eb healthcare 01-12 avlprod - europabio … · 01 manifesto 2011 - 2012 healthcare biotechnology...

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Manifesto 2011 - 2012

TABLE OF CONTENTS01 INTRODUCING YOU TO HEALTHCARE BIOTECHNOLOGY

02 DID YOU KNOW THAT

03 A WORD FROM THE CHAIR OF THE HEALTHCARE COUNCIL

04 OUR CORE ETHICAL VALUES

05 ACHIEVING BETTER POLICY-MAKING THROUGH SCIENCE

07 ACHIEVING REGULATIONS THAT SUPPORT INNOVATION

09 ACHIEVING BETTER ACCESS TO MARKET THROUGHOUT THE EU

11 CREATING OPTIMAL CONDITIONS FOR EUROPE’S HEALTHCARE BIOTECH SMES

12 ENSURING COHERENCE FROM EUROPEAN TO NATIONAL LEVEL

EuropaBio represents the interests of the

biotechnology industry towards the

European institutions so that legislation

encourages and enables biotechnology

companies in Europe to innovate and

provide for our society’s unmet needs.

The European Association for

BioIndustries, was created in 1996 and

represents 66 corporate and 7 associate

members operating worldwide, 4

Bioregions and 22 national biotechnology

Associations representing some 1800

small and medium sized enterprises.

Our corporate members are involved in a

wide range of activities: human and animal

healthcare, diagnostics, bio-informatics,

chemicals, biofuels, crop production,

agriculture, food and environmental

products and services.

EuropaBio also welcomes associate

members such as international commercial,

financial asset management and other

service providing companies, regional

biotechnology development organisations

and scientific institutes. The common

denominator among all our members is

the use of biotechnology at any stage of

research, development or manufacturing.

For more information, please visit

www.europabio.org

INTRODUCING YOU TO HEALTHCARE BIOTECHNOLOGY

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Healthcare biotechnology refers to amedicinal or diagnostic product or a vaccine that consists of, or has been produced by the use of, living organisms.Often recombinant DNA (a form of DNAthat does not exist naturally and whichcombines DNA sequences that wouldnot normally occur together in order to establish new functions) forms the basis for such biotechnologicallymanufactured products.

Healthcare biotechnology has a tremendous impacton meeting the needs of patients and their families –it not only encompasses medicines and diagnosticsthat are manufactured using a biotechnological process, but also gene and cell therapies and tissue engineered products.

Today, the majority of innovative medicines, whethermanufactured using biotechnology or via a chemicalsynthesis like a traditional small molecule medicine,and many diagnostic products, are made available byapplying modern biotechnology in their developmentand/or manufacturing processes.

More than 350 million patients have already benefited from approved medicines manufactured through biotechnology to treat or prevent cancers, heart attacks, stroke, multiple sclerosis, leukaemia, diabetes, rare and other diseases.

650 new biotech medicines and vaccines are currently being developed for more than 100 diseases.

In Europe, there are more than 60 approved orphan medicinal products, most of them biotech medicines, for the prevention or treatment of rare, life-threatening or serious conditions.

Whilst the individual number of patients suffering from rare diseases might be low, all together, more than 30 million Europeans are affected.

With the completion of the human genome mapping and the resulting improved understanding of inter-individualvariability, current medical science is evolving towards a “personalised” approach in which we are better able todevelop and subsequently target medicines to patients who are more likely to benefit.

The pharmaceutical industry is increasingly shifting towards biotechnology. Projections estimate that in 2014, 50% of the top 100 drugs will be biotech medicines.

By 2015, the OECD estimates that healthcare biotechnological knowledge will be used in the development processfor all new pharmaceuticals.

More than 70% of biotech and pharmaceutical companies in the EU-27 have less than 50 employees. Although small,biotech SMEs provide the high value-added jobs that will help the EU achieve its goal of becoming the foremostknowledge-based economy in the world.

Recently, larger biopharmaceutical companies have tended to place greater reliance on outsourced R&D, mostlycoming from emerging biotech SMEs. These programmes now represent as much as 30% to 50% of the pipeline formany major companies.

DID YOU KNOW THAT...

