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ECONOMICREGULATORYETHICAL & SOCIALPATIENTS PUBLIC COMMUNICATION

NA report on the nanomedicine economic, regulatory, ethical and social environment

• Patients’ Needs – Our research showsthat patients want nanomedicine and they want toknow more about it from reliable sources. TheEuropean Commission, national governments, andtrade and research associations all have a role toplay in ensuring dialogue with, and informationprovision to, patients.

• Ethical and Societal Aspects -Ethical engagement with nanomedicine needs tobegin with the very concept of 'nanomedicine', aword that now groups diverse research activitiestogether. Nanomedical researchers, physicians,patients, and policy makers will all benefit when, onthe basis of philosophical and social analysis, theprogramme and purpose of nanomedicine arebetter understood and more clearly defined.

• Economic Impact - Reliable data isneeded to predict the impact of nanomedicine onhealthcare costs and benefits, and market growth.This information is required to enable the EMEA tomake decisions on early interventions and nationalauthorities to make reimbursement decisions.

• Regulation - A proactive regulatory systemis required that ensures better coordination andharmonisation of regulatory procedures, earlydialogue with users and stakeholders, and takesaccount of the economic cost implications ofregulation. Given its recently enhanced role, itseems reasonable to suggest that DG SANCOshould take the lead in encouraging European levelregulatory bodies to achieve this aim. At MemberState level, national governments shouldencourage national regulatory bodies to takesimilar action.

• Communication – The EuropeanCommission should provide credible andaccessible sources of balanced information aboutnanomedicine, to facilitate understanding anddialogue.

* Ref. Economic Impact Working Group

Nanomedical applications are not just atheoretical possibility – for example, the RoundTable has identified forty-five products that arealready on the market . However, the field ofnanomedicine is still a relatively new one. Thismeans that as this report is published, Europe isat an ideal moment to consider the impacts andconsequences of nanomedicine, as well asaction required as a result.

Several factors serve to underline the particularrelevance and timeliness of this report. Therecently enhanced role of DG SANCO, and theEuropean Commission’s anticipated strategicAction Plan for Nanosciences andNanotechnologies 2010-2015, rank amongthese. Another factor is the scale and depth ofimpact that nanomedicine may deliver, whichshould not be underestimated. Nanomedicine isenabling us to take a significant step forward inunderstanding and treating disease, by shiftingattention to the molecular level.

As well as adding another layer to healthcare,nanomedicine also presents us with arguablythe best case study of changing business modelsin terms of the move from curative to preventivemedicine. In the context of health being viewedincreasingly as ‘well-being’ rather than ‘absenceof disease’, nanomedicine may have much tocontribute.

Nanomedicine is also covering new ground inthat it is combining many previouslyunconnected disciplines, such as economics,supply chain and insurance, to name but a few.This convergence of different fields means thatwe need to be very clear about where and howwe start thinking about the impact ofnanomedicine.

For all of these reasons, not taking action nowwould be a wasted opportunity. By doing nothing,we would significantly risk blocking thedevelopment of innovative procedures in Europe,to the detriment of European research anddevelopment, the healthcare industry, and, mostimportantly, patients.

It’s never too early to act until it’s too late.

The NanoMed Round Table brought together expert stakeholders from acrossEurope within five Working Groups, each of which considered a specific fieldhighly relevant to decision-making regarding nanomedical innovations.

The Groups’ key findings were as follows:

1 US National Institutes ofHealth:http://nihroadmap.nih.gov/nanomedicine

2 The European MedicinesAgency, whose “mainresponsibility is theprotection and promotion ofpublic and animal health,through the evaluation andsupervision of medicinesfor human and veterinaryuse”: www.ema.europa.eu

3 The European CommissionDirectorate General forHealth and Consumers

Although very promising, nanomedicine may add new dimensions to many

ethical, societal and economic issues. For the promises to be

realised and to achieve the maximum benefit of

nanomedical innovations for everyone, the way has to

be paved for a safe, integrated and responsible

approach to nanomedicine. This will also be a

necessary condition for the sustainable

competitiveness of nanomedical research

and development in Europe, and of its

healthcare industry. It is therefore of

primary importance to understand the

possible impacts and consequences of

nanomedicine in advance.

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The European Commission should:• establish a platform to provide credible and accessible

sources of balanced information on the methods, benefitsand risks of nanomedicine.

• investigate funding opportunities for EU level trade andresearch associations to produce lay information usingstakeholder dialogue on nanomedicine research.

• support patient organisations to investigate whethernanomedicine is currently/potentially useful in treatingtheir condition (with a view to their providing balancedinformation to patients if so), and provide funding toidentify and understand the issues that it raises for them.

• develop communication guidelines for the variousnanomedicine stakeholders, and provide good practiceexamples.

