ANNUAL REPORT 2 0 1 32.3 manufacturers’ environmental responsibility: creation of 2 sectors 2.4 learned societies 2.5 patient associations 2.6 ariis 2.7 cep, ifis, schools, universities,

2 0 1 3A N N U A LR E P O R T

2 0 1 3R E P O R TN N U A L

02

Leading professional organisation representing the medical devices and the healthcare information and communication technologies sector (set up in 1987)

• 340 members: SMEs, mid-sized companies and subsidiaries of international groups marketing a wide range of technolo-gies for personal and collective use (consumables, equipment, technical aids, implants, instrumentation, software, etc.)

• Medical Device Market in France: €19bn (source: PIPAME Report - June 2011) – SNITEM scope: €11bn

• Workforce: 65,000 people (source: PIPAME Report - June 2011)

• For some sectors, member companies account for 100% of the market and, taken as a whole, 85% of market players in sales terms

• First professional organisation in the health industries sector to be ISO 9001-certified (since 2006)

As a representative of the medical technologies industry and the public authorities’ preferred contact, SNITEM either sits on or has a consultative vote in several committees and bodies, including the following in particular:

• Interface Committees for the French National Drug and Health Products Safety Agency (ANSM),

• The French National Authority for Health’s National Committee for the Assessment of Medical Devices and Health Technolo-gies (CNEDiMTS),

• High Council on the Future of Health Insurance (HCAAM),• Strategic Committees for Sectors (CSF),• Strategic Council for Healthcare Industries (CSIS),• Solidarity Fund for Retaining Autonomy (CNSA) Technical Aids

Award Observatory,• Central Bureau for Medical Pricing (BCTM),• T2A Operational Group, led by DGOS,• Board of the Biological and Medical Engineering Association

(AGBM),• Board of ANTEL (National Telemedicine Association),• Advisory committees for the WEEE (waste electrical and

electronic equipment) and PIMW (Potentially Infectious Medical Waste) sectors at the Ministry of the Environment,

• LNE/G Med Certification Committee,• LNE/G Med MD scientific committee (CSMED),• AFNOR Strategic Health Orientation Committee (COS),• Member of the National Health Conference (CNS); 8th board:

Healthcare product Industries,• and others.

A brief introduction to SNITEM

SNITEM’s mandates


03

M e s s a g e f r o M

the PRESIDENT

The SNITEM General Assembly to be held on 24 June will elect a new President. Here and now, I would like to wish the new president the best of success in their future undertakings. In this last «message» as President I would like to take the opportunity to thank all those that have supported me during the course of my 6-year mandate. The members of the Executive and Administrative Boards have, of course, helped me in steering our professional organisation. Not forgetting all the SNITEM members who have put their trust in me to represent SNITEM throughout all these years and who have backed all the main focus areas pursued by the Board of Administration. I will never forget the people who worked on the SNITEM team without whose dedication the union could never have functioned.

Lastly, I would like to pay special tribute to the rich dialogue held throughout these 6 years with all the actors in the healthcare sector. The companies in the medical devices

sector market products that contribute to developing our healthcare system; it is this exchange, that is at once constructive and demanding, that fosters and develops the mutual understanding that is vital to our progress.


04

M e s s a g e f r o M

the DIRECTOR GENERAL

The 2013 General Assembly was the occasion for presenting members of SNITEM with a picture of an activity that is ever stronger and more representative of the sector. I would also like to take the opportunity here to pay tribute to the presidency of Christian SEUX, which is about to end. Six months after it became official, the merger with APPAMED is a resounding success with SNITEM welcoming new members every month. This does not mean, however, that the medical devices sector is going through an easy time. The growing number of members no doubt demonstrates the attractiveness of SNITEM but, make no mistake, it also shows that the sector is undergoing a period of extremely intense and rapid change in its regulatory environment and that businesses need to know, understand and forward-plan for these changes.

It is our role to support them and to continually explain to the public authorities the exact nature of their business activity, their needs, the conditions required for their development and their ability to continue to supply patients and healthcare

professionals with products that meet their needs. One of the milestones this year has, without a doubt, been the publication of several implementing laws of the Bertrand Act. They are making profound changes on the landscape while, since September, Brussels has begun discussions with far-reaching consequences on the development of the regulatory framework governing medical devices with regard to their market access.

1 23

A brief introduction to SNITEMSNITEM’s mandates Message from the President Message from the Director General

1 MILESTONES

1.1 MERGER WITH APPAMED Reorganisation of manufacturer work groups Team changes 1.2 AFTERMATH OF THE BERTRAND ACT Advertising Relations between Industry and Healthcare professionals Intra-GHS assessment Technical specifications for certain medical devices Creation of interface committees 1.3 CSIS AND CSF Strategic Council for Healthcare Industries Strategic Committees for sectors 1.4 SECTOR TAXATION: ACTIONS & DISCUSSIONS

(PLF, PLFSS, IGAS REPORT)1.5 HAZARDOUS SUBSTANCES / ENDOCRINE DISRUPTORS 1.6 RECAST OF MEDICAL DEVICES DIRECTIVES

2. RELATIONS WITH OUR PARTNERS AND THE ENVIRONMENT

2. 1 MD ASSESSMENT POLICY CNEDIMTS Re-assessment of generic lines2.2 MD ECONOMIC POLICY CEPS Follow up on the framework agreement 2.3 MANUFACTURERS’ ENVIRONMENTAL RESPONSIBILITY:

CREATION OF 2 SECTORS2.4 LEARNED SOCIETIES 2.5 PATIENT ASSOCIATIONS 2.6 ARIIS2.7 CEP, IFIS, SCHOOLS, UNIVERSITIES, ETC. TRAINING

AND INFORMATION INITIATIVES RUN BY SNITEM

3. EXTERNAL COMMUNICATION AND INFORMATION FOR MEMBERS

3.1 COMMUNICATION FOCUSED ON OUR PARTNERS AND THE HEALTHCARE ENVIRONMENT

3.2 PRESS RELATIONS 3.3 TRADE FAIRS 3.4 SNITEM INFO MAGAZINE3.5 SNITEM WEBSITE 3.6 LOOK AT HEALTHCARE: THE CLUB3.7 SEMINARS, TOOLS & INFORMATION MEDIA

RESERVED FOR MEMBER COMPANIES

Annex 1Annex 2Annex 3Annex 4


1


07

1 M e r g e r w i t h

APPAMED

Announced in June 2011 and initiated over the following months, SNITEM’s merger with the Syndicat de l’industrie des dispositifs de soins médicaux (APPAMED - French Manufactur-ers Association of Medicare Devices) was finalised in January 2013, following the last APPAMED General Assembly at which the members unanimously approved the merger with SNITEM. This merger, desired by the member companies and based on the existence of a set of common issues, is underpinned by shared contacts and demonstrates identical interests. By combining their forces in a single structure, SNITEM, medical device businesses will acquire a more powerful tool for dealing with current and future regulatory and economic changes. In a constantly changing environment, businesses are pooling their resources and experience, thereby representing a united sector within its sectoral diversity. SNITEM is currently the single, preferred contact for the public authorities for both the city and hospital sectors.

Welcomed by several institutional stakeholders, this merger offers member companies a wide range of skills and expertise in their core business areas. SNITEM work groups have therefore been rethought and redefined so as to integrate the specifici-

ties and issues common to all members in their examination of the profession.

SNITEM’s 340 member companies are involved in a diverse range of discussion and decision-making structures. Up till now, some fifty or so work and/or discussion groups coexisted, organised in a complex and confusing tree diagram that did not give members a clear and consistent vision of “which group does what?” and “to which group can the member bring its expertise?”.

Bolstered by the drive to optimise and/or refocus team skills on the areas of expertise required by the nature of our business sector and by the merger with APPAMED, this tree has been simplified and streamlined thus enabling the determination - based on a set of effective operating procedures - of:

• 10 Centres identifying SNITEM’s sector components by key activity areas divided into sector-dedicated groups; operational groups dealing with issues specific to a given product or service scope;

.1Reorganising manufacturer

work groups


08

1 • 4 Cross-disciplinary Groups and 6 Focus Groups created to deal with topics of general interest or topics common to several different sectors.

(The detailed list of work groups is given in the annex to this report.)

On 1 January 2013, COMIDENT became a Corresponding Member of SNITEM. COMIDENT groups industrials specialising in the manufacture and distribution of a full range of dental materials and equipment to dental surgeons and dental pros-thetists. This membership is linked to a partnership agreement that provides for deeper and further reaching relations and actions between the two organisations.

Since the last General Meeting, SNITEM’s team has welcomed several new profiles. Firstly, APPAMED employees have joined the SNITEM team. An Industrial Affairs Centre has been created, backed up by two sector managers. A dedicated management department dealing with Market Access issues has also been set up. A Human Resources and General Administration manager has been missioned to support the General Secretariat. Lastly, a job position for SME/ETI and Economic Development has been created and is currently in the process of recruitment. This managerial position will provide support and information tailored to the organisation and needs of SME/ETI.