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650 new biotechmedicines and vaccinesare currently beingdeveloped for morethan 100 diseases

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Investment in healthcare innovation will be essential insecuring the economic future of Europe. This will be achievedfirstly by helping to ensure a fit population with a lower burden of disease, secondly byproviding a valuable, leadinghigh-tech industry sector inEurope and thirdly by pushingthe boundaries of science toincrease our understanding ofthe disease mechanisms and toaddress unmet medical needs.Researchers today are increasinglyable to understand the pathwaysand molecular mechanisms of a given disease and of clinicalresponse. Creating more predicable outcomes based on diagnostic-therapeutic combinations is the essence of greater capabilities for personalised medicine.

Over the last two years, thefinancial crisis has had a dramaticand negative impact on thehealthcare biotechnology industry, not only by limitingaccess to finance for smallercompanies, but also by pressingnational governments intoimplementing measures tocontain costs in their healthcaresystems and on their science andresearch budgets. Often the firstaffected area by these costcontainment measures is thespending on research into, anduptake of, innovative biotechmedicines. Often short-term by nature, these measures, including narrow HealthTechnology Assessments (HTAs)and pricing and reimbursementprocesses, should ensure thatpatients benefit in the long-termfrom these healthcare innovationswhile ensuring health systemsget value for money.

The European Commission (EC)has launched its Strategy to

achieve a more competitive andsocially inclusive European Unionby 2020, as well as the firstEuropean Innovation Partnershipin the field of active and healthyageing. Furthermore,Commission Vice-PresidentAntonio Tajani is leading a newinitiative to improve access toinnovative medicine in theEuropean Union (EU) - the so-called “Process on CorporateResponsibility in the Field ofPharmaceuticals”. Nevertheless,there is growing concern amongthe healthcare biotech industrythat an irreversible disconnect is emerging between the long-term access policies promotedat EU level and the short-termactions taken at EU MemberStates level.

EuropaBio welcomes the EU institutions’ impetus to revitalisethe competitiveness of the sector.However, the EU must also recognise that there is a needfor a more coherent approachfor setting policies. This wouldultimately ensure that positiveand constructive initiativesimplemented at one level arenot undermined at another. The European Commission, inclose collaboration with MemberStates, has a unique strategicposition to address this issue.This Manifesto intends to provide some suggestions onhow the EC can fulfil this role.

Healthcare biotechnologyprovides patients with new andtargeted solutions for a widerange of major diseases suchas cancer, diabetes or stroke.However, while healthcare biotechnology can supportgovernments in their efforts toenhance the sustainability oftheir healthcare systems, costcontainment measures can alsohave the contradictory effect

of hampering innovation andaccess for patients by delayingor limiting entry into market ofnew technologies.

EuropaBio Healthcare Councilmembers are committed todeveloping new products thathelp society live better, longerand healthier. This Manifesto,the EuropaBio Healthcare CouncilPolicy Roadmap for 2011-2012,sets out how EuropaBio willcontribute, through a transparentand open dialogue with all relevant stakeholders, to thedevelopment and implementationof sound policies that will leadto innovative solutions to unmetmedical needs.

Thomas Bols,Vice President Health Policy & Market Access,Merck Serono, and Chair of the EuropaBioHealthcare Council (2009 – 2011)


A WORD FROM THE CHAIR OF THE HEALTHCARE COUNCIL

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EuropaBio is committed to the socially responsible use ofbiotechnology to improve thequality of lives, to treat and curediseases, to improve the qualityand quantity of food, to producechemicals and to sanitise and to prevent release of hazardouswastes. EuropaBio recognises its responsibility to addresssocietal ethical concerns and toencourage, through constructivedialogue between stakeholders,a better mutual understandingof such concerns. These concernsencompass cultural or religiousaspects, possible environmentalimpact and the adequacy ofregulations. The association andits members have thereforedeveloped a set of Core Ethical Values.

These Core Ethical Values areaddressed to consumers,patients, the industrial and agricultural communities, politicians, legislators, the mediaand others who wish to knowabout the key ethical values thatunderpin our work. All membersof EuropaBio commit to theseCore Ethical Values and adhereto them as an integral part ofthe bylaws of the association.

They can be viewed at:http://www.europabio.org/positions/general/CoreEthicalValues2009.pdf

OUR CORE ETHICAL VALUES

We listen to society and help addressethical issuesProgress in science and technology also raisesquestions about its outcomes (such as the useand applications of the products thereof).

