14 de desembre 2022

Making competition work

 Antitrust Policy in Health Care Markets

After reviewing all these issues included in the book, do you still think that true competition could work in health care?

In US, the evidence is that remedies doesn't cure the disease (collusion, monopoly, dominant position abuse).


1. Health Care Markets and Competition Policy 1

1.1 The Marketplace of Health Care Spending 1

1.2 Competitive Concerns 3

1.3 Antitrust Policy 4

1.4 Plan of the Book 5

1.5 Concluding Remarks 12

2 Antitrust Policy in the United States 14

2.1 Introduction 14

2.2 The Economic Rationale for Antitrust Policy 14

2.3 Political Foundation of Antitrust Policy 19

2.4 Antitrust Treatment of Monopoly and Cartels 23

2.5 The Clayton Act 26

2.6 Private Antitrust Suits 27

2.7 Class Action Suits 31

2.8 Concluding Remarks 33


3 Patents and Monopoly Pricing of Pharmaceuticals 37

3.1 Introduction 37

3.2 The Patent System 39

3.3 Patents and Monopoly Pricing 42

3.4 Patent Licensing 47

3.5 Antitrust Remedies 51

3.6 Government Policy Proposals toward Prescription

Drug Pricing 52

3.7 Extensions: Medical Devices and Orphan Drugs 64

3.8 Concluding Remarks 68

4 Patents and Exclusionary Product Hopping 74

4.1 Introduction 74

4.2 Exclusionary Product Hopping 75

4.3 Legal Challenges to Product Hopping 78

4.4 Solutions, If Any 88

4.5 Concluding Remarks 92

5 Bundled Discounts and PeaceHealth 95

5.1 Introduction 95

5.2 Bundled Discounts 96

5.3 Bundled Discounts in Health Care Settings 99

5.4 Anomalies of the Discount Attribution Test 105

5.5 Antitrust Treatment of Bundled Discounts 109

5.6 Concluding Remarks 112


6 Collusion in Health Care Markets 117

6.1 Introduction 117

6.2 A Basic Cartel Model 117

6.3 Collusion among Physicians and Surgeons 121

6.4 Collusion among Hospitals 126

6.5 Collusion among Pharmaceutical Manufacturers 128

6.6 Collusion among Medical Device Manufacturers 131

6.7 Collusion among Health Insurers 132

6.8 Concluding Remarks 134

7 Collusion in Generic Drug Markets 136

7.1 Introduction 136

7.2 The Competitive Promise of Generic Pharmaceuticals 137

7.3 The Incentive to Collude 140

7.4 The Alleged Conspiracies 142

7.5 Economic Consequences of Collusion 150

7.6 Deterring Price Fixing 152

7.7 Concluding Remarks 154

Appendix: Alleged Participants in Generic Pharmaceutical

Drug Conspiracy 154

8 The Hatch-Waxman Act, Patent Infringement Suits,

and Reverse Payments 168

8.1 Introduction 168

8.2 The Hatch-Waxman Act 169

8.3 Reverse Payment Settlements 172

8.4 The Actavis Decision 177

8.5 The Post-Actavis Experience 186

8.6 Legislative Remedies 192

8.7 Private Damage Actions 197

8.8 Concluding Remarks 200

Appendix: The Economics of Settlements 200

9 The Alleged Insulin Conspiracy 204

9.1 Introduction 204

9.2 Insulin: A Brief History 205

9.3 The US Insulin Market 207

9.4 Pharmacy Benefit Managers 215

9.5 Collusion in the Insulin Market 220

9.6 Concluding Remarks 225

10 Licensing of Health Care Professionals 230

10.1 Introduction 230

10.2 Economic Concerns with Professional Licensing 232

10.3 North Carolina Dental and the State Action Doctrine 236

10.4 Licensing to Exclude Competition 242

10.5 Economic Effects of Mandated Supervision 245

10.6 The Empirical Evidence 249

10.7 Concluding Remarks 250


11 Monopsony, Dominant Buyers, and Oligopsony 257

11.1 Introduction 257

11.2 Basic Model 258

11.3 Dominant Buyer Model 267

11.4 Oligopsony 270

11.5 Monopsony in Health Insurance Markets 273

11.6 Antitrust Treatment of Monopsony 275

11.7 Concluding Remarks 277

12 Countervailing Power: Physician

Collective Bargaining 279

12.1 Introduction 279

12.2 Bilateral Monopoly 280

12.3 Physician Cooperative Bargaining 286

12.4 Competitive Concerns 296

12.5 Concluding Remarks 298

13 Group Purchasing Organizations, Monopsony, and

Antitrust Policy 300

13.1 Introduction 300

13.2 What Do We Know about GPOs? 301

13.3 GPOs and the Exercise of Monopsony Power 302

13.4 Foreclosure of Suppliers 307

13.5 GPO Funding Mechanisms 312

13.6 Antitrust Enforcement Policy 315

13.7 Concluding Remarks 319


14 Collusion in the Nurse Labor Market 325

14.1 Introduction 325

14.2 The Shortage of Nurses 326

14.3 A Simple Analysis of an Employer Cartel 329

14.4 Recent Antitrust Litigation 333

14.5 Antitrust Damages 336

14.6 Antitrust Policy 341

14.7 Concluding Remarks 343

15 Collusion in the Oocyte Market 345

15.1 Introduction 345

15.2 Collusion in the Oocyte Market 346

15.3 Antitrust Standards 348

15.4 Economic Effects of Price Ceilings 351

15.5 Rule of Reason Analysis 352

15.6 Antitrust Injury and Damages 357

15.7 Disposition of Kamakahi 362

15.8 Concluding Remarks 365

16 No-Poaching Agreements and Antitrust Policy 368

16.1 Introduction 368

16.2 Background 370

16.3 No-Poaching Agreements in Health Care:

Seaman v. Duke University 373

16.4 Damage Theory 375

16.5 Government Regulation 381

16.6 Concluding Remarks 383


17 The Economics of Horizontal Mergers 389

17.1 Introduction 389

17.2 Mergers to Monopoly 390

17.3 Mergers of Producers to Realize Efficiencies 393

17.4 Mergers of Buyers to Realize Efficiencies 397

17.5 Merger Efficiencies Resulting in Increased Quality 401

17.6 Concluding Remarks 404

18 Horizontal Merger Policy 405

18.1 Introduction 405

18.2 Horizontal Merger Policy 406

18.3 Defining the Relevant Antitrust Market 410

18.4 Economic Evidence of Competitive Effects 412

18.5 Mergers and Their Anticompetitive Effects: Sutter

Health 415

18.6 Agency Analysis of Mergers in Health Care Markets 419

18.7 Concluding Remarks 431

19 The Economic Theory of Vertical Integration 434

19.1 Introduction 434

19.2 Vertical Integration 435

19.3 Vertical Integration and Competitive Distribution 439

19.4 Successive Monopolies in Production and Distribution 444

19.5 Competitive Concerns with Vertical Mergers 448

19.6 Empirical Evidence on Vertical Mergers 450

19.7 Mergers of Complementary Input Suppliers 451

19.8 Concluding Remarks 455

20 Vertical Merger Policy 457

20.1 Introduction 457

20.2 Legal Foundation 458

20.3 The 2020 Vertical Merger Guidelines 461

20.4 A Merger in Biotechnology: Illumina/GRAIL 465

20.5 The Merger of a Health Insurer and a Physician Group:

UnitedHealthcare/DaVita 469

20.6 The Merger of a Hospital System and a Physician Group:

St. Luke’s/Saltzer 472

20.7 Concluding Remarks 476

21 Concluding Remarks

12 de desembre 2022

Pandemethics (4)

