Promoting Responsible Business in Pharmaceuticals and Private Healthcare Sector
Presented on key findings of the BRCC Project in Gujarat, focusing on the pharmaceutical and private healthcare sectors. The project aimed to address regulatory and operational constraints faced by businesses in India and encourage responsible corporate conduct.
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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 PROJECT- GUJARAT 11th September, 2012
Presentation Points 3 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 4 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 Responsible Ethical Society friendly Environment friendly Optimal Practical Facilitating Inclusive Sustainable
Business Regulation & Corporate Conduct Mandatory Regulation Guiding Benchmarks Government Conduct 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
Key Areas of Inquiry 9 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 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 15 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 RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Status of Field Work 16 Ahmed abad Vadoda ra Bharuc h Particulars Valsad Total Pharmaceuti cal Firms Private Hospitals Medical Representati ves Prescription Collection Associations 40 10 12 13 75 50 10 8 7 75 25 10 - - 35 135 - 10 - 145 7 - 7 - - RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
17 Findings of Pharma Sector Environment Related Inquiry RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Findings of Phase I: Pharma Firms 18 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
Difficulties and Expectations of Pharma firms to follow GMP 19 Difficulties % Expectations from Government & Associations % Financial constrains 37.96 Financial support (Govt) 40.51 Too tough Rules & regulations Lack of Government support 14.81 Awareness programme (Govt) 27.85 48.39 12.96 Regular Interaction with Govt 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 RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Contribution of the Pharma industry to the environmental impacts 20 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 21 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 22 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.. 23 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
24 Findings of Pharma Sector Marketing & Distribution Related Inquiry RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Marketing & Distribution 25 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 26 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 27 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 28 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 RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Findings from Pharma Association.. 29 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 Association.. 30 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.. 31 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
32 Findings of Private Health care sector Environment Related Inquiry RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Private Hospital study results 33 Coverage of private hospitals under study Capacity of bed % 10-30 26 31-60 40 61-90 20 >91 14 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 34 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 35 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: BMW 36 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 37 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 38 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 39 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 40 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
41 Findings of Private Health Care Sector Marketing & Distribution Related Inquiry RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Private Hospital study results: 42 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: 43 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.. 44 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 45 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 Analysis 46 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 47 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% 42.75% 28.96 % 58.33% RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Emerging Messages 48 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 49 RDC/ CUTS/ BRCC-Gujarat : 11-9-2012
Status of Field Work Total Contacte d (Phone/E mail) 300+ Not Not Intereste d/Visite d Answered after Appointm ent 15 Interest ed to talk Gate Out Respondents Pharma 200 100 10 P. Hospitals 300+ 150 150 50+ 5 MRs 60+ 20 40 3 0 Hosp. for Prescription 50+ 30 20 7 10 Associations 9 7 2 0 0
