Working Documents for the GIRP Annual General Assemblygirp.eu/sites/default/files/memberarea/4 -...

European Healthcare Distribution Association

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 Annual General Assembly

9th November 2016, 17:00 to 18:00, Sofitel Brussels Europe Hotel, Brussels, Belgium

MEETING DETAILS

Date 9th November 2016

Time 17:00 to 18:00

City/Country Brussels, Belgium

Address

Sofitel Brussels Europe Hotel

“Paul Henri Spaak II+III” meeting rooms

Place Jourdan 1 1040 Brussels

Contact

T: +32 2 235 51 19

F: +322 235 51 01

W: www.sofitel-brussels-europe.com

TABLE OF CONTENT

Agenda Item 1: Agenda of the Meeting of the GIRP Autumn General Assembly .......................................... 2

Agenda Item 2: Minutes of the last Annual General Assembly .................................................................... 3

Agenda Item 3: GIRP priorities and programme of professional activities .................................................. 11

Agenda Item 3: Link to General Management Report .............................................................................. 13

Agenda Item 4: Celesio letter - GIRP Board delegate ............................................................................... 14

Agenda Item 5: Application liaison membership ...................................................................................... 15

Agenda Item 6: GIRP Proposed budget 2017 .......................................................................................... 16

Agenda Item 6: GIRP membership contributions 2017 ............................................................................. 18

Agenda Item 6: GIRP members EMVO contributions 2017 ....................................................................... 21

Agenda Item 7: Report - GIRP Emergency contact list test run ................................................................ 22

Agenda Item 8: Link to GIRP statistics, margins overview and country reports .......................................... 26

Agenda Item 9: Link to IPF study presentations ...................................................................................... 27

Agenda Item 10: GIRP meetings overview 2015-2016 ............................................................................. 28

Agenda Item 10: GIRP Breakfast Reception in the European Parliament - 6 December 2016 ...................... 30

Agenda Item 11: Invitation to host GIRP Annual Meeting and Conference in 2018 .................................... 31

Agenda Item 12: Draft Joint Supply Chain Actors Statement on Information ............................................. 32




Agenda Item 1: Agenda of the Meeting of the GIRP Autumn General Assembly

16:00 EU HEALTH POLICY BRIEFING

Agenda of the Meeting of the GIRP Autumn General Assembly 9th November 2016, 17:00 to 18:00, Sofitel Brussels Europe Hotel, Brussels

WHO AGENDA INFO INPUT DECISION KEY

RJ 1. Welcome and approval of the meeting agenda

1. Notification of meeting guidelines/anti-trust statement o

RJ: René Jenny

TT: Thomas

Trümper

MDP: Monika Derecque-Pois

MF: Martin FitzGerald

RJ 2. Approval of the minutes of the last meeting on 5th June 2016, Noordwijk, the Netherlands o

ALL 3. Approval of GIRP’s priorities and programme of professional activities and presentation of

General Management Report o o o

ALL 4. Changes in GIRP Board delegates o o

RJ,

MDP 5. Information on new GIRP liaison members o

RJ, TT, MDP

6. Financial matters

a) Verification of status of membership

b) Approval of the GIRP budget and membership contributions for 2017

o o

ALL 7. Report on GIRP’s emergency preparedness test run o o o

ALL 8. GIRP collection of statistical data o o o

ALL 9. IPF study on “Distribution profile and efficiency of the full-line pharmaceutical wholesale

industry sector” o

MDP

ALL 10. Overview of upcoming GIRP meetings o o o

ALL 11. Official selection of venue for GIRP Annual Meeting and Conference 2018 o o o

ALL 12. Miscellaneous o

3




Agenda Item 2: Minutes of the last Annual General Assembly

Minutes of the GIRP Annual General Assembly

5th June 2016, 17:00 to 18:00

“Kroon” meeting room, Hotel van Oranje, Noordwijk, the Netherlands

COUNTRY ASSOCIATION/ COMPANY MEETING DELEGATE

AUSTRIA PHAGO Bernd Grabner

BELGIUM NVGV – ANGR Eric Van Nueten

BULGARIA Bulgarian Association of Pharmaceutical Wholesalers

Olia Vassileva

CROATIA Oktal Pharma, Medika, PHOENIX Farmacija Jasminko Herceg

CZECH REPUBLIC AVEL Tomas Votruba

DENMARK MEGROS Proxy to Arne Øverby

ESTONIA ERHL Ahti Kallikorm

FINLAND ATY Antti Vatanen

FRANCE CSRP Emmanuel Déchin

GERMANY PHAGRO Lothar Jenne

GREECE PAPW Irene Markaki

HUNGARY HAPW Sándor Küttel

ICELAND Distica Gylfi Rútsson

IRELAND PDF Proxy to Marc Owen

ITALY ADF Proxy to Marc Owen

LATVIA LZLA Marcis Rutulis

LITHUANIA LAPW Proxy to Leon Jankelevitsh

LUXEMBOURG GGRLPP Proxy to René Jenny

NETHERLANDS BG Pharma Roger Sorel

NORWAY Norwegian Association of Pharmaceutical Wholesalers

Arne Øverby

POLAND PELION S.A. Zbigniew Molenda

PORTUGAL GROQUIFAR Rui Carrington

ROMANIA ADRFR Robert Popescu

SERBIA Serbian Chamber of Commerce – Group of Pharmaceutical Wholesalers

Lovorka Nikolic

SLOVAKIA ADL Proxy to Tomas Votruba

SLOVENIA TZS Miha Lavric

SPAIN FEDIFAR Miguel Valdes

SWEDEN LDF Proxy to Oliver Windholz

SWITZERLAND Pharmalog René Jenny

U.K. HDA UK David Cole

Alliance Healthcare Deutschland AG Thomas Trümper

Celesio AG Marc Owen

COFARES Juan Ignacio Güenechea

NOWEDA Proxy to Lothar Jenne

Oriola-KD Eero Hautaniemi

PHOENIX Oliver Windholz

Pharma Privat Proxy to Lothar Jenne

SECOF Olivier Bronchain

ACTION

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13. Welcome and approval of the meeting agenda

The President, Mr. René Jenny, welcomes the members and verifies that all delegates have

received the agenda and meeting documents in accordance with the meeting procedures. The President draws the members’ attention to the meeting guidelines. The agenda was

sent on 4th May 2016, the working documents on 27th May 2016. Mr. René Jenny asks for the approval of the agenda, which is unanimously given.

14. Approval of the minutes of the last meeting

The minutes of the last meeting, which was held in Brussels on 11th November 2015, were sent by email on 30th November 2015 and have been included in the working documents.

All action points have been completed.

Mr. René Jenny asks for the approval of the minutes which is unanimously given.

GIRP office to

upload minutes on the members only

area

15. Message of the President and presentation of the Annual Report

Mr. René Jenny informs the members that GIRP has produced a technical annual report, which is a legal requirement for the association. Within this report the President and the

Director General have included a message to the members taking stock of the most important developments and activities in the last year. The report has been included in the

working documents.

Ms. Monika Derecque-Pois mentions that GIRP has also produced a public Annual Report which also reflects the developments of the last year and gives an overview of GIRP’s

activities as well as GIRP’s main priorities. The public Annual Report will be distributed to a wide audience of stakeholders and is available for the members in hard copy and in

electronic version on the GIRP website.

16. Financial matters

- Examination and approval of annual accounts and the audit report of 2015 Ms. Monika Derecque-Pois presents the annual accounts for 2015. The audited figures were included in the working documents. The overall result is positive. The budget also shows

the status of GIRP’s current accounts. There are no comments or questions on the annual

accounts.

The President informs that the Board has recommended the approval of the annual accounts

and the audit report to the General Assembly. As there are no further questions or comments, he asks the General Assembly for the approval of GIRP’s annual accounts 2015

and the audit report 2015, which is unanimously given.

