Transcript Promoting Responsible Business in Pharmaceuticals

WELCOME
1
Promoting Responsible Business in Pharmaceuticals and
Private Healthcare Sector
STATE LEVEL STAKEHOLDER DIALOGUE
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
CUTS INTERNATIONAL – RAMAN
DEVELOPMENT CONSULTANTS PVT. LTD.
PRESENTATION ON KEY
FINDINGS: BRCC PROJECTGUJARAT
11th September, 2012
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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
BRCC Project Overview
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Business Regulation and Corporate Conduct - BRCC
Implementers:
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Consumer Unity & Trust Society (CUTS International)
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Norwegian Institute of International Affairs (NUPI)
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Raman Development Consultants Pvt. Ltd. (RDC) – Gujarat
State Partner
Duration: April 2011 to December 2012
BRCC Project
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Sectoral Focus :
Pharmaceutical Sector
 Private Healthcare Sector
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Geographical Focus :
Andhra Pradesh
 Gujarat
 Himachal Pradesh
 West Bengal
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Policy & Regulatory
Framework
Optimal
Practical
Facilitating
Business
Responsible
Ethical
Society
friendly
Environment
friendly
Development
Inclusive
Sustainable
Business Regulation & Corporate
Conduct
Mandatory
Regulation
Guiding
Benchmarks
Government
Conduct
Society
Environment
Objectives of the Project
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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
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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
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Environment Problem :
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Current level of adverse environmental Impact
Why have the regulatory safeguards not worked where there are significant impacts
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What should be done to make these regulation work, so that such adverse impacts
can be minimized?
Marketing & Distribution Problem :
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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
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Environment Problem :
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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:
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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
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Government Department
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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
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IDMA
Indian Pharmaceutical Association
Pharma Export Council
Ahmedabad Chemist Association
Gujarat State Medical Representatives Association
Stakeholders for Pharma Sector
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Industrial Associations
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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
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Government Department
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Medical Associations
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Health and Family Welfare Department
Gujarat Pollution Control Board
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 firmManager/ 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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Status of Field Work
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Particulars
Pharmaceuti
cal Firms
Private
Hospitals
Medical
Representati
ves
Prescription
Collection
Associations
Ahmed Vadoda Bharuc
abad
ra
h
Valsad
Total
40
10
12
13
75
50
10
8
7
75
25
10
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35
135
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10
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145
7
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-
7
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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Findings of Pharma Sector –
Environment Related Inquiry
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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
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RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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)
Too tough Rules &
regulations
Awareness programme (Govt)
14.81
Lack of Government 12.96
support
Regular Interaction with Govt
Lack of awareness
among
firms/association
6.48
Updating firms on recent development
related to technology, Policies,
Regulations (Associations)
No difficulty
22.22
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
%
40.51
27.85
48.39
29.03
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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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Findings of Pharma Sector – Marketing
& Distribution Related Inquiry
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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’
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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%)
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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%).
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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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Findings from Pharma Association..
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India Drug Manufacture’s Association (IDMA) &
& Associated Chambers of Commerce and Industry of
India (ACCII)
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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 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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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Findings of Private Health care sector –
Environment Related Inquiry
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Private Hospital study results
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Coverage of private hospitals under study
Capacity of bed
%
10-30
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31-60
40
61-90
20
>91
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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 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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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 %
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33.33% reported that there is a need for
improvement in BMW rules
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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’
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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Findings of Private Health Care Sector
– Marketing & Distribution Related
Inquiry
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
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:
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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..
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Ahmedabad Medical Association:
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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
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Coverage: 145 prescriptions from different hospitals in
Ahmedabad
In Subscription part:
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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 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
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Findings from Prescription Analysis
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WHO prescribing indicators
Percentage of drugs prescribed
by generic name
Percentage of encounters with
an antibiotic prescribed
Percentage of encounters with
an injection prescribed
Percentage of drugs prescribed
from essential medicines list
Prescription analysis
8.97%
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
42.75%
28.96 %
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 sector
 Combination of negative and positive incentives for firms for
compliances to rules and regulations
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RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Thank You
49
RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Status of Field Work
Respondents
Total
Not
Not
Contacte
Intereste Answered
Interest
d
d/Visite
after
ed to
(Phone/E
d
Appointm
talk
mail)
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