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The European Association of Pharmaceutical Full-line Wholesalers Groupement International de la Répartition Pharmaceutique the vital link in healthcare Rue de la Loi 26, Box 14 T +32 (0)2 777 99 77 E [email protected] 1040 Brussels, Belgium F +32 (0)2 770 36 01 W www.girp.eu Working Documents for the GIRP Managing Board Day 1: 23 rd January 2014, 10:30 am – 12:30 pm, GIRP office, Brussels MEETING DETAILS Date 23 rd January 2014 Time 10:30 am to 12:30 pm City/Country Brussels/Belgium Address GIRP Office Rue de la Loi 26, box 14 1040 Brussels Belgium Contact Tel.: +32 2 777 99 77 Fax: +32 2 770 36 01 www.girp.eu Email: [email protected] TABLE OF CONTENT Agenda Item 1: Agenda of the meeting .................................................................................................... 2 Agenda Item 2: Minutes of the last meeting.............................................................................................. 3 Agenda Item 3: Financial Status 2013 ...................................................................................................... 8 Agenda Item 3: List of GIRP sponsors in 2014 ........................................................................................ 11 Agenda Item 5: Medical devices legislation package – status of lobbying activities .................................... 12 Agenda Item 6: Outline of GIRP Working Groups .................................................................................... 17 Agenda Item 7: Business Programme Annual General Meeting 2014 in Vienna .......................................... 25 Agenda Item 8: Meeting overview .......................................................................................................... 28

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Page 1: Working Documents for the GIRP Managing Board - Information for full...Travel (Transport & Hotel) ... this in practice, can be solved in many ways. ... Referat 122 – Medizinproduktesicherheit

The European Association of Pharmaceutical Full-line Wholesalers

Groupement International de la Répartition Pharmaceutique the vital link in healthcare

Rue de la Loi 26, Box 14 T +32 (0)2 777 99 77 E [email protected]

1040 Brussels, Belgium F +32 (0)2 770 36 01 W www.girp.eu

Working Documents for the GIRP Managing Board

Day 1: 23rd January 2014, 10:30 am – 12:30 pm, GIRP office, Brussels

MEETING DETAILS

Date 23rd January 2014

Time 10:30 am to 12:30 pm

City/Country Brussels/Belgium

Address

GIRP Office

Rue de la Loi 26, box 14 1040 Brussels

Belgium

Contact

Tel.: +32 2 777 99 77

Fax: +32 2 770 36 01 www.girp.eu

Email: [email protected]

TABLE OF CONTENT

Agenda Item 1: Agenda of the meeting .................................................................................................... 2

Agenda Item 2: Minutes of the last meeting.............................................................................................. 3

Agenda Item 3: Financial Status 2013 ...................................................................................................... 8

Agenda Item 3: List of GIRP sponsors in 2014 ........................................................................................ 11

Agenda Item 5: Medical devices legislation package – status of lobbying activities .................................... 12

Agenda Item 6: Outline of GIRP Working Groups .................................................................................... 17

Agenda Item 7: Business Programme Annual General Meeting 2014 in Vienna .......................................... 25

Agenda Item 8: Meeting overview .......................................................................................................... 28

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Agenda Item 1: Agenda of the meeting

Agenda of the GIRP Managing Board

23rd January 2014, 10:30 am – 12:30 pm, GIRP office Brussels

WHO AGENDA INFO INPUT DECISION KEY

RJ 1. Welcome and approval of the meeting agenda o o

RJ: René Jenny

MDP: Monika Derecque-Pois

RJ 2. Approval of the minutes of the last meeting o

ALL

3. Preparation of the Board meeting

a) Financial status 2013/2014

b) Status of sponsorship

o o o

MDP 4. Status European Stakeholder Model (ESM) o

MDP 5. Medical devices legislation package – status of lobbying activities o

RJ 6. Outline of GIRP Working Groups o

MDP 7. Business programme Annual General Meeting 2014 in Vienna o

ALL 8. Miscellaneous

LUNCH

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Agenda Item 2: Minutes of the last meeting

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Agenda Item 3: Financial Status 2013

Financial Status 2013

G.I.R.P. AISBL

Budget Actual at % budget Projection at % budget Budget % budget

Euro 2013 31/12/2013 2013 31/12/2013 2013 2014 2013

Travel (Transport & Hotel) 75.000,00 84.519,93 113% 75.000,00 100% 75.000,00 100%

