2011 annual report edma

Annual Report2011

Laboratory testing has indeed an essential part to play in the healthcare chain; from prevention and diagnosis to monitoring of the treatment. Not only does it take into account the predisposition, the price determination of the disease and its severity but also allows assessment of its efficacy and adjustment, disease management in case of chronic pathologies and confirmation of therapy efficacy to rule out any risk for persistence of disease.

Making a Real Difference in Health & Quality of Life

ForewordThe President’s View: solid foundations in a time of challenges 1

MeMber’s Corner SMEs and Global IVD Forerunners together 3

stakeholders 5

who is whoEDMA Executive Committee 7

FoCus on

Operation Rebranding EDMA - Diagnostics for Health 9

The Public Affairs Committee Helping members understand and shape their external environment 10

Market Trends A resilient sector despite the economic downturn 11

Health Technology Assessment More efficiency for the future of healthcare 13

IVD Legislation in Europe The coming of age 14

Health Literacy Better education, better patient outcomes 15

Convergence Through Engagement A way forward in a global world 17

Companion Diagnostics and Personalized Medicine A revolution of knowledge in healthcare 18

Join edMa 19

at your serviCeEDMA Staff 20

table oF Contents

1 EDMA ANNUAL REPORT 2011

Our diverse membership encompasses 21 national associations (and indirectly

hundreds of highly-specialised and innovative SMEs) and 42 corporate associate members. In late 2011, The Binding Site became our newest member. I truly believe this reflects the strengthening position of the association vis-à-vis the various Brussels healthcare stakeholders.

EDMA has worked hard to develop a solid network of partners with close links to the European institutions, other industry associations, patient organisations, regulatory agencies and other global IVD associations.

Following a rebranding exercise in late 2011, EDMA will continue to harvest both new stakeholder relations and reinforce those that already exist as the association becomes more ambitious in continuing to enhance its voice at the European and international level.

It is still dismaying to learn that less than 1% of European healthcare expenditure is allocated to in vitro diagnostics, not considering that nearly two thirds of all clinical decisions are influenced by a diagnostic test. As I have argued before, it is absolutely necessary to work towards changing the ingrained mind-set that diagnostics are an expensive and burdensome investment. On the contrary, EDMA has long asserted that diagnostics are an excellent investment for the future through the development of better targeted treatments for patients and lessening both the financial and physical burden on national healthcare infrastructures and resources.

European society and lifestyles are changing with an increasingly ageing population being one of the great challenges of the coming decades. EDMA is ensuring that our industry is at the

forefront of providing all-inclusive solutions, such as our growing emphasis on Health Technology Assessment (HTA), a major focus for our members that includes the development of Companion Diagnostics and Personalised Medicine.

Throughout 2011, EDMA has also made significant progress in providing continued guidance to the European institutions in regards to the revision of the IVD Directive, an imperative regulatory concern in the years to come. Being a long-term project, it is expected that by the second quarter of 2012, the European Commission will publish its proposal for a new legislative instrument for the regulation of IVD devices. EDMA will participate proactively and work closely with other stakeholders in responding to the proposal and ensuring the best possible outcome for the entire industry.

Our specialised market research programmes, EDMS (European Diagnostic Market Statistics) and MIS (Market Information System) also continue to strengthen their roles. Of course, the need for accurate data is vital, as it provides the backbone to our message that IVDs bring socio-economic as well as patient benefits.

EDMA has also reached out to build stronger ties with IVD associations from every region of the world, in both developed and developing markets, the latter of which is promising to yield exciting new possibilities for our industry.

In my introduction to the 2010 Annual Report, I asserted that the IVD industry is no longer the “Cinderella of healthcare.” I now feel absolutely confident to say that the strong position of IVDs is crucial to further the advancement of European healthcare provisions is definitely no longer a mere fairy tale but a promising reality.

ForewordDr. Jürgen SchulzeEDMA President CEO of Sysmex EMEA

The President’s View: solid foundations in a time of challenges

2011 has been a highly

eventful year and I have seen

first-hand as EDMA President

how much the association

with the contribution of all

its members has achieved in

what can be seen as a very

challenging period. Despite

the severe economic climate,

I remain convinced that the

future of the IVD industry will

be a bright one as our industry

is one that continues to foster

and seek innovation.

EDMA ANNUAL REPORT 2011 2EDMA ANNUAL REPORT 2011 2


MeMber’s Corner

SMEs and Global IVD Forerunners together

21 national association Members (naMs)

Romania Portugal Italy United Kingdom

Czech Republic Denmark Netherlands Spain

Greece Hungary Ireland Poland

Norway Austria Finland Slovakia

France Switzerland Sweden Belgium

Germany

EDMA membership brings together 21 National Associations in European countries and 42 major companies engaged in the research, development, manufacturing or distribution of IVD products. Through its affiliated National Associations, EDMA represents in total more than 500 companies.

EDMA ANNUAL REPORT 2011 4

42 Corporate associate Members (CaMs)


Delivering Results via Stakeholder Management The healthcare sector has undergone major transformations in the past few years, growing in complexity. Although the subsidiarity principle still prevails, it is incontestable that both the European institutions as well as international bodies like the World Health Organisation are becoming increasingly influential in shaping the political agenda and setting public health priorities.