- Outstanding membership fees 2016 and consequences of non-payment The Director General states that all members have paid their membership fees for 2016

with the exception of the Pharmaceutical Companies Association, Georgia.

As decided in the Board meeting, GIRP will proceed according to the statutes, which

mention that in case of non-payment of fees two months after the date that the last of two

reminders has been sent by registered letter, this will equal a resignation by the member concerned, coming into effect at the end of the year for which all fees are due. The last

reminder was sent by registered letter on 19th May 2016.

17. Request for discharge from liability of the Board, President, Director General

and auditors

The President informs that at the end of each reporting period the General Assembly is asked to give discharge from liability to the members of the Board, the President, the

Director General and the auditors. Mr. René Jenny asks for discharge from liability.

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Discharge from liability is unanimously provided for the Board, the President, the Director

General and the auditors.

18. Information on new GIRP liaison members

The Director General reports that Merck & Co (MSD in Europe) and Servier have applied for membership within the new GIRP liaison membership category. The Managing Board and

Board members have unanimously approved both applications.

19. Report on GIRP’s emergency preparedness test run

On 6th April GIRP has carried out a test run of its emergency contact list, which is part of

GIRP’s commitment to an emergency preparedness plan at the European level. The full

report of the test has been included in the working documents and an overview of actions taken to improve the outcome has been provided by Ms. Monika Derecque-Pois. As it is

considered crucial that GIRP is able to deliver fast and accurate information on stock levels in case of an emergency, it is decided that the GIRP office should carry out another test of

the emergency contact list during Autumn.

GIRP to carry out

another emergency

test during Autumn

20. Overview of upcoming GIRP meetings

International Pharmaceutical Distribution Conference, 12th – 13th September 2016, London

The 3rd International Pharmaceutical Distribution Conference will take place at the Grosvenor House Hotel in London between 12th-13th September 2016 and will be organised

jointly by GIRP, HDMA, IFPW and HDA UK.

GIRP has been involved in the programme planning since the beginning and has helped to identify suitable speakers for the event. The agenda of the meeting is in its final stages and

GIRP will promote the event among its members. The members are asked to promote the event within their respective organisations.

International Federation of Pharmaceutical Wholesalers General Membership Meeting, 14th - 16th September 2016, London

The General Membership Meeting of the International Federation of Pharmaceutical

Wholesalers will take place at the Landmark Hotel in London between 14th-16th September 2016. GIRP will promote this meeting among its members as well.

The members are asked to promote both events within their respective organisations and the GIRP office will send the invitations with further information by e-mail over the course

of the next weeks.

Directors of Associations meeting

The Directors of Associations meeting will take place on 23rd September 2016 in Lisbon,

Portugal. The meeting will be preceded by a dinner on 22nd September. GIRP is currently identifying the most appropriate venue and will communicate the practical details shortly.

GIRP Autumn Meetings, 9th – 10th November 2016, Brussels

GIRP’s Autumn Meetings will take place in Brussels between 9th-10th November 2016. The members are asked to fill in a survey to identify the subjects of interest for the Autumn

conference scheduled for the morning of 10th November. The GIRP office will extend the survey to the members who are not present as well.

The Director General also mentions that GIRP, together with ADF, has organised a site-visit of a pharmaceutical wholesaler in Catania for Mr. Giovanni la Via, Chairman of the ENVI

Committee in the European Parliament and host of the European Parliament Lunch

Reception last November. Mr. la Via has very much appreciated the site-visit and, at this

GIRP to communicate

practical details for Directors of

Associations

meeting

GIRP office to continue survey on

topics for the

Autumn Conference

6




occasion, was invited to host the EP Lunch Reception on 10th November 2016 as well. The

GIRP office will follow-up with his office for confirmation.

The President and Director General thank Mr. Giuseppe Scrofina from ADF and Mr. Leonardo Ferrandino from Celesio for their assistance in the organisation as well as for their

contributions during the event.

GIRP Vienna Meetings, 19th – 20th January 2017, Vienna

Ms. Derecque-Pois informs about the upcoming GIRP meetings to be held in Vienna

between 19th and 20th January 2016. At that time the small and medium sized full member

associations will have to nominate their delegates to the GIRP Board and all groups subsequently to the Managing Board for the 2017-2019 mandate. The schedule of the

meetings has been included in the working documents and will also be communicated by e-mail.

GIRP Educational Academy: Technical Supply Chain Conference, 8th – 9th March 2017,

Brussels

GIRP’s second Technical Supply Chain Conference will take place in Brussels between 8th –

9th March 2017. The GIRP office will start working on the programme for the event in the next weeks and will invite the GIRP members to attend, in due time.

21. Miscellaneous

Registration of GIRP logo

Mr. Martin FitzGerald reports that the GIRP office has registered the GIRP logo, both the

simple version as well as the version with the tagline “the vital link in healthcare” for trademark protection for the Benelux countries. The trademark protection will be extended

for all EU countries as agreed by the Managing Board and Board.

Survey on generic tendering procedures

The Director General points out that the GIRP office has carried out a survey on generic

tendering procedures in the 6 largest markets in Europe, which concluded that generic tendering is no longer as problematic for wholesalers as it was in the past, with the

exception of the Netherlands. She therefore asks the General Assembly if the issue of generic tendering in retail represents a problem in any other country and if this is the case,

to notify the GIRP office.

As there are no additional comments or observations, the President, Mr. René Jenny, thanks the members for their participation and closes the meeting.

Members to notify

the GIRP office in case generic

tendering is still a

problem on national level

7




8




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Agenda Item 3: GIRP priorities and programme of professional activities

LEGISLATION & REGULATORY AFFAIS

MEMBERSHIP NETWORKING & COMMUNICATIONS

REFINING STRATEGY

Work on the further development of the European Medicines Verification Organisation (EMVO) to roll out national medicines Verification Systems – technical, financial and legal aspects.

Support members in claiming their rights to be involvement in the national medicines verification organisations.

Continue work with the European institutions to ensure the impact of the Regulations for Medical Devices and in-vitro diagnostics on wholesale distributors is minimised.

Ensure GIRP involvement in UDI working group to follow developments and to avoid extended tracking requirements for low risk medical devices.

Work with European Institutions on EC proposal for a regulation on veterinary medicinal products and ensure that batch number and expiry date are included in machine readable format as batch number recording will be mandated and try to get the notion of a public service obligation introduced

Continue to drive forward an agenda for increased GIRP membership and ensure greater geographical coverage.

Continue to provide support with individualized services for GIRP members in dealing with unique national problems and offer advice and support to companies.

Convene a regional focus meeting and a meeting of associations’ directors.

Support members with the implementation of the Delegated Regulation at national level and advise members with the establishment of National Medicines Verification Organisations such as review of documentation.

Raise member awareness of the framework for connecting to the national medicines verification system.

Provide advice and support on data ownership and access.

Support members with the implementation of the European Good Distribution Practice Guidelines with a focus on risk management issues.

Support members, at their request, with

Further develop and establish new contacts with the European Commission, European Parliament, European Medicines Agency (EMA) and national Medicines Agencies and other pertinent international organisations. Particular focus on involvement of the PAPC (Public Affairs and Policy Committee).

Continue to strengthen contacts with manufacturers, pharmacists, patients and payers directly and through their representative associations.

Continue with thematic discussions with supply chain partners on issues such as medicines shortages, access to medicines, sustainability of the healthcare system, etc.

Revise the interest of GIRP members in the current working groups.

Organise industry reception and seminar.

Presentations at workshops, seminars and conferences.

Organise site visits to member facilities for supply chain partners as and when required.

Ensure GIRP’s English name change is well understood by all members and efficiently communicated to the outside.

Ensure that value added services of GIRP’s members are further promoted to authorities and stakeholder groups.

Run dedicated training sessions for GIRP members and supply chain partners on supply chain topics.

