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Renaissance Hotel, Brussels16 September 2009

Building a Biobanking ResearchInfrastructure For Europe

BBMRI Stakeholder’s Forum

Building a Biobanking ResearchInfrastructure For Europe

BBMRI Stakeholder’s ForumInformation/Discussion Meeting

Renaissance Hotel, Brussels

16 September 2009

CONTENTS

1. The report and its aim

2. Introduction

3. BBMRI: The Power of Many

4. Advancing biobanking through collaboration

5. Providing an ethical and legal platform

6. Talking points

1. Standardisation versus harmonisation

2. Expert centres

3. Public attitudes to industry

4. Getting back to the patient

5. Consent – to what?

6. The need for communication

7. Appendix I: Meeting Agenda

Appendix II: Evaluation Form Summary

Appendix III: Speaker’s Dinner Meeting Summary

Appendix IV: Highlighted Press Coverage


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THE REPORT AND ITS AIM

This report covers the main discussion threads atand conclusions from the BBMRI Stakeholder’sForum in Brussels on 16 September 2009, whichbrought together researchers from academiaand industry, patient organisations, researchadministrators and ethicists and lawyers from all overEurope. Since many of the points raised in thevarious sessions covered the same topics, this reportis not a chronological, blow-by-blow account. Rather,it seeks to summarise the discussions that took placeand the talking points that emerged. This report hasbeen produced by the meeting rapporteur, PeteWrobel. The report should be read in conjunctionwith the recommendations produced from acombination of the meeting evaluation forms andthe dinner for speakers; these are reproduced insummary form in the Appendices.

INTRODUCTION

One of the great strengths of Europe’s medicalresearch is that it has a large number of biobanks– organised repositories of human biologicalsamples from both healthy and ill people. Withoutthese, Europe’s medical research would be severelydisadvantaged.

Europe leads the world in biobanking, but there ismuch more to be done. Europe’s biobanks, thoughnumerous and containing a huge amount ofsamples, lack a network that would make thosesamples available to researchers across thecontinent (and beyond) who can make best use ofthem.

It was the realisation of what could be achievedthrough biobank networking that led the EuropeanUnion to designate biobanking as one of its firstEuropean Research Infrastructure projects, and todedicate €5 million to helping it get going. And soBBMRI, the Biobanking and Biomolecular ResourcesResearch Infrastructure, was born.

The first aim of the BBMRI Stakeholders Forum wasto build an international community – “a real forum”as Forum Chairman Michael Griffith put it whenopening the meeting – out of the diverse stakeholdergroups. But Griffith did not stop there: “We also wantto increase awareness of the need for networkbiobanking activities in Europe and right across theworld. And finally we want to develop support forkey activities in biobanking,” he said.

More immediate Forum objectives were to providean update of what BBMRI has achieved so far, thento provide a platform for stakeholders to raiseconcerns and questions, and finally, said Griffith, toencourage stakeholders to become activelyinvolved, not only in the meeting but going forwards.

Apart from the many points and suggestions toemerge, there was one overarching conclusion: theneed to develop sectoral subgroups of theStakeholder’s Forum. Many of the questions askedabout the involvement of patients and industry weregetting slightly different answers from differentsectors, Griffith noted in his closing remarks, andBBMRI needs to understand what those answers are.


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BBMRI: THE POWER OF MANY

With more than 200 associated groups, BBMRI is thelargest research infrastructure project in Europe.

While biobanking is one of Europe’s truly recognisedresearch strengths, said Eero Vuorio from theUniversity of Turku, Finland, like everything else inEurope the whole system is fragmented. Therepositories are all national and often too small formodern genetic analyses. “To obtain the power ofmany we have to be able to combine the resourceswe have,” he said. “This is what BBMRI is all about.”

That work has already started, and Vuoriodescribed the fruits of the preparation phase. Withmembership constantly increasing, governanceissues are becoming increasingly important. Vuoriooutlined a possible legal structure for BBMRI as aEuropean Research Infrastructure Consortium(ERIC). If successful, it would make BBMRI the firstto infrastructure to achieve the new legal statusrecently enabled by the European Council, as Jean-Emmanuel Faure from the European Commissionexplained. That would be “really exciting”, saidChristian Ohmann, Chair of the NetworkCommittee of ECRIN, the European ClinicalResearch Infrastructure Network.

Vuorio described the proposed structure as a“multisided hub and spoke”. This would have acentral secretariat, with national members eachwith their own biobanks and resource centres, andassociated partners in hospitals, universities andother service providers.

In all, BBMRI has a variety of Work Packagespreparing different aspects including projectmanagement, population-based biobanks, disease-based biobanks, biomolecular resources andtechnologies, databases and biocomputing, ethical,legal and social issues (ELSI) and funding andfinancing.

A major focus of the preparatory phase, said KurtZatloukal from the Medical University of Graz,Austria, has been to assess what resources existand what technologies are available. “We are notstarting from scratch but using previous work as abuilding block,” he said, such as the OECD’s BestPractice Guidelines for Biological Resources. As anOECD process it guarantees that what BBMRI doesin Europe will be compatible with similar initiativeselsewhere in the world.

In what Zatloukal described as “a very strong signalof commitment”, BBMRI has just launched aprototype process in which the most advancedbiobanks will try to implement basic aspects of theinfrastructure on a voluntary basis.

The general policies have already been affirmed.BBMRI will respect the primacy of national andEuropean legislation. No data on individuals will bepublicly accessible. There will be fair access forresearchers, after ethical committee approval. OECDguidelines on informed consent, infrastructure andmanagement will be implemented. BBMRI still needsto develop standard operating procedures forsample collection and processing – these, saidZatloukal, will be based the WHO IACR guidelinesfor cancer research.

