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GROUPEMENT INTERNATIONAL DE LA REPARTITION PHARMACEUTIQUE EUROPEAN ASSOCIATION OF PHARMACEUTICAL FULL-LINE WHOLESALERS

Managing Board Meeting 3rd June 2012

10 am to 12 pm

Penha Longa Hotel & Golf Resort « Imperial Suite »

Estrada da Lagoa Azul Sintra - Linhó 2714 - 511

Portugal Phone: (351) 21 924 9011 Fax: (351) 21 924 9007

WORKING DOCUMENTS

the vital link in healthcare



GROUPEMENT INTERNATIONAL DE LA REPARTITION PHARMACEUTIQUE EUROPEAN ASSOCIATION OF PHARMACEUTICAL FULL-LINE WHOLESALERS

MANAGING BOARD MEETING 3rd June 2012

Agenda Item 1: Agenda of the Managing Board meeting of 3rd June 2012 .................. 3

Agenda Item 2: Minutes of the meeting of 3rd February 2012, Vienna ......................... 5

Agenda Item 3a: NVGV/ANGR letter announcing Board representation change ............ 12

Agenda Item 3b: Application form from Romanian association .................................... 13

Agenda Item 3c: GIRP annual accounts and audit report ............................................ 15

Agenda Item 3c: Financial status 2012 ...................................................................... 21

Agenda Item 4: Amended GIRP by-laws art. 4.4 and 10 in EN and FR ....................... 23

Agenda Item 4 : BDO report on GIRP VAT situation ................................................... 27

Agenda Item 5: Follow-up activities from GIRP / AstraZeneca workshops .................. 33

Agenda Item 6: GIRP draft CSR statement ............................................................... 34

Agenda Item 6: GIRP draft Code of Conduct ............................................................ 36

Agenda Item 8: European Alliance for Personalised Medicines call to action ............... 39

the vital link in healthcare



Agenda Item 1: Agenda of the Managing Board meeting of 3rd June 2012

AGENDA GIRP Management Board Meeting

3rd June 2012 10 am to 12 pm

“Imperial Suite”, Penha Longa Hotel & Golf Resort, Lisbon AgendaMB030612

WHO AGENDA INFORMATION INPUT DECISION KEY

RJ 1. Welcome and approval of the agenda of the meeting RJ=René Jenny

MDP=Monika Derecque-Pois

EH=Eero Hautaniemi

HJ=Heinrich Jacoby

RJ 2. Approval of the minutes of the last meeting of 3rd February 2012

RJ/MDP/EH

3. Preparation of the Board meeting

a. Changes in Board representation

b. Applications for Full Membership

c. Financial matters

Presentation of the Annual Report

Recommendation to the General Assembly to accept the annual accounts, the audit report of 2011 and to give discharge to the Board, Director General and auditors

Financial status 2012



Outstanding membership fees 2012 and consequences of non-payment

Status of sponsorship

d. Update on Belgian VAT situation and potential solutions

RJ, ALL 4. Modification of the GIRP by-laws art. 4.4 and 10 (see annex for EN and FR versions) and BDO report

MDP, HJ 5. Outcome of GIRP / AstraZeneca workshops

RJ, ALL 6. Discussion on GIRP code of conduct and corporate social responsibility statement

ALL 7. Brainstorming on means to avoid supply shortages

RJ 8. Miscellaneous



Agenda Item 2: Minutes of the meeting of 3rd February 2012, Vienna

MINUTES GIRP Managing Board

3rd February 2012 – 11 am to 1 pm “Breuer” meeting room, Sofitel Stephansdom, Vienna

MEMBERS present excused

Mr. René Jenny, President x

Dr. Heinrich Jacoby, Vice-President x

Mr. Miguel Valdés, Vice-President x

Mr. Marc van Gelder, Vice-President x

Mr. Reimund Pohl, Vice-President x

Mr. Eero Hautaniemi, Treasurer x

Ms. Monika Derecque-Pois, Director General x

GUESTS

Mr. Lothar Jenne x

Mr. Wolfgang Mähr x Actions

PROCEDURAL MATTERS

1. Welcome and approval of the agenda of the meeting GIRP President, Mr. René Jenny gives a warm welcome to the members of the Managing Board as well as to the invited guests. He verifies that all members have received the agenda and the meeting documentation as sent on 10th January 2012 and 27th January 2012 respectively. The President asks for the approval of the agenda of the meeting, which is unanimously given.

2. Approval of the minutes of the last meeting of 8th November 2011, Brussels

The President asks for approval of the minutes of the last meeting held on 8th

November 2011 in Brussels. The members unanimously approve the minutes.

GIRP office to load minutes

3. Preparation of the Board Meeting Financial status 2011 The Director General presents the financial status 2011 and reports that GIRP has gained one more sponsor for 2012, the company CAPPI, producing totes and cold chain boxes. This sponsor will contribute 20,000 Euro to the 2012 budget. Furthermore, there



will be no payment due in 2012 for the European Medicines Verification Organisation (EMVO), but it should be foreseen in the 2013 budget. Furthermore, the Director General informs the members that the VAT situation in Belgium has changed. New legislation was passed and entered into force in January 2012. According to the new regulation, GIRP will no longer have the possibility to partially recover VAT. Ms. Monika Derecque-Pois explains that VAT has become a black-and-white issue. Associations are either exempted from it or not, depending on whether the organisation can be considered a trade union or not. A summary of this new legislation was included in the Working Documents. Ms. Monika Derecque-Pois explains that if GIRP can no longer deduct VAT, this would have great impact on the budget (around 70,000 Euro). GIRP has asked the Belgian VAT authorities for an opinion, which is still pending. The Managing Board suggests that GIRP should inquire about the possibility to set up a services company. Developments on the Memorandum of Understanding and the joint Coding & Identification system The Director General informs the members that following the comments on the MoU received during the last Managing Board and Board meeting, GIRP renegotiated with EFPIA and PGEU and succeeded in having all concerns voiced by the GIRP organs taken into account: MoU should state that it is not legally binding All future legally binding documents have to include an exit clause EMVO should finance itself after three years of operation She also informs the members that EAEPC, the parallel traders association has decided to join the EFPIA/GIRP/PGEU project on medicines verification. They are currently revising the MoU to become a full member of the EMVO (European Medicines Verification Organisation), which will imply some changes to the current version of the MoU. The Director General also reports that EGA is no closer to joining the project. In fact, EGA insists to have serial numbers pre-printed and not to include the batch number and expiry date in the code on the pack for cost reasons, which is not advantageous for GIRP members. Furthermore, EGA insisted during the Commission hearing on 20th December 2011 that wholesalers should verify all medicines carrying safety features. EDQM On 26th and 27th January, EDQM has invited all stakeholders as well as medicines agencies to Strasbourg for their workshop during which the eTACT medicines verification system was presented. EDQM changed the model from a “track and trace” approach to a verification system. This is due to GIRP’s strong opposition against a “track and trace” model and to GIRP’s members’ numerous replies to EDQM’s consultation. Ms. Monika Derecque-Pois points out that the big difference to the EAEPC/EFPIA/GIRP/PGEU initiative is that eTACT is a government-led model and not a stakeholder-led model and the danger is that governments may buy into this system. This was stressed by the fact that 13 medicines agencies were present at the EDQM workshop. An interesting, but equally worrying presentation was made about the “track and trace” system in place in Turkey. To make the system fully functional all packs need to be scanned by the wholesalers at the point of dispatch.