Further expand the industry membership category.

Promote the IPF study.

Promote reflections on impact of new medicines pricing models on members.

Reflection process on possible contributions of our sector to improved access to innovative and affordable medicines as well as on the sustainability of healthcare systems.

Create closer links to associations and /or companies representing the non-reimbursed market of members’ business areas.

Launch a reflection process on how to attract the flow of high-tech high-value medicine in the retail channel.

12




as basis for the right to be supplied.

Closely monitor and report on other legislative and regulatory developments and report accordingly.

Raise institutional awareness of the impact of over-regulation on the wholesale sector.

issues of a European dimension.

Expand industry membership and revise service offer.

Organise site visits and events.

Continue organising dedicated supply chain conferences.

Streamline and harmonise GIRP’s communication material.

13




Agenda Item 3: Link to General Management Report

www.girp.eu/ Member Area/ Information for full members/ GIRP Management Report

14




Agenda Item 4: Celesio letter - GIRP Board delegate

15




Agenda Item 5: Application liaison membership

16

the vital link in healthcare




Agenda Item 6: GIRP Proposed budget 2017

INCOME BUDGET '16 FORECAST @15/10/2016 BUDGET '17

Contributions 1.120.313,14 1.118.061,32 1.138.421,65 102%

Full Members Associations 439.955,33 439.955,32 439.955,33 100%

Pan European Companies / Groups (8) 434.098,92 434.098,88 434.098,92 100%

Associated Professional Members 11.258,89 9.007,12 9.367,40 83%

Associated External Members

/ Sponsors 235.000,00 235.000,00 255.000,00 109%

Other Income 285.250,00 390.423,53 408.500,00 143%

Events Participation and

Liaison Membership 185.000,00 286.923,53 305.000,00 165%

EMVO Contributions Member Associations 100.000,00 100.000,00 100.000,00 100%

Interest & Miscellaneous Income 250,00 3.500,00 3.500,00 1400%

TOTAL 1.405.563,14 1.508.484,85 1.546.921,65 110%

EXPENDITURE BUDGET '16 FORECAST 15/10/2016 BUDGET '17

General and Overhead Costs 1.055.250,00 1.088.065,27 1.100.750,00 104%

Office Costs and General Expenditures 85.000,00 88.100,00 91.500,00 108%

Staff and Consultants Fees 769.250,00 786.450,00 789.750,00 103%

Travel costs, PR and receptions 155.000,00 165.000,00 170.000,00 110%

Communication and Publications 46.000,00 48.515,27 49.500,00 108%

Events 243.000,00 272.079,67 328.000,00 135%

Congress 200.000,00 200.000,00 210.000,00 105%

Managing Board & Board 12.000,00 12.000,00 12.000,00 100%

Working Groups 16.000,00 16.000,00 18.000,00 113%

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Fora / Regional Meeting / DoA 15.000,00 44.079,67 88.000,00 587%

Other Expenditure 90.500,00 90.590,39 93.500,00 103%

IFPW Membership Fee 8.000,00 6.840,39 10.000,00 125%

EMVO Membership Fee & Costs 80.000,00 80.000,00 80.000,00 100%

Tax, Banking & Miscellaneous Expenditure 2.500,00 3.750,00 3.500,00 140%

TOTAL 1.388.750,00 1.450.735,33 1.522.250,00 110%

GLOBAL RESULT 16.813,14 57.749,52 24.671,65 - %

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Agenda Item 6: GIRP membership contributions 2017

Full Members

COUNTRIES GDP (bio€) 2015

KEY 2017

INHABITANTS 2015

Contribution 2016

Contribution 2017 (no increase)

Luxembourg 52 1,00 576.249 3.874,33 3.874,33

Ireland 256 2,50 4.658.530 9.685,83 9.685,83

Portugal 179 2,50 10.341.330 9.685,83 9.685,83

Greece 176 2,50 10.793.526 9.685,83 9.685,83

Finland 209 2,50 5.487.308 9.685,83 9.685,83

Denmark 266 2,50 5.707.251 9.685,83 9.685,83

Norway 349 3,75 5.213.985 14.528,75 14.528,75

Austria 339 3,75 8.700.471 14.528,75 14.528,75

Sweden 444 3,75 9.851.017 14.528,75 14.528,75

Belgium 409 3,75 11.289.853 14.528,75 14.528,75

Switzerland 599 5,25 8.325.194 20.340,25 20.340,25

Netherlands 676 6,50 16.979.120 25.183,16 25.183,16

Spain 1.081 9,00 46.438.422 34.869,00 34.869,00

Italy 1.636 10,00 60.665.551 38.743,33 38.743,33

France 2.181 10,00 66.661.621 38.743,33 38.743,33

United Kingdom 2.575 10,00 65.341.183 38.743,33 38.743,33

Germany 3.032 10,00 82.162.000 38.743,33 38.743,33

Estonia 20 1,75 1.315.944 6.780,08 6.780,08

Hungary 109 2,50 9.830.485 9.685,83 9.685,83

Slovenia 39 1,75 2.064.188 6.780,08 6.780,08

Czech Republic 167 2,50 10.553.843 9.495,91 9.495,91

Slovak Republic 78 1,75 5.426.252 6.647,14 6.647,14

Latvia 24 1,75 1.968.957 6.647,14 6.647,14

Bulgaria 44 1,75 7.153.784 6.647,14 6.647,14

Poland* 427 6,50 37.967.209 4.937,88 4.937,88

Serbia 33 1,75 7.076.372 6.647,14 6.647,14

Croatia* 44 1,75 4.190.669 6.647,14 6.647,14

Lithuania 37 1,75 2.888.558 6.647,14 6.647,14

Romania 160 3,75 19.759.968 13.896,46 13.896,46

Iceland 15 1,00 332.529 2.712,03 2.712,03

TOTAL Associations

439.955,33 439.955,33

Direct Member Companies

Celesio 54.262,36 54.262,36

PHOENIX 54.262,36 54.262,36

SECOF 54.262,36 54.262,36

COFARES 54.262,36 54.262,36

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Alliance Healthcare Germany

54.262,36 54.262,36

Pharma Privat 54.262,36 54.262,36

Oriola 54.262,36 54.262,36

Noweda 54.262,36 54.262,36

European Companies/Group

434.098,92 434.098,92

TOTAL 874.054,24 874.054,24

Weight GDP

50%

Weight inhabitants

50%

Factor 1

GDP < 10 0

GDP > 10 and < 100

0,5 Inhabitants < 1.000.000

GDP > 100 and < 300

1,25 Inhabitants > 1.000.000 and < 12.500.000

GDP > 300 and < 500

2,5 Inhabitants > 12.500.000 and < 25.000.000

GDP > 500 and < 1.000

4 Inhabitants > 25.000.000 and < 50.000.000

GDP > 1.000 5 Inhabitants > 50.000.000

Key = factor 1 + factor 2

Fee = basis (fee of Luxembourg) * Key

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Associated Professional Members

2015 2016 2017

Farmalogist Serbia 2.196,86 2.251,78 2.308,07

Katren Russia 2.196,86 2.251,78 2.308,07

TEKB Turkey 2.196,86 2.251,78 2.308,07

Eurapharma 2.196,86 2.251,78 2.308,07

Total Associated Professional Members 8.787,43 9.007,12 9.232,29

Supporting members

2015 2016 2017

IMS 65.000,00 65.000,00 65.000,00

Insight Health 50.000,00 50.000,00 50.000,00

KNAPP 40.000,00 40.000,00 40.000,00

Schäfer PEEM 40.000,00 40.000,00 40.000,00

CAPPI 20.000,00 20.000,00 20.000,00

Sensitech 20.000,00 20.000,00 20.000,00

Total Supporting Members 235.000,00 235.000,00 235.000,00

Liaison members

2016 2017

TEVA 5.000,00 5.000,00

Mylan 5.000,00 5.000,00

Merck Group 5.000,00 5.000,00

MSD 5.000,00 5.000,00

Sandoz 5.000,00 5.000,00

Actavis 5.000,00 0,00

Servier 5.000,00 5.000,00

AstraZeneca 0,00 5.000,00

OPHACO 5.000,00 5.000,00

Total Liaison Members 40.000,00 40.000,00

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Agenda Item 6: GIRP members EMVO contributions 2017