The European Commission, national governments, industryand independent grant organisations should allocate asignificant percentage of financial resources in the field ofnanomedicine to public communication.

The European Commission and national funding agenciesshould integrate public involvement in decision making onpriorities in research funding and encourage, train andreward scientists in public engagement activities.

Patient organisations should be involved in the work of theEuropean Technology Platform on Nanomedicine and the“NANOfutures” European Technology Integration andInnovation Platform in Nanotechnology initiative, and beencouraged to participate in governmental stakeholder fora.Patients’ involvement in EU and national policy makingprocesses should also be institutionalised.

Parliamentarians at EU and national level should conductmulti-stakeholder hearings, to deliberate in a comparativemanner the value of basic nanomedical research forprevention, diagnosis and therapy of disease.

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The European Commission and national governmentsshould:

• integrate the deliberation of ethical and societal issueswith consideration of the feasibility of particulardevelopments in nanomedicine.

• encourage social science and humanities research thatgoes beyond the risks and benefits of medical innovationsto include the consideration of promises, hopes andanxieties.

• support the development of a broader range ofmethodologies for research on the environmental, healthand social implications, and on the ethical, legal and socialaspects, of nanomedicine.

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The European Commission and national governmentsshould:

• together with the European Science Foundation and theEuropean Research Council, initiate a deliberative processabout the possibly distinctive features of nanomedicinethat include its social and ethical dimensions. This processshould inform the setting of EU Framework Programmeand national research agendas.

• in consultation with patient organisations, continue todiscuss priorities for nanomedicine and fund theirresearch and development, encouraging the integration ofnational nanomedicine strategies to ensurecomplementarity.

• establish partially public-funded technology-specificreference centres linking early development with clinicalresearch and clinical practice.

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The European Commission should: • establish and promote supporting mechanisms that boost

the effectiveness of the existing regulatory framework,especially by harmonising regulatory procedures onreporting and data collection.

• ensure the proportionate responsiveness of regulatorypolicies through engagement and partnership with usersand stakeholders, as well as taking into account factors thatdiffer between Member States (e.g. national regulatoryinfrastructures and cultures), and monitoring health andenvironmental impact.

• support institutional mechanisms that facilitate a commonperspective regarding clarity, objectivity and commonpractice for credibility and authority.

• Regulators should take into consideration the economicimplications of regulation for nanomedicine and the fundingsupport needed for access to regulatory expertise and extracompliance investment, especially for SMEs.

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Companies and clinicians should produce data based onwell-defined criteria of cost-effectiveness for the economicevaluation of nanotechnology-based innovations in clinicaltrials and health technology assessment studies.

The European Commission should:• together with national governments, promote and support

projects in partnership with key stakeholders, to assessthe cost-effectiveness of nanomedical innovations as earlyas possible.

• launch a health economics project to assess the economicimpact and emergence of new cost models relating tonanotechnological innovations in preventive medicine andthe monitoring of chronic diseases.

• provide funding to examine access issues relating tonanomedicine products.

• support further research to work with bodies representingclinicians to gauge awareness of novel possibilities arisingfrom nanomedicine and incorporate these into clinicalpractice.

• National reimbursement agencies and public and privateinsurers should establish a European working group toconsider the future impact of innovative approaches inhealthcare systems with nanotechnology as a case study.

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The European Commission should:share the NanoMed Round Table’s conclusions withinternational expert groups to improve European andinternational strategies for maximising the positiveeconomic impact of nanomedicine together withnational governments, involve low-income countriesin developing a fair and sustainable global policy onbenefit sharing in nanomedicine.

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There is low awareness and knowledge of nanomedicine amongpatients and patient organisations, even in condition areas where it isbeing used. The overwhelming majority of patients would like toreceive more information on nanomedicine, ideally via the internet,from patient organisations and/or clinicians.

oÉÅçããÉåÇ~íáçå NThe European Technology Platform on Nanomedicine and “NANOfutures”European Technology Integration and Innovation Platform in Nanotechnology,together with the European Patients’ Forum, should explore the involvement ofpatient organisations in the work of the Platforms, to provide input from patients’perspective and improve patients’ understanding of nanomedicine. For thesereasons, patient organisations’ views should also actively be sought as part of anyother nanomedicine strategy development at EU level.

oÉÅçããÉåÇ~íáçå OThe European Commission has produced much useful information on the interneton nanotechnology aimed at the general public, e.g. short films, leaflets andbrochures. It should organise the production of similar lay information onnanomedicine, which could be used by patient organisations, clinicians and themedia.

oÉÅçããÉåÇ~íáçå PEuropean-level trade and research associations should produce lay informationusing stakeholder dialogue on nanomedicine research. National-level trade andresearch associations should disseminate this information in their country’slanguage(s) to patient organisations, media and bodies representing clinicians. TheEuropean Commission should investigate what existing programmes should orcould fund this, and/or develop new funding streams where required, e.g. scienceand society programmes or European Science Foundation.

oÉÅçããÉåÇ~íáçå QPatient organisations should be supported by the European Commission toinvestigate whether nanomedicine is currently or potentially useful in treating theircondition, and if so to enable engagement in nanomedicine with a view to providingbalanced information to patients and carers.

oÉÅçããÉåÇ~íáçå RThe European Commission, working with the European Patients’ Forum, shouldidentify and engage with patient organisations that already communicate to theirmembers on nanomedicine, and work with them to produce a ‘best practice’ casestudy and toolkit (e.g. FAQs, webpages, short files) to help guide and support otherpatient organisations.