GIRP to inquire about the possibility to set up a services company



Update on GIRP preparation for the Delegated Act consultation The Director General informs the members about the status of preparations for the input to the Commission’s Delegated Act consultation. In addition to a joint response by EAEPC, EFPIA, GIRP and PGEU on the joint views, GIRP is preparing its own response on the points which are of special importance to pharmaceutical wholesalers such as the elements included in the code and the verification process. Furthermore, she reports on a meeting to prepare GIRP’s reply, which took place the previous day. The meeting was composed of experts from the Economic and Social Affairs, the Technical and the Legal Affairs Committee. The Members of the Managing Board briefly discuss on the way the calculations are made and ask the GIRP office to include the highest possible realistic cost estimation to make clear that the scanning of all packs at the point of dispense is not an option and to forward all documents showing the status of preparations to the Managing Board. Furthermore, explanations on the costs and procedures should be added as well as the possibility that some warehouses would need to close down due to a lack of space and new ones would have to be constructed. Questionnaire and meeting on supply quota systems The Director General reports on a meeting that took place the previous day on the impact of supply quota systems, which was comprised of GIRP members, who filled in the questionnaire established by Mr. Giuseppe Scrofina, GIRP Board member from Italy. Some replies were directly received by Mr. Scrofina and some were sent to the GIRP office. The GIRP office forwarded the replies to Mr. Scrofina subject to the permission of the respondent. During the meeting on 2nd February, a compiled version of only the general responses of the questionnaires was presented and discussed, along with a revised and updated version of the Article 82 EC position paper on supply quotas systems. Due to the fact that there is no coherent situation throughout the EU Member States, the meeting was concluded with the decision that no further action should be taken on European level in this respect. If national actions are taken, GIRP will provide support and documentation if needed. The Members of the Managing Board briefly discuss the situation of shortages in Europe and state that it is important to emphasise the fact to all stakeholders and policy makers that it is not full-line wholesalers who cause shortages. It was agreed that during the next meeting a brainstorming session on how the situation can be improved should be scheduled. Update on the GIRP membership wish list An overview of the current status of GIRP full-membership shows that the situation has significantly improved. However, there are still two countries where some action is urgently needed, which are Lithuania and Romania. Lithuania Despite a meeting with Armila on 5th June in Tallinn, at which also Dr. Thomas Trümper participated, there has been no further development. Mr. Reimund Pohl reiterated his explanation given during the previous meeting that the economic situation in Lithuania is really difficult and that the association is more retail than wholesale oriented. However, he will make a renewed effort with his subsidiary in Lithuania and the President and the Director General will again approach Dr. Thomas Trümper. Romania

GIRP office to forward all documents showing the status of preparations for the Delegated Acts consultation to the Managing Board GIRP office to schedule brain storming session on means to avoid shortages during the next meeting. Mr. Reimund Pohl and Dr. Thomas Trümper to support full



Ms. Derecque-Pois informs that the GIRP office has sent to the new Romanian association a complete set of information material about GIRP along with the application form and the annual membership fee. The Romanian association was offered to pay in 2012 only 50% of the membership fee, but despite all efforts, there has been no decision. A&D Pharma still remains associated member of GIRP. It was decided that Dr. Thomas Trümper should be asked if he can help in this respect. Croatia As the treaty concerning the EU accession of Croatia to the European Union was signed at the end of the year, it seems likely that Croatia will become the 28th member of the EU in July 2013. It would be preferable to have the association as full member instead of PHOENIX Farmacija, which is currently the case. The first approach has been made through Dr. Thomas Trümper, with Octal Pharma, whose President is also the President of the Croatian association, but despite numerous follow-up efforts by the GIRP office, there was no reaction on behalf of the Croatian association. Bulgaria The new Bulgarian association of pharmaceutical wholesalers became member of GIRP as from 1st January 2011. However, GIRP’s associated member Sting is still reluctant to join the association despite several meetings with them last year. Information on the creation of a European association for healthcare logistics and transport promotion Ms. Derecque-Pois informs the members that GIRP has received a press release about the creation of the association EALTH. The press release was included in the Working Documents. In meantime, Ms. Derecque-Pois has met with Mr. Jean-François Fusco, who is the Director of the association, but working for Aexxdis, self-proclaimed company for “Advanced and Expert Distribution Services in Healthcare and Well-Being” based in France. Mr. Fusco introduced himself to GIRP and has also met with EFPIA. GIRP was informed that EFPIA has sent Mr. Fusco the MoU and that EALTH initially has interpreted this and our meeting as well as the one with EFPIA as a sign that his association is welcome to join the EMVO. A discussion between EFPIA, GIRP, PGEU and EAEPC clarified that EALTH would only be welcome as affiliated member, as EALTH members do not act on their own account and responsibility, as they are contracted by pharmaceutical manufacturers for their logistic or manufacturing services. The discussion is concluded: GIRP should watch EALTH’s activities and the GIRP President should meet Mr. Fusco. GIRP work programme 2012 Priorities and objectives for lobbying activities The President informs that the main priorities of the second part of 2011 will continue to be the priorities for 2012 which comprise: the work on the delegated act consultation the collaboration with EFPIA, PGEU and now EAEPC on the European medicines

verification system with the objective to present to the Commission a workable, robust and cost-effective solution to meet the requirements established by the Falsified Medicines Directive as well as the anticipated requirements of the Delegated Acts and

the follow-up on the GDP guidelines revision.

