IPCAA 6th Annual Seminar on Compliance 2017 Copenhagen 28 – 30 March 2017 In association with ETHICS

FromstrengthtostrengthAnna Frick (IPCAA Past President) and Dominique Laymand (president of Ethics) welcomed a packed room of delegates to the 6th edition of the IPCAA seminar on compliance. Each said a few words about their respective organisations and both agreed that the IPCAA-Ethics cooperation continues to be a huge success. This year’s conference had attracted more delegates than ever with no spare seats available. The programme had evolved continuously and the presentations and discussions promised to be even more interesting this year.

Pre-Seminar:anintroductiontohealthcarecomplianceandmeetingsThe half-day pre-Seminar (on the 28th) also attracted record numbers and was a great introduction for those less familiar with the area. The main tutors Dave O’Shaughnessy and Martin Hess gave a solid grounding in the topic with liberal use of real life case studies to illustrate situations in which codes may be breached.

MainseminarThe tried and tested format of 3 half day sessions was adopted with each having renowned key note speakers followed by in depth debate with expert panellists representing Pharma, medical societies and PCOs. There were also a couple of breakout sessions where delegates were all engaged working through exercises designed to bring out the practicalities of the topic. The ‘master of ceremonies’ was Martin Hess (Roche) with his characteristic flair and enthusiasm. Panels were expertly moderated by Christian-Claus Roth (Novartis) and Anna Frick (Roche).

Session1:Whatdoesbehavingethicallyreallymean?Prof. Dr. Mark Pieth. (Basel Institute of Governance} ‘Ethical business relationships - what should we have learned?’ Prof Pieth had worked on the FIFA corruption case but he turned his attention to healthcare asserting that we shouldn't think that Pharma was a corruption-free zone. Wherever there were large sums of money difficulties may arise. In healthcare, the bill is largely paid by the taxpayer, healthcare is a fundamental of survival and tension is inevitable. There followed an analysis of healthcare industry activity through the eyes of Prof Pieth, a lawyer specialising in the corruption area. One particularly interesting perspective is where marketing and medical education meet. Marketing forces and marketing itself are perfectly legitimate. Continuous medical education is essential and this should be unbiased. On individual sponsorship of doctors, he saw no particular problem if it was obvious and declared. Paying speakers is acceptable if this is for time they invest but not to ‘say nice things’ about the company’s products. Speakers should of course declare their interests. He also mentioned China where the government had made an example of one company but the issues might be tracked back to very decentralised decision making. Dominique Laymand. (Ethics) “Understanding Ethics where the healthcare industry and healthcare professionals meet.” Dominique returned to the stage to talk from the perspective of a healthcare compliance officer. She started with the observation that people in professional

life may have less good judgement than in private life. This was to echo what we were to hear from Prof Palazzo at the conclusion of the seminar when he spoke about the effects of the environment on how people behave. Dominique reminded us that being lawful is the minimum standard. We should also be ethical. Each stakeholder must contribute and it is not helpful to finger point at other players. Having shared principles is important and maybe only a few were necessary. In fact, she briefly presented six high level principles that could be a foundation. This idea was endorsed and attention was drawn to the Consensus Statement that IFPMA had worked on with international bodies representing doctors, pharmacists, nurse, patients and others as a significant piece of work in this area. Delegates could refer to this, the major codes and many other reference documents on the meeting app. Dominique concluded with an old story from Baghdad. In response to the question: ‘what shall I do to receive the most for that which I spend?’ The wise one replied that, ‘the Priceless Ingredient of every product is the Honour and Integrity of its maker’. This is maybe as true today as it was all those years ago when the fable was written.

PanelDiscussion.The key note speakers Prof. Dr Mark Pieth and Dominique Laymand were joined by Steve Sealy (European Respiratory Society), Angela von Bieberstein (IPCAA) and Sofie Melis (IFPMA) to explore further the session question ‘What does behaving ethically really mean?’ Questions and comments were introduced from the floor and via the meeting app. A broad ranging discussion generated a good deal of interest. Below are just a few of the points that were made.

