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 -

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 from June 07th, 2005

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 !“

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

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)

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

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

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

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

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 ?

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 ! ………………

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)  …