 Ethical Failures of the COVID-19 Pandemic Response


1 Introduction and Analytic Framework 1

Part I War on Paper 37

2 Ethics in Governance: Pandemic Response as a Vital Interest 39

3 The Ethics of Response to Plague on Distant Shores 61

4 The Ethics of Practices in Pandemic Response 79

Part II Friction 97

5 The Need/Failure to Prepare and Prevent 99

6 The Need/Failure to Anticipate and Pre-empt 127

7 The Need/Failure to React, Adequately Prioritise and Persevere 155

8 The Need/Failure to Honestly Account and Take Responsibility 193

9 Lessons, Recommendations, Conclusion 213

03 de desembre 2022

The roots of good governance (3)

 High Performance Boards: Improving and Energizing your Governance


Part I: The Four Pillars of Board Effectiveness 1

Joanne Marker and Board Service 3

Chapter 1 The Four Pillars of Board Effectiveness 9

The First Pillar: People Quality, Focus, and Dedication 11

The Second Pillar: Information Architecture 14

The Third Pillar: Structures and Processes 15

The Fourth Pillar: Group Dynamics and Board Culture 17

Chapter 2 Governance Challenges around the World 20

Scientific Lessons from Natural Selection 22

What is Transformational Leadership? 23

Should We Trust Leaders? 24

The Governance DNA 26

Chapter 3 The Successful Director: Values and Character 28

Duty of Care 30

Duty of Loyalty 32

Integrity: A Key Characteristic of Board Directors 32

Chapter 4 The First Pillar: People Quality, Focus, and Dedication 35

Quality 35

Focus 38

Dedication 41

Chapter 5 The Second Pillar: Information Architecture 45

How Complete is Your Information? 46

Chapter 6 Board Structures and Processes 50

Processes 51

Committee Structure 52

Board Secretary 53

Lead Director or Vice Chair 55

Chapter 7 Group Dynamics and Board Culture 56

Understanding Group Dynamics 57

Coalitions Within a Board Are Inevitable – and they Feed into Politics 60

Boards Fall into Traps 63

Drawing Strength from the Board’s Potential 66

Developing Self-Awareness 67

Board Culture 69

Part II: Board Failures and Challenges 77

Chapter 8 Four Areas of Board Failure 79

Chapter 9 Risks and Ensuring the Right Board Risk-Philosophy 82

Chapter 10 A Board Member’s Practical Guide to Risk Thinking 85

The Physical Health Check: Technical Risks 86

The Mental Health Check: Behaviours 89

The Strategic Risk Check 93

The Governance Risk Check 94

Chapter 11 Elements of Advanced Risk Techniques for Board Members: From Quants to Cyber 97

The Why and How of Quantitative Risk Assessment for Boards 98

Integration of Risks 101

The Outcome of Risk Assessment 102

Cyber Risk 104

Chapter 12 Crisis Management 107

Crisis as a Turning Point 110

There is Work to Be Done In Peaceful Times 111

Communication Principles 111

Another Powerful Weapon: Gathering Information 113

A Crisis Will Shed Light On Boardroom Fissures 115

Procedure vs. Authenticity 117

Communicate Your Way to Rebuilding Trust 118

Chapter 13 The Four Tiers of Conflicts of Interest 120

Tier-I Conflicts: Individual Directors vs. Company 122

Tier-II Conflicts: Directors vs. Stakeholders 124

Tier-III Conflicts: Stakeholders vs. Other Stakeholders 131

Conflicts of Interest within a Group of Stakeholders 135

Tier-IV Conflicts: Company vs. Society 136

Chapter 14 High-Level Fraud and Active Board Oversight 141

Why Does High-Level Fraud Happen? 143

Injustice 147

Lax Oversight 148

Problematic Culture 149

Financial Illiteracy 151

How to Create an Effective Oversight Environment 152

Preventing Injustice: Broaden the Notion of Conflict of Interest 152

Preventing Lax Oversight: Build Appropriate Frameworks 153

Preventing Toxic Behaviours: Create a Positive Culture 156

Strengthen Board Oversight Expertise with Special Focus on Legal, Compliance, Risk, Fraud, and Financial Reporting 159

Tools For Anti-Fraud Activities: Assessment, Prevention, Detection, and Investigation 160