The President emphasises that now more so than ever, GIRP needs to put the role of pharmaceutical full-line wholesalers for medicines provision and the healthcare system overall in the spotlight. In this respect the IPF study provides a good basis for

membership of Lithuania. Dr. Thomas Trümper to be asked for his support in Romania and Croatia. GIRP President to meet with the EALTH Director.



arguments. GIRP will widely distribute the slides with the executive summary and the study to European decision-makers and the other European stakeholders in the healthcare sector. GIRP will also encourage all its members to make active use of the study results especially in the countries covered. Priorities of GIRP Councils, Committees, Project Groups Ms. Monika Derecque-Pois informs that since the last Board meeting none of GIRP’s usual Committees or Councils have met. She reports that an excellent project group was formed out of the Technical and Legal Affairs Committee, which elaborated the reply on the GDP guidelines consultation. GIRP will activate this group for the preparation of a Commission hearing on the revised GDP guidelines. The Autumn conference was an excellent first practice in this sense. Currently, a project group composed mostly of members of the Legal Affairs, Technical and Economic and Social Affairs Committee is very active to elaborate GIRP’s input to the Delegated Act consultation. For this reason currently no further separate meetings are scheduled for the Committees and Councils. GIRP will schedule separate meetings of the Committees again when there is a necessity or otherwise once their joint work is done. As laid down in the strategy approved on 8th November 2011, GIRP will move more towards project oriented groups dealing with issues of interest to GIRP’s membership. In this respect the setting-up of an eHealth project group is well advanced. After an initial mapping exercise the terms of reference and the work programme have been laid down and a first face to face meeting will take place in the coming months. GIRP also has applied for membership in an eHealth stakeholder group, which will be created by DG Information Society and Media and we hope that our application will be successful. The President emphasises that he is very happy that Mr. Eero Hautaniemi has taken on the “Project Championship” of the eHealth group and his personal commitment to advance the agenda. The President states that after Mr. Reimund Pohl, who has taken on the very first “Project Championship” on membership & enlargement, Mr. Lothar Jenne, who took on the “Project Championship” on the EMVO and Mr. Eero Hanutaniemi, who took on the “Project Championship” on eHealth, the launch of a new project group on patient compliance and home care would be required. Mr. Marc van Gelder volunteers to become the “Project Champion” of this group and states that he is perfectly willing to drive the agenda, but the actual work will be delegated. The GIRP office is asked to draft terms of reference for the new project group. The Retail Council and the Advisory Council Supply Chain Solutions will schedule one meeting each during the year in order to report about the progress of the project groups and to discuss developments in their specific area of business.

GIRP office to elaborate terms of reference

4. EC initiatives – corporate social responsibility and code of conduct – initiative on active and healthy ageing

Corporate social responsibility and code of conduct GIRP has already previously reported about DG Enterprise’s initiative on Corporate Social Responsibility (CSR). A progress report will be given during the subsequent Board Meeting as well as during the EU Health Policy Briefing. However, the issue on ethics and transparency should be tackled in the Managing Board as it was also discussed during the last meeting. On European level, all



stakeholders in the pharmaceutical sector currently collaborate on the drafting of an “Ethical Charter” and the European umbrella organisations are asked for their codes of conduct or ethical charters. GIRP has been asked by the European Commission to be a member of the Ethics and Transparency Committee as the EC sees a need for the “Ethical Charter” to comprise all actors in the pharmaceutical sector on European level. The Director General states that all other organisation already have such code of conducts or charters. A respective presentation by EFPIA was included in the Working Documents. The President points out that GIRP needs to be fully accepted as the representative voice of an ethical business sector. The members of the Managing Board discuss the need for a “Charter of Transparency” or a “Code of Ethical Conduct”, pointing out that this may have an impact on the company members, but agreeing that due to the fact that some company members are quoted on the stock exchange, it is not possible to stay outside of ethical codes. It is therefore concluded that GIRP should collect what is already available from its members (Mediq, Celesio) and make a respective proposal but keep it on the level of the Managing Board until its approval on the broad lines.

GIRP to collect available CSR information from its members and present a Draft Code Charter of Ethics/Conduct to the next meeting of the Managing Board

5. Upcoming GIRP events

a. Workshops AstraZeneca The President informs that there are three workshops scheduled with AstraZeneca, which will be discussed further during the Board meeting, but it is important that the Members of the Managing Board help GIRP in insisting that all workshop participants also participate at the preparatory meeting and share their views beforehand by returning the questionnaires in order to streamline the GIRP approach during the meeting. The Members of the Managing Board stress that it is important that GIRP will outline during the introductory part of the workshop, the value and efficiency of full-line wholesaling and that increased collaboration can lead to a better future for both parties.

b. Leadership Forum, 26th to 27th March 2012, London Ms. Monika Derecque-Pois provides a detailed overview of the status of participation at the Leadership Forum. After a short discussion, the members of the Managing Board advice to cancel/postpone the Leadership Forum and to ask EFPIA if a meeting could be added to their Executive Committee in order to increase participation.

c. Regional Meeting, 26th to 27th April 2012, Budapest The President informs that more information about the Regional Meeting would be given during the Board meeting and states that GIRP is happy that Mr. Reimund Pohl as “Project Champion” for Membership & Enlargement will participate at the meeting and furthermore that GIRP could ensure the participation of EFPIA’s Director General, Mr. Richard Bergstöm on 27th April, where the session will also be open to pharmacists and industry representatives. The President strongly advises the Managing Board members to attend the meeting and also to encourage their subsidiaries and members to participate as this meeting, which has specifically been scheduled to increase their awareness about European activities, how they can get them more involved and what could be the benefit for them.

