welcome rdc/ cuts/ brcc-gujarat : 11-9-2012 1 promoting responsible business in pharmaceuticals and...
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WELCOME
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Promoting Responsible Business in Pharmaceuticals and Private Healthcare
Sector
STATE LEVEL STAKEHOLDER DIALOGUE
PRESENTATION ON KEY FINDINGS: BRCC PROJECT- GUJARAT
11th September, 2012
CUTS INTERNATIONAL – RAMAN DEVELOPMENT CONSULTANTS PVT. LTD.
Presentation Points
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A brief introduction to the project A brief introduction to the Approach & methodology Key Stakeholders Findings of Pharma Sector – Environment Related
Inquiry Findings of Pharma Sector – Marketing &
Distribution Related Inquiry Findings of Private health care sector – Environment
Related Inquiry Findings of Private health care Sector – Marketing &
Distribution Related Inquiry
BRCC Project Overview
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Business Regulation and Corporate Conduct - BRCC
Implementers:
Consumer Unity & Trust Society (CUTS International)
Norwegian Institute of International Affairs (NUPI)
Raman Development Consultants Pvt. Ltd. (RDC) – Gujarat State Partner
Duration: April 2011 to December 2012
BRCC Project
Sectoral Focus : Pharmaceutical Sector Private Healthcare Sector
Geographical Focus : Andhra Pradesh Gujarat Himachal Pradesh West Bengal
Policy & Regulatory Framework
Business Development
OptimalPractica
lFacilitat
ing
Responsible
EthicalSociety friendly
Environment
friendly
InclusiveSustaina
ble
Business Regulation & Corporate Conduct
Regulation
Mandatory
Guiding
Benchmarks
Conduct
Government
Society
Environment
Objectives of the Project
Address the regulatory and operational constraints faced by businesses in India.
Motivate firms to adopt ‘Responsible Corporate Conduct’. Evolve a policy discourse between business community
and policymakers to facilitate a policy environment that promotes business development in a sustainable manner.
Thrust: Encouraging responsible corporate conduct and building optimal regulatory framework through focused, informed and continuous discourse among government, business and stakeholders
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Key Areas of Inquiry
Current Situation and gaps Why have the regulatory safeguards not
effective in addressing the gaps? What should be done to make the
regulatory safe guards work? What role is expected from the industry
collectives?
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Critical Issues in Pharmaceutical Sector
Environment Problem :• Current level of adverse environmental Impact• Why have the regulatory safeguards not worked where there are
significant impacts ?• What should be done to make these regulation work, so that such
adverse impacts can be minimized?
Marketing & Distribution Problem :• Current status of incentives provided by companies to doctors and
chemist• Its impact on ‘Rational Use of Drugs’• Why have these incentives continued despite regulations?• What can be done to ensure companies undertake their marketing
supporting rational use of drugs?• Presence of expired drugs in the market? Reasons of presence in spite of
regulations• What should be done to make betterment in the drug supply chain?
Critical Issues in Private Healthcare Sector
Environment Problem :• Current status of bio-medical waste management practices by hospitals and diagostic
service providers • If situation is problematic, explore why it is so despite regulations• How the situation can be corrected• Steps taken by hospital associations/industry bodies• What are the good practices? Drivers of good practices
Marketing & Distribution Problem:• Prevalence of ‘cuts/commission to doctors by diagnostic service providers• Why ‘cut/commissions’ exist in spite of regulatory safeguards?• How the situation can be corrected• Steps taken by hospital associations/other associations• What are the regulatory barriers?• Extent to which Standard Treatment Protocol are followed• Reasons for deviation and other non compliances• How it can be ensured hospitals promote alignment with Standard Treatment Protocols• Adequate measures by HCPs to respect and address diagnosis & treatment related
queries of clients?• Any other self regulatory mechanisms in place?
