Access to Medicines-final

8/10/2019 Access to Medicines-final

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Economic barrier to access to medicine


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Access to medicines is critical to the provision ofequitable, affordable, and quality health care inlow and middleincome countries (LMICs).

According to WHO estimates, the meanavailability of essential drugs in LMICs is 35% bypublic sector and rest through OOPE.

Medicines also accounts for a high proportion ofhouseholds outofpocket (OOP) expenses,accounting for as much as 70% of all householdsspending on health care.


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Public Vs. total health expenditure(%of GDP2010-14 ) source :- http://data.worldbank.org/indicator/SH.XPD.PUBL . accessed on 21/12/14

02

468

1012

14161820

public spending aspercentage of GDP

total spending aspercentage of GDP
http://data.worldbank.org/indicator/SH.XPD.PUBLhttp://data.worldbank.org/indicator/SH.XPD.PUBLhttp://data.worldbank.org/indicator/SH.XPD.PUBL


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Spending on drugs as % of total publicbudget on health source:-http://data.worldbank.org/indicator/SH.XPD.PUBL

0%10%

20%30%40%50%60%

70%80%90%

100%

total healthbudget(public)

% spending on drugs


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Access to Medicine


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Per capita expenditure on drugs bystates source:- HLEG report,2011.


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Expenditure on drugs as % of Healthexpenditures


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Distribution of DRUG budget


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Inference

The ratio of private to public spending on drugs in India is4:1.

Skewed priorities in drug spending by state govts., wheresome state (Raj., Orissa..) spent their 90% of budget on

tertiary care on the other hand states like TN.. contributeshalf of drug budget to primary and secondary care. Even SHI fails to protect the population from this CHE

because they cover low frequency high cost treatments,whereas the main drugs spending are on high frequencylow cost treatments.

None of HI covers out patients expenses or gives medicalbenefits.


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Rational Use of Medicines


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What is rational use?

Medicine use is rational (appropriate, proper, correct) when patients receivethe appropriate medicines, in doses that meet their own individualrequirements, for an adequate period of time, and at the lowest cost both tothem and the community

Irrational (inappropriate, improper, incorrect) use of medicines is when one ormore of these conditions is not met.

Worldwide, it is estimated that over half of all medicines are prescribed,dispensed or sold inappropriately.

Irrational use may take many different forms, for example, poly pharmacy,over-use of antibiotics and injections, failure to prescribe in accordance withclinical guidelines and inappropriate self-medication.


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Check list for rational use

WHO/INRUD (International Network for theRational Use of Drugs) indicators:

% medicines from essential medicines list

% treated according to clinical guidelines

% medicines prescribed by generic name

% of diarrhea cases prescribed ORS

% of ARI cases prescribed antibiotics


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Consequences of irrational use

Irrational use of antibiotics(in viral infectionsand diarrhea, OTC sale of AB)

Non adherence to treatment/ development ofdrug resistance

increase morbidity and mortality/ Failure ofpublic health programme.

Wastage of resources


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MDR TB in India

100 private doctors prescribed 80 differentregimes, most of which were inappropriateand expensive(Uplekar,1991)

Only 6 of the 106 respondents wrote aprescription with a correct drug regimen. 106doctors prescribed 63 different drug regimens.There was tendency to over treat with moredrugs for longer durations.(Udwadia,2010).


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Demand for pharmaceuticalsPhysician Make decision on behalf of consumer

Not aware of financial consequences

Consumer Not the decisions maker Bear the economic burden of the

product costs(in absence of insurance)

Third party payer(if any) Not involved in any therapeuticdecisions

Pharmacist Who actually sell product to theconsumer

His choice and decision determines

the economic burden.


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Drivers of irrational use

Pharma industry Top ten products(10% of market sale share)- 2 are irrational

vitamin combination, cough and third is liver tonic ofdubious efficacy.

10/25 belongs to blood tonic, cough expectorant, nonessential drug formulations, analgesics, nutrients etc. eitherhazardous or non essential or irrational

46 banned fixed dose combination (FDC)in Indian market. 1067 FDCs in Indian market by getting approval from state

drug controller by circumventing DCGI.