Congress 130.000,00 140.946,04 108% 144.000,00 111% 200.000,00 154%

Office supplies 7.500,00 9.928,01 132% 7.600,00 101% 8.000,00 107%

Website 12.000,00 12.481,00 104% 15.000,00 125% 10.000,00 83%

Telecom 15.000,00 14.826,30 99% 10.000,00 67% 12.000,00 80%

Post 6.000,00 5.951,79 99% 4.900,00 82% 6.000,00 100%

Fee President 55.350,00 58.544,76 106% 55.350,00 100% 56.750,00 103%

Girp Office Staff1 300.000,00 300.391,98 100% 300.000,00 100% 307.500,00 103%

Girp Director General 161.191,50 161.191,44 100% 161.191,50 100% 165.220,00 102%

Board 8.000,00 7.891,45 99% 7.500,00 94% 8.000,00 100%

Working Groups 18.000,00 30.966,93 172% 39.000,00 217% 18.000,00 100%

Managing Board 5.000,00 4.969,49 99% 5.000,00 100% 5.000,00 100%

Bookkeeping external 13.000,00 13.000,00 100% 13.000,00 100% 13.500,00 104%

Auditor + VAT + control 4.300,00 4.300,00 100% 4.300,00 100% 4.300,00 100%

Office Rent 52.000,00 57.342,83 110% 52.000,00 100% 54.000,00 104%

Membership IFPW 5.500,00 5.745,37 104% 5.745,37 104% 6.000,00 109%

Public Relations & Rest., Reception 70.000,00 85.728,42 122% 70.000,00 100% 70.000,00 100%

Publications 12.000,00 14.017,88 117% 15.000,00 125% 12.000,00 100%

Subscriptions 16.000,00 19.898,34 124% 16.000,00 100% 16.000,00 100%

Legal Advice 38.000,00 38.150,04 100% 38.000,00 100% 38.950,00 103%

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Technical Equipment 9.000,00 10.298,72 114% 7.500,00 83% 9.000,00 100%

Study communication 0,00 0,00 0% 0,00 0% 0,00 0%

Leadership Forum / Regional Meeting 15.000,00 0,00 0% 3.000,00 20% 15.000,00 100%

Misc.tax&bank 3.000,00 2.864,88 95% 3.000,00 100% 3.000,00 100%

VAT not recoverable 0,00 0,00 0% 0,00 0% 0,00 0%

EXPENSES 1.030.841,50 1.083.955,60 105% 1.052.086,87 102% 1.113.220,00 108%

Contribution Full Members Associations 382.072,67 388.614,65 102% 389.323,82 102% 397.902,10 104%

Contribution Pan European Companies/Group (7) 446.951,25 450.833,52 101% 401.722,27 90% 356.319,47 80%

Contribution Associated Professional

Members 10.455,00 12.546,00 120% 12.546,00 120% 12.859,65 123%

Contribution Associated External Members /

Sponsors 195.000,00 215.000,00 110% 215.000,00 110% 215.000,00 110%

Other income (Events participation and sponsorship) 100.000,00 135.932,41 136% 127.774,38 128% 120.000,00 120%

Interest & other income 5.000,00 1.654,79 33% 4.500,00 90% 4.000,00 80%

REVENUES 1.139.478,92 1.204.581,37 106% 1.150.866,47 101% 1.106.081,22 97%

RESULT 108.637,42 120.625,77

98.779,60

-7.138,78

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Status accounts on 31/12/2013 Status Business Account 12.371,57

Status Savings Account 305.434,90

Invoices and costs to be paid 31/12/2013 44.371,47

Belgian VAT to receive back =

53.161,41

1 Communication and Events Manager (Viktoria Keri) [FT –int.]; Membership and Corporate Affairs Manager (Anneliese Gattringer) [FT –int.]; Economic and European Affairs Manager (Magda Savin) [FT –int.]; Deputy Director General (Martin FitzGerald) [PT –ext. consult]; Office Manager (Mihai Rotaru) [PT -ext]; Communications officer (Emer Begley) [PT –ext. consult.]; Trainee (Ruth NicGinnea) [FT –int]; Trainee (Susanne Tischler) [FT –int]. Also ancillary costs included.

