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 23/06/09

Financial Times Welcome and Introduction Andrew Jack 23/06/09

A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES 23 June 2009 23/06/09

Growth and Investment Group, DFID Opening remarks Calum Miller 23/06/09

International MeTA Secretariat Brian Elliott 23/06/09

Brian Elliott, Executive Director, International MeTA Secretariat CONSULTATIVE MEETING WITH THE PHARMACEUTICAL INDUSTRY 23 June 2009, London Medicines Transparency Alliance(MeTA) Creating a level playing field in emerging markets

Meeting objectives
To 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 medicines
improve information and increase transparency: on price, quality, availability and promotion
support 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
A dding 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
Pr oviding 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 23/06/09

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
23/06/2009 MeTA

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

International Secretariat, [email_address]
www.MedicinesTransparency.org
23/06/09 MeTA

In Country MeTA – How MeTA works in four pilot countries 23/06/09

Pharmaceutical and Healthcare Association of the Philippines Reiner W. Gloor MeTA 23/06/09

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 Projects
Regular 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)

Pharmaceutical Manufacturers Association of Ghana (PMAG) Paul Lartey MeTA 23/06/09

MeTA – Ghana Formal Launch Establishment of Secretariat 12 th Nov. 2008 10 th 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 23 rd April, 2009
Work plan under development
Website launched
www.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 Sector
Policy
Regulation
Healthcare delivery
Private Sector
- Manufacturing
Distribution
Retail
Other healthcare
Mission hospitals
Private hospitals/clinics
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 1
Professional Associations 3
Pharmaceutical Society of Ghana
Ghana medical Association
Nurses and midwives Council
Governing Council
International Agencies 2
WHO
DFID
Ghana Food and Drugs Board 1
Private Sector 4
Pharmaceutical Manufacturers Association of Ghana
Wholesalers Group PSGh
Retail Group PSGh
Association of Licensed Chemical Sellers
Civil Society Organizations 2
Health Access Network
Media 1
Academic Institutions 2
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?
?

Uganda Pharmaceutical Manufacturers Association Nazeem Mohamed MeTA 23/06/09

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
Lack of Data
Insufficient Skills/technology
Poor patient information
Poor distribution/access
Unfair Competition
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
Medicines Price Survey
On line access to drug information held by National Drug Authority
Create public awareness to control self medication
Promote transparency in planning, provision and accountability of medicines by Govt

Medicines Price Survey
Objective
Provide 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
Objective
Disseminate 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 Sector Future 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!!)

Jordanian Association of Manufacturers of Pharmaceuticals and Medical Appliances Hanan Sboul MeTA 23/06/09

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

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.

Stakeholders in MeTA Council 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/

National Priorities & Workplan for MeTA - Jordan
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 data
B: 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:

Committee I

Committee II

Committee III

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

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

Thank You for your attention
Questions to:
[email_address]
www.japm.com

Epirus Oriol Ramis MeTA 23/06/09

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:
select some one to report back. Flip charts are encouraged
allow 1-2 minutes for personal thinking before engaging in group work.
arguments forbidden
everyone is free to share what he/she wants & everyone is responsible for it.
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

Plenary group feedback discussions MeTA 23/06/09

Peter Stephens, IMS HEALTH Wilbert Bannenberg, Technical Director, MeTA Transparency, data and information to be disclosed in MeTA pilot countries MeTA 23/06/2009

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

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

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)
23/06/2009 MeTA
… 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

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

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

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
MeTA

International MeTA Secretariat Andrew Chetley MeTA 23/06/09

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

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. Affordable prices ACCESS 1. Rational selection 4. Reliable health and supply systems 3. Sustainable financing

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 MeTA

Will poor people in these countries have greater access to medicines? 16/09/2008 MeTA

[email_address]
www.MedicinesTransparency.org
16/09/2008 MeTA

Indian Pharmaceutical Alliance Dilip Shah MeTA 23/06/09

London 23 June 2009 By D G Shah Secretary General Indian Pharmaceutical Alliance Industry Engaging with the MeTA Concept and Principles

Outline of Presentation
Global Experience
Pro–Competitive Policy Framework
Balanced Policy Approach
Indian Experience
IPA: 06/09

Global Experience IPA: 06/09 Prices of ARV Triple Combination : 2000-2003 Source: Sources and Prices of Medicines June 2003, A Joint Unicef, UNAIDS, WHO, MSF Project Prices Per Patent Per Year Originator $ $727 Originator $ 10439 Brazil $2767 Hetero $347 Ranbaxy $295 Aurobindo $209 Hetero $201 Cipla $350 Originator $ $ 931

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

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

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

Balanced Policy Approach
Policy Framework
Short Term & Long Term
Cost v/s Quality, Safety, Efficacy
Current Needs & Future Growth
Access & Innovation
IPA: 06/09

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

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

THANK YOU [email_address] IPA: 06/09

Panel discussion and industry feedback MeTA 23/06/09

Andrew Jack – Financial Times Chair MeTA 23/06/09

Panel MeTA 23/06/09

MeTA International Advisory Group Sophia Tickell MeTA 23/06/09

Indian Pharmaceutical Alliance Dilip Shah MeTA 23/06/09

American Pharmaceutical Group Workstream Chris Mockler MeTA 23/06/09

European Generics Medicines Association Rory O’Riordan MeTA 23/06/09

Andrew Jack Summary and Conclusions MeTA 23/06/09

Thank You ! 23/06/09

Me Ta Private Sector Meeting 23 June 2009

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Me Ta Private Sector Meeting 23 June 2009 — Presentation Transcript