Assessment 161

Prevention 161

Detection 161

Investigation 162

Part III: Board Best Practices 165

Chapter 15 The Board as a Strategic Asset 167

Five Definitions of Strategy 168

Clarifying the Board’s Role 171

Taking Context into the Mapping Process 174

The Impact of Context on Strategic Views and Roles of the Board 175

The Board’s Ultimate Strategic Significance 176

Chapter 16 A Primer on Finance Essentials for Directors 177

Reading Financial Reports 178

Understanding Ratios to Analyse Operating Strategies 179

Interpreting Between the Lines of Financial Statements 181

How to Identify Red Flags in Financial Statements 182

Implementing Desired Capital Structure 184

Understanding Valuation Fundamentals 185

Making Better M&A Decisions 187

Overseeing Risk 189

Joanne Marker and Board Values at Comfre 193

Chapter 17 Board Leadership and Values 197

Quality Boards Live and Breathe Integrity 198

Which and Whose Values? 199

Board Values vs. Organisational Values 202

Family Values in Business 203

Chapter 18 The Intricacies of Subsidiary/Holding Governance 204

Structures 206

Culture 208

Chapter 19 Fostering Entrepreneurship from the Board 210

‘Best Practice’ Governance vs. Entrepreneurship 211

Boards Should Actively Encourage Entrepreneurship 212

Chapter 20 The Board’s Oversight Framework for M&As 217

Creating a Deal-Making Mindset 218

Seeing the Bigger Picture 220

Staging Deals with Maximum Precision 220

Integration 225

Confronting Litigation Involving M&As 226

Joanne Marker Confronts Failing Board Culture 229

Chapter 21 The Chair–CEO Relationship 233

The Role of the Chair 233

Chairs are Increasingly Active 237

Chair–CEO Dynamics – the Hallmarks of a Productive Relationship 238

Tests of the Chair–CEO Relationship 240

The Ideal Attributes of a Chair 242

Chapter 22 The Board–Management Relationship 244

Supervision 244

Support 246

Blurring the Board–Management Relationship 247

Writing Governance Codes is Easier Than Changing Behaviours 248

Chapter 23 Effective Diversity 251

Diversity is Good . . . But Why; and When? 251

Diversity as a Considered Choice 252

Gender 253

Culture 255

Personality 256

Age 257

Social Background 259

We Have Embraced Diversity . . . Now What? 260

The Chair’s Role in Building and Nurturing Diversity 262

Chapter 24 The Talent Pipeline 265

The Board’s Responsibility for Talent Management 265

The New Talent Dynamic: Culture, Values, Community 268

Chapter 25 Boards and Social Media 272

JP Morgan’s Failed Foray into Twitter Q&A 273

Why Boards Should Understand Social Media 274

What Boards Should Do 276

Chapter 26 Boards and Investors 279

The Move toward Increasing Shareholder Engagement 281

Chapter 27 Managing Stakeholders 283

Shareholders vs. Stakeholders: A Definition 284

How to Identify a Company’s Key Stakeholders 285

The Board Can Be Instrumental in Shaping the CEO–Stakeholders Conversation 285

Anticipating Stakeholders’ Influence and Impact 286

Chapter 28 Stewardship from the Board 289

Building Upon a Rich Cross-Disciplinary Legacy of Thought 291

Psychological, Organisational, and Cultural Influences on Stewardship 291

Steward Leaders Build on their Unique Strengths to Drive Stewardship 292

Steward Leaders Deliver Long-Lasting, Meaningful, and Inclusive Impact 293

Becoming a Steward Leader: What it Takes 295

Stewardship Risks 297

Boards Are Key to Fostering Stewardship 297

Conclusion 299

02 de desembre 2022

The roots of good governance (2)

 The Handbook of Board Governance: A Comprehensive Guide for Public, Private, and Not-for-Profit Board Members


1 The Handbook of Board Governance: An Introduction and Overview 1

Richard Leblanc

I The Board’s First Responsibility: The Right CEO 43

2 CEO Succession Planning Trends and Forecast 45

Gary Larkin

3 CEO Succession Planning 58

David F. Larcker and Brian Tayan

4 CEO Succession: Lessons from the Trenches for Directors 77

Mark B. Nadler

Appendix 1 Model CEO Succession Planning Charter 98

Richard Leblanc

Appendix 2 Model CEO Position Description 105

Richard Leblanc

II The Board’s Second Responsibility: The Right Board Chair 111

5 The Nonexecutive Chairman: Toward a Shareholder Value Maximization Role 113

Henry D. Wolfe

6 Great Boards Don’t Exist Without Great Chairs 148

Elizabeth Watson and Heather Kelsall

7 What’s in a Name? The Lead Director Role at U.S. Public Companies 164

Richard Fields and Anthony Goodman

Appendix 3 Model Board Chair Position Description 192

Richard Leblanc

III Who is at the Board Table? Board Composition, Dynamics, and Decision-Making 197

8 Director Independence, Competency, and Behavior 199

Richard Leblanc

9 Board Behaviors: How Women Directors Influence Decision Outcomes 233

Dr. Mary Halton

10 The State of Gender Diversity in Boardrooms 253

Dr. Nancy Gianni Herbert

11 Every Seat Matters 269

Annie Tobias and Lina Pallotta

12 The Art of Asking Questions as a Director 283

J. Lyn McDonell

13 Board Succession, Evaluation, and Recruitment: A Global Perspective 301

Jakob Stengel

Appendix 4 Model Individual Director Position Description 319

Richard Leblanc

Appendix 5 Model Conflict of Interest Policy for Directors 323

Richard Leblanc

IV The Work of the Board 333

A. Climate governance 333

14 Climate Change and Directors’ Duties: Closing the Gap Between Legal Obligation and Enforcement Practice 335

Ellie Mulholland, Sarah Barker, Cynthia Williams, and Robert G. Eccles

15 Board Oversight and Climate Change: What Directors Need to Know 369

Patricia A. Koval

16 Responsible Boards for a Sustainable Future 398

Dr. Yilmaz Argüden

17 Corporate Governance to Advance Business and Society 434

Alice Korngold

B. Technology Governance 467

18 Technology and the Corporate Board 2020 and Beyond 469

Dr. Gary L. Evans

19 Responsive Governance in a Digital World: The Need to Up-Skill 492

Dr. Elizabeth Valentine, Dr. Steven De Haes, and Dr. Anant Joshi

20 The Impact of Blockchain Technology for Corporate Governance 526

Jack J. Bensimon

21 Blockchain: An Introduction for Boards of Directors 556

Dr. Elizabeth Valentine, Dr. Greg Timbrell, Lachlan Feeney, and Dr. John Puttick

22 Reflections of a Board Chair on the Christchurch Massacre: Governing Social Media 578

Drew Stein

C. Risk and Financial Governance 595

23 Financial Literacy and Audit Committees: A Primer for Directors and Audit Committee Members 597

Jason Masters

24 Corporate Governance in an Age of Populism 624

John Zinkin

25 A Call to Action for Geopolitical Governance 641

Sean West and Rohitesh Dhawan

26 Governing Boards, Risk Management, and Deliberative Thinking 655

Michael Useem

27 Lawyers’ Advice to Directors on Overseeing Executive Pay 672

Howard Levitt and Allyson Lee

28 Accountant’s Advice to Company Directors: Directors’ Obligations to Detect Top-10 Frauds 687

Dr. L. S. (Al) Rosen

29 Ten Tell-Tale Signs ofPossible Fraud: A Director’s Primer 704

James Hunter

30 100 Questions Directors Should Ask When Assessing the Effectiveness of Risk Systems 713

