|Dr Eleanor Brooks (Edinburgh)||EU health policy in the aftermath of COVID-19|
|Dr Sabrina Röttger-Wirtz (Maastricht)||The interplay between global standards and EU pharmaceutical regulation|
|Carlos D. Bravo Laguna (IBEI)||A Central Player in a Global Crisis Network? The Role and Weight of Europe in the West African Ebola Outbreak|
|Professor Tamara Hervey (City)||Healthcare in the Withdrawal Agreement: a gap analysis|
|Professor Albert Sánchez Graells (Bristol)||Healthcare procurement as a service of general economic interest|
|Dr Mary Guy (Lancaster)||Towards a European Health Union – What Role for Member States?|
EU health policy in the aftermath of COVID-19
Dr Eleanor Brooks (Edinburgh) – 2 September 2020
Large parts of the EU’s existing health policy have been driven by crisis – BSE, HIV/AIDS, Thalidomide, the breast implant scandal, H1N1, SARS – but COVID-19 was something different. Rather than affecting a single traded good (beef, medicines, implant technologies) or a small number of member states, COVID-19 affected all, requiring the kinds of response usually reserved for natural disasters, and had no simple, regulatory solution. This presentation introduces the EU’s response to COVID-19 and describes how its health policy framework has been altered in the aftermath of the immediate crisis. It assesses the extent to which crisis-driven policy change was ‘different’ this time, and what this might mean for the EU’s role in health going forward.
The interplay between global standards and EU pharmaceutical regulation
Dr Sabrina Röttger-Wirtz (Maastricht) – 16 September 2020
As the COVID-19 crisis has brought to the forefront of attention, pharmaceuticals are “global products” developed, tested, manufactured and marketed throughout different countries. It is not surprising that this has fostered the harmonization of regulatory requirements in the form of technical and scientific standards. Regulatory power is shifting to the global level. But who makes the rules that ensure the quality, safety and efficacy of medicinal products on the EU internal market? This presentation will focus on my research on the standard-setting process in the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) and critically examine the influence of these global standards on the EU legal and policy framework. In the presentation, I will also make some preliminary comments on currently ongoing global regulatory cooperation in the COVID-19 crisis.
Healthcare in the Withdrawal Agreement: a gap analysis
Professor Tamara Hervey (Sheffield) – 4 November 2020
One of the successes of the European Union is its provisions on the coordination of social security entitlements, which go a long way to making free movement of people across the European Union a practical reality. This is where the relevant EU rules on cross border health care are situated, along with the Patients’ Rights Directive. This is the legal basis for EHIC and S1/S2 entitlements to cross border health care. The Withdrawal Agreement between the UK and the EU seeks, in general, to limit the harm to EU citizens in the UK and UK citizens in the EU at the end of the transition period. But there are a number of gaps in its protections, and these include gaps in the social security provisions, where cross-border healthcare entitlements are situated. This paper outlines the key gaps and reflects on what they mean both for individuals and at a more systemic level as EU-UK relations unfold in health domains.
Healthcare procurement as a service of general economic interest
Professor Albert Sánchez Graells (Bristol) – 25 November 2020
In March 2019, the Department of Health and Social Care (DHSC) entrusted one of its arm’s-length entities–Supply Chain Coordination Limited (SCCL)–‘with services of general economic interest to manage and oversee the administration of the NHS Supply Chain in relation to NHS funded products and services’. SCCL already had a central position in the management of the so-called New Operating Model (NOM) for NHS procurement, but was about to receive direct funding from DHSC–estimated at about £250m/year. The letter of entrustment sought to ensure compliance with EU State aid rules and, in particular, with the four cumulative conditions formulated by the CJEU in the landmark Altmark case to establish compliance with Art 107 TFEU. This talk will explore the potential shortcomings of DHSC’s entrustment letter from the perspective of EU State aid compliance and, more generally, assess the extent to which centralised (healthcare) public procurement can be treated as an SGEI and, consequently, exempted from compliance with the EU competition rules.
Towards a European Health Union – What Role for Member States?
Dr Mary Guy (Lancaster) – 16 December 2020
Calls for a European Health Union in response to the COVID-19 pandemic have been growing over several months, and given greater impetus recently following reference in Commission President Von der Leyen’s inaugural State of the Union address, with suggestions that Treaty change may be necessary.
Elaborating what a European Health Union looks like, and can achieve, is no small task, yet some common themes are starting to emerge. Two considerations are whether the current legal frameworks are fit-for-purpose, and whether the interaction between the EU and Member States needs to be reviewed.
This presentation discusses my recent EJRR opinion piece examining Article 168(7) Treaty on the Functioning of the European Union (TFEU), which outlines the Member State competence vis-à-vis national health policy and healthcare system organisation. This provision has arguably also contributed to perceptions that initial EU-level responses to COVID-19 were limited.
However, there has also existed a ‘counter narrative’, suggesting that various aspects of EU-level activity has challenged this possible predominance of Member State protection of their healthcare systems. This has emerged in connection with competition policy, and more notably, in connection with the European Semester economic policy assessments.
This opinion piece provides an original assessment of Article 168(7) TFEU to argue that Treaty change to redress the balance between EU and Member State competence regarding national healthcare systems may be uncalled for given both the flexibility afforded by the provision and the complexity and diversity of Member State healthcare systems.
|Professor Katherine Fierlbeck, Dr Tomislav Sokol, Dr Eleanor Brooks, Professor Tamara Hervey, Dr Olga Löