1. 1 Pharmaceutical System Strengthening from the Perspective of an International Organization Availability, Prices, NCDs and Generics Dr. Richard Laing Department of Essential Medicines and Pharmaceutical Policies World Health Organization Antalya August 2011

2. 2 Target 8.E: In cooperation with pharmaceutical companies, provide access to affordable essential drugs in developing countries Indicator 8.13. Proportion of Population with Access to Affordable, Essential Drugs on a Sustainable Basis Access to medicines is required for the fulfilment of MDG 8

3. 3 2003 2008 WHO/HAI Joint Activity on Essential Medicine, Prices and Affordability Source http://www.haiweb.org/medicineprices/manual/documents.htmlhttp://www.haiweb.org/medicineprices/manual/documents.html

4. 4 Low public sector availability leads patients to the private sector, where medicines are unaffordable

5. 5 Reliance on originator brand products makes treatment more unaffordable

6. 6 Increased focus on chronic diseases is therefore needed to achieve MDG Target 8.E "Further support is needed for chronic, noncommunicable diseases such as cardiovascular disease, cancer, diabetes and chronic respiratory disease." (MDG Report 2008) "Governments, in collaboration with the private sector, should give greater priority to treating chronic diseases and improving the accessibility of medicines to treat them" (MDG Report 2009) Access to report and data: http://www.who.int/medicines/mdg/en/index.html

7. 7 Differences in the availability of selected medicines for acute and chronic conditions Results from 50 medicine price and availability surveys undertaken using the WHO/HAI methodology in 40 countries (2003 – 2008) Source Cameron et al 2011Cameron et al 2011

8. 8 Average availability of medicines chronic diseases by therapeutic class, generics, all countries

9. 9 What do NCD medicines cost without tariffs, taxes and mark-ups?

10. 10 High prices, low availability and poor affordability can have many causes Low public sector availability: –lack of resources or under-budgeting –inaccurate forecasting –inefficient procurement / distribution –low demand/slow-moving products High private sector prices: –high manufacturer’s selling price –high import costs –taxes and tariffs –high mark-ups

11. 11 Separate prescribing and dispensing Control import, wholesale and/or retail mark-ups through regressive mark-up schemes Provide tax exemptions for medicines Where there is little competition, consider regulating prices Patented medicines –use the flexibilities of trade agreements to introduce generics while a patent is in force –differential pricing schemes whereby prices are adapted to the purchasing power of governments and households in poorer countries. Many policy options exist

12. 12 Improve procurement efficiency Ensure adequate, equitable, and sustainable financing, e.g. –Health insurance systems that cover essential medicines –Make chronic disease medicines available in the private sector at public sector prices Prioritize medicine budget, i.e. target widespread access to a reduced number of essential generic medicines for NCDs, Promote generic use: –preferential registration procedures, e.g. fast-tracking, lower fees –ensure the quality of generic products –permit generic substitution and provide incentives for the dispensing of generics –educate doctors/consumers on availability and acceptability of generics Other Policy options

13. 13 Total potential cost savings and average percentage savings that could be obtained from switching private sector consumption from originator brands to lowest-priced generics, for a limited basket of medicines Country (n= number of medicines) Total potential cost savings (2008 USD) Average percentage savings across individual medicines* China, public hospitals (n=4)$86,492,27665.1% Colombia (n=9)$3,229,09288.7% Ecuador (n=12)$3,066,40763.2% Indonesia (n=9)$6,405,59784.2% Jordan (n=11)$887,26255.9% Kuwait (n=6)$64,2619.3% Lebanon (n=8)$4,397,43267.5% Malaysia, private hospital and retail sectors (n=10)$7,419,94267.2% Source WHR 2010 Chapter 4

14. 14 Total US generic market share has risen over each of the past 5 years Generic Share of Total Prescriptions Generic prescription share reached 78% in 2010 which was 4% higher than 2009 levels. This share gain is caused by a 3% gain in the available market for generics (81 to 84% in 2010) as well as a 1% gain in generic efficiency (93% vs. 92%). Most states allow pharmacists to substitute generics when available, others require a doctor’s direct instruction or restrict substitution for specific therapies where differences between brands and generics may impact patients. The broad availability of discounted generics is a further positive influence on efficiency. X Source: IMS Health, National Prescription Audit, Dec 2010 COMPARISON OF 2010 VERSUS 2009 SPENDING Chart notes Prescriptions dispensed include retail pharmacies and longterm care facilities. Generic prescription share represents the percentage of unbranded and branded generic prescriptions dispensed annually. Generic availability is measured by evaluation of products at the form level that have a comparable generic available on the market in the time period. Generic efficiency is calculated based on the percentage of generic prescribing of the generically available market.

15. 15 Source: IMD MIDAS, Dec 2010 X Generic Share of Total Volume Germany generic market dynamics 15

16. 16 Source: IMD MIDAS, Dec 2010 X Generic Share of Total Volume Austria generic market dynamics 16

17. 17 Source: IMD MIDAS, Dec 2010 X Generic Share of Total Volume Brazil generic market dynamics 17

18. 18 Source: IMD MIDAS, Dec 2010 X Generic Share of Total Volume South Africa generic market dynamics 18

19. 19 Time to market after patent expiry is a key issue

20. 20 Brand Prescription Share of Molecule Post-Expiry In US, Generics capture over 80% of a brand’s volume within 6 months Source: IMS Health, National Prescription Audit, Dec 2010

21. 21 Germany brand erosion after loss of exclusivity Germany Brand Volume Share of Molecule Post-Expiry Source: IMS MIDAS Monthly, Mar 2011. *2010 curve contains incomplete periods. % SHARE OF PRE-EXPIRY MOLECULE TOTAL SU MONTHS SINCE PATENT EXPIRY 21