F. Edward “Ted” Price

31 Risk Oversight for Directors: A Practical Guide 719

Stephen J. Mallory

32 Risk Governance: Leading Practice and Demographic Impacts 739

Ingrid Robinson

D. Strategic Governance 759

33 Agile Governance 761

Scott Koerwer and Joseph Perfetti

34 The Three Dilemmas for Creating a Long-Term Board 786

Ariel Fromer Babcock, Robert G. Eccles, and Sarah Keohane Williamson

35 Strategic Blindspots in the Boardroom 815

Estelle Métayer

E. Human Capital and Compensation Governance 839

36 Winter is Coming: The Approaching Human Capital Management Storm 841

Solange Charas and Michael Young

37 The Effective Compensation Committee 861

Steven Hall and Steven Hall Jr

38 Compensation Governance and Performance-Based Executive Compensation 889

Paul Gryglewicz

39 Measuring and Improving Pay for Performance: Board Oversight of Executive Pay 906

Stephen F. O’Byrne

40 Designing Performance for Long-Term Value: Aligning Business Strategy, Management Structure, and Incentive Design 930

Mark Van Clieaf

41 Mind the Gap: How Human Resources Can Become More Integral to the Corporate Boardroom Agenda 953

Jay A. Conger and Edward E. Lawler III

F. Legal and Governance Responsibilities of Directors 967

42 Board Risk and Responsibility Under Regulatory and Criminal Law 969

Norm Keith

43 Riding Between Cars: The Position of the Corporate Secretary 987

Douglas K. Chia

44 Ensuring Good Governance and Business Success in International Subsidiaries 1004

Thomas C. Sears

V Shareholder Engagement and Board Accountability 1021

45 The Rise of Investor Stewardship 1023

Stephen Davis

46 Director/Shareholder Meetings 1049

Stephen Erlichman

47 Dual-Class Share Firms in Developed Market Economies 1066

Anita I. Anand

48 For Directors: The Long-Term Relationship Between Directors, Companies, and Institutional Investors 1088

Carol Nolan Drake

49 Proxy Scorecards Will Empower Investors 1111

James McRitchie

VI Not-For-Profit Governance 1127

50 Charitable and Not-for-Profit Organization Governance 1129

Donald J. Bourgeois

51 The Best of Boards, the Worst of Boards: The Not-for-Profit Experience 1145

Adam Quinton

52 Fundraising Best Practices for Not-for-Profit Boards of Directors 1164

Stephanie Cory

VII Small and Medium Company Governance 1179

53 Governance of Small and Medium-Sized Entities 1181

Jo Iwasaki

54 Private Versus Public Company Governance: Top-13 Questions for Board Members to Consider 1197

Carol Nolan Drake and Sally J. Curley

55 Cannabis Governance: Advice for Current and Prospective Directors in This Emerging Industry 1220

Steve Chan

VIII Global Corporate Governance 1229

56 Cross-Border Corporate Governance 1231

Hari Panday

57 Corporate Governance in Asia-Pacific 1260

John Zinkin

58 Boards of Directors of Chinese Companies 1287

David H. Zhu, Wei’An Li, and Yaowei Zhang

59 The Russian Corporate Governance Story 1316

Alexander A. Filatov

60 CARICOM (Caribbean Community) Governance 1333

Ronaele Dathorne-Bayrd

61 King IV: Taking Corporate Governance to the Next Level 1343

Parmi Natesan and Dr. Prieur Du Plessis

01 de desembre 2022

How to fix current public problems?

 Solving Public Problems. A Practical Guide to Fix Our Government and Change Our World

A radical rethinking of the role of the public servant and the skills of the public workforce, this book is about the vast gap between failing public institutions and the huge number of public entrepreneurs doing extraordinary things—and how to close that gap.  

26 de novembre 2022

Pharma and Medtech market access

 Commercializing Successful Biomedical Technologies


1 - The biomedical drug, diagnostic, and devices industries and their marketspp 1-35

2 - Markets of interest and market research stepspp 36-62

3 - Intellectual property, licensing, and business modelspp 63-103

4 - New product development (NPD)pp 104-171

5 - The regulated market: gateway through the FDApp 172-225

6 - Manufacturingpp 226-263

7 - Reimbursement, marketing, sales, and product liabilitypp 264-316

25 de novembre 2022

Wellbeing as a top priority

Open access book by Tim Besley et al.

Why not focus directly on increasing measured human happiness? Why not try to improve people’s overall quality of life, as it is subjectively seen by citizens themselves?


 Introduction: Making Wellbeing Policies Effective

Timothy Besley & Irene Bucelli

Wellbeing as the Goal of Policy

Richard Layard

Accounting for Consequences and Claims in Policy

Paul Dolan

Weighing the Costs and Benefits of Public Policy: On the Dangers of Single Metric Accounting

Johanna Thoma

Wellbeing in Public Policy: Contributions Based on Sen’s Capability Approach

Paul Anand

Incorporating Wellbeing and Mental Health Research to Improve Pandemic Response

Michael Daly & Liam Delaney

COVID-19 and Mental Health and Wellbeing Research: Informing Targeted, Integrated, and Long-Term Responses to Health Emergencies

Annette Bauer

Health, Wellbeing, and Democratic Citizenship: A Review and Research Agenda

Christopher J. Anderson et al.

Health and Disability Gaps in Political Engagement: A Short Review

Mikko Mattila

24 de novembre 2022

Pharma competition and innovation

 My speech at the Reial Acadèmia de Medicina de Catalunya, 22/11/2022:

23 de novembre 2022

Reframing the human body as a cellular ecosystem

 The Song of the Cell. An Exploration of Medicine and the New Human

In The Song of the Cell, Mukherjee tells the story of how scientists discovered cells, began to understand them, and are now using that knowledge to create new humans. He seduces you with writing so vivid, lucid, and suspenseful that complex science becomes thrilling. Told in six parts, laced with Mukherjee’s own experience as a researcher, a doctor, and a prolific reader, The Song of the Cell is both panoramic and intimate—a masterpiece.

A must read!!! 

17 de novembre 2022

Personalized, stratified or precision medicine: the expectations behind a concept

 Contested futures: envisioning “Personalized,” “Stratified,” and “Precision” medicine

Rather than pinpointing which of these terms is the “correct” one or delineating the “true” meaning of each, to know how we should critically approach the concepts we need an awareness of the discursive contexts in which they are mobilized. This is because the context ultimately structures the social and ethical implications that “personalization,” “stratification,” or “precision” will have for medicine and healthcare systems, and for different stakeholders. As big health data, predictive and systems-level analysis are, themselves, emergent phenomena, the terminology applied in the discursive spaces around these new biotechnologies and approaches cannot be abstracted from their context. Rather, when we apply the “personalization,” “stratification,” and “precision” terms, we invoke particular associations, connotations, “hopes” and “truths” that are part of pre-existing epistemologically and ethically loaded discourses that reflect broader and weightier struggles over what is a good future.


16 de novembre 2022

Pharma, big pharma (18)

Knowledge Accumulation and Industry Evolution

This book explores how the biotechnology and pharmaceutical sector is affected by innovation, growth and public policy.

11 de novembre 2022

Pharma, big pharma (17)

 Big Pharma. The Money Behind the Pills


Chapter 1

Big Pharma’s New Deal: Acquisition and Little Innovation

Blockbuster Drugs Are So Last Century BY ALEX BERENSON

When Academia Puts Profit Ahead of Wonder BY JANET RAE-DUPREE

Grant System Leads Cancer Researchers to Play It Safe BY GINA KOLATA

Are Doctors Too Wary of Drug Companies? BY PAULINE W. CHEN, M.D.

Valeant’s History of Deal-Making BY WILLIAM ALDEN

Roche to Buy InterMune for $8.3 Billion BY ANDREW POLLACK AND MICHAEL J. DE LA MERCED

Why Are So Few Blockbuster Drugs Invented Today? BY DAN HURLEY

$2.6 Billion to Develop a Drug? New Estimate Makes Questionable Assumptions BY AARON E. CARROLL

Stop Subsidizing Big Pharma BY LLEWELLYN HINKES-JONES

Ways to Fund Research on Rare Diseases THE NEW YORK TIMES

AstraZeneca to Acquire Majority Stake in Acerta Pharma BY CHAD BRAY

Explaining Valeant: The Main Theories BY STEVEN DAVIDOFF SOLOMON

Chapter 2

Monopolies and Exclusivity Drive Price Spikes

Runaway Drug Prices BY THE NEW YORK TIMES

Costly Hepatitis C Drugs for Everyone? BY THE NEW YORK TIMES

New Cholesterol Drugs Are Vastly Overpriced, Analysis Says BY ANDREW POLLACK

Inflated Drug Prices THE NEW YORK TIMES

Drug Goes From $13.50 a Tablet to $750, Overnight BY ANDREW POLLACK

Big Price Increase for Tuberculosis Drug Is Rescinded BY ANDREW POLLACK

Valeant Under Investigation for Its Drug Pricing Practices BY ANDREW POLLACK

Senators Condemn Big Price Increases for Drugs BY ANDREW POLLACK

No Justification for High Drug Prices BY THE NEW YORK TIMES

Another Drug Pricing Ripoff BY THE NEW YORK TIMES

The EpiPen, a Case Study in Health System Dysfunction BY AARON E. CARROLL

The Complex Math Behind Spiraling Prescription Drug Prices BY KATIE THOMAS

The Lesson of EpiPens: Why Drug Prices Spike, Again and Again BY ELISABETH ROSENTHAL

