Medical Affairs in Emerging Markets
How can medical affairs capability be enhanced to unlock the Brazilian, Russian, Indian and Chinese pharma markets?
The pharma markets of Brazil, Russia, India and China (BRIC) are becoming increasingly complex with developments, such as the increasing use evidence-based prescribing, putting medical affairs (MA) teams under pressure. But in BRIC countries a one size fits all approach to MA will not cater for diverse operational, cultural and regulatory environments. Where are the gaps in capability? What are the opportunities for pharma to better embed MA into commercial strategies? How is regulation limiting MA operations? Where should support and investment be targeted?
To answer these strategic questions we interviewed experienced regional and local MA professionals from each country to reveal in Medical Affairs in Emerging Markets- BRIC the specific opportunities and challenges they face.
Local MA experts in each country explore.
Brazil.
'A critical issue in Brazil is not having a forecast of when regulatory agencies will approve clinical trials, new drug applications, or marketing authorisations. The timing of the setting up of MA teams is critical–one needs to optimise costs related to MA departments and weigh these against the benefits obtained from engagements with KOLS and other stakeholders. If a product takes longer than anticipated to be launched, postponing MA resource allocation may strategically benefit the company. Timing is one of the biggest challenges in Brazil.' .
Danilo Guidini Lopes
Daiichi Sankyo
Russia
'Prioritising local suppliers is absolutely true in Russia. This is not a topic of lowest price; rather, the high priority is making the local manufacturer the choice. In my company, anything related to participation in tender interactions is covered by Market Access and KAMs. Medical Affairs do not participate in negotiation activities except in cases where we are asked to provide medical and scientific information to support a particular product.'
Alexandra Safronova
Boehringer Ingelheim
India
'Thought leader management is very important. This is key opinion leader management. I would put it as 15 to 20 percent of the job profile. For each therapy area, MA is responsible for listing the top thought leaders for the company. Each of these people is expected to be engaged in various areas, be it a trial, a survey, or an advisory board. Throughout the year, we work with them. We ensure that the thought leaders are also giving their inputs to us.'
Neeladri Chowdhury
Cipla Ltd
China
'The high turnover rate of qualified and high-skilled medical personnel in a pharma company impacts the consistency and implementation of the MA strategy. This can negatively impact brand image due to lack of loyalty within the scientific community.'
Linshu Shang
Sanofi
What to expect
A detailed report exploring the status, potential and specific challenges of medical affairs in the BRIC economies, based on:
The pharma markets of Brazil, Russia, India and China (BRIC) are becoming increasingly complex with developments, such as the increasing use evidence-based prescribing, putting medical affairs (MA) teams under pressure. But in BRIC countries a one size fits all approach to MA will not cater for diverse operational, cultural and regulatory environments. Where are the gaps in capability? What are the opportunities for pharma to better embed MA into commercial strategies? How is regulation limiting MA operations? Where should support and investment be targeted?
To answer these strategic questions we interviewed experienced regional and local MA professionals from each country to reveal in Medical Affairs in Emerging Markets- BRIC the specific opportunities and challenges they face.
Local MA experts in each country explore.
- What are the roles and involvement of medical affairs teams and how does this differ country to country?
- How significant is stakeholder engagement and what strategies are employed?
- To what degree–and how–does MA support access to healthcare?
- What role does MA play in pricing, reimbursement and tendering negotiations?
- How advanced is MA's capacity for data and evidence generation pre and post launch?
- How effectively is MA using medical education to drive KOL engagement and therapy messages?
- How advanced is the use of digital technology by MA and where is it finding most traction?
- What is the future outlook for MA in BRIC?
Brazil.
'A critical issue in Brazil is not having a forecast of when regulatory agencies will approve clinical trials, new drug applications, or marketing authorisations. The timing of the setting up of MA teams is critical–one needs to optimise costs related to MA departments and weigh these against the benefits obtained from engagements with KOLS and other stakeholders. If a product takes longer than anticipated to be launched, postponing MA resource allocation may strategically benefit the company. Timing is one of the biggest challenges in Brazil.' .
