Me Ta Private Sector Meeting 23 June 2009

MeTA Consultative Meeting with Pharmaceutical Industry

A LEVEL PLAYING FIELD IN EMERGING MARKETS:

IMPROVING ACCESS TO MEDICINES

23 June 2009

10/04/23

Financial Times

Welcome and Introduction

Andrew Jack

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A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES

23 June 2009

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Growth and Investment Group, DFID

Opening remarks

Calum Miller

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A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES

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International MeTA Secretariat

Brian Elliott

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Brian Elliott, Executive Director, International MeTA SecretariatCONSULTATIVE MEETING WITH THE PHARMACEUTICAL INDUSTRY 23 June 2009, London

Medicines Transparency Alliance(MeTA)Creating a level playing field in emerging markets

7

Meeting objectivesTo inform, consult, engage with and receive feedback from the pharmaceutical industry on MeTA’s concepts, principles and operations – especially MeTA’s aspirations

to promote and encourage ethical business practices and fair competition in developing country pharmaceutical markets through transparency

that this process will lead to increasing access to essential medicines in these markets

What is MeTA? International multi-stakeholder alliance to promote dialogue and encourage and support change.

Country support through the MeTA International Secretariat, funds from DFID, and technical assistance from partners.

•Multi-stakeholder alliances in seven pilot countries to focus on what can be done to:

increase access to quality medicinesimprove information and increase transparency: on price, quality, availability and promotionsupport stronger governance and more accountability

MeTA Core Principles Governments are responsible for providing access to

health care, including access to essential medicines Stronger and more transparent systems and improved

supply chain management will increase access increasing equitable access to medicines improves

health and enables other human development objectives to be achieved

Improved information about medicines can inform public debate, and provide a basis for better policy

A multi-stakeholder approach that involves all sectors – private, public and civil society - will lead to greater accountability

MeTA’s goal MeTA’s overall goal is to increase

access to essential medicines for the poorest of the poor in developing countries

MeTA proposes that a fundamental and key condition for this goal to be achieved is the creation of a level playing field for ethical pharmaceutical companies, research based and generics, locally and internationally based.

The level playing field Poor patients could afford essential medicines Fake and sub standard drugs eliminated Stockouts and theft in the public sector and leakages from

the public to the private sector controlled High government taxation reduced or eliminated importers, distributors, wholesaler and retailers margins

curtailed Registration and regulatory procedures streamlined Medicines rationally prescribed Ethical codes and promotion standards observed IP rights protected as described under TRIPS - country's

legitimate need for processes to obtain fair access to essential medicines recognised

The benefits of a level playing field Fair competition Higher volume sales Accurate market information

Not just another ATM initiative

Not reinventing the wheel Adding value to existing country

ATM efforts through transparency and multi-stakeholder working

Testing the approach in different country settings,

Actively engaging stakeholders at country and international levels

Providing a validated model for further countries.

Not just another attack on pharma prices

MeTA’S multi-stakeholder process calls for

Transparency and progressive disclosure of data and information on quality, price, availability and promotion into the public domain

Full transparency around all of the barriers to access in the 7 pilot countries

Discussion, assessment, evaluation and analysis of these data and information by three stakeholder groups in a structured and collaborative setting in each country.

The scope of MeTA

•Currently 7 pilot countries•Possibility of expansion to others after evaluation of pilot

MeTa Country commitments Establish an effective multi-stakeholder

forum and strengthen stakeholder capacity to engage

Progressive disclosure of data in four areas

Quality Availability Price Promotion Private Sector Consultation identifying the

key private sector stakeholder groups and suggesting private sector priorities to inform an overall strategic direction for MeTA

MeTA in-country progress

Ghana Jordan Kyrgyzstan Peru Philippines Uganda Zambia

Stakeholdersengaged

Yes Yes Yes Yes Yes Yes Yes

MeTA Councilformed

25 14 tbc 15 24 12 30

Govt to GovtAgreement

n.a. Signed Signed n.a. n.a. n.a. n.a.

