Post on 22-Jan-2015
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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
10/04/23
A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES
23 June 2009
10/04/23
Growth and Investment Group, DFID
Opening remarks
Calum Miller
10/04/23
A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES
23 June 2009
10/04/23
International MeTA Secretariat
Brian Elliott
10/04/23
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
10/04/23MeTA 24
International Secretariat, info@metasecretariat.org
www.MedicinesTransparency.org
A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES
23 June 2009
10/04/23
In Country MeTA –
How MeTA works in four pilot countries
10/04/23
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)
A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES
23 June 2009
10/04/23
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?
A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES
23 June 2009
10/04/23
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!!)
A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES
23 June 2009
10/04/23
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
A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES
23 June 2009
10/04/23
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
A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES
23 June 2009
10/04/23
Plenary group feedback discussions
MeTA 10/04/23 95
A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES
23 June 2009
10/04/23
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
A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES
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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
A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES
23 June 2009
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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
A LEVEL PLAYING FIELD IN EMERGING MARKETS: IMPROVING ACCESS TO MEDICINES
23 June 2009
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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