Danilo Guidini Lopes
Daiichi Sankyo
Russia
'Prioritising local suppliers is absolutely true in Russia. This is not a topic of lowest price; rather, the high priority is making the local manufacturer the choice. In my company, anything related to participation in tender interactions is covered by Market Access and KAMs. Medical Affairs do not participate in negotiation activities except in cases where we are asked to provide medical and scientific information to support a particular product.'
Alexandra Safronova
Boehringer Ingelheim
India
'Thought leader management is very important. This is key opinion leader management. I would put it as 15 to 20 percent of the job profile. For each therapy area, MA is responsible for listing the top thought leaders for the company. Each of these people is expected to be engaged in various areas, be it a trial, a survey, or an advisory board. Throughout the year, we work with them. We ensure that the thought leaders are also giving their inputs to us.'
Neeladri Chowdhury
Cipla Ltd
China
'The high turnover rate of qualified and high-skilled medical personnel in a pharma company impacts the consistency and implementation of the MA strategy. This can negatively impact brand image due to lack of loyalty within the scientific community.'
Linshu Shang
Sanofi
What to expect
A detailed report exploring the status, potential and specific challenges of medical affairs in the BRIC economies, based on:
- An examination of the 29 key issues most relevant to MA teams in each country
- 16 targeted questions put to experts in each country working for companies such as Biogen, Boehringer Ingelheim, GSK and AstraZeneca
- Their responses which provided 117 current insights supported by 209 directly quoted comments
- A cross-country comparison of key MA activities within BRIC
- Ana Beatriz Perez do Amaral - Regional Medical Affairs Analyst for the Merck Group, Brazil
- Danilo Guidini Lopes - Medical Affairs Manager at Daiichi Sankyo, Brazil
- Alexandra Safronova - Medical Director at Boehringer Ingelheim, Russia
- Ekaterina Stukalina - Global Medical Affairs Leader, Respiratory, at AstraZeneca, Russia
- Neeladri Chowdhury - Director of Medical Affairs at Cipla Ltd, India
- Sujay Kulkarni - Senior Manager of Medical Affairs and Pharmacovigilance at GlaxoSmithKline, India
- Linshu Shang - Head of Medical Liaison, Haematology and Transplant at Sanofi, China