22. 22 Austria brand erosion after loss of exclusivity Almost no loss at 6 months and only 15% at 1 year Austria Brand Volume Share of Molecule Post-Expiry Source: IMS MIDAS Monthly, Mar 2011. *2010 curve contains incomplete periods. % SHARE OF PRE-EXPIRY MOLECULE TOTAL SU MONTHS SINCE PATENT EXPIRY 22

23. 23 S. Africa brand erosion after loss of exclusivity 21% loss after 6 months & 34% after 1 year S. Africa Brand Volume Share of Molecule Post-Expiry Source: IMS MIDAS Monthly, Mar 2011. *2010 curve contains incomplete periods. % SHARE OF PRE-EXPIRY MOLECULE TOTAL SU MONTHS SINCE PATENT EXPIRY 23

24. 24 24 Generic Market Shares 2010 Value & Volume Generic pricing regimes affects savings! % Total Market - Retail

25. 25 Generic market highly segmented and countries vary greatly! Company generics Branded Generics INN generics All coexist and compete for the same space National Policies must adjust to the national realities

26. 26 26 Even after patent expiration brands still retain a sizeable volume share in some countries 26 Source: IMS Health, MIDAS, Market Segmentation, MAT Dec 2010, Rx only. *Market Segmentation universe

27. 27 Components of a generics policy Prerequisite: Quality assurance recognized by prescribers & patients " Generics policies" is a broad term comprising a heterogeneous set of specific practices, including: –Fast track registration: abbreviated and less costly registration procedure for generics, Bolar provision –Procurement of medicines under INN or generic name; –Encouraged or mandatory prescribing by generic name; –Generic substitution by pharmacists; –Information and incentives for generic utilization to prescribers, pharmacists and consumers; –Selective financing of generics in positive lists, reference price systems, procurement by tendering, IPR policies.

28. 28 Conclusions In all but high income countries out of pocket payment is the most frequent form of payment for medicines When health insurance is introduced and covers medicines they need to have generic policies in place Where people have to pay out of pocket generic policies individuals can reduce costs by about 60% and this could make the difference between death or impoverishment and survival.

29. 29 Questions?

30. 30 But implementation may be difficult: Public advertisement, Guatemala, 2006 and 2010 "I have diabetes. If my medication fails, I could suffer a diabetic coma." "I don't take chances. I only use originals"

31. 31 Morocco (n=6)$3,175,43551.8% Pakistan (n=9)$12,606,08351.2% Peru (n=11)$2,520,35678.7% Philippines (n=9)$9,415,31957.1% South-Africa (n=7) † $3,461,60078.9% Thailand (n=7)$1,348,66975.7% Tunisia (n=3)$280,00125.8% Ukraine (n=4)$458,89252.3% United Arab Emirates (n=12)$10,671,58753.0% Total potential cost savings and average percentage savings that could be obtained from switching private sector consumption from originator brands to lowest-priced generics, for a limited basket of medicines Country (n= number of medicines) Total potential cost savings (2008 USD) Average percentage savings across individual medicines*

32. 32 Data, methods and caveats Standard units instead of prescriptions used as volume measure to calculate generics share and brand erosion after loss of exclusivity (LOE) Pricing of generics and no-longer-protected brands after LOE varies significantly by country and results in a different volume balance between generics and brands The number of generic competitors available after LOE varies by country; fewer products produce less brand erosion Intellectual property protection enforcement is not at the same level in all countries; generics prior to a brand’s LOE are more likely to be available in pharmerging markets than in the developed markets Country-specific epidemiology needs guide different policies and market dynamics related to unmet medical need (i.e. antiretroviral drugs in South Africa) 32

33. 33 Brazil brand erosion after loss of exclusivity Brazil Brand Volume Share of Molecule Post-Expiry Source: IMS MIDAS Monthly, Mar 2011. *2010 curve contains incomplete periods. % SHARE OF PRE-EXPIRY MOLECULE TOTAL SU MONTHS SINCE PATENT EXPIRY 33

34. 34 In US, continuing therapies grew slowly as brands continued to decline Chronic Disease Continuations and Refills Source: IMS Health, National Prescription Audit, Dec 2010

35. 35 WHO/HAI Pricing Policy Papers To assist policy-makers and others, WHO and HAI are developing a series of reviews on pharmaceutical pricing policies and interventions, with a focus on low- and middle-income countries. Five reviews have now been published on: External Reference Pricing http://www.haiweb.org/medicineprices/05062011/ERP%20final%20May2011.pdfExternal Reference Pricing The Role of Health Insurance in the Cost-Effective Use of Medicines http://www.haiweb.org/medicineprices/05062011/Health%20insurance%20final%20May2011.pdfThe Role of Health Insurance in the Cost-Effective Use of Medicines The Regulation of Mark-ups in the Pharmaceutical Supply Chain http://www.haiweb.org/medicineprices/05062011/Mark-ups%20final%20May2011.pdfThe Regulation of Mark-ups in the Pharmaceutical Supply Chain Competition Policy http://www.haiweb.org/medicineprices/05062011/Competition%20final%20May%202011.pdfCompetition Policy Sales Taxes on Medicines http://www.haiweb.org/medicineprices/05062011/Taxes%20final%20May2011.pdfSales Taxes on Medicines http://www.haiweb.org/medicineprices/05062011/Taxes%20final%20May2011.pdf Source http://www.haiweb.org/medicineprices/ http://www.haiweb.org/medicineprices/