Michael Griffith and Eero Vuorio

Kurt Zatloukal

“To obtain the power of many we have to beable to combine the resources we have”- Eero Vuorio


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“One size won’t fit all,” he said. “We are taking the‘adaptor’ approach, building on national andexisting approaches. We can’t combine everything,so we will combine what is suitable.”

Zatloukal introduced a subject that was to take upmuch of the discussion later on: cooperation withindustry. “Particularly important will be collaborationon quality management,” he said, working to provethe concept that the newinfrastructure will improve the wayresearch is performed.

BBMRI, he said, is looking at the ideaof “expert centres” that mightfacilitate industry’s access to datawithout giving the impression ofcommercialisation. These expertcentres would not directly shiftsamples to industry, but would carryout bespoke analyses for industry(this would also reduce requirementsfor transporting samples).

There are, though, a number of critical issues to besolved before these expert centres can be created– not least funding, and the principles aroundinformed consent from sample donors.

Funding in general remains a priority for BBMRI. AsGeorges Dagher from INSERM, France, explained,most funding for biobanks is short term. BBMRIwants to link fragmented funding sources into “afew sustainable dedicated streams”, he said. Oneidea is to ask national and regional biobanks toapply for European structural funds.

In order to further convince stakeholders andfunders, BBMRI has asked economic experts todevelop reports on its likely impact on healthcareand the wider economy. This will take into accountthe impact of coordination on national and regionalbiobanks, not just at the European level.

The discussion that followed showed that allstakeholders are united in their belief that the BBMRI

initiative is sorely needed. “We haveto share data,” said Hildrun Sundsethof the European Cancer PatientCoalition. “From the industryperspective,” said Detlef Niese fromNovartis Pharma, “BBMRI is not justlaudable, it is essential, not only in theEuropean context but globally aswell.”

Detlef Niese

“From the industryperspective, BBMRI isnot just laudable, it isessential, not only inthe European context

but globallyas well.”

- Detlef Niese


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ADVANCING BIOBANKING THROUGHCOLLABORATION

The whole point of BBMRI is to leverage the powerof many, and so it was no surprise that a session oncollaboration formed a central part of theStakeholder’s Forum.

The session began with a presentation by UlfLandegren from Uppsala University, Sweden, whodescribed BBMRI’s work in gathering the tools foranalysing biobank samples and reported on twomain achievements. First, it has created a Webportal for molecular tools, www.molmeth.org,designed as a dynamic database with modules thatcan be updated. Second, it is preparing a catalogueof protein binding agents, trying to raise bindersagainst all human proteins. The catalogue is not yetavailable, he said.

In addition, as reported later in the meeting, BBMRIhas taken several initiatives over harmonisation ofdata, including a minimum data set.

Another BBMRI Work Package is looking atdatabase harmonisation and IT infrastructure. Thechallenge here, said Jan-Eric Litton of the KarolinskaInstitute, Sweden, is that data definitions changeover time.

The underlying principles of the model have beenset: confidentiality of donors, a user-centredapproach, up-to-date technologies, flexibility,extensibility, efficient query processing – and lastbut not least “a very, very low effort to join”.

Litton’s colleagues in BBMRI are also coping withthe challenge of how to connect to existingmedical ontologies, as well as how to integratedata on phenotype and genotype – all the whiledealing with different national and regionallanguages, and the variety of ethical, legal andsocial issues.

The Work Package is looking at standardisationbut, admitted Litton, “the situation is verycomplicated in Europe”. It will take a final look inthe spring, though Litton doubted whether therewould be a recommendation on standardisation.What is industry thinking? That is, perhaps, thewrong starting point. David Cox from Pfizer, SanFrancisco, put it very directly: “Industry doesn’tspeak with one voice, not even within a singlecompany.” Instead, speaking as a scientist, he saidthere are “really interesting opportunities forpublic–private collaborations, and challenges too –but not insurmountable ones”.

Although the public does not normally associateindustry with open access and altruism, things arechanging. Above all, said Cox, “the pharmaceuticalindustry needs to engage the broader scientificand healthcare community in a more collaborativefashion in order to achieve its goals.” Why?Historically, he said, there has been poor alignmentof molecular understanding to clinical need.Industry starts with clinical outcome, he said. “Butyou can’t start with the clinical outcome unless youhave the samples and patients you need, and thereisn’t enough of this in companies.”

Ulf Landegren, Jan-Eric Litton

David Cox


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For Cox, there are several challenges. They includehow to link biobank materials to multiple sourcesof healthcare information while protecting allstakeholders. “It’s the biggest missing part rightnow,” he said. “You can have the biggest collectionbut if it’s not linked with epidemiologicalinformation it’s not that useful scientifically.”

And then there is the issue ofreconciling altruism and opencollaboration with intellectualproperty and profit. The solution, hesaid, is collaboration at theprecompetitive stage: “Focus onthat and work as a true scientificand intellectual partner.”

Andrew Lyall, project manager ofELIXIR, Cambridge, UK, warned thatCox and his industrial colleagues“have work to do to persuadecompanies that this is the right way”.The way forward said Cox, is for scientists – inindustry and academia – to lead by example: “Set uppre-competitive collaborations and show how itworks,” he said, rather than waiting for companies toset policies.

Finally, Cox warned academia against looking atindustry merely as a source of cash: “Private sectorcontributions of knowledge and data are moreimportant than money,” he said.

One knowledge contribution that private industrycould make might be in how to coordinatebiobanks internationally, to judge from the

contribution of Julie Corfield from AstraZenecaR&D, UK. The company decided in 2000 that therewas “significant value in globalising our biobankingactivities”, she said. The challenges AstraZenecafaced in international collaboration, and in seekingto adopt standard categorisations, are not unlikethose faced by BBMRI.