Market profile of drugs doesn't reflect the disease profile ofthe country

Supply driven demand for many classes of drugs.


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Physiciansdispensing vs. non dispensing doctors

2.38

32% 26%53% 66% 66% 63%

1

1.67

18%42%

61%29%

50%73%

3

0

0.5

1

1.5

2

2.5

3

3.5

dispensing doctors

non dispensing doctors


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National list of essential medicines

those that satisfy the priority health -care needs of the population .

selected with due regard to public health relevance, evidence on efficacy andsafety, and comparative cost-effectiveness.

intended to be available within the context of functioning health systems at

all times in adequate amounts, in the appropriate dosage forms, withassured quality and adequate information, and at a price the individual andthe community can afford.

The implementation of the concept of essential medicines is intended to beflexible and adaptable to many different situations; exactly which medicines

are regarded as essential remains a national responsibility


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Advantages

The list would meet the health care requirements ofmajority of the population.

It is easier to put systems in place for procurement andsupply and monitor their performance if the list of

medicines is not huge. Availability of basic medicines for larger populations

can be better ensured. Quality of medicines can be monitored better.

Doctors, pharmacists and nurses can be betterinformed and educated about the medicines in the list Monitoring of the system can be better done to assess

for procurement, supply, storage, quality and use.


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Availability of EM in states(2005)

34.89% 30%

10% 12.50%3.30% 0%

80%

0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%

budget spent on EDL

budget spent on EDL


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EML towards rational use of drugsIdeal situation Current scenario

Drug and therapeutics committee Not formed in every stateTN ,Kerala and Delhi working in thisdirection.

Formulary and Standard TreatmentGuidelines

Only on papers , not in practice

Good Procurement, Distribution andStorage System for Medicines

Only in TN, Delhi and Rajasthan

Quality Assurance System for Medicines

Health Epidemiological data Lots of data, but never used for makingEDL

Health Economics data For CB ratio


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Generic drugs

Generic drug is a pharmaceutical product,usually intended to be interchangeable withan innovator product, that is manufacturedwithout a license from the innovator companyand marketed after the expiry date of thepatent or other exclusive rights.


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Generic substitution

Empirical evidence suggests that generics savemoney because prices decline post patent expiryand there is fast generic uptake.

Competition after patent expiry leads to lowprices, high generic s penetration and savings tohealth systems.

generic paradox results in market share forboth the branded and the generics in post-patentmarket, with price of branded medicines oftenincreasing rather than decreasing.


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Generic prices and Competition(kansvoos,2008)


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Current scenario in India.


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Problem area the brand scam

Drug makers and pharmaceutical trading agencies create an impressionthat branded generics are vastly superior to unbranded generics (whichare often procured in the public health system and are available topatients free of cost). Even medical professionals consider unbrandedgenerics to be substandard medicines. To add to the confusion, brandedgenerics in India have been artificially divided by academicians andpolicymakers into two categories: branded products, which apparentlyrefer to drugs made by reputed companies and promoted throughdoctors, and so-called branded generics , drugs apparently made by lessreputed companies and promoted through retailers

All drugs in India also have to meet the same requirements with regard toquality, irrespective of whether they are marketed under the INN or tradename, and regardless of the route of promotion.


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Problem area Rx malpractice

For patients to access low-cost generic drugs,it is important that drug companies reducetheir profit margin, pharmacies stock andpromote them and prescribers start writingthem. Although the Medical Council of India'scode of ethics for doctors explicitly mentions

that Every physician should, as far as possible,prescribe drugs with generic names, thispractice is seldom followed.


