1. 1/7 Are Patients Today Sufficiently Informed? Right and Ethics 10 October 2007

2. 2/7 Brief introduction of Forum Industry association (registered as economic & interest grouping) representing affiliates of international research based pharmaceutical companies. Founded in October 2002, celebrating its 5th anniversary. Uniting 20 world leading manufacturers of original – innovative medicinal products: AbbotLundbeck AlconMerck Sharp & Dohme (Board) AmgenNovartis (Board Vice-presidency) AstraZenecaNovo Nordisk BayerPfizer (Board Presidency) Biogen IdecPharmaSwiss Eli Lilly (Board)Roche GlaxoSmithKlineSanofi-aventis (Board) GrunenthalSchering-Plough Jannsen-CilagServier

3. 3/7 Major activities & scope of work Partner in discussions with health authorities and other players to enable quick and quality access of modern innovative treatments to patients Provide and follow high ethical standards with efficient monitoring and sanctioning system to assure undisputable behaviour of the innovative industry. Share Worldwide & European experiences, knowledge and information to assist in forming transparent and operational legislation at national level in regard to medicinal products and health care in general.

4. 4/7 Why patient rights and ethics? LOCAL REASONS: Currently Act on Patients Rights being approved in the Parliament.  14 rights including “right to be informed and to participate” are listed. Patients are becoming more and more aware and demanding – so called “patient empowerement” – both on national and international level. Discussions between industry and regulatory bodies on distinction between information and advertising. Pharmaceutical industry is highly limited by legislation on nature and substance of information delivered to patients. Motivate open and fair discussion on important health care issues among key players in Slovenia – fully include patients.

5. 5/7 Why patient rights and ethics? EU TRENDS: EU Commission report to European Parliament in 2007 in regards to information to patients General and expert (EU Pharmaceutical Forum with working group on Information to Patients) discussions about proper model of information delivering  more liberal than presently, but less agressive or direct than in USA European association of pharmaceutical industry is currently working on two important ethical documents (to be binding for pharmaceutical industry by July 2008 latest): - amendement to current Code of Practice on Prescription Medicines - new Code of Practice on Relation of Pharmaceutical Industry Towards Patient Associations

6. 6/7 Goals of today’s conference Put patients to the center of discussion. Establish a relation between legal restrictions and patient’s right to be informed. Find a way to ensure that information received by patients is transparent, objective and of highest quality. Provide a comprehensive overview of the relation to patient information from all parties involved: patients, doctors, regulatory bodies, interest groupings, industry. Form conclusions or findings that will serve as guidelines for future work and co-operation.

7. 7/7 Thank you! www.firdpc.com