the vital link in healthcare 1 the european association of pharmaceutical full-line wholesalers the...

The vital link in healthcareThe vital link in healthcare 1The vital link in healthcare

The European Association of Pharmaceutical Full-line Wholesalers

The vital link in healthcare


GIRP’s views on the European Commission proposal for a revision of European Good

Distribution Practice Guidelines

Cold Supply Systems and Solutions conference

15 February 2012

The vital link in healthcareThe 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


prescribes & advises

Why are medicines readily available when and where needed?...

communicatesinnovation

dispenses & advises

Pharmacistdevelops & manufactures

medicines

Manufacturer

has an illnessPatient

makes a diagnosisDoctor

Wholesaler

…pharmaceutical full-line wholesalers act as the vital link in healthcare!


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

GIRP’s 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.


GIRP Members

Association Members Company Members

31 European countries


GIRP Associated & External Members

Associated Members External Members

Alba Ukraine


Agenda






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


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


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


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


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


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


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


Agenda






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


Agenda






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

ComplianceLegislation

6 months

January 2013Transposition of

FMD into national law

2014Publication of

Delegated Acts

D+3 years

III/IV 2017 Safety features –

Member States without pre-existing measures

D+9 years

III/IV 2023Safety features –

Member States with pre-existing measures

July 2011Publication 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)


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.

The vital link in healthcareThe vital link in healthcare 20The vital link in healthcare


The vital link in healthcare


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 - [email protected]

Thank you for your attention.

Martin FitzGeraldDeputy Director General

the vital link in healthcare 1 the european association of pharmaceutical full-line wholesalers the...

Documents

vital link

role of wholesale distributors

members of girp

defined slide

coldchain products

secondary packaging

impact of proposed new

rp qualification