MeTA Secretariatformed

Yes Yes Yes Yes Yes Yes Yes

Pre-MoU work done Yes Yes Yes Yes Yes Yes Yes

MoU Signed Yes Yes In process Yes Yes Yes Yes

Workplan approved 12 months 12 months 12 months 12 months 12 months 12 months 6 months

Work started Yes Yes Yes Yes Yes Yes Yes

MeTA 10/04/23

23/06/2009MeTA 19

Key implementation challenges

Stakeholder engagement and maintaining interest

Insufficient legislation/regulation and excessive bureaucracy

Difficulties in extracting and accessing information

Lack of tools for analysing and assessing information

Lessons learned in countries Needs to be country-led Time to get the right people at the table and

develop relationships between stakeholders Consensus builds with exchange of views Stakeholder commitment is key Building trust is an essential part of the

initiative. Some problems need tough political action;

starting with less controversial issues is key. Systems and structures for disclosing data

often do not exist and may have to be created.

Key priorities for MeTA

Progressive disclosure of data about medicines Developing and testing a new multi-

stakeholder approach including identifying and trying to fill gaps in the MeTA Councils; preparing stakeholders for meaningful engagement

Ensuring the strong engagement of the private sector at country and international level

Increasing the voice of patients and consumers which involves strengthening capacity and opportunity for their engagement

Documenting innovation, change and good practice across the programme.

MeTA – after the pilot phase

After a successful evaluation in mid 2010, MeTA may include more countries

This means that building fair competition on level playing fields will be in progress in a significant number of countries

Expanded MeTA will require further funding and technical partners

MeTA asks the Pharma industry To support the MeTA principles of transparency and

multi stakeholder dialogue at international level To engage with MeTA at country level:

– Begin the process of progressive disclosure of data and information concerning price, quality, availability and promotion

– Engage with the other stakeholders through the MeTA Councils in the dialogue arising from these disclosures aimed at eliminating barriers to access to essential medicines

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International Secretariat, info@metasecretariat.org

www.MedicinesTransparency.org

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In Country MeTA –

How MeTA works in four pilot countries

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Pharmaceutical and Healthcare Association of the Philippines

Reiner W. Gloor

MeTA 10/04/23 27

MeTA Philippine Projects Strengthened the secretariat; Project

Coordinator and Website Master now on board

Developed the MeTA Philippine website ( www.metaphilippines.org.ph)

Organized the Civil Society Group (CSO) and established systems for their inclusion in the MeTA council. CSOs have established CHAT (Coalition for Health and Transparency)

MeTA Philippine ProjectsRegular council meetings to discuss critical

issues on:

~ Cheap Medicine Bill ~ Marketing Practices ~ BFAD Strengthening Bill ~ Final list of work plans

Level of Engagement of Stakeholders

• CSOs have a non-technical perspective of the issues

• MeTA has a responsibility to educate CSOs on the technical and legal aspects of the pharmaceutical business. (Funding from MeTA for CSO still pending)

Role of Pharma Sector In MeTA Key Issues

Get involved in the core processes of MeTA and providing them representation in the Council

Cooperate with and support MeTA in its initiative to extract pharmaceutical information to achieve utmost transparency throughout the supply chain

Besides PHAP, PCIP (Philippine Chamber of Pharmaceutical Industry) is now also a member

Opportunities for the Pharma Sector

MeTA is key to leveling the playing field among pharma companies

Develop a strong culture of ethical marketing in both the private and public sectors (e.g. gov’t procurement)

Opportunities for the Pharma Sector

Support of MeTA objective of transparency and access to medicines will reduce the need for government intervention

MeTA can map out internationally acceptable marketing practices

MeTA & the Pharma Industry - Future Strategy

Call for approval of country work plans

and awarding

Key Questions for Breakout Groups

Should a Maximum Retail Price be imposed at all?

Supreme Court Ruling (exempting registration with BFAD of imported medicines)

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Pharmaceutical Manufacturers Association of Ghana (PMAG)

Paul Lartey

MeTA 10/04/23 37

MeTA – Ghana

Formal LaunchEstablishment of Secretariat

12th Nov. 200810th Sept. 2008 Jan 2009 - June

• Multi-stakeholder group assembled

• Formally inaugurated by Dep. Min of Health

• Launch by Deputy Minister of health

• Excellent media coverage

• Secretariat staffed• CSO/Media training on

23rd April, 2009• Work plan under

development• Website launchedwww.metaghana.org

Inauguration of Governing Council

MeTA – Ghana: Milestones Operating secretariat Standardized data collection tools developed and operating Coordinated data collection/collation system established