Core Ethical Values are addressed to consumers, patients,the industrial and agricultural communities,politicians, legislators,the media and otherswho wish to know about the key ethicalvalues that underpin our work.

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ACHIEVING BETTER POLICY-MAKING THROUGH SCIENCE

Personalised medicine

With the completion of thehuman genome mapping, itbecame clear that biology ismuch more complex thanexpected. Research into understanding inter-individualvariability at several molecularlevels has continued world-wide.Private and public scientificdevelopments are strongly driving the medical paradigmtowards an approach that ensures the right treatment, tothe right patient at the righttime. This personalised medicineapproach combines predictivediagnostic and therapeutic toolsto create predictable outcomesand tailor medical treatment to the individual characteristicsof each patient. This change isnot only driven by scientificadvances but also by society’sdemand for novel solutionsto old problems and more efficient therapies.

Modern healthcare biotechnologymethods and tools such as geneand cell therapies have thepotential to answer this demand,providing personalised, innovative, safe, and effectivehealthcare biotech products for patients. There are now a

growing number of biomarkers,genetic and proteomic testsbeing developed and validatedto identify patients who willmost likely respond to associated treatments.

Applications of personalisedmedicine go beyond therapeuticusage and are also increasinglyused in drug developmentfrom pre-clinical to clinical development. A variety of tools help identify respondents,non-respondents and patientswho are likely to suffer fromadverse reactions. As a result,pre-clinical and clinical trials arelikely to become smaller, safer,more focused, faster and lessexpensive.

Science is a fast driver of innovation,providing patients with cutting-edgehealthcare solutions to address unmetmedical needs.eds. EuropaBio’s role is to foster open discussion andexchange between all relevant stakeholders inorder to improve the understanding of the latestdevelopments in science. Ultimately, EuropaBiobelieves that a better understanding of scienceleads to the setting of better policies.

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Personalised medicine combinespredictive diagnosticand therapeutic toolsto create predictableoutcomes and tailormedical treatment to the individual characteristics ofeach patient.

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From a public health perspective,tailoring treatments to patientswho are most likely to derivebenefits from them will contribute to a re-distribution of financial resources in healthcare systems in a morerational way. The personalisedmedicine approach has thepotential to bring more effectiveand safer treatments on themarket as well as reducing theuse of ineffective treatmentsand the number of adversereactions – thereby reducingunnecessary hospitalisations.

Rare Diseases & OrphanMedicines

Ten years after the adoption of the European Regulation(EC/141/2000) on orphan medicinal products (OMPs),

more than 60 new treatmentsfor rare, chronically debilitatingand life-threatening diseaseshave received a positive opinionfrom the European MedicinesAgency (EMA) recommendingthe granting of a marketingauthorisation. More than 720 applications for orphan designation have been grantedfor products in development totreat more than 200 differentrare diseases. The approvedtreatments resulting from the OMP Regulation make a significant difference forpatients, bringing hope to some30 million Europeans and theirrelatives, affected by one of the5,000 to 7,000 rare diseases.

However, much still needs tobe done since many patientsstill face delays in access to

treatment: access to OMPsin Europe remains slow andvariable, despite the high unmet medical need, the lack of alternative treatments in most cases and/or the addedsignificant clinical benefit that these therapies mustdemonstrate before being granted a marketing authorisation.

Achieving better policy-making through science by:

Fostering a multi-expert platform for discussion and experience sharing through the EuropaBio Task Force onPersonalised Medicine.

Contributing to the development of an innovative and coherent EU policy and regulatory framework that is responsive to the scientific evolution in personalised medicine and healthcare delivery.

Continuing the dialogue with all relevant policy and regulatory stakeholders to communicate the potential roleand impact of personalised medicine on the healthcare biotech industry, from drug discovery to market access.

Advocating for a complete implementation of the initiatives put forward in the European Commission (EC)Communication on Rare Diseases and agreed by the EU Member States in the Council Recommendation on Rare Diseases, which will greatly increase access to treatment for rare disease patients in the EU.

Working at EU level with the EU Committee of Experts on Rare Diseases (EUCERD) and at national level throughthe EUROPLAN initiative to develop and implement coordinated national plans for rare diseases ensuringeffective diagnosis, treatment and care for rare diseases.