Managing Board members to insist on questionnaires replies and participation to preparatory meetings. GIRP to ensure that full-line wholesaling efficiency is outlined at the beginning of workshops. GIRP to enquire if a joint session can be added to EFPIA’s Executive Committee Managing Board members are kindly asked to attend and to encourage participation of their subsidiaries



d. 53rd Annual General Meeting, 3rd to 5th June 2012, Lisbon

The pre-announcement was sent to members on 27th January 2012. The early bird registration closes on 10th February. Participants who register and settle the payment before that date will receive 100 Euro discount on the participation fee (1550 Euro). Business Programme The Director General informs that the conference programme is slowly coming together. In this respect, GIRP is happy to report that Commission President Barroso has agreed to send a video message and that Commissioner John Dalli as well as Steve Collis, the CEO of AmerisourceBergen and David Brennan, the CEO of AstraZeneca have has confirmed their attendance. GIRP is also advised by the Managing Board to invite George Barrett, the CEO of Cardinal Health as a keynote speaker to the international session. The schedule for the meetings in Lisbon has been set-up as follows:

Managing Board (MB members only) - 3rd June, 10 am - 12 pm Board (Board members only) - 3rd June, 2 pm - 4 pm EU Health Policy Briefing (full members only) - 3rd June, 4 pm - 5 pm Annual General Assembly - 3rd June, 5 pm - 6 pm Welcome Dinner - 3rd June; 8 pm onwards Annual Conference Day 1 - 4th June, 9 am - 6 pm Gala Dinner - 4th June, 8 pm onwards Annual Conference Day 2 - 5th June, 10 am - 1 pm Farewell Lunch - 5th June, 1 pm onwards

and members GIRP to invite George Barrett

6. Miscellaneous

The President states that with the old by-laws it was necessary to reappoint the Director General every second year. However, subject to the new by-laws this is no longer necessary. Here therefore asks the members of the Managing Board, if they believe that it is necessary to stick to the old procedure. As this is not the case, the Managing Board will make a respective recommendation to the subsequent Board meeting.

As no further issues are raised, the President thanks the members of the Managing Board for their active and constructive participation to the meeting.



Agenda Item 3a: NVGV/ANGR letter announcing Board representation change



Agenda Item 3b: Application form from Romanian association





Agenda Item 3c: GIRP annual accounts and audit report

In Euro Budget 2011 Actual at 31/12/2011

% budget 31/12/2011 Budget 2012

% budget

2011Travel (transport & hotel) 70.000,00 72.511,00 104% 75.000,00 107%

Congress 180.000,00 171.574,35 95% 200.000,00 111%Office supplies 7.000,00 7.934,21 113% 7.000,00 100%Website 12.000,00 11.526,07 96% 12.000,00 100%Telecom 18.000,00 15.238,47 85% 18.000,00 100%Post 7.000,00 4.243,72 61% 7.000,00 100%Fee President 54.000,00 54.000,63 100% 54.000,00 100%

Girp Office Staff1 260.000,00 265.104,96 102% 280.000,00 108%

Girp Director General 117.260,00 135.260,04 115% 157.260,00 134%Board 8.000,00 6.910,93 86% 8.000,00 100%Working Groups 10.000,00 19.886,12 199% 15.000,00 150%Managing Board 4.500,00 7.791,44 173% 5.000,00 111%Bookkeeping external 12.500,00 12.500,00 100% 12.750,00 102%Auditor+VAT+control 4.200,00 4.200,00 100% 4.250,00 101%Office Rent 47.000,00 50.981,75 108% 48.000,00 102%Membership IFPW 3.500,00 2.268,60 65% 5.000,00 143%Public Relations& Rest., Reception 70.000,00 70.505,77 101% 70.000,00 100%

Publications 10.000,00 12.833,64 128% 12.000,00 120%Subscriptions 11.500,00 9.575,40 83% 11.500,00 100%Legal Advice 20.000,00 36.301,41 182% 36.000,00 180%Technical Equipment 8.000,00 10.106,89 126% 8.000,00 100%

Study 30.000,00 40.336,52 134% 6.000,00 20%

Workshops 7.500,00 0,00 0% 0,00 0%

Leadership Forum 5.500,00 10.796,00 196% 14.000,00 255%Misc.tax&bank 4.500,00 1.237,86 28% 4.000,00 89%VAT not recoverable 27.000,00 33.218,52 123% 24.000,00 89%

EXPENSES 1.008.960,00 1.066.844,30 106% 1.093.760,00 108%

Contribution Full Members Associations 316.822,65 338.601,44 107% 356.021,73 112%

Contribution Pan European Companies/Group (9)

427.500,00 427.500,00 100% 436.050,00 102%

Contribution Associated Professional Members 20.000,00 20.000,00 100% 8.000,00 40%

Contribution Associated External Members / Sponsors

175.000,00 175.000,00 100% 175.000,00 100%



Other income (Events participation and sponsorship)

115.000,00 115.950,00 101% 115.000,00 100%

Interest & other income 7.000,00 6.934,98 99% 7.000,00 100%

REVENUES 1.061.322,65 1.083.986,42 102% 1.097.071,73 103%

RESULT 52.362,65 17.142,12 3.311,73

Status accounts on 31/12/2011 Status Business Account 24.314,82 Status Savings Account 303.498,38

Invoices and costs to be paid 14.978,27

1 Event Management and Administration (Viktoria Keri) [FT –int.]; Information and Communication Manager (Maren Holoda) [FT –int.]; Administrative Assistant (Magda Savin) [FT –int.]; Legal Adviser (Martin FitzGerald) [PT –ext. consult]; Office Manager (Sointu Raisanen) [PT -ext]; Communications officer (Kevin Nolan) [PT –ext. consult.]; Trainee (Jasmin Weinert) [FT –int]; Trainee (Mihai Rotaru) [FT –int]. Also ancillary costs included.