COUNTRIES GDP

(bio€) 2015

KEY 2017

INHABITANTS 2015

Contribution 2017

Luxembourg 52 1,00 576.249 1.054,86

Ireland 256 2,50 4.658.530 2.637,15

Portugal 179 2,50 10.341.330 2.637,15

Greece* 176 2,50 10.793.526 0,00

Finland 209 2,50 5.487.308 2.637,15

Denmark 266 2,50 5.707.251 2.637,15

Norway 349 3,75 5.213.985 3.955,73

Austria 339 3,75 8.700.471 3.955,73

Sweden 444 3,75 9.851.017 3.955,73

Belgium 409 3,75 11.289.853 3.955,73

Switzerland** 599 5,25 8.325.194 0,00

Netherlands 676 6,50 16.979.120 6.856,59

Spain 1.081 9,00 46.438.422 9.493,74

Italy* 1.636 10,00 60.665.551 0,00

France 2.181 10,00 66.661.621 10.548,60

United Kingdom 2.575 10,00 65.341.183 10.548,60

Germany 3.032 10,00 82.162.000 10.548,60

Estonia 20 1,75 1.315.944 1.846,01

Hungary 109 2,50 9.830.485 2.637,15

Slovenia 39 1,75 2.064.188 1.846,01

Czech Republic 167 2,50 10.553.843 2.637,15

Slovak Republic 78 1,75 5.426.252 1.846,01

Latvia 24 1,75 1.968.957 1.846,01

Bulgaria 44 1,75 7.153.784 1.846,01

Poland 427 6,50 37.967.209 1.371,32

Serbia** 33 1,75 7.076.372 0,00

Croatia 44 1,75 4.190.669 1.846,01

Lithuania 37 1,75 2.888.558 1.846,01

Romania 160 3,75 19.759.968 3.955,73

Iceland 15 1,00 332.529 1.054,86

Turkey 632 9 78.741.053

TOTAL Associations 100.000,73

GDP Factor Inhabitants GDP < 100 0,5 Inhabitants < 1.000.000

GDP > 100 and < 300 1,25 Inhabitants > 1.000.000 and < 12.500.000

GDP > 300 and < 500 2,5 Inhabitants > 12.500.000 and < 25.000.000

GDP > 500 and < 1.000 4

Inhabitants > 25.000.000 and < 50.000.000

GDP > 1.000 5 Inhabitants > 50.000.000

Key = factor 1 + factor 2 Fee = basis (fee of Luxembourg) * Key

*Greece, Italy - EU countries with an exemption will pay as of 2023 only or as soon as connected **Switzerland, (Serbia, Macedonia) - non-EU and EEA-countries will pay as soon as they are connected

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Agenda Item 7: Report - GIRP Emergency contact list test run

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Agenda Item 8: Link to GIRP statistics, margins overview and country reports

Link to compilation of statistical data, country reports and margins overview:

www.girp.eu/ Member Area/ Information for full members/ Data/ GIRP Data/ 2015

27





Agenda Item 9: Link to IPF study presentations

www.girp.eu/ Member Area/ Information for full members/ Data/ GIRP DATA/ GIRP IPF study 2016

28





Agenda Item 10: GIRP meetings overview 2015-2016

Type Meeting Date Time Location

Autumn Meeting 2016 Managing Board and Board meeting 09 November 2016 11h00 - 15h00 GIRP office, Brussels

Autumn Meeting 2016 EU Health Policy Briefing and General Assembly (full members only)

09 November 2016 16h00 - 18h00 Sofitel Brussels EU Hotel, Brussels

Autumn Meeting 2016 GIRP & IMS Dinner 09 November 2016 19h30 onwards La Vigne Restaurant, Brussels

Autumn Meeting 2016 Autumn Conference 10 November 2016 09h00 - 12h00 Sofitel Brussels EU Hotel, Brussels

Autumn Meeting 2016 EP Lunch Reception 10 November 2016 12h30 - 14h30 European Parliament, Brussels

other EP Breakfast Reception 06 December 2016 08h00 - 9h45 European Parliament, Brussels

Vienna Meetings 2017 Board and Managing Board nominations (small and medium sized associations meeting)

19 January 2017 14h00 - 16h00 Sofitel Stephansdom, Vienna, Austria

Vienna Meetings 2017 Managing Board nominations (companies meeting)


Vienna Meetings 2017 Managing Board nominations (associations meeting)


Vienna Meetings 2017 Dinner / Heuriger 19 January 2017 19h30 onwards tbc, Vienna, Austria

Vienna Meetings 2017 Managing Board and Board meeting 20 January 2017 11h00 - 16h00 Sofitel Stephansdom, Vienna, Austria

Vienna Meetings 2017 EU Health Policy Briefing (full members only)


Vienna Meetings 2017 75. Ball der Pharmazie 21 January 2017 20h00 onwards Hofburg Palace, Vienna, Austria

other GIRP Industry Networking Reception 26 January 2017 17h00 onwards De Warande, Brussels

General Membership Meeting GIRP General Membership Meeting 08 March 2017 09h00 – 12h30 Marriot Hotel, Brussels

GIRP Educational Conference GIRP Supply Chain Conference 08 March 2017 14h00 – 18h00 Marriot Hotel, Brussels

GIRP Educational Conference GIRP Supply Chain Conference Dinner 08 March 2017 19h30 onwards tbc, Brussels

GIRP Educational Conference GIRP Supply Chain Conference 09 March 2017 09h00 – 17h00 Marriot Hotel, Brussels

GIRP Educational Conference Training on risk assessment 10 March 2017 09h00 – 16h00 GIRP office, Brussels

29





Regional Meeting GIRP Regional Meeting Dinner 16 March 2017 evening La Dogana del Buongusto, Milan, Italy

Regional Meeting GIRP Regional Focus Meeting 17 March 2017 All day NH Touring, Milan, Italy

Annual Meeting & Conference 2017, Madrid

Informal Dinner 27 May 2017 19h00 onwards tbc, Madrid, Spain


Managing Board and Board meeting 28 May 2017 12h00 - 15h30 Westin Palace Hotel, Madrid, Spain


EU Health Policy Briefing and General Assembly (full members only)

28 May 2017 16h00 - 18h00 Westin Palace Hotel, Madrid, Spain


Welcome Dinner 28 May 2017 20h00 onwards Palacio de Linares, Madrid, Spain


Conference Day 1 29 May 2017 09h00 - 18h00 Westin Palace Hotel, Madrid, Spain


Gala Dinner 29 May 2017 20h00 onwards Casino de Madrid, Madrid, Spain


Conference Day 2 30 May 2017 09h30 - 13h00 Westin Palace Hotel, Madrid, Spain


Farewell Lunch 30 May 2017 13h00 - 15h00 tbc, Madrid, Spain

Joint Managing Board and Board Joint Managing Board and Board meeting 11 September 2017 11h00 - 15h00 GIRP office, Brussles

Directors of Associations Directors of Associations Dinner 21 September 2017 evening Helsinki, Finland

Directors of Associations Directors of Associations Meetin 22 September 2017 All day Helsinki, Finland

Autumn Meeting 2017 Internal Meetings 21 November 2017 All day Brussels, Belgium

Autumn Meeting 2016 Autumn Conference 22 November 2017 All day Brussels, Belgium

Autumn Meeting 2016 EP Lunch Reception 22 November 2017 All day European Parliament, Brussels

30




Agenda Item 10: GIRP Breakfast Reception in the European Parliament - 6 December 2016

HEALTHCARE DISTRIBUTION: THE IMPACT OF OVERREGULATION 6 DECEMBER 2016, 8:00 - 9:45

In the Salon des Membres, European Parliament

Rue Wiertz 60, 1047 Brussels, Belgium

REGISTER HERE

Feeling the pressure and financial burden of overly strict interpretations of EU regulations and guidelines?