- Cezary Statuch - VP Medical International Markets for Biogen, Switzerland
- Eric Toppy- National Account Executive for Braeburn Pharmaceuticals, US
- Usman Iqbal - Senior Director of Medical Affairs and HEOR at Trevena, Inc., US
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1. SUBJECT SYNOPSIS
1.1 Sources
2. RESEARCH METHODOLOGY AND OBJECTIVES
2.1 Methodology
2.2 Which experts were interviewed and why?
3. KEY INSIGHTS SUMMARY
4. ISSUES AND INSIGHTS
4.1 Brazil
4.1.1 Identifying the Roles and Levels of Involvement of Medical Affairs in Brazil
4.1.1.1 Issue Summary
4.1.1.2 Questions
4.1.1.3 Key Insights
4.1.1.4 Supporting Quotes
4.1.1.5 Intelligence Exhibits
4.1.1.6 Sources
4.1.2 The Significance of Stakeholder Engagement in Brazilian Medical Affairs Strategy
4.1.2.1 Issue Summary
4.1.2.2 Questions
4.1.2.3 Key Insights
4.1.2.4 Supporting Quotes
4.1.2.5 Sources
4.1.3 The Role of Medical Affairs in Supporting Access to Healthcare in Brazil
4.1.3.1 Issue Summary
4.1.3.2 Questions
4.1.3.3 Key Insights
4.1.3.4 Supporting Quotes
4.1.3.5 Intelligence Exhibits
4.1.3.6 Sources
1.4.The Role of Medical Affairs in Pricing, Reimbursement and Tendering in Brazil