The team currently boasts a range of profiles and a wide array of expertise, which is available to members (organisation chart in the annex to this report).

A new system for collecting data on sector-specific statistics and registration in SNITEM general meetings, baptised Sphinx, was set up a year ago. This is the first stage of a major redesign of the information and communication system used for members. SNITEM has initiated root and branch reforms of its information system designed to bring it into line with recent technological developments. The SNITEM extranet, as it stands today, is also being redesigned to transform it into a genuine collaborative hub, close to the corporate community. This new ergonomic and intuitive area will be reserved for SNITEM Members: they will find here information on work groups, general briefing meetings, standards watch, and so on. This hub will be populated with new data month-by-month, reflecting user expectations. This hub will be opened to members in 2014.

Team changes

Redesigning the information system


09

1 a f t e r M a t h o f t h e

BERTRAND ACT

The law on strengthening the safety of drugs and health products, better known by the name of “Loi Bertrand” (law No. 2011-2012

of 29 December 2011 relating to the strengthening the safety of drugs and

health products published in the Official Journal on 30 December 2011), has made profound changes to the legislative and regulatory framework governing the healthcare products industry. Several decrees have been published this year, amending the following in particular:

Set up under the Bertrand Act, the provisions relating to controls on the advertising of medical devices provide blanket coverage of all companies in the sector and all medical devices, irrespective of whether the promotional material is intended for healthcare professionals or the general public. Effective as of 1 January 2013, these new regulations have forced businesses to review their whole range of promotional material within a very short time frame (exhibition stand, brochure, brief introductory document, film, PowerPoint presentation, etc.) so as to ensure their compliance. SNITEM has been regularly consulted by the public authorities during the drafting of the recommendations.

Since 1 January 2013, ANSM authorisation is mandatory for the distribution of promotional material on a large number of products (listed in the annex to this Report).

Between the 21 and 31 December 2012, nearly 800 licence applications were filed with ANSM for its authorisation.

New recommendations are expected soon covering websites and clinical allegations. Manufacturers are again engaged in discussions with the various key contacts.

Relations between medical device manufacturers and healthcare actors are strictly regulated. The law has both strengthened the provisions of the anti-gift act and set up a system of transparency between businesses and healthcare actors which requires publication of these associations. The decree enforcing this new publication requirement has finally been published. This decree includes a second section that sets out the provisions of the anti-gift act (Article 4133-6 of the French Public Health Code). The interpretation circular of 29 May 2013 completes this legal framework.

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Relations between Industry and Healthcare professionals

Advertising


010

1 Transparency of the advantages granted by businesses manu-facturing or marketing healthcare and cosmetic products for human use or “Sunshine Act à la française”.

All businesses manufacturing or marketing healthcare products or providing services relating to such products shall make public all benefits in kind or in cash procured directly or indirectly above a threshold figure of 10 euros, in addition to the existence of any agreements it signs with actors in the field of healthcare1.

This decree eventually plans the setting up of a single public website used to publish all information on any agreements or benefits of a tax-inclusive value equal to or greater than 10 euros.

Pending the setting up of this website, and on a transitional basis, such information shall be published: - on the one hand, by businesses on their own website or on a

website shared by two or more companies or on the relevant trade union website

- and, on the other hand, by the colleges for healthcare profes-sionals, no later than on 1 October of the current calendar year and 1 April of the following year respectively, for agreements signed and benefits agreed during the first and second half of the calendar year.

Businesses are also to send this same information to the colleges for healthcare professionals no later than 1 August of the calendar year for operations conducted during the first half of the calendar year and no later than 1 February of the following year for operations carried out during the second half of the calendar year.

For the legislator, this new transparency system shall help to dispel any suspicions that might have emerged over the issue of independence, particularly that of healthcare professionals, learned societies and the specialised press, following certain health scandals. This mechanism is separate from the anti-gift act (Article L.4113-6 of the French Public Health Code): it has a different scope and purpose.

Strengthening of the anti-gift act The Bertrand Act strengthened the provisions of the anti-gift act by:- broadening the scope of Article L4113-6 of the French Public

Health Code to cover students, to associations of students aiming to work in the health professions and associations re-presenting healthcare professionals,

- covering all system-related agreements prior to companies requesting the opinion of the competent professional bodies,

- notifying the professional bodies of the implementation of the agreements.

1. This includes healthcare professionals; associations for healthcare professionals; foundations, learned societies and consultancy firms or organisations working in the healthcare products or ser-

vices sector; healthcare institutions; students intending to work in a healthcare profession and the related representative associations and groups; associations for users of the healthcare system;

companies publishing press articles, editors of radio or television services and editors of public online communication services; editors of software that assists in drug prescription and issue; legal

entities that either provide or participate in initial training of healthcare professionals.


011

1 On publication of these texts, SNITEM demonstrated its proac-tiveness by providing its members with summary notes and a legal analysis. To help its members in the best possible way and answer their questions, SNITEM provided them with a Q&A session on the Sunshine Act within 10 days of the decree’s publication. A FAQ sheet on the anti-gift act is also in the process of being updated. A briefing and training session was also organised to answer members’ questions on legal and practical issues. Members will also receive examples of clauses and contracts to help them with their efforts.

The Bertrand Act introduces the obligation for certain medical devices funded by hospital services (GHS –homogeneous hospital stay groups) to be registered on a list to enable their reimbursement, and also to be purchased and used by healthcare institutions (Article L. 165-11 of the French Social Security Code).

The MD in question are invasive or at-risk MD that come under the homogeneous categories defined by the order.

The decree was published on 15 September 2012 and sets out the procedures for assessments by the French National Committee for Evaluating Medical Devices (CNEDiMTS) and for

registering these medical devices on the list. The procedures are similar to those used to register or renew a registration on the LPPR. Note two exceptions, however: the absence of the determination of an Expected Improvement in Service (ASA) and the absence of a CEPS (Economic Committee for Health Products) pricing. Note that there is no charge for this list as the MD is covered under the GHS pricing.

However, the order(s) that will decide the categories of the relevant MD are currently pending publication.

The law states that the French National Drug and Health Products Safety Agency (ANSM) is henceforth responsible for monitoring compliance with the technical specifications governing certain medical devices registered on the LPPR (Article L165-1-2 of the CSS).

The implementing decree (No. 2012-1135) was published on 10 October 2012. It defines the monitoring procedures and the terms and conditions for setting the financial penalty applicable to companies that fail to meet their obligations.

ANSM can therefore conduct unannounced seizures of products at healthcare establishments, distributors, manufac-turers, agents, or at a public place of sale.

Intra-GHS assessment

Technical specifications for certain medical devices


012

1 The decision of which medical devices to monitor is taken at the initiative of certain health authorities or based on an annual monitoring programme specified by ANSM.

Financial penalties may reach 10% of a product’s Sales in France with collection of any unjustified sums and financial compen-sation for the seized products. Any failure to comply with the technical specifications is likely to result in the health insurance organisation terminating its coverage of the medical device.

ANSM has not yet published its programme.

Interface committees form one section of ANSM’s new orga-nisation. This is based on four commissions, four technical watch committees and the interface committees. The latter enables the Agency to exchange information with stakeholders in their active field and to codify exchanges hitherto considered informal and with no legal basis.

Four missions were assigned to the medical devices and in vitro diagnostic medical devices (DIV) Interface Committee: - identify key topics as part of a works programme - facilitate discussion so as to provide all the necessary

information and explanations - propose measures aiming to increase the number of medical

devices and in vitro diagnostic medical devices by promoting

innovation, in compliance with European regulations and for the patient’s benefit, in addition to product safety

- propose measures designed to implement secure online com-munications and information exchange between the parties, particularly concerning documents filed with ANSM under the regulations.

With an equal number of representatives from trade orga-nisations and the Agency, the committee comprises twelve members appointed by the Agency on 12 May. SNITEM and its representatives (industrials and permanent) hold half the seats allotted to trade organisations.

The committee will meet at least three times a year and may link its deliberations to permanent or ad hoc work groups in order to propose measures designed to improve safety and the provision of medical devices.

Creation of interface committees


013

1 C s i s a n d

CSF

The CSIS came into being in 2004 in response to the observation that healthcare industries create value and contribute to France’s economic development. Bringing together manufac-turers in the healthcare field and the government, it takes the shape of a forum for discussion and informal exchange. The objective is to define a strategic view by setting up partnership measures aimed at increasing France’s competitiveness and attractiveness.

Strongly involved since 2009, the medical devices sector has seen its representation increase year-on-year. Chaired by Jean-Marc Ayrault, and co-chaired by Ministers of Industrial Renewal, Health and Research, the sixth edition will be held on 5 July (originally scheduled for early June).