Join us in the European Parliament on 6 December 2016 from 8:00 – 9:45 to discuss the impact and

implications of overregulation with European decision-makers. This event offers healthcare distributors a unique opportunity to discuss issues affecting their daily business with Members of the European

Parliament European Parliament, the European Commission and the owners and top executives of small

and medium-sized distributors across Europe, such as Ms. Elisabetta Gardini (MEP), Mr. Paul Rübig (MEP), Mr. Lothar Jenne (Max Jenne Arzneimittel Grosshandlung KG), Mr. Alojz Peterle (MEP)

and Mr. Tom Vandenkendelaere (MEP).

Don’t miss this important opportunity to speak up and have your voice heard!

Register here and don’t forget to book your hotel room by 11 November 2016!

Looking forward to seeing you there,

GIRP TEAM

GIRP European Healthcare Distribution Association

Rue de la Loi 26, 10th floor, box 14 B - 1040 Brussels Belgium

phone: +32 2 777 99 77 email: [email protected] web: www.girp.eu

The information contained in this communication and its attachment(s) is intended solely for the use of the individual or entity to whom it is addressed and others authorized to receive it. It may contain confidential or legally privileged information. If you are not the intended recipient you are hereby

notified that any disclosure, copying, distribution or taking any action in reliance on the contents of this information is strictly prohibited and may be unlawful. If you have received this communication in error, please notify us immediately by responding to this email and then delete it from your system.

Please consider our environment before printing this email

http://www.girp.eu/healthcare-distribution-impact-overregulationhttp://www.girp.eu/healthcare-distribution-impact-overregulationhttps://book.radissonred.com/reservation/cityRateSearch.do?facilitatorId=BIGMOUTHMEDIAREZIDOR&citySearchForm.city=&citySearchForm.country=&rateSearchForm.forcedCitySearch=false&rateSearchForm.homePageSearchType=&rateSearchForm.redemptionSearch=false&rateSearchForm.redemptionCalSearch=false&rateSearchForm.currencyCode=&rateSearchForm.hotelSortFilter=&rateSearchForm.rateSortFilter=%28sort%28availableRates%29%29&rateSearchForm.modifySearch=true&storeHotelSortFilter=true&rateSearchForm.clearFilter=true&rateSearchForm.hotelCodes=BRUZR&rateSearchForm.forcedHotelSearch=true&rateSearchForm.hotelName=Radisson+RED+Hotel%2C+Brussels&rateSearchForm.hotelCode=BRUZR&rateSearchForm.checkinDate=12%2F05%2F2016&rateSearchForm.checkoutDate=12%2F06%2F2016&rateSearchForm.numberRooms=1&rateSearchForm.occupancyForm%5B0%5D.numberAdults=1&rateSearchForm.occupancyForm%5B0%5D.numberChildren=0&rateSearchForm.occupancyForm%5B1%5D.numberAdults=1&rateSearchForm.occupancyForm%5B1%5D.numberChildren=0&rateSearchForm.occupancyForm%5B2%5D.numberAdults=1&rateSearchForm.occupancyForm%5B2%5D.numberChildren=0&rateSearchForm.occupancyForm%5B3%5D.numberAdults=1&rateSearchForm.occupancyForm%5B3%5D.numberChildren=0&rateSearchForm.occupancyForm%5B4%5D.numberAdults=1&rateSearchForm.occupancyForm%5B4%5D.numberChildren=0&rateSearchForm.occupancyForm%5B5%5D.numberAdults=1&rateSearchForm.occupancyForm%5B5%5D.numberChildren=0&rateSearchForm.occupancyForm%5B6%5D.numberAdults=1&rateSearchForm.occupancyForm%5B6%5D.numberChildren=0&rateSearchForm.occupancyForm%5B7%5D.numberAdults=1&rateSearchForm.occupancyForm%5B7%5D.numberChildren=0&rateSearchForm.occupancyForm%5B8%5D.numberAdults=1&rateSearchForm.occupancyForm%5B8%5D.numberChildren=0&rateSearchForm.ecertCodeForNonEligibleRate=&rateSearchForm.rmcCode=&rateSearchForm.ecertCode=&rateSearchForm.corporateAccountID=&rateSearchForm.promotionalCode=GIRP16&rateSearchForm.travelAgencyId=&rateSortFilter=(sort(availableRates))mailto:[email protected]://www.girp.eu/

31




Agenda Item 11: Invitation to host GIRP Annual Meeting and Conference in 2018

From: Seamus Feely [mailto:[email protected]] Sent: lundi 25 juillet 2016 10:00

To: Monika Derecque-Pois Cc: Martin Fitzgerald ; Gwynne Morley ; Ger Rabbette ; Reilly, Paul ; Keyes, David ; Liam Quinn ([email protected]) Subject: Annual General Meeting and Conference 2018

Dear Monika,

I wish to refer to our recent discussions and to confirm that the members of the Irish Pharmaceutical Distributors Federation are happy to host the GIRP Annual General Meeting and Conference in 2018.

If this offer is acceptable, we can discuss suitable dates and venues in due course.

I would also like to thank both Martin and yourself for the valuable insights that you shared with us at our meeting last week and we look forward to working more closely with you in the future.

Yours Sincerely,

Seamus Feely

mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]

32




Agenda Item 12: Draft Joint Supply Chain Actors Statement on Information

Draft Joint Supply Chain Actors Statement on Information and

Medicinal Products Shortages

Introduction

Shortages of medicinal products are a growing issue of concern across the European Unioni,ii,iii

and indeed globally (2012, 2014)iv. There is increasing evidence that shortages occur across the

EU and that a wide range of medicines are affectedv,vi,vii,viii,ix,x. Several factors can give rise to

the cause of medicines shortagesxi,xii,xiii,xiv. The causes of shortages are understood to be

multifactorial, including problems in production, global consolidation of manufacturing,

unintended impacts of pricing and tendering policies, as well as problems within the supply

chain. This paper does not expand further on issues of causation and, by extension, solution.

Rather, it addresses the need for better information collection, communication and

transparency in order to: ameliorate patient care impacts via improved management of

shortages; and, to enhance understanding of the extent and nature of medicines shortages.

Despite steps already taken to address some of the causes of medicine shortages, the problem

persists. It is clear is that without reliable information regulators, industry, parallel distributors,

pharmaceutical wholesalers, health professionals and, of course, patients, cannot take steps to

limit the negative effects that interruptions in medicines supply have upon patient care and

health system performance.

European associations representing manufacturers of medicinal products, parallel distributors,

pharmaceutical wholesalers and pharmacists have come together to work jointly on proposed

principles for improving collection, communication and transparency of information on

shortages of medicinesxv. Everyone is in agreement that reliable information systems are an

essential step in communicating the problems of shortages. Whilst it is recognised that such

systems need to be implemented at national level, and therefore to be responsive to specific

national concerns and regulation, a number of principles underpin efficient, effective and

reliable information systems.

Our primary concern, and the main motivation for forming this joint statement, is the health

and wellbeing of patients. It is our ethical and public duty as actors within the pharmaceutical

supply chain (manufacturers, parallel distributors, pharmaceutical wholesalers and health

professionals) to minimise the impact of shortages, where we are capable of doing so. This

statement is part of this process and focuses solely on one issue of potential redress: improved

information collection and publication about shortages.

