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Access to Medicines: Role of Generic Drugs

Access to Medicines: Role of Generic Drugs . Presentation at CIPS Workshop, September 6, 2013 -S.Srinivasan, LOCOST Email: chinusrinivasan.x@gmail.com. Definitions. Patented Drug: Exclusive monopoly of drug Generic = Drug out of Patent

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Access to Medicines: Role of Generic Drugs

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  1. Access to Medicines: Role of Generic Drugs

    Presentation at CIPS Workshop, September 6, 2013 -S.Srinivasan, LOCOST Email: chinusrinivasan.x@gmail.com
  2. Definitions Patented Drug: Exclusive monopoly of drug Generic = Drug out of Patent Generic Generics = Unbranded Generics sold as aspirin, paracetamol, etc. Branded Generics = Out of patent drugs sold under brand names, eg. Dispirin, Calpol, etc.
  3. India’s Pharma Industry Total Sale Rs 73,000 cr within India (Mar 2013 IMS) Exports Rs 65,000 cr Unbranded generics : Rs 7000 cr 3rd largest by volume, 13th by value “Pharmacy of the developing world”
  4. India: Poverty Amidst Plenty? Medicines are overpriced and unaffordable in India.. Medicines constitute 50 to 80 percent of health care costs in India Health care is the second-most leading cause of rural indebtedness, after dowry. No universal health insurance in India Crumbling public health system, the first choice of patients is a private practitioner which means more out of pocket expenditures apart for loss of wages etc
  5. Government Expenditure on Drugs (%)
  6. FDCs and Irrational Medicines Nowhere in the world there are 100,000 brands (of generics) A study by LOCOST (2012) says 50 % of the top-selling 300 medicines (IMS 2009) are not in the National List of Essential Medicines, 2011. Many unnecessary drugs including medicines of uncertain efficacy, safety, such as ginseng, liver extract, Vitamin E, and nimesulide; irrational combinations of antibiotics, which lack therapeutic justification; Many irrational FDCs - only 65 % of the top selling 300 are rational (LOCOST 2012) Need for clear criteria for weeding out irrational and useless medicines
  7. Paracetamol Market
  8. Some other reasons for poor access to the right medicine at affordable prices Aggressive Drug Promotion by drug companies Inducements to doctors Over/under prescribing by doctors Cut Practice
  9. Factors Underlying Irrational Use of Drugs Prescribers lack of education and training. lack of drug information heavy patient load pressure to prescribe generalization of limited beliefs misleading beliefs about efficacy Patients drug misinformation misleading beliefs inability to communicate problems Drug Regulation Chemist Sale of non essential drugs. Over the counter sale of useless drugs availability of non-essential drugs informal prescribers Industry Unethical promotion misleading claims Keeps profit before peoples health IBN News
  10. Pricing Anomalies of India’s Drugs Overpricing Profit margins can be up to 4000 percent Different brands of same drug sell at vastly different prices Most drugs out of Govt price regulation
  11. For example if doctor has to treat a patient of blood cancer, he may advice the salt Imatinib by various brand names. If he has prescribed brand Glivec a months course will cost Rs.1,24,000/-to the patient. Whereas, the same anti cancer drug, but with a different brand name Veenat costs just Rs.11,400/-. And Cipla supplies the generic equivalent of this drug (@-imitib) at Rs. 8,000/-only, also Glenmarksupplies it for Rs. 5,720/-! All these brands contain the same salt Imatinib, in the same quantity, conform to the same quality standards and are equally effective.