Later, in the final panel session,Georges Dagher explained whatconcrete steps are being takentowards collaboration betweenacademia and industry, including aclosed workshop in Paris in Octoberbringing together people fromindustry and BBMRI to discuss theoutline of the new expert centres, aswell as what services and facilitiesthe consortium can provide. Thiswill be followed by an open meetingon biobanks on 16 December, also inParis, a big part of which will focus

on expert centres. Dagher also invited industry tocontribute to the White Paper that BBMRI iscontributing to the European Parliament.

“Industry doesn’tspeak with onevoice, not evenwithin a single

company.”

-David Cox


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PROVIDING AN ETHICAL AND LEGALPLATFORM

PATIENTS

The point of departure for any discussion aboutethics has to be the patient, and Fabrizia Bignamifrom Eurordis, the European Organisation for RareDiseases, who spelled out what patients expect:“That BBMRI will be the place where internationalharmonisation of biobanking practices is achieved.And we would like it to actively involve patients inthe governance of any future biobank infrastructure.”

That infrastructure, she said, should be “the referencepoint for biobanking in Europe and beyond”, so thatprofessionals and patients are easily attracted.Patients, she said, can help in awareness campaigns,but they are “ready for more direct involvement”.This should be systematic, “not just two or threepeople in a Stakeholder Forum”, she said.

Her view was echoed by Neil Formstone, a patientrepresentative from the Wales Cancer Bank, wherepatients were involved in the biobank’s governanceright from the start. “You have to accept that wehave to be in at the very beginning of the process.No faits accomplis.” he said, “Patients don’t expectyou to do everything they ask, but they do wanttheir opinions to be listened to and taken intoaccount when taking a decision” he added.

“What I would say to the researchers is that we arewilling to help,” said Rod Mitchell from theEuropean Federation of Crohn’s & Ulcerative ColitisAssociations. “We don’t have a lot of money but weare passionate about what we are involved in.”

ACCESS

Once a biobank is established, how does it decidewho should get the samples? That was the questionaddressed by Martin Yuille from the University ofManchester, UK, and an associate coordinator ofBBMRI (though speaking in a personal capacity).Yuille put forward the concept of a “fair accesspolicy” to ensure that annotated human samples aretreated not as commodities but as what he called a“shared national resource”.

Access, said Yuille, needs to be driven by science.“You can’t treat all stakeholders as having equalrights. You are doing all this for the benefit ofscience; if two parties argue [over access tosamples], you have to work out which is the bestresearch.”

Fortunately, no one needs to re-invent the wheelover fair access. UNESCO has already done it. “Fair”means “fair to everyone”: to the donor, the collector,the researcher, the biobank, and to various legalentities. For the donor, said Yuille, it means “first of allprivacy and confidentiality”. And all deposits andwithdrawals must be backed with evidence ofresearch ethics committee approval.

Alastair Kent, Erik Tambuyzer, Fabrizia Bignami, Neil Formstone

Martin Yuille

““Fair” means “fair to everyone”: to thedonor, the collector, the researcher, thebiobank, and to various legal entities.”

- Martin Yuille uu


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HARMONISATION

The complexities – and the importance – of theethical, legal and social issues (ELSI) are such thatBBMRI has a Work Package dedicated to them.BBMRI has as an explicit remit to develop aninfrastructure properly embedded into EuropeanELSI frameworks. And that, as pointed out byJasper Bovenberg from the Legal PathwaysInstitute for Health and Bio-Law in the Netherlands,raises the question of what “European” is in theethical context.

However, if harmonisation is easier thanstandardisation when it comes to databases, it stillseems to be a step too far in ethics. “How can wetalk about ethical harmonisation in Europe whenwe have just faced the stem cell dispute?” askedErik Tambuyzer from Genzyme, Belgium. “It wouldprobably be more adequate to speak about anequivalent high level of standards overall,” addedSilvia Matile-Steiner from F. Hoffman-La Roche,Switzerland.

ETHICS

Given such a wide possible field, where doesBBMRI focus? On consent, access and feedback,privacy and harmonisation, said Bovenberg. Itamounts, he said, to an ongoing process “driven bythe interplay of many different voices”.

One way of easing ethical issues could be to developbest practices on access to biobanks so thatresearchers might have a smoother passage whenseeking ethical committee approval, suggested KarlFreese from DG Sanco, European Commission. Theproblem, of course is that ethics committees havenot agreed on common standards and practices, anddo not look likely to any time soon. That, saidZatloukal, is why BBMRI is considering setting upone ethics committee within ERIC to deal with allprojects going through it.

But ethics is not all about hurdles. Alastair Kentfrom the Genetic Interest Group, UK, took apositive view. “When you look at publicparticipation in research, it is important to givepeople the information to enable them to make adecision to be involved… Too often ethics are seenas a way of stopping scientists doing things.” Hisplea: “Start using ethics as a tool to makeprogress.”

A key issue is public opinion. In order to assess it,BBMRI has held focus groups in Austria and theNetherlands, as well as working with theEurobarometer survey. The key findings are thatthere appears to be a broad lack of knowledge andunderstanding of biobanks, and that peoplebecome more positive once they know more.

Lea Harty, Silvia Matile-Steiner


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THE LAW

When it comes to law, the current situation in theEuropean Union is a patchwork, said Bovenberg.“But top-down EU harmonisation is problematicand time consuming. The alternative is to build onexisting expertise.” BBMRI is doing this bydeveloping a legal platform using Wiki technologyto unearth what evidence is out there. “Wikiprovides BBMRI with a practical tool to uploaddocuments,” he said – directing people to the Wikiplatform at www.legalpathways.eu.

One issue that should not present legal hurdles isthe movement of data and samples. “BBMRI is aEuropean Community resource,” said Bovenberg.“That opens the way to a certain approach totackling the legal patchwork problem. We can tryto harmonise and it will take years, but if you haveestablished home state compliance you can shiftyour data across Europe. As long as there arecommon minimum standards met there is a freeflow of data and samples.”