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Problem area regulatory negligence

Brand name medicines in India cause the cost of treatment to spiral and arealso a frequent but under-reported cause of medication errors. More than60,000 brands exist in the Indian market but there is no registry of thesedrugsIn our clinical practice, almost every day we see dozens of patients who areunable to find the drugs their doctors have prescribed, because the brandname drugs in the prescription they carry are available at only a few selectshops close to their doctor's clinic.The Drug Prices Control Order (DPCO) initially placed price limits on 348medicines deemed essential in India, a number that shrank to just 74 drugsby 1995Most drugs required to treat diseases of public health importance were eitherunderrepresented in this list or were not represented at allThe list did not include vaccines, oral rehydration salts, drugs for cancer orcoronary artery disease, and included very few drugs for respiratory diseases,hypertension, and diabetes


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Problem area market failure

Drugs not listed in the DPCO started gettingcostlier, and the rise in drug prices consistentlyoutstripped the prices of all other commodities

An analysis of the top-selling 300 brandssuggested that 62% of them contained medicinesoutside the NLEM, and of the 115 FDCs only 20%could be considered rational

These medicines and such combinations wouldbe outside the purview of price control, and thiswould reduce the efficacy of price control as anintervention to reduce healthcare-related costs.


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Problem area lack of essentialmedicines in the market

The July 2012 edition of Current Index ofMedical Specialities (CIMS), a prescriberhandbook, does not mention a single

preparation which contains ferrous sulphate inthe dose mentioned in the NLEM 2011 .Hundreds of iron preparations are available inthe market they contain salts with poorefficacy or co-existing with other nutrients(vitamins, minerals including zinc, aminoacids) which do not increase their efficacy


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Problem area - Unnecessary andirrational fixed dose combinations

More than 40% of the formulations in India are composedof FDCs , a proportion which is unprecedented. For examplethe NLEM which lists 348 medicines has only 15combinations of medicines

In India, the FDCs often lack pharmacological justification.India's most widely available antibiotic combination ofampicillin/amoxicillin and cloxacillin is pharmacologicallyirrational , compromises the treatment of staphylococcalinfections because the dose of cloxacillin in the FDC is halfof what it ought to be, and promotes the development ofdrug resistance. The use of other FDCs of antibiotics likeciprofloxacin + metronidazole has contributed to increasingresistance in enteric infections like typhoid fever.


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FDCs often also contain chemicals which lack efficacy but increasethe cost of therapy. For example, an FDC of painkillers withserratiopeptidase, a drug isolated from silkworm intestine, iscommonly prescribed in India. This drug was voluntarily withdrawnfrom the market in Japan by its manufacturer Takeda in 2011, whenclinical trials failed to show evidence of its efficacy compared toplacebo, but continues to be popular in India.

A number of FDCs are downright hazardous. The EuropeanMedicines Evaluation Agency approved Nimesulide only forrestricted and short term use in adults. The agency warned thatcombination of this drug with other painkillers like paracetamol

could adversely affect the liver . Yet, several leading Indiancompanies (Lupin, IPCA, and Dr Reddy's Laboratories) market suchFDCs in India.


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The presence of unnecessary and ineffective drugs makesthe process of drug regulation even more daunting as theauthorities waste their time and resources fixing the pricesor monitoring the quality of preparations which should nothave been manufactured in the first place. For example, theNational Pharmaceutical Pricing Authority has determinedprices for 78 formulations of cloxacillin, a medicine which isunder price control. All these 78 formulations are irrationalas they contain combinations of cloxacillin with variousother antibiotics (ampicillin, amoxicillin, cefixime,

cefpodoxime), and varying concentration of lactobacillusspores (20-60 million)


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Jan aushadi

In november,2008 first store open in Amritsar An ambitious project of government to open stores in all the 612

districts in India. Till date 109 stores in 13 states. For not proper working of the project govt. says it s because of

weak drug supply chain. Lalit Jain, vice-chairman of the Small and Medium Enterprises (SME)

Pharma Industries Confederation, says that companies exclusively producing generic drugs have had a tough time contributing theirdiscount-rate meds . Although 175 of our member companiesexpressed their willingness to supply the essential drugs and alsorun the Jan Aushadhi stores, [the Department ofPharmaceuticals]does not want us [to], he says .(Jayaraman 2010)


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Inference

Generic markets are fundamentally different frombranded markets as they compete as commoditiesrather than innovative, niche products.

The in- patent market rewards innovation , the post patent market creates space for innovation.

