Business Responsibility in the Pharmaceutical and

advertisement
Gunjan
Organisation for
Community
Development
Goal: To stimulate better business to
achieve sustainable development
objectives in India
Objectives:
 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.
 Address the regulatory and operational
constraints faced by businesses in India.
Pharmaceutical
Sector
Private Healthcare Sector
A.
Environment
RESEARCH PROBLEM:
 What is the level of adverse environmental
impact (especially in terms of pollution) from
Pharmaceutical companies in the state?
 Why have the available regulatory safeguards
not worked in places where impacts were found
to be significant?
 What should be done to make these regulations
work, so that there are no such adverse
environmental impacts in future?
B.
Marketing & Distribution
RESEARCH PROBLEM:
What is the current status of incentives
(cuts/commissions) provided by Pharmaceutical
companies to Doctors and Chemists in the state?
 What impact does it have on ‘Rational Use of Drugs’?
 Why have these incentives continued to be provided
by the companies, in spite of regulatory safeguards
being in place?
 What can be done to ensure that companies
undertake their marketing activities keeping in view
the principle of ‘Rational Use of Drugs’

A. Environment
RESEARCH PROBLEM:





What is the current status of bio-medical waste
management practices being followed by hospitals
and diagnostic service providers in the state? If the
situation is problematic, why is it so – in spite of
regulatory safeguards?
How can the situation be corrected?
What have been the steps taken up by the hospital
associations/industry bodies to deal with the
problem?
What are the good practices?
What are the drivers of good practices and how can
these be scaled up or replicated?
B.
Marketing & Distribution
RESEARCH PROBLEM:
 How prevalent is the act of ‘cuts/commissions to
doctors (individuals/in hospitals)’ among diagnostic
service providers in the state?
 Why have these cuts/commissions to doctors
existed in spite of regulatory safeguards in place?
 How to combat the situation? What have been the
efforts of hospital associations and other such
collectives to deal with the problem? What are the
regulatory barriers, if any?
Firms:
 Pharmaceutical firms
 Private health care hospitals
Sectoral Associations:
 Pharma association
 Private hospital Association
 MR association
 Chemist Association
 State level business chambers
Regulators/Government Agencies:
 Government healthcare machinery
 State Pollution Control Board
 Municipal corporations
Other:
 Consumers
 Communities



Fact finding visit was undertaken and on the basis of that
institutions were identified to seek support in research
activities.
Primary advocacy was done during the inception meeting in
which representatives of stake holders were explained about
the research goals, objectives and process.
Research study is being conducted in three phases:
First phase: Questionnaires were filled with
 Pharma firms
 Private hospitals
 prescription audit
Second phase: Questionnaires were filled with
 Pharma associations
 Medical Rep associations
 Chemist associations
 BMW agency
 Hospital associations
Third phase:

State level government agencies like food and drug controller,
SPCB, Environment, Health and family welfare
All the production units are following GMP and they
think that GMP ensures quality products that give
goodwill to the firms and facilitate in getting Govt.
Contracts.
 All the large industries, 56% medium scale and 36%
small scale industries have dedicated Environmental
Management department.
 Most of the small and medium scale industries (77%)
don’t have CSR policies while around 70% large
industries have CSR policy in place.
 None of the firms is aware about the National
Voluntary Guidelines on Social Environmental and
Economic Responsibilities of Business (NVGs).

Around 83% large and medium scale firms
sponsors events (meeting, workshop, seminar,
etc.) for the doctors.
 Though asking whether doctors ask for gift
most of the organisations said no but talking
informally they said this is part of the business.
 Asking about the Code of Medical Ethics
Regulations, 2002 - Medical Council of India
formulated by Medical Council of India (MCI)
around 66% are not aware about it.

