1. Gudbjorg Edda Eggertsdottir President EGA, President Iceland & Strategic Projects, Actavis Rome, 17 June 2013

2. EGA - introduction Established in 1993 Based in Brussels  International non-profit organisation under Belgian law (ASBL). Pan European (not only EU) Representing over 1000 companies Around 50 direct members Direct membership for both companies and national associations  different categories

3. About the EGA The official representative of the European generic and biosimilar medicines industry Membership examples Multinationals Sandoz Actavis Stada Teva Mylan Hospira Fresenius Regional Gedeon Richter Egis Zentiva Small Local Combino Pharm Farmoz Consilient Health National Associations Azzogenerici (Italy) FeBelGen (Belgium) Apogen (Portugal) Bogin (Netherlands) GEMME (France) ProGenerica (Germany) BGMA (The UK)

4. 4 The EGA and its member companies and associations support and promote: The sustainability and competitiveness of the European generic and biosimilar medicines industry European, national and regional measures which increase market access to generic and biosimilar medicines The creation of a European regulatory and IP framework that ensures immediate access to the post patent market for generic and biosimilar medicines Global adoption of high quality EU like standards for APIs, generic medicines and biosimilar medicines EGA Mission

5. Role of the EGA To inform the EGA members of trends, developments and implications of any scientific, legal and technical issues impacting on the generic medicines’ industry  EGA-EU Brief To provide educational and technical assistance to the members and to general public  EGA Conferences: Annual Conference, Regulatory Affairs, Legal Forum, Biotech etc. To provide a network of information, co-operation and assistance with other generic medicines associations at national and international level.  National Associations group  IGPA (International Generic Pharmaceutical Alliance with US, Canada, Japan) To represent the common interests of its members at EU level and seek measures to ensure access to generic medicines for patients  European Commission, European Parliament, Council, EMA, National Authorities…

6. Key facts about generic medicines Generic Medicines Bring Savings of 35€ Billion p.a. in the EU 27 Generic medicines account for almost 50% More than 1000 Generic Companies Employing 150,000 Employees in Europe One of the Most Competitive Sectors in Europe of volume share and 7 % of turnover to R&D Exporting to more than 100 countries outside the EU. of value share 18% 6

7. EGA SHARES MANY OF YOUR VISIONS Community pharmacy: Sharing our vision? 7

8. Key goal Despite the constant pressure for change, the ultimate goal of modern health care as well as pharmacy practice should always be to provide patients with the best and most cost-effective care possible. In the context of national competences in healthcare policy, the community pharmacy network is ready to play a significant role in helping national health systems to meet today’s and tomorrow’s challenges This goal is fully shared by EGA 8

9. Enhance medicine safety and access to medicines Strengthen medicines supply chain to prevent falsified medicines reaching the patient  Along with manufacturers, pharmacists are the key player in preventing falsified medicine from reaching the patient. Without the pharmacist making sure before dispensing, that the medicine is authentic, everything other players in the supply chain do, would be in vain 9

10. Enhance medicine safety and access to medicines Work with stakeholders to prevent medicine shortages  Can we improve forecasting throughout the supply chain?  Small markets present a special problem –Small products –PIL printed out in the pharmacy? 10

11. Contribute to the efficiency and quality of the health system Continue to promote and facilitate greater use of cheaper medicines via appropriate substitution when suitable  Pharmacists are key players when it comes to advocating for greater use of generics  Pharmacists can provide unbiased information about the quality and efficacy of generics 11

12. Dispensing Generic Medicines should be incentivized 12 Increase savings for the Health system Remuneration scheme that incentivises the dispensing of the lower price medicines Establish remuneration linked to the level of achievement of a substitution goal Incentives for pharmacies to dispense generic medicines

13. Contributing to the efficiency and quality of the health system The generic industry, through EGA and individual companies, would like to team up with the pharmacy profession in educating doctors, healthcare professionals, government and patients about the fact that generics and biosimilars are of equal quality and efficacy as originator products. We would like to work with pharmacies in developing educational programs. 13

14. 14 Using Generic medicines should be incentivized Incentives for patients to use generic medicines Information campaigns Information campaigns Implement a system where patients refusing generic medicines have to pay upfront total value of the branded product and only reimbursed later Increase savings for the health system

15. Economical Considerations External Reference Pricing External reference pricing is not an appropriate tool for reducing prices of multisource products such as generic medicines (according also to WHO) Generic medicines should be exempt from ERP systems as their low prices can only be sustained in high volume generic medicines markets with low requirements for physician education about the value of generic medicines National governments and payers have much more efficient tools for price reductions in the off patent market. A dynamic and competitive market environment should be promoted, that generates savings by optimising generic medicines usage and by increasing the volume of generic medicines market 15

16. Improve Public Health Support safe and effective self-care and self-medication when providing health advice Many generic companies are developing new and cost-effective OTC products, promoting OTC switches... 16

17. Generic industry offers modern, cost effective treatment The generic industry is your partner in modern healthcare  In CEE in particular modern treatment is often not available to patients, due to cost, until the generic is launched 17

18. Closing remarks Generics are key to create savings in health care  Market penetration still varies widely between countries – huge savings still to be achieved Price cuts are creating difficulties for the generic industry  Sustainable pricing and reimbursement systems need to be established  External Reference Pricing to be improved or abandoned The generic industry would like to team up with pharmacists to educate stakeholders about medicines 18

19. Grazie mille 19