With its solid network of partners (see non-exhaustive list on Page 6), EDMA has ensured that the requirements of the IVD industry are adequately addressed within the EU.

EDMA closely cooperates with the European institutions and with a series of patient and professional organisations to create synergies and join forces on mutual priorities.

By enhancing these valuable contacts, EDMA and its membership continuously increase awareness of the added value of in vitro diagnostics to maximise the impact of our activities.

stakeholders

EDMA and its extensive network of contacts

21 National Association

Members, 42 Corporate

Associate Members,

500 companies represented

across Europe. With these

robust numbers, EDMA

continues, year after year,

to successfully represent

the interests of the in vitro

diagnostic industry

vis-à-vis the most relevant

stakeholders.


Directorate-General forHealth & Consumers

Policymakers & Payors

TM

Industry Associations Doctors & Scientific Associations

Patients Associations

Think Tanks European Cervical Cancer Association


who is who

EDMA Executive Committee

dr. Jürgen schulzePresident EDMAvdGh - sysmex

Dr. Jürgen Schulze became a board member of EDMA in 2003 and was elected as the Association’s President in 2009. He is the CEO and President of SYSMEX Europe, Middle East and Africa after having held several other positions in SYSMEX since 1995. Dr. Schulze has also been on the board of the German National Association VDGH since 1997 and has been elected President from 2007 to 2009. Prior to joining Sysmex, he has held several business functions in the IVD industry, mainly linked to Merck AG and Bayer Diagnostics, both in Europe and the USA.

Christian ParryVice President EDMA

sFrl - stago

Christian Parry is the Production Director at Stago. He has held several positions within the company, such as Head of International Marketing & Sales and R&D Managing Director. Vice President of the French Association SFRL, he is also the rappor teur for the National Association of the Regulatory Affairs Commission.

benny onsTreasurer EDMAunaMeC - bd

Benny Ons is Director of Regulatory Affairs, Regulatory Compliance and Quality Management at BD Biosciences Europe. He is also chairman of the EDMA Regulatory Affairs Committee, and Vice Chair of the GHTF (Global Harmonisation Task Force) Study Group 1. At the EDMA board, he represents the Belgian Association, UNAMEC.

kathy turnerVice President EDMAabbott diagnostics

Kathy Turner is Divisional Vice President at Abbott Diagnostics, Area Europe. She has held several positions with increasing responsibility within the company heading, inter alia, Commercial Operations, Global Strategy, Product Portfolio Management, Marketing, Scientific Affairs, Business Development, Market Research and Communications.

ugo Mario GayassobioMediCa -

diasorin

Ugo Gay, Diasorin’s Regional Vice President for Europe and Africa, represents the Italian Association, Assobiomedica. He started his career in 1985 at the family business Pietro Gay Spa in the textile sector. From there, he moved to the Istituto Biologico Chemioterapico before joining Diasorin in 2000.

Werner Hofacher is the Corporate Vice President, Commercial Operations Europe of Beckman Coulter. He joined Beckman Coulter in 2004 as the Managing Director for Germany and Vice President, Commercial Operations Central Region after having worked for Baxter International in Germany where he held the position of Vice President Renal for Europe. Before that he was the Managing Director for Germany of DADE Diagnostics. In the Executive Committee he represents the Swiss Association SVDI/ASID.

werner hofachersvdi/asid -

beckman Coulter


David Martin is currently Country Division Head at Bayer Diabetes Care and MERA, being before Marketing Director at Bayer UK as well for Bayer Diabetes Care and MERA. A seasoned professional in the IVD industry, David Martin is member of EDMA IVD in Healthcare Project as well as in working parties on Diabetes.

david Martinbivda - bayer

Michael Heuer entered Roche Diagnostics Manneheim as Product Manager Immunoassays in 1983. Throughout his career with Roche, he has held different leading Marketing and Sales positions in Germany and the United States, before being appointed Head of the Roche Near Patient Testing Business Area in Austria in 2001. From 2004 to 2007, he was Head of the EMEA Subregion-1 covering Central and Eastern Europe, Turkey, Greece and South Africa. He currently heads the EMEA-LATAM Diagnostics Region (Europe, Middle East, Africa and Latin America) within Roche Diagnostics.

Michael heuerroche diagnostics ltd

Vivian Wang is the President of LifeScan Europe Middle East and Africa (EMEA) which is part of the Diabetes Care Franchise of Johnson & Johnson. She joined Johnson & Johnson in 1991 and has served in marketing and general management roles in the United States, Asia Pacific, and Australia for the Consumer and Vision Care franchises prior to assuming her current role.

vivian wangJohnson & Johnson

Stefan Wolf works at Siemens Healthcare Diagnostics as CEO for the HHS Business Unit for the DX division. The HHS Business Unit, headquartered in Marburg,Germany, includes Hematology, Hemostasis, and dedicated systems for Syva, Plasma Proteins, and Infectious Disease (MTP) testing. Formerly he used to be General Manager and Vice President of Region EMEA I, with its countries Germany, Switzerland, Austria, SEE, Italy, Poland & Russia. He joined the former Dade Behring in 1981 and has since then held several positions in Sales, Research & Developmet, Marketing, Service, Production & Operations and General Management.

stefan wolfsiemens healthcare diagnostics Gmbh

Rika Dutau is Vice President and Managing Director at Cepheid Europe. She joined Cepheid in 2007, being before VP and General Manager at Teleflex Medical where she was responsible for the surgical businesses across Europe, the Middle East and Africa. Previously, she held a variety of senior management, sales, marketing and business development roles in the medical device and critical care industry.

rika dutauCepheid

Michel Bonnier has more than 20 years of experience in the diagnostics field industry where he occupied various positions entirely focusing in the commercial activity such as product manager, group manager, subsidiary managing director (Canada).