Communicating the medical, economic and social value of OMPs to policy-makers, regulators and other relevantstakeholders, particularly by contributing to the discussion on the implementation of the Clinical Added-Value of Orphan Drugs (CAVOD).

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ACHIEVING REGULATIONS THAT SUPPORT INNOVATION

Clinical Trials

A harmonised, transparent andevenly implemented regulatoryframework for clinical trialsthroughout the EU is vital forthe European bioscience industryto thrive. The adoption of theClinical Trials Directive2001/20/EC was an importantfirst step towards harmonisingthe requirements and processesin EU Member States andshould have created synergiesand time savings. However, the uneven and inconsistentimplementation of the Directiveby EU Member States hasresulted in cumbersome, lengthy and costly processes for clinical trial sponsors.

For EuropaBio, patient safety is of paramount importance.However, there is no supportingevidence that multiple layers ofregulatory approvals enhancethe safety, rights or well-beingof patients – the very objective ofthe Clinical Trials Directive. Thus,the additional administrativerequirements appear redundant.What we do know, however, isthat there has been a dramaticdrop in the number of drugdevelopment companies formedin Europe in recent years. Notonly is this a major concern forthe biopharmaceutical industry,but also, the societal aspects

need to be highlighted.Ultimately, patients will bedenied access to innovativemedicines.

Better regulation is requirednow if we want to maintain aninnovative and viable Europeanbioscience industry that cancompete globally. EuropaBiowelcomed and contributed tothe EC’s impact assessmentconcerning the application ofthe Directive and believes theEuropean Institutions should usethis opportunity to thoroughlyreview the legal framework and its implementation and, if necessary, to propose newlegislation. Only in this way canwe achieve real harmonisationand consistency in the approvaland conduct of clinical trials inthe EU in accordance with GoodClinical Practice principles.

Incentives for the development of newindications for authorisedmedicinal products

Restoring the EU as a world leader for biotech innovationand avoiding delays for patientaccess to innovative treatmentsare essential and obvious policy objectives. Healthcarebiotechnology gives rise to new possibilities for treatments,therefore addressing unmet

A sound EU regulatory framework encouragesand stimulates responsible innovation to helppeople live longer and healthier lives. EuropaBiobrings its expertise and experience into all keyregulatory discussions to help in the developmentof a predictable and workable framework. ds.

EuropaBio’s involvement in and commitment to such anapproach will ultimately improve timely access to new medicines and the competitiveness and attractiveness to investors of the healthcare biotech sector in Europe.

Better regulationis required now if wewant to maintain aninnovative and viableEuropean bioscienceindustry that cancompete globally.

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Achieving regulations that support innovation by:

Actively engaging with regulators and policy makers and contributing to the revision of the Clinical Trials Directive.

Continuing the dialogue with key stakeholders to communicate the detrimental impacts on the European bioscienceindustry if a harmonised, transparent and evenly implemented regulatory framework for clinical trials in the EU is notimplemented as quickly as possible.

Raising awareness about the gradual R&D paradigm shift within which disease mechanisms are increasingly understoodand more new indications for already approved products are developed.

Continuing the ongoing dialogue with all relevant stakeholders about the appropriateness of the current EU incentiveschemes to reward R&D efforts, within the context of this R&D paradigm shift.

Working to ensure that certain fundamental issues, which still remain unclear, such as the naming and labellingrequirements for biosimilars as well as their pharmacovigilance tracking, are adequately addressed.

Working at EU Member State level, in close collaboration with the EuropaBio’s National Associations Council, to addresslegal and regulatory implementation issues such as national rules on interchangeability and automatic substitution.

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medical needs much more than in the past. The medicalresearch model is evolving withresearchers departing from theold model of “one disease – onemedicine” and focusing insteadon understanding the pathwaysand molecular mechanisms of a given disease.

This mechanistic understandinghas shown that many diseasesthat were considered as unrelated actually share common molecular features.These features could be targetedby a medicine specifically forthis pathway. As a result,research and drug developmentdoes not stop with the creationof a product for one specificcondition, but will continuethroughout and beyond its lifecycle.

A new consensus is now needed on how important newmedicines or new applicationsfor existing medicines can be brought to patients in a sustainable way. A fair andappropriate reward system supporting innovation wouldencourage more investment into R&D of new uses for authorised medicines.