  12. Profitability of Pharmaceutical Industry (Profit Before Tax; as % of Sales)
  13. Market Profile of Anti diabetics
  14. No Antidiabetics in PHCs? In a study done of medicine access in PHCs in tribal areas in Baroda dt, no antidiabetics were found in stock.
  15. Why market cannot decide medicine prices in India? Pharma markets do not work generally – in favour of the consumer Because of asymmetry, no real decision making power of buyer, etc. Because buyers and sellers have different bargaining strengths (info asymmetry) Sellers and doctors decide Buyers (patients) have little or no choice Buyers have to make decision usually under distress
  16. “Competition” does not reduce prices! Same drug is sold at different prices by the SAME company too! Brand Leader often also the Price Leader (costliest drug is most sold). Therefore competition does not automatically bring down the prices. In fact more players seems to result in a range of prices.
  17. Brand Leaders are Indeed Price Leaders
  18. Govt’s Response: DPCO 2013/NPPP 2012 All 348 drugs in NLEM 2011 under price control Ceiling price: simple avg price of prices of brands with more than 1 % mkt share Touches 12-15 % of the mkt of Rs 72000 crores. Leaves most FDCS and other formulations untouched Escape hatches: combinations, non-standard dosages Most ceiling prices are still in the range of 200 to 4700 % margin
  19. Our Prayersas of August 2013 Essential drug list to be expanded to more than 348 Combinations shld also be under price control Cost based price control than market based price control All irrational medicines should be removed Only rational drugs marketed in India Free drugs for all in public sector Govt use CL on essential drugs under patent
  20. Generic = Brand?
  21. Equivalence of Generic Drugs and Brand Name Drugs The study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand name counterparts and no evidence was found that branded cardiac drugs worked any better than generic heart drugs Source: Kesselheimet al. Clinical equivalence of generic and brand name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008;300(21)2514-2526
  22. Generic and Innovator Drugs Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT, Yang Y, Yu LX, Woodcock J. Ann Pharmacother. 2009 Oct;43(10):1583-97. doi: 10.1345/aph.1M141. Epub 2009 Sep 23. OBJECTIVE: To evaluate how well the bioequivalence measures of generic drugs approved in the US over a 12-year period compare with those of their corresponding innovator counterparts. CONCLUSIONS: The criteria used to evaluate generic drug bioequivalence studies support the FDA's objective of approving generic drug formulations that are therapeutically equivalent to their innovator counterparts.
  23. Generic Drugs: Problems Quality Bioequivalence/bioavailability issues At present Bioequivalence of generics is only a problem of some 40 medicines like warfarin, digoxin, carbamezipine. In general in vitro BA tests (like dissolution) plus compliance with IP parameters is considered good enough.
  24. Bioequivalence Curves
  25. Biological Patent Cliff
  26. Generic Name Drugs are Cheaper Cheaper does not mean lower quality.  Generic manufacturers are able to sell their products for lower prices because they are not required to pay for costly advertising, marketing, and promotion.  In addition, multiple generic genericcompanies are often approved to market a single product; this creates competition in the market place, often resulting in lower prices.
  27. Case Studies Public Health System: Govts of Tamil Nadu, Kerala, Rajasthan, Gujarat Jan Aushadhi, Jeevandhara Scheme Not for profit sector: LOCOST, Vadodara CMSI, Chennai
  28. Some features of TNMSCTamil Nadu Medical Services Corporation