His previous to last position was as marketing Director of bioMérieux France and since 2007 he is the Public Health Vice President of bioMérieux wthin the Public Health Department which is in connection with organizations dedicated to facilitate the access to diagnostics in developing countries.

Michel bonnierbioMérieux


Following an exciting and comprehensive rebranding exercise, EDMA proudly unveiled

a brand new logo and tagline (image below) during its 2011 European IVD Forum. Today with a refreshed website, restyled newsletter and a new identity, EDMA aims to lead the way in operational excellence and expand its engagement in advocating the value of the in vitro diagnostics industry. Operation Rebranding has been more than a mere old wine in new bottles exercise. It is an ambitious step encompassing EDMA’s determination to drive forward its activities to substantially enhance the voice and recognition of the IVD industry at the European and international levels. The rebranding mirrors the spectrum of its varied membership of highly-innovative SMEs, on one hand, and of large international companies, on the other.

With the increasing role of the in vitro diagnostic industry in the formulation and implementation of European healthcare policy, the new logo distinctly anchors EDMA in the minds of all relevant stakeholders as the active force behind the industry engagement with key European policy makers and other healthcare associations.

The force of the visual is accentuated by its simplicity as well as the direct articulation through the tagline “Diagnostics for Health”. Last but not least, the use of a vivid red has direct connotations with the human body whilst the royal blue narrates the seriousness of EDMA as a reliable partner to advocate the added value of in vitro diagnostics to citizens health.

FoCus onOperation Rebranding: crafting the perfect diagnostic message for the years to come

Miriam GargesiPublic Affairs and Communications Director


Our goal is to unlock the full potential of diagnostic testing and thereby improve

patient outcomes by ensuring an adequate legislative framework. To take an active role in the agenda-setting, EDMA has built a sophisticated network vis-à-vis the European Parliament, the Council of Ministers and the European Commission, which are fundamental to our strategic advocacy ambitions.

As a highly-innovative sector with short product life cycles, our key objectives include promoting rapid access and demonstrating timely detection of patients at risk, identifying early stages of

Dagmar Kownatka, Chair of the Public Affairs Committee and Head of Professional Relations EMEA/LatAm for Roche Diagnostics:EDMA takes an active, constructive and engaging approach in order to shape European policies on in vitro diagnostics by promoting the benefits that IVDs provide to patients. Being part of the association also means that I am in touch with contemporary developments in my field and it is very stimulating to work with so many great professionals to shape our companies’ business environment. I know that through my engagement with EDMA I can really make a difference and contribute to the decision-making process in various policy fields that are of relevance to my company, such as diabetes care and its management.

Fernanda Gellona, Vice Chair of the Public Affairs Committee and Director General of Assobiomedica:There certainly are multiple benefits to being a member of an industry association. EDMA facilitates privileged access to key decision-makers for its members which allowed me to come to Brussels in 2011 and meet high-level Italian representatives working for the EU institutions, such as MEPs, Commission officials and representatives of the Permanent Representation to the EU. This provided me with an excellent opportunity to discuss matters closest to my heart, such as the late payment situation in Italy and the need to simplify and clarify public procurement procedures. I would certainly say that this contact programme led to strong and meaningful relationships that are of great value to me and the members of Assobiomedica.

disease as well as monitoring treatment progress via the use of in vitro diagnostics.

As Public Affairs specialists, we provide strategic information on ongoing and upcoming initiatives at the EU level and devise targeted advocacy activities that raise awareness of the valuable role our technologies play for the provision and delivery of healthcare. Through its focus on early diagnosis, our industry is in a privileged position to contribute to the sustainability of healthcare systems in times of economic insecurity and against the background of an ageing society.

FoCus onThe Public Affairs Committee: helping members understand and shape their external environment

EDMA’s Public Affairs

Committee is responsible

for promoting the medical

and economic benefits of

IVDs for healthcare systems

and disease management

strategies. The Committee

brings together Government

Affairs, Health Policy and

Public Affairs experts from

IVD companies and national

associations. Together with

the Public Affairs department

at EDMA, they take an

active role in analysing policy

developments in order to

inform and shape European

policymaking that will affect

the IVD business.


Every year EDMA publi-shes macro-econo-

mic data and healthcare expenditure figures for the European Union as well as the European Free Trade Association (EFTA) to show the per-

formance of the IVD industry.

The fact remains that over 60% of the information held on the patient record comes from diagnostic tests and the growing awareness that IVD testing is a cost-efficient way of providing information required for earlier diagnosis and management of many diseases.