4.1.4.1 Issue Summary
4.1.4.2 Questions
4.1.4.3 Key Insights
4.1.4.4 Supporting Quotes
4.1.4.5 Sources
4.1.5 The Role of Medical Affairs in Data and Evidence Generation in Brazil
4.1.5.1 Issue Summary
4.1.5.2 Questions
4.1.5.3 Key Insights
4.1.5.4 Supporting Quotes
4.1.5.5 Sources
4.1.6 The Importance of Ensuring Robust Medical Education in Brazil
4.1.6.1 Issue Summary
4.1.6.2 Questions
4.1.6.3 Key Insights
4.1.6.4 Supporting Quotes
4.1.6.5 Intelligence Exhibits
4.1.6.6 Sources
4.1.7 The Potential of Digital Advances in Medical Affairs in Brazil
4.1.7.1 Issue Summary
4.1.7.2 Question
4.1.7.3 Key Insights
4.1.7.4 Supporting Quotes
4.1.7.5 Sources
4.1.8 The Future of Medical Affairs in Brazil
4.1.8.1 Issue Summary
4.1.8.2 Questions
4.1.8.3 Key Insights
4.1.8.4 Supporting Quotes
4.1.8.5 Intelligence Exhibit
4.1.8.6 Sources
4.2 Russia
4.2.1 Identifying the Roles and Levels of Involvement of Medical Affairs in Russia
4.2.1.1 Issue Summary
4.2.1.2 Questions
4.2.1.3 Key Insights
4.2.1.4 Supporting Quotes
4.2.1.5 Intelligence Exhibits
4.2.1.6 Sources
4.2.2 The Role of Medical Affairs in Ensuring Healthcare Delivery in Russia
4.2.2.1 Issue Summary
4.2.2.2 Questions
4.2.2.3 Key Insights
4.2.2.4 Supporting Quotes
4.2.2.5 Sources
4.2.3 The Significance of Stakeholder Engagement in Medical Affairs Strategy in Russia
4.2.3.1 Issue Summary
4.2.3.2 Questions
4.2.3.3 Key Insights
4.2.3.4 Supporting Quotes
4.2.3.5 Intelligence Exhibits
4.2.4.6 Sources
4.2.4 The Role of Medical Affairs in Pricing, Reimbursement and Tendering in Russia
4.2.4.1 Issue Summary
4.2.4.2 Questions
4.2.4.3 Key Insights
4.2.4.4 Supporting Quotes
4.2.4.5 Sources
4.2.5 The Role of Medical Affairs in Data and Evidence Generation in Russia
4.2.5.1 Issue Summary
4.2.5.2 Questions
4.2.5.3 Key Insights
4.2.5.4 Supporting Quotes
4.2.5.5 Sources
4.2.6 The Importance of Ensuring Robust Medical Education in Russia
4.2.6.1 Issue Summary
4.2.6.2 Question
4.2.6.3 Key Insights
4.2.6.4 Supporting Quotes
4.2.6.5 Sources
4.2.7 The Potential of Digital Advances in Medical Affairs in Russia
4.2.7.1 Issue Summary
4.2.7.2 Question
4.2.7.3 Key Insights
4.2.7.4 Supporting Quotes
4.2.7.5 Sources
4.2.8 The Future of Medical Affairs in Russia
4.2.8.1 Issue Summary
4.2.8.2 Question
4.2.8.3 Key Insight
4.2.8.4 Supporting Quotes
4.2.8.5 Intelligence Exhibit
4.2.8.6 Sources
4.3 India
4.3.1 Identifying the Roles and Levels of Involvement of Medical Affairs in India
4.3.1.1 Issue Summary
4.3.1.2 Questions
4.3.1.3 Key Insights
4.3.1.4 Supporting Quotes
4.3.1.5 Intelligence Exhibits
4.3.1.6 Sources
4.3.2. The Significance of Stakeholder Engagement in Medical Affairs in India
4.3.2.1 Issue Summary
4.3.2.2 Questions
4.3.2.3 Key Insights
4.3.2.4 Supporting Quotes
4.3.2.5 Intelligence Exhibits
4.3.2.6 Sources
4.3.3 The Relevance of Medical Affairs Strategy in India
4.3.3.1 Issue Summary
4.3.3.2 Questions
4.3.3.3 Key Insights
4.3.3.4 Supporting Quotes
4.3.3.5 Sources
4.3.4 The Role of Medical Affairs in Data and Evidence Generation in India
4.3.4.1 Issue Summary
4.3.4.2 Questions
4.3.4.3 Key Insights
4.3.4.4 Supporting Quotes
4.3.4.5 Sources
4.3.5 The Potential Contribution of Medical Affairs to Pricing Decisions in India
4.3.5.1 Issue Summary
4.3.5.2 Question
4.3.5.3 Key Insight
4.3.5.4 Supporting Quote
4.3.5.5 Source
4.3.6 The Future of Medical Affairs in India
4.3.6.1 Issue Summary
4.3.6.2 Question
4.3.6.3 Key Insights
4.3.6.4 Supporting Quotes
4.3.6.5 Intelligence Exhibit
4.3.6.6 Sources
4.4 China