The works focus on 5 topics that the public authorities consider as high priority:• Administrative streamlining and efficacy• Research and Innovation in France in 20 years’ time• Challenges for industrial manufacture in 2020• Healthcare industries and the information society

• Healthcare industries and companies

Work groups have been set up for each topic and are supported by several specialist sub-groups.

SNITEM is strongly involved in every single group. The 5 groups were coordinated by an manufacturer from the MD sector. The groups proposed some 40 worksheets in all, some of which are specific to our sector.

Their work is closely linked to that of the CSF (see below) and to the measures that will be put forward. This provides a real opportunity for the medical device industry to assert its spe-cificities, to make known its difficulties and its challenges and to thereby suggest structural and administrative changes in partnership with the authorities.

Created in 2010 further to the convention on industry and on finding that there was a lack of governance of the strategic industrial sectors, these committees meet a dual objective: to fill a lack of structuring in these sectors by defining sector

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Strategic Committees for sectors

The Strategic Council for Healthcare Industries


014

1 strategies shared by stakeholders, and to increase sector com-petitiveness by building a sustainable relationship between the various stakeholders.

In continuation of France’s National Pact for Growth, Com-petitiveness and Employment, and the reorganisation of the Conférence Nationale de l’Industrie (CNI - National Industry Council), the Minister of Industrial Renewal, Arnaud Montebourg, wished to revive the Strategic Committees for Sectors (CSF) with greater political resonance than previously.

One CSF is dedicated to Health Technology Industries (CSF-ITS) with a focus on the Medical Device sector presented as having problems of growth and industrialisation.

A new organisation has been set up, comprising a tripartite ins-titutional presidency (Ministers for Industrial Renewal, Health and Research), identical to the CSIS, and an Industrial Vice-Presidency. Seven multi-disciplinary work groups have been formed, bringing together manufacturers and representatives of ministries and government departments. SNITEM, as a trade organisation, is part of the CSF and is involved in all the work groups. Several work directions have been defined; these aim to:• strengthen and improve France’s attractiveness as a place of

research, development and production for health industries• promote French leadership in terms of medical innovation

• improve sector solidarity by increasing public / private partnerships

• increase France’s involvement in industrial clinical trials• conquer new export markets

Over 40 proposals have also been submitted to the relevant ministers. By mid-2013, some of these proposals will lead to a sector contract setting out the commitments shared by both manufacturers and the public authorities.

2 0 1 3


015

1 s e C t o r t a x a t i o n : t h o u g h t s & a C t i o n s

(PLF, PLFSS, IGAS report)Medical devices businesses will face a sharp acceleration in the regulatory processes governing their activity (see above), particularly under the provisions currently being discussed at European level on the draft regulation relating to medical devices. The large increase in their various tax components over the last few years should be viewed in the context of the rise in costs linked to these reforms: 50% increase in 2010 of the tax rate on the promotion of medical devices, increase in the LFSS (Social Security Funding Act) for 2012 of approx. 17% of the rate and broadening of the tax base on sales of medical devices, increase (or creation), still in the LFSS for 2012, of additional taxes to be paid to the HAS.

The 2013 PLFSS has increased the sector’s taxes by introducing a registration duty for requests for prior authorisation of advertising. However, the provision that has attracted wide negative comment, in addition to that voiced by companies, concerns the broadening of the tax base to cover the promotion of medical devices and, in particular, the extension of the base over the costs of scientific congresses or advertising seminars. SNITEM, which has challenged the fairness of applying this tax to medical device sectors from the outset, is clearly contesting this measure. The information/training role played by employees covered by this tax base (note that this concerns a regulatory requirement), the absence of an automatic link between the

increase in volumes and the increase in the numbers of these employees, which is closely related to the nature of the medical devices themselves2 but which can also be explained by the impact of the healthcare system’s organisation on their level of use, are all valid reasons that justify the stance taken by our trade organisation. The decision taken against this background to specifically raise the costs allowance to 75% (the original proposal suggested 50%) has nevertheless lessened the negative impact of this provision.

In parallel to these provisions, the PLF was used to introduce a certain number of arrangements concerning the research tax credit. SNITEM used this occasion to remind everyone of the usefulness of this system for businesses in our sector.

More recently, concerning taxation on healthcare products, SNITEM took note of the proposals set out in the IGF/IGAS report of October 2012 (published in April 2013) and submitted its comments. Note that SNITEM was one of the trade organi-sations that was consulted on this topic last July.

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2. Example of the impossibility of placing a third hip replacement!


016

1 h a z a r d o u s s u b s t a n C e s /ENDOCRINE DISRUPTORS

There is a legitimate concern in monitoring the risks likely to be generated by the presence of certain substances in the manufacture of healthcare products. This concern is covered by the laws governing the marketing of medical devices.

The end of 2012 saw numerous discussions concerning the use endocrine disruptors in medical devices. These discussions led to the passing of law No. 2012-1442 of 24 December 2012 published in the French Official Journal of 26 December 2012, that aims to suspend the manufacture, import, export and marketing of any food packaging containing Bisphenol A. Prior to the vote, SNITEM ran several actions designed to raise the public authorities’ awareness of the risks of banning BPA in medical devices. The position tabled on this occasion, and sent to several of key players, was fed by many contributions from manufacturers at both national and European level, relayed by Eucomed. On this occasion, SNITEM also met with the Plastics Trade Union and the French Chemical Industries Union (UIC) with which it was able to work on ensuring that the manufactu-rers’ challenges and needs are better taken account of.

To sum up, Article 3 of this law has amended the French Public Health Code by introducing a new section devoted to the ban on the use of certain materials in medical devices:- ban on the use of tubing containing di-(2-ethylhexyl) phthalate

in paediatric, neonatal and maternity departments as from 1 July 2015 (new Article L. 5214-1 of the Public Health Code);

- ban on the use of baby bottles that contain Bisphenol A and meet the medical device definition set out in Article L. 5211-1 (new Article L. 5214-2 of the Public Health Code).

Bisphenol A is found in polycarbonates, polysulfones and epoxy resins frequently used in medical devices due to the physical and mechanical properties. In particular, they make it possible to ensure the transparency and rigidity of plastics as well as giving them a useful dimensional stability. A survey of manu-facturers revealed that BPA were used in a great number of devices. The endocrine disrupting properties that would affect human health are currently suspected by extrapolating data from toxicological studies carried out on certain animal species, which are yet to be corroborated by epidemiological studies in humans.

.5


017

1 Nevertheless, the uncertainties raised by the use of Bisphenol A have led several national and European bodies to debate the issue; several reports should be published on this topic during 2013.

SNITEM has collected and consolidated a large body of data on medical devices containing Bisphenol A and on the nature of the contact between the MD and the user in order to contribute to these studies, especially that being run by SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks) on the safe use of Bisphenol A in medical devices. We are continuing to monitor developments in this area.

Concerning phthalates, based on currently available scientific knowledge, the risk represented by certain phthalates (phthalates classified as CMR 1A or 1B) is deemed sufficient-ly serious to merit the introduction of Europe-wide statutory controls as of 2007 through Directive 2007/47 amending Directive 93/42.

After endocrine disruptors, it is now the use of ethylene oxide, used to sterilise certain medical devices, that is being questioned by public authorities following a report by the Social Affairs Inspectorate (IGAS), published in late December. As of early 2013, ANSM questioned manufacturers that use this type of sterilisation and asked SNITEM to make an inventory of MD sterilised using EO in maternity, neonatal and paediatrics departments, and to assess possible alternatives. It was also

decided on the same occasion that there is a need to clarify interpretation of standard 10933-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals, which proposes maximum dosages for patients weighing 70 kg which are not suitable for children. With this in mind, we have launched a joint study with CETIM looking at the desorption of ethylene oxide from plastic materials aimed at identifying which materials allow the best desorption and limit residual quantities. Following this project, ANSM should publish its re-commendations over the next few months.

The trend towards increased controls on substances continues with the entry into force on 1 January 2013 of a new requirement to declare the use of nanoparticles, irrespective of whether they are manufactured in France or imported from abroad.

Public authorities and the general public alike are, more than ever, focusing their attention on the substances used in healthcare products. Innovation in terms of providing patients with ever greater quality and safety is set to become a major challenge for our industry in the years to come.


018

1 r e C a s t i n g t h e d i r e C t i v e s o n

MEDICAL DEVICES

A planned recast of European Directives on medical devices, prepared by the European Commission, is currently under review by European institutions. The European Parliament should make a statement on this text next September, after which the Council of the European Union will publish a formal notification of its opinion. Final adoption could take place towards mid-2014 with entry into force around mid-2017.