Better information about medicines shortages is required in order to:

33




Put in place contingency solutions to minimise negative impacts to patient care (e.g.

initiate urgent communication to prescribers / pharmacies / wholesalers and

preparation of bespoke out-of-license or magisterial products)

Enable best management and distribution of existing stocks

Provide verified and meaningful information to patients about why a disruption, delay

or change in their therapy is necessary, and when resumption of supply is anticipated

Implement a rapid alert and solution finding process between the Supply Chain Actors

in urgent cases with severe health related implications

Improve understanding of the nature of the problems, the balance of causes and main

policy dynamics to be addressed to prevent shortages occurring in the first place

Mitigate the impact on patients by providing clear and properly evaluated information

for communication with healthcare professionals (e.g. the INN) to facilitate:

o Generic substitution1 or, where this is not an option,

o Therapeutic alternatives2

The purpose of this statement is to outline guiding principles about medicines shortages

information and to make recommendations on the specific features of the ideal information

systems. We hope that these recommendations will help to enhance systems at the national

level, and potentially form the basis of future European level action.

Examples of best practice, illustrating the principles of the paper, are provided in the Annex.

Principles

1 Detection and Assessment of a Shortage*

There is no universally accepted definition of a medicine shortage in Europe. For the purpose

of setting up an effective information system of medicine shortages we suggest a conceptual

approach (Figure 1: Potential system of detection and assessment of a medicine shortage) that would lead to early

detection of shortages upon appropriate assessment of reports of suspected shortages, and

ultimately will help to understand and prevent medicine shortages related problems.

For this kind of system to work it is important to define a ‘suspected medicine shortage’ and

establish a simple mechanism to assess a ‘signal’ and decide on whether it is an actual

medicine shortage. We adopt a patient centred view in defining a ‘suspected medicine

shortage’ and, as such, we define a suspected medicine shortage, for the purposes of an

1 Where permitted by national rules 2 In consultation with, or with referral to the prescriber

34




information and reporting system, as “the inability for a community or hospital pharmacy, as a

result of factors beyond their control, to supply a medicinal product to a patient within a

defined period, for example 72 hours”3. While creating such a definition, it should be noted

that it is the impact on patients arising from the unavailability of the medicine they require

that is paramount. Therefore, we believe that it is important that all suspected shortages of

medicines are recorded whether they are single or multi-source products.

The report of suspected medicine shortage does not necessarily mean that a medicine is in

short supply. The evaluation of signal(s) of a potential shortage is required to establish

whether or not there is a potential negative public health impact arising from shortage of

medicine.

Another important factor to consider when assessing a suspected shortage is whether the

product is multi-source or single-source. In general, if the product is of multi-source origin (and

can therefore be substituted by another product where permitted) then this may be decided

not to be recorded as an actual shortage.

Additionally, the nuances of national reimbursement and substitution rules need to be taken

into consideration. Whilst respecting Member States’ competencies in the domain of

substitution and reimbursement, we believe that, in the case of shortages of specific

reimbursable medicinal products, national reimbursement rules should not impede the

provision of alternative medicines to patients.

All supply chain actors involved in supply of the concerned product should take part in the

assessment of a suspected medicine shortage (a supply chain stakeholder panel) and ensure

that the most up-to-date information on a medicine is made available.

In cases where a medicine shortage is confirmed, a supply chain stakeholder panel may decide

to make this information public and provide further information to authorities and patients.

*Section 1 should not be taken in isolation. We note that the European Medicines Agency (EMA) is leading work on

the European level to develop definition(s) for medicine shortages in collaboration with supply chain stakeholders

and we strongly support this effort to ensure harmonised definitions, which in turn should enable comparing data

within and between countries in order to understand the root causes of shortages betterxvi. Under the auspices of

the work led by EMA, industry trade associations have also proposed a definition of “meaningful [supply]

disruption” for European use, which refers to disruptions due to manufacturing or quality issues, which may or

may not result in shortagesxvii.

3 Agreed definition by the Supply Chain Supply Chain Actors Working Group on 8th July 2015, adapted

definition from the French Public Health Code and later adopted in the Decree on Medicine Shortages https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000032922434&categorieLien=id

35




(i)

(ii) Figure 1: Potential system of detection and assessment of a medicine shortage

2 Sources of Information

Visibility of supply information and awareness of shortages across the supply chain must be

improved to allow a more responsive reaction to interruptions in supply. For example,

manufacturers will be aware of a potential supply disruption of their products due to

manufacturing/quality issues which are obliged to be reported to Competent Authorities

following EU legislation (cf. Annex II). Sometimes pharmacists experience or foresee supply

difficulties before the industry or wholesalers are aware that there is, or will be, a problem.

We believe that information systems should therefore be open to reports from manufacturers,

wholesalers, parallel traders, pharmacists and other healthcare professionals, with reference

to the origin of reports of suspected shortages. We are also aware that in an age of widespread

use of social media and mobile technology, patients/the public are increasingly taking a more

active role in their care. As such, it is desirable that information systems give thought to a

mechanism for patient engagement where appropriate (e.g. the potential to signal a suspected

shortage, as is the case for the Farmanco system in the Netherlandsxviii).

It is important to reference the origins of reports of suspected shortages, e.g. whether they are

from Supply Chain Actors, public authorities or elsewhere in order to help to evaluate the

Community or hospital pharmacy orders a medicine from an

authorised wholesaler (s)

Repeated orders are denied to the pharmacy for

72 hours

The pharmacy reports a suspected medicine

shortage to the national information system on

medicine shortages

Supply chain stakeholders continuously monitor data

to detect 'signals' and assess them

Supply chain stakeholder panel evaluates data and

makes a decision with regard to the suspected

medicine shortage

Supply chain stakeholder panel confirms the medicine shortage

Supply chain stakeholder panel assess

appropriatness to make information about a

medicine shortage public

Communicating with and informing stakeholders,

competent authorities and the public

Manufacturers, parallel traders and wholesalers

and other healthcare professionals report a suspected/potential medicine shortages

Suspected

medicine shortage

‘Signal’ of a medicine

shortage

Medicine

shortage

36




accuracy of the reports. We recognise, that some reports may be inaccurate – for example,

they may be out of date. Reports therefore should, where possible, be verified with relevant

Supply Chain Actors (e.g. via a Supply Chain Stakeholder Panel). The process of verification

does not grant Supply Chain Actors a veto over the suspected shortage reports. Disputes about

the veracity or accuracy of a report could be settled by agreement among Supply Chain Actors

in accordance with a national Supply Chain Actors‘ Code (see below point 8).

In order to aid clear and consistent reporting of suspected shortages, a standardised reporting

template is suggested and the reporting template of the Parenteral Drug Association (PDA) in

their “Technical Report No. 68 (TR 68), Risk-Based Approach for Prevention and Management

of Drug Shortages” provides a good case study.xix

3 Level of Access

Patients and the public, the ultimate payers of medicine, need timely access to medicines.

They also require access to information from their healthcare professional and other sources

to support the use of their medicines. In the case of a medicine shortage, patient organisations

may be involved in mitigating potential risks and help to support patients with information and

advice.

Principles of disclosure and transparency are being adopted in a number of areas in the

pharmaceutical sector as a whole. In this spirit, we believe that access to information on

confirmed shortages should be generally made available where appropriate. Information

should be collated and appropriately assessed, verified, non-alarmist, non-prescriptive and

made available to all who provided it.

There is a potential that wider general access to certain information may in itself lead to supply

distortions, possibly exacerbating or even causing shortagesxx. Therefore only verified

information should be made available. The potential for such distortions needs to be

addressed within an appropriate ethical context during assessment process, and should not be

considered a blanket objection to open access.

Beyond this, we believe that open access to verified information about medicines shortages

should be the default position of information systems, such as that of the FDA, ASHP and EMA

at international levelsxxi,xxii, with restricted access imposed only on reasonable and justifiable

grounds, on an ad hoc basis, and in accordance with a national Supply Chain Actors Code.