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Agenda Item 3: List of GIRP sponsors in 2014

Company Country Company description

IMS Health USA IMS Health is the world’s leading information, services and technology company dedicated to making healthcare perform better.

Insight Health Germany Market research and health care research in the medical field

KNAPP Austria New technology to warehouse logistics

SSI Schäfer Austria Logistics system and software, storage and conveying

CAPPI France Designing, testing and manufacturing customized packaging solutions for temperature-sensitive and pharmaceutical products

IBS USA/Italy Pharmaceutical distribution software

SENSITECH Netherlands

Sensitech offers a wide range of services that include the ongoing collection, management, and storage of temperature-sensitive supply chain data, as well as the analysis and reporting required to translate data into actionable information.

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Agenda Item 5: Medical devices legislation package – status of lobbying activities

GIRP Overview of National Lobbying Activities

Report on contacts – outcome of contacts with your country’s Council delegate/

representative

Name Ms Danielle Van Mulukom

Country Netherlands

Function Senior policy advisor

Address Ministry of Health

2500 EJ The Hague Netherlands

Email [email protected]

Telephone +31 70 3406542

Fax -

Contacted on 08/11/2013 & 22/11/2013

Outcome

On November 19 the Working Party has discussed article 12.

With regard to article 12.b there was less support to (partly) change the

wording. Despite earlier feedback that they would give full support to GIRPs position concerning Article 12 b, it seems member states highly emphazise the

importance of adequate information for users and patients. Distributors also have a responsibility in the chain in this respect. How to control and to secure

this in practice, can be solved in many ways. It is estimated that there will be little support to change this article.

At the meeting there was much support for the (German) proposal (largely in

line with the GIRP amendment) to skip article 12.c as whole.

As expected there has been no discussion about articles 13 & further.

Actions to be taken We keep each other informed

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Name Dr. Matthias Neumann

Country Germany

Function Federal Ministry of Health (AIMDD, MDD, IVDMD Legislation)

Address

Bundesministerium für Gesundheit Referat 122 – Medizinproduktesicherheit

Friedrichstraße 108

10117 Berlin Tel +49 (030) 20640 – 2636

Email [email protected]

Contacted on ongoing

Outcome

PHAGRO is in contact with the German representative who is in charge of the Regulation. The Council will be drafting a paper including the positions of all

the Council members. The BMG is aware of PHAGRO’s position. In Germany, the issue of the registration procedure of medical devices is similar to the one

for medicinal products. It is currently strongly debated and the German health

insurance companies exercise a lot of pressure in this respect. Thus the BMG is more focused on other content issues than Article 12.

Actions to be taken

Name Mr. Gian Marco Currado

Country United Kingdom

Function Head Dep. EU & International Policy & Strategy, Medicines and Healthcare

products Regulatory Agency

Email [email protected]

Contacted on 15 November 2013

Outcome

The standpoint of the representative is that the wording of the Article 12 of the proposal for a regulation on medical devices is acceptable the way it is now

because he believes that it will be interpreted in such way that wholesalers

would only need to show that they are taking a proportionate approach to checking the packs.

Actions to be taken The British Association of Pharmaceutical Wholesalers will continue to discuss

with its national authorities.

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Name Dr.

Dr.

Annamaria

Pietro

Donato

Calamea

Country Italy

Function

Head of Units, Ministry of Health, Department of Planning and Organisation of

the National Health Service - Directorate General of Medical Devices, pharmaceutical services and safety in healthcare

Email [email protected]

[email protected]

Contacted on

Outcome The person responsible of the MDD in Italy is currently taking the same view

as the UK.

Actions to be taken Mr. Scrofina from ADF will continue to discuss with the representatives to explain the implications of leaving the wording out for potential interpretation

rather than pressing for a concrete wording immediately.

Name Prof. Dr. Wolfgang Ecker

Country Austria

Function Bundesministerium für Gesundheit

Email [email protected]

Contacted on

Outcome

In Austria first informal contacts have taken place. The Austrian Council

representative has signalled that they may be willing to support GIRP’s position in the Council. Further discussions are planned to take place still before

Christmas.

The Austrian Chamber of Commerce has contacted Prof. Dr. Eckert on behalf of ARGE Pharmazeutika.