– Pricing– Quality– Availability– Rational use

Mechanisms established– Managing and analyzing– Quarterly dissemination

Facilitation of peer oversight across healthcare professions Annual multi-stakeholder open forum

Stakeholders

Public S

ecto

r

-Poli

cy

-Reg

ulatio

n

-Hea

lthca

re

deliv

ery

Private Sector

- Manufacturing

- Distribution

- Retail

Oth

er h

ealth

care

- Miss

ion

hosp

itals

- Priv

ate

hosp

itals/

clinic

s

Advocacy

Groups- Civil Society

Organizations

- Media

Government (Policy) 4– Health– Trade– Finance – Attorney General

Government drug programs 2– GNDP– National Drug Inf. Resource Center

Health Care Providers 3– Ghana Health Service– Christian Health Assoc. of Ghana– Association of Private Medical and

dental Practitioners

National Hlth. Ins. Authority 1Professional Associations 3

– Pharmaceutical Society of Ghana– Ghana medical Association– Nurses and midwives Council

Governing CouncilInternational Agencies

2− WHO− DFID

Ghana Food and Drugs Board1

Private Sector4

‒ Pharmaceutical Manufacturers Association of Ghana

‒ Wholesalers Group PSGh‒ Retail Group PSGh‒ Association of Licensed Chemical

Sellers

Civil Society Organizations 2‒ Health Access Network

Media1

Academic Institutions2

25 Member Council

Level of Engagement

3 Governing Council meetings to date – fully attended– >5 Absentees– Apologies sent

Establishment of sub-committees:– Administration and management– Technical– Advocacy

Obtaining commitment of new Minister of Health Resolution to register as Not-for-Profit Draft Constitution under review

Missing Links? Adequacy of media involvement

– Representatives from Ghana Journalists Association

Representation from major pharmaceutical manufacturers– 70% of medicines are imported– Need to include Reps of Ethical Pharmaceutical Manufacturers

Association?

Ghana Statistical Services– Observer on the Council recruited

Traditional healers Association– To be part of annual open forum

Ghana MeTA secretariat

Staffed and in operation– Located in the premises of the GNDP– Staffing:

– Snr. Technical Advisor– Technical Coordinator– Office Manager– Accountant– Data Analyst

Decision to relocate from MOH– Space constraints– Quest for independence

Pharmaceutical Sector in Ghana

Majority of medicines in the country are imported– ~30% Locally manufactured– ~60% Imported from Asia– ~10% US/EU

Significant problem with fake and substandard drugs– 10 – 30%

Local Pharmaceutical Industry Industry started in Ghana in 1957 35 Companies registered with PMAG Currently supply <30% of the country’s needs Narrow portfolio of medicines

– Analgesics– Haematinics– Antimalarials– 1 ARV manufacturer– 3 Antimalarial manufacturers

Challenges to the Local Industry Key essential drugs (HIV/Malaria) purchased entirely through donor

funds– Requirement for WHO prequalification– No local producer is WHO prequalified

High local cost of production– Access to affordable financing– Cost of utilities– Needed economies of scale

Cheap/fake imports– Copies of innovators– Dumping – Trojan horse gifts– Sub standard drugs

Perception of inferior quality

Opportunities

Survey by ECOWAS and GTZ shows the Ghana industry to be strongest– Relatively more stringent regulator FDB– Quality – GMP compliance– Capacity (<40% utilization)

3 Companies working toward WHO prequalification

Technologically more advanced– First API manufacturing capacity in West Africa– Equipment and facilities upgrading toward compliance

Possible Role of MeTA Transparency around quality of locally manufactured vs.

imported drugs– Collection and dissemination of available data

– Fake’ drugs– Substandard drugs– Adulterated drugs

Encouragement of partnering between local and major pharmaceutical manufacturers– Capacity building as contribution– Capacity utilization of local industry

– Lower cost of local labor for local supply– Capacity utilization for economies of scale

?Key Question

What are the barriers, pros and cons to collaboration between major pharmaceutical

manufacturers and the local industry?