Stakeholders for Pharma Sector
Government Department Health and Family Welfare Department Gujarat Pollution Control Board Food and Drug Control Administration Commissioner of Industries
Associations of Pharmaceutical Industry including Small, Medium and Large Scale Manufacturers (Formulation and Bulk drug Industries) & Other related stakeholders IDMA Indian Pharmaceutical Association Pharma Export Council Ahmedabad Chemist Association Gujarat State Medical Representatives Association
Stakeholders for Pharma Sector
Industrial Associations Gujarat Chamber of Commerce and Industry Associated Chambers of Commerce and Industry of India (ACCII) FICCI ASSOCHAM Local GIDC Associations District Level Industrial Associations
Academic Institutions Individual Pharmaceutical Firms Civil Society Organizations Media Community residing in proximity of Pharma Units
Stakeholders for Private Healthcare Sector
Government Department Health and Family Welfare Department Gujarat Pollution Control Board
Medical Associations Gujarat Medical Council Indian Medical Association Ahmedabad Medical Association
Private Hospitals Biomedical waste management units Academic Institutions Civil Society Organization Media Consumers availing services of private hospitals
Approach and Methodology
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Respondent Data collection tool Approach
Pharmaceutical firm- Manager/ Director/ CEO/ Accountant
Semi-structured questionnaire & collect best practices documents
Scheduled interview with prior consent on tele-talk/ eMail/ personal visit
Private Hospital- RMO/ Manager/ CEO/ Accountant
Semi-structured questionnaire & collect best practices documents
Scheduled interview with prior consent on tele-talk/ eMail/ personal visit
Medical Representative
Semi-structured questionnaire
Snow balling
Prescription Analysis
Prescription of OPD Patients
Xerox/ Digital photo with consent
Associations Semi-structured questionnaire
Scheduled interview with prior consent on tele-talk/ eMail/ personal visit
Status of Field Work
Particulars Ahmed
abadVadoda
raBharuc
hValsad Total
Pharmaceutical Firms
40 10 12 13 75
Private Hospitals
50 10 8 7 75
Medical Representatives
25 10 - - 35
Prescription Collection
135 - 10 - 145
Associations 7 - - - 7
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Findings of Pharma Sector – Environment Related Inquiry
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Findings of Phase I: Pharma Firms
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Good Manufacturing Process (GMP) 93.33 % firms are aware, 83.08 % respondents all
elements of GMP as below: Disposal of sewage & wastes in conformity with
requirement of SPCB, Standard operating procedures for sampling,
Inspecting and testing of raw materials, Verification of environmental procedures, Filling products in powder form exercised with special
care so as to avoid contamination of environment Filter installed to retain dust and protect the local
environment
Difficulties and Expectations of Pharma firms to follow GMP
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Difficulties % Expectations from Government & Associations
%
Financial constrains 37.96 Financial support (Govt)40.51
Too tough Rules & regulations
14.81 Awareness programme (Govt)
27.85Lack of Government support
12.96 Regular Interaction with Govt
48.39
Lack of awareness among firms/association
6.48 Updating firms on recent development related to technology, Policies, Regulations (Associations)
29.03
No difficulty 22.22
Contribution of the Pharma industry to the environmental impacts
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Type of pollution 1-5 scale (%) 6-10 scale (%)
Air 59.1 40.92
Water 54.85 45.17
Land 76.47 23.52
Hazardous Waster 60.00 40.00
Health problems in community
61.53 38.45
Occupational health 57.89 42.1
• 33.33 firms discuss it in board room meeting• 86.48 % ensure compliance to env. Practice even in outsourcing through contract or
encouragement
Contribution of the Pharma industry to the environmental impacts
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82.86% respondents expects different regulatory laws and implementation according to nature of the unit and size of firms
65.33 % firms does not have dedicated Environment Management Department
98.48 % did not receive any assistance from government
Social responsibility of Pharma firms
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81.43 % firms covered under survey does not have CSR policy
Out of the firms which reported doing some CSR activities, half of them reported doing it out of individual philanthropic sentiments
91.78 % reported being Unaware of NVGs
Pharma Associations..
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India Drug Manufacture’s Association (IDMA)
Large and medium firms highly adhere regulatory compliance of the different segments of the pharma sector in the state while small firms adhere at medium level.
Lack of awareness among firms/ association and financial constraints reported as among major difficulties to adhere regulatory requirements of GMP by firms
Government should consider providing financial support and should keep firms interest also in mind while formulating such regulations
IDMA does interact with government and other stakeholders on different issues of pharma
Findings of Pharma Sector – Marketing & Distribution Related Inquiry
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Marketing & Distribution
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Use of Medical Representatives was reported as a major strategy for M&D by 73.24 % firms
68.42 firms reported awareness on Code of Medical Ethics Regulations, 2002
57.50% of firms reported awareness on Uniform Code for Pharmaceutical Marketing Practices
Marketing & Distribution
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41.18 % firms reported sponsoring events for doctors
77.42 % of firms reported that Doctors ask MRs for gifts during their visits
68.57% firms reported considering it as bad conduct to ask for gifts
40% firms reported indulging into distribution of gifts/incentives in order to maximize profit and gain new markets, while 24.44 % think that it is ‘essential to survive’
Findings from MR study
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80% of MR reported that that meeting with the doctors is primarily a part of marketing strategy
Based on the responses, the value addition through the meetings by MRs can be classified as follows: Information related to new drugs in market
(60%) Information on latest development in
pharma industry (37.14%) Building good relationship between Doctors
and pharmaceutical firms (48.17%)
Findings from MR study
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85.7% MRs reported being asked by Doctors for any kind of gifts/incentives during their visit
Reporting about the motive of asking for gifts/incentives, major reasons reported were: To promote product (54.28%) Giving time to MR to meet (28.51%).