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The majority of patients view nanomedicine as a technology that could addressmany unmet medical needs and they support nanomedicine research.

oÉÅçããÉåÇ~íáçå SThe European Commission and national governments in consultation with patientorganisations should continue to discuss priorities for nanomedicine and fund theirresearch and development. To ensure complementarity and avoid duplication, theEuropean Commission should encourage the integration of national nanomedicinestrategies.

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Patients do not view nanomedicine as inherently unsafe, but there is a lack of clearunderstanding about the potential safety aspects that may be unique to it. Thisshould be addressed through appropriate safeguards and the communication ofinformation. Patients have mixed views on whether nanomedicine is different fromother new types of medical research.

oÉÅçããÉåÇ~íáçå TWhere governments have organised stakeholder fora to discuss the potential risksand benefits of nanotechnologies including nanomedicine, they should encouragepatient organisations to participate. Where such fora do not exist, governmentsshould urgently consider establishing them.

oÉÅçããÉåÇ~íáçå UThe European Commission should provide funding for focus groups and otherparticipatory methods (e.g. citizen conferences, interviews, surveys) in a number ofEuropean countries, to identify and understand the spectrum of issues thatnanomedicine raises for patients and their families.

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Further research is desirable on access to nanomedicine products and clinicalpreparedness.

oÉÅçããÉåÇ~íáçå VThe European Commission should provide funding for a project examining accessissues relating to nanomedicine products (diagnostic and therapeutic).

oÉÅçããÉåÇ~íáçå NMThe European Commission should support further research to work with bodiesrepresenting clinicians and other healthcare professionals to: a) gauge awareness ofnovel possibilities arising from nanomedicine and incorporate these into clinicalpractice, and b) assist CPD/CME (Continuous Professional Development/ContinuingMedical Education) to anticipate novel possibilities and formulate appropriateresponses.

K E Y P O I N T S

Patients have relatively lowlevels of knowledge andawareness of nanomedicine, butthey would like moreinformation.

Despite this low level ofknowledge there are high levelsof support among patients fornanomedicine products andresearch.

Patients have clear views onhow and from whom they wouldlike to receive this information.

Patients do not think thatnanomedicine is inherentlyunsafe, but there is a lack ofclear understanding about thepotential safety aspects.

Nanomedicine is an opportunitythat patients want to seeembraced. Equally, there is asignificant and time-criticalopportunity to inform patientsabout it.

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Questions which hitherto have become central to reflection on nanomedicineinclude: The ‘right not to know’ – The development of nanotechnologically-enabled diagnostictools is likely dramatically to widen the gap between diagnostic capability andavailable therapies. What rights and means do citizens have not to know, or makeknown, the results of diagnostic tests?The ethics of human enhancement - How should we determine the permissibility and regulation of interventions that could be applied beyond the therapeutic contexts to enhance individuals’ physical and mental capabilities? Demographic effects - The Nano Cancer Initiative of the US National Institutes ofHealth has claimed that, by 2015, no one will suffer or die from cancer. Although thisseems unrealistic, such a drastic decrease of mortality would have a considerableimpact on social security systems.

Such questions focus on applications (e.g. new diagnostic tools or brain-machineinterfaces) which are envisioned by various promoters of nanomedicine and whichresonate powerfully within popular culture. Their discussion relies upon theassumption that such applications are realistic in the short or medium term.

oÉÅçããÉåÇ~íáçå NSince the discussion of implications of hypothetical but unlikely products is unhelpful,the European Commission and national governments should integrate thedeliberation of ethical and societal issues with consideration of the feasibility ofparticular nanomedicine developments. This requires assessment of the visionsdriving nanotechnological developments, as well as historically and theoreticallyinformed analyses of the cultural tendencies, societal aspirations, and commercialtrends that influence nanotechnology for medicine and health.

oÉÅçããÉåÇ~íáçå OThe European Commission and national governments should support thedevelopment of a broader range of methodologies for research on the environmental,health and social (EHS) implications and the ethical, legal and social aspects (ELSA)of nanomedicine.1 This requires the explicit formulation of the criteria used todetermine what is relevant for public deliberation.