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Uganda Pharmaceutical Manufacturers Association

Nazeem Mohamed

MeTA 10/04/23 52

Uganda Pharmaceutical Market: Dynamics

• 90% of medicines imported and subsidized (India/China)

• Only 6 local manufacturers, working at around 50% capacity

• Educated workforce but with low skill base• Manufacturers unable to access donor funds• High cost of operations (finance, utilities, etc)• Good regulatory authority but lacking resources

Challenges for the Private Sector - Pharmaceuticals

1. Lack of Data

2. Insufficient Skills/technology

3. Poor patient information

4. Poor distribution/access

5. Unfair Competition

6. Insufficient Government Support

Issue: Lack of Data

No data available on;– Product sales, usage, dosage, etc– Therapy area trends, e.g. CVD– Pricing of products at different levels of supply chain– Appropriate use/mis-use of products by consumers

Difficult to attract investors due to lack of transparency of market

Issue: Insufficient Skills/Technology

Science teaching very academic with little industrial experience

Formulation and new product development skills limited

Maintenance of equipment (e.g. HPLC, HVAC) difficult

Regulatory environment getting more stringent!

Need for facilitating technology transfer from MNC’s and others

Issue: Poor Medicines Distribution

5% of population live in cities with 95% of pharmacies!!

Access to a pharmacy or licensed drug store difficult in rural areas

Few pharmacists - most outlets run by traders with no training!!

Medicines for “Public use” diverted to “Private market” (Corruption!!)

Barriers for local Manufacturers

Exclusion from Donor funded procurement (WHO pre-qualification?)

Cheap imports subsidized by source countries Access to technology/skills is limited Variations in Quality of raw material Power shortage/high energy costs, poor

infrastructure ------ high cost of Production! Regulatory authority increasingly stringent

Recommendations

• Assistance in Technology and Skill transfer to aid local manufacturers

• Find ways to use Global Fund to procure from local manufacturers (non-tariff barrier)

• Consider centralized raw material sourcing• Consumer education/information on correct use

of medicines• Transparency of Market data to allow growth of

local industry

MeTA Uganda: Structure Council

– Civil Society– Private sector – Government– Rotating Chair

Secretariat– Member from each stakeholder– Coordinator

Meetings– Council, secretariat and stakeholders mtgs

MeTA Uganda: Projects

1. Medicines Price Survey

2. On line access to drug information held by National Drug Authority

3. Create public awareness to control self medication

4. Promote transparency in planning, provision and accountability of medicines by Govt

Medicines Price Survey

ObjectiveProvide an accurate and regular survey of prices and availability of medicines along the supply chain

Deliverables Quarterly pricing/availability surveys Highlight shortages/stock outs Highlight margins at different levels, e.g.

manufacturer, wholesaler, retailer Recommend pricing policy to Govt

On line access to drug information

ObjectiveDisseminate accurate information on registration data base and usage of medicines in the country

Deliverables Electronic on line register of medicines at NDA Capture all imports/exports of medicines Clinical and Pharmacovigilance data

Create public awareness to control self medication

Objective

Empower communities to reduce “abuse” of medicines

Deliverables Awareness campaigns on specific groups of

medicines, e.g. anti-malarials Training for community medicine handlers Media campaigns (radio, street theatre, etc)

Promote transparency in procurement of medicines

Objective

Funds for public procurement of medicines are used correctly

Deliverables Evaluate the implementation of the Health

Sector Plan (Global Fund, etc) Recommendations for improvement

Private Sector & MeTA

Private Sector Needs MeTA Projects

Lack of Data Addressing (pricing/NDA)

Insufficient Skills Not addressed

Poor Patient Information Addressing (HEPS/PSU)

Poor Distribution Partly addressed (MoH)

Unfair Competition Not addressed

MeTA /Private SectorFuture Considerations??

Facilitate access to “experts” willing to help with skill transfer

Create a buddy system with MNC’s to ease transfer of technology

Enable used but valuable equipment to be donated to private sector

Align goals of academia with the private sector (industrial experience!!)