Actions to be taken

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Name Ms. Carmen Abad

Country Spain

Function Agencia Espaňola de Medicamentos y Productos Sanitarios

Email [email protected]

Contacted on meeting on 20th December 2013

Outcome Ms. Abad believes that a wholesaler cannot be classified as a distributor and

therefore the provision does not apply to wholesalers

Actions to be taken

Name Ms. Emmanuelle Barsky

Country France

Function bureau dispositifs médicaux de la direction générale de la santé au ministère de la santé

Email [email protected]

Contacted on

Outcome

According to the French government, through the Medical Devices Bureau of

the Ministry of Health, article 12 does not pose any particular problems as the obligations on distributors exist in other economic sectors as well.

For example, in the toy industry, the same obligations exist for manufacturers and distributors. However, this does not mean that each toy box has to be

opened for verification. To this effect, the EC has published a guide for the

application of the directive:

http://ec.europa.eu/enterprise/sectors/toys/files/tsd-guidance/tsd_rev_1-

6_explanatory_guidance_document_en.pdf.

Despite our efforts to convince the French government of the particularities of

our sector, and their willingness to listen to our arguments, the fact that other

economic sectors have to abide to similar provisions will make it difficult to obtain any derogations.

Actions to be taken

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Name Ms. Josiane Van der Elst

Country Belgium

Function Director General in the Directorate General Inspection, FAGG

Email [email protected]

Contacted on 12th December 2013

Outcome

The Belgian authorities have the same interpretation as GIRP, that according

to the current text, every pack would need to be opened. The Belgian

representatives believe that this burden on wholesalers would be completely out of proportion. Therefore the Belgian authorities assured that they will

reflect about the best way how to raise this point during the Council meeting.

Actions to be taken

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Agenda Item 6: Outline of GIRP Working Groups

GIRP Working Groups’ Terms of Reference

Please note that the GIRP membership guidelines are applicable to all GIRP Committees, Councils and Project Groups. The guidelines were approved by the GIRP Managing Board and Board and should

serve to ensure continuity in the work of the working groups and provide guidance on subjects under

discussion. In particular, we would like to draw your attention to the tightened requirement of 50% minimum attendance of all meetings.

OK TO DISCUSS:

Technical issues relevant to the sector represented by the association

Publicly available information on market trends and general promotional opportunities

Industry public relations or advocacy activities

NOT OK TO DISCUSS:

Issues concerning price changes, pricing strategies, terms of sales, price mark-ups, discounts,

allowances, credit terms, etc. on a company level

Costs of distribution, cost accounting and methods of computing costs on a company level

Individual company figures on or plans as to sources of supply, inventories, sales, marketing and promotion

Any matters relating to individual suppliers or customers, including any attempted collective

action that might have the effect of excluding suppliers or customers from the market

Information as to future plans of individual companies concerning technology, investments

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Name Technical Committee (TC)

Description

The main task of the Technical Committee is to raise the profile of pharmaceutical full-line wholesalers, from a quality point of view, towards the partners of the supply

chain and the authorities (national, international and European) as this will lead to an

advantageous market environment for full-line wholesalers. It also assists with the associations’ replies to consultation documents and analyses legislation with regard to

its impact on the operational aspects of pharmaceutical wholesalers’ business. The Technical Committee aims to provide, when possible, early warning about emerging

technical problem due to adherence to new obligations, rules and standards and

identify the pros and cons of proposed changes that can occur in the business. The Technical Committee furthermore assists in the drafting and reviewing of GIRP’s

position and advocacy papers from a technical viewpoint.

Work plan

Delegated Acts to complement the Falsified Medicines Directive

Implementation of the European Good Distribution Practice Guidelines

(2013/C 68/01)

Revision of European Medical Devices legislation and European Commission

recommendation on Unique Device Identification (UDI) for medical devices European Stakeholder Model – for a European Medicines Verification System

– technical issues

Cold chain and narcotic products storage and delivery

Following development in relation to regulatory aspects of the distribution of

active substances (APIs)

Membership1

Participation is open to the staff of any GIRP full member company/association with technical expertise. Participants should have a high level of expertise and knowledge

in the development of technical aspects of wholesaling (storage, pick-pack, etc.), as well as IT expertise.