TALKING POINTS

1: STANDARDISATION VERSUS HARMONISATION

At the heart of any database is the definition of thedata being held – and with biobanks having grownup over a period of up to 50 years, dealing withdifferent diseases and different populations,definitions vary. What, then, is the potential forBBMRI to standardise definitions across Europe?

Take care, was the response from stakeholdersfrom industry and academia. Detlef Niese warnedagainst clear categorisations: “They all assumethat our disease taxonomy is accurate,” he said.“Pathology is descriptive at the moment, we needto move to the molecular basis.” Martin Yuillewarned that standardisation is a very longprocess.

Definitely harmonisation not standardisation, saidDavid Cox. “You can’t put everything together butyou can get a lot out,” he said, adding, “If you wantan international group you won’t get everyone toagree to one standard.”

“You have to harmonise rather than standardise,with the goal of interoperability,” said Barend Mons,a biologist-turned-bioinformatician involved in theConcept Web Alliance, a global network buildingbottom-up standards across languages, acrossjargon.

Silvia Matile-Steiner agreed. Her company,F. Hoffman La Roche, has biobanks around theworld, in both pharmaceuticals and diagnostics.“We have been working on harmonising them,and have come across all the issues that havebeen mentioned during the day. We found that itis impossible to make a policy that is absolutelyidentical all over the world, because users have tocomply with local regulations.” Her solution: thestandards should be equal everywhere as far aspossible, and there, a policy can give the basics,but we must be aware that local legislation canadd additional or different requirements. Aboveall, more consistency is needed in the processesof informed consent and ethics committeeapproval.

Neil Formstone, Jasper Bovenberg

“BBMRI is a European Community resource.”

- Jasper Bovenberg uu


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2: EXPERT CENTRES

One of the biggest challenges facing BBMRI is howto give industry access to samples and data. Withoutthis, there is little likelihood of the network leading tonew treatments for patients. Yet if surveys are to bebelieved, the public is wary of giving samples thatwill be used by industry. “People are relatively willingto give samples to biobanks,” saidEero Vuorio. “But when you talkabout giving samples to industry thepercentage drops dramatically.”

But as Vuorio pointed out, academiadoesn’t develop drugs: industrydoes. So how to deal with this Catch22? One solution proposed byBBMRI is expert centres underBBMRI control to which sampleswould be shipped and then analysedon behalf of companies. Industrialstakeholders were clearly intriguedwith the idea, and could see benefits.

The idea also looks somewhat like the rare diseasecentres of reference, said Karl Freese from theEuropean Commission, adding that these are alsoimportant as they are a legal environment linked topatient rights in cross-border healthcare. “You mightfind it useful to link up with the rare diseasecommunity,” he said.

Lea Harty of Pfizer, Connecticut, saw expert centresas a mechanism for making the most use of aprecious resource. What, though, would be thebusiness model? And were there any more details ofthe operating model? Also from Pfizer, David Cox

was unsure of the concept as described. “Withexpert centres, I wouldn’t see people doing it forindustry but industry being a partner.”

In fact, BBMRI is still at the early stages ofdeveloping the concept, and now wants to sit downwith industry and discuss how it might work whileguaranteeing value for industry. “What we can

foresee is that we have to ensureconfidentiality for industry and thatindustry can exploit the intellectualproperty for product development,”said Kurt Zatloukal. What matters, hesaid, is that the results of the analysisare returned to the public.

Emmanuel Chantelot from EuropeanBiopharmaceutical Enterprises,Belgium, was looking for someclarification. BBMRI, he said, wastrying to do two things here: on theone hand pulling together biobanks

across Europe to share benefits; and on the otherhand to provide a service offering to SMEs and largepharma. “At this stage it is not yet crystal clear howBBMRI as an entity can deliver on both, different,goals,” he said.

3: PUBLIC ATTITUDES TO INDUSTRY

There is a general view, backed up by some opinionresearch, that the public is wary about biobanksworking with industry. “As a Brussels dinosaur I havesat through long debates about human material. Ifthe general public gets a notion that it is for profit,you have lost everything,” said Hildrun Sundsethfrom the European Cancer Patient Coalition.

“I don’t think it is wise to stop here and just acceptthat we have difficulties in communicating andunderstanding,” said Detlef Niese. “It’s a two-waystreet. There are examples where companies haveplaced some of their material in the public domain,such as breast cancer. We should look at theseexpert centres [see Talking Point 2] not as ways ofhiding the relationship, but do it in the bright sunlightand develop absolutely transparent relationships.”The way around the problem, said Martin Yuille, is

“We should look at

these expert centres

not as ways of hiding

the relationship, but

do it in the bright

sunlight and develop

absolutely transparent

relationships.”-Detlef Niese


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collaboration. What matters then is the terms ofcollaboration between scientists, whether they arein a company or not.

Among patients the word “biobank” often raisesmore worries than concerns, said patientrepresentative Valentina Bottarelli from Eurordis.She too made a plea for clarity and transparencyabout the aims and objectives of biobanks.Patients want results from what happens with theirresearch, she said.

It is not clear, however, to what extent industry’suse of samples actually deters potential donors.Neil Formstone, a patient representative from theWales Cancer Bank, UK, declared thatpharmaceutical company involvement is simply nota problem. “It has never been an issue with anyperson [donating],” he said. But, he added, “Whenyou see pharma companies making billions ofpounds of profits, you’ve got to communicate thewhole process to the public.” His approach was oneof frankness: “We are honest. We say that if yoursample goes to a pharma company and theymanage to create a therapy that it will not be intime to help you.” Use patients to get thesearguments across, he said.

4: GETTING BACK TO THE PATIENT

To what extent can or should biobanks get back todonors if it appears that the samples they have givenindicate that they are at risk of a particular disease?