Breakoutsessionon‘Whatbehavingethicallyreallymeans’Delegates divided into mixed professional groups to have in-depth discussions and to tackle the task of agreeing some ethical principles relevant to medical education that healthcare companies, medical associations and PCOs could agree on. So, that meant getting practical on those ‘shared principles’ that had been discussed earlier in the day. Lots of ideas emerged and were captured on the meeting app to be shared with other delegates. Just a few selected ideas are listed below.

“Eachindustryhasits‘hotspots’.Healthcarecompaniesaregenerallyveryriskaware”

“Wemustdistinguishbetweenprovidersofmedicaleducationandbeawareoftheirvestedinterests”

“Usingreallife,relevantexamplecasestudiescanshowthebenefitsofworkingethically”

“Complianceisapositivethingforacompany”

“TheIFPMACodeComplianceNetworkhasbeenrenamedthe‘EthicsandBusinessIntegrityCommittee;-Notetheemphasisshiftfromcompliancetoethicsandintegrity”

“Codesareusefulbutcanbetoodetailed.Youshouldleaveroomforprofessionaljudgement”

“Theprinciplesfordigitalcommunicationarethesameasforothermedia.Wedon’tneedanothercodespeciallyfordigital.”

“Legalunderstandthelaw–butnotalwaysthereasonsbehindit!”

“Whatisethicalisdifferentfordifferentgroups.Itisimportanttobetransparentaboutwhatyouaredoing”

Medical education should be undertaken for a valid reason to fulfil an educational gap/need

Medical education should be transparent and accountable

Be transparent in your dealings with HCPs and with financial transactions (should be well declared)

Remember to be patient-centric always. The focus should be on the interest of the PATIENT

Medical education should provide fair and balanced content

Medical education should be designed to improve patient outcomes

Think of cost of a booth v how many patients' lives could have been saved with that funding. Is large footprint necessary? Focus investment in another area?

Providing education is a joint responsibility – no one group ‘owns’ it

Distinguish clearly between Medical Education vs. Promotion

Financial support to HCPs should always be made based on Fair Market Values and should be transparent

Act with integrity to contribute to a positive image of the pharmaceutical industry

Honesty and full communication between all parties

Know how to do the right thing-even though no one is watching

Clearly indicate and label the different activities and communication objectives

Ethical behaviour is owned by all

Keep education and patient needs in mind in everything we do

Session2CodesintoPractice–thelatestnewsDelegates were brought right up to date on the practicalities of the Pharma and Medical Devices codes and in particular their application in the medical conference arena. Marie-ClairePickaert(EFPIA):‘ReportingTransfersofValue’Marie-Claire sketched out the origins and implementation of the EFPIA disclosure code. Despite the overarching European approach of the EFPIA code there were still significant differences at a national level with some countries having additional legal provisions. Also, it seems that there has been far from universal support from doctors to allowing full transparency of transfers of value they have received. Interestingly in Germany Spiegel Online had processed and made available data originating from company disclosures. Companies also report the data in different ways although they are obliged to make their systems clear though publishing a methodology statement. National interpretations of data protection legislation are complicating reporting and Marie-Claire outlined the options open to companies with regard to Applicable Privacy Regulations (see visual)

AlineLautenberg(MedTechEurope):‘ImpactoftheMedTechEuropeCodesofar’With the new MedTech Europe code having been in force since the beginning of the year the IPCAA Seminar on Compliance came at an ideal time to share first impressions of its practical implementation. Aline explained the six main changes to the code governing medical device and diagnostics companies in Europe (see visual). This sector did not see transparency as the complete answer and had therefore, additionally, targeted direct sponsorship of meeting delegates. Additionally, educational grants would be made public at a European level over a single platform. Already it was clear that phasing out direct sponsorship was a long process. Also, the complexity of local realities and laws had to be considered and investment in stakeholder outreach is essential. Aline reflected that with the conference vetting system that preceded the new code by a few years, now they very rarely saw cases of non-compliance.

PanelDiscussionMarie-Claire Pickaert and Aline Lautenberg were joined by Anne-Sophie Bricca (MedTech Europe), Anna Frick (IPCAA), Annalisa Ponchia (AC Forum) and Jovana Paredes (Global Conference Organisers) to take the discussion further on code developments relevant to medical education. Delegates also contributed questions and views. Here are some snippets from the discussion.