EDMA has witnessed governments around Europe in 2010 have continued to apply short-sighted limitations on testing volumes and reimbursements in an attempt to balance budgets.

This has transpired despite of the changed role of the patient – thanks to the recent health

literacy initiatives and the availability of new and promising technologies, such as Companion Diagnostics.

Another factor leading to slow down in market growth is the continued consolidation of laboratories leading to increase of purchase volume impacting price negatively. Despite volume increases the overall monetary value of diagnostic testing has decreased impacting profits of IVD manufacturers.

Overall revenue growth in Europe was roughly 2.0% in 2010 as opposed to 3.0% in 2009. Major growth was registered in cardiology testing, bone disease and diabetes. Latest figures reveal that the 2011 IVD supplier growth will only be in the range of 0.5 - 1.0% with negative growth in Portugal, Slovakia and Spain. Stagnant or slightly negative growth was experienced in Belgium, France, Italy and Switzerland. On availability and confirmation of 2011 trends by the National IVD Trade Associations the final European IVD revenue performance 2011 versus 2010 will be published by EDMA mid-year 2012.

A very strong double digit growth was observed in the segment related to the management of hospital acquired infections, whereas all other areas such as routine clinical chemistry and haematology remained stagnant or declined. This trend explains why revenue growth in 2010 was significantly lower than in 2009, which continued in 2011. One major double digit growth driver was Vitamin D in 2011.

European average IVD sales as of Total Healthcare Expenditure remained stable at 0.8%, whereas IVD expenditure per capita reached € 20.6 (therefore slightly increasing from € 20.1). In relation to overall healthcare expenditure IVDs are not a relevant cost factor despite their contribution to evidence based medicine. Greece (-13.7%), Hungary (-4.0%) and Ireland (-3.6%) registered or demonstrated the worst market performances due to, inter alia, late payments from public administration (Greece) and increased costs of energy and labour (Hungary).

FoCus onEuropean IVD Market Overview: lights and shadows at a time of economic downturn

EDMA figures indicate

that the total revenues of

the European In Vitro

Diagnostics industry grew

by roughly 2.0% in 2010,

reaching € 10.5 billion.

The largest market shares

are, as in previous years, held

by Germany (€ 2.1 billion),

France (€ 1.8 billion),

and Italy (€ 1.7 billion).

Germany 2158

Mio €

Estonia

Cyprus

Lithuania

Latvia

Slovenia

Slovakia

Hungary

Romania

Bulgaria

Ireland

Norway

Finland

Denmark

Czech Republic

Sweden

Greece

Austria

Portugal

Poland

Switzerland

Netherlands

Belgium

UK

Spain

Italy

France

0 500 1000 1500 2000 2500

13

3

25

24

31

32

52

75

77

80

97

100

134

162

177

190

249

258

293

294

316

340

774

1094

1703

1773

■ EDMS

■ Estimation by EDMA Market Research Committee and National Trade Associations

total ivd Market 2010:

• EU-27 (except LU&MT): € 10.132 Mio.

• EU-27 (except LU&MT) + EFTA (except ICE&LIE): € 10.524 Mio.

Helene WashingtonChair, EDMA Market Research Committee Manager Market Research & Assessment EMEA & India


* The applied exchange rates are the 2010 annual average exchange rates published by Oanda (www.oanda.com). Applying a single exchange rate to both 2009 and 2010 sales data eliminates possible fluctuations of market size and market growth due to exchange variations. The data regarding population and healthcare expenditure are from the annual OECD report. UK data does not reflect the market share of companies which do not participate in EDMS. Swiss data include Lichtenstein.