Meetings Minimum twice per year

Chairmanship Rotating

1 for the current members, please see GIRP Working Group Members List

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Name Legal Affairs Committee (LAC)

Description

The main task of the Legal Affairs Committee is to help raise the profile of

pharmaceutical full-line wholesalers, from a legal point of view, in the

associations position vis a vis the external environment – supply chain partners, health authorities and other relevant stakeholders.

The objective is to follow developments in the legislative and regulatory

domain with a primary focus on assessing the impact that legislative and regulatory proposals have on the business of pharmaceutical full-line

wholesalers.

The legal affairs committee is also charged with duties related to the

commenting on public consultation and preparing the position of GIRP in relation to legislative and regulatory proposals.

The legal affairs committee assists GIRP proposing suggested amendments

as the legislative and regulatory proposals pass through the respective institutions of the European decision making bodies.

The legal affairs committee is furthermore responsible for commenting from a

legal perspective positions on the development of GIRP advocacy papers,

statements and documents which form a critical aspect of the work of the association.

The legal affairs committee also follows health policy and healthcare system

legal framework developments in the different EU Member States. The legal affairs committee is responsible for preparing for the association all

duties related to legal aspects for the smooth operation of the association.

Work plan

The Delegated Acts to complement the Falsified Medicines Directive – follow

up actions. Follow and support with the implementation of the European Good

Distribution Practice Guidelines (2013/C 68/01).

Follow and support lobbying efforts of GIRP in relation to the revision of

European Medical Devices legislation and European Commission recommendation on Unique Device Identification (UDI) for medical devices.

European Stakeholder Model – for a European Medicines Verification System

– legal and political issues Other EU legislative and regulatory proposals – EU data protection,

transparency directive, general products safety directives, …

Membership2

Participation is open to the staff of any GIRP full member company/association with a legal background is preferable as well as in-depth knowledge of pharmaceutical law

and knowledge of competition law. Participants should have a high level of expertise

and knowledge in the development of legal aspects of full-line wholesaling.

Meetings Approximately 4 times per year

Chairmanship Rotating

2 for the current members, please refer to the Legal Affairs Committee - List of Active Members

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Name Advisory Council Supply Chain Solutions (ACSCS)

Description

GIRP set up its Advisory Council Supply Chain Solutions in order to be able to discuss

and promote to the supply chain partners the diversified range of services that GIRP Members provide. This includes discussions about homecare services, specialty

products, pre-wholesaling etc.

Work plan

examine different ways of improving communication and increasing mutual

understanding with the pharmaceutical industry

examine issues such as for example collaborative forecasting for ordering and

replenishing screen possibilities for joint ordering platforms and defining standards for

data interchange

promote advanced shipping notifications and electronic invoices

revise the content and structure of the GIRP Wholesale Brief (for eventual

external use)/ to elaborate an external communication tool for the pharmaceutical industry

establish an information database on the range of wholesalers’ services and

to ascertain information on which members offers what kind of services improve the representation of wholesalers at manufacturer-oriented

conferences

conduct a fact-finding mission to obtain manufacturers’ needs and

requirements

keep the manufacturers’ services presentation updated with most recent

developments develop and keep the manufacturers database

Membership3

Participation in the council is open to the staff of any GIRP full member company and

involvement is actively encouraged especially from those companies that are developing manufacturer services. Participants should have a high level of expertise

and knowledge in the development of manufacturer services and have a clear vision and commitment to actively contribute to the work programme.

Meetings approx. 4 times per year

Chairmanship Mr. Thomas Ehmann

3 for the current members, please see GIRP Working Group Members List

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Name Advisory Council Retail (ACR)

Description

The Advisory Council Retail aims to inform / support members with retail interests

about the pharmaceutical retail business, to discuss new developments which impact pharmacy retail and elaborate health care services which can be provided by retail

pharmacies in a cost effective manner.

Work plan

Revision and update of pharmacy chain ownership overview

Evaluation of the impact of EU health policy developments on retail

pharmacies, including: The Falsified Medicines Directive & Delegated Acts

Impact of the pharmacovigilance legislation EC initiative on active and healthy ageing and unding possibilities through

Horizon 2020 Discussion about retail specific results of GIRP IPF study

Mapping of product range and services by country

Membership4

Participation in the Advisory Council Retail is open to the staff of any GIRP full member company and involvement is actively encouraged especially from those

companies that are developing pharmacy and patients services through or supporting retail business. Participants should have a high level of expertise and knowledge in

the pharmaceutical retail market and the development of pharmacy services and have

a clear vision and commitment to actively contribute to the work programme.

