30th October 2014, New Delhi

BUSINESS RESPONSIBILITY GUIDELINES FOR PHARMACEUTICAL SECTOR IN INDIA

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Overview of Indian Pharmaceutical Sector Regulatory Environment Key Stakeholders Industry Association – Key role to play Rethinking Business Responsibility – A previous

study by CUTS Mapping of ESG issues in Pharma sector Key issues for consideration

OUTLINE OF PRESENTATION

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Ranked 3rd in volume and 14th in value terms, globally

Expected to grow toUS$55bn by 2020 Highly fragmented sector > 20,000 firms

(L/M/S) Industry faced with allegations of

malpractice Access to good quality, affordable, essential

medicines is still a challenge

1. INDIAN PHARMA SECTOR: OVERVIEW

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Highly regulated sector: various policies, laws, institutions

Policy/law set at national level and implemented by state

Detailed yet complicated regulatory framework (N & S legislation/institutions)

Little or no coordination between regulatory agencies Stringent GMP enforcement (Schedule M, D&C Act

1940) Strict government price regulation (DPCO, 2013)

2. REGULATORY ENVIRONMENT

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Government (MoHFW, DoP0, CDSCO, State FDA)

Pharmaceutical firms Pharma Associations – crucial role to play Healthcare providers (Doctors, Hospital ) Pharmacists Patients/consumers

Key Stakeholders

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National-level Associations:- Indian Pharma Alliance (IPA)- Indian Drug Manufacturers Association

(IDMA)- Bulk Drug Manufacturers Association

(BDMA) - Org of Pharma Producers of India (OPPI)- Confederation of Indian Pharma Industry

(CIPI) State associations also present in many states No institutional basis for interaction: Nat &

State Assocn

3. PHARMA ASSOCIATIONS – KEY PLAYERS

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Awareness of legislations good, but compliance often weak

No institutionalised process of Interaction between sectoral association and government/regulators

Sectoral associations not responsible for monitoring behaviour of members --Co regulation – one of the mechanism to ensuring better compliance

Sectoral analysis of pharma sector (key issues and corresponding NVG Principles) – in the matrix form

Findings of a previous CUTS study (BRCC)

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GOAL & PURPOSE Key goal (pharmaceutical sector): provide good quality

medicines at affordable price High public interest element, unlike other sector(s) Output from industry used as input for health sectorNATURE OF SECTOR High private participation for providing public goodCo-REGULATION An opportunity for industry and government to play

complementary roles Guidelines/Codes in existence Associations are interested Industry led guidelines, for better buy-in

4. WHY NVG FOR PHARMA SECTOR?(NATURE & READINESS)

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Juxtaposing Critical Issues pertaining to the Pharmaceutical Sector on the NVGs

Framework

Mapping of Key ESG Issues in Pharmaceutical

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Refrain from unethical promotion and marketing of drugs

Addressing information asymmetry – for communities, patients, consumers, etc.

Disseminating knowledge and sharing ‘good practices’ by the pharma industry

Encouraging whistle blower policy at firm level Dealings between Pharma companies and

doctors Compliance with relevant laws, regulations

NVG Principle I: Ethics, Transparency & Accountability

[business should conduct and govern themselves with ETA]

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Promote NVGs principles throughout the invert ‘supply-chain’ and ‘contract manufacturers’

Unused/date expired medicines disposal

Drug recalls

NVG Principle II: PRODUCT LIFE CYCLE SUSTAINABILITY

[Business should provide goods and services that are safe and contribute to sustainability

throughout their Life Cycle]

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Training and enforcement of occupational safety standards

Safe handling of chemicals and equipment (GLP)

Presence of employee’s grievance redressal mechanism at firm level

Overall work place safety Gender sensitivity and zero-tolerance

for harassment

NVG Principle III: EMPLOYEES’ WELL-BEING

[Business should promote the wellbeing of all employees]

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Adequate attention to mapping of ‘relevant stakeholders’

Development of a strategy for stakeholder engagement with special attention to: communities at risk, patients, PAP, etc.

NVG Principles IV: STAKEHOLDER ENGAGEMENT

[Business should respect the interests of, and be responsive towards all stakeholders, espacially those who are disadvantaged, vulnerable and

marginalised]

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Well-laid out and communicated policy on ‘Clinical Trials’ – [access to new medicines will be a challenge]

Policy for proper care and compensation in-case of mishaps

Engagement with human rights experts and practitioners for advice

NVG Principle V: HUMAN RIGHTS

[Business should respect and promote human rights]

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Achieving Energy Efficiency Keeping emissions (air) and discharges

(water) within the prescribed standards Management of hazardous wastes Moving towards better water efficient

production

NVG Principle VI: ENVIRONMENT[Business should respect, protect and make

efforts to restore the environment]

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Productive and continuous engagement on relevant policy matters

Support initiatives on key issues viz. Prescription Audit, Rational Use of Drugs, etc.

Pricing

NVG Principle VII: Policy Advocacy[Businesses, when engaged in influencing

public and regulatory policy, should do so in a responsible manner]

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Investing and developing (through R&D) innovative yet affordable medicines

Continue to give adequate attention to production of good quality ‘generic medicines’

Work towards improving access to essential drugs, especially in remote locations

Principle VIII: INCLUSIVE GROWTH[Business should support IG and equitable

development]

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Proper labelling and disposal of medicines

Promotion of ‘rational use of drugs’ Redressal mechanism for customers

Principle IX: CUSTOMER VALUE[Business should engage with and provide value to their customers and consumers in

a responsible manner]

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Prioritization of the key dimensions – environment most critical with second and third order impacts

How is the voice of the patient addressed?

Doctor-pharma company relationship

Clinical trials

Key issues for consideration

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Can we add to the dimensions for each of the principles ?

NVG’s for mid sized companies since they are part of the value chain of the large manufacturers – how should this be structured? Should we go by turnover, standard definition or nature of product/process?

Any other aspects?

Key question for discussions

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How can the industry associations present here offer a way forward for the implementation of the NVG?

How can co-regulation enable?

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THANK YOU