Countries Population GdPGdP / capita the

the / capita

the as % GdP

ivd mkt. 09

ivd mkt. growth

rate 08-09ivd mkt. /

theivd mkt. /

capita

000 Mio € € Mio € € % Mio € % % €

source oeCd 2009 source edMa

Germany 82,834 2,397,100 29,268 278,345 3,399 11.60% 2,157.91 -0.10% 0.80% 26.1

France 62,451 1,907,145 30,448 224,699 3,587 11.80% 1,773.00 4.20% 0.80% 28.4

UK* 61,349 1,626,627 26,696 159,095 2,611 9.80% 773.85 6.20% 0.50% 12.6

Italy 59,018 1,519,702 25,781 143,998 2,443 9.50% 1,702.50 1.10% 1.20% 28.8

Spain 46,073 1,503,974 32,746 100,231 2,182 6.70% 1,093.70 0.50% 1.10% 23.7

Netherlands 16,448 571,979 34,839 68,413 4,167 12.00% 315.8 2.20% 0.50% 19.2

Greece 11,284 235,017 20,829 21,893 1,940 9.30% 190 -13.60% 0.90% 16.8

Portugal 10,665 168,610 15,862 17,287 1,626 10.30% 258 -0.80% 1.50% 24.2

Belgium 10,556 339,162 31,416 36,886 3,417 10.90% 340 1.80% 0.90% 32.2

Sweden 9,385 320,685 34,479 32,458 3,490 10.10% 177.28 4.00% 0.50% 18.9

Austria 8,388 274,320 32,802 30,308 3,624 11.00% 249 2.00% 0.80% 29.7

Denmark 5,544 222,634 40,339 25,649 4,647 11.50% 134.29 2.60% 0.50% 24.2

Finland 5,363 171,193 32,065 15,674 2,936 9.20% 99.96 2.00% 0.60% 18.6

Ireland 4,470 159,645 35,803 15,222 3,414 9.50% 80 -3.60% 0.50% 17.9

Luxembourg 502 38,072 77,225 2,957 5,998 7.80% - - - -

eu-15 394,330 11,455,865 - 1,173,114 2,985 10.24% 9,345.29 1.50% 0.80% 23.7

Poland 38,187 338,302 8,867 24,846 651 7.30% 292.95 8.20% 1.20% 7.7

Romania 21,462 117,071 5,445 5,364 249 4.60% 75 10.30% 1.40% 3.5

Czech Rep 10,517 143,584 13,980 11,836 1,152 8.20% 162.36 4.10% 1.40% 15.4

Hungary 10,000 94,985 9,465 7,065 704 7.40% 51.87 -4.00% 0.70% 5.2

Bulgaria 7,564 33,906 4,457 1,877 247 5.50% 76.8 3.50% 4.10% 10.2

Slovakia 5,425 63,050 11,682 5,747 1,065 9.10% 31.62 2.00% 0.60% 5.8

Lithuania 3,329 26,811 8,003 2,008 599 7.50% 25.22 1.00% 1.30% 7.6

Latvia 2,248 18,767 8,300 977 432 5.20% 24.22 0.50% 2.50% 10.8

Slovenia 2,025 35,384 17,517 3,279 1,623 9.30% 31.2 4.00% 1.00% 15.4

Estonia 1,339 886 661 62 46 7.00% 13.23 2.00% 21.30% 9.9

Cyprus 803 16,947 21,263 899 1,128 5.30% 3.06 2.00% 0.30% 3.8

Malta 414 5,712 13,797 419 1,012 7.30% - - - -

eu-27 (eu-15 + new Ms) 497,643 12,351,270 - 1,237,493 2,494 10.00% 10,132.82 1.70% 0.80% 20.4

Switzerland* 7,822 387,914 50,092 44,197 5,707 11.40% 294.22 -1.60% 0.70% 37.6

Norway 4,889 297,487 61,604 28,569 5,916 9.60% 97.21 2.50% 0.30% 19.9

Iceland 318 9,091 28,500 878 2,751 9.70% - - - -

total (eu-27 + eFta) 510,672 13,045,762 - 1,311,136 2,576 10.10% 10,524 1.50% 0.80% 20.6

european GdP, the and ivd Market 2010


So how exactly do sound and transparent HTA processes contribute to enhancing the

efficiency of healthcare systems? HTA compliments the information available on the performance of the technology as specified on its label (assessed by regulatory agencies) by providing insight in the value of the technology for healthcare and society while considering multiple aspects in the context of a specific healthcare system.

To obtain the best possible outcomes, HTA processes therefore require the proper involvement of patients, healthcare professionals and industry. When the needs and concerns as well as the expertise of these stakeholders are taken into consideration, HTA has proven a useful tool to facilitate decision-making that allows for the efficient allocation of resources and an informed uptake and diffusion of health technology. HTA should thus encourage and reward innovation with the greatest value to patients and society.

Thereby, HTA should benefit both patients and healthcare payers by allowing faster, evidence-based access to innovative technologies that are clinically sound and cost-effective, while helping to eliminate treatments and practices that are shown to deliver more limited health benefits or less financial value.

However, HTA is by no means a harmonised procedure, and criteria on which HTA decisions are based vary widely across the EU, which can lead to unequal access to treatment.

Industry involvement in HTA – value or bias?

Against this background it is of ever greater importance that the healthcare industry is recognised as a valuable partner in the overall HTA process and that the independence of

HTA agencies in providing advice to payers and governments is strengthened at the same time.

Over time, most HTA systems at the national and/or regional level have evolved in this direction and strive to increase industry engagement, both at the policy level and in specific technology assessment processes. This evolution is crucial as it will lead to system and methods improvements. In support of these developments, a broad coalition of stakeholders has conducted a series of joint advocacy activities over the past months to emphasise the added value of industry involvement in both the HTA policy formulation and in the assessment of specific technologies.

The benefits of industry involvement in the development of HTA policy and methodologies at European level are numerous, such as capitalising on the industry’s in-house HTA-capacity and their role in assuring efficiency and quality in healthcare. To this end, EDMA members have continued in 2011 their active engagement in the Stakeholder Advisory Groups of the EUnetHTA Joint Action 2010-12 which brings together experts from the European Commission, local HTA agencies and not-for-profit organisations that produce or contribute to HTA.

Apart from feeding into the policy-making processes, EDMA members have also shown that they are in a privileged position to provide expertise and experience on specific technologies that are undergoing assessment by HTA agencies. They have expertise in HTA over time and across countries and not only produce or sponsor the vast majority of evidence, but also have a sophisticated understanding of their products. In the upcoming months, EDMA will therefore continue to spread the message that IVD manufacturers are a gateway to innovation and need to be recognised as such.