31/12/2011 ASSETS Euro

FINANCIAL ASSETS

Guarantees 115,62

AMOUNTS RECEIVABLE WITHIN ONE YEAR

VAT to be reimbursed 7.083,50 VAT to be reimbursed NL 67,26

7.150,76

CASH AT BANK

Fortis (210-0831484-52) 24.109,18 Fortis (035-4554847-59) 9,35 Fortis (035-7053460-49) 300.669,03 Fortis (035-7691177-88) 1.100,00 Fortis (035-7735934-31) 1.700,00

327.587,56

DEFFERED CHARGES Deferred charges 20.919,41



20.919,41

TOTAL OF ASSETS 355.773,35

31/12/2011 LIABILITIES Euro

SOCIAL FUNDS

Initial funds 177.920,18 177.920,18

ALLOCATED FUNDS

Allocated funds 70.000,00 70.000,00

RESULTS

Expenses in excess of revenues year 2006 - 54.154,71 Revenues in excess of expenses year 2007 59.747,01 Expenses in excess of revenues year 2008 - 10.431,83 Revenues in excess of expenses year 2009 72.393,22 Revenues in excess of expenses year 2010 696,69 Revenues in excess of expenses year 2011 17.142,13

85.392,51

AMOUNTS PAYABLE WITHIN ONE YEAR

Suppliers 1.260,03 Invoices to be received 5.436,90 Social debts (social security contributions, provisions) 12.343,03

19.039,96

DEFFERED REVENUES AND ACCRUED CHARGES

Accrued charges 3.420,70 3.420,70

TOTAL OF LIABILITIES 355.773,35



31/12/2011

RESULT Euro

REVENUES

Contributions Members Associations 338.601,44 Contributions Pan European Companies/Group 427.500,00 Contributions Associated Members 16.000,00 Contribution Associated External Members / Sponsors 175.000,00 Other sponsorship (Website / Events participation) 119.950,00 Interest and other incomes 6.934,98

1.083.986,42

EXPENSES

Travel. (transport & hotel) 72.511,00 Congress 171.574,35 Office supplies 7.934,20 Website 11.526,07 Telecom 15.238,47 Post 4.243,72 Fee President 54.000,63 GIRP Office Staff 265.104,96 GIRP Director General 135.260,04 Board 6.910,93 Working Groups 19.886,12 Managing Board 7.791,44 Bookkeeping external 16.700,00 Office Rent 50.981,75 Membership IFPW 2.268,60 Public Relations, Restaurants & Reception 70.505,77 Publications 12.833,64 Subscriptions 9.575,40 Legal advice 36.301,41 Technical equipment 10.106,89 Study communication 40.336,52 Leadership Forum 10.796,00 Misc. taxes & bank 1.237,86 VAT not recoverable 33.218,52

1.066.844,29

Revenues in excess of expenses year 2011

17.142,13



AUDITOR’S REPORT TO THE GIRP ANNUAL GENERAL ASSEMBLY ON THE FINANCIAL STATEMENTS OF THE EUROPEAN ASSOCIATION OF

PHARMACEUTICAL FULL-LINE WHOLESALERS (GIRP) FOR THE YEAR ENDED 31 DECEMBER 2011

In accordance with the legal and statutory requirements, we report to you on the request of the Board of Directors. This report contains our opinion on the true and fair view of the financial statements as well as the required additional statements (and information). Unqualified audit opinion on the financial statements We have audited the financial statements for the year ended December 31, 2011, prepared in accordance with the financial reporting framework applicable in Belgium, which shows a balance sheet total of euro 355.773,35 and a profit for the year of euro 17.142,13. The Board of Directors is responsible for the preparation and the fair presentation of these financial statements. This responsibility includes: designing, implementing and maintaining internal control relevant to the preparation and fair presentation of financial statements that are free from material misstatement, whether due to fraud or error; selecting and applying appropriate accounting policies; and making accounting estimates that are reasonable in the circumstances. Our responsibility is to express an opinion on these financial statements based on our audit. We conducted our audit in accordance with the legal requirements and the Auditing Standards applicable in Belgium, as issued by the Institute of Registered Auditors (Institut des Réviseurs d’Entreprises / Instituut van de Bedrijfsrevisoren). Those standards require that we plan and perform the audit to obtain reasonable assurance whether the financial statements are free from material misstatement, whether due to fraud or error. In accordance with the above-mentioned auditing standards, we considered the association’s accounting system, as well as its internal control procedures. We have obtained from management and from the association’s officials the explanations and information necessary for executing our audit procedures. We have examined, on a test basis, the evidence supporting the amounts included in the financial statements. We have assessed the appropriateness of accounting policies and the reasonableness of the significant accounting estimates made by the association as well as the overall financial statement presentation. We believe that these procedures provide a reasonable basis for our opinion. In our opinion the financial statements of the association EUROPEAN ASSOCIATION OF PHARMACEUTICAL FULL-LINE WHOLESALERS (GIRP) for the year ended December 31, 2011, give a true and fair view of the association’s assets, liabilities, financial position and results of operations in accordance with the financial reporting framework applicable in Belgium.



Additional statements (and information) The compliance by the association with the law of 27 June 1921 related to not-for-profit associations, international not-for-profit associations and foundations is the responsibility of management. Our responsibility is to supplement our report with the following additional statements (and information), which do not modify our audit opinion on the financial statements: - Without prejudice to formal aspects of minor importance, the accounting records were

maintained in accordance with the legal and regulatory requirements applicable in Belgium. - There are no transactions undertaken or decisions taken in violation of the association’s by-

laws or the law of 27 June 1921 related to not-for-profit associations, international not-for-profit associations and foundations that we have to report to you.



Agenda Item 3c: Financial status 2012

Budget Budget Budget Budget Actual at % budget Euro 2009 2010 2011 2012 5/18/2012 2012

Travel (Transport & Hotel) 70,000.00 70,000.00 70,000.00 75,000.00 43,254.99 58% Congress 200,000.00 200,000.00 180,000.00 200,000.00 102,559.20 51% Office supplies 7,500.00 7,500.00 7,000.00 7,000.00 2,806.27 40% Website 15,000.00 12,000.00 12,000.00 12,000.00 11,526.07 96% Telecom 20,000.00 18,000.00 18,000.00 18,000.00 6,837.77 38% Post 8,000.00 7,500.00 7,000.00 7,000.00 2,893.03 41% Fee President 53,300.00 53,300.00 54,000.00 54,000.00 27,180.37 50% Girp Office Staff1 260,000.00 260,000.00 260,000.00 280,000.00 113,132.13 40% Girp Director General 117,260.00 117,260.00 117,260.00 157,260.00 65,525.00 42% Board 8,000.00 8,000.00 8,000.00 8,000.00 4,284.70 54% Working Groups 10,000.00 10,000.00 10,000.00 15,000.00 5,655.00 38% Managing Board 4,500.00 4,500.00 4,500.00 5,000.00 1,373.45 27% Bookkeeping external 12,500.00 12,500.00 12,500.00 12,750.00 4,495.00 35% Auditor + VAT + control 4,200.00 4,200.00 4,200.00 4,250.00 1,500.00 35% Office Rent 44,000.00 47,000.00 47,000.00 48,000.00 21,533.99 45% Membership IFPW 1,700.00 3,000.00 3,500.00 5,000.00 5,012.80 100% Public Relations & Rest., Reception 70,000.00 70,000.00 70,000.00 70,000.00 22,940.38 33% Publications 17,000.00 17,000.00 10,000.00 12,000.00 8,198.99 68% Subscriptions 15,000.00 15,000.00 11,500.00 11,500.00 12,546.82 109% Legal Advice 50,000.00 20,000.00 20,000.00 36,000.00 15,000.00 42% Technical Equipment 8,000.00 8,000.00 8,000.00 8,000.00 2,683.45 34% Study communication 0.00 0.00 30,000.00 6,000.00 6,000.30 100% Workshops 0.00 0.00 7,500.00 0.00 11,143.82 n/a Leadership Forum / Regional Meeting 0.00 0.00 5,500.00 14,000.00 14,657.03 105%