This recast of the regulations follows on from several amendments introduced since1998, the year in which CE marking was extended to cover all medical devices. Nevertheless, the European Commission is hereby proposing an unprecedented strengthening of the regulation. The European Commission began work to fast-track its preparation after having completed the previous recast in (Directive 2007/47/CE). The PIP fraud made it necessary to ensure that the planned amendments (see in particular - audit, inspection, watch) were sufficiently strong and appropriate, which triggered the 2011 setting up of a “stress test” of the European Commission’s proposed draft.

Along with the other European federations EUCOMED and COCIR to which it belongs, SNITEM supports the principle of a recast

of the regulatory provisions. The challenges of the current recast concern the need to have a set of sound procedures covering health safety requirements that are also capable of fostering innovation by allowing rapid access to patients and healthcare professionals. A compromise will have to be found in the options of the debate under this Parliament in order produce a tailored response to these challenges. In particular, the intention of certain members of the European Parliament to introduce a marketing authorisation similar to that used for drugs, without strengthening health safety, would be a major barrier to having patients access innovations within reasonable times and, due to the related costs, would result in the disap-pearance of therapeutic alternatives and diagnostics in a field largely dominated by “niche” markets.

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2


020

2 M dASSESSMENT POLICY

Medical device assessments by the French National Authority for Health (HAS), were marked this year not only by the decree setting out the assessment procedures for certain MD covered by the GHS (see above), but also by the strengthening of the HAS medico-economic mission.

The Social Security Financing Act for 2012 extended the HAS’s mission to include the medico-economic assessment of healthcare products in view of their reimbursement. This makes the assessment a key criterion in the CEPS’s pricing of drugs and medical devices.

The implementing decree (No. 2012-1116), published in October 2012, set out the conditions for making this assessment and lists which MD would require a medico-economic assessment. The MDs currently targeted by this action include those for which a manufacturer claims a level I, II or III Expected Improvement in Service (ASA) and which are likely to have a major impact on health insurance spending. Note that CEPS may request medico-economic studies as part of a contractual agreement.

The HAS specialist committee in charge of medico-economic assessments is the Committee for Economic Assessments and Public Health (CEESP). This assessment will be operational as from October 2013.

For the second year running, the number of post-registration studies (EPI) requested by CNEDiMTS is falling (around 10 studies per year). To support member companies in carrying out these studies, SNITEM has sent its members a detailed practical guide describing the pitfalls to be avoided and the steps to follow when conducting EPIs.

Also, as provided for in the Framework Agreement, all the actors consider it a good idea to set up tripartite discussion meetings (CEPS, HAS and manufacturers) following a request for an EPI.

Over the last 12 months, the French National Authority for Health (HAS) has completed 8 product category re-assess-ments:• Joint implants - knee and elbow• Spinal column implants• Bone substitutes• MD for medical compression• Implants for bypass• MD and related services for home-based respiratory assistance• Facial prostheses

The HAS is also carrying out a number of other re-assessments, i.e. on joint implants for shoulders and MD for treatment of sleep apnoea.

.1 CNEDiMTS

Re-assessment of generic lines


021

2 M dECONOMIC POLICY

Each year, the provisions regulating the Economic Committee for Health Products (CEPS) require it to set the tariffs and prices for the medical devices cited in the list of products and services (LPP). To do this, it has to take account of the objectives spelled out in the guidance letter of the relevant ministers (see letter dated April 2013). The objectives listed for 2013 include how to enhance innovations that drive therapeutic advances as well as compliance with annual targets for health insurance spending trends. In the latter case, this means the CEPS implementing cost-containment measures through cuts in tariffs and prices in order to get manufacturers to play a role in containing health insurance accounts.

This brief description outlines the most visible part of the changes affecting the medical devices sector, often regarded - wrongly - as the only part. However, a large part of this business activity is not covered by the LPP in towns and cities and, in hospitals, comes under the «Pricing according to Activity» approach and the development of a policy for bulking procurements.

Over the last year, some products have been taken off the LPPR’s list and the additional list. This is the case for vascular patches, which are now covered by hospital charges (GHS). Note that registrations in the GHS derive from proposals by the “Operational Group” made up of representatives from the T2A mission (DGOS), healthcare establishment federations, CNAMTS, the French National Surgery Council and representa-tives for the manufacturers (SNITEM in particular). The group proposes recommendations to the Hospitalisation Council concerning the medical and economic relevance of integrating IMDs in the GHS. The Council then sends these recommenda-tions to the Minister responsible for arbitrating any resulting inclusions.

Several files are currently under review at the CEPS in order to plan:• changes to the current LPPR nomenclature based on HAS

opinions. This is the case, for instance, for MD for aerosol-therapy, home perfusion, plus home-based oxygen therapy and respiratory assistance,

.2 Delisting from the LPPR and Listing in GHS

Changes to nomenclature and pricing

022

2 or • price reviews (not accompanied by changes to the nomencla-

ture). This is the case, for example, of orthopaedic implants, pacemakers, MD for ostomy and incontinence nursing, the project opinions for some of which have already been published.

Signed on 16 December 2011, the medical devices framework agreement has now been in existence for eighteen months. The details provided on procedures (especially concerning post-registration studies) and definitions (see the chapter on contractual life) form a useful basis for discussions by manu-facturers and, where applicable, by SNITEM and CEPS. The annual follow-up meeting to this agreement, held on 21 May, reviewed its operation together with a certain number of development directions for the framework agreement. In some cases, these agreement amendment proposals concern translation of the provisions adopted by decree (i.e. the intro-duction into the agreement of provisions governing medical-economic assessments following the publication of decree No. 2012-1095 of 28 September 2012); in other cases this has involved examining the benefit of detailing the current provisions (particularly those covering post-registration studies) or of adding new provisions. Work on drafting is in progress.

Follow-up on the framework agreement



023

2 M a n u f a C t u r e r s ’ e n v i r o n M e n t a l r e s p o n s i b i l i t y :CREATION OF 2 SECTORS

Medical device manufacturers are paying increasing attention to environmental issues.

Over the last twelve months, the sector saw the creation of two new eco-organisations in our sector concerning two categories of waste: professional waste electrical and electronic equipment (WEEE) and potentially infectious medical waste (PIMW).

SNITEM, driven by the environmental group, will be joining forces with the eco-organisation, Récylum, in order to create a WEEE sector for businesses working in the field of medical devices. This was approved by the public authorities in August 2012 and already numbers over 80 member companies.

The collection and processing of potentially infectious medical waste and sharps generated by patients on self-treatment programmes is covered by DASTRI, an association that was approved by the public authorities on 20 December 2012. It is worth highlighting that the publication of this decree is the outcome of more than five years of work and negotiations on the part of the firms concerned.

Company involvement in these sectors is proof of our industry’s commitment to dealing with environmental issues. SNITEM members currently contribute to 5 Extended Producer Res-ponsibility (REP) segments, which will soon include two new segments of interest to our sector, gas bottles and furniture waste.

.3


024

2 l e a r n e dSOCIETIES

SNITEM is pursuing and strengthening its relations with a number of learned societies. These discussions take the form of partnerships, joint work efforts and studies, and participa-tion in scientific functions events.

Such actions by SNITEM include, but are not limited to, regular discussions with the Société Française de Chirurgie Orthopédique et Traumatologique (SOFCOT - French Society of Orthopaedic Surgery and Traumatology), Société Française de Radiologie (SFR - French Society of Radiology), Société de Pneumologie de Langue Française (SPLF - Francophone Pulmonology Society), Conseil National de la Cardiologie (French National Heart Foundation), Société Française de Chirurgie (French Society for Surgery), and the Société Française d’Anesthésie et de Réanimation (French Society of Anaesthesia & Intensive Care), to name just a few.

For the last five years now, SNITEM has been meeting with patients’ associations approximately every other month to present and exchange information on a cross-disciplinary, sector-based or topical issue.

These meetings gather several associations and representa-tives of SNITEM. These discussions aim primarily to arrive at a common understanding of the respective challenges i.e. those both of patients and manufacturers.

.4 p a t i e n tASSOCIATIONS

.5


025

2 ARIIS

ARIIS, Alliance for Research and Innovation in Healthcare Industries, was created in 2010 under the aegis of the FEFIS (French Federation of Healthcare Industries). ARIIS’ mission is to break down the walls of private research initiatives and build synergies between drugs, medical technology, diagnostics, bio-technologies, which apply to drugs for humans and animals, and thereby participate in developing an environment that encourages the development of innovation. As a member of FEFIS, SNITEM is an ex-officio member of ARIIS and as such sits on the Executive Committee. For 2 years now, it has been closely involved in organising the “Ateliers de Giens” that combine workshops with round tables and discussions or plenary

conferences. In 2011, the scope covered by the Meetings in Giens was extended to include all the healthcare technologies, including medical devices in particular. Every year since then, there has been a round table focusing specifically on MD. The latest meetings, held in October 2012, provided an opportunity to discuss the assessment and pricing of medical procedures and the related medical devices. MD have also been discussed at a round table on medico-economic assessments. This year will see another round table reserved for focus areas relating to the MD industry.

