Public consultation in preparation of a legal proposal to combat counterfeit medicines for human use

Public health community

Period of consultation

From 11 March 2008 to 9 May 2008.

Contributions to and results of the consultation

A summary of the responses is available here.

The following submitting parties requested their submission not to be published (all): Eli Lilly and Company, Bayer Healthcare, SICPA and Thornton & Ross Ltd. The following submitting parties requested their submission not to be published (parts): PANalytical B.V. and First Ondemand Ltd.

Below are the public responses to the abovementioned public consultation:

Consumers, patients, academics

• EAASM - European Alliance for Access to Safe Medicines (EU)
• EFNA - European Federation of Neurological Associations (EU)
• IAPO - European Patients Forum (& International Alliance of Patient's Organizations (EU) : [1] - [2]
• European Research into Consumer Affairs (EU)
• Polish Consumer Federation (PL)
• FPP - Polish Patients Federation (PL) : [Polish version] - [English translation]
• BEUC - The European Consumers Organisation (EU)
• Katherine Eban (US)
• Carsten Löbel (DE)
• Isaac Leo Bain (Brazil)
• Kristina M.. Lybecker (US)
• Marianne Berrens (US)
• Paola De Sanna (IT)
• Paola Magri (IT)
• Stefan Thomsen (DE)

Health professionals, pharmacists, health insurances

• Académie nationale de pharmacie (FR) : [1] - [2] - [3] - [4] - [5]
• AIM - Association Internationale de la Mutualité
• ABDA - Bundesvereinigung Deutscher Apothekerverbände (DE)
• EAHP - European Association of Hospital Pharmacists (EU)
• GKV - German Statutory Health Insurance Funds (DE)
• Guild of Healthcare Pharmacists (UK)
• NCHCD - National Centre for Hereditary Coagulation Disorders (IE)
• Ordre National des Pharmaciens de France (FR) : [1] - [2] - [3]
• PGEU - Pharmaceutical Group of the European Union (EU)
• CPME - Standing Committee of European Doctors (EU)

Industry

• ACS DOBFAR (IT)
• Adorkem Technology (IT)
• Aegate (UK)
• AIPES - Association of Imaging Producers and Equipment Suppliers (BE)
• Amgen Inc. (US)
• Antibioticos (IT)
• Archimica (IT)
• Ares S.p.a. (IT)
• AESGP - Association of European Self-Medication Industry (EU)
• ABPI - Association of the British Pharmaceutical Industry (UK) : [1] - [2]
• Authentix (US)
• Axess Technologies (UK)
• Bilcare (India)
• Biosint S.p.A. (IT)
• Biotechnology Industry Organization (US)
• Boehringer Ingelheim Bidachem (IT) : [1] - [2]
• Bracco S.p.A (IT)
• Bristol-Myers Squibb (UK)
• BAPW - British Association of Pharmaceutical Wholesaler's (UK)
• Bruker optics (DE) : [1] - [2]
• Buscaini Emilio (IT)
• Cambrex Profarmaco Milano (IT)
• Catalent (US)
• Celesio (EU)
• CPA - Chemical Pharmaceutical Association (EU)
• Colorcon (UK)
• CU Chemie Uetikon GmbH (DE)
• Derivados Quimicos (ES)
• DSM (NL)
• LEEM - Les Entreprises du Médicament (FR)
• Erregiere (IT)
• EuropaBio (EU)
• EAEPC - European Association of Euro-Pharmaceutical Companies (EU
• GIRP - European Association of Pharmaceutical full-line wholesalers (EU)
• CEFIC - European Chemical Industry Council (EU) : [1] - [2] - [3]
• FECC - European Association of Chemical Distributors (EU)
• EFPFIA - European Federation of Pharmaceutical Industry and Associations (EU) : [1] - [2] - [3]
• EGA - European Generics Association (EU)
• EIPG - European Industrial Pharmacist's Group (EU)
• EQAC - European Quality Assurance Confederation (EU)
• European Qualified Person Association (EU) : [1] - [2] - [3]
• EUTICALS SpA (IT)
• Farmabios (IT)
• Farchemia S.r.L. (IT)
• Federchimica - Aschimfarma (IT)
• First Ondemand Ltd.
• GE Healthcare (UK)
• GlaxoSmithKline (UK)
• GCPA - Good Clinical Practice Alliance (EU)
• GS1 in Europe (CH)
• GS1 Healthcare Ireland (IE)
• Hewlett Packard (US)
• IDIS (UK)
• Indena (IT)
• InfraTrac (US)
• IAA - International Authentication Association
• International Pharmaceutical Excipients Council : [1] - [2] - [3]
• INTA - International Trademark Association
• Inwind (IT)
• Irish Pharmaceutical Healthcare Association and PharmaChemical Ireland (IE)
• Janhsen Consulting (DE)
• Johnson & Johnson (US)
• Labochim (IT)
• LEO Pharma (DK)
• LittleTom Digitals (ES)
• Lundbeck A/S (DK)
• Lundbeck Pharmaceuticals Italy SpA (IT)
• Malta Chamber of Small and Medium Enterprises (MT) : [1] - [2]
• Malta Federation of industries (MT)
• Melocchi (IT)
• Montavit Ges.m.b.H. (AU)
• NanoInK (US)
• NPSG - National Pharmaceutical Supply Group (UK) : [1] - [2] - [3]
• Novartis (CH)
• PANalytical B.V. (NL)
• Pfizer (US)
• PhRMA - Pharmaceutical Reserch and Manufacturers of America (US)
• Philip Morris International
• PPTA - Plasma Protein Therapeutics Association
• Polish Association of Parallel Importers of Medicinal Products (PL) : [1] - [2]
• Polpharma
• Procos (IT)
• Prodotti Chimici e Alimentari SpA (IT)
• Reckitt Benckiser (UK)
• Recordati S.P.A. (IT)
• Roche (CH)
• Sanofi-Aventis (FR)
• Schering-Plough (UK)
• SecureRF (US)
• Sifavitor (IT)
• Società Generale per l'Industria della Magnesia S.p.A. (IT)
• Solmag (IT)
• Stralfors (SV)
• SupplyScape (UK)
• TEVA SICOR (IT)
• Verband der Arzneimittelimporteure Deutschlands e.V. (DE)
• Verband forschender Arzneimittelhersteller (DE)
• VES - Vereniging Euro-Spécialités (NL)
• Zach System (IT)

Targeted stakeholders

Contributions from all stakeholders and interested parties are welcome. This includes, for example, associations representing patients, health care professionals, the industry, as well as academic bodies. Citizens are also welcome to contribute to this consultation.

Objective of the consultation

These measures relate to:

1. Manufacture, placing on the market of medicinal products and related inspections.
2. Import, export, transit (transhipment) of medicinal products.
3. Manufacture, placing on the market of active substances and related inspections.

For the purpose of this public consultation, which concentrates on sectoral pharmaceutical EU-legislation, the Commission has identified three areas of regulation of medicinal products where improvements to the regulatory framework could make a real contribution to protecting against counterfeit medicinal products. Counterfeiting of medicinal products has become an increasing threat for patients, healthcare professionals and industry and a concern for EU and national policy-makers. The Directorate-General Enterprise and Industry is consulting all stakeholders and interested parties on key ideas for amending the regulatory framework for medicinal products in an effort to combat the counterfeiting of medicinal products.

The consultation document

The consultation document can be downloaded here.

Protection of personal data

The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.

Additional information:

• Falsified medicines
• Falsified medicines - Major developments
• Video - EU fights fake medicines
• Q&A Directive on falsified medicines