    260 drugs in its EDL (2011-12) Surgicals 75 items, sutures 113 items 21 fast moving drugs account for 80 % of procurement budget ‘Speciality” drugs 292 (2010-11) - 10 drugs account for 85.6 % One drug – Temozolamide caps - 52 % CAT scan and X Ray centres 21 % of popln utilization in 2001-02 (currently 40 %) Services top to bottom level of care Drugs are free (Source partly: MaulinR.Chokshi. TN Drug Procurement Model, Nov 2008, WHO-SEARO)
  29. TNMSC: Scan Centers At present 45 nos. of single slice CT scan centers in the Government Hospitals all over the State (min. 1 CT scanner in each dist.) and 4 slice CT scanners one each at Govt. General Hospital, Chennai, ICH & Govt. Hospital for Children, Chennai are in operation. 45 scan centers Category Plain With Contrast Inpatients Rs. 350/- Rs. 550/- Outpatients Rs. 500/- Rs. 700/-
  30. TNMSC: Other Supportive Services MRI scan centers in 9 govt hospitals: Rs 2500 (plain); Contrast: Rs 1500 extra Lithotripsy Regional diagnostic centers Sale counter at Chennai for: Cyclosporin Cap. USP 2. Cyclosporin Oral Solution USP 3. Anti Snake Venom Serum IP 4. Human Insulin (Short acting) 5. Human Insulin (Intermediate acting) Lab Services
  31. 25 warehouses
  32. Inside Warehouse at Sivagangai
  33. STORAGE STORAGE 34 District Drug Warehouses for proper storage.
  34. Q.C. QUALITY ASSURANCE All drugs received are stored in quarantine area. Sample are sent to QC cell at RMSC head office. Samples are coded & sent to empanelled labs. Examination of samples is carried out as per pharmacopeias. If sample is found “as of standard quality” then only drugs are issued to hospitals. Video – QC Lab
  35. The Spread of RMSC RMSC Along with 71 National Program Drugs supplies by GoI
  36. A positive side effect! Generics advertised by pvt pharmacists!
  37. Some Comparisons
  38. MRP for 10 tabs Rs. 27.50 Rs. 39.30 Rs. 31.50 Purchase price for 10 tabs Rs. 2.02 Rs. 23.70 Rs. 2.27 ManufacturerisCipla for all the three brands One branded & Two generic Generic Branded Generic To search low cost branded drugs, please visit : www.rmsc.nic.in, www.rmsc.co.in or www.tnmsc.com
  39. Enabling Legislations-1
  40. Enabling Legislations- 2 Tamil Nadu Transparency in Tenders Act, 1998 (Tamil Nadu Act 43 of 1998) and Tamil Nadu Transparency in Tenders Rules, 2000. The Act and its Rules have clear and illustrative provisions covering the entire procurement cycle which the TNMSC follows. Need for something similar in Gujarat – the Gujarat Public Health Act needs to be passed
  41. Necessities For MAKING MEDICINES AFFORDABLE Generic prescribing Adoption of essential drugs list Standard Treatment Guidelines Centralized drug procurement : open tender system Distribution of Low cost drugs through Govt. drug counters Public awareness and demand generation
  42. If drugs are made available free in public health services? People seeking tt in public health facilities will increase Decrease in patients going to pvt practitioners and retail drug shops And get less exploited Decrease in related indebtedness, impoverishment
  43. HLEG Recommendations Scale Up Public Spending on Drugs (0.4% GDP): Expected to reduce OOP; Strengthen Public Procurement System: Supply quality generic drugs and enforce rational use; Centralised Procurement & Decentralised Distribution System; Warehouses at every district level; Retail outlets can be set up (or contracted-in) atleast one at every block level and 4-5 at district headquarters. Drug supply to such stores linked to centralized procurement at state level, so that drugs are of equal quality & costs are minimized by removing intermediaries.
  44. Key Characteristics of an Efficient & Reliable Procurement & Distribution System Atleast 15% of public funds; Procure EDL medicines (National and state level EDL at three levels; periodic revisions); Traditional medicines list; Prescription and Dispensing through STGs; A two-bid open transparent tendering process; A 2 passbook system; Warehouses at every district level; An Empanelled laboratories for drug quality testing; Enactment of Transparency in Tender Act; Prompt Payments; Prescription audits & social audits;
  45. Indicators of Success for Centralised Procurement No out of stock at all levels Even specialised medicines procured Patients do not have to go to retail pharmacists Increased utilisation of public health facilties Specialised retail shops for snake bites, antirabies No retail shops around hospitals/public health facilties
  46. How much does medicines for all cost? Rs 200 crores TNMSC medicine budget per year approx Under assumptions of about 40 percent of those ill using public health services It costs around Rs 6000 cr Eventually this figure will go to Rs 12,000 cr per year for full utilization Assumption is that these are at TNMSC prices which are very low: 3 to 40 times cheaper than market prices
  47. What are the Barriers to Access to Medicines in Public Health Systems None except in the mind Failure of imagination In this case it does not even take much imagination As the homework has already been done in 2-3 states of India Resistance from pharma and medical lobbies need to be negotiated
  48. Systemic Changes Required in the Run Up to Medicines for all (say by 2020) Right to medicine and health needs to be legislated as a fundamental human right. All essential drugs shld be under price control All irrational medicines should be removed Only rational drugs shld be marketed/approved in India Govt use CL on essential drugs under patent Easy takeover of Indian Pharma companies should be stopped
  49. For more information, contact us at email: locost@sify.com website: www.locostindia.com Ph: 91 265 2830009 91 999 877 1064 (Srinivasan) 91 917 300 0787 (Krishna)
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