It’s a difficult subject, with no clear ethical or legalguidance. Nor is it even clear what should be fedback to patients. Most of the time we don’t knowwhat the information we get from sequencingpeople’s genes means, said David Cox: “You needtrials to know whether this variant results in thisoutcome, and more importantly whether you cando anything about it.”

As Jasper Bovenberg explained, the law differs inevery jurisdiction. But he said that at internationallevel there is a growing tendency to stipulate thatresearchers have an obligation in general to feedback results to patients. That obligation can be

quite specific. “In the Netherlands, you could makea case that if the information relates to a treatablecondition that there is an obligation on theresearcher to contact the patient,” he said.

There is a big grey area where there is informationthat could be of interest to the participant. And,said Bovenberg, it could be very costly to go backto thousands of patients every time you have afinding. But, he said, there should be an obligationto at least have a policy on when to feed back andhow. Indeed, a survey in Italy indicated that all thepeople who could understand the information theywere given said yes to being contactable in thefuture regarding use of their samples.

Patients, it appears, do want to know. StephenMacMahon from the Irish Patients Association, saidthat he was still not convinced as a patient advocatethat patients cannot be informed if somethingshould be identified. Neil Formstone said that ifpossible, yes, new information should be fed backto patients – but it cannot be promised. “You’ve gotto be real with people,” he said.

Barend Mons, George Dagher


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5: CONSENT – TO WHAT?

Informed consent continues to attract muchdiscussion, especially from the patient perspective.Biobanks draw a distinction between blanketconsent (covering anything) and broad consent(covering most uses), and the OECD guidelines gofor broad consent. The Eurobarometer surveyfound that although the issue ofanonymity is considered moreimportant than consent, there isopposition to broad consent forms.

But as Alastair Kent pointed out,public attitudes are inconsistent:“They think it commonsense thatbiobanks should share and network,but they don’t like giving broadconsent.” And in practice, said NeilFormstone, there is no problem: theexperience at the Wales CancerBank is that 98.7% of patients agreeto consent when approached before surgery, and99.5% after surgery.

The answer, perhaps, is to involve patients andhealthy people much more in the process ofresearch. Martin Yuille outlined a project inManchester, UK, that aims to change the way inwhich consent is obtained from citizens in relationto research. Citizens will be asked to opt in toparticipating in medical research in a general way.This separates consent to research from consent totreatment. The result, he said, will be that citizensbecome advocates of and participants in research.“New types of research would be enabled because

you would be in touch with people you couldcontact for further information.”

Certainly, there was no support at the Forum forthe idea of “automatic sampling”, that is, a legalframework where the presumption is that patientsconsent to their samples being used for biobankingunless they explicitly say otherwise. Avril Daly,

speaking for Retina Europe, alsopointed to the responsibilities ofprofessionals to protect patientswith serious problems who maygive samples without thinking.Hildrun Sundseth called for a “verycomprehensive policy”, adding thatsince information can affect thewhole family, consent “is not onlythe patient’s decision”.

Clarifying consent procedures maymake things easier going forwards,but that still leaves the question of

how to deal with all the samples collected underearlier consent regimes. As Lea Harty explained,“We have been doing biobanking for just ten years,but even in that time we have seen large changesin the ethical landscape and the kinds of researchbeing done – so many of the older consents maybe limited.”

A final issue was raised by Martin Yuille: the ability towithdraw consent once given. “We haven’t been ableto implement this yet,” he said, “but we feel it is veryimportant.”

Eibhlin Mulroe, Avril Daly

“More or less no one

in Europe knows what

a biobank is.”-Herbert Gottweis

Herbert Gottweis


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6: THE NEED FOR INTERACTIONWITH THEPUBLIC

“More or less no one in Europe knows what abiobank is.” That, said Herbert Gottweis, Universityof Vienna, is one result of the research BBMRI hascarried out into public attitudes to biobanking.“There is a huge communications job to be done,”said Eibhlin Mulroe from IPPOSI, Ireland.

As Gottweis pointed out, most people in Europe arenot patients and don’t see themselves as patients.“But they are there, and they are voters, and they canvery easily get upset about things,” he said. Part ofthe challenge, as noted elsewhere in the Forum, isthat Europe is so diverse.

“There are substantial inconsistencies when it comesto public opinion,” Gottweis said. But one point iscrucial: given that all the groups surveyed said thatthey did not know about biobanks, they developtheir ideas on the individual questions as they mightdo in a discussion. “So public opinion is neverconsistent. Typically its very contradictory,” he said.

One strategy being pursued by BBMRI is to create aWeb 2.0 structure that will enable not justcommunication but also interaction with Europeanpublics.

Closing the meeting, Forum Executive ManagerDerick Mitchell pledged BBMRI's commitment tofirmly establish the role of stakeholders as part of animplemented BBMRI network. "In order to build atrusted relationship with stakeholders, we need toput them at the heart of the decision makingprocess, and this meeting has signaled the beginningof that relationship".

1. BBMRI Stakeholder’s Forum should

develop the following working

subgroups

a. Patient Group Stakeholders –

“The Patient Role”

b. Industry Stakeholders –

“Pre-Competitive Research”

c. Biobanking Community –

“Data Harmonization”

2.BBMRI Stakeholder’s Forum should be

incorporated into a transparent

communication strategy towards the lay

public and patients for addressing

public perception and societal benefits.

3.Any Public-Private cooperation

between BBMRI and industry needs to

be fully defined to protect public

interest and needs.

4.BBMRI should establish an ethical

review committee

5.The definition and advisory role of

“stakeholders”, within BBMRI

governance, needs to be clarified.

6.BBMRI should develop closer links with

the following groups

a. EU e-health

b. The publishing community

c. The Innovative Medicines Initiative

(IMI)

Derick Mitchell

MAIN RECOMMENDATIONS

The following recommendations were producedfrom a combination of Appendix II and III.