FoCus on

Health Technology Assessment: more efficiency for the future of healthcare

Health Technology Assessment

(HTA) is a multidisciplinary

field of policy analysis that

studies the medical, social,

ethical, and economic

implications of development,

diffusion and use of health

technology in a systematic,

transparent, unbiased and

robust manner. With the aim

of informing the formulation of

safe, effective health policies

that are patient focused and

seek to achieve best value,

HTA is increasingly playing a

central role in how national

healthcare priorities are set

and how service provision

is delivered throughout the

European Union.

Jennifer CainChair, EDMA HTA Taskforce Director, Payment Policy Global Public & Government Affairs, Novartis


Something old – Given the broad agreement that the existing directive worked very well, it is not surprising that many of its elements will remain in place. In particular most of the essential requirements, the use of common technical specifications and the key role of harmonized standards will be part of the revised text.

Something new – Since 1998 science has advanced and so has regulatory thinking. As such new regulatory concepts around software, companion diagnostics, genetic testing and point of care testing devices will be addressed in the upcoming revision to reflect the reality in the field.

Something borrowed – In the last ten years most of the innovative thinking when it comes to regulatory systems has been done at the international level within the Global Harmonization Task Force (GHTF). From the GHTF several key concepts are being borrowed and integrated into the revised text. This will change the whole classification and conformity assessment systems of the directive and also the way in which clinical evidence for IVDs is addressed by manufacturers.

Something blue – When the Commission put together the new approach; they summarized the key concepts in the Blue guide. The Blue

guide described the regulatory principles which products that circulate freely within the single market need to follow. The new approach has since been revised but IVDs are asked to follow the single market principles. Changes such as the functioning of notified bodies and regulation of distribution practices will be implemented in the IVDD revision from the new approach recommendations.

A silver sixpence – A bride’s sixpence represented the hopes for financial stability in the next phase of her life. Similarly, the underlying discussions on the regulatory system have been the question of how these directives are financially viable. While not officially part of the revision process, the financing of the regulatory system will be one of the key forces shaping the sector in 2012.

In 2011, EDMA worked closely with the European Commission and competent authorities to prepare the conceptual basis for the revision of the regulatory system. As in any wedding planning, logistical details are the first priority. Not only will EDMA’s regulatory team work to ensure the smooth transition but also expertise will be pulled in from within the membership and engagement of national decision makers through national associations playing a defining role in the shaping of events in 2012.

FoCus on

IVD legislation in Europe the coming of age

There is an old saying in

English, that on her wedding

day a bride must always have

with her:

Something old,

Something new,

Something borrowed,

Something blue,

And a silver sixpence

in her shoe.

Remarkably these key

elements at play transfer

smoothly to the revision of

the IVD Directive.


The doctor’s suggestion sounds reasonable and with health literacy on the rise, it is now a common practice. However, there seems to be a huge discrepancy between how a patient interprets a scientific brochure versus the desired message.

A recent study from the European Commission has shown that just one in five people fully appreciate all the information provided by health professionals. Moreover, of those who do not understand what they are told, only 43% say they ask for clarification when details are not clear.

Health literacy has become imperative to people’s motivation and access to understand, appraise and apply health information in order to make judgements. It furthers the ability to make decisions in everyday life concerning healthcare, disease prevention, and health promotion.

Limited health literacy can therefore hamper patients’ ability to manage their disease as

they will encounter issues in filling out complex forms, locating providers and services or even sharing their health history.

It is a fact that informed patients manage their diseases better. Therefore, fostering their active involvement must be an A-topic in all healthcare stakeholders’ agendas, IVD industry included.

This is clearly not an easy mission. There are indeed structural (time with health provider, patient forms, navigation of healthcare system), emotional (fear, perception of risk, embarrassment), and informational barriers (lack of medical knowledge, complex medical information and instructions) to health literacy.

Lab Tests Online and MedicalLab, the two health literacy platforms coordinated by EDMA, have well understood these challenges and contribute every day to overcome these barriers and to achieve one ambitious yet crucial mission: unlocking patients’ potential for better health outcomes.

FoCus on

Health Literacy Educate, Prevent, Empower

A typical scenario in hospitals

and clinics across Europe:

Doctor:

Do you understand what you

should do once you go back

to your place?

Patient:

Yes, I do.

Doctor:

Well, by all means here is the

leaflet with all facts.

If you have any concerns,

please read it carefully.


Which tests are commonly performed during pregnancy? How are glucose levels measured to keep diabetes under control? How is my cholesterol checked?Until ten years ago, finding accurate answers to such questions and specifically in vitro diagnostic test related inquiries was not only challenging but at most times impossible.

However, since its launch in 2001 by the American Association of Clinical Chemistry, Lab Tests Online has revolutionised the scenario and shows promising progress in health literacy in the years to come.

This is particularly true in continental Europe, where thanks to the partnership with ten EDMA industry associations such as AFPM (Romania), Apifarma (Portugal), Assobiomedica ( Italy), CZEDMA (Czech Republic), FENIN (Spain),

Hellasmes (Greece), HIVDA (Hungary), IPDDL (Poland), SFRL (France), and VDGH (Germany). This multilingual, peer-reviewed, patient-centered, and non-commercial information portal on laboratory testing has consistently increased its number of visitors (380000 monthly). At first hand proving that the work of clinical laboratory professionals, although unnoticed is yet a crucial- element in realm of patient’s symptoms and the doctor’s diagnosis.