Assurances should be established about the information flow and where the publication of

specific information should be restricted to Supply Chain Actors as fear of inappropriate

publication of certain sensitive information may act as a disincentive to its disclosure.

To avoid the potential for misattribution of blame by lay readers of the database, information

about known, or indeed unknown, supply disruption causes should be provided e.g.

“temporary disruption to manufacturing process by required upgrade”, “no disruption at

manufacturing level, “unknown supply chain problem.”

37




4 Content

We believe that information systems should be as reliable, up-to-date and as comprehensive

as possible. It should allow identification of the medicinal product in short supply (in

accordance with the principles above, this should be by brand where appropriate), and where

possible the cause and likely duration of the shortage.

Information systems should ideally contain forms of archiving to enable an overview of trends

in shortages to be provided. This can further enhance public understanding of the nature of

the problem and help to better direct policy interventions. An example of this is provided by

University of Utah monitoring and analysis of drug shortages over time in the USA, providing

new insights into the nature of the problem and where the best focus of long term policy

resolution may lie4.

We also believe that if a medicine suspected to be in shortage has an alternative, i.e. via

generic substitution5 or, in the case of a proprietary non-prescription medicine, there is an

alternative with the same ingredients available, the unavailability could still be reported as a

suspected shortage by healthcare professionals or wholesalers. This is because wholesalers are

not allowed to substitute orders and, in some cases, pharmacists require proof of a shortage in

order to enable substitution and, in the case of the OTC medication, the information held on

the database (for example the expected duration of delay) could be used to inform their

patients when their preferred proprietary OTC medicine will be available again for purchase. As

such, this could facilitate the work of pharmacists in finding the appropriate replacement

therapy or action, and treatment of patients will not be interrupted. Pharmacists, with their

knowledge of medicines and products, may be in position to offer training or support to other

professionals on the correct selection and use of substituted products.

5 Alternative Treatments

The effects of shortages can be mitigated if patients have access to suitable alternatives, either

by way of generic substitution or the use of therapeutic alternatives as appropriate. Generic

substitution, where possible, has been demonstrated to be an important solution to medicines

shortages. KNMP’s “Farmanco” system reports that 62% of shortages in the Netherlands are

effectively managed through substitution with generic medicinesxxiii. The multi-source nature

of generic medicines means that this might entail substitution of a branded medicine for a

generic, a generic for a branded medicine or one generic for another.

In order to respect

(i) Member State’s competencies in regulating the dispensing of medicines,

(ii) the professional autonomy of the healthcare professionals involved and

5 Where permitted by national rules

38




(iii) the desire for patients to be involved in their own care,

we believe that information systems should not suggest specific alternative products, whether

they are multi-source substitutes or therapeutic alternatives. Instead, the systems should

simply indicate whether alternatives are available from one or more suppliers, allowing

decisions regarding substitution and therapeutic alternatives to be made at practice (pharmacy

and prescriber) level.

6 Governance

Supply Chain Actors are fundamental to the provision of information. As argued above, we

believe Supply Chain Actors have a duty to mitigate the effects of shortages. Where

information systems are not in place at national level, we believe that Supply Chain Actors

should be proactive in cooperating to develop and/or advocating for such systems.

Supply Chain Actors’ involvement in the governance of information systems – including the

participation of patients – would help to ensure that systems are broadly based, responsive,

efficient, user-friendly and ultimately meeting primary needs. Ideally, systems should have a

level of coordination with each other in order to enable improved understanding of the

international nature of medicines shortages. We recognise that national competent authorities

have a role in the governance of information systems for medicines shortages (as cited in the

examples below). Partnership between authorities and Supply Chain Actors may be preferred

in some Member States, and is strongly welcomed by Supply Chain Actors. In order to facilitate

the flow of information and reporting we recommend that definitions are harmonised both

nationally and at European level. We believe that for an effective system, there should not be

any barriers to reporting of suspected shortages by healthcare professionals and wholesalers.

However, we believe that the principles laid out in this statement are essential to ensure that

information systems are truly effective, and therefore should also be respected by national

competent authorities.

7. Competition Rules

We recognise that collaboration between Supply Chain Actors potentially gives rise to

competition law issues, especially in the market based manufacturing sector. Supply Chain

Actors should be aware of their obligations in this respect, and should seek legal counsel where

appropriate. It is of paramount importance that any initiatives by Supply Chain Actors are

undertaken in the public interest with the sole objective of improving the provision of

information on shortages.

8. A Supply Chain Actors Code

Given the potential consequences for patients of an inability to access medication, shortages

of medicines are both a practical and a moral problem.

Collaboration between national Supply Chain Actors to provide information systems should be

underpinned by a Code of collaborative action. The Code should address, as a minimum:

(iii) the provision of information to the system;

39




(iv) removal of information from the system;

(v) advisory timeframes;

(vi) verification of information;

(vii) procedure of assessment of suspected shortages;

(viii) withholding of information from the system which may have detrimental effects;

(ix) making information on medicine shortages public;

(x) mutual assistance to mitigate the effect of shortages; and,

(xi) resolution of disputes between Supply Chain Actors.

Recommendations

European associations representing manufacturers of medicinal products, parallel distributors,

pharmaceutical wholesalers and pharmacists have come together and are in agreement that

reliable information systems are an essential step in communicating shortages. While it is

recognised that such systems need to be implemented at national level, and therefore to be

responsive to specific national concerns and regulation, a number of principles underpin

efficient, effective and reliable information systems:

1. Transparency in the supply chain is crucial to mitigate shortages before they arise.

Supply chain actors on national level should therefore have a tool to communicate

openly and without barriers.

2. Detection and Assessment of Medicine Shortage: Reporting of suspected medicine

shortages is encouraged in a similar spirit to the reporting of suspected adverse drug

reactions. ‘Signals’ of medicine shortages can then be periodically assessed by, for

example, a national Supply Chain Actor stakeholder panel to establish if signals are

suspected or actual shortages.

3. Information Source: In order to aid clear and consistent reporting of suspected

shortages, a standardised reporting template is suggested. Information systems should

be open to reports from manufacturers, wholesalers, parallel traders, pharmacists and

other healthcare professionals, with reference to the origin of reports of suspected

shortages. Reports, where possible, could be verified with relevant Supply Chain Actors,

but in any case, have to be confirmed prior to considering any form of publication.

4. Level of Access: In order to aid mitigation of shortages, access to information on

suspected shortages should be made available to all Supply Chain Actors. Access to

information on verified shortages should be generally available to the public where

appropriate and meaningful and restricted access imposed only on reasonable and

justifiable grounds, on an ad hoc basis, and in accordance with a national Supply Chain

Actors Code. Information should be collated and verified, non-alarmist, non-

prescriptive, meaningful and made available to all who provided it. Patient

organisations, may be involved in mitigating potential risks and help to support patients

with information and advice.

5. Content of Information System: Information systems should be as reliable, up-to-date

and as comprehensive as possible. They should allow identification of the medicinal

40




product in short supply (by brand where appropriate), and where possible state the

cause and likely duration of the shortage (also causes arising from outside the supply

chain such as pricing and reimbursement issues). The systems should indicate (where

appropriate) whether alternatives are available from one or more suppliers, allowing

decisions regarding substitution and therapeutic alternatives to be made at practice

level.

6. Governance: Supply Chain Actors should be proactive in cooperating to develop and/or

advocating for such systems at national level. Partnership between authorities and

Supply Chain Actors is strongly encouraged by Supply Chain Actors. Collaboration

between Supply Chain Actors to provide information systems should be underpinned

by a national Code of collaborative action.

7. Competition Rules: Supply Chain Actors should be aware of their obligations in this

respect, and should seek legal counsel where appropriate.

41




Annex I: Examples of Best Practice Full practice examples are provided below. There are traditionally two types of Information

systems available namely ones lead and set up by stakeholders and government lead systems.