40% MRs reported that it is a regular practice to give gifts to doctors, while 60 % reported that gifts are distributed only on special occasions
54.28 % MRs reported awareness about UCPMP
Findings from Pharma Association..
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India Drug Manufacture’s Association (IDMA) &
& Associated Chambers of Commerce and Industry of India (ACCII)
Both association do not have specific mechanism to monitor marketing strategy of member firms.
Both are aware of Code of Medical Ethics Regulations, 2002 and also were in favor of it
Both association are unaware of Uniform Code for Pharmaceutical Marketing Practices.
Findings from Pharma Association..
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Ahmedabad Chemist Association Incentive regime – reasons are commercial motivation of
doctors and weak regulatory framework Increasing number of companies and number of products is the
main challenge faced by ACA MR's working with different pharmaceutical firms often create
pressure on chemists to increase sale of their products Chemists often sell over the counter (OTC) drugs without
prescription Prescriptions often contain expensive medicines in spite of the
availability of cheaper generic version Aware about Medical Ethics Regulations, (Professional conduct,
Etiquette and Ethics) 2002 formulated by Medical Council of India (MCI) and The Uniform Code of Pharmaceuticals Marketing Practices
Findings from Pharma Association..
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Medical Representative Association Gifts are distributed on regular basis not on only some special occasion. Such gifts are booked by pharma firm under “Gratification” head
Aware about Medical Ethics Regulations & The Uniform Code of Pharmaceuticals Marketing Practices
Incentive regime” in pharma industry is contributed mainly by business strategy of pharma industry, commercial motivation of doctors, and weak regulatory framework
Fix remuneration would be more stable option for MRs Regulatory set-up is not sufficient and optimal enough to ensure responsible and ethical corporate conduct on the part of Pharmaceutical Firms
GSMRA never had interaction with any other body
Findings of Private Health care sector – Environment Related Inquiry
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Private Hospital study results
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Coverage of private hospitals under study
69.33 % of private hospitals reported following some guidelines/code of conduct for providing optimal healthcare service to the patients
79.73% reported maintaining patient satisfaction record and want it be mandatory. Same % of respondents mentioned it to be mandatory.
Capacity of bed %
10-30 26
31-60 40
61-90 20
>91 14
Private Hospital study results
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In term of interactions with SPCB, 53.52% found it as “OK, the way it is”, while 32.39 felt there is a “need for improvement”
In terms of interactions with state health administration and 40.91 % find it as “OK, the way it is” while 33% reported that there is a “need for improvement”
80.82% private hospitals reported that they are not part of any association of hospitals
Private Hospital study results: BMW
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98.65 % private hospitals are aware of BMW rule 1998
Various mode through which the Hospitals manage BMW were found reported as follows: Through private BMW service provider –
78.21 % Though common BMW treatment facility –
17.95 % Stand alone facility in hospital- 1.28 %
33.33% reported that there is a need for improvement in BMW rules
Private Hospital study results: BMW
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Almost all (>99%) the hospitals reported that their staff has undergone the training on BMW. About half of these (50%) reported undergoing process oriented training
82.43% private hospitals reported having some specific mechanism in place to carry out quality assessment of BMW
71.62% hospitals reported submitting periodic reports on BMW management, mainly to SPCB
Private Hospital: BMW: Difficulties & Expectations
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Challenges % Expectations from Government
%
Lack of awareness and training
24.55 Training by SPCB & private hospitals
57.14
High cost charged by BMW service provider/ irregularity
20.00 Modernization of BMW systems
13.10
Difficulties in segregation & Storage
10.91
Private Hospital study results
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65.75 % hospitals reported having a CSR policy in place
89.04% private hospitals reported providing free of cost/concessional treatment to BPL or poor patients
83.10 % hospitals reported no awareness about NVGs
Findings from Private Health care Association
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Associated Chambers of Commerce and Industry of India (ACCII): Challenges relating to the Private Healthcare and
Pharmaceutical Sector were reported as mainly - Nexus between private health care and pharma sector, Increasing cases related to unethical practices from the part of
private health care system Profit oriented approach of private health care sector Lack of regulatory framework to ensure responsible conduct from
private health care sector Aware about NVG and BMW rules For Long term solution of BMW issues Consistent and better
informed government regulations, strict enforcement of regulations and self regulations are key strategies
Findings from BMW Service Providers
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Large hospitals perform “fair” for BMW management while medium and small hospitals perform “poor’
Less willingness of hospitals to manage BMW
Waste received from hospitals are segregated properly
SPCB performance was described as ‘good’
Findings of Private Health Care Sector – Marketing & Distribution Related Inquiry
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Private Hospital study results:
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75. 68 % hospitals reported no awareness about UCPMP
77.03 % reported being aware of Medical Ethics Regulations, 2002
45.71 % hospitals reported having mechanisms in place to ascertain their in-house and/or empanelled doctors follow such guidelines
64.38 % hospitals are in favor of support mandatory prescription audit while 32.88 % are not in favor of it.