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SESSION 1: BBMRI – THE POWER OF MANY

9:00am This session focused on BBMRI preparatory phase goals and achievements andelaborated on the sustained funding and financing solutions for this key resource.Future interactions with clinical, industry, academic, patient and user stakeholders werealso highlighted.

Session Chair: Christian OhmannEuropean Clinical Research Infrastructure Network (ECRIN)

Panel Chair: Emmanuel Chantelot

European Biopharmaceutical Enterprises (EBE)

TIME PRESENTER TITLE OF TALK

09:05am Jean-Emmanuel Faure “The European Union actions

DG-Research, European Commission for Research Infrastructures”

09:25am Eero Vuorio “BBMRI: Preparation Phase

University of Turku, Finland and European Context”

09:45am Kurt Zatloukal “BBMRI: Towards Implementation”

Medical University of Graz, Austria

10:05am Georges Dagher “Funding and Financing”

INSERM, France

10:15am Markus Perola “Population-Based Biobanks

National Public Health Inst., in a Global Context”

Helsinki, Finland

10:25am Thomas Meitinger “Overview on Participation of

HelmholtzZentrum, Disease-Related Biobanks”

München, Germany

10:35am PANEL AND OPEN FORUM DISCUSSIONPanelists: Chairs and Speakers from Session 1 andDetlef Niese, NovartisHildrun Sundseth, European Cancer Patient Coalition

SESSION 2: ADVANCING BIOBANKING THROUGH COLLABORATION

11:30am The construction of the BBMRI network will facilitate technological platforms in areassuch as biological resources, high-throughput techniques, bioinformatics and otheradvanced analytical tools for data analysis. Such platforms will also foster collaborationbetween academic, clinical, patient and industry stakeholders leading to thedevelopment of new diagnostic, prognostic, and therapeutic tools for human diseasesand their variants

Session Chair: Jean-Jacques CassimanEuropean Society of Human Genetics (ESHG)

Panel Chair: Frank WellsEuropean Forum for Good Clinical Practice (EFGCP)

APPENDIX I: MEETING AGENDA


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11:30am Ulf Landegren "Gathering the tools for

Uppsala University, Sweden analysing biobank samples"

11:40am Jan-Eric Litton “Database harmonisation

Karolinska Institute, and IT infrastructure”

Stockholm, Sweden

11:50am David Cox “International Biobanking:

Pfizer, Biotherapeutics and Opportunities and challenges for

Bioinnovation Center, private-public collaboration”

San Francisco, CA

12:10pm Julie Corfield “Collaboration in Biobanking:

Astrazeneca R&D, Charnwood, UK sustaining R&D activities of the

Pharmaceutical Industry”

12:30pm PANEL AND OPEN FORUM DISCUSSIONPanelists: Chairs and Speakers from Session 2 andBarend Mons, The Netherlands Bioinformatics Centre (NBIC)Valentina Bottarelli, EURORDISStephane Berghmans, European Science Forum

SESSION 3: PROVIDING AN ETHICAL AND LEGAL PLATFORM

2:00pm BBMRI aims to provide a platform for ethical, legal and societal guidance onbiobanking in general. This session included an evaluation an evaluation of theEuropean ethical and legal frameworks and will endeavour to identify solutions on howto implement a pan-European infrastructure. Representatives from all stakeholdergroups discussed the possible impacts of the BBMRI initiative on each group.

Session Chair: Alastair KentGenetic Interest Group, European Genetic Alliances Network (EGAN)

Panel Chair: Erik TambuyzerGenzyme Corp.


2:00pm Fabrizia Bignami “Biobanks:

EURORDIS and Patients' Role and Expectations”

The EuroBioBank Network

2:20pm Martin Yuille "Fair access: a practical approach to

University of Manchester policy on access for European biobanking"

United Kingdom

2:40pm Neil Formstone “Biobanks:

Patient Representative, Patients’ Inputs and Outcomes”

Wales Cancer Bank


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3:00pm Jasper Bovenberg “BBMRI:

Legal Pathways Institute Ethical, Legal and Societal Issues”

for Health and Bio-Law,

The Netherlands

3:20pm PANEL AND OPEN FORUM DISCUSSIONPanelists: Chairs and Speakers from Session 3 andLea Harty, Pfizer Global R&D, CT, USASilvia Matile-Steiner, Hoffman La Roche

SESSION 4: STAKEHOLDER’S OPEN FORUM PANEL

4:00pm The BBMRI Stakeholder’s Open Forum Panel has been assembled from a combinationof meeting speakers and stakeholder representatives. As part of a comprehensiveprocess of dialogue and exchange of ideas, this panel engaged in a 60-minute openforum to allow for interactive communication and engagement with relevantstakeholders.

Session Chair: Michael GriffithChair of BBMRI Stakeholder’s Forum

Panel Chair: Eero VuorioUniversity of Turku, Finland

4-5pm PANEL AND OPEN FORUM DISCUSSIONForum Panelists:Tobias Schulte in den BaumenPublic Health Genomics European Network (PHGEN)Jean-Emmanuel FaureDG-Research, European CommissionKurt ZatloukalMedical University of Graz, AustriaJeanette Ridder-NumanMinistry of Education, Culture and Science, The NetherlandsRod MitchellEuropean Federation of Crohn’s & Ulcerative Colitis Associations (EFCCA)Herbert GottweisUniversity of ViennaLea HartyPfizer Global R&D, CT, USANeil FormstonePatient RepresentativeErik TambuyzerGenzyme Corp.

5:00pm CLOSING REMARKSDerick MitchellExecutive Manager, BBMRI Stakeholder’s Forum


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The following answers are in order of abundanceof responses received.

