working documents for the girp annual general assemblygirp.eu/sites/default/files/memberarea/4 -...
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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
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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
European Healthcare Distribution Association
Groupement International de la Répartition Pharmaceutique the vital link in healthcare
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
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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
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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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
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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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
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
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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
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
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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
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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
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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
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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
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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
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.
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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
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.
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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
Agenda Item 3: Link to General Management Report
www.girp.eu/ Member Area/ Information for full members/ GIRP Management Report
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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
Agenda Item 4: Celesio letter - GIRP Board delegate
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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
Agenda Item 5: Application liaison membership
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the vital link in healthcare
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
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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the vital link in healthcare
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
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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the vital link in healthcare
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
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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the vital link in healthcare
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
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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the vital link in healthcare
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
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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the vital link in healthcare
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
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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the vital link in healthcare
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
Agenda Item 7: Report - GIRP Emergency contact list test run
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the vital link in healthcare
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
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the vital link in healthcare
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
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the vital link in healthcare
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
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the vital link in healthcare
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
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
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the vital link in healthcare
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
Agenda Item 9: Link to IPF study presentations
www.girp.eu/ Member Area/ Information for full members/ Data/ GIRP DATA/ GIRP IPF study 2016
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the vital link in healthcare
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
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)
19 January 2017 16h00 - 18h00 Sofitel Stephansdom, Vienna, Austria
Vienna Meetings 2017 Managing Board nominations (associations meeting)
19 January 2017 16h00 - 18h00 Sofitel Stephansdom, Vienna, Austria
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)
20 January 2017 16h00 - 17h00 Sofitel Stephansdom, Vienna, Austria
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
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the vital link in healthcare
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
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
Annual Meeting & Conference 2017, Madrid
Managing Board and Board meeting 28 May 2017 12h00 - 15h30 Westin Palace Hotel, Madrid, Spain
Annual Meeting & Conference 2017, Madrid
EU Health Policy Briefing and General Assembly (full members only)
28 May 2017 16h00 - 18h00 Westin Palace Hotel, Madrid, Spain
Annual Meeting & Conference 2017, Madrid
Welcome Dinner 28 May 2017 20h00 onwards Palacio de Linares, Madrid, Spain
Annual Meeting & Conference 2017, Madrid
Conference Day 1 29 May 2017 09h00 - 18h00 Westin Palace Hotel, Madrid, Spain
Annual Meeting & Conference 2017, Madrid
Gala Dinner 29 May 2017 20h00 onwards Casino de Madrid, Madrid, Spain
Annual Meeting & Conference 2017, Madrid
Conference Day 2 30 May 2017 09h30 - 13h00 Westin Palace Hotel, Madrid, Spain
Annual Meeting & Conference 2017, Madrid
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
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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
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/
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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
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]
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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
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:
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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
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
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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
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
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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
(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
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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
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.”
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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
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
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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
(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;
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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
(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
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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
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.
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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
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.
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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
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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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
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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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
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