Companyeventsaren’tvettedbytheMedTechcodesystembecausetheyareadifferentsortofevent,resourceislimitedandcompaniesself-committocomplyingwiththecriteria.TheEFPIAE4Ethicssystemalsodoesnotassesscompanyevents.

AccesstocasereportsforcomplaintsagainstPharmaisnotuniversal.SomecountriesliketheUKpublishextensivedetailsbutinmanycountriesnothingisavailableunlesspublicationisusedasasanction.Thesituationissimilarfor

MedTech.Therewasdelegateconcernbecausecasereportsareinsightfulandusefulinensuringfuturecompliance

BreakoutsessionHealthcare Companies, Medical Associations and PCOs split into separate groups to agree a list of requests for clarification on codes and positions to be put to the other two groups. They were told they could ask about anything relevant to a forthcoming congress. This was designed to highlight areas of uncertainty where the different interest groups might usefully carry on the good work and liaise after the seminar had finished. Some of the requests are listed on the next page.

Whycan’ttherebeconvergenceofcodes?Despiterequestswehavelostfocusonassociationsandindustrysectorsbuilding

codestogether.

Evenwithinasinglecompanyyoucanstillgetdifferentcode

interpretations.

Itcanbeachallengetobesureweareprovidingthemedical

educationHCPsreallywantandneed

Therearemultiplegroupsrepresentingdoctorssoitisdifficulttogetclarityontheireducationalneedsandhowindustrycansupportthose.

Therearebigdifferencesbetweencountriesinhow

medicaleducationisprovided

Companiesshouldhaveaneducationstrategy.

Transparencymayhaveledtotoogreatanemphasisonfundingnumbers.RatherthereshouldbeafocusonWHATcompaniesdoratherthanhow

muchitcosts.

‘Dear colleagues, Please clarify:’ A good description of the forthcoming conference: length, topic – Objectives, ongoing medical education or new topic, past history of same.

Are the code rules, including transparency likely to change again?

As an industry please connect with your peers at IPCAA and the taskforce.

How will the sponsorship changes affect us?

Who is deciding future venues?

How can companies become more consistent in their code interpretations?

Have you applied for CME accreditation?

Have the medical association been in contact with the local compliance body?

Can they share the overall budget and what is the surplus being used for?

Are hotels going to be booked via the PCO and are costs going to be transparent?

To deal with uncertainties we should try to get all stakeholders together to openly discuss the issues and approach to be taken, network and learn from peers and previous experiences

More Information needed in planning phase to ensure location and venue are appropriate when pitching.

Where are HCPs coming from? Does the conference comply with industry's ethical rules?

Establish a core group of industry, medical association and PCO. Industry sponsor day helps secure commitments

Sustainable: concern about huge amount of waste as most congresses are one-off.

Can we attract HCPs with financial need or younger HCPs

What are company budgets for forthcoming congresses? And how is it divided – booth, delegate sponsorship etc.

Could this congress be virtual/hybrid?

Q & A Maintaining the annual seminar’s reputation for up-to-date practically orientated information Martin Hess, the moderator, took an opportunity to pose some questions that hadn’t been fully covered to the experts and leaders. Here’s some of what they said: Will there be changes to the EFPIA codes anytime soon?

• No. The code must be implemented in each country so changes create a massive project.

• There may however be additional guidance but, for transparency topics, it wouldn’t apply immediately.

Are 5 star hotels totally forbidden? • Individual company and national code guidance may vary.

• Business hotels are acceptable in principle, boutique hotels are not.

• Some companies have a positive list of hotels that they consider acceptable.

• Hotels such as Hilton may be 5 star. It would be helpful if they decided whether they wish to be luxury leisure properties or business venues – they can’t really be both.

How will data privacy laws affect disclosure? • New European legislation is imminent.

• Meetings are taking place to determine the probable effects on disclosure and EFPIA will share information with IPCAA for distribution.

Should VAT be included in transfer of value disclosure amounts?

• There is no consistency. • Some national associations have

provided guidance. • Companies should include their

policy in their methodology note. How do we deal with the many ‘one man companies’ that have sprung up as recipients of transfers of value?

• Generally, they are considered as ‘Health Care Organisations’ but you would have to ask for consent under data privacy legislation if the individual owner is identifiable.