 Hospital
association has been initiated with
the objective to create a forum for the
members to discuss technical and
administrative issues and to protect the
rights riteria c and update the knowledge.
 Currently Private Hospital Association of
district Shimla (……) has a base of 70-75
members and any set up run by the
allopathic doctor can be the member of the
association.
 Criteria
to be a member of hospital association is
not well defined and only criteria which has come
up during discussions that any Hospital managed
by allopathic doctors can be the member of the
association.
 No guidelines have been developed so far for the
member hospitals to ensure responsible conduct
from their part.
 Clinical establishment act formulated by GoI and
state government was discussed during the last
meetings.


The Clinical Establishment (Registration and Regulation) Act 2010,
which will be implemented soon in the state, is likely to make life
difficult for private practitioners here as the state has already
given ascent for its implementation.
Private practitioners thinks that

Act had been framed keeping in mind corporate hospitals and health insurance
schemes at the cost of poor patients and doctors doing private practice.

Act prescribed minimum standards for up to 10 bed clinics and
hospitals. If the minimum standards for buildings, equipments and
trained manpower as prescribed in the Act were implemented, the cost
of running 10 bed hospitals would go up to about Rs 3.5 lakh per
month.
The Act also prohibits examination, diagnosis and treatment of
patients at unregistered places which will restrict free medical
camps, eye camps or first aid posts, especially in rural areas.
 Even home deliveries would be illegal.
Heavy penalties proposed in the Act. As it says registration of a
medical establishment can be cancelled if convicted under the Act
and there is no provision for revocation of cancellation.


 Patient’s
satisfaction record is being
maintained by the hospitals, but it was not
very clear to the surveyors, how this was
being done [‘Bell’ story]
 Members of the association are not aware
about the National Voluntary Guidelines on
Social, Environment and Economic
Responsibilities of Business
 There is no interaction with any of the
entities except IMA in last one year.
 Doctors and nurses are working on hybrid
model (Salary + per case payment)
 Doctors
agree that the idea of standard
treatment code will set the framework of
treatment.
 None
is aware about Uniform code for
pharmaceutical Marketing Practices(UCPMP)
 No policy or guidelines have been developed for
the members to ensure rational use of drugs.
 No prescription audit is envisaged so far but
preliminary discussion has been initiated for the
same.
 Association
has not taken action against any
member so far.
 No response was given to identify the factors
which have contributed to the emergence of
unethical behaviour in private health care.
 Association never tried to bring together different
stakeholders (chemist, pharma industries etc.) to
discuss health care related issues like standard
procedure protocols, rational use of drugs and
incentive structures.
 Association
is aware about BMW rules 1998 and
think there is scope for improvement as it is
not being managed professionally and need
capacity building of BMW agencies.
 Irregular services by the agency creates a lot
of problems.
 Encouraging Private agencies might resolve the
challenges faced for the disposal of the biowaste.
 Association
is not aware on National
Voluntary Guidelines on Social,
Environmental and Economic Responsibilities
of Business that have recently been issued by
the Ministry of Corporate Affairs,
Government of India.
 Association interact with State Pollution
Control board as and when any issue comes
otherwise send reports timely to the board.
 Incentives
by Pharma firms and Weak
regulatory framework/institutions dealing with
marketing and distribution factors have
contributed to the present “incentive regime
"in the pharmaceutical industry
 No mechanisms within the association to
monitor the marketing strategy has been
developed so far.
 Marketing spurious medicines, Neglecting the
licensing requirements and Regulatory
adherence are to be considered as major
misconduct.
 Association
is aware of Code of Medical Ethics
Regulations, 2002 formulated by Medical Council
of India (MCI) and is satisfied with its present form
but not aware of the UCPMP (Uniform Code for
Pharmaceutical Marketing Practices).
 As far as level of awareness among the member
firms about regulation and regulatory authorities
related to pharmaceutical industry is concerned,
only few of the bigger firms keep themselves
aware of regulations pertaining to pharmaceutical
industry.
 Sectoral
associations in both pharma and
health care is a weak link in the state.
 There is lack of information about relevant
regulation among the players of both the
sectors.
 State Pollution Control Board has played a
proactive role in the state.
Download