collaboration with key stakeholders process requirements and consider process automation tools and workflows.
Participants were then asked a number of polling questions
- Reputational and legal/regulatory risk were screen as the biggest risks;
- Lack of resources to monitor effectively third party risk, no continuous control monitoring of third parties and no (global) visibility of third party risks were highlighted as the top three challenges;
- In most organisations different departments manage different third party risks, often with different methodologies and in different tools;
- Most companies have automated parts of the process, but various components are still handled manually;
Deloitte then presented two different case studies were they helped clients establishing a third party risk management framework, implementing a technology and creating a roll out strategy. Patrick Wellens then presented a Bayer case study. Patrick elaborated on the rationale for a third party oversight project, the scope, the implementation challenges and key take-aways for a successful implementation.
November 2019 – Talent management in Compliance
On November 22, 2019 the Working Group Life Science convened at the offices of Walder Wyss law firm in Zurich and further discussed the topic “ Talent Management in compliance”. More in particular the Working Group brainstormed, discussed and came up with concrete actions Compliance officers can take to ensure they are well embedded within and understand the business, how and where to acquire key skills needed for the role as Compliance officer and what is needed to raise the profile of compliance as a talent pool and/or attractive place for other functions to work in.
In order to develop talent in compliance it is very important that compliance professionals are embedded within and understand the business. The group discussed concrete actions to make this happen and came up with following ideas:
- Access to decision making bodies (Board, Regular management meeting)
- Embedded into different business/business units by have regular 1:1 team meetings
- Understand the goals/strategic plan of the business
- Partner with/be a member of strategy team
- Rotation of business into compliance and vice versa
- Ensure Compliance has the necessary capabilities so they can translate this for the stakeholders to make the right decisions
- Clear policies and procedures to support the decision making in an efficient way
The group discussed actively the key skills a compliance officer should have and how such skills could be acquired.
On the Job
|Understand the Business||√||√||√||√|
|Approach Business proactively||√||√||
|Good communication skills||√|
|Do not shy away from difficult decisions||√||√||√|
|Consistency in decisions||√||√||√|
|Open Minded- Growth Mindset||√||√||√||√|
What is needed to raise the profile of compliance as a talent pool/as an attractive place for other functions to work in?
- Develop clear criteria for identifying talents (within the company and within compliance)
- Define target roles & steps to get there
- “ Is compliance the beginning or the end”?
- Country Head(s) could be given short term assignment(s)
- Provide a broader “personal” onboarding service to CEO to raise the profile of compliance
September 20, 2019 – Working Group Life Sciences
About 20 people from the Working Group Life Science convened in Roche to discuss the topic “capability building and talent development”.
After an initial introduction by Patrick Wellens (Bayer), Esther van Weert (Roche) moderated an interactive app session where respondents were asked to respond to a number of questions related to talent management/talent development. Although the group does not consist of a statistical significant size, nevertheless the responses provided show that there is room for improvement:
- 56% of respondents stated that their company does not have a clearly defined talent pool in Compliance function;
- 90% of respondents mentioned that their company does not have specific career paths for talents in compliance;
- 80% of respondents mentioned that their company does not have clear succession plans for key compliance professionals;
- 70% of respondents felt that management sees performance management/talent review as internal process to comply with rather than a business critical activity
- 80% mentioned that their company does not have any KPIs regarding talent development
Afterwards the members split up in three parts and discussed in great details:
- Group 1: Compliance as a respected business partner with a seat at the table- Which capabilities are needed for the future?
- Group 2: Talent development: which activities, programs and exposure are needed?
- Group 3: Succession Planning and career paths- what actions are needed?
The various subgroups later on presented their thoughts to the larger group.
June 2019 Parallel Trade/Imports
On June 14, 2019 over 20 participants of the working group Life Sciences convened at the premises of Tillotts Pharma in Rheinfelden.
Amalia Athanasiadou – Legal and Compliance Counsel Tillotts – presented the audience with the legal framework of parallel trade/parallel imports and discussed a number of cases/fines under EU Competition law. Stephan Gussman from SEG Consulting then presented a real life scenario (with some of the facts changed to client confidentiality) and asked each of the participants what concrete actions (and in which order) they would undertake in the given circumstances. This triggered a very interactive discussion on the pros and cons of specific actions amongst the participants. Stephan moderated the discussion and provided the audience with a methodology to handle the case.
On February 22, 2019 – Working Group Life Sciences
26 members of the working group life sciences convened on February 22 in the offices of Bayer Consumer Care AG to discuss the challenges and solutions around compliance training. Whereas compliance training is one of the key pillars of a compliance management program to prevent unethical practices, the question for most companies is how and in what format to provide employees with concise, interactive and relevant training.
After a welcome by Patrick Wellens (Bayer), Jan Wesiack (Roche) and Kathy Tench (KPMG) explained the audience that choosing between principle and rule based compliance trainings, dealing with “training fatigue” of employees and measuring the effectiveness of the compliance training are the main challenges for most companies. The training approach selected by companies usually depends on the number of people to be trained, the budget and resources available, the risk appetite and the amount of legal requirements to provide certain mandatory trainings. Kathy and Jan presented the pros and cons of classroom versus web based training and highlighted some of the major recent interactive training tools available: learning scenarios where decisions taken by the employee will directly impact how the scenario will unfold; micro-learnings with push notifications, trainings apps with a personalized curriculum and control quizzes. The working group experienced firsthand to play and discuss ethical dilemma game.
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 organisational 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.
These are the upcoming dates for our Annual General Meetings:
Thursday, 21 March 2024
Thursday, 20 March 2025
If you are an ECS member, you are cordially invited to our Annual General Meetings! Each AGM is followed by discussion on current compliance topics and an networking Apèro.