.6


026

2 C e p , i f i s , s C h o o l s , u n i v e r s i t i e s , e t C . t r a i n i n g a n d i n f o r M a t i o n i n i t i a t i v e s

run by SNITEM

SNITEM is participating in several regional and national training initiatives. It is also linked to strategies deployed by the State and dedicated to employment and training in the healthcare sector.

As such, it has been particularly involved in setting up the Prospective Studies Contract (CEP). After the 2009 CSIS, one of whose measures targeted in-service training, the DGEFP (Direction Générale de l’Emploi et de la Formation Profes-sionnelle - Directorate General for Vocational Training and Employment) – proposed to support manufacturers by means of a CEP addressing its various components: drugs for human and animal use, medical technologies and medical devices, and in vitro diagnosis. This study was accompanied by the im-plementation of an experimental system of job planning and development across 2 employment basins, designed to prevent industrial change and, where applicable, any possible restruc-turing. The selected basins are the Rhône-Alpes and Normandy/Centre regions.

Missioned to the Arthur D. Little & BPI firms and completed in early 2013, this study provided an economic assessment

together with a forward-looking vision of healthcare industry activities – by key activity segment – in France at the 2.5 and 10 year horizons, and the outcomes for organisations and the employment scene.

.7

What is a CEP?Following proposals by labour and management, gathered together at the National Vocational Training Council in Lille in December1987, the French Prime Minister requested the creation of a prospective system to track developments in jobs and skills bases. As part of the broadening of the Fund’s efforts to improve working conditions, created in 1977 and intended to implement actions designed to improve the working conditions of employees exposed to nuisances, the Prospective Studies Contract3, since renamed the Forecast Studies Contract4 (or CEP), are “advisory sup-port systems for professional sectors coming under the scope of collective bargain-ing”. Unlike other studies, CEP (forecast or prospective) are part of an issue con-cerning changes in jobs and skills bases, common to labour and management alike. The formation of a minimum agreement on this issue has been encouraged by the deployment, since 1993, of the technical support system which “where neces-sary, aims to help professional sectors define their project and draft specifications by highlighting the economic, technological and socio-organisational priorities that have to be structured by the CEP. This system mainly targets professional sectors that lack a logistics structure and the necessary ability to conduct studies and analy-ses. This technical support can, in some cases, be focused on a rapid diagnosis on one or two points deemed of primary importance by the sector and likely to facilitate negotiations between trade organisations employees’ unions”5.

3 Circular No. 753 of 21 March 1988

4 Circular No. 935 of 10 February 1993

5 Circular for the Delegation for Vocational Training of 10 February 1993

027

2 This also made it possible, nationally, in each test basin and based on the economic, demographic and technological data, to draw up a short and medium-term diagnostic of develop-ments in trades and occupations and to propose scenarios for medium-term trends. SNITEM and a panel of manufacturers have been involved in building this Prospective Studies Contract.

The conclusions of this study have been used to issue recom-mendations on which actions can provide the best possible support for developments in jobs and skills in this sector (GPEC - Jobs and Skills Management Planning, for sensitive trades, job barometer, employment and inclusion of young people by pooling means between large companies and SMEs, training initiatives targeting unpopular occupations (regulatory affairs, etc.). These recommendations will soon be carried and/or validated, in partnership with the DGEFP, the sector’s joint la-bour-management collecting bodies and the trade unions, and by the various healthcare industry sectors according to their needs and difficulties. These recommendations have also been proposed as part of measures for the Strategic Partnership Contract for the Sector (CSF) and the 2013 CSIS (Strategic Council for Healthcare Industries).

In parallel to these initiatives being rolled out on a strategic national and multi-professional scale, schools and universi-ties offering courses linked to medical technologies and ICTs approach SNITEM for support, where necessary, in building a training programme tailored to fit the expectations and requi-rements of potential recruiters. This common thought process generates dynamic programmes that are closely aligned with industry concerns.

For instance, recent forecasts in terms of regulatory develop-ments (see above) and the growth in the number of regulations have led tutors at the Université Claude Bernard – Lyon1 to propose a Master M2 in regulatory affairs for medical devices. Delivered at two of its units - Polytech Lyon6 and the Institut des Sciences Biologiques et Pharmaceutiques de Lyon 1 - this course has been designed jointly with SNITEM and the biomedical engineering schools’ network.

The work begun under the CEP is also based on the work carried out by the cross-disciplinary group, SNITEM Human Resources. This group has mapped out around sixty business areas in our sector (excluding administration and finance) that can be viewed on the extranet and the SNITEM website. Lastly, in addition to this initiative, SNITEM has been involved in creating a website, in partnership with the FEFIS (Fédération Française des Industries de Santé – French Federation of Health Industries) and ONISEP which lists, more broadly, standard and specific jobs in the healthcare industries: www.imfis.fr This website, designed for manufacturers, students, and national schools and universities seeks to promote the business offer in our industries with regard to the awarded qualifications.

6 The Ecole d’ingénieur de Lyon 1


028

2SNITEM’S INTERVENTIONS

TELEHEALTH, TELEMEDICINE - National Telemedicine Association Congress (ANTEL)

- Telehealth hub

- HIT (Health Information Technologies) 2013

- Marseille Provence Chamber of Commerce and Industry

CE MARKING - ESIL Polytech Marseille

- Ecole des Mines in St Etienne Gardanne

- Lille University

- Faculty of Pharmacy in Chatenay-Malabry

MEDICAL DEVICE TRACEABILITY- Master 2 Quality assurance for healthcare products (Paris V)

- Global GS1 Healthcare Conference

- Professional degree (Paris VI)

- Eurasanté Lille

CLINICAL ASSESSMENT OF MD- Master 2 Regulatory environment for businesses

and healthcare products (Montpellier 1)

- Master 2 Drug regulations in the EU

(Lille University)

- Master Healthcare Marketing (Pierre and Marie Curie University)

- Inter-University Diploma for training of investigators in clinical trials

MEDICAL DEVICE REGULATIONS- Master 1 Public health: Health safety and quality of care (Paris V)

- Master 2 Healthcare economics, management and regulation: Healthcare

Industries: rules and regulations (Paris V)

- Master 2 Regulatory affairs for healthcare industries (Paris V)

- Master Regulatory Affairs (Paris V)

- 12th edition of LEXPOSIA: European law trade fair, conference on current events

in medical law

- Master 2 Health safety and surveillance (Paris V)

DEVELOPMENTS IN RELATIONS BETWEEN INDUSTRIALS AND PROFESSIONALS IN THE HEALTHCARE SECTOR - Annual extension class in traumatology

- Master 2 Technical & Regulatory Affairs (Paris V)

- French Radiology Congress 2012


3SNITEM communications naturally take many forms as they target a range

of different publics, whether member manufacturers, the environment

(politicians, institutions, healthcare professionals, etc.) and the press.

A number of actions and tools are reserved for members, while others

concern our whole environment.


030

3SNITEM is seeking to improve people’s knowledge and recognition of the medical devices sector through a variety of initiatives during 2013 and 2014. This is why, this year, it has decided to renovate its sector-specific institutional communica-tion tools, along with the professional organisation itself. The issue of these new communication media (brochure, e-presen-tation) is scheduled for the second half of 2013.

In addition, on 25 April, SNITEM launched the first journalism award (written press/ Internet and radio) devoted entirely to medical technological innovations. This Award is also open to journalism schools. The award will be presented on Tuesday 3 December 2013 by an independent multi-disciplinary jury comprising 8 members and chaired by Prof. Jacques Marescaux, President of the Institute for Research into Cancers of the Digestive System (IRCAD), Director General of the Strasbourg University Hospital Institute, Head of the Digestive and Endocrine Surgery Department, Gastro-Hepatic Centre, New Civilian Hospital in Strasbourg.

By means of press articles and radio reports, the Medical Devices Media Award aims to increase awareness and un-derstanding of a sector that remains largely unknown. All the

information on this award can be seen on the SNITEM website

(www.snitem.fr).

Lastly, sometime during 2014, SNITEM will be organising an

event designed to provide greater insight into the medical

devices sector.

.1 C o M M u n i C a t i o n f o C u s e d o n o u r p a r t n e r s a n dt h e h e a l t h C a r e e n v i r o n M e n t

Pour mieux faire connaître le progrès technologique médical au bénéfice des

patients et des professionnels de santé, le SNITEM lance le Prix Media

du Dispositif Médical.

Le concours distingue le travail de journalistes qui contribueront au

développement des connaissances des dispositifs médicaux

innovants. Cette première édition du Prix Media du Dispositif

Médical s’adresse aux journalistes de la presse écrite/

web, radio ainsi qu’aux écoles de journalisme.

Toutes les soumissions seront validées par un jury

pluridisciplinaire composé de représentants des

medias, du monde médical, des patients,

de la recherche, de la communication.