Meetings approx. once per year

Chairmanship TBD

4 for the current members, please see GIRP Working Group Members List

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Name Economic and Social Affairs Committee (ECOSOC)

Description

The Economic and Social Affairs Committee (ECOSOC) discusses cost segmentation of full-line wholesaling companies, pricing and reimbursement systems in Europe,

market developments on national and European level, remuneration systems for medicines distribution and the economic impact of political and legal measures on the

full-line wholesaling business.

Work plan

Analysis and revision of GIRP data:

o GIRP statistics o GIRP country reports

o GIRP margin overview Update on EU Health policy developments:

o Information on Delegated Act and current developments

o Developments regarding the European Medicines Verification System

o Medical devices regulatory framework updates Support for the Ariadne task force for countries in difficulty

Support and help for national associations to deal and negotiate with local

authorities

Evaluation of the different types of wholesale remuneration systems

Possible EU funding opportunities for studies on the wholesale business and

pharmaceutical sector

Membership5

Participation is open to the staff of any GIRP full member company/association with sound economic expertise. Participants should have a high level of expertise and

knowledge in the development of economic aspects of the wholesale business and of

the pharmaceutical market in general.

Meetings Twice per year

Chairmanship Mr. René Jenny

5 for the current members, please see GIRP Working Group Members List

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The GIRP Project Groups were set up following a decision of the GIRP Board that, as a guiding

principle, GIRP should accommodate all business interests of its members, including special business interest shared by a cluster of companies.

Name Patient Compliance and Homecare Project Group (PCH)

Description

The Patient Compliance and Homecare Project Group is dedicated to enhancing collaboration among a cluster of GIRP member companies which provide services in

the areas of patient compliance and homecare. The main objective of this project

group is to identify, create and/or participate in projects of mutual benefit to the members of the group and make these services known to the European institutions

and other stakeholder organisations as well as to social insurance organisations. The point of reference for any projects undertaken by this group should be the benefit of

patients.

Work plan

Participation in the European Innovation Partnership on Active and Healthy

Ageing action A1 Prescription and adherence to medical plans Update and revision of the compilation of GIRP presentation on ‘Patient

Compliance and Homecare Services’ Update of the mapping exercise Patient Compliance & Homecare

Develop a formula for quickly mobilising the group of members to participate

in and / or lead key initiatives launched by public authorities, or other

stakeholders

Consider ethnic issues in connection with the delivery of services in the field Approach manufacturers and patient groups to make them aware of the

possibilities

Contact the healthcare authorities and different categories of payers, such as

insurance companies in order to promote the services offered by GIRP

members Continue the collection of evidence on the positive impact of patient

compliance and homecare services on healthcare costs and the wide-ranging

benefits that arise from increased patient compliance Discuss pharmacovigilance issues and subjects such as safety and quality in

homecare

Membership6

Participation is open to the staff of any GIRP full member company/association that runs or is involved in patient compliance and/or homecare programmes. Participants

should have a high level of expertise and knowledge in the field of patient compliance and/or homecare services. All members should have a clear vision and commitment

to actively contribute to the work programme.

Meetings Twice per year

Chairmanship TBD

6 for the current members, please see GIRP Working Group Members List

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Name eHealth Project Group

Description

The main objective of this project group is to identify, create and/or participate in eHealth and mHealth projects of mutual benefit to the members of the group and to

exchange best practice information with a view to setting highest standards for the sector overall.

Work plan

Update on activities on EU level:

o European Innovation Partnership Active and Healthy Ageing

o Commission eHealth stakeholder group

o 2nd eHealth Action Plan Update of the mapping the sector (eHealth services offered by members)

Monitor the upcoming European Commission Green Paper on mHealth, due

for publication in early 2014

Contact different stakeholders active in the eHealth and mHealth sectors in

order to cross-share experiences Discuss subjects such as electronic interaction and decision support systems

Membership7

Participation is open to the staff of any GIRP full member company/association that runs or offers eHealth services. Participants should have a high level of expertise and

knowledge in the field of eHealth and/or mHealth and/or ICT services. All members should have a clear vision and commitment to actively contribute to the work

programme.

