1. The vital link in healthcare 1 The European Association of Pharmaceutical Full-line Wholesalers The vital link in healthcare The European Association of Pharmaceutical Full-line Wholesalers GIRPs views on the European Commission proposal for a revision of European Good Distribution Practice Guidelines Cold Supply Systems and Solutions conference 15 February 2012

2. The vital link in healthcare 2 Agenda 4.Relationship between Falsified Medicines Directive and the proposed new GDPs 3.Distinguishing GDP requirements from GMP requirements – the overlaps 2.Impact of proposed new GDPs on wholesale distributors – assessing the proposed changes 1.The role of wholesale distributors in the pharmaceutical supply chain

3. The vital link in healthcare 3 prescribes & advises Why are medicines readily available when and where needed?... communicates innovation dispenses & advises Pharmacist develops & manufactures medicines Manufacturer has an illness Patient makes a diagnosis Doctor Wholesaler …pharmaceutical full-line wholesalers act as the vital link in healthcare!

4. The vital link in healthcare 4 What is GIRP? Founded in 1960, GIRP is the umbrella organisation of pharmaceutical full-line wholesalers in Europe The members of GIRP –Employ about 140,000 staff –Hold products on stock from over 3,500 manufacturers –Supply above 100,000 medicines across the continent to more than 170,000 pharmacies GIRPs members, the European pharmaceutical full-line wholesalers, guarantee the safe and efficient supply of all medicines to all patients through their public service function - providing the vital link in healthcare.

5. The vital link in healthcare 5 GIRP Members Association Members Company Members 31 European countries

6. The vital link in healthcare 6 GIRP Associated & External Members Associated Members External Members Alba Ukraine

7. The vital link in healthcare 7 Agenda 4.Relationship between Falsified Medicines Directive and the proposed new GDPs 3.Distinguishing GDP requirements from GMP requirements – the overlaps 2.Impact of proposed new GDPs on wholesale distributors – assessing the proposed changes 1.The role of wholesale distributors in the pharmaceutical supply chain

8. The vital link in healthcare 8 Responsible Person (RP) New requirement to ensure permanent presence of RP at each distribution site operated –Suggests RP has to be physically present 24 hours per day Today most Member States require one RP for all distribution sites of a wholesale distributor in the country Additional costs would be exorbitantly high & overly disproportionate; hundreds of highly qualified additional staff would have to be hired –Over 1,600 warehouses operated in Europe by GIRP members, annual cost increase of approximately 20 million Euro –Costs not covered by current remuneration systems for wholesale distributors Specific provisions regarding the RP (qualification, power of delegation, availability, presence) should be left to discretion of Member States as currently RP should be reachable around the clock RP must have right to appropriately delegate his/her tasks

9. The vital link in healthcare 9 Environmental control New requirement on environmental control too vague & too broad in scope to be a suitable requirement for the storage and transport of medicinal products Wholesale distributors are handling finished medicines in secondary packaging, which provides sufficient protection inside their facilities as well as in the delivery vehicles –Today warehouses of wholesale distributors equipped with heating & cooling systems to ensure the adequate storage temperature of medicines –Humidity is not a problem for medicinal products in their secondary packaging in Europe Controls including humidity control may be necessary for manufacturing medicinal products, but this requirement should not be applied to medicinal products in their secondary packaging

10. The vital link in healthcare 10 Validation and qualification All wholesale distributors have an existing Quality Management Systems in place, which covers all aspects of handling, storing and distributing medicinal products The current draft GDP Guidelines suggest that GMP validation levels are applied to GDP activities, which is overly disproportionate Wholesale distributors accept in principle the notion of validation, the scope, extent and level of the validation in the draft proposal needs to be clearly defined

11. The vital link in healthcare 11 Storing medicinal products separately The implementation of the requirement to store medicinal products separately from other products would entail a complete restructuring of wholesalers warehouses and current operations Today medicinal products are stored in the warehouses according to their demand frequency (slow-moving items, fast-moving items, etc.) to commission the medicinal products ordered by the pharmacy at maximum speed and least possible time delay with a high degree of efficiency and security. An exception would be cold-chain products, which are stored separately. As pharmaceutical wholesale distributors are only involved in the handling, storage and distribution of medicinal products in their secondary packaging, no product contamination can occur