Les lauréats se verront remettre leur

prix lors d’une cérémonie en

présence du jury.

Participez au

du Dispositif MédicalPrix Media

er1

Clôture de dépôt des dossiers de candidature le 31 octobre 2013

Pour tout savoir sur les modalités de participation, vous pouvez vous

rendre sur le site www.snitem.fr

Créer les instruments et les services du progrès médical

affiche prix media EXE.indd 1 30/04/13 15:20


031

3 p r e s s

RELATIONS

SNITEM continues to strengthen its external communication policy used to spread knowledge of the medical devices sector and to contribute to debates on related topics. Therefore, in addition to press releases and conferences, SNITEM has set up workshops that will introduce journalists to the various, often poorly-understood, aspects of the MD industry.

The press releases issued by SNITEM over the last 12 months mainly covered:

- CE marking (October 2012), linked to a press workshop - The SNITEM - APPAMED merger (October 2012) - Funding of telemonitoring systems for implantable cardioverter defibrillators - Launch of the first Medical Devices Media Award - The telemedicine sector in 2020: white paper published by Syntec Numérique and SNITEM.

The SNITEM website has a space reserved for downloading releases and excerpts found in the press and relating to the various positions taken by SNITEM.

.2


032

3 t r a d e

FAIRS

SNITEM also participated in several trade fairs and scientific congresses in the medical technologies sector. It also plays an active role in the conferences, training sessions or workshops proposed at these events. This year, SNITEM has taken part in:

• Europharmat Congress, in Lille.SNITEM had a stand in the exhibitors’ area and also took part in several themed events dealt with during the Congress:- Reimbursement of medical devices: developments, require-

ments and consequences for businesses- Technical & Regulatory news: impact on MD manufacturers

• Journées Françaises de Radiologie (JFR – French Radiology Congress), in Paris SNITEM’s stand provided communication on SNITEM’s new structure as well as on the eco-organisation created with Récylum.

• SNITEM also took part in a plenary conference reserved for radiologists on the topic: Relations between Industrials and Healthcare Professionals, changes since the Bertrand Act.

• Annual SOFCOT congress

• GERES event The annual Event organised by GERES provided SNITEM and the safe medical devices group with an opportunity to report on the contri-bution of safe medical devices to preventing blood exposure accidents (financial costs generated by BEA, the role of safe MD in their prevention, disparity in the deployment of safe products, etc.).

.3

Sécurisés 2011Non-sécurisés 2011

42% 58%

Les accidents d’exposition au sang (AES) font partie des risques professionnels les plus graves dans le domaine de la santé. La sensibilisation, la formation des personnels de santé et la mise à disposition de matériels de sécurité ont démontré leur intérêt et leur efficacité dans la diminution significative du nombre d’AES.

PREVENTION DES ACCIDENTS D’EXPOSITION AU SANG :rôle des DM sécurisés

SNITEM – Groupe DM sécurisés*

* B. BRAUN MEDICAL SAS - BECTON DICKINSON FRANCE SAS - COVIDIEN FRANCE SAS - DIDACTIC GROUPE - FB MEDICAL - PEROUSE MEDICAL

PFM Médical France SAS - SMITHS MEDICAL FRANCE - TERUMO FRANCE - VYGON

Le coût financier des AESCoût total estimé des AES en France : environ 18 millions d’euros dont : Traitement prophylactique : 2.1 M€ Arrêt de travail : 7.3 M€ Suivi biologique : 5.0 M€ Consultation médicale :3.4 M€ Coût moyendirect d’un AES : environ 260€

Coût moyen total : environ 450€

Estimation à partir des données AES-RAISIN 2005

Le nombre d’AES estimé à partir d’études du RAISIN fait état d’environ

32000 AES annuels pour le segment des établissements de soins.

Néanmoins, la sous déclaration, estimée à 70 %, laisse supposer que la réalité

de ce risque AES est nettement sous-estimée.

51% des infirmiers diplômés d’état en France a déjà été victime d’un AES*.

Des outils efficaces et innovants sont développés pour prévenir les AES mais leur utilisation n’est pas encore systématique pour les personnels soignants. Les études menées par le groupe DM sécurisés du SNITEM ont mis en évidence une forte disparité entre les secteurs publics et privés ; or, il parait nécessaire d’offrir un même niveau de protection au personnel quel que soit le secteur d’exercice. De plus, on observe aujourd’hui un ralentissement de la conversion avec un plateau aux alentours de 20 % du matériel, ces chiffres doivent encore s’améliorer pour augmenter la sécurité de tous. La transposition rapide de la directive 2010/32 en droit français permettrait d’offrir aux professionnels de santé des outils supplémentaires pour lutter contre les AES.

Contexte

Les AES en France, une réalité

Les DM sécurisés, une solution peu utilisée...

Copyright © Décembre 2012 SNITEM - Tous droits réservés

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

public privé

Non sécurisésDM sécurisés

70%

30%

95%

5%

Répartition des DM sécurisés dans les secteurs public et privé

Sécurisés 2011Non sécurisés 2011

Marché DM piquants tranchants en 2011

81%

19%

Aiguilles de Huber

Les aiguilles de Huber présentant un risque important connaissent une sécurisation importante,

Sécurisés 2011Non-sécurisés 2011

98%

2%Injectionalors que pour certains, tout reste à faire !

* Etude CELTIPHARM, dossier les accidents d’exposition au sang - Avenir & Santé, octobre 2012

Selon une étude réalisée par le groupe DM sécurisés

du SNITEM, en 2011 moins de 20% du matériel utilisé

par les soignants en établissement de santé était

sécurisé.

Cette étude révèle de fortes disparités dans le recours

à ce type de matériels, l’accès des professionnels de

santé à des dipositifs médicaux sécurisés dépendant

fortement de leur lieu de travail.

0

5

10

15

20

25

2008 2009 2010 2011

Evolution du taux de pénétration des DM sécurisés

10.55% 10.92%

18.09%19.44%

SécurisésNon sécurisés

52%48%

Perfusion/Prélèvementd’autres secteurs sont en voie de sécurisation,

Conclusion

033

3 • Health and Independence Show SNITEM attended the first edition of the redesigned Health and Independence Show, grouping shows on Hôpital Expo, Geront’Expo and HIT.

SNITEM and its representatives also spoke at the following events:- conference organised by the FHF and CNR Santé on telemedi-

cine serving chronic diseases - TV studio “What are the economic models for telemonitoring

of chronic diseases? Presentation of the White Paper - Telemedicine 2020”

- first European meetings for public procurement of innovation in healthcare. The hospital purchaser, a new player for industrial innovation in Europe.



034

3 t h e M a g a z i n e

SNITEM Info

SNITEM info is SNITEM’s quarterly journal. Organised around a central dossier that alternates sector and cross-disciplinary issues, the journal focuses on testimonials from manufactu-rers, healthcare professionals and key players involved in the running of the healthcare system.

The latest dossiers dealt with the following topics:- Medical devices - Innovations in cardiology - The pivotal role of MD in healthcare organisation - Funding for innovation - MD in cities

All issues can be viewed and downloaded on the SNITEM website.

More and more people are visiting the SNITEM website. In addition to the institutional columns, the website offers areas for viewing and downloading documents published by SNITEM alone or jointly with its partners, in particular:- Telemedicine 2020: economic models for telemonitoring of

chronic diseases, in partnership with Syntec Numérique- The D3E scope, in partnership with SIDIV and Récylum,- and so on.

A Medical Devices photo gallery has been put together using images provided by member companies. The nine sections of the gallery, organised by major topic, provide direct insight into the diversity and heterogeneity of medical devices and technologies.

.4 s n i t e M

WEBSITE.5


035

3 l o o k a t h e a l t h C a r e :The CLUB

Set up by SNITEM in 2008, the Look at Healthcare Club is an informal forum for discussion and debate among SNITEM’s member companies and key figures from the world of healthcare, political and administrative decision-makers, healthcare pro-fessionals, and so forth. At each dinner, a leading figure renowned for his or her expertise is invited to speak on a topic relating to their area of expertise and the healthcare environment. This is followed by discussions with all the guests. The dinners are held around five times a year and gather some 60 or so participants.

The Look at Healthcare Club hosted the following participants over the last year:- Fabrice Henry, President of UNOCAM (French Union of Sup-

plementary Health Insurance Organisations)- Michel Yahiel, Social Advisor to the President of the Republic,- Claude Evin, Director of ARS (Regional Healthcare Agency),

Ile-de-France- Etienne Caniard, President of the Mutualité Française,- Jean Debeaupuis, Head of the Directorate General of Health

Care Supply (DGOS).

.6


036

3In addition to the above-mentioned actions and tools which are available to members, SNITEM is also developing other tools which are reserved exclusively for them. This naturally features general and sector-specific information circulated by SNITEM, covering:- the latest news on regulatory, legal and economic issues

relating to the medical technologies and ITC sectors, - analyses of pieces of legislation and legal summaries,- minutes of sector-based and cross-disciplinary group meetings, - more general information on the healthcare market,- standards monitoring, via the dedicated AFNOR portal.

