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WELCOME. Promoting Responsible Business in Pharmaceuticals and Private Healthcare Sector STATE LEVEL STAKEHOLDER DIALOGUE. CUTS INTERNATIONAL – RAMAN DEVELOPMENT CONSULTANTS PVT. LTD. PRESENTATION ON KEY FINDINGS: BRCC PROJECT- GUJARAT. 11 th September, 2012. Presentation P oints.

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welcome
WELCOME

Promoting Responsible Business in Pharmaceuticals and Private Healthcare Sector

STATE LEVEL STAKEHOLDER DIALOGUE

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

presentation p oints
Presentation Points
  • 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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

brcc project overview
BRCC Project Overview

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
BRCC Project
  • Sectoral Focus :
    • Pharmaceutical Sector
    • Private Healthcare Sector
  • Geographical Focus :
    • Andhra Pradesh
    • Gujarat
    • Himachal Pradesh
    • West Bengal
slide6

Policy & Regulatory Framework

Business

Development

Optimal

Practical

Facilitating

Responsible

Ethical

Society friendly

Environment friendly

Inclusive

Sustainable

business regulation corporate conduct
Business Regulation & Corporate Conduct

Mandatory

Regulation

Guiding

Benchmarks

Government

Conduct

Society

Environment

objectives of the project
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

key areas of inquiry
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?

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

critical issues in pharmaceutical sector
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
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
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 sector1
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
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
Approach and Methodology

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

status of field work
Status of Field Work

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

findings of phase i pharma firms
Findings of Phase I: Pharma Firms
  • 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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

contribution of the pharma industry to the environmental impacts
Contribution of the Pharma industry to the environmental impacts
  • 33.33 firms discuss it in board room meeting
  • 86.48 % ensure compliance to env. Practice even in outsourcing through contract or encouragement

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

contribution of the pharma industry to the environmental impacts1
Contribution of the Pharma industry to the environmental impacts
  • 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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

social responsibility of pharma firms
Social responsibility of Pharma firms
  • 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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

pharma associations
Pharma Associations..
  • 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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

findings of pharma sector marketing distribution related inquiry
Findings of Pharma Sector – Marketing & Distribution Related Inquiry

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

marketing distribution
Marketing & Distribution
  • 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 reportedawareness on Uniform Code for Pharmaceutical Marketing Practices

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

marketing distribution1
Marketing & Distribution
  • 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’

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

findings from mr study
Findings from MR study
  • 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%)

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

findings from mr study1
Findings from MR study
  • 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 reportedawareness about UCPMP

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

findings from pharma association
Findings from Pharma Association..
  • 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.

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

findings from pharma association1
Findings from PharmaAssociation..

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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

findings from pharma association2
Findings from PharmaAssociation..

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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

findings of private health care sector environment related inquiry
Findings of Private Health care sector – Environment Related Inquiry

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

private hospital study results
Private Hospital study results
  • 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.

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

private hospital study results1
Private Hospital study results
  • 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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

private hospital study results bmw
Private Hospital study results: BMW
  • 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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

private hospital study results bmw1
Private Hospital study results: BMW
  • 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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

private hospital bmw difficulties expectations
Private Hospital: BMW: Difficulties & Expectations

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

private hospital study results2
Private Hospital study results
  • 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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

findings from private health care association
Findings from Private Health care Association
  • Associated Chambers of Commerce and Industry of India (ACCII):
    • Challenges relating to the Private Healthcare and Pharmaceutical Sectorwere 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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

findings from bmw service providers
Findings from BMW Service Providers
  • 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’

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

findings of private health care sector marketing distribution related inquiry
Findings of Private Health Care Sector – Marketing & Distribution Related Inquiry

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

private hospital study results3
Private Hospital study results:
  • 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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

private hospital study results4
Private Hospital study results:
  • 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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

private healthcare association
Private Healthcare Association..

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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

findings from prescription analysis
Findings from Prescription Analysis
  • 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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

findings from prescription analysis1
Findings from Prescription Analysis
  • 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

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

findings from prescription analysis2
Findings from Prescription Analysis

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

emerging m essages
EmergingMessages
  • 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 sector
  • Combination of negative and positive incentives for firms for compliances to rules and regulations

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012

thank you
Thank You

RDC/ CUTS/ BRCC-Gujarat : 11-9-2012