4.4.1 Identifying the Roles and Levels of Involvement of Medical Affairs in China
4.4.1.1 Issue Summary
4.4.1.2 Questions
4.4.1.3 Key Insights
4.4.1.4 Supporting Quotes
4.4.1.5 Intelligence Exhibits
4.4.1.6 Sources
4.4.2 The Significance of Stakeholder Engagement in Medical Affairs in China
4.4.2.1 Issue Summary
4.4.2.2 Questions
4.4.2.3 Key Insights
4.4.2.4 Supporting Quotes
4.4.2.5 Intelligence Exhibits
4.4.2.6 Sources
4.4.3 The Relevance of the Medical Affairs Strategy in China
4.4.3.1 Issue Summary
4.4.3.2 Questions
4.4.3.3 Key Insights
4.4.3.4 Supporting Quotes
4.4.3.5 Intelligence Exhibits
4.4.3.6 Sources
4.4.4 The Role of Medical Affairs in Data, Evidence and Value Discussions in China
4.4.4.1 Issue Summary
4.4.4.2 Questions
4.4.4.3 Key Insights
4.4.4.4 Supporting Quotes
4.4.4.5 Sources
4.4.5 The Strategic Value of Medical Education in China
4.4.5.1 Issue Summary
4.4.5.2 Question
4.4.5.3 Key Insights
4.4.5.4 Supporting Quotes
4.4.5.5 Sources
4.4.6 The Potential of Digital Advances in Chinese Medical Affairs
4.4.6.1 Issue Summary
4.4.6.2 Question
4.4.6.3 Key Insights
4.4.6.4 Supporting Quotes
4.4.6.5 Intelligence Exhibits
4.4.6.6 Sources
4.4.7 The Future of Medical Affairs in China
4.4.7.1 Issue Summary
4.4.7.2 Question
4.4.7.3 Key Insights
4.4.7.4 Supporting Quotes
4.4.7.5 Intelligence Exhibits
4.4.7.6 Sources
1.1 Sources
2. RESEARCH METHODOLOGY AND OBJECTIVES
2.1 Methodology
2.2 Which experts were interviewed and why?
3. KEY INSIGHTS SUMMARY
4. ISSUES AND INSIGHTS
4.1 Brazil
4.1.1 Identifying the Roles and Levels of Involvement of Medical Affairs in Brazil
4.1.1.1 Issue Summary
4.1.1.2 Questions
4.1.1.3 Key Insights
4.1.1.4 Supporting Quotes
4.1.1.5 Intelligence Exhibits
4.1.1.6 Sources
4.1.2 The Significance of Stakeholder Engagement in Brazilian Medical Affairs Strategy
4.1.2.1 Issue Summary
4.1.2.2 Questions
4.1.2.3 Key Insights
4.1.2.4 Supporting Quotes
4.1.2.5 Sources
4.1.3 The Role of Medical Affairs in Supporting Access to Healthcare in Brazil
4.1.3.1 Issue Summary
4.1.3.2 Questions
4.1.3.3 Key Insights
4.1.3.4 Supporting Quotes
4.1.3.5 Intelligence Exhibits
4.1.3.6 Sources
1.4.The Role of Medical Affairs in Pricing, Reimbursement and Tendering in Brazil
4.1.4.1 Issue Summary
4.1.4.2 Questions
4.1.4.3 Key Insights
4.1.4.4 Supporting Quotes
4.1.4.5 Sources
4.1.5 The Role of Medical Affairs in Data and Evidence Generation in Brazil
4.1.5.1 Issue Summary
4.1.5.2 Questions
4.1.5.3 Key Insights
4.1.5.4 Supporting Quotes
4.1.5.5 Sources
4.1.6 The Importance of Ensuring Robust Medical Education in Brazil
4.1.6.1 Issue Summary
4.1.6.2 Questions
4.1.6.3 Key Insights
4.1.6.4 Supporting Quotes
4.1.6.5 Intelligence Exhibits
4.1.6.6 Sources
4.1.7 The Potential of Digital Advances in Medical Affairs in Brazil
4.1.7.1 Issue Summary
4.1.7.2 Question
4.1.7.3 Key Insights
4.1.7.4 Supporting Quotes
4.1.7.5 Sources
4.1.8 The Future of Medical Affairs in Brazil
4.1.8.1 Issue Summary
4.1.8.2 Questions
4.1.8.3 Key Insights
4.1.8.4 Supporting Quotes
4.1.8.5 Intelligence Exhibit
4.1.8.6 Sources
4.2 Russia
4.2.1 Identifying the Roles and Levels of Involvement of Medical Affairs in Russia
4.2.1.1 Issue Summary
4.2.1.2 Questions
4.2.1.3 Key Insights
4.2.1.4 Supporting Quotes
4.2.1.5 Intelligence Exhibits
4.2.1.6 Sources
4.2.2 The Role of Medical Affairs in Ensuring Healthcare Delivery in Russia
4.2.2.1 Issue Summary
4.2.2.2 Questions
4.2.2.3 Key Insights
4.2.2.4 Supporting Quotes
4.2.2.5 Sources
4.2.3 The Significance of Stakeholder Engagement in Medical Affairs Strategy in Russia