Meetings Twice per year

Chairmanship TBD

7 for the current members, please see GIRP Working Group Members List

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Agenda Item 7: Business Programme Annual General Meeting 2014 in Vienna

Draft Conference Programme

GIRP 55th Annual General Meeting 2

nd – 3

rd June 2014, Vienna, Austria

Conference Day I, 2nd June 2014

Opening

Mr. René Jenny, President, GIRP

Welcome address by the Austrian Association of Pharmaceutical Wholesalers ARGE Pharmazeutika

Dr. Andreas Windischbauer, President of ARGE Pharmazeutika, Managing Director Herba Chemosan

Keynote address

Mr. Alois Stöger, Minister of Health, Austria

Keynote addresses

Fostering an innovative agenda in healthcare Mr. Tonio Borg, European Commissioner for Health and Consumer Policy, European Commission

Megatrends in healthcare Mr. Per Båtelson, Chairman of the Board, Karolinska University hospital, Stockholm

Coffee break

Partnerships in the Austrian medicines supply chain

Panellists:

Dr. Andreas Windischbauer, President of ARGE Pharmazeutika, Managing Director, Herba Chemosan

Mag. Max Wellan, President of the Austrian Chamber of Pharmacists

Dr. Robin Rumler, President of Austrian Pharmaceutical Industry Association (Pharmig), Managing Director of Pfizer Austria

Challenges and opportunities from the perspective of society and medicines Dr. Christa Wirthumer-Hoche, Head of the Austrian Medicines Agency (AGES) TBI

Lunch break

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eHealth – a strategic investment in healthcare access for patients anytime, anywhere Mr. Thomas Hendrik Ilves, President, Estonia TBC

How eHealth can improve the quality and safety of healthcare for patients

Keynote address

Mr. Paul Timmers, Director, Directorate H Sustainable & Secure Society, DG CONNECT, European Commission TBC

Developing and adapting mHealth programmes across Europe Mr. Eduardo Pisani, Director General, IFPMA

Session chairperson: TBD

Panellists:

Mr. Pierre Chancel, Head of Sanofi Diabetes, Sanofi TBI

Ms. Emely Kelly, Celesio (MyMed) TBC

Mr. Štefan Krchňák, President PGEU TBI

Dr. Clemens Martin Auer, Austrian Ministry of Health, Director Section 1 Health Systems and Coordination TBC

Coffee break

Securing medicines access by advancing Public Service Obligations Session chairperson: TBD

Keynote address

Mr. Daniel Bahr, former Health Minister Germany TBI

Panellists:

Dr. Isabelle Adenot, President, Conseil National de l'Ordre des Pharmaciens

Representative of Belgian Government TBI

Ms. Josiane Van der Elst, Director General in the Directorate General Inspection, FAGG TBC

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Conference Day II, 3rd of June 2014

European and international trends in the wholesale sector (IMS session)

Mr. Per Troein, Vice President Strategic Alliances, IMS Health

Mr. Doug Long, Vice President, Industry Relations IMS Health

Coffee break

Building an innovative supply chain in an era of uncertainty – working together Session chairperson: Dr. Roger Sorel, Board Member, European Association of Pharmaceutical Full-line Wholesalers (GIRP)

Panellists:

Mr. Stephan Borchert, Member of the Board, Celesio AG

Mr. Wolfgang Mähr, Regional Director, Alliance Healthcare

Mr. Aleksandr Kraytser, Head Channel Management Region Europe, Novartis Pharma AG

Mr. John Chave, Secretary General, Pharmaceutical Group of the European Union (PGEU)

Mr. Nick Haggar, Head of Western Europe, Middle-East & Africa, Sandoz, President, EGA TBC

Mr. Dipankar Bhattacharjee, President and Chief Executive Officer Generics Europe, Teva Pharmaceuticals Europe B.V

How innovative partnerships in the EU foster patients access to cancer drugs. A model for other therapeutic areas?