• Recipient rather than beneficiary should be disclosed

• Some companies have decided that they will disclose identities subject to the applicable laws

Session3:Thefutureofmedicaleducationandconferences:Whoownsmedicaleducation?SadekBeloucif,M.D.,Ph.D.(SorbonneParis-CitésUniversity&AvicenneHospital,Paris):BusinessIntegrityandEthicsinPractice.Arewelivinguptoexpectations?:Dr Beloucif described a shared approach to values-driven compliance in Medical Education Activities. In response to the question ‘Who owns medical education? his answer was the Health Care Professionals themselves with the (conscious or unconscious) help of the public, Regulatory Authorities and Industry. However, with this Health Care Professionals take on greater responsibility and they must have an understanding of this responsibility.

Sadek said that according to Sigmund Freud, there are 3 ‘impossible’ jobs: Teaching; Governing and Treating and he explained how these linked well to the challenges of medical education. Medicine is not simply a technical job. Patients want, deserve, and need attention. Medicine must have a humane response which can be learnt at the bedside, during conventions (value of human interactions) and with simulation of “ethical” challenges. PanelDiscussion.Dr Beloucif was joined by Daniel Waigl (CIRSE), Roeland van Aelst (Ethics), Alesa Lehmann Ivancic (IPCAA)and Marie-Claire Pickaert (EFPIA) to explore the topic further with input from delegates as well. Here are some of the points voiced:

Weshouldunderstandthemotivationbehindgroupsprovidingmedicaleducation.Forcompanies–isitproductcentred?

Industry’scontributionshouldnotjustbeaboutfinance

provision–Itshouldbeatruepartnership

Companieshaveadutytoeducateontheirinnovations.

Industryhasaroleinknowledgedistribution

WeareALLbiasedinonewayoranother.

Biascanbemanaged.Therecipientofmedical

educationisthedoctorbutthebeneficiaryisthepatient.

Transparencyisnotenough.WeneedtoshifttoTRUST.

ClosingKeynotespeech:WhyGoodPeopledoBadThingsProf.GuidoPalazzooftheUniversityofLausanne:‘FromYaletojail.Whygoodmanagersmakeunethicaldecisions’.This final presentation of the seminar was gripping and thought provoking leaving delegates with a useful insight into the psychology behind ethics and compliance. Prof Palazzo looked into the real life, headline grabbing compliance scandals and used learning gained from classic psychology experiments to introduce concepts that were useful to the audience in their efforts to achieve compliance and ethical behaviour in their organisations. He referred to wrongdoing involving Volkswagen, Enron, Wells Fargo, Nazism and others and drew lessons that are relevant today. Guido explained that we perceive the world through a filter and a slippery slope of incremental change can lead to ethical blindness – a ‘bubble of reality’. Context can be stronger than reason and a corporate tunnel vision can result (see visual). Factors including unrealistic targets, humiliating performance evaluation, aggressive language and competition can lead to a culture of fear. In a high-pressure environment people do what is necessary to survive. Lessons from real life examples gave sound practical support to the experimental evidence. Guido commented that the warning signs may not be noticed through the normal compliance lens.

Itwouldbehelpfultobemoreoutgoingtothepubliconthe

roleofcomplianceandethicsintheindustry.

Iwonderifindustryreallyhasawilltosupportmedicaleducation

thatitdoesn’tcontrol.

Regulationcanencouragecompaniestodotheirownsiloeducationratherthanactas

partners.

Theethicalprinciplesthatdriveallcodesarethesame.Weshouldbeabletoworkmoreinpartnershipifwedon’tconcentratetoomuchonthe

technicaldetailsofcodes

Ourcompanyhasa‘ChiefPatientOfficer’reportingtothe

CEO.

Disappointingthatonly30%ofHCPschoosetodisclosethetransfersofvaluetheyreceivedespiterecommendationsfromprofessionalbodies

We were left energised and eager to look beyond our usual perspectives on compliance. Feedback of the seminar proves once more the value of this event and we are already looking forward to our next edition in 2018. In order to get the date as soon as it is out, sign up for our e-news on www.ipcaa.org. Report written by Paul Woods for IPCAA, April 2017