Through word-of-mouth, off-line promotional materials, search engine optimization and referential links more and more patients are relying on this project’s high quality standards, which are also certified by the Health on the Net Foundation (HON Code) and acknowledged by the European Commission on the official EU-Health Portal.

www.labtestsonline.info

Lab Tests Online: Teaching the world what we do

Another initiative specifically tailored to fill the health literacy gap is MedicalLab, the multilingual, interactive website created by EDMA in collaboration with Diagned, the national IVD association in the Netherlands.

By providing concise explanations of the different types of medical laboratory tests (examples based on blood, urine, or tissue samples) and the function they have in prevention, diagnosis, prognosis and therapy, MedicalLab plays an important educational role. MedicalLab provides a real-life look at in vitro tests with the use of animations.

Apifarma, BIVDA, Diagned, IPDDL and SFRL, EDMA’s Portuguese, British, Dutch, Polish and French member associations, as well as JACRI, the Japanese IVD association have made MedicalLab available in their respective languages.

www.medical-lab.info

MedicalLab: a backstage look at laboratory testing

FoCus on


EDMA members are engaged in a global environment and work in a global setting. In this regard, it is natural that EDMA provides support for its members for those activities. For that reason EDMA has worked in 2011 to coordinate activities of its members in China, Saudi Arabia, Russia, South Africa and Malaysia. This represents key markets, and areas of opportunity to influence developing legislation which EDMA has taken on board.

Strategically the pursuit of global activities is a priority for EDMA since activities at the global level will have a significant impact in Europe. This is particularly the case of the work carried out at the level of the Global Harmonization Task Force (GHTF), where for many years regulators and industry have worked together to try to find a path towards regulatory convergence. 2012 will be the year in which the GHTF sunsets, its work drawing to a close as authorities organize themselves into the International Medical Devices Regulators Forum (IMDRF). The new group will include regulators from the original GHTF members (EU, US, Canada, Australia and Japan) while the emerging economies have also been invited to participate particularly China, Brazil, India and Russia, and most importantly the WHO. The re-organization changes the governance of the system but not the engagement by EDMA. EDMA remains engaged with IMDRF projects and supporting the goals of convergence through the development and implementation of international guidelines as well as to its strategic goal.

Developing partnerships is key to the success of global activities. The IVD industry around the world is facing similar concerns and questions which is why not only has the engagement extended to the regulators EDMA works with but also equally important is the extent of the increased engagement of

EDMA with associations around the world. The development of closer ties with Advamed Dx (US), JACRI (Japan, reagents), JAIMA (Japan, instruments), CBDL (Brazil), IVD Australia and IMEDA (Russia) are some of its examples. The coming year 2012 is expected to be a time of enhanced collaboration to ease together into working with the new IMDRF and on other global issues.

Working with the World Health Organization and in particular its pre-qualification programme for diagnostics is noteworthy as it has the potential to impact those areas of the world currently not covered by regulations. EDMA has been engaged with the WHO pre-qualification programme since its inception and continues its collaboration with the same objective in mind – convergence of the requirements around the world.

Why is convergence so important? Ultimately all IVDs, irrespective of where they are being used around the world need to be safe and effective for the patients in order to deliver information which is relevant for diagnosis and ultimately treatment of medical conditions. Conceptually, there are very few reasons why there should be different criteria for a device to be safe and effective and convergence of the requirements is not only a boon to industry as it facilitates the dissemination of technologies and devices but also to physicians and patients who will benefit from these devices.

Convergence is on-going and to an extent an aspirational goal – the work will continue. EDMA would like to express our thanks to our members, in particular the Globalisation task force for their commitment and support in this challenging area of activity. Without their engagement most of this work would not have been possible.

FoCus on

Convergence through engagement A way forward in a global world

Activities at a global level are

intrinsically more complex

and resource consuming than

activities at the European level.

Yet EDMA throughout 2011

has remained engaged

with regulatory activities

around the world.

Jesús Rueda RodríguezRegulatory Affairs Director


Nonetheless, the initial analysis of the human genome in 2001 clearly marked the arrival of a new era in healthcare. In little more than a decade, researchers all around the world have made significant advances in the diagnosis and treatment of high-burden diseases such as cancer by personalising medical interventions on the basis of the patients’ genomic information.

Companion diagnostics and personalised medicine aim at improving patients’ health through targeting specific treatments to individual patients or groups of patients based on their characteristics, such as the over-expression of a certain protein. Applying these innovative methods and tools offers significant advantages over the traditional “trial-and-error” and «one-size-fits-all» approaches and has the potential to create predictable patient outcomes and reduce inefficiencies in healthcare systems.

Companion diagnostic tests enable the selection of previously diagnosed patients who are most likely to react favourably to a specific treatment. Thereby, response rates can be improved and fewer patients are needlessly exposed to the risk of side-effects from medicines that will be ineffective in their system. Moreover, understanding the underlying molecular mechanisms of diseases also enables selecting treatment sequences and their duration.