Misc.tax&bank 9,000.00 5,000.00 4,500.00 4,000.00 495.70 12% VAT not recoverable 15,000.00 27,000.00 27,000.00 24,000.00 12,168.65 51% EXPENSES 1,019,960.00 996,760.00 1,008,960.00 1,093,760.00 525,404.91 48%

Contribution Full Members Associations 325,018.75 310,056.25 316,822.65 356,021.73 362,563.01 102% Contribution Pan European Companies/Group (9) 425,000.00 382,500.00 427,500.00 436,050.00 436,050.00 100% Contribution Associated Professional Members 20,000.00 16,000.00 20,000.00 8,000.00 12,240.00 153% Contribution Associated External Members / Sponsors 197,400.00 197,000.00 175,000.00 175,000.00 195,000.00 111% Other income (Events participation and sponsorship) 128,000.00 115,000.00 115,000.00 115,000.00 119,010.00 103% Interest & other income 2,500.00 2,000.00 7,000.00 7,000.00 2,356.93 34% REVENUES 1,097,918.75 1,022,556.25 1,061,322.65 1,097,071.73 1,127,219.94 103%

RESULT 77,958.75 25,796.25 52,362.65 3,311.73 601,815.03

Status accounts on 15/05/2012 Status Business Account 263,997.65 Status Savings Account 702,569.29

Invoices and costs to be paid 15/05/2012 44,645.09 Belgian VAT to receive back = 19,698.26 1 Event Management and Administration (Viktoria Keri) [FT –int.]; Information and Communication Manager (Maren Holoda) [FT –int.]; Administrative Assistant (Magda Savin) [FT –int.]; Legal Adviser (Martin FitzGerald) [PT –ext. consult]; Office Manager (Sointu Raisanen) [PT -ext]; Communications officer (Simon Saba) [PT –ext. consult.]; Trainee (Elsa Sousa) [FT –int]; Trainee (Jacqueline Anaïs Gies) [FT –int]. Also ancillary costs included



Agenda Item 4: Amended GIRP by-laws art. 4.4 and 10 in EN and FR

For the full version of the English language GIRP by-laws including the suggested amendments, please consult the GIRP website: http://girp.eu/cms/index.php?/eng/MEMBERS-ONLY/INFORMATION-SERVICE/GIRP-STRUCTURE-BY-LAWS/GIRP-by-laws-with-suggested-amendments-2012-EN

GIRP BY- LAWS

Approved by the General Assembly 18th January 2008

amended by decision of the statutory General Assembly of 12th November 2008

amended by decision of the statutory General Assembly

of 3rd June 2012

Article 4.4 - External members

Admission to the Association as an "external member" is open to any company or organisation, whether pharmaceutical or not, having professional interests in common with Full-Line Wholesalers.

This category of membership is specifically dedicated to the representation of sponsors. The Association provides services to the sponsors.

Article 10 - The Secretariat The Secretariat consists of a Director General and, as applicable, staff members to carry out designated functions. It shall manage the bodies of the association and co-ordinate the activities of the association. In accordance with the authority and responsibilities delegated to it by the General Assembly or the Board or the Managing Board, the Secretariat shall take charge for the implementation of the decisions made by the General Assembly, the Board and the Managing Board. The Secretariat of the Association also provides member specific advice and consultancy services in the remit of its mission. Such services are provided for the benefit of its members operating at the national, European and international levels. The Association supports members with the provision of tailored made services which are delivered to individual members and where such services are dedicated to the promotion of their role in the interests of



public health and for ensuring the safe and continuous supply of all registered medicines to patients in Europe. Member specific services shall not be provided where a conflict of interest exists or is likely to exist between the Association and other members or between members, and where such services do not promote the overall mission of the Association. The Director General has all the powers in the following areas for which he is responsible: 1. daily management of the Association, according to the list of powers granted by the Board and

about which he is to report to the President; 2. financial administration of the Association; 3. preparation, along with the Treasurer, of the annual budget and the follow-up of its application; 4. implementation of the Association’s policy as established by the General Assembly and the Board; 5. the achievement, implementation and follow-up of the Association’s activities as well as drafting

the relevant report; 6. the administration of which he must take charge for all General Assemblies, Board and Managing

Board meetings; 7. monitoring and recording of the results of each vote during General Assemblies and Board and

Managing Board meetings; 8. execution and follow-up in general of all specific tasks and missions defined by the Board and the

Managing Board; 9. archiving of documents relative to the Association. 10. hiring and dismissal of staff, deciding on promotion and salary conditions, after prior approval of

the President. 11. execution of members specific advice and consultancy services. The Director General may delegate specific powers in order to take care of the specific tasks or responsibilities assigned to him.



For the full version of the French language GIRP by-laws including the suggested amendments, please consult the GIRP website: http://girp.eu/cms/index.php?/eng/MEMBERS-ONLY/INFORMATION-SERVICE/GIRP-STRUCTURE-BY-LAWS/GIRP-by-laws-with-suggested-amendments-2012-FR

STATUTS DE GIRP

Adoptés par l’Assemblée Générale du 18 janvier 2008

Modifié par la décision statutaire de l’Assemblée Générale du 12 novembre 2008

Modifié par la décision statutaire de l’Assemblée Générale du 3 juin 2012

Article 4.4 – Membres externes

L’admission à l’Association en qualité de « membre externe » est ouverte à toute société ou organisation, pharmaceutique ou non, ayant des intérêts professionnels communs avec les Grossistes à assortiment complet.