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Jordanian Association of Manufacturers of Pharmaceuticals and Medical Appliances

Hanan Sboul

MeTA 10/04/23 69

OUTLINE

Brief on Jordanian pharmaceutical industry  Brief on MeTA project in Jordan Structure of MeTA in Jordan, who is at the table, and

who is not but should be key priorities for MeTA Jordan, workplan Role of pharmaceutical sector in MeTA Key issues, and

how MeTA will benefit the sector Challenges

Jordanian Pharmaceutical Industry

Started in 1962

16 companies, 17 branches outside Jordan

Export oriented; to 66 export markets. Major export markets are Saudi Arabia & Algeria

Local market share; 50% in volume & 28% in value

Essential for Jordan economy; employment & export

Strategic alliances with international firms

Among the Jordanian industry’s objectives

Making medicines available and affordable Addressing fundamental inefficiencies in the

pharmaceutical market Increasing transparency and accountability in

medicines supply chains

Leveling the playing field &achieving transparency in medicines

72

MeTA initiative: DFID/ UK in collaboration with WHO & WB

Consultations in Jordan in 2007 resulted in design & plan for a country- led MeTA. MeTA council in Jordan started in May 2008 and held official launch in May 2009.

73

Stakeholders in MeTA Council

74

WHO DFID WB

Jordan MeTA Secretariat

Location- hosted by the High Health Council Staffing: pharmacist, administrative officer and

accountant Website: national website under construction

http://www.medicinestransparency.org/meta-countries/jordan/

75

National Priorities & Workplan for MeTA - Jordan

76

• MeTA Council developed a workplan within a framework with integration / collaboration of all the players in the Jordan pharmaceutical sector

• The framework is based on the structure of the National Drug Policy (NDP) 2002 document

• Workplan consists of following elements:A: Baseline dataB: Three working groups

A: Baseline Data Activities to generate baseline data within MeTA workplan to be

shared amongst MeTA stakeholders:

Private Sector Mapping (conducted March 2009)

Supply Chain Mapping (conducted April 2009)

WHO Level II Pharmaceutical Sector Assessment - includes household and health facility surveys on price and availability (ongoing)

Drug Utilization database - CSO Alliance (planned July-Dec 2009)

Data/findings will be disclosed on Jordan MeTA website & discussed in Public Forum October 2009

B: Three Working Committees:

78

Committee I

79

Committee II

Committee III

81

Role of Pharmaceutical Sector in MeTA Key Issues How will MeTA benefit the Sector?

Be active in the transparency process, active representation

Learn how to benefit from the transparency, requires capacity building for the sector

Do studies on impact of transparency related measures on accessibility and affordability of medicines, may include: outcomes in public procurement, monitoring of promotional activities

82

Challenges

Willingness of the private sector to share information, such as information related to prices, promotional activities and quality

Building capacity of private sector to actively get engaged in the process

83

Thank You for your attentionQuestions to:

info@japm.com

www.japm.com

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Epirus

Oriol Ramis

MeTA 10/04/23 86

GROUP WORK

Predefined small group discussion.

Increases the chances of contrasting views.

Facilitates dialogue

Method: Small groups directed to look for answers to one question:

1. select some one to report back. Flip charts are encouraged2. allow 1-2 minutes for personal thinking before engaging in group

work.3. arguments forbidden 4. everyone is free to share what he/she wants & everyone is

responsible for it.5. allow time for each participant to talk (45 minutes/9= 5 minutes)

Facilitation to help the group to do the task

Temporary organisation likely to experience some of the MeTA tensions and hence becoming material to be explored.

Q1: Pricing Do you see a role for MeTA in the clarification

(through data disclosure) of the supply chain in countries as a way to ensure a more rational and sustainable pricing systems? What would you be expecting, as a private sector actor, from MeTA?

How do you think the manufacturing industry could help MeTA?

Q2: Quality

MeTA is concerned in setting up local interventions to support the eradication of fake and substandard drugs in these markets through more transparency and improved national regulation and other interventions.

To what extent do you think that can be effective? What meaningful actions do you suggest?

Q3: Availability

Drugs availability is often described as a/the major problem in most countries.

Supply chains and local manufacturing are weak. What would you expect for an initiative as MeTA to contribute? And, how do you think the private sector could also contribute?

Q4: Ethical Practices

Unethical practices prevent both a good functioning market and an efficient and equitable supply chain.

Do you see opportunities for MeTA to contribute effectively to the eradication of these practices in developing economies and to the chronic disruptions (including leakages) of public and private supply chains?

