FACT OR FICTION What Healthcare Professionals Need to Know about Pharmaceutical Marketing in the European Union HEALTH ACTION INTERNATIONAL ACTION HEALTH FACT OR FICTION? What Healthcare Professionals Need to Know about Pharmaceutical Marketing in the European Union Fact or Fiction? What Healthcare Professionals Need to Know about Pharmaceutical Marketing in the European Union Published by: Health Action International Overtoom 60 (2) | 1054 HK Amsterdam | The Netherlands Tel: +31 20 412 4523 | www.haiweb.org Licensing: This report is licensed under the Creative Commons Attribution-NonCommercial 4.0 International Licence. To view a copy of this licence, visit http://creativecommons.org/licenses/ by-nc/4.0/. This publication received funding under an operating grant from the European Union’s Health Programme (2014–2020). The content of this publication represents the views of the author only and is his/her sole responsibility; it cannot be considered to reflect the views of the European Commission and/or the Consumers, Health, Agriculture and Food Executive Agency, or any other body of the European Union. The European Commission and the Agency do not accept any responsibility for use that may be made of the information it contains. HEALTH ACTION INTERNATIONAL ACTION HEALTH Table of Contents Acronyms ii Preface iv Introduction 1 Promotion across the Pharmaceutical Product Lifecycle 3 True Innovation or Just Marketing? 7 Pharmaceutical Marketing 11 Promotional Strategies Used by Pharmaceutical Companies 15 What Protects Healthcare Professionals from Unethical Behaviour by Pharmaceutical Companies? 35 Provisions of European Union Legislation 36 Industry Codes of Conduct 39 Why Self-Regulation Does Not Work 42 Conflicts of Interest 47 Change Starts with You 48 Best Practice Prescribing 49 Annex: Useful Links and Contacts 52 Bibliography 54 i Acronyms ABPI Association of the British Pharmaceutical Industry COPD Chronic Obstructive Pulmonary Disease DTCA Direct-To-Consumer Advertising EC European Commission ECC European COPD Coalition EFPIA European Federation of Pharmaceutical Industries and Associations EU European Union HAI Health Action International IPCRG International Primary Care Respiratory Group KOLs Key Opinion Leaders LIF Läkemedelsindustriföreningen (Sweden) NHS National Health System (United Kingdom) MHRA Medicines and Healthcare Products Regulatory Agency MPA Medical Products Agency OTC Over-The-Counter PMCPA Prescription Medicines Code of Practice Authority R&D Research and Development US United States of America ii HEALTH ACTION INTERNATIONAL ACTION HEALTH iii Preface Healthcare professionals are highly exposed to pharmaceutical marketing activities. Evidence shows that exposure to information from pharmaceutical companies does not lead to net improvements in prescribing, but can negatively affect prescribing and professional behaviour (Wazana, 2000; Norris et al., 2005; WHO & HAI, 2009; Spurling et al., 2010). Education about pharmaceutical promotion can affect Learning Objectives trainees’ awareness and attitudes, which helps counter • To identify and assess the methods used in pharma- the influence of promotional practices (Norris et al., ceutical promotion activities. 2005; Carroll et al., 2007; Lea et al., 2010). Healthcare professionals come into contact with promotional • To understand the impact of pharmaceutical promo- materials during their studies. However, most medical tion techniques on clinical practice and public health. students do not obtain adequate education on how to critically respond to pharmaceutical promotion (Mintzes, • To learn about the European Union (EU) regulatory 2005; Mansfield et al., 2006; Austad et al., 2011). This framework on pharmaceutical promotion and the leaves many healthcare practitioners unprepared for problem of self-regulation. ethically challenging situations that ultimately impact their • To enable critical appraisal of pharmaceutical promo- ability to objectively prescribe, or advise patients about, tion activities in a way that safeguards evidence-based medicines. medicine. 