The SNITEM Newsletter, addressed to all members, is published around ten times a year and reviews the actions undertaken and monitored by SNITEM: from Recast to the CSIS, from ma-nufacturer eco-responsibility to the MD Media Award. There is also an English version.

Note that SNITEM has made a particular point of deploying new support tools for its members over the past year. This has mainly involved the publication of practical guides, which provide genuine decision-making tools, such as:

• Guide to post-registration studies, or how to conduct an EPI?; what are the pitfalls to avoid? what processes should be encouraged? (led by the Market Access group)

• Guide to research studies in France concerning MD – what type of research topics? which procedures? (also available in English) (led by the Clinical Trials group)

Several notes, summary sheets, FAQ are circulated on:- Access to the reimbursable products market (city and hospital)- Electrical and electronic waste (scope, actions, etc.)- The Sunshine Act- The Anti-Gift Act- and others.

Information seminars reserved for members answer the expectations of member manufacturers. Faced with the sector’s growing body of legal, regulatory and economic news, SNITEM now organises themed briefing sessions on a regular basis. These seminars provide useful insight and analysis of a chosen focus area and are illustrated by feedback from manufacturers. Institutional partners, lawyers, economists, consulting firms, all specialised in the healthcare sector, are

.7 s e M i n a r s , t o o l s & i n f o r M a t i o n M e d i a

r e s e r v e d f o r M e M b e r M a n u f a C t u r e r s

037

3 often invited to speak. These seminars also provide the perfect opportunity for members to meet up and discuss issues with their key contacts (HAS, CEPS, CNEDIMTS, etc.).

Over the last twelve months (June 2012-June 2013), these briefing sessions have attracted nearly 1,500 members, i.e. 2.5 times more participants than the previous year! On average, over 95% of participants claim to be happy with their day at the close of the session!This exponential upwards dynamic highlights the interest and usefulness of organising this type of company-specific briefing session. The high attendance rate is proof that the topics addressed by SNITEM over the period match members’ expec-tations:- Advertising of Medical Devices (4 seminars, July 2012,

November 2012, April 2013),- The new ANSM organisation, with the participation of ANSM

representatives (November 2012),- UDI, international news, with the participation of Europharmat,

DG SANCO, EUCOMED and GS1 (December 2012),- MD assessment by the HAS/CNEDiMTS, with the participation

of representatives of the CNEDiMTS (February 2013),- Post-registration studies, with a speech by the President of

the CNEDiMTS and representatives of the HAS (April 2013),- Medical economics: implementation of the decree and presen-

tation of the tools, with speeches by the President and Vice-President of the CEPS, representatives of the HAS, CNAMTS and DGOS (May 2013),

- Public accounts: outlook for the MD sector, with the participa-tion of representatives of the OFCE (June 2013),

- Changes in MD Directives: Recast (June 2013),- Sunshine Act à la Française and anti-gift act, with speeches

by specialist law firms (June 2013).

In parallel to these weeks focusing on specific topics, briefing sessions giving an overview of sector news will be held about 4 times a year. These will be led by all the SNITEM directors and will give participants an opportunity to learn about future changes at a very early stage in the process.


A N N E XL

1 2 3 4


039

1 l i s t o f s n i t e MCENTRES & WORK GROUPS

Anaesthesia Intensive Care Operating Theatre• Disinfection sterilisation• Monitoring, assisted ventilation & perfusion• Extracorporeal Circulation (ECC)• Surgical instruments and ancillary products

Imaging & Image Media• Image media, equipment and networks• Ultrasound• Imaging

Technical Aids, Disability Compensation• Medical beds • Wheelchairs (VPH)

Skin, Wounds and Healing• Prevention & treatment of bed sores

Pneumo ORL Ophthalmology• Home-care Respiratory Assistance • Aerosoltherapy • Audiology • Ophthalmology

Perfusion, Transfusion, Endocrinology Metabolism• Enteral nutrition • Insulin pumps • Safe medical devices

Urology, Nephrology, Gynaecology, Gastro-intestinal and Digestive System• Dialysis • Digestive Endoscopy • Gastroplasty band • Wall repair implants and pelvic statics • Breast implants

DeDicateD work groups by sector

(this list is not complete as it is createD accorDing to the neeDs of a representative members’ segment):

Orthopaedics• Total prostheses - knee • Total prostheses - shoulder • Total prostheses - elbow • Lumbar disc prostheses • Spinal column implants • Total prostheses - ankle • Bone substitutes

Neurology, Cardiovascular• Heart valves • Aortic stents Thoracic • Aortic stents Abdominal • Implants for bypass • Vascular stents • Cardiac Rhythm Management (CRM)• Arterial embolisation • External cardioverter defibrillators (ECD)

Medicare MD (e.g. APPAMED) • Medical compression stockings• Compression bands • Orthoses / Traumatology • Care / healing • Injection equipment for self-treatment • Ostomy / incontinence

Cross-disciplinary groups • Regulatory affairs including Clinical Trials, Clinical assessments, Environment, Phthalates, Advertising, Group Visits, Sterilisation (ethylene oxide / Prion circular), second-hand MD, Guide to MD regulations, etc.

• Legal Affairs including Relations between Industrials and Healthcare Profes-sionals

• Public Affairs

• Access to the reimbursable products market including innovation, post-registration studies, medico-econo-mic assessments

• Focus groups Market Logistics & Traceability, Market Regulations (consolida-ted purchasing, e-commerce, collection), ICT, Export, Taxation (MD taxes and dues), Human Resources

040

1 2 0 1 3R E P O R TN N U A L

041

2Advertising for the general public and professionals • Product for filling of cutaneous depressions

Advertising for professionals • Implantable cardioverter defibrillator• Implantable cardiac defibrillation leads• Implantable pacemaker and its accessories• Implantable pacing lead• Coronary stent• Breast implant• Ankle prosthesis• Knee prosthesis• Hip prosthesis• Shoulder prosthesis• Intraocular lens• Surgical laser generator• Intracranial stent

l i s t o f p r o d u C t s s u b j e C t t o AUTHORISATION


042

3 a l p h a b e t i C a l l i s t

OF MEMBERS 3 M FRANCE

AABBOTT France Division ABBOTT VASCULARABBOTT PRODUCTS SASABS-BOLTON MEDICALACCURAYADDMEDICAAESCULAPAGENCINOXAGFA HCESAIR LIQUIDE MEDICAL SYSTEMSALCON SA (LABORATOIRES)ALLERGAN FRANCE SASALSANZAAMBU SarlAMERICAN MEDICAL SYSTEMSAMO FRANCE SASAMPLATZER MEDICAL FRANCEANIOS (LABORATOIRES)ANNIE BAUER CONFORTARION (Laboratoires)ARTERIAL REMODELING TECHNOLOGIESARTHREXASEPT INMED

ASPIDE MEDICALASTON MEDICAL/SGMATOS MEDICALAUDIO MEDICAL INDUSTRIE (AUDIOMEDI)

BB. BRAUN AVITUMB. BRAUN MEDICAL SASBARD FRANCE SASBAUERFEIND FRANCEBAXTER SASBD UNITE DIABETEBECTON DICKINSON FRANCE SASBEIERSDORF BERTHEAS & CIEBIO PROFILEBIOM’UPBIOMATLANTEBIOMET FRANCE SARLBIOMET SASBIOSENSORS FRANCE SASBIOSPHERE MEDICALBIOTECHNIBIOTRONIK FRANCEBIOXAL

BOSTON SCIENTIFIC SASBREAS MEDICALBROTHIER (LABORATOIRES)BRUNEAU (ETS)BSN MEDICAL SAS

CCAIR LGLCARDIAL SACARE FUSION France 309CARESTREAM HEALTH FranceCARILENE (LABORATOIRES) CARL ZEISS MEDITEC SASCARPENTERCARVADYS SASCAT (Laboratoire)CELONOVA BIOSCIENCES OF EUROPE B.VCERAVER CEREPLASCERMAVEINCHRISTEYNS FRANCE SA Division santé Laboratoire PhagogèneCIZETA MEDICALICLARIANCE SPINECOCHLEAR France SAS


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3 COLGATE PALMOLIVECOLLIN COLOPLAST LaboratoiresCOMIDENTCONCEPTUS SASCONVATEC (LABORATOIRES)COOK FRANCECOOPERCORDIS SASCOUSIN BIOTECHCOVIDIEN FRANCE SASCREASPINECYBERONICS

DDENTSPLY IH SASDEPUY FRANCEDEVICOR MEDICALDIDACTIC GROUPEDIFFUSION TECHNIQUE FRANÇAISE (LA)DISTRIMEDDIXI MICROTECHNIQUES SASDJO France SASDRÄGER MEDICAL SASDR. WEIGERT FRANCE SAS