Dr. Andreas Penk, President Oncology Europe, Country Manager Germany, Pfizer

Closing address

Ms. Monika Derecque-Pois, Director General, European Association of Pharmaceutical Full-line Wholesalers (GIRP)

Farewell lunch

Post-conference workshop: European Stakeholder Model progress update TBC

Mr. Richard Bergström, Director General, European Federation of Pharmaceutical, Industries and Associations (EFPIA)

Mr. John Chave, Secretary General, Pharmaceutical Group of the European Union (PGEU)

Dr. Heinz Kobelt, Secretary General, European Association of Euro Pharmaceutical Companies (EAEPC)

Ms. Monika Derecque-Pois, Director General, European Association of Pharmaceutical Full-line Wholesalers (GIRP)

Mr. Adrian van den Hoven, Director General, European Generics Association (EGA)

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Agenda Item 8: Meeting overview

Type Meeting Date Time Location

Managing Board

Managing Board (MB members only) 01 June 2014 10 am - 12 pm Palais Hansen Kempinski Vienna, Austria

Managing Board (MB members only) 12 November 2014 tbc Brussels

Managing Board (MB members only) 07 June 2015 10 am – 12 pm Belgrade, Serbia

Board

Board (Board members only) 01 June 2014 2 pm - 4 pm Palais Hansen Kempinski Vienna, Austria

Board (Board members only) 12 November 2014 tbc Brussels

Board (Board members only) 07 June 2015 2 pm – 4 pm Belgrade, Serbia

Working Groups/Project Groups

Advisory Council Supply Chain Solutions tbc tbc tbc

Advisory Council Retail tbc tbc tbc

Technical Committee 5 March 2014 10 am - 1 pm GIRP office, Brussels

Legal Affairs Committee 12 March 2014 12 pm - 2 pm GIRP office, Brussels

Economic and Social Affairs Committee 5 February 2014 10 am - 4 pm GIRP office, Brussels

eHealth and Patient Compliance and Homecare tbc tbc tbc

Annual General Meeting 2014, Vienna

Managing Board (MB members only) 01 June 2014 10 am – 12 pm Palais Hansen Kempinski Vienna, Austria

Board (Board members only) 01 June 2014 2 pm – 4 pm Palais Hansen Kempinski Vienna, Austria

EU Health Policy Briefing (full members only) 01 June 2014 4 pm – 5 pm Palais Hansen Kempinski Vienna, Austria

Annual General Assembly 01 June 2014 5 pm – 6 pm Palais Hansen Kempinski Vienna, Austria

Welcome Dinner 01 June 2014 8 pm onwards Heuriger Mayer am Pfarrplatz, Vienna, Austria

Annual Conference Day 1 02 June 2014 9 am – 5 pm Palais Hansen Kempinski Vienna, Austria

Gala Dinner 02 June 2014 8 pm onwards Palais Liechtenstein, Vienna, Austria

Annual Conference Day 2 03 June 2014 10 am – 1 pm Palais Hansen Kempinski Vienna, Austria

Farewell Lunch 03 June 2014 1 pm onwards Palais Hansen Kempinski Vienna, Austria

Autumn Meeting 2014

Managing Board (MB members only) 12 November 2014 tbc Brussels

Board (Board members only) 12 November 2014 tbc Brussels

EU Health Policy Briefing (full members only) 12 November 2014 tbc Brussels

Autumn General Assembly 12 November 2014 tbc Brussels

GIRP & IMS Dinner 12 November 2014 tbc Brussels

Autumn Conference 13 November 2014 tbc Brussels

EP Lunch Reception 13 November 2014 12:30 pm - 3 pm European Parliament, Brussels

Annual General Meeting 2015, Belgrade

Managing Board (MB members only) 07 June 2015 10 am – 12 pm Belgrade, Serbia

Board (Board members only) 07 June 2015 2 pm – 4 pm Belgrade, Serbia

EU Health Policy Briefing (full members only) 07 June 2015 4 pm – 5 pm Belgrade, Serbia

Annual General Assembly 07 June 2015 5 pm – 6 pm Belgrade, Serbia

Welcome Dinner 07 June 2015 8 pm onwards Belgrade, Serbia

Annual Conference Day 1 08 June 2015 9 am – 5 pm Belgrade, Serbia

Gala Dinner 08 June 2015 8 pm onwards Belgrade, Serbia

Annual Conference Day 2 09 June 2015 10 am – 1 pm Belgrade, Serbia

Farewell Lunch 09 June 2015 1 pm onwards Belgrade, Serbia

Managing Board and Board Meeting Strategy Review Meeting tbc tbc Brussels

Directors of national Associations meeting Directors of national Associations meeting tbc tbc Berlin

Regional Meeting Regional Meeting tbc tbc tbc