Chapter 3

Disease Branding and the Profusion of Diagnoses


Disease Branding BY BEN SCHOTT

Still the ‘Age of Anxiety.’ Or Is It? BY DANIEL SMITH

Ruling Is Victory for Drug Companies in Promoting Medicine for Other Uses BY KATIE THOMAS

A.D.H.D. Seen in 11% of U.S. Children as Diagnoses Rise BY ALAN SCHWARZ AND SARAH COHEN

Is It Really A.D.H.D. or Just Immaturity? BY KJ DELL’ANTONIA

Overselling A.D.H.D.: A New Book Exposes Big Pharma’s Role BY STEVE SILBERMAN

A Profusion of Diagnoses. That’s Good and Bad. BY DHRUV KHULLAR, M.D.

Chapter 4

The Money Behind Epidemics: Preventing, Treating and Healing

For Profit, Industry Seeks Cancer Drugs BY ANDREW POLLACK

F.D.A. Advisory Panel Backs Preventive Use of H.I.V. Drug BY DENISE GRADY

Advocating Pill, U.S. Signals Shift to Prevent AIDS BY DONALD G. MCNEIL JR.

Painkillers Resist Abuse, but Experts Still Worry BY ALAN SCHWARZ


The Insanity of Taxpayer-Funded Addiction BY THE NEW YORK TIMES

F.D.A. to Expand Medication-Assisted Therapy for Opioid Addicts BY SHEILA KAPLAN

As Opioid Prescriptions Fall, Prescriptions for Drugs to Treat Addiction Rise BY ABBY GOODNOUGH

Chapter 5

The Trump Administration vs. Big Pharma

The Real Reason Medicare Is a Lousy Drug Negotiator: It Can’t Say No BY MARGOT SANGER-KATZ

The Fight Trump Faces Over Drug Prices BY KATIE THOMAS

Trump Vows to Ease Rules for Drug Makers, but Again Zeros In on Prices BY KATIE THOMAS

Drug Lobbyists’ Battle Cry Over Prices: Blame the Others BY ERIC LIPTON AND KATIE THOMAS

Draft Order on Drug Prices Proposes Easing Regulations BY SHEILA KAPLAN AND KATIE THOMAS

Lower Drug Prices: New Proposals Carry Lots of Promises BY KATIE THOMAS AND REED ABELSON

What Big Pharma Fears Most: A Trump Alliance With Democrats to Cut Drug Prices BY ROBERT PEAR

Trump Proposes to Lower Drug Prices by Basing Them on Other Countries’ Costs BY ROBERT PEAR

10 de novembre 2022

Understanding Population Health

Population Health and the Future of Healthcare


Defining Population Health

The Road to Population Health: A Changing Society

The Road to Population Health: A Changing Healthcare System

The Roots of Population Health

Health Status and How to Measure It

The Social Determinants of Health and Illness

Paying the Piper: Health Disparities

Population Health and Healthcare Delivery

Population Health and Public Policy

Traditional Approaches to Community Health Data

Data Needs for the Population Health Model

The Role of the Community in Population Health Improvement

09 de novembre 2022

Trends in Population Health

A History of Population Health. Rise and Fall of Disease in Europe

In A History of Population Health Johan P. Mackenbach offers a broad-sweeping study of the spectacular changes in people’s health in Europe since the early 18th century. Most of the 40 specific diseases covered in this book show a fascinating pattern of ‘rise-and-fall’, with large differences in timing between countries. Using a unique collection of historical data and bringing together insights from demography, economics, sociology, political science, medicine, epidemiology and general history, it shows that these changes and variations did not occur spontaneously, but were mostly man-made. Throughout European history, changes in health and longevity were therefore closely related to economic, social, and political conditions, with public health and medical care both making important contributions to population health improvement.


08 de novembre 2022

Trends in health expenditure

 Money and Medicine. The Evolution of National Health Expenditures


Chapter 1: Introduction: The Transformation of Medicine

Chapter 2: Hammurabi to Middlemarch, 1750 BCE to 1850 CE

Chapter 3: The Rise of Modern Medicine, 1880 - 1975

Chapter 4: Global and National Market Trends 1950 - 2020

Chapter 5: Scaling Up

Chapter 6: Contracts: Buying & Selling Medicine

Chapter 7: USA: A Case Study of Leadership and Excess

Chapter 8: Population Aging

Chapter 9: Temporary Fluctuations, Trend Shifts, Lags, and Inertia

Chapter 10: Measuring NHE: Accounting, Boundaries and Budgets

Chapter 11: Forecasting National Health Expenditures: 2030 to 2130

Chapter 12: Conclusion: Seeing the Growth Curve Bend

04 de novembre 2022

Is prevention better than cure?

 The Great Health Dilemma. Is Prevention Better than Cure?

The proverbial benefits of prevention over cure are self-evident—and yet we are reluctant to invest in staying healthy. Resolution of this age-old dilemma begins with a timeless truth: the benefits of good health come at a cost: prevention is not better than cure at any price. That logic leads to a testable—and refutable—proposition: that prevention should be favoured when an imminent, high-risk, high-impact hazard can be averted at relatively low cost. Application of this idea helps to explain why cigarette smoking is still commonplace, why the world was not ready for the COVID-19 pandemic, why the idea of a ‘sin tax’ is misconceived, why billions still do not have access to safe sanitation, why the response to climate change has been so slow, and why public health advice often falls on deaf ears. Much more money and effort are invested in health promotion and prevention today than is commonly thought, but the enormous avoidable burden of illness is reason to seek incentives for investing still more. The principles, together with a series of case studies in diverse settings, offer 12 lessons for prevention. These are methods and motives for shifting the balance away from reactive medical treatment, bypassing illness and injury, to promote better health and well-being.


03 de novembre 2022

Improving health

Whose Health Is It, Anyway?

How the world around us affects our health and life trajectory, and how our wider environment can help us to make easier health choices:

 1. Introduction 1

2. Are we healthy? It’s complicated 11

3. Is our health system ready for the future? 29

4. The social drivers of health 45

5. The commercial drivers of health 63

6. Shared values, shared health, shared prosperity 83

7. Does the healthcare system help or hinder our health? 99

8. The promise of technology 119

9. So whose health is it? Time to value total health 135

21 d’octubre 2022

Megaproviders are the driver of a megaproblem

 Big Med. Megaproviders and the High Cost of Health Care in America

Dranove and Burns trace Big Med’s emergence in the 1990s, followed by its swift rise amid false promises of scale economies and organizational collaboration. In the decades since, megaproviders have gobbled up market share and turned independent physicians into salaried employees of big bureaucracies, while delivering on none of their early promises. For patients this means higher costs and lesser care. Meanwhile, physicians report increasingly low morale, making it all but impossible for most systems to implement meaningful reforms.