Although there already are some very promising companion diagnostics and personalised medicine on the market, the potential of “omics” technologies (e.g. genomics, proteomics, transcriptomics, metabolomics) is still largely unexplored and several challenges remain with a view to the further translation of research outcomes into actual products. It is thus essential that the EU’s role in innovation is augmented to make science deliver its advances for European patients.

EU industrial policies should strengthen cornerstones for successful R&D. In particular, EDMA calls for a proportionate regulatory regime which will foster innovation and guarantee the safety and efficacy of companion diagnostics and personalised medicine. Due to their different nature, the regulatory pathways for placing an in vitro diagnostic (IVD) medical device and a medicinal product on the market are different, but policy-makers need to ensure the timely availability of both products to patients once the efficacy of the system has been proven. Health Technology Assessment (HTA) therefore needs to take account of the specificities of these technologies. Patient access is important, but the issue of reimbursement is crucial. We must address the scenario in which a pharmaceutical is already available, but a barrier to treatment is created because the companion diagnostic is not yet reimbursable through national healthcare systems.

In this respect, the upcoming revision of the IVD Directive (98/79/EC) and debates on other relevant pieces of legislation (Transparency, Data Protection and Clinical Trials Directives) will pave the way towards making companion diagnostics and personalised medicine a fully integrated element of the healthcare equation in Europe.

EDMA and its member companies strongly believe that companion diagnostics and personalised medicine offer healthcare providers and policy makers an ideal tool to face growing demands of healthcare from an aging population. This in turn to obtain efficiency gains against the backdrop of economic and budgetary austerity. We are committed, more than ever, to helping science and citizens enjoy the benefits of companion diagnostics and personalised medicine, as we strongly believe that, in the profound words of Nobel Prize winner Rita Levi Montalcini, “we need to add life to our days and not days to our life”.

FoCus onCompanion diagnostics and personalised medicine: a revolution of knowledge in healthcare

Recently, personalised

medicine has emerged

as a leading paradigm in

healthcare. However,

providing the right treatment

to the right patient at the

right time is no longer a

new concept in healthcare.

Hippocrates (460-377 BC)

already knew that “it is more

important to know what sort

of a person has a disease

than to know what sort

of disease a person has.”

Geert CallaertsChair EDMA Companion Diagnostics Taskforce Associate Director, Regulatory Affairs, Johnson & Johnson


Access to reliable information sources and the ability to judge the significance and likely speed of change are also vital. EDMA delivers insight into the forthcoming legislative challenges and actively intervenes in the legislative, regulatory and standard-setting processes.

Added values of EDMA membership

1. Gain competitive advantage By accessing information at an early stage regarding major issues which will influence the strategic planning process.

• EDMA accelerates members’ decision-making ability by providing timely insight into regulatory developments that impact IVD manufacturers, together with unparalleled market intelligence on the European IVD sector.

• EDMA members save both time and financial resources by having access to exclusive analyses and expert opinions via convenient online and offline communications tools.

2. Extend network of contacts EDMA organises regular events which bring together policy-makers, industry experts, academics and professional and patient groups to discuss key issues such as late payments, vigilance or environmental practices.

• EDMA meetings provide a unique opportunity to stay informed whilst making contacts of value to your business.

3. Influence industry thinkingBy participating in EDMA’s internal working groups, exchanging views and pooling expertise to deal with issues of common interest, members can be influential in setting industry policy.

• EDMA members elaborate common industry positions and key messages to be presented to policymakers, whether for short-term regulatory issues, or for longer term healthcare policy strategy.

4. Be heard by the European institutionsEDMA is the recognised and legitimate organisation for open debate between the IVD industry and decision makers at the EU level and other international bodies.

• Involvement in all relevant EU processes would demand vast resources for an individual manufacturer. Working through EDMA, members amplif y their impact through extensive networks and interaction with major stakeholders in the political and regulatory environment.

Join us

Added values of EDMA

EDMA plays a valuable

‘‘diagnostic” role for its

members by screening

ongoing EU activities

relevant to the IVD industry.

Possession of timely and

pertinent information is crucial

for IVD industry leaders

looking to make informed

decisions regarding

the design and operation

of their businesses.


General Management

Dr. Volker OedingDirector General ad interim

Patricia De BuylOffice Manager

Caroline RaetsAssistant

Regulatory Affairs Department

Jesús Rueda RodríguezRegulatory Affairs Director

Petra ZoellnerRegulatory Affairs Manager

Katalin MátéRegulatory Affairs Officer

Public Affairs and Communications Department

Miriam GargesiPublic Affairs and Communications Director

Shweta KulkarniCommunications Manager

Vanessa PottSenior Public Affairs Officer

Engage and Promote!

This year become a member of EDMA! Be part of our network to actively promote the added value of IVDs in the overall healthcare equation! Visit us online at:http://www.edma-ivd.eu/

European Diagnostic Manufacturers AssociationPlace des Maïeurs, 2 - 1150 Woluwe Saint-Pierre - Brussels - BelgiumTel. +32 2 772 22 25Fax +32 2 772 23 [email protected]

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