Cette catégorie d'adhésion est spécifiquement réservée à la représentation des sponsors. L'association rend des services aux sponsors.

Article 10 - Le Secrétariat Le Secrétariat se compose d’un Directeur général et, le cas échéant, de membres du personnel qui exercent des fonctions spécifiques. Il gère les organes de l’association et coordonne les activités de l’association. Conformément aux pouvoirs et aux responsabilités qui lui sont délégués par l’Assemblée Générale, le Conseil d’Administration ou le Comité de Direction, le Secrétariat prendra en charge la mise en application des décisions prises par l’Assemblée Générale, le Conseil d’Administration et le Comité de Direction. Le Secrétariat de l'association fournit également des conseils spécifiques et des services de consultance aux membres, de manière individualisée, dans le respect des buts de l'association. Ces services sont fournis pour le bénéfice individuel deses membres opérant au niveau national, européen ou international. L'association assiste ses membres individuellement en leur fournissant des services sur mesure. Ces services ont pour objectifs, entre autres, la promotion du rôle qu’ils jouentdans l'intérêt de la santé publique et la garantie d’un approvisionnement sûr et continu en médicaments autorisés pour tous les patients en Europe. Les services spécifiques ne seront pas fournis en cas de conflits d'intérêts avérésou potentiels entre l'association et d’autres membres ou entre les membres ou dans le cas où ces services ne seraient pas conformes aux buts de l'association. Le Directeur général dispose de tous les pouvoirs dans les domaines suivants dont il est responsable:



1. la gestion journalière de l’Association, conformément à la liste des pouvoirs conférés par le Conseil d’Administration et dont il doit faire rapport au Président;

2. la gestion financière de l’Association; 3. la préparation, avec le Trésorier, du budget annuel et le suivi de son application; 4. la mise en pratique de la politique de l’Association telle qu’établie par l’Assemblée Générale et le

Conseil d’Administration; 5. la réalisation, la mise sur pied et le suivi des activités de l’Association ainsi que l’établissement

d’un compte-rendu y relatif; 6. le secrétariat dont il doit s’occuper lors de toutes les réunions des Assemblées Générales, du

Conseil d’Administration et du Comité de Direction; 7. le contrôle et l’enregistrement des résultats de chaque vote lors des réunions des Assemblées

Générales, du Conseil d’Administration et du Comité de Direction; 8. l’exécution et le suivi, d’une manière générale, de toutes les tâches et missions spécifiques définies

par le Conseil d’Administration et le Comité de Direction; 9. l’archivage des documents relatifs à l’Association. 10. le recrutement et licenciement des membres du personnel, les décisions sur promotion et salaires,

sous réserve de l’accord préalable du Président. 11. mise en œuvre des services spécifiques de conseils et de consultance. Le Directeur Général pourra déléguer des pouvoirs spécifiques afin d’effectuer des tâches ou des responsabilités spécifiques qui lui ont été attribuées.



Agenda Item 4 : BDO report on GIRP VAT situation













Agenda Item 5: Follow-up activities from GIRP / AstraZeneca workshops

Workshop 1 – DtP AZ will discuss internally if they would like to follow up on some of the following subjects:

‐ The combi model ‐ The highest price model ‐ IMS data (for which product and where) ‐ Quota communication

Workshop 2 - Supply chain efficiency GIRP will do the following follow-up activities:

‐ Send expectation for CPFR (Collaborative Planning, Forecast and Replenishment of which VMI (Vendor Managed Inventory) is a part) to AZ

‐ Arrange workshop to discuss CPFR AZ will do the following follow-up activities:

‐ Talk to Anci Kvarnstrom about standardisation for 3D barcode/ASN ‐ Send expectation for CPFR (Collaborative Planning, Forecast and Replenishment of which

VMI (Vendor Managed Inventory) is a part) to GIRP ‐ Discuss internally if it would be interesting to use wholesalers as agents in direct sales to

pharmacy Workshop 3 – Future distribution of medicine AZ will do the following follow-up activities:

‐ Discuss internally if they would like to continue with initiatives mentioned in workshop ‐ Create wish list what they would like to have in a specialty product distributor



Agenda Item 6: GIRP draft CSR statement

GIRP’s Corporate Responsibility Statement

2012 STATUS – Confidential draft

VERSION – Thursday, April 5, 2012

ABOUT GIRP GIRP is the umbrella organisation of pharmaceutical full-line wholesalers in Europe. It represents the

national associations of over 600 pharmaceutical full-line wholesalers serving 31 European countries,

including major pan-European pharmaceutical full-line wholesaling companies. Through their network of

operational facilities, they distribute over 130 billion Euros worth of medicines every year. In the

performance of their public service role, pharmaceutical full-line wholesalers absolutely guarantee the

highest level of quality, integrity and excellence. GIRP members are the trusted supply chain partners in

guaranteeing medicines' safety of manufacturers, pharmacists, healthcare professionals and, above all,

patients.

Full-line wholesaling is the vital link in the effective delivery of healthcare in Europe. Full-line wholesalers

not only deliver all medicines used in their geographical area of activity within a short time span, but also

provide customised solutions to all the complex supply chain needs of manufacturers, pharmacist, payers,

and patients. These services are of tremendous benefit to all partners in the supply chain and ultimately

to the significant benefit to the millions of patients right across Europe. As healthcare service providers,

full-line wholesalers are central to the provision of public health.

The pharmaceutical full-line wholesale distribution sector recognises and acknowledges the need to act

responsibly towards society and the communities in which it operates.

Therefore CSR is a fully integrated element of GIRP’s strategy and operation.

Most importantly, it should be emphasised that the sectors primary role and major social responsibility is

to contribute to their communities in which they operate in and beyond including developing countries

and towards the less fortunate in society. The sector has made and continues to expand its efforts to

ensure that patients have access to the medicines whenever, wherever needed.

GIRP directly as an association and/or through his memebers will establish, within the limits of the

possible actions, long-term programmes which cover as wide as possible the spectrum of societal

activities:



1. Healthcare programmes in third world countries – providing financial, professional and personal

expertise to support medical professionals working in developing countries. Medicines, medical

equipment and other healthcare products are donated to charitable organisations and charitable

schemes which are dedicated to healthcare development in developing countries.

2. Education and training programmes in cooperation with universities, research centres and other

bodies are supported and which are dedicated to providing safe and quality assured healthcare

products and services to the wider population.