Rooms

Room 1: Council Chamber Room 2: Censor Room Room 3: Linacre 1 room Room 4: Linacre 2 room

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Plenary group feedback discussions

MeTA 10/04/23 95

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Peter Stephens, IMS HEALTH

Wilbert Bannenberg, Technical Director, MeTA

Transparency, data and information to be disclosed in MeTA pilot countries

MeTA 23/06/2009 97

MeTA’s Focus MeTA’s focus will be on strengthening developing

country capacity to collect, analyse, disseminate and use data on medicine quality, availability, pricing and promotion.

We work in a multi-stakeholder approach This will help improve transparency and accountability

around the way medicines are selected, regulated, procured, distributed, supplied and then prescribed to and used by patients.

MeTA 98

What is IMS HEALTH? Trusted source of pharmaceutical intelligence 104 countries, 130,000 suppliers, 730,000

outlets Billions of transactions, >60 million anonymised

longitudinal patient records, 260 million consultations world-wide per annum

Used by supply chain, manufacturers and regulators

Why does IMS want to help MeTA?

Corporate strategy Corporate responsibility

Transparency

Coverage

History

How has or can IMS help MeTA?

Data– Peru

Capacity strengthening on a not-for-profit basis– Sub-Saharan Africa

Trusted Third Party– To minimise business risk and open up opportunities for all stakeholders, including IMS

What will help tip the balance in favour of disclosure? Active encouragement by principals of importers to

share data Dissemination and analysis of import data Opportunities versus risk modelling for public & private

supply chains– Based on understanding real market conditions; analysis

outside Gov’t Validation of outlet survey data using actual sales data

– Needs only partial disclosure; policy based on real information

Transparency?

Improving information access, scrutiny and use, in order to support the development of viable, efficient medicines markets and supply systems that benefit all developing country consumers– Transparency = not only disclosure of the price,

quality, use, availability of medicines; but also: – how to use the information to identify barriers, and

to agree on solutions

23/06/2009 MeTA 103

23/06/2009 MeTA 104

Key data collected in MeTA[Mainly through disclosures by stakeholders] Price data of medicines

– Procurement prices (~ MSH Intl price indicator)– Retail prices private, public sector (~WHO/HAI methodology)– Components (tax, VAT, margins, profit etc)

Quality and registration status– Medicines, GMP plants, GDP wholesalers, Licensed outlets

Availability (basket) Promotion (being developed)

…for each area:• Policy• Practices• Outcomes?

Contextual information collected

[From surveys rather than from disclosures] Supply chain operations

– Supply chain mapping data Affordability

– Generic utilization data, cost of treatment (related to salary) Equitable access

– Data on health and medicines expenditure by income group, and experiences of treating key illnesses by income group.

Rational use– Household survey data, prescribing data in health facilities

23/06/2009 MeTA 105

Who should disclose what? Government: VAT, taxes, budget, selection,

quantification, Procurement agency: purchase & selling prices DRA: quality and registration data, inspection, QC

lab results Private sector: prices, margins, availability,

promotion codes of conduct Civil society / academics: Availability (equity),

Affordability, Rational use

23/06/2009 MeTA 106

What should this lead to?

Better information to the sector & general public

More engagement in MeTA Councils All stakeholders better informed More trust and collaboration between

stakeholders Seeking improved, joint solutions Better access to medicines

– Key hypothesis to be proven!

23/06/2009 MeTA 107

MeTA 108

Thank you!

Wilbert Bannenberg Email: wilbert@metasecretariat.org Mobile: +31-6-20873123 MeTA website: www.MedicinesTransparency.org

Peter Stephens Email: pstephens@uk.imshealth.com Mob: +44-7711-148653 IMS website: www.imshealth.com

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International MeTA Secretariat

Andrew Chetley

MeTA 10/04/23 110

Andrew Chetley

Communication and Capacity Strengthening Director

International MeTA Secretariat

23 June 2009, Consultative meeting with

the pharmaceutical industry, London

Medicines Transparency Alliance (MeTA): The core principles

MeTA 16/09/2008 111

5 key principles

Responsibility for access Role of transparency Importance of equity Importance of evidence-based

policy Mutual accountability through

multi-stakeholder action

16/09/2008 2

1. Responsibility for access

Governments are responsible for providing access to health care, including access to essential medicines

23 June 2009 3

2. Role of transparency

Stronger and more transparent systems and improved supply chain management will increase access

16/09/2008 3

3. Equity

Increasing equitable access to medicines improves health and enables other human development objectives to be achieved

16/09/2008 4

4. Evidence-based policy

Improved information about medicines can inform public debate, and provide a basis for better policy

23 June 2009 6

2. Affordableprices

ACCESS

1. Rationalselection

4. Reliablehealth and

supply systems

3. Sustainablefinancing

5. Mutual accountability through mutli-stakeholder action

A multi-stakeholder approach that involves all sectors – private, public and civil society - will lead to greater accountability

23 June 2009 7

What’s new about MeTA?