Current regulatory framework encourages high pricesfor generics and limits potential savings to the patientand health systems.

Lack of competitive forces limits generic penetration,price reduction and therefore savings.


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Research and developmentR&D


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One of the most important kinds of public goods are thosethat involve the production of new knowledge, especiallythrough investments in research and development (R&D).Since knowledge is non-rival, "meaning that the use ofknowledge by one person does not diminish its availabilityfor others, it makes sense for society to ensure that newknowledge is widely available and actually used. Yet if thefruits of R&D are freely available, profit-maximizing firmswill lack the incentive to invest in R&D in the first place. Thepragmatic approach in balancing the need for availability of

knowledge with the need for private incentives to invest inR&D is to combine two policy instruments: public financingof R&D in combination with patent protection for privateinvestors in R&D.


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Source: Chirac P, Torreele E. Lancet . 2006 May 12; 1560-1561.

A Fatal Imbalance

Tropical diseases:18 new drugs(incl. 8 for malaria)

Tuberculosis: 3new drugs

1.3%21 new drugsfor neglected

diseases98.7%1,535 new drugs

for other diseases

(1975-2004)

Tropical diseases (including malaria) andtuberculosis account for:12% of the global disease burdenOnly 1.3% of new drugs developed


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Some diseases straddle two categories, particularly if treatmentand/or prevention is sensitive to distinct strains in rich and poorcountries. AIDS falls between Type I and Type II , and malaria fallsbetween Type II and Type III. Still, the basic principle that R&D

tends to decline relative to disease burden in moving from Type I toType III diseases is a robust empirical finding. Type II diseases areoften termed neglected diseases and type III diseases very

neglected diseases .


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Malaria accounts for around 3 percent of the total global burden ofdisease , as measured by disability-adjusted life years ( 45 million DALYs outof a world total of 1.4 billion DALYs ), with more than 99 percent of theburden in the developing world. Total biomedical research of the publicand private sectors is estimated to be around $60 billion per year, or $42

per DALY. Malaria research outlays are perhaps $100 million, or $2.2 perDALY. Thus, the malaria R&D per DALY is around one-twentieth of theglobal average. It is notable and disturbing that the premier public-privatepartnership for developing new malaria drugs, the Malaria MedicinesVenture (MMV) , currently disburses less than $10 million per year in

funding .


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Source: WHO- IFPMA Roundtable (Table 11, Priorities Infection Diseases for which additional R&D is required).


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Source:- (Bloeman,2014.)


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Reasons for Global Pharmaceutical companiesoutsourcing R&D to India..!!

ff


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R&D(CRMS) in India in differenttherapeutic areas

Therapeutic class No. of compounds indifferent stages

Metabolic disorder 2

Respiratory disorder 4

CVD 7

Anti- Malaria 1

RA 11

Diabetes-2 9

Anti diarrheal 1

cancer 20

Anti biotic 5

TB 1


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10/90 gap

R&D Pattern reflects the market opportunityrather than global public health priorities.10% spending on public health problems thataccount for 90% of the global disease burden.Most of the research happen in industrializedeconomies


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Source:- (Bloeman,2014.)

f


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PUSH and PULL mechanisms forstimulating R&D on neglected diseases

Source:-(Rand,2011)


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The current scenario in R&D for neglecteddiseases is gloomy.

Despite PPP, soft loans, grants and other

incentives, firms are not showing interest in ND. The success of Open Source drug DevelopmentProgramme also depend upon the willingness ofthe industry in taking product to the market.

The only way out is the revival of public sector,which earlier play a leading role in making Indiaself sufficient in drugs.


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Access to vaccines


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The Vaccines Context

Vaccines are biological rather than chemical products. The productionprocesses that ensure quality and potency are more complex and costly.

Delivery systems, including cold storage, transportation, training andmonitoring are more costly, labor-intensive and must be sustained overyears for some vaccines.

Clinical trials and regulatory approval, particularly for new vaccines, areoften costly and time consuming and can have a different framework.