Q1: What was the best thing about thisStakeholder’s meeting?

1. Networking with wide variety of stakeholdergroups and experts together in an openenvironment – very rarely available otherwise.

2. Excellent Stakeholder Representation.3. Update on BBMRI progress and current status.4. Hearing different perspectives and learning

about how BBMRI is addressing its keychallenges.

5. The quality of information, exchange ofknowledge, debate and discussions frompanels.

Q2: What do you think are the main benefits ofBBMRI?

1. Harmonization and coordination of EuropeanBiorepositories and Biobanks with emphasis ondata harmonization.

2. To overcome fragmentation and become aone- stop-shop for Biobanks.

3. To turn sample collections into effectivebiobanks who share resources

4. A common European approach to makingsamples + data available all over Europe inorder to foster innovative medical research.

5. Collaboration across member states,particularly in area of Rare Diseases.

Q3: What are your main concerns about BBMRI?

1. Public-Private Cooperation.2. Academic research is over-represented.

Industry has had no involvement thus far, andthere is not enough patient involvement.

3. A real risk of lack of focus when bringingmultiple threads of discussion together – inneed of an ethical issues overview watchingbrief.

4. Lack of transparency, no clear communicationstrategy for lay public and patients in particularfor addressing public perception, societalbenefits. Need to partner with the generalpublic, not just patients.

5. Preparing and implementing standardprocedures aimed at harmonization.

Q4: Have you any advice for how we canimprove our forum?

1. Make more subgroups with industry, patients,etc. - like in P3G.

2. PP cooperation needs to be fully defined toprotect public interest/needs/welfare.

3. Need a communication strategy built into theBBMRI to communicate progress to publicmore clearly.

4. Need more dissemination of BBMRI activitiestaken through local and national medicaldoctor associations, university medical schools,research institutes.

5. Cooperation with industry will only beimproved project by project – should start jointprojects in PPP.

Q5: Are there any issues which you requirefurther clarification on?

1. Academic-Industry cooperation2. How will the prototype be developed?3. How can donors directly benefit?4. Patient Involvement.5. How will BBMRI handle the sample release

processes which are part of each biobank whenBBMRI approves a project application forsamples from these biobanks

APPENDIX II: MEETING EVALUATION FORM SUMMARY


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September 15th, 2009

AGENDA

Dinner discussions

Summary of Dinner Discussions

1. The rapid implementation of BBMRI is seen as animportant signal for the success of the ESFRIroad map. To some extent BBMRI is seen as anicebreaker facilitating the implementation ofother biological and medical sciences researchinfrastructures.

2. The model of expert centres was extensivelydiscussed and was highly appreciated by allparticipants. Several research collaborationswith the industry are positioned in a pre-competitive environment and would allowwonderful opportunities to share the researchdata generated with the public domain. Thiswould create an important added value.Upcoming meetings of BBMRI and industryrepresentatives should help specify the bestmodels for public-private partnerships in thecontext of BBMRI. Also, the internal and externaldifficulties of data harmonisation were discussedin the context of pharmaceutical companies.

3. The importance of BBMRI developing closer linkswith EU e-health was discussed. This area ofactivity has to deal with standardization /harrmonisation and confidentiality / security ofhealth records across Member States.

4. The need for a coherent BBMRI funding andlegal policy in which should be communicatedto the general public and to policy makers wasemphasized during discussions. The lack of

proper communication between policy makersand scientists was seen as a major obstacle inthis regard.

5. BBMRI’s efforts in adopting the ERIC legal statusare highly appreciated by the EuropeanCommission particularly because BBRMI couldbe one of the first infrastructures to demonstratethe benefits of this new legal entity. In order toachieve agreement on the statutory seat of ERICit was recommended that the Research Ministerof the hosting country officially expresses his

interest.

APPENDIX III – SPEAKER’S DINNER MEETING SUMMARY

Kurt Zatloukal, Robert-Jan Smits, Michael Griffith

Welcome Michael GriffithChair, BBMRI Stakeholder’s Forum

Introduction Robert-Jan SmitsDG-Research, European Commission

BBMRI Kurt ZatloukalChair, BBMRI Coordination Unit


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http://www.nature.com/nature/journal/v461/n7263/full/461448a.html

Biobanks need pharma

Which is why Europe’s citizens need reassurance that their donationswill be in the public interest.

Medical geneticist Thomas Meitinger remembers when biobanking was a simple craft. As a postdoc thirty years ago,he travelled from Oxford to Yugoslavia to track down a family afflicted with a rare disease causing blindness. Thefamily listened enthusiastically as he explained his research over a fish dinner. He returned with blood samples andover the next decade used them to identify the single gene defect that caused the condition.

Biobanking — collecting tissue or body fluids alongside medical information — is now a large-scale affair. Genomicsallows geneticists to track down not just the single genes that convey a strong risk of disease, but also the many low-risk genes associated with the diseases that kill most of us, such as cancer, diabetes and cardiovascular disease. Butthese very weak gene signals can be picked up only in studies of large populations of up to hundreds of thousands ofpeople.

Europe leads the world in biobanking. It has more than 400 biobanks, some involving hundreds of thousands ofdiseased and healthy individuals. It is now seeking to make the most of that resource: the European Commission isfunding a preparatory study aimed at linking the biobanks into one distributed infrastructure. Now Meitinger, whocurrently works at the Institute of Human Geneticsin Neuherberg, Germany, and the rest of the scientific consortium driving the effort, called the Biobanking andBiomolecular Resources Research Infrastructure (BBMRI), must find stable funding for the project and arrange accessfor the scientific community.

That’s a lot of tough challenges at a time when the general public is sensitive to any issue involving genes andbiological material. Key concerns in biobanking are those of anonymity and whether true informed consent can begiven by individual donors now too numerous to be educated over dinner.