EECHOSENS S.A.S.U.ECOLAB SNCEDAP TMS SAEDWARDS LIFESCIENCESENDOLOGIX InternationalENGINEERING MEDICAL APPLICATIONEOS IMAGINGESAOTE FranceESCARIUS LaboratoiresETHICON SASETIAMEUROBIO (Laboratoires)EUROSEUROSILICONE SASEUROSPINEEUSA PHARMAEV3EXPANSCIENCE LaboratoiresEYE TECH CARE

FFIIFIMEDFOURNITURES HOSPITALIERES INDUSTRIEFRANCEMEDFRESENIUS KABI FRANCE

FRESENIUS MEDICAL CARE FRANCEFRESENIUS VIAL SASFUJIFILM Medical Systems France SAS

GGALDERMA Q-MEDGAMBRO SASGAMIDA TECHGE HEALTHCAREGENEVRIER (LABORATOIRES) GENZYME SASGERI-COMMUNICATIONGERMITECGIBAUDGIVEN IMAGING SASGN HEARING SASGRAFTYSGRANDET M. (ETS)

HHEMODIAHEMOTECH SASHEXACATH FRANCEHEXAMEDICALHILL-ROM Industries SAHILL-ROM SASHITACHI MEDICAL SYSTEMS


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3 HOLLISTER FRANCEHORUS PHARMA HOSPAL SASHOSPIRAHUTCHINSON SANTE

IIHSIN2BONESINNOTHERA (LABORATOIRES) INSTITUT GEORGES LOPEZ - IGLINTEGRA LIFESCIENCES SERVICESINTERVASCULAR SAS INTUITIVE SURGICAL SASINVACARE POIRIER ITEM

JJOHNSON & JOHNSON SANTE BEAUTE FranceJULIUS ZORNJUVA PRODUCTION (LABORATOIRES)

KKARL STORZ Endoscopie France SAKASIOSKCI Médical (Laboratoire)KIMBERLY CLARKKISCO International

KOMET FranceKONICA MINOLTA MEDICAL & GRAPHIC IMAGING EUROPE BVKREUSSLER PHARMA

LLABODIALLANDANGERLARSLASSERTEUXLDR MEDICALLEMAITRE VASCULARLIFE PARTNERS EUROPELILLY FRANCELIMA FRANCE SAS MEDICAL SYSTEMSLIMMED SARLLINDE France S.A. - Medical operations - Linde HealthcareLOHMANN & RAUSCHER (LABORATOIRES)

MMAQUET SASMARQUAT GENIE BIOMEDICALMATHYS ORTHOPEDIEMAUNA KEA TECHNOLOGIESMAX LORNEMEDACTA

MEDARTISMEDEXMEDI FRANCEMEDIAN TECHNOLOGIESMEDICAL INNOVATION DEVELOPPEMENTMEDICALBIOMATMEDICREA INTERNATIONAL / EUROPE FRANCOPHONEMEDIPREMA SAS / LEGROSMEDISPORTMEDITOR SASMEDLINE INTERNATIONAL FRANCEMEDTRONIC FRANCE SASMICROVALMICROVENTIONMIDMARK EUROPE SASMINVASYSMÖLNLYCKE HEALTH CARE (LABORATOIRE)MORIA SA

NNANOBIOTIXNESTLE CLINICAL NUTRITION FRANCENEURELEC SANIHON KOHDENNIPRO BIOCORPNOBEL BIOCARE


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3 NORAKERNOVACORNOVO NORDISKNUTRICIA NUTRITION CLINIQUE

OOBLOLEA MEDICALOLYMPUSOPTIMEDORLIMAN EUROPE SARLORTHOMEDICAOST - DEVELOPPEMENTOSTEOMED FranceOTTO BOCK FRANCEOURY GUYE et Fils

PPANSEMENTS RAFFINPAUL HARTMANN PENTAFERTE FrancePENTAX FRANCE LIFE CAREPEROUSE MEDICALPEROUSE PLASTIEPETERS SURGICALPFM Médical France SASPHARMA 2000 (LABORATOIRES)

PHILIPS FRANCE Activité HealthcarePHILIPS France Activité Healthcare – Respironics PHONAK FRANCEPHUSIS SASPHYSIDIAPIERRE FABRE DERMO-COSMETIQUEPIERRE FABRE MEDICAL DEVICESPLASTO TECHNOLOGIESPLEXUS MEDICAL FRANCEPOURET MEDICALPREVORPRIMAXPRODIMEDPRODITIONPROSTEELPROTEC’SOM (Laboratoire)PROTEOR HANDICAP TECHNOLOGIEPROTHEOS INDUSTRIEP.V.P. - Laboratoire SEBBIN

QQUERYO MEDICAL

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RECKITT BENCKISER FRANCEREINEMAILLE SASRESMEDRESMED ParisRICHARD FRERESROCHE DIAGNOSTICSRUPIANI

SS-INTERSAFE ORTHOPAEDICSSAMSUNG ELECTRONICS FRANCESANOFI AVENTIS FRANCESBMSCHILLER MEDICAL SASSCIENCE ET MEDECINE (SEM)SCIENT’XSEMESSERFSIEMENS AUDIOLOGIESIEMENS HEALTHCARE FRANCESIGVARISSLEEPINNOV TECHNOLOGYSM EUROPESMALL BONE INNOVATIONS INTERNATIONALSMITH & NEPHEW ORTHOPAEDICSSMITH & NEPHEW SAS


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3 SMITHS MEDICAL FRANCESOBER (LABORATOIRES)SOFRADIM SOFRAMEDICALSOPHYSASORIN GROUP FRANCE SASSPINE VISIONSPINEWAYST JUDE MEDICAL FRANCESTARKEY FRANCESTENTYSSTERI-SERVICESSTRYKER FRANCE SASSTRYKER ORTHOPAEDICS BENOIST GIRARDSTRYKER SPINE SASSUPERSONIC IMAGINESYMBIOSSYNTHES SYSMEXSYST’AMSYSTAGENIX WOUND MANAGEMENT

TTBI MEDICALTE ME NATECHNOLOGIE MEDICALE

TELEFLEX MEDICAL TERUMO FRANCE (LABORATOIRES)TETRA MEDICALTHERADIALTHIEBAUD SASTHT Bio-science GroupTHUASNETLVTORNIERTOSHIBA MEDICAL FRANCE SATROPHY

UUNION PLASTICURGO (LABORATOIRES)

VVASCUTEK FRANCEVECTECVERMEIREN FRANCEVEXIM SASVILLARDVITATRON FRANCEVIVACY (LABORATOIRES)VOLUNTISVYGON

WWEINMANNWIDEX SASWINNCARE SASWRIGHT MEDICAL FRANCE SASWYM FranceW.L. GORE & ASSOCIÉS

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ZZIMMER FRANCEZIMMER SPINEZOLL Médical France


4 t e a M

ORGANISATION CHART


Dr. Brigitte CongarD-Chassol Director ofMedical and Economic Affairs & Export Quality Manager

François-régis Moulines

Director ofPublic Affairs and Communication

Christel CheMinais

Director of Legal Affairs & Ethical Issues

anne Josseran

Director ofMarket Access

PasCale Cousin

Director of Technical and Regulatory Affairs

in the reCruitMent ProCess

Manager for SME and Economic Develoment

Jean-BernarD sChroeDer

Director ofIndustrial Affairs

Monique Borel

Secretary General

Joël guillou

Director of Regulations, Reimbursements & Market Logistics

natalie allarD

Head of Internal Communication

FlorenCe ollé

Pharmacist - Technical and Regulatory Affairs

DiDier gosso

Sector Manager aManDine DeMol

Head of HR & General Administration

sylvie Casanovas

Head of External Communication

aurelie lavorel

Sector Manager ann-Carolyn oleJnik

Assistant, Reception, General & Prospection Services

Coralie soutiF

Administrative and Financial Assistant

aline PainChauD

Head of Statistics

Marie-angele DuranD

Part-timeAssistant to the General Secretariat

FatiMa haMiD

Assistant - Technical & Regulatory Affairs Department

Marie-FranCe Berton

PA,Industrial Affairs

Catherine Martin

Assistant, Public Affairs and Communication and Legal & Ethical Affairs

Catherine enthiMe

Assistant, Internal & External Communica-tion Departments

esther Coline

Assistant,Medical Affairs, Regulations, Reimbursements & Market Logistics

Pierre Duran-CaMPana

Director of Information Systems (work share arrangement)

eriC le roy

Director General

isaBelle hellarD

Assistant, General Management & Market Access

Documents

ANNUAL REPORT 2 0 1 32.3 manufacturers’ environmental responsibility: creation of 2 sectors 2.4 learned societies 2.5 patient associations 2.6 ariis 2.7 cep, ifis, schools, universities,