In Big Med, Dranove and Burns combine their respective skills in economics and management to provide a nuanced explanation of how the provision of health care has been corrupted and submerged under consolidation. They offer practical recommendations for improving competition policies that would reform megaproviders to actually achieve the efficiencies and quality improvements they have long promised.

This is an essential read for understanding the current state of the health care system in America—and the steps urgently needed to create an environment of better care for all of us.

You'll find an excellent review here

20 d’octubre 2022

Health technology assessment: now is the time


Key message:

La información que genera la evaluación económica puede servir de ayuda en el momento de tomar una decisión, toda vez que la consideración de la dimensión de eficiencia es fundamental para la solvencia de cualquier sistema sanitario, si bien nadie pretende que sea el único elemento a tener en cuenta en un proceso tan complejo. En modo alguno. El papel de los evaluadores debe ser ayudar a los representantes de los ciudadanos y a los decisores sanitarios para que estén mejor informados, con objeto de que los recursos públicos sean asignados de una manera más transparente y racional. Las decisiones deben apoyarse en criterios técnicos claros y objetivos, y en una sólida metodología científico-técnica, pero los argumentos técnicos no pueden sustituir a las decisiones políticas y profesionales.

A pesar de la evidente utilidad de la EETS, ésta no ha terminado de implantarse de manera sólida y sistemática en España. En este sentido, en ocasiones se ha mencionado que el complejo organigrama sanitario y el reparto competencial puede haber jugado en contra del uso de la evaluación económica en nuestro país. No obstante, cabe argumentar que en otros países europeos donde las competencias están tanto o más descentralizadas que en España ello no ha sido óbice para que la evaluación económica desempeñe un papel relevante para informar en los procesos de establecimiento de prioridades y financiación pública en el campo de la política sanitaria (Zozaya et al., 2022). Asimismo, cabe objetar que una parte de las políticas del medicamento siguen estando fuertemente centralizadas en nuestro país (los procesos de decisión sobre financiación y fijación de precio) y, sin embargo, esta centralización tampoco ha favorecido la aplicación de estas técnicas.

La evolución de la EETS en España se caracteriza por la falta de determinación política para implantar un verdadero sistema que resulte determinante en la incorporación de los avances tecnológicos en nuestro sistema sanitario. Aunque existe un marco constitucional y legal que exige el cumplimiento del principio de eficiencia en la asignación de los recursos del SNS, y a pesar de que se ha introducido en la normativa el requisito de considerar la información generada por las evaluaciones económicas para la financiación de innovaciones tecnológicas resulta difícil determinar la relevancia de la eficiencia en dichas decisiones.

La falta de una concreción legal y de un desarrollo reglamentario de los criterios relacionados con la eficiencia, así como de las funciones de los órganos responsables de valorarla, generan una enorme indeterminación que desactiva las virtudes de la EETS. Los destinatarios de estas decisiones (laboratorios, profesionales sanitarios, pacientes) se encuentran ante un amplio margen de discrecionalidad que genera mucha incertidumbre hasta el punto de desconocer el peso específico de la eficiencia en la decisión de incorporación o no de una nueva tecnología y, en su caso, de fijación de su precio.

Asimismo, resulta sorprendente que la EETS se lleve a cabo por las Administraciones sanitarias de forma separada entre los medicamentos y el resto de tecnologías sanitarias. Es dudoso que respecto de la regulación ésta sea la solución óptima. Esta separación podría tener su racionalidad en el pasado, pero muchas innovaciones que llegan a nuestro sistema ponen de manifiesto que esta separación administrativa cada vez es menos funcional y que la creación de compartimentos estancos es un problema evidente a la hora de aprovechar economías de escala que se diluyen entre organizaciones evaluadoras que cuentan con recursos preciosos, pero limitados, y distintos cometidos. Por tanto, parece claro que las evaluaciones realizadas en ambos campos tendrían que estar interrelacionadas, por lo menos en la práctica, incluso si son desarrolladas por organismos diferentes, dadas las proximidades metodológicas entre ellas y la necesidad de utilizar eficientemente a las estructuras y técnicos capaces de realizarlas.

En este sentido, la calidad de los estudios concretos de evaluación de medicamentos y tecnologías sanitarias aún presentan margen de mejora, si bien la adhesión a guías metodológicas consensuadas puede resultar de gran ayuda en este empeño (Giménez et al., 2020). Su cantidad, sin embargo, ha sido modesta, de modo que la productividad de los órganos encargados de realizarla es limitada, o bien otros cometidos han sido prioritarios en sus actividades. Hay que tener en cuenta que dichos órganos tienen medios limitados, que el funcionamiento en red impone costes de transacción y que los trabajos de evaluación de la eficiencia son minoritarios dentro de sus actividades habituales.

En materia regulatoria, la normativa de la evaluación de las tecnologías sanitarias, exceptuados los medicamentos, es relativamente satisfactoria, por lo menos sus normas de superior rango y en los aspectos procedimentales. Por el contrario, la regulación de la evaluación de los medicamentos merece un juicio más crítico. La calificamos de fragmentada, asistemática, discontinua, parcial e insuficiente. Esta situación requiere una iniciativa ambiciosa para mejorarla y completarla a todos los niveles normativos.

También el desarrollo de estudios concretos de evaluación económica de los medicamentos para apoyar su posicionamiento terapéutico y las decisiones concretas de financiación pública y precios a lo largo del tiempo ha sido muy limitado. En la actualidad, se aprecia una voluntad política positiva para poner remedio a esta situación. Se ha concretado ya en iniciativas concretas de planificación (Estrategia IPT), organización (REvalMED), dotación presupuestaria y formación. Sin embargo, el camino por recorrer es largo y exige acciones de amplio alcance, de la mano de desarrollos legislativos al máximo nivel.

La EETS es una exigencia ineludible en la actualidad para cualquier sistema sanitario desarrollado. Obtener información sobre eficiencia puede no ser sencillo, ya que exige un trabajo organizado, cualificado y riguroso y el esfuerzo por parte de los decisores en interpretar los resultados de estos análisis. Sin embargo, no evaluar tecnologías sanitarias incorporando toda la información disponible supone un coste social de oportunidad difícilmente justificable (Puig-Junoy y Oliva, 2009). De hecho, si el principal objetivo de una agencia evaluadora de medicamentos o tecnologías sanitarias, es elaborar información de interés para guiar una toma de decisiones que favorezca una prestación sanitaria efectiva, segura, eficiente, equitativa y responsable con la sostenibilidad económica del sistema sanitario, la evaluación económica debe estar necesariamente presente en el proceso. La alternativa a introducir elementos claros y objetivos en el diseño y evaluación de las políticas sanitarias es actuar desde la opacidad, con falta de responsabilidad y rendición de cuentas a la ciudadanía (Oliva y Puig-Junoy, 2017), estando expuestos a que grupos de presión y elementos mediáticos marquen las agendas de las políticas de salud (Campillo-Artero, García-Armesto y Bernal-Delgado, 2016).