Biosimilars

Biological medicines are farmore complex than chemicalpharmaceuticals. This meansthat they are harder to preciselycharacterise, manufacture andcopy than chemical medicines,whose ingredients are easilyidentifiable and can be exactlyreproduced. Small variations in the structure of all biologicalmedicines may lead to differences in safety, efficacyand/or quality.

Biological medicinal productssimilar to a reference medicinalproduct (i.e. biosimilars) do notusually meet all the conditionsto be considered as a genericmedicinal product, mainly dueto manufacturing process characteristics, raw materialsused, molecular characteristicsand therapeutic modes of action.

The concept of a biosimilarmedicine was introduced in theCommunity Code relating tomedicinal products in 2004. TheEC has subsequently developedan abridged approval pathwayfor such medicines and the EMA has developed a numberof guidelines concerning the

required data needed for marketing approval. Despite the fact that progress has beenmade with the introduction of a legislative specific regulatory-framework for biosimilars,EuropaBio believes that thereare still some issues whichremain to be addressed, such as the naming and labellingrequirements for biosimilars,pharmacovigilance tracking,interchangeability (i.e. whereproducts can be exchanged onewith another without a significantrisk of adverse health outcome)and automatic substitution (i.e.the practice by which a differentproduct to the one specified on the prescription is dispensedto the patient without the prior consent of the treatingphysician). EuropaBio believesthat automatic substitutionshould not be allowed in thecase of biological medicines andthat the physician should alwaysbe involved in the decision toinitiate or change treatmentwith a biological medicine.


ACHIEVING BETTER ACCESS TO MARKET THROUGHOUT THE EU

Value of Innovation in Health Policy

The healthcare biotechnologyindustry is a critical source ofinnovation and, as such, is a keyplayer within the EC reflection“Vision for European Union in2020”. Today, the sector is seventimes larger than it was tenyears ago and has a 20% annualgrowth rate. However, due tothe complexity of the sector (i.e.products, policies and regulatoryenvironment), healthcare biotech’s contribution to society is at best underestimated.

The value of an innovation tends to be split into at leasttwo categories: breakthroughinnovation and incremental innovation. Breakthrough innovation can either be established by a landmark discontinuity or be the result of discrete incremental improvements. Such minor increments may ultimately bejust as important to patients. An example from within thehealthcare biotech area could be an improved mode of administration of a medicinerather than a new medicine assuch. Failing to also acknowledgeand reward all categories of

innovation – including incrementalinnovation – will undermine a vital part of the innovationprocess.

EuropaBio’s role is two-fold: i) promote the medical, economic and societal benefitsof biotech innovation and ii) engage with all relevant stakeholders in constructiveinteractions to explore ways tomaintain and to strengthen theindustry’s innovative efforts.

Health TechnologyAssessment (HTA)

Many EU Member States haveestablished Health TechnologyAssessment (HTA) processes tosystematically determine therelative “value for money” provided by new technologies –including biotech medicines –to, ultimately, support decision-makers in their pricing and reimbursement decisions.

However, HTA evaluations havea potentially critical impact onpatient access to treatment and on the rate of innovationavailability when used instead as a tool of cost-containmentpolicies in healthcare. Rewards to innovation should be

Regardless of their country of residence,all patients deserve timely access toinnovative therapies. However, as EU Member States increasingly resort to cost-rationing measures to contain theirhealthcare expenses, promoting the value and uniqueness of biotech medicines has becomeessential to ensure that tools such as HTA or tenders are used appropriately and do not reduce patients’ access to life-saving therapies.

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Rewards to innovation should be appropriately and fairly grantedbased on holisticassessments of newand of existing technologies.

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Achieving better access to market throughout the EU by:

Continuing to bring specific healthcare biotech expertise to all the forums on HTA, in particular the Joint Action onHTA, the Swedish EU Presidency Assessing Drug Effectiveness project (SPADE) and the discussions on the role ofthe EMA in assessing the relative efficacy of products.

Increasing the understanding of the impact of HTA processes and their use on Small and Medium Enterprises(SMEs) through the whole product life-cycle, and developing recommendations for EU and national authorities to address SME-specific HTA hurdles.

Continuing to communicate on the specific clinical, social and economic value of healthcare biotech products and increase the understanding among all stakeholders.