4.2.3.1 Issue Summary
4.2.3.2 Questions
4.2.3.3 Key Insights
4.2.3.4 Supporting Quotes
4.2.3.5 Intelligence Exhibits
4.2.4.6 Sources
4.2.4 The Role of Medical Affairs in Pricing, Reimbursement and Tendering in Russia
4.2.4.1 Issue Summary
4.2.4.2 Questions
4.2.4.3 Key Insights
4.2.4.4 Supporting Quotes
4.2.4.5 Sources
4.2.5 The Role of Medical Affairs in Data and Evidence Generation in Russia
4.2.5.1 Issue Summary
4.2.5.2 Questions
4.2.5.3 Key Insights
4.2.5.4 Supporting Quotes
4.2.5.5 Sources
4.2.6 The Importance of Ensuring Robust Medical Education in Russia
4.2.6.1 Issue Summary
4.2.6.2 Question
4.2.6.3 Key Insights
4.2.6.4 Supporting Quotes
4.2.6.5 Sources
4.2.7 The Potential of Digital Advances in Medical Affairs in Russia
4.2.7.1 Issue Summary
4.2.7.2 Question
4.2.7.3 Key Insights
4.2.7.4 Supporting Quotes
4.2.7.5 Sources
4.2.8 The Future of Medical Affairs in Russia
4.2.8.1 Issue Summary
4.2.8.2 Question
4.2.8.3 Key Insight
4.2.8.4 Supporting Quotes
4.2.8.5 Intelligence Exhibit
4.2.8.6 Sources
4.3 India
4.3.1 Identifying the Roles and Levels of Involvement of Medical Affairs in India
4.3.1.1 Issue Summary
4.3.1.2 Questions
4.3.1.3 Key Insights
4.3.1.4 Supporting Quotes
4.3.1.5 Intelligence Exhibits
4.3.1.6 Sources
4.3.2. The Significance of Stakeholder Engagement in Medical Affairs in India
4.3.2.1 Issue Summary
4.3.2.2 Questions
4.3.2.3 Key Insights
4.3.2.4 Supporting Quotes
4.3.2.5 Intelligence Exhibits
4.3.2.6 Sources
4.3.3 The Relevance of Medical Affairs Strategy in India
4.3.3.1 Issue Summary
4.3.3.2 Questions
4.3.3.3 Key Insights
4.3.3.4 Supporting Quotes
4.3.3.5 Sources
4.3.4 The Role of Medical Affairs in Data and Evidence Generation in India
4.3.4.1 Issue Summary
4.3.4.2 Questions
4.3.4.3 Key Insights
4.3.4.4 Supporting Quotes
4.3.4.5 Sources
4.3.5 The Potential Contribution of Medical Affairs to Pricing Decisions in India
4.3.5.1 Issue Summary
4.3.5.2 Question
4.3.5.3 Key Insight
4.3.5.4 Supporting Quote
4.3.5.5 Source
4.3.6 The Future of Medical Affairs in India
4.3.6.1 Issue Summary
4.3.6.2 Question
4.3.6.3 Key Insights
4.3.6.4 Supporting Quotes
4.3.6.5 Intelligence Exhibit
4.3.6.6 Sources
4.4 China
4.4.1 Identifying the Roles and Levels of Involvement of Medical Affairs in China
4.4.1.1 Issue Summary
4.4.1.2 Questions
4.4.1.3 Key Insights
4.4.1.4 Supporting Quotes
4.4.1.5 Intelligence Exhibits
4.4.1.6 Sources
4.4.2 The Significance of Stakeholder Engagement in Medical Affairs in China
4.4.2.1 Issue Summary
4.4.2.2 Questions
4.4.2.3 Key Insights
4.4.2.4 Supporting Quotes
4.4.2.5 Intelligence Exhibits
4.4.2.6 Sources
4.4.3 The Relevance of the Medical Affairs Strategy in China
4.4.3.1 Issue Summary
4.4.3.2 Questions
4.4.3.3 Key Insights
4.4.3.4 Supporting Quotes
4.4.3.5 Intelligence Exhibits
4.4.3.6 Sources
4.4.4 The Role of Medical Affairs in Data, Evidence and Value Discussions in China
4.4.4.1 Issue Summary
4.4.4.2 Questions
4.4.4.3 Key Insights
4.4.4.4 Supporting Quotes
4.4.4.5 Sources
4.4.5 The Strategic Value of Medical Education in China
4.4.5.1 Issue Summary
4.4.5.2 Question
4.4.5.3 Key Insights
4.4.5.4 Supporting Quotes
4.4.5.5 Sources
4.4.6 The Potential of Digital Advances in Chinese Medical Affairs
4.4.6.1 Issue Summary
4.4.6.2 Question
4.4.6.3 Key Insights
4.4.6.4 Supporting Quotes
4.4.6.5 Intelligence Exhibits
4.4.6.6 Sources
4.4.7 The Future of Medical Affairs in China
4.4.7.1 Issue Summary
4.4.7.2 Question
4.4.7.3 Key Insights
4.4.7.4 Supporting Quotes
4.4.7.5 Intelligence Exhibits
4.4.7.6 Sources