Otros países han incorporado hace tiempo estas herramientas en sus procesos de toma de decisiones, especialmente en el campo de los medicamentos. El llegar con retraso nos permite aprender de sus errores y adaptar a nuestro medio aquellos procesos que han demostrado ser útiles y adecuados (Oliva, Antoñanzas y Rivero Arias, 2008; Lobo, 2015 y 2016). También nos permite ver que los retos presentes en España son compartidos con otros países vecinos y que no hay un modo único de resolverlos, sino diferentes alternativas que deben enmarcarse en el contexto de las necesidades, los recursos, la cultura, la organización y las normas de cada país (Zozaya et al., 2022). Asimismo, tenemos claros ejemplos de buenas prácticas realizadas en nuestro país desde hace tiempo sobre las que apoyarnos para seguir avanzando (Giménez et al., 2020).

La falta de impacto de la evaluación de la eficiencia en España no se ha debido a la falta de profesionales calificados para realizar estos estudios ni para interpretar la información que aportan estas técnicas. Con los incentivos, coordinación y liderazgo adecuados (Abellán Perpiñán y Martínez Pérez, 2016) el volumen de trabajos realizados y su calidad podrían ser superiores a los actuales. Las barreras de uso y aplicación de la evaluación económica en la toma de decisiones ya han sido identificadas y su persistencia se debe al desinterés mostrado por los decisores de más alto nivel y a la debilidad de aquellos agentes que han entendido su relevancia, pero que no han podido influir en su aplicación real.

Para concluir, el marco legal y la práctica de las Administraciones sanitarias deberían haber normalizado desde hace tiempo el uso sistemático de la evaluación de la eficiencia como herramienta de ayuda para la toma de decisiones en el ámbito sanitario español. No ha sido así, aunque reformas recientes apuntan a un cambio en este sentido. Una ventaja evidente de la evaluación económica es que hace explícita una información incorporable en el proceso de toma de decisiones sobre la asignación de los recursos escasos entre alternativas excluyentes que compiten entre sí. Quizás precisamente estos elementos que aluden a la transparencia y a la rendición de cuentas, y que han favorecido su incorporación en otros países europeos, han jugado en su contra en el nuestro. Es tiempo de cambiar esta situación de manera definitiva. Por ello, no cabe sino insistir en que uno de los mayores retos de nuestro sistema de salud es mejorar sus normas y avanzar hacia una cultura de buen gobierno (Meneu y Ortún, 2011; AES, 2013; Oliva, Peiró y Puig-Junoy, 2013; Repullo y Freire, 2016). En este proceso, un aspecto clave es interiorizar que la evaluación, no ya la económica, sino la evaluación, en sentido amplio, no es meramente una opción o un conjunto de herramientas relativamente útil. Es parte del gran cambio que precisamos para garantizar la solvencia de nuestro sistema de salud y para que éste continúe mejorando el bienestar de nuestra sociedad, tal y como lo ha hecho en las últimas décadas.


 Carrie Mae Weems

La orilla del tiempo. La Antigua Roma,

de la serie “Deambulando”, 2006

Cortesía de la artista y la Jack Shainman Gallery, Nueva York.

19 d’octubre 2022

The farce of confidential drug prices (3)

 Exploring the consequences of greater price transparency on the dynamics of pharmaceutical markets

The 2018 OECD report Pharmaceutical Innovation and Access to Medicines suggested that increased price transparency could promote public accountability, while potentially delivering efficiencies to health systems by including economic considerations in coverage, treatment decisions and budget allocation. Despite this, precisely what should be made more transparent, and how greater transparency would affect the functioning of markets, have been poorly characterised. To help frame the policy debate, the OECD undertook an exploration of the potential consequences of greater price transparency on market dynamics. The work included a roundtable and a series of semi-structured interviews, with participation by 19 experts in pharmaceutical pricing, economics of pharmaceutical markets, competition, and law. With an extensive review of the current practice and relevant literature as a preface, this report presents the key findings from those consultations.


18 d’octubre 2022

Drug pricing overhaul

 Pricing for Medicine Innovation: A Regulatory Approach to Support Drug Development and Patient Access

The message:

We introduce a regulatory approach we term “Pricing for Medicine Innovation” (PMI), which departs dramatically from the market-equilibrium assumptions of conventional (neoclassical) economics. The PMI approach recognizes the centrality of collective investments by government agencies and business firms in the productive capabilities that underpin the drug development process. PMI specifies the conditions under which, at the firm level, drug pricing can support both sustained investment in these capabilities and improved patient access. PMI can advance both of these objectives simultaneously by regulating not just the level of corporate profit but also its allocation to reinvestment in the drug development process. PMI suggests that although price caps are likely to improve drug affordability, there remain two potential issues with this pricing approach. Firstly, in an innovation system where a company’s sales revenue is the source of its finance for further drug development, price caps may deprive a firm of the means to invest in innovation. Secondly, even with adequate profits available for investment in innovation, a firm that is run to maximize shareholder value will tend to use those profits to fund distributions to shareholders rather than for investment in drug innovation. We argue that, if implemented properly, PMI could both improve the affordability of medicines and enhance the innovative performance of pharmaceutical companies.

 David Hockney

16 d’octubre 2022

Professionalism, current challenges (2)

 Medical Professionalism In An  Organizational Age: Challenges And Opportunities

This article aims to start a dialogue on how these changes may affect the key responsibilities of medical professionalism: putting patient interests first, maintaining and enhancing physicians’ medical  competence, and sustaining trust in the doctor-patient relationship. We identify several potentially effective strategies. They include policies to promote an institutional culture committed to professionalism and to enlarge physicians’ role in institutional leadership. We also address how the principles of professionalism might guide physician compensation formulas, policies governing transparency, and best practices for strengthening the relationships between physicians and newly empowered patients.


14 d’octubre 2022

Pandemethics (3)

 The Ethics of Pandemics. An Introduction

Table of Contents

1. Introduction: Why Ethics of Pandemics?

2. The General Principle of Pandemic Response

3. Rationing of Scarce Health Care Resources

4. Pandemics in an Unequal World

5. Restricting Freedom

6. Inducing Voluntary Behavioral Change

7. Moral Mathematics under Uncertainty.

13 d’octubre 2022

The architects of choice


How “nudges” by government can empower citizens without manipulating their preferences or exploiting their biases.

We're all familiar with the idea of “nudging”—using behavioral mechanisms to encourage people to make certain choices—popularized by Richard Thaler and Cass Sunstein in their bestselling 2008 book Nudge. This approach, also known as “libertarian paternalism,” goes beyond typical programs that simply provide information and incentives; nudges can range from automatic enrollment in a pension plan to flu-shot scheduling. In Nudging, Riccardo Viale explores the evolution of nudging and proposes new approaches that would empower citizens without manipulating them paternalistically. He shows that we can use the tools of the behavioral sciences without abandoning the principle of conscious decision-making.

A controversial approach. 

12 d’octubre 2022

Pharma, big pharma (16)

 The Truth About the Drug Companies. HOW THEY DECEIVE US AND WHAT TO DO ABOUT IT

From the former editor-in-chief of the New England Journal of Medicine and now a member of Harvard Medical School’s Department of Global Health and Social Medicine, Marcia Angell

11 d’octubre 2022

The decline of pharma R&D productivity (2)

Science needs to move beyond luck if it is to design better drugs for the brain

The Economist:

Between 2011 and 2020 the likelihood of a drug in psychiatry being approved by the Food and Drug Administration was 7.3%. In neurology it was 5.9%. (The industry average is 7.9%.) As well as being less likely to succeed in trials (see chart), neurology drugs also take much longer, on average, to develop, further decreasing their appeal

According to the Global Burden of Disease project 12 mental-health disorders affect about 970m people. Their prevalence has increased by 48% since 1990 as the population has grown. With more than one in ten people on the planet affected, it is a global problem, although what data are available suggest it is more marked in Western countries (see map).