3. Environmental programmes aiming to ensure the pharmaceutical full-line wholesale distribution

sector takes an active role in the protection of the environment in the areas where they have the

greatest impact – packaging, waste, buildings and transportation.

4. Community based programmes in which support is provided to healthcare professionals for the

benefit of local communities.

5. Health and safety programmes dedicated to ensuring operations wide health and safety practices

are to the highest level for the benefit of employees in the healthcare sector.

GIRP members CSR programmes frequently go beyond these main social responsibility areas and include

initiatives which make the provision of medicines and healthcare services accessible and easier, which

facilitate skills and know-how transfer and which support disease elimination and prevention

programmes.

The vision for the pharmaceutical full-line wholesale distribution sectors’ role in global healthcare is to

facilitate the continueous and timely access to medicines that save and improve the lives of millions of

people and, in partnership with governments and other organisations, to help improve access to them.

GIRP European Association of Pharmaceutical Full-line Wholesalers Brussels, April 2012



Agenda Item 6: GIRP draft Code of Conduct

Code of Conduct for the European Association of Pharmaceutical Full-line Wholesalers

2012 STATUS – Confidential draft

VERSION – Thursday, April 5, 2012

ABOUT GIRP GIRP (The European Association of Pharmaceutical Full-line Wholesalers) was founded in 1960 and is the umbrella organisation of pharmaceutical full-line wholesalers in Europe. GIRP unites over 750 pharmaceutical full-line wholesalers across 31 countries and their national associations, giving them a strong voice on EU level. GIRP members are the vital link in healthcare, connecting manufacturers to pharmacists and other healthcare professionals, but above all ensuring patients the continuous availability of medication. GIRP offers its members individual as well as collective support services and assistance that affects their business on a daily basis. GIRP works with member national associations and companies to help them with unique issues at national level by providing advice, information, statistics and other data. Our aim is to tailor our services to their key priorities and challenges. PREABLE Mutual trust and respect, customer focus, innovation and achievement, as well as quality, reliability and safety are the core values of the pharmaceutical full-line wholesale distribution business. For the purposes of this Code of Conduct, the membership of GIRP refers to member companies and associations and extends to subsidiaries of company members and the members of the member associations. GIRP membership conducts business in an environment that is diverse and global. As an association of associations and companies, the members of GIRP operate diverse businesses subject to a variety of cultures, local laws and regulations. Despite the variety of different economies and societies, there are core values and responsibilities that guide members in their daily operations and relationship with partners, customers and the public at large. This Code of Conduct sets out basic principles to guide all members. All Members are encouraged to comply with the spirit of this Code. If a law or regulation conflicts with a policy in this Code, members must comply with that law or regulation. If members have any questions about this Code or potential conflicts with a law or regulation, are advised to contact the President (who in turn will contact the Board, the Director General and legal counsel) to deal with such matters. SPECIFIC PROVISIONS Essential aim The membership of GIRP strives:



to fulfil the core role and public service function of pharmaceutical full-line wholesaling:

to carry and distribute the complete assortment of products in range and depth within the framework set by the authorities and the market to meet the needs of those with whom they have normal business relations in their geographical area of activity on the same day/within less than 24 hours*. *certain exception due to unique market structures e.g. Finland, Sweden, etc... and where no impediment exists by virtue of trade trends or regulation

to adhere to the requirements as laid down in European legislation (regulating wholesale distribution of medicines products) namely Directive 2001/83/EC of the European Parliament and of the Council on the community code relating to medicinal products for human use and as amended by Directive 2001/24/EC and as further amended by Directive 2011/62/EU relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products. This includes any further amendments or delegated legislation of the European institutions connected to the above mentioned legislation.

to abide by the European Good Distribution Practice (GDP) guidelines (94/C63/03) and

subsequent revisions. Openness The companies and associations in GIRP aim to produce information about their business and the business of their members / subsidiaries openly and honestly, taking into account any continuous duty of disclosure as well as restrictions on information exchange. Competition GIRP member companies and associations believe in fair competition. They support the fair development of competition and act according to the applicable laws and regulations. GIRP members for the purposes of association meeting are guided by GIRPs meeting guidelines. Marketing of products and services GIRP member companies and associations strive to produce reliable services in strict observance of the guidelines issued by its customers and partners and in compliance with legislation. Environmental friendliness The companies in GIRP are committed to creating a sustainable relationship with its environment. Working environment and conditions GIRP member companies and associations strive to create and develop a working environment in which all of its employees can work safely and efficiently to achieve the stated goals. Discrimination and equality All employees, applicants for employment and partners are equal in the eyes of GIRP members and they are treated as such, regardless of race, skin colour, religion, gender, age, origin or descent, any disability or disadvantage, sexual orientation, civil status, citizenship or any other discrimination factor prohibited by law. Bribery and illegal offers or other remunerative activities



GIRP member companies and associations require employees not to give or receive any bribes that influence decisions related to business operations or that have a significant personal nominal or monetary value. Personnel are instructed to avoid personal and financial activities that may be in conflict with their employment relationship Compliance with the code The Code applies to all Members, and all individuals representing Members are encouraged to ensure compliance with the Code. Confidentiality All Members maintain the confidentiality of confidential non-public information entrusted to them by the Association in their capacity as a Member or representative of a Member, except when the Association authorizes disclosure or when required by laws, regulations or legal proceedings. “Confidential Information” is all non-public information entrusted to or obtained by a Member by reason of his or her position as a representative of the Association, including without limitation non-public information that might be of use to competitors or harmful to the Association, its Members, or its stakeholders. Violations of the code Members who violate this Code will be subject to internal disciplinary action, which may include suspension or termination of membership. Consequences for non-commitment to the commitments set out in this Code are also further defined in the Associations articles of association (Article 5.2). Conflicts In accordance with Article 15.3 of the GIRP by laws specific mediation and dispute resolution procedures may be set out in the internal rules. Any conflict arising with the association shall be submitted to alternative dispute resolution procedures in the first instance. Amendments This Code may be amended by the Board. FINAL REMARKS The aims of this Code of Conduct will be achieved only if all involved persons collaborate hand in hand. GIRP European Association of Pharmaceutical Full-line Wholesalers Brussels, April 2012



Agenda Item 8: European Alliance for Personalised Medicines call to action