Organising a series of workshops, in partnership with other industry associations, on the specific policy, regulatoryand access hurdles for the most innovative healthcare biotech technologies.

Contributing to the revision of the Transparency directive; to ensure that the future framework takes intoconsideration the pricing and reimbursement issues associated with emerging technologies; in close collaborationwith other industry associations.

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appropriately and fairly grantedbased on holistic assessments ofnew and of existing technologies.Such assessment should acknowledge key elements suchas value to society as well as tothe economy, ethical views ofdisease management, impact onproductivity and quality of life,and value to both the patientsand to the community (i.e. patients’ relatives, caregiversand employers). Current EU efforts to provide a commonmethodological framework toHTA systems such as the JointActions on HTA should be giventhe right consideration and befurther integrated into a widerEU innovation policy to ensureconsistency of approaches.

EuropaBio calls for a robust and participative frameworkgoverned by transparency and in which relative effectivenessand HTA would be a tool toencourage the development ofnew and innovative therapies for the benefit of patients, whilst

allowing health care planners toappropriately fund and manageresources effectively in thesefinancially uncertain times.

Access to Innovative Medicines

In some EU Member States, purchasers (i.e. governments,hospitals, institutions and insurers)increasingly resort to procurementprocedures in order to awardcontracts for the supply of biotech medicines. Due to thecomplex nature of biotech medicines, biopharmaceuticalprocurement is a particularlycomplex process which involvesmany steps, authorities and suppliers/manufacturers.

EuropaBio acknowledges that all biotech products approvedby the EC, FDA or a similarregulatory authority qualify forthe current Good ManufacturingPractice (GMP) standards andhave been approved to safelyand effectively address a given

indication. However, by nature,healthcare biotech products aredifferent from each other, andare much more complex thansmall-molecule medicine.Therefore, it is important thattheir unique features be borne in mind when discussing the viability of tendering for biotechmedicines.

Patient safety is of courseparamount and within biotechproducts, which in most instancesaddress debilitating or life-threatening diseases, smallvariations in a “similar” but not“identical” product can be crucial.Therefore, whilst EuropaBio acknowledges that tenderingmight be an appropriate tool for purchasing biotech productswithin some specific fields; overall, EuropaBio does notbelieve that tendering with a sole focus on price is anappropriate way forward formedicines in general, includingbiotech products.


Small is the new big

In the EU, SMEs compriseapproximately 99% of all firmsand provide two out of three ofthe private sector jobs. Globally,SMEs account for 40% to 50%of GDP. Biotech SMEs areknowledge-based enterprisesand provide the high value-added jobs that will helpthe EU achieve its goal ofbecoming the foremost knowledge-based economy inthe world. Furthermore, SMEsare a major contributor to innovation and these companiesform what is described as asymbiotic relationship withlarge, multi-national companiesacross the healthcare, energyand agricultural sectors, pavingthe road for improved healthcarefor Europe’s citizens.

Within the healthcare sector, larger pharmaceutical companiesare increasingly looking to smallbiotech companies to improvetheir pipeline and provide theinnovation needed to remaincompetitive. These same large

companies have also becomeincreasingly reliant on externalR&D, mostly performed bySMEs. These programmes nowrepresent as much as 30% to50% of the pipeline of manymajor pharmaceutical companies.Therefore it is critical that theEU is able to ensure that there isadequate funding for theseSMEs. Too many potentiallygreat innovations go to wastebecause of a lack of funding. Ithas been recognised by severalmember states (e.g. France andthe UK) that there is a marketfailure due to the long R&Dtimelines, the increasing costsand the high risks associated withbiotech medicine developments.Potentially lifesaving treatmentsare often either put on hold, are significantly delayed or terminated altogether. In the end, this results in fewer innovative treatments reachingpatients in dire need.

The EuropaBio SME Platformworks together with stakeholdersto provide policy makers withrecommendations on how to

best support biotech SMEs,which often have specific issueswhen compared to SMEs fromother industry sectors. ThePlatform brings together SMEs,national biotech industry associations, venture capitalistsand financing bodies, amongstother stakeholders. It is dedicated to highlighting issuesand solutions of particularly highrelevance for SMEs on topics,such as financial constraints, the optimisation of EU fundinginstruments and patents.