10 d’octubre 2022

Paying for rare diseases drugs

The next generation of rare disease drug policy: ensuring both innovation and affordability

The study finds that while 5% of drugs with an orphan indication cost more than $500,000 per year in US, these drugs make up only 0.08% of all patients treated by drugs with an orphan indication. The majority (52%) of patients who receive treatment an orphan drug get the treatment for <$50,000.

09 d’octubre 2022

Pharmaceutical contracts and prices

  Introduction to Market Access for Pharmaceuticals


Chapter 1: Health as a Good

Chapter 2: Decision-Making in Public Health

Chapter 3: Definition and Concepts

Chapter 4: HTA Decision Analysis framework

Chapter 5: Early HTA Advice

Chapter 6: Overview of Market Access Agreements

Chapter 7: External Reference Pricing

Chapter 8: Gap between Payers and Regulators

Chapter 9: Early Access Programs

Chapter 10: Market Access of Orphan Drugs

08 d’octubre 2022

Building a think tank

 Build a think tank. A guide for policy entrepreneurs

Using this guide 8
The reasons for creating this companion guide 8
Using this companion guide 8
Introduction 11
The importance of supporting new think tank development 11
Unravelling the definition of think tanks 13
What’s in the name? 13
Defining think tanks 14
Think tank functions 15
Summing up 16
The Why? questions 18
Why do you want to set up a think tank? 18
Why do think tanks aim to influence policy? 23
Are you sure you want to establish a think tank? 25
The What? questions 26
What will your think tank do? 26
What is the context? 27
What do you want to achieve by setting up a think tank? 33
What issues will the think tank focus on? 37
What will the think tank want to influence? 38
What will its business model be? 40
The Who? questions 46
Who will govern it? (And how?) 46
Who will lead the think tank? 51
Who will engage with it? 56
Who will work for it? 60
Who will fund it? 65
Who will support it? 71
The How? questions 72
How will it carry out research? 72
How will it be managed? 79
How will it communicate? 82
How will it monitor its progress? 88
How will you ensure its credibility? 92
How will it adapt to change? 95
How will it engage with evolving technology? 99
The ‘When’? questions 101
When to start? 101
When to let go? 106
Checklist: Establishing a think tank 108
References and resources 110
On the definition and functions of think tanks 110
Boards and governance 111
Creating and managing think tanks 111
Policy impact 111
Communications 112
Funding and financial management 112
Context 113
Evidence-informed policy 113
List of Boxes, Figures and Tables 114

07 d’octubre 2022

Market access for expensive therapies (or how to overcome prices) (2)

 Gene and Cell Therapies-Market Access and Funding


Chapter 1        Introduction to cell and gene therapies concepts and definitions in US and EU

Chapter 2        cell and gene therapies: genuine products and potential for dramatic value

Chapter 3        cell and gene therapies: Regulatory aspects in US and EU

Chapter 4        the need for new HTA reference case for cell and gene therapies

Chapter 5        How to mitigate cell and gene therapies uncertainties and HTA risk adverse attitude?

Chapter 6        Cell and gene therapies funding: challenges and solutions for patients’ access

Chapter 7        Conclusion

06 d’octubre 2022

Market access for expensive therapies (or how to overcome prices)

 Managed Entry Agreements and Funding for Expensive Therapies

Key reference to understand what's going on in this topic. Recommended.


1. Introduction to Managed Entry Agreements

2. Definition and Classification of MEAs

3. From Coverage with Evidence Development to Individual Performance-Based Agreements in Italy

4. Coverage with Evidence Development for Multiple Sclerosis Drugs in the UK: A "Costly Failure"?

5. Country Comparison of the Implementation of Managed Entry Agreements

6. Novel Funding Models for Expensive Therapies

7. Managed Entry Agreement for Cell and Gene Therapies

02 d’octubre 2022

The decline of pharma R&D productivity (how much are we willing to pay for failure (95%) or success (5%)?)

Global Trends in R&D . Overview through 2021 

The productivity of the clinical development process can be considered as a measure of trial outputs (drugs, innovation, trial success, etc.), compared to a measure of trial inputs or resources dedicated to obtaining those outputs (e.g., aspects of trial complexity, duration, monetary investments, etc.). Such measures of success, complexity and trial duration were selected for inclusion in the productivity index as described above. Increases in success will increase productivity overall as will decreases in complexity or duration. Conversely, decreases in success will drive down the productivity index, as do increases in complexity and duration.

Clinical development productivity — a composite metric of success rates, clinical trial complexity and trial duration — declined in 2021, continuing an overarching 10-year trend. Despite a second year of decreasing trial complexity, the ongoing decline in success rates has resulted in reduced average trial productivity. Trial success rates fell to their lowest in more than 10 years to an average 5% likelihood of progressing successfully through all phases.

01 d’octubre 2022

Health systems design

 Building a High- Value Health System

Countries and institutions worldwide face the challenge of planning and paying for health care that effectively meets the needs of citizens and employees. While there are many criticisms of existing healthcare models, current literature offers little guidance for individuals who want to carry out the work of redesigning and improving their health system.

22 de setembre 2022

Pharmaceutical innovation and value extraction

 Pharmaceutical innovation sourcing

Figure below shows that 23% of new medicines came from public bodies and private-private collaboration and they didn't apply for any marketing authorisation.

21 de setembre 2022

Managing the decline in Pharma R&D

Global Trends in R&D. OVERVIEW THROUGH 2021

A decade ago I posted this: Gestionar el declivi. John Kay said in 2011:

"When an industry model is broken, the best business strategy may be to manage its decline"

Now a new report confirms that the process continues after a decade.

From IQVIA report:

The composite success rate across all development phases and therapy areas declined to 5.0% in 2021, which can be attributed to an appetite for increased scientific risk in clinical development programs as the bar for efficacy and safety rises, as well as increased pauses in product development due to the pandemic.

Across disease areas, probability of success varies considerably, and 2021’s composite success rate fell below the 10-year trend in all areas except for vaccines and cardiovascular.

 That's all folks.

16 de setembre 2022

Human genomics vs. clinical genomics

 Today my suggestion is to read the post by Eric Topol with the same title. 

It begins with this statement:

We’re now well over 20 years since the first human genome was sequenced, but with few exceptions the massive amount of data that has been generated has not been transformed to routine patient care.

So, why?

02 de setembre 2022

Political determinants of health

 The Political Determinants of Health

In this book, Daniel E. Dawes argues that political determinants of health create the social drivers—including poor environmental conditions, inadequate transportation, unsafe neighborhoods, and lack of healthy food options—that affect all other dynamics of health. By understanding these determinants, their origins, and their impact on the equitable distribution of opportunities and resources, we will be better equipped to develop and implement actionable solutions to close the health gap.