Note: information based on the state of affairs at the date of the publication of this joint

statement

A. Stakeholder lead system examples

Austria

There are two information systems in Austria.

System1:

1. Detection and Assessment of Medicine Shortage: The system is operated by Datacare and

provides a web based interface which facilitates communication between

pharmaceutical manufacturers and wholesale distributors for making wholesale

distributors aware of the likelihood of a shortage and / or reporting effective medicine

shortages to pharmaceutical wholesalers.

2. Information Source: In the event of a wholesale distributor experiencing a stock-out,

the concerned wholesaler initiates a request for the manufacturer to upload

information onto the database. Manufacturers can proactively upload information onto

the database.

3. Level of Access: It is accessible to wholesale distributors and pharmaceutical

manufacturers. Information is passed to pharmacies in the event of a stock out at the

level of the wholesale distributor.

4. Content of Information System: The following content appears in the system – reason

for delivery problem; explanation for shortage; estimated duration of supply disruption;

contact person (if possible), and helpful information for healthcare professionals.

5. Governance: The system is operated by Datacare a company owned by the wholesale

distributor association PHAGO in conjunction with pharmaceutical manufacturers

(Pharmig).

System 2:

1. Detection and Assessment of Medicine Shortage: The system is based on the online

publication called “index of medicines” to which a ‘box’ was added for the purpose of

informing about shortage. The box is populated by the manufacturer – including

probable length of shortages, potential replacement, cause, and contact person for

additional questions.

2. Information Source: Information is provided by pharmaceutical manufacturers.

3. Level of Access: System is accessible to all health professionals and supply chain

operators in the case that they are customers of the publishing company of “index of

medicines”.

4. Content of Information System: The following content appears in the system – product

name; probable duration of the shortage; potential replacement; cause of the shortage

and a contact person for questions.

42




5. Governance: The system is operated by pharmacies (hosted by Österreichischer

Apothekerverlag) in-conjunction with pharmaceutical industry (Pharmig).

France

1. Legal basis: Supply chain operators have the following obligations due to Health Law

2016-41, decree 2012-1096 and decree 2016-993:

Manufacturer / MAH must inform ANSM (L’Agence nationale de sécurité du

médicament et des produits de santé) of any stock out or risk of stock out for

medicinal products of major therapeutic interest,

MAH informs the supply chain actors in case of stock out for medicinal products of

major therapeutic interest

ANSM publishes the information available on its own website. The information

remains visible for the duration of the shortage

Full-line wholesalers must inform manufacturers of any shortages not notified by

the ANSM,

MAHs have to make available a call-centre (or an equivalent organisation, e.g. ‘DP-

Ruptures system”) in order to manage the shortages and supply medicines in case

of emergency.

A shortage is defined as the impossibility for a pharmacist, after asking two wholesalers, to dispense a medicine for the 3 consecutive days.

2. Information Source: All supply chain actors (manufacturers, wholesalers, community or

hospital pharmacists) can notify shortages experienced at their level, both top-down

and bottom-up to the ‘DP-Ruptures’ system. Pharmacists are encouraged to notify

shortages through an automated system.

3. Level of Access: System allows:

• Communication with the Medicines Agency: for manufacturers, notification of a shortage or risk of shortage; dialogue with the Agency in terms of shortage management and traceability. • Communication with customers: top-down information dissemination in relation to anticipated shortage management; upward transmission of information allowing centralisation of notifications of observed shortages; reactive information in answer to the notification of an observed shortage.

4. Content of Information System: Company, Product name, type of medicine (“of major

therapeutic interest” or not), foreseeable date of shortage, cause of the shortage,

expected date of availability, possible alternatives; in addition, in the communication

with the French Medicines Agency (ANSM) only: market share, stocks available,

measures included in the Shortage Management Plan (if applicable) including corrective

solutions (such as generics, alternative treatments, importation etc.).

5. Governance: The French regulatory body for all pharmacists (Ordre national des

pharmaciens) uses and hosts an existing IT network connecting all supply chain actors

(community pharmacies, hospital pharmacies, full-line wholesalers, manufacturers) and

health authorities. This network, originally developed to support shared medication

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records, has since come to support rapid information exchange systems on batch

recalls and safety alerts. The build-on system called "DP-Ruptures", was launched in

February 2013 by the Ordre, followed by a pilot phase from August 2013 onwards.

Since October 2014, the service is being gradually deployed. In September 2015,

around 3000 community pharmacies and hundreds of hospital pharmacists are involved

in the system, as well as 55 manufacturers and health authorities (Medicines Agency,

plus 8 Regional Health Agencies). As the “DP-Ruptures” system is usable on a voluntary

basis, the exchanges with ANSM can be made by e-mail ([email protected])

and the information with customers can be made through the call-center. Completing

the system, the agency publishes its notification on its own website.

The Netherlands

1. Detection and Assessment of Medicine Shortage: Submissions are usually made by

pharmacies and each submission is checked by the respective MAH.

2. Information Source: The submission system is open to reports from manufacturers,

wholesalers, pharmacists, other healthcare professionals and patients.

3. Level of Access: The Dutch system allows for public access to the information.

4. Content of Information System: The following content is contained in the system:

product name; reason for shortage; expected data of availability, and possible solution

for patients (substitution; compounding; importing, and possible alternatives). The

information remains visible in the system for the duration of the shortage plus one

additional month.

5. Governance: The system operating in the Netherlands (“Farmanco”) is hosted and

governed by KNMP – the Royal Dutch Pharmacists Association.

Portugal

1. Detection and Assessment of Medicine Shortage: The system automatically registers

the information on medicines not delivered to pharmacies by wholesalers. This

automatic registry is done during the process of reception and verification of orders

delivered to pharmacies. The information is used by CEFAR (centre for health research

and evaluation) to produce a report every month.

2. Information Source: Shortages notifications by pharmacies to the National Association

of Pharmacies (ANF) are on a voluntary basis although 65% of pharmacies participate in

the system daily.

3. Level of Access: ANF keeps the history of shortages from the beginning of the system.

The information is sent by CEFAR to the national agency (Infarmed).

4. Content of Information System: The file created in the process by Sifarma (pharmacy

stock management and dispensing software) is sent to ANF where the daily information

is collected including name, strength, pharmaceutical form, package size and price,

name of the market authorization older, name of the supplier (wholesaler), number of

units in shortage.

file:///C:/Documents%20and%20Settings/Ddebourg/Local%20Settings/Temp/Local%20Settings/Temp/XPgrpwise/[email protected]

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5. Governance: System is developed and supported by ANF. The pharmacy system is

hosted at the IT department of ANF.

Spain

1. Detection and Assessment of Medicine Shortage: Information Center on Supply of

Medicines (CISMED) established by the Spanish General Pharmaceutical Council

manages the information sent directly by pharmacies to the regional pharmaceutical

councils. The information is communicated through the application of pharmacy order

management system. Information is registered in the system when order of goods has

been denied by all wholesalers that pharmacy works with and pharmacy gets response

message "There are no stocks".

2. Information Source: All pharmacies are connected to the information system.

3. Level of Access: Regional pharmaceutical councils receive information about supply

disruptions in the province and refer aggregated information to the General Council.

The data is then consolidated, analysed and processes. Report is then sent to the

competent authority, the National Medicines Agency.

4. Content of Information System: Information contained in the system is: the national

product number; the number of units of each medicine within an order that has not

been supplied to a pharmacy; name of wholesalers that have not been able to serve the

orders; any other information about the activity of the pharmacy.

5. Governance: CISMED is an information system set up by community pharmacists that

allows to detect in real time, general situations of supply disruptions based on the

reports from community pharmacies. It provides information to the Spanish supply

chain actors and health authorities on availability of medicines in pharmacies and

allows pharmacists to know about potential supply disruptions and provide timely

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