Copying of vaccines may be more difficult or costly than in the case ofmedicines. The ability to reproduce a vaccine production process oftendepends on know how or trade secrets or tacit knowledge that iswithheld from public documentation such as patent applications.

The overall market for vaccines is smaller than for medicines. The totalvalue from sale of vaccines is below 2% of total sales of pharmaceuticalproducts. Of the global market for new vaccines, a small fraction is indeveloping countries. This acts as a commercial disincentive forundertaking research and development of new products.


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India has traditionally been self-sufficient in vaccine production andis also an exporter of certain vaccines. Despite this, Immunisationcoverage in the country has been extremely limited. Evidence fromthe last two decades, drawn largely from National Family HealthSurveys (NFHS 1-3), shows only a marginal increase in or stagnantcoverage rates of immunisation.10 The Expanded Program ofImmunisation (EPI) covers BCG, Polio, DPT, and measles. FullImmunisation coverage, in children aged 12-23 months, stood at44% in 2005-06 as against 42% in 1998-99. While eighteconomically advanced states reported a decline in Immunisationcoverage rates, a few backward states have reported marginallyimproved Immunisation coverage rates during this period.10However, the recent shortages of vaccines in India created by theshutdown of vaccine producing Public Sector Units (PSUs) haveraised doubts about maintaining self- sufficiency in vaccineproduction, especially for Universal Immunisation Program (UIP)vaccines.

R d ti


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Recommendations

Increase public spending on drugs from current 10% to atleast 30%.

All essential medicines under price control. Essential medicine list at district level.

Strengthening of the public sector to be self reliant in drugsand vaccines. Promotion of rational use of drugs through prescriber,

patient and public education. An institute like NICE for critical evaluation of drugs and

vaccines for inclusion into public health sytem. Transfer the Department of Pharmaceuticals to the Ministry

of Health.


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ReferencesUplekar MW, Shepard DS. Treatment of tuberculosis by private general practitioners in India. Tubercle. 1991Dec;72(4):284-90Udwadia ZF, Pinto LM,

Uplekar MW (2010) Tuberculosis Management by Private Practitioners in Mumbai, India: Has Anything Changed inTwo Decades? PLoS ONE 5(8): e12023. doi:10.1371/journal.pone.0012023

National Commission on Macroeconomics and Health, Government of India. Report of the National Commissionon Macroeconomics and Health.New Delhi: National Commission On Macroeconomics And Health,MoHFW, GoI;2005

Jayaraman, Killugudi. 2010. "Troubles beset 'Jan Aushadhi' plan to broaden access to generics." Nat Med 16(4):350-350.

Bhargava A. The crisis in access to essential medicines in India: key issues which call for action. Indian Journal ofMedical Ethics Vol X No 2 April-June 2013.

Joseph R. The R&D Scenario in IndianPharmaceutical Industry. Working paper. RIS.2011.

Sorenson.C. :Product development partnerships (PDPs) for neglected diseases: considerations on governance.Health Economics, Policy and Law (2009), 4: 1 10 Cambridge University Press 2009doi:10.1017/S1744133108004702.

Mrazek F. :Stimulating pharmaceutical research and development for neglected diseases. Health Policy 64 (2003)75/88.


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Kanavos P, Costa -Font J, Seeley, E. (2008). Competition inoff-patent drug markets.Issues, regulation and evidence.Economic Policy, Vol. 55, July, pp. 498-539.

Planning Commission of India: High Level Expert GroupReport on Universal Health Coverage for India.GoI.2011.

Kotwani A.:Where are we now: assessing the price,availability and affordability of essential medicines in Delhias India plans free medicine for all. BMC Health ServicesResearch 2013.

Watal J. Access to Essential Medicines in DevelopingCountries: Does the WTO TRIPS Agreement Hinder It?

Cullet P.: Amended Patents Act and Access to Medicinesafter Doha. Economic and Political Weekly June 15, 2002.


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Bloeman S.: TRADING AWAY ACCESS TOMEDICINES REVISITED How the Europeantrade agenda continues to undermine access

to medicines.Oxfam, 2014.

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