1. HUG work team ‚membership / build community‘ Brussels, 20th June 2005  statements from HUG members  general remarks regarding expansion  prioritization of new members  summary  lists of manufacturer/associations - Volker Zeinar -

2. Statements from HUG members Mark Hoyle (Tyco)  various requirements being levied by customers world-wide  we need to appreciate customers objective  and get to know background information to the various requirements  suggestion :  hold a separate forum and invite all those placing requirements  objective = understanding cust. requirem. as a whole  chance = bounce ideas and present technical issues associated with requests  establish a common focus that allows to set GS1 standards  generate a win – win – win situation (harmonize customer requirements and fulfill via GS1 standards) Rich Hollander (Pfizer)  we need first a clear mission statement along with description of focus areas  VZ  absolutely agree !!! to my eMail from June 07th, 2005

3. Expansion of community General recommendation (VZ) Don‘t involve too many different stakeholders in an early phase of concept discussion, because :  interests are frequently too different  only discussions instead of development and realization  often an organizational challange (schedule face to face meetings, …) avoid a never ending story ! „We may not only talk about product identification, but have to think in processes !“

4. Prioritization of new members Priority 1 = first level core team members  all initial HUG members (GS1 + manufacturer)  further global player from manufacturer side  to select from the manufacturer list  e. g. Fresenius, Paul Hartmann, Bayer, … what could they contribute ?  better balance between US – Europe – Asia Pacific manufacturer desirable !  active participation on the definition of the strategy  highest interest on harmonized solutions, because ‚differentiation of national health markes (world-wide) is a cost factor‘ timeline of involvement  immediately

5. Balance ? current situation / gaps / necessity to optimize core team GS1 Head Office / U.S. / Japan AmericaEuropeAsia Pacific Pharma Medical Device Astra Zeneca B. Braun GlaxoSmithKline Aventis Bayer Fresenius B. Braun + Aesculap Smiths Medical Fresenius Paul Hartmann Lohmann-Rauscher Abbott Baxter Hospira Johnson & Johnson Merck & Co. NACDS Pfizer Baxter BD Boston Scientific Johnson & Johnson Medtronic Procter & Gamble Tyco Eisai Fujisawa Takeda ??? Terumo ??? black bold = kick-off participants italic = kick-off regrets red = new members (suggestion)

6. Prioritization of new members Priority 2 = second level legal/regulatory bodies members  organizations with responsibility for drugs + medical devices  from US, Europe, Asia Pacific  to select from the list (Ulrike)  important are e. g. FDA, EMEA, Ministry of Health & Welfare Japan, … what could they contribute ?  could be key player for : harmonize market requirements, find global solutions  in discussion with these organization we can get the feeling whether it is realistic to find a global solution  they have the power to release regulations  they (should) have the highest interest in patient safety  positive experience with FDA in the US (they consider manuf. arguments, e.g. FDA-rule doesn‘t contain variable data on unit-of- use level) timeline of involvement  as soon as possible after the general strategy of the HUG was defined clearly  clear mission statement is a pre-requisite

7. Prioritization of new members Priority 3 = third level potential users members  hospitals  pharmacies (hospital, retail chain dispensary, mail order pharmacy)  distributors / wholesalers what could they contribute ?  verify + optimize strategy and ensure to meet ‚practical‘ aspects  could be partner for pilot projects  main interests  hospitals/pharmacies : patient safety, traceability  distributors/wholesalers : supply chain efficiency (logistics)  question : are hosp./pharm. interested to participate in pilot projects ?  experience Germany  very difficult (costs !) timeline of involvement  after development of a strategy and discussion with legal/regulatory bodies

8. Prioritization of new members Priority 4 = fourth level information network members  profit oriented GPO‘s (e.g. Health Trust, …)  national purchasing organizations (e.g. NHS UK)  re-packager  manufacturer associations (country specific) what could they contribute ?  support function  distribution of the finished, proofed strategy  via associations it‘s possible to get in contact to local manufacturer timeline of involvement  after first tests and positve concept proof

9. Prioritization of new members Priority 5 = fifth level consulting members members  Internet provider  SAP, Microsoft  AIM (Auto ID Manufacturer)  … what could they contribute ?  IT / technical experts  support realization  particularly eBusiness issues (communication, material master data, …) timeline of involvement  ad hoc, depending on the issues to be discussed

10. Summary expansion steps c o n s u l t i n g m e m b e r s information network core team legal / regulatory bodies potential users strategy development harmonization + global solutions verification + test support immediately after definition of the general strategy after the detailed strategy defined after first tests & concept proof on demand WHEN ? WHAT ?

11. List of manufacturer  Abbott (PH)  Amgen (PH)  Astra Zeneca (PH)  Aventis (PH)  Baxter (PH + MD)  Bayer (PH)  B. Braun + Aesculap (PH + MD)  BD (MD)  Beiersdorf (MD)  Boehringer Ingelheim (PH)  Boston Scientific (MD)  Bristol-Myers Sq. (PH)  Coloplast (MD)  Eisai (PH)  Fresenius (PH + MD)  Fujisawa (PH)  GlaxoSmithKline (PH)  Hospira (PH)  Johnson&Johnson (PH + MD)  Kimberley Clark (MD)  Lilly (PH)  Lohmann-Rauscher  Medtronic (MD)  Merck & Co. (PH)  Novartis (PH)  Novo-Nordisk (PH)  Paul Hartmann (MD)  Pfizer (PH)  Procter & Gamble (MD)  Roche (PH)  Sanofi-Synthelabo (PH)  Schering AG (PH)  Schering-Plough (PH)  Smiths Medical (MD)  Stryker (MD)  Takeda (PH)  Terumo (MD)  Tyco (MD)  Wyeth (PH)  3M (MD) 20 parties already involved ! ………………

12. List of associations  EAHM= European Association of Hospital Managers  EAHP= European Association of Hospital Pharmacists  EDMA= European Diagnostic Manufacturer Association  EFAHP= European Foundation for Advancement of Healthcare Practitioners (WHO)  EHMA= European Health Management Association  EMA= European Medical Association  EMEA= European Medicines Agency (body of EU)  EUCOMED= European Association of Medical Device Manufacturer  CEN= European Committee for Standardization  …  FDA= Food and Drug Administration  HDMA= Healthcare Distribution Management Association  GHFT= Global Harmonization Task Force  …  Ministry of Health & Welfare (JP)  …