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Nanomedical research is hugely ambitious. In the search to understand and treatdisease, it shifts attention beyond the cellular to the molecular level, and seeks tocontrol a pathway from the molecular level right up to patients’ and physicians’ dailyroutines. Analysis of the scientific and technological ambitions of nanomedicalresearch directs us to a view of nanomedicine as, primarily, basic research on theunderstanding, diagnosis and treatment of disease.

Moreover, the lack of a clear-cut definition of ‘nanomedicine’ could be an opportunityto configure nanomedical research so as to mark a departure from ‘business asusual’. Some prominent actors in the field suggest that the novelty of nanomedicine isits adoption of a ‘bottom-up’ approach which draws on principles of self-organisationand on systems theory more generally. Accordingly, nanomedicine might be defined,for funding purposes, as medical research grounded in systems biology. The notion ofthe system encompasses many orders of magnitude, from the molecular level all theway up to societies and healthcare services, so this definition affords a uniqueopportunity to incorporate ethical and societal perspectives into the research process.

oÉÅçããÉåÇ~íáçå PThe European Commission’s Research Directorate-General, the European ResearchCouncil and the European Science Foundation together with national funding agenciesand research ministries, should initiate a deliberative process about the possiblydistinctive features of nanomedicine that include its social and ethical dimensions. Thisprocess might include the development of roadmaps and should inform the setting ofEU Framework Programme and national research agendas, and engage the scientificcommunities and their governing bodies, including academies of science.

Nanomedicine is the subject of high expectations and considerable public investment,but has yet to prove itself. In order to assess the value of basic nanomedical research,we might ask where a nanomedical approach is most productive and beneficial forresearchers, healthcare systems and societies.

oÉÅçããÉåÇ~íáçå QParliamentarians at EU and Member State level should conduct multi-stakeholderhearings that encompass public and world health advocates and patient groups. Theaim should be to deliberate in a comparative manner the value of basic nanomedicalresearch for prevention, diagnosis and therapy of disease. Scientific input should beprovided from fields as diverse as medical anthropology, international law, bioethicsand cancer research. Such hearings will focus and strengthen nanomedical researchand raise public awareness of its possibilities and expectations.

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Health used to be defined as ‘normal functioning’, or as the absence of disease, but isnow increasingly viewed as ‘well-being’, or as living to the fullness of one’s capacities.Irrespective of whether and when nanomedical research lives up to its scientific andtechnological ambitions, it is already a part of these developments. A host of issuesarises where commercial interests and medical research intersect.Nanotechnologically-enabled diagnostic tools, for example, expand possibilities ofself-diagnosis and self-treatment, contributing to a reorganisation of medicalexpertise. At the same time, the marketing of diagnostic capabilities empowersindividuals but also exploits their vulnerabilities and anxieties.

oÉÅçããÉåÇ~íáçå RThe European Commission and national governments should encourage socialscience and humanities research that goes beyond the risks and benefits of medicalinnovations to include the consideration of promises, hopes and anxieties. Suchresearch should assess the emerging divisions of roles and responsibilities betweenpatients, physicians, hospitals, e-health information systems, insurers andconsumers. It should also identify safeguards that could and should be provided bypublic health care systems.

If health is defined as the absence of disease or as normal functioning, it is an unevenlydistributed public good. However, when it is defined more broadly as living to thefullness of one’s capacities, the gap between rich and poor countries widens further,broadening responsibilities and opportunities for benefit sharing.

oÉÅçããÉåÇ~íáçå SThe European Commission and national governments should create ways of involvinglow-income countries in the development of a fair and sustainable global policy onbenefit sharing in nanomedicine. Avenues for this might include internationalorganisations such as UNESCO2 and bodies which work towards and monitor theimplementation of the United Nations Millennium Development Goals3.

K E Y P O I N T S

Ethical engagement withnanomedicine begins with thevery concept of ‘nanomedicine’, aword that now groups diverseresearch activities together.Nanomedical researchers,physicians, patients and policymakers will all benefit when, onthe basis of philosophical andsocial analysis, the programmeand purpose of nanomedicine arebetter understood and moreclearly defined.

The discussion of ethical andsocietal questions aboutnanomedicine must be informedby consideration of the feasibilityof nanomedicine applications.

As well as the significance ofnanomedical innovations,promises, hopes and anxietiesshould also be considered.

Low-income countries must beinvolved in the development of fairand sustainable global policy onbenefit sharing in nanomedicine.

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1 This includes calls for research onforesight and technology assessment ofnanomedical developments, as well asthe design and evaluation of publicengagement exercises.

2 United Nations Educational, Scientificand Cultural Organization

3 www.un.org/millenniumgoals

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How Should the Economic Impact of Nanomedicine be Evaluated?Nanotechnology will be considered in health economics only if it brings significantadded therapeutic value. Data on clinical effectiveness must therefore be acquiredprior to any attempt to evaluate economic significance. Societal and economiccriteria (going far beyond the cost of treatment) also need to be taken into account.