12. The vital link in healthcare 12 Tracking of delivery routes Requirement for tracking delivery routes is disproportionate measure and the installation of tracking devices adds extra costs, which are not justified –Wholesale distributors are not delivering medicinal products in bulk, but are bundling several manufacturers products and are delivering very small quantities – in many cases one piece only –The delivery routes usually comprise the same customers in normal/usual geographical area of activity and only change very little on a day to day basis –The consignees, as the recipients of medicines, are known and products can be recalled from them

13. The vital link in healthcare 13 Deliver into care of consignee Provision that delivery must be handed into the care of the consignee is especially problematic –Wholesale distributors operate out of hours and night deliveries and frequently do not hand the deliveries directly into the care of the consignee –Have special provisions to leave the medicinal products in the premises of the pharmacy (for the ones where a key is available) or to leave them in night-time delivery hatches or in a specific drop box The wording of the proposal could suggest that wholesale distributors have an obligation to deliver directly into the hands of the pharmacists, which will prevent wholesale distributors from delivering over-night and from using existing methods for deliveries

14. The vital link in healthcare 14 Wholesale distribution authorisations for subcontractors / outsourced activities Proposal addresses outsourcing of activities and introduces a number of overly strict new requirements to control this typical aspect of normal business operations Requirements could be interpreted to cover all aspects of wholesale distributors activities and not be limited only to those activities directly related to the handling, storage and distribution of medicinal products Highly impractical requirement; should be constricted to only those activities, which are directly related to the handling and storage of medicinal products

15. The vital link in healthcare 15 Agenda 4.Relationship between Falsified Medicines Directive and the proposed new GDPs 3.Distinguishing GDP requirements from GMP requirements – the overlaps 2.Impact of proposed new GDPs on wholesale distributors – assessing the proposed changes 1.The role of wholesale distributors in the pharmaceutical supply chain

16. The vital link in healthcare 16 GDP versus GMP Current draft covers series of provisions only applicable to pharmaceutical manufacturers and are GMP orientated standards –No indication made which provisions are applicable to which actors Principles of GDP should not include GMP requirements –Wholesale distributors are not permitted to interfere with actual medicinal product –Only handling, storing & delivering medicinal products in secondary packaging GDP guidelines need to make distinction between provisions applicable to manufacturers, distributing their products & wholesale distributors

17. The vital link in healthcare 17 Agenda 4.Relationship between Falsified Medicines Directive and the proposed new GDPs 3.Distinguishing GDP requirements from GMP requirements – the overlaps 2.Impact of proposed new GDPs on wholesale distributors – assessing the proposed changes 1.The role of wholesale distributors in the pharmaceutical supply chain

18. The vital link in healthcare 18 FMD timeline, including batch recording FMD mandates batch recording, Delegated Act to specify safety features Wholesale distributors require batch number in machine-readable format, included in code on pack (safety feature) Batch recording as mandated by GDP guidelines, should not come into effect before Delegated Acts are implemented 2011 P D Compliance Legislation 6 months January 2013 Transposition of FMD into national law 2014 Publication of Delegated Acts D+3 years III/IV 2017 Safety features – Member States without pre-existing measures D+9 years III/IV 2023 Safety features – Member States with pre-existing measures July 2011 Publication FMD Official EU Journal III/IV 2012? New GDP guidelines (Batch number included in code, machine-readable) P I/II 2013? GDPs in operation (batch recording)

19. The vital link in healthcare 19 Conclusion GDP proposal goes far beyond what is necessary to ensure safe handling, storage & transportation of medicines GDP guidelines need to make distinction between provisions applicable to manufacturers, distributing their products & wholesale distributors Proposed new requirements are burdensome to achieve a relatively limited step forward to overhaul a currently well-functioning quality system The measures from a cost perspective are disproportionate compared to expected additional benefits Typically European Commission is obliged to carry out a relevant impact assessment ahead of new legislative proposals. While the GDP Guidelines are not necessarily categorised as a formal legislative instrument, they will be implemented into national legislation. Therefore GIRP urges a thorough reflection on the cost implications of new GDP guidelines.

20. The vital link in healthcare 20 The vital link in healthcare The European Association of Pharmaceutical Full-line Wholesalers The vital link in healthcare The European Association of Pharmaceutical Full-line Wholesalers Rue de la Loi 26, 10th floor, B – 1040 Brussels Phone: +32 2 777 99 77 Fax: +32 2 770 36 01 www.girp.eu - girp@girp.org Thank you for your attention. Martin FitzGerald Deputy Director General