One example is the Seventh EU Framework Programme forResearch (FP7), where the targetis to increase the number ofparticipating SMEs. So far, despite making SMEs a priority,within health proposals, only10.8% of the budget is currentlydirected to SMEs (the targetbeing 15%). The need for fundingfor translational research shouldalso be acknowledged: contraryto basic research, which is morespeculative and takes more timeto be implemented, appliedresearch is characterised by

Creating optimal conditions for Europe’s healthcare biotech SMEs by:

Continuing to work to ensure a bigger proportion of SMEs in FP7 and FP8 by suggesting concrete changes thatlower the administrative burden for SMEs and make the topic proposals more suited for SME applications.

Being a “one-stop shop” for information on developments and opportunities for biotech SMEs, at European and national levels, through our “SME Centre” portal on the EuropaBio website.

Supporting the realisation of a common EU patent. This would be a landmark improvement for SMEs to protecttheir inventions at an affordable cost, and without the need to validate patents at a national level as theycurrently must do.

Continuing our support of the EMA SME Office through active involvement in workshops and meetings.

Contributing to the work of the Innovation Union provisions to avoid internal market fragmentation, eliminate restrictive interpretation of State Aid for SMEs and to improve more general access to finance for those SMEs.

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being capable of having animpact in practice within a relatively short time-frame, and by often representing anincremental improvement tocurrent processes rather thandelivering radical breakthroughs.

Ensuring coherence fromEuropean to national level

EuropaBio represents over 20National Associations whichtogether form the NationalAssociations Council (NAC); aplatform which helps to ensurethe coordination of EuropaBioactions throughout Europe atMember State level, giving afocus to developing Europe'sbiotech sector and strengtheningits scope both in Europe andinternationally. NationalAssociations in particular supportover 1,800 SMEs and play asignificant role in our vision of abio-based economy for Europe.Since healthcare is a nationalcompetence amongst MemberStates, the NAC provides a fundamental bottom upapproach to the regulatory framework, as well as an insight

into the national landscape ofbiotechnology and how thisunderstanding can inform policymarkers at the European level.

Agenda 2020 is characterised bythe need for a smart, sustainable,inclusive and greener economy. Inorder for this vision to becomereality for the healthcare sector,it is essential that we considerhow decisions at the Europeanlevel shape national policy inorder to produce a truly patient-centered healthcare system forEurope. This approach isincreasingly important in light of unprecedented financial, economic and social strainsunder which national healthcarebudgets operate.

From one Member State to another, the lack of harmonisationin the implementation of EUlegislation can greatly hamperinnovation by creating a varietyof divergent, and sometimesconflicting, legal environmentslimiting the development andaccess to new biotech medicines.EuropaBio will continue to workwith National Associations inorder to adopt a holisticapproach to policy-making andimplementation at the Europeanlevel and in turn ensure effectiveand innovative Europeanhealthcare systems for patients’ benefit.

Ensuring coherence from European to national level by:

Working together to ensure consistent and workable implementation of EU policies at Member State level,particularly on issues related to biosimilars.

Being actively involved in the review of the Clinical Trials Directive (and other legislation, for example theTransparency Directive) process in order to have a harmonised, transparent and evenly implemented regulatoryframework across the EU, ensuring Europe’s healthcare biotech sector remains competitive globally.

Ensuring EuropaBio is the EU’s ambassador for biotechnology companies, disseminating information in a familiarcontext and language.

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EuropaBio is the voice of the European biotech Industry.

It represents the interests of the industry towards the European institutions so that legislation encourages and enables biotechnologycompanies in Europe to innovate and provide for our society’sunmet needs.

The European Association for BioIndustries was created in 1996 and represents 66 corporate and 7 associate members operatingworldwide, 4 Bioregions and 22 national biotechnology associationsrepresenting some 1800 small and medium sized enterprises.

Our corporate members are involved in a wide range of activities:human and animal healthcare, diagnostics, bio-informatics, chemicals,biofuels, crop production, agriculture, food and environmental products and services.

EuropaBio also welcomes associate members such as internationalcommercial, financial asset management and other service providingcompanies, regional biotechnology development organisations and scientific institutes. The common denominator among all ourmembers is the use of biotechnology at any stage of research, development or manufacturing.

Avenue de l’Armée, 6 B-1040 BrusselsTel: +32 2 735 03 13www.europabio.org

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