Measuring and Maximising the Positive Economic Impact of Nanomedicine

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Up to now health economics studies do not cover innovations coming fromnanotechnology, so data regarding the economic assessment of nanotechnologicalinnovations in the healthcare sector is scarce.

oÉÅçããÉåÇ~íáçå NCompanies and clinicians should produce data based on well-defined criteria ofcost-effectiveness for the economic evaluation of nanotechnology-based innovationsin clinical trials and health technology assessment studies.

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Early medico-economic assessment is critical to recognise as early as possible(ideally at the pre-clinical stage) the potential applications of nanomedicalinnovations; this enables assessment of maximised therapeutic value for patients.

oÉÅçããÉåÇ~íáçå OThe European Commission and national governments should promote and supportprojects in partnership with health economists, technology developers, clinicalresearchers, healthcare providers and patient associations, with comparisonsacross Europe, to assess the cost effectiveness of nanomedical innovations as earlyas possible.

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When added therapeutic value is clearly demonstrated, e.g. in the case of unmetmedical need, reimbursement generally occurs. However, nanotechnology is mostoften considered as one innovation among others, without recognising its deepimpact on the definition of medical practices.

oÉÅçããÉåÇ~íáçå PNational reimbursement agencies, along with public and private insurers, shouldestablish a European working group to consider the future impact of innovativeapproaches in healthcare systems across Europe, taking nanotechnology as a case study.

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Nanotechnology applications may offer new solutions for preventive medicine andthe growing need for diagnostic and monitoring tools. The added value ofnanotechnology for consumer-driven markets in healthcare and well-being mustalso be considered.

oÉÅçããÉåÇ~íáçå QThe European Commission should launch a health-economics project to assess theeconomic impact and emergence of new cost models relating to nanotechnologicalinnovations in preventive medicine and the monitoring of chronic diseases.

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This is critical to avoid false investments, optimise clinical benefits and therefore tomaximise economic impact.

oÉÅçããÉåÇ~íáçå RThe European Commission and national governments (especially health andresearch ministries and bodies) should establish technology-specific referencecentres linking early development with clinical research and clinical practice. Thesecentres should be partially publicly-funded.

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Europe’s competitiveness must be ensured at every level of nanomedicineinvestment, from basic research to reimbursement.

oÉÅçããÉåÇ~íáçå SThe European Commission should share the conclusions of the NanoMedRoundtable with international expert groups in order to improve European andinternational strategies for maximising the positive economic impact ofnanomedicine.

K E Y P O I N T S

Reliable data is needed to predictthe impact of nanomedicine onhealthcare costs and benefits,and market growth.

If urgent action is not taken, the current lack of data andeconomic models will hinder the development ofnanomedicine in Europe.

Early health economicsassessment is crucial torecognise the potentialapplications of nanomedicalinnovations as early as possibleand therefore enable maximumpatient benefit.

The future impact ofnanotechnology innovations inhealthcare systems, and theiradded value in preventivemedicine should be assessed.

Action is required to ensure theeffective organisation ofnanomedicine in Europe andEurope’s competitiveness in theface of worldwide competition.

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Better coordination and harmonisation of existing regulatory procedures is urgentlyneeded to facilitate data collection and improve regulatory clarity. Priorities are theclarifying of the regulatory pathway for ‘combination products’ (which bear thefeatures of different medical products and even food or cosmetic products), definingcommon terminology and relevant data, and promoting data collection efficiency.

oÉÅçããÉåÇ~íáçå NAt the current development stage, regulatory policy should focus on promoting theharmonisation and responsiveness of existing regulatory systems. The EuropeanCommission should establish and promote supporting mechanisms that boost theeffectiveness and responsiveness of the existing regulatory framework.

oÉÅçããÉåÇ~íáçå OThe European Commission should strengthen its efforts to clarify the regulatorypathway and classification of combination products in the EU, and actively seekinternational collaboration to improve consistency between different jurisdictions.

oÉÅçããÉåÇ~íáçå PThe European Commission should devote efforts to defining common terminologyand relevant data in nanomedicine, actively supporting the clarification of datarequirements concerning safety, efficacy and clinical endpoints for the evaluation ofeffect of the products.

oÉÅçããÉåÇ~íáçå QThe European Commission should take advantage of the merits of recent medicalproduct regulation initiatives (e.g. seek international collaboration in establishingcommon reporting schemes to promote the efficiency and effectiveness of productauthorisation), and use the Cross-border Healthcare Directive to facilitate datacollection on common clinical issues and boost expertise for the clinical applicationof nanomedicine.