Another, potentially incendiary, issue is whether the pharmaceutical industry should have the same access rights tobiobanks as academic researchers. Europe’s citizens could easily turn against biobanking if they start to feel exploitedfor financial gain. The BBMRI must accommodate industry while avoiding such a backlash.

Biobank resources may be fundamental to understanding the molecular bases of common complex diseases, but it isthe pharmaceutical industry that will develop the treatments for such ailments. Companies generate their own biobanks,but these cannot reach the scale necessary to move forward. Industry wants access to large public biobanks, and theBBMRI recognizes its obligation to facilitate new medicines. The consortium hopes that relentless outreach andappropriate control of banked materials will achieve this without antagonizing the public.

At the consortium’s first stakeholder meeting last week, patient groups declared that they don’t care who gets holdof their diseased tissue “so long as it is out of our bodies and being used to do clinicalgood”. But the large majority of healthy donors will need more persuading that profit-making industry should getaccess to their voluntary tissue donations.

The concept of expert centres, unveiled by the BBMRI at the meeting, should help. These would do all the molecularanalyses on material requested for an approved study and provide data only to clients. Donors’ material would notmove out of the biobanking infrastructure, and data would be stored for re-use in other studies, so industry couldnot gain exclusive rights.

Industry must also be prepared to give something back, in the form of access to its own biobanks and their richlyfinanced expertise. Research departments across all companies believe that biobanks and the molecular informationgenerated from them are outside the competitive realm, but their managers tend to be wedded to secrecy. Somanagers must be persuaded to follow their researchers’ instincts, before the public gets the idea that industry isthere only to exploit, gets deterred from donating, and the whole enterprise becomes tainted with distrust.

© 2009 Macmillan Publishers Limited. All rights reserved

APPENDIX IV – HIGHLIGHTED PRESS COVERAGE

EDITORIALS NATURE|Vol 461|24 September 2009


22 |

Published: Thursday 17 September 2009

A pan-European biobanking initiative looks set to become the first research consortium to benefit from VAT-free status under a new regulation agreed by EU leaders in May.

Background

Collections of biological materials such as DNA, tissues, cells or blood can be stored in biobanks to help scientistsconduct research into cures for diseases. Samples are usually anonymised or coded so that researchers cannotidentify the individual whose tissue or blood they are working with. There are at least over 100 biobanks dottedacross Europe, but the system for collecting and using the material varies significantly from country to country. In2008, the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) was set up, with an initial budgetof €5 million to improve coordination between biobanks.

The BBMRI is one of 44 initiatives funded by the European Strategic Forum on Research Infrastructures (ESFRI),supported by the EU's Seventh Framework Programme (FP7). Its preparatory phase was initially envisaged as lastingtwo years, although this may be extended. In May, the European Council adopted a regulation to treat this type ofresearch infrastructure in the same manner as international organisations for taxation purposes. So-called EuropeanResearch Infrastructure Consortia (ERIC) will benefit from a VAT exemption as well as reduced administrative costs.The group of biobanks would also be exempt from excise duty if it is established as an international agency underthe European Research Infrastructure Consortium (ERIC) scheme, and could employ staff in several member statesunder a common contract. This would allow greater mobility for employees who could move between offices whileretaining health and social security benefits. Biobanking experts, gathered in Brussels yesterday (16 September),said Europe is a world leader in the field but needs a more cohesive network of biobanks in order to attractpharmaceutical firms, some of which have moved to Asia in recent years. Kurt Zatloukal from the Medical Universityof Graz, Austria, who coordinates the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) saidthe group aims to harmonise standards in the collection and usage of biomaterials. "Access to biological materialsis essential to exploiting technology for the benefit of academia and the pharmaceutical industry. However, we neednew resources and a more structured infrastructure to overcome current fragmentation and inefficiencies," he said.

Need for common standards

Zatloukal noted there are currently no common standards for using DNA, tissue and blood samples, and that qualityvaries significantly across Europe. Applying a "one-size-fits-all" model will not work, he said, adding that Nordiccountries have a tradition of collecting biomaterial, while others are suspicious of sharing personal data with theauthorities. The European group is likely to implement new OECD guidelines on the collection of biomaterials,marking its intentions to lead on a global scale. To qualify for ERIC status, a pan-European agency must anchor itselfin a single member state. Austria and the Netherlands have both expressed an interest in hosting the BBMRI, but thefinal decision will have to be worked out at ministerial level. Eero Vuorio, from the University of Turku in Finland, saidelevating the biobank initiative to ERIC status will mean starting with a small group of the most advanced memberstates, with others joining later. The consortium already has registered over 50 participating biobanks as well asmore than 200 associate members from the EU, Norway, Iceland, Switzerland, Turkey and Israel, but not all of thesewill be part of the ERIC. The move comes as the EU executive is beginning the groundwork for its next major researchfunding plan, the Eighth Framework Programme for Research (FP8), which will replace the current plan in 2013. Amajor boost in support for Europe's biobanks is expected as policymakers are keen to build up capacity in an areaseen as a future growth area.

Positions

Michael Griffith, chairman of the BBMRI Stakeholders' Forum, said the network is moving from the preparatoryphase towards implementation and must now involve patients, industry, clinicians, funding agencies and end-usersin the process. He said it is important to listen to their concerns and provide more information to the public.

Eero Vuorio from the University of Turku in Finland said the more that people understand about biobanking, themore they accept it.

http://www.euractiv.com/en/science/eu-biobank-benefit-vat-exemption/article-185516

EU 'biobank' first to benefit from VAT exemption


For more information on activities of theBBMRI Stakeholder’s Forum:

Contact [email protected] or visit www.bbmri.eu

www.bbmri.eu

bbmristakeholder’sforumnew.bbmri-eric.eu/wp-content/uploads/2016/07/... · 9/16/2009 ·...

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