85.2% of medical students surveyed in France (n=2,101) This guide and its workshop series build on the publication, reported feeling inadequately educated about conflicts of Understanding and Responding to Pharmaceutical interest arising from interactions with the pharmaceutical Promotion: A Practical Guide, produced by Health Action industry (Etain et al., 2014). International, in collaboration with the World Health Organization, in 2009. Being able to identify promotional activities and to understand their impact to medical practice enables The examples used in this publication are not exhaustive, critical appraisal. In not helping (future) healthcare but are included to provide insight into the pharmaceutical practitioners to develop such skills, practitioners may be industry’s strategies and resources as case studies. left to interpret misinformation as fact and to prescribe or dispense specific medicines where other treatment options should be considered. This guide and associated workshops have been developed to address this oversight by providing an overview of pharmaceutical marketing practices and the ethical issues that arise from them. iv HEALTH ACTION INTERNATIONAL ACTION HEALTH Most medical students do not obtain adequate education on how to critically respond to pharmaceutical promotion. v HEALTH ACTION INTERNATIONAL ACTION HEALTH Introduction Medicines are an essential intervention of the healthcare system. However, their potential benefits, harms and affordability must always be weighed against that of alternative treatments, including the option to not medicate. In this way, best care is evidence-based and responsible. The rational use of medicines is crucial to protect patients’ safety and the sustainability of healthcare systems. Pharmaceutical companies fulfill an important role Pharmaceutical regulations should ensure that in producing medicines. However, they also have a commercial interests do not override the values responsibility to their shareholders to maximise prof- of good clinical care, individuals and society. its and returns on investment. With the potential for However, too often, regulatory frameworks are not sizable profits at stake, the pharmaceutical industry effective in preventing the provision of deceptive clearly has a vested interest in influencing which information. Laws on pharmaceutical promotion medicines are prescribed and dispensed to patients. are not restrictive enough and there is too much Companies promote their products via various reliance on self-regulation for the oversight of means to maximise profits. promotional activities. Codes of conduct created by the pharmaceutical industry to regulate itself are not Prescribers and dispensers of medicines play an dissuasive enough. important gatekeeper role in the health system. For this very same reason, they are often the key focus Increasingly, healthcare practitioners are relied of the pharmaceutical industry’s promotional activi- upon to navigate the overwhelming quantity of ties. Product advertising and promotion is something pharmaceutical promotion materials and to appraise we encounter on a daily basis. However, unlike other the therapies and medicines released onto the consumer products, the promotion of medicines has market. Understanding the powers at play and how significant ethical considerations. Pharmaceutical specific promotional activities are designed to marketing has three key potential effects: influence healthcare professionals’ decision-making is key to ethical clinical practice. • A negative impact on health outcomes of individuals and, potentially, their families and communities; • The undermining of patients’ trust in healthcare professionals as independent and evidence-based experts who protect their best interests; and • A negative impact on the cost and sustainability of health systems. 1 2 Promotion Across the Pharmaceutical Product Lifecycle Promotion across the Pharmaceutical Product Lifecycle The marketing strategy for most consumer goods aims to maximise profitability by increasing sales volumes. Most companies use a standard product lifecycle methodology that focuses on the introduction, growth, maturity and decline of a product to maximise profits. However, as Figure 1 demonstrates, pharmaceutical company strategists say that a longer lifecycle that reaches across three distinct product stages should be considered: The Drug Life Opti- misation Model (DLO). FIGURE 1. The Drug Life Optimisation Model Source: Bernard, 2013 As opposed to the more traditional approach, the DLO model incorporates early-stage development planning. According to pharmaceutical competition consultant, Stan Bernard, “successful launches are actually won in the pre-launch years, usually in clinical phases II and III” (2013). DLO advocates claim that this approach allows companies “to plan and execute pre-launch activities much earlier to position the product and generate stakeholder awareness and demand. Moreover, it enables the commercial launch team to pre-empt counter-launches, brand pre-positioning, and unfavourable messaging from competitors.” One of the main concerns of this model is that it leverages industry-sponsored clinical trials as a marketing tool. Companies are often criticised for favouring the publication of studies with positive results and for practising selective reporting of outcomes within published studies to make the therapy look more promising. Some well-known examples