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This requires, among other measures, meaningful engagement with users andstakeholders.

oÉÅçããÉåÇ~íáçå RThe European Commission should establish and promote early dialogue with thedifferent stakeholders on regulatory issues concerning nanomedicine, and ensurethe regulatory framework for nanomedicine is grounded in users’ experience.

oÉÅçããÉåÇ~íáçå SPatients’ involvement in the nanomedicine policy making process should beinstitutionalised at both EU and national levels.

oÉÅçããÉåÇ~íáçå TThe European Commission should facilitate the accessibility of regulatory expertiseby establishing user-friendly mechanisms which encourage early dialogue withregulatory bodies and regulatory partnership in order to facilitate consensus on datarequirements.

oÉÅçããÉåÇ~íáçå UThe European Commission should:consider the appropriate application of the subsidiarity principle in regulatingnanomedicine, taking into consideration national regulatory infrastructures andcultures. The need for capacity building at national level should also be addressed inEU regulatory policy to ensure regulatory policies take into account factors such asthe situation in different Member States, different sizes of companies and differenttypes and applications of nanotechnologies.

oÉÅçããÉåÇ~íáçå VThe European Commission should ensure continued efforts to address and monitorthe health and environmental impact of nanomedicine, including improvingawareness of environmental, health and safety (EHS) issues of nanomaterials, bothin hospitals and nanomedicine companies.

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Mechanisms that offer credibility and authority are needed to support andencourage responsible practice in the development of innovative products.

oÉÅçããÉåÇ~íáçå NMThe European Commission should support institutional mechanisms that facilitate acommon perspective with regard to clarity, objectivity, and common practice forcredibility and authority, e.g. joint efforts on development of testing protocols,standards and best practice.

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The cost of accessing regulatory expertise and meeting regulatory requirementscan present significant barriers to bringing innovative nanomedicine to market.

oÉÅçããÉåÇ~íáçå NNRegulators should take into consideration the economic implications of regulationfor nanomedicine, including impact on timeline, insurability and the funding supportneeded for access to regulatory expertise and extra compliance investment,especially for SMEs and academic institutions.

K E Y P O I N T S

In order to enable responsibleinnovation in nanomedicine, theregulatory framework shouldfacilitate a scientifically-basedsocietal learning process, i.e. bybeing flexible enough to allowsociety to acquire, exchange andaccumulate knowledge andexperience in dealing with a newtechnology.

For effective implementation ofthe existing regulatoryframework, there is a need forbetter coordination andharmonisation of regulatoryprocedures, especially those onreporting and data collection.

Essential to the responsivenessof the regulatory framework areearly dialogue with users andstakeholders, and differentiatedconsiderations taking intoaccount factors such as nationalregulatory infrastructures andcultures.

Regulatory policy for innovativemedical products must take intoconsideration the economicimplications of regulation.

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NO A report on the nanomedicine economic, regulatory, ethical and social environment NPA report on the nanomedicine economic, regulatory, ethical and social environment

aÉÑáåáåÖ=k~åçãÉÇáÅáåÉ=~åÇ=`çããìåáÅ~íáçåThere is much uncertainty in defining the term ‘nanomedicine’, not least becausethis relatively new field is transdisciplinary, blurring established boundaries andcombining previously unconnected fields. When considering this report’srecommendations this uncertainty must be taken into account, as publicengagement and deliberation can only be effective if there is agreement on acommon foundation on which to build dialogue.

For the purpose of this report ‘communication’ also needs to be defined. The goal ofany nanomedicine communication strategy must be to initiate public debate,deliberating on both personal and social consequences of innovations andacknowledging that a simple discussion of risks and benefits should only be astarting point for dealing with the complex concerns of a technology-dependentsociety. Furthermore, the communication requirements of individual members ofthe public can greatly differ, so it is vital for any successful communication strategyto take the range of understandings and expectations into account.

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Communicating about nanomedicine is increasingly important because of itssignificant potential to raise societal and ethical questions concerning risks andbenefits; and have an emotional and material impact (arising from benefits anduncertainties) due to the large number of people affected.

However, there is still a considerable lack of public awareness about nanomedicine.At the same time, social, ethical and legal questions are being raised concerningsafety, environmental and long-term effects. The best way to answer the demandsof an inquiring public is to develop and implement a strategic approach for activepublic debate.

Any communication strategy needs to take into account the significant changes incommunication methods; for example, the internet and new media are replacingdoctors as the primary source of medical information. Communication practicesmust therefore be continuously innovative in order to reach as wide and varied anaudience as possible.

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In order to enable patients to make informed decisions, the public needs access toreliable and credible sources of information and fora to debate and discussquestions about needs, risks and benefits as well as ethical and social issues relatedto nanomedicine.

oÉÅçããÉåÇ~íáçå NThe European Commission should establish a platform to provide credible andaccessible sources of balanced information on the methods, benefits and risks ofnanomedicine, focusing on the communication needs of patients and the medicalcommunity.

Establishing such a platform would make it easier for the public to understandfundamental nanomedical issues, and would also support the communication tasksof stakeholders such as doctors, patient groups and health insurers.

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The majority of current nanomedical research and development is conducted bysmall or medium-sized enterprises (SMEs) which often do not have the know-how,staff time and financial resources required for initiating and implementingsuccessful communication strategies. This can significantly delay or hinder thedevelopment, introduction and application of innovative nanomedical treatments, tothe detriment of nanomedicine’s medical and economic impact in Europe.

The communication aspects of the related fields of food and environment must becarefully differentiated, or negative tendencies concerning these fields may havedetrimental effects on nanomedicine.

oÉÅçããÉåÇ~íáçå OThe European Commission should develop communication guidelines for thevarious nanomedicine stakeholders and provide good practice examples. Particularcare should be taken to differentiate between the communication aspects of therelated fields of food, environment and nanomedicine.

Ensuring sufficient resources for communication is important becauseinefficient or inadequate communication about nanomedicine can lead, on a smallscale, to the rejection of an individual treatment method. On a larger scale, anumber of such cases of rejection could lead to distrust and fear of the entire field.The question is how to finance communication in a field which is struggling to defineitself and which has long development times and therefore long investment returntimes, meaning that profits are currently negligible.

oÉÅçããÉåÇ~íáçå PThe European Commission, national governments, industry and independent grantorganisations should allocate a significant percentage of financial resources in thefield of nanomedicine to public communication. The goal of this financial allocationshould be to encourage public engagement, foster dialogue and move beyond thesimple discussion of risks versus benefits.

K E Y P O I N T S

Public engagement anddeliberation about nanomedicineat all levels is fundamental if weas a society want to profit fromthe hopes and promises investedin nanomedicine.

Credible and accessible sourcesof balanced information must beprovided, together with fora todebate and discuss questionsabout needs, risks, benefits andethical and social issues relatingto nanomedicine to facilitateunderstanding and dialogue.

Communications know-howneeds to be fostered amongnanomedicine stakeholders,otherwise the development,introduction and application ofinnovative nanomedicaltreatments will be significantlydelayed or hindered.

Good communication needsadequate financing – this shouldbe built into all nanomedicinefunding.

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NQ A report on the nanomedicine economic, regulatory, ethical and social environment NRA report on the nanomedicine economic, regulatory, ethical and social environment

ChairProf Sir John Beringer Formerly Pro Vice-Chancellor, University of Bristol, Symbiotic Consultancy Ltd, UKCoordinatorProf Julian Kinderlerer TU Delft, Netherlands/ University of Cape Town, South Africa/ European Group on

Ethics in Science and New Technologies ManagementDr David Bennett Delft University of Technology, The Netherlands & St Edmund’s College,

University of Cambridge, UKDr Klaus-Michael Weltring Bioanalytik-muenster, GermanySerene K. Chi TU Delft, Netherlands

tmO=m~íáÉåíëÛ=kÉÉÇëChair Alastair Kent Director, Genetic Interest Group, UKParticipantsDr David Bennett Delft University of Technology, The Netherlands & St Edmund’s College,

University of Cambridge, UKProf Dr Sir John Beringer Formerly Pro Vice-Chancellor, University of Bristol, Symbiotic Consultancy Ltd, UKAvril Daly Fighting Blindness, IrelandLaura Gilbert RapporteurMelissa Hillier Genetic Interest Group, UK Dr Mahendra Gonsalkorale Former member of European Parkinson's AssociationLorraine Le Floch Independent Patient, European Multiple Sclerosis Platform (EMSP)Sabine Lobnig European Patients ForumRod Mitchell Chairman, European Crohn's and Colitis Organization (ECCO)Liuska Sanna European Patients Forum

tmP=bíÜáÅ~ä=~åÇ=pçÅáÉí~ä=^ëéÉÅíëChairProf Alfred Nordmann Technische Universität Darmstadt, Germany & University of South Carolina, USAParticipantsDr Johann S. Ach Universität Münster, GermanyDr David Bennett Delft University of Technology, The Netherlands & St Edmund’s College, University

of Cambridge, UKProf Dr Sir John Beringer Formerly Pro Vice-Chancellor, University of Bristol, Symbiotic Consultancy Ltd, UKProf Marianne Boenink University of Twente, NetherlandsDr Donald Bruce Edinethics Ltd., Edinburgh, ScotlandDr Karin Christiansen University of Aarhus, DenmarkProf José Manuel de Cózar University of La Laguna, SpainDr Arianna Ferrari Technische Universität Darmstadt, Germany Robert Geertsma RIVM Bilthoven, NetherlandsProf Uffe Juul Jensen University of Aarhus, DenmarkJan Reinert Karlsen University of Oslo, NorwayProf George Khushf University of South Carolina, USADr Thorsten Kohl Technische Universität Darmstadt, Germany (Researcher, Rapporteur)Dr Ineke Malsch Malsch TechnoValuation, NetherlandsDr Sabine Müller Universität Bonn, GermanyProf João Arriscado Nunes University of Coimbra, PortugalProf Jan Helge Solbakk University of Oslo, NorwayProf Mariachiara Tallachini University of Milano, ItalyDr Susana Vidal UNESCO, UruguayDr Klaus-Michael Weltring Bioanalytik-muenster, Germany

The Working Group thanks the Brocher Foundation in Geneva for hosting its second meeting at its facility for conferences about bioethical dimensions of medical research. For editorial support, the Group thanks Sarah Davies.

tmQ=bÅçåçãáÅ=fãé~ÅíChairDr Françoise Charbit CEA, France ParticipantsDr François Berger Grenoble Hospital and INSERM, FranceProf Dr Sir John Beringer Formerly Pro Vice-Chancellor, University of Bristol, Symbiotic Consultancy Ltd, UKDr Bernhard Buehrlen Fraunhofer Institute for Systems and Innovation Research, GermanyDr Giorgio Cassara Don Gnocchi Foundation, ItalyDr Paul Garassus Clinique du Tonkin, FranceDr Laurent Levy Nanobiotix, FranceDr Christine M’rini Mérieux Alliance, FranceDr Christine Muzel Philips Healthcare, NetherlandsProf Reinhard Rychlik Institute for Empirical Health Economics, Burscheid, GermanyDr Jürgen Schnekenburger University Clinic Münster, GermanyDr Paul Smit Philips Healthcare, NetherlandsDr Klaus-Michael Weltring Bioanalytik-muenster, Germany

tmR=oÉÖìä~íáçåChairMark Cantley Formerly European Commission Research Directorate-General, UKParticipantsProf John Adams University College London, UKDr Mike Adcock Durham University, UKProf Dr Sir John Beringer Formerly Pro Vice-Chancellor, University of Bristol, Symbiotic Consultancy Ltd, UKSerene K. Chi Delft University of Technology, The NetherlandsProf Ken Donaldson University of Edinburgh, UKDr Bärbel Dorbeck-Jung University of Twente, NetherlandsJoel D’Silva Leuven University, BelgiumDr Thomas K. Epprecht Swiss Re, SwitzerlandDr Steffi Friedrichs Nanotechnology Industry Association, BelgiumDr Peter Hatto CEN/ISO, UKDr Juergen Hirschfeld Bayer, Germany Dr Peter Kearns OECD, FranceProf Julian Kinderlerer Delft University of Technology, The Netherlands/ University of Cape Town, South

Africa/ European Group on Ethics in Science and New Technologies Dr Horst Siebold Siemens, Germany Prof Rogério Sá Gaspar University of Lisbon, PortugalDr Rob Slobbe Philips, NetherlandsDr Klaus-Michael Weltring Bioanalytik-muenster, GermanyDr Jiang Yu Chinese Academy of Science, China

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NS A report on the nanomedicine economic, regulatory, ethical and social environment

tmS=`çããìåáÅ~íáçåChairProf Dr Wolfgang M. Heckl Deutsches Museum/ TU München, GermanyParticipantsDr David Bennett Delft University of Technology, The Netherlands & St Edmund’s College, Universityof Cambridge, UKProf Dr Sir John Beringer Formerly Pro Vice-Chancellor of University of Bristol, Symbiotic Consultancy Ltd, UKMark Cantley Formerly DG Research, UKRichard Hayhurst Hayhurst Media, UKMelissa Hillier Genetic Interest Group, UKPaul Hix Deutsches Museum, GermanyDr Andreas Jordan MagForce Nanotechnologies AG, GermanyDr Ulrich Kernbach Deutsches Museum, GermanyProf Dr Harald Krug EMPA Materials Science & Technology, SwitzerlandProf Dr Phil Macnaghten Durham University, UKHayley Birch Science Writer/Editor, UKProf Dr Harald Fuchs WWU Münster, GermanyDr Antje Grobe Risk Dialogue Foundation, SwitzerlandProf Kathy Sykes University of Bristol, UKWiebke Pohler LMU München, GermanyDr Michael Schillmeier LMU München, GermanyBart Walhout Rathenau Institute, NetherlandsDr Klaus-Michael Weltring Bioanalytik-muenster, Germany

Other ContributorsDr Simon Baconnier Connective Tissue Cancer Network, FranceDr Bruno Bonnemain Guerbet, FranceProf Gérard Duru University of Lyon, FranceDr Philippe Mourouga Sanofi Aventis, FranceDr Detlef Niese Novartis, SwitzerlandProf Dr Lode Vereeck Member of the Flemish Parliament, Belgium

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