“Learning to engage in dialogue means to move from hearing to listening.”

16/09/2008 118MeTA

Will poor people in these countries have greater access to medicines?

16/09/2008 119MeTA

16/09/2008MeTA 120

info@metasecretariat.org www.MedicinesTransparency.org

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Indian Pharmaceutical Alliance

Dilip Shah

MeTA 10/04/23 122

123

London23 June 2009

ByD G Shah

Secretary General Indian Pharmaceutical Alliance

Industry Engaging with the MeTA Concept and Principles

Outline of Presentation

124

Global Experience

Pro–Competitive Policy Framework

Balanced Policy Approach

Indian Experience

IPA: 06/09

125

Global Experience

IPA: 06/09

Prices of ARV Triple Combination: 2000-2003

0

2000

4000

6000

8000

10000

12000

jul/0

0Sep Nov

jan/

01 Mar

May

July

Sep Nov

jan/

02 Mar

May

July

Sep Nov

jan/

03 Mar

Generic Originator

Source: Sources and Prices of Medicines June 2003, A Joint Unicef, UNAIDS, WHO, MSF Project

Originator $ $727

Originator $ 10439

Brazil $2767 Hetero $347

Ranbaxy $295Aurobindo $209

Hetero $201

Cipla $350

Originator $ $ 931

Pri

ces P

er

Pate

nt

Per

Year

126

Global Experience

Lesson from Prices of ARV Triple Combination

Predictability of Demand

Sustainability of Funding

Economy of Scale

Single Regulatory Approval

Transparency in Procurement

Multi-Sources of Supply

IPA: 06/09

127

Pro-Competitive Policy Framework

Creating Conditions for Affordable Medicines

Augmenting Supply

Encouraging New Entrants

Reducing Risks – Stability of Policy

Rewarding Enterprise

Weighing Cost v/s Benefits

IPA: 06/09

128

Pro-Competitive Policy Framework

Barriers to Affordable Medicines

Multiple Regulatory Approvals

Fragmented Capacities

High-Risk Business

Over Regulation of Industry

Single Source of Supply

IPA: 06/09

129

Balanced Policy Approach

Policy Framework

Short Term & Long Term

Cost v/s Quality, Safety, Efficacy

Current Needs & Future Growth

Access & Innovation

IPA: 06/09

130

Indian Experience

Lessons from Drugs (Prices Control) Order, 1979

Shortages/ Black Marketing of Medicines

Emergence of Spurious & Counterfeits

Slowdown of Investment

Statement from 1986 Drug Policy

“Creating an environment conducive to new investment into the Pharmaceuticals industry, to encouraging cost-effective production with economic sizes and to introducing new technologies and new drugs”.

IPA: 06/09

131

Indian Experience

Lessons from Drugs (Prices Control) Order, 1995

Abundance of Medicines Except Price Controlled Products

Intensely Competitive Market

Robust Growth

Innovations in Delivery Mechanism

Quality & GMP – Differentiator from Others

IPA: 06/09

132

THANK YOUdgshah@vision-india.com

IPA: 06/09

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Panel discussion and industry feedback

MeTA 10/04/23 134

Andrew Jack – Financial Times

Chair

MeTA 10/04/23 135

Panel

MeTA 10/04/23 136

MeTA International Advisory Group

Sophia Tickell

MeTA 10/04/23 137

Indian Pharmaceutical Alliance

Dilip Shah

MeTA 10/04/23 138

American Pharmaceutical Group Workstream

Chris Mockler

MeTA 10/04/23 139

European Generics Medicines Association

Rory O’Riordan

MeTA 10/04/23 140

A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES

23 June 2009

10/04/23

Andrew Jack

Summary and Conclusions

MeTA 10/04/23 142

Thank You !

10/04/23