Improving the access to Essential Medicines Dr Rino Coladangelo MB BS MRCP CEO Rephine Ltd

1. Improving the access to Essential Medicines Dr Rino Coladangelo MB BS MRCP CEO Rephine Ltd Improving the access to essential Medicines Bucharest 2012

2. Rephine Ltd • Founded in 1998 • UK headquarters • Staffed by leading experts in pharmaceutical manufacture • Rephine provides: • Pharmaceutical manufacturing consultancy worldwide • GMP audits of pharmaceutical suppliers and manufacturers • Supplier evaluation Improving the access to essential Medicines Bucharest 2012

3. Improving the access to Essential Medicines 15 minutes! Which medicines are essential How to fund them How to obtain them Agenda Improving the access to essential Medicines Bucharest 2012

4. What is an essential medicine? All medicines available for all patients – impractical Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford. (WHO 2002) WHO list of essential drugs About 350 drugs on list Romania list of approved reimbursable drugs About 5,000 items on list UK list of drugs and preparations 22,000 items US FDA national drug code list 49,096 items Which medicines are essential Improving the access to essential Medicines Bucharest 2012

5. Costs of Branded drugs in the UK and Romania Improving the access to essential Medicines Bucharest 2012

6. Drug costs: Brand versus Generic Improving the access to essential Medicines Bucharest 2012

7. Drug costs: Branded Generic versus Genericexample: Lisinopril 10mg tablet Improving the access to essential Medicines Bucharest 2012

8. Costs agreed for Branded drugs in Romania are good compared to UK Shift from Branded to generic drugs will reduce unit costs significantly Reduction of use of branded generics will reduce unit costs and level of co-payments Exclusion of certain drugs from approved list will reduce total costs Cost conclusions Improving the access to essential Medicines Bucharest 2012

9. Branded product prices are negotiated and are at similar levels to other countries in EU There are rarely any stock issues of medicines availability For generic drugs, the current position is that there are multiple suppliers of the same product, many foreign multinational companies and local Romanian producers Obtain supplies of essential medicines Improving the access to essential Medicines Bucharest 2012

10. Most important step is to introduce a method of evaluation of drugs for cost-effectiveness The way forward Improving the access to essential Medicines Bucharest 2012

11. Top ten Romanian medicines by value; 2011 Improving the access to essential Medicines Bucharest 2012

12. Top ten Romanian drugs 2011 Improving the access to essential Medicines Bucharest 2012

13. Licensing authorities, eg EMA, FDA only concerned with drug safety and efficacy. No interest in cost or comparability to similar products. Individual country evaluation is necessary of each product The process is long and can be difficult Romania can use examples of evaluations from other countries Evaluation of medicines for cost effectiveness Improving the access to essential Medicines Bucharest 2012

14. Most important step is to introduce a method of evaluation of drugs for cost-effectiveness Educate physicians and patients regarding generic versus branded products The way forward Improving the access to essential Medicines Bucharest 2012

15. Physicians need to have the best information possible in any easily accessible format, and kept updated. Educate patients via appropriate channels: TV, radio, newspapers, internet…. Make the generic versions of drugs attractive to the public and the prescribers Education / Information Improving the access to essential Medicines Bucharest 2012

16. Most important step is to introduce a method of evaluation of drugs for cost-effectiveness Educate physicians and patients regarding generic versus branded products Funding issues to be addressed by a combination approach The way forward Improving the access to essential Medicines Bucharest 2012

17. Funds are limited so controls need be applied Controls on supply Reimbursement list (eg top 200 drugs =50%spend in uk) Tariff Costs Manufacture quality of products; anti counterfeiting Stocks Control of demand Physician information Patient Education Funding the Medicines Improving the access to essential Medicines Bucharest 2012

18. Most important step is to introduce a method of evaluation of drugs for cost-effectiveness Educate physicians and patients regarding generic versus branded products Funding issues to be addressed by a combination approach Seek to encourage local manufacture of medicines The way forward Improving the access to essential Medicines Bucharest 2012

19. Romania has a good pharmaceutical manufacturing capability; EU quality standards are being met The biggest producer is a subsidiary of an Indian company A lot of competition of supply from external manufacturers Devise ways of facilitating local supply Local manufacture Improving the access to essential Medicines Bucharest 2012

20. Develop local definition of what are essential medicines in Romania by cost effectiveness review of medicines. Costs of individual medicines can be reduced by switch to generic, renegotiation of tariff prices, and local manufacture Education / information of physicians and patients is integral to success Principal messages Improving the access to essential Medicines Bucharest 2012

21. Improving the access to Essential Medicines Bucharest 2012 Rino Coladangelo rcc@rephine.com Improving the access to essential Medicines Bucharest 2012

22. Costs of certain drugs in the UK and Romania(100% reimbursed) Improving the access to essential Medicines Bucharest 2012