83.78 % hospitals reported not having any specific instrument to guide doctors on medicine prescriptions and allowed doctors to prescribe medicine at their discretion
Private Hospital study results:
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60.27 % private hospitals does not have any in-house guideline on Rational Use of Drugs in the hospitals
49.32% hospitals favored mandatory STP for private hospitals while 50.68% did not favor it
75% hospitals reported existence of a nexus between hospitals and pharma industry, necessary for two interdependent business entities.
On questioning hospitals about what they consider as determinants of unethical behavior in private healthcare in state, following major responses were reported: 25.23 % - weak regulatory framework 23.42 % - incentives by pharma firms 22.52 % - commercial motivation of doctors
Private Healthcare Association..
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Ahmedabad Medical Association: The AMA does neither have any state/locality-specific regulatory
instruments (code/manual/guidelines etc.) put in place for the private healthcare providers/doctors to follow nor does they have any monitoring mechanisms to ascertain its compliance
Unaware of NVG and UCPMP, aware of Medical Ethics Regulations, 2002
Lack of communication between government and private hospitals is the key issue faced by Private health sector
AMA does not developed any specific instrument (policy/code/manual/guideline etc.) for its member doctors on medicine prescriptions nor on rational use of drugs
STP should be mandatory for doctors/ private hospitals State health/local health administration should do prescription
audit, and private healthcare sector should disease registry
Findings from Prescription Analysis
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Coverage: 145 prescriptions from different hospitals in Ahmedabad
In Subscription part: Gender and age of patient were mentioned in 13.8% prescriptions Address of the patient was not mentioned in any the prescription T for tablet and Inj for injection mentioned in all Dose of drug was not completely written in 75.8% of prescription Duration of treatment were not mentioned in 84.13% of
prescription Direction of use of drug was not properly mentioned in
77.24%case In all 81.37% prescription were illegible
Findings from Prescription Analysis
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In 37.24 % prescriptions 1-2 drugs were prescribed
In 42.07 % prescriptions 3-4 drugs were prescribed
In 20.69 % prescriptions 5 or >5 drugs were prescribed
Findings from Prescription Analysis
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WHO prescribing indicators Prescription analysisPercentage of drugs prescribed by generic name
8.97%
Percentage of encounters with an antibiotic prescribed
42.75%
Percentage of encounters with an injection prescribed
28.96 %
Percentage of drugs prescribed from essential medicines list
58.33%
Emerging Messages
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Stricter monitoring and effective implementation of rules and regulation by regulators
More, systematic and mandatory efforts for Capacity building of all stakeholders and leadership by state
Systematic efforts to promote increased self regulation with associated sizeable incentives
Industry collectives to take up a more proactive role in effective implementation of regulations
Increased inter-sectoral dialogues for environmental issues due to pharma and private health care firms
Mechanism to curb unethical practices in the sectorCombination of negative and positive incentives for firms
for compliances to rules and regulations
Thank You
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Respondents
Total Contacte
d (Phone/E
mail)
Not Interest
ed to talk
Interested/
Visited
Not Answered
after Appointm
ent
Gate Out
Pharma 300+ 200 100 15 10
P. Hospitals 300+ 150 150 50+ 5
MRs 60+ 20 40 3 0
Hosp. for Prescription
50+ 30 20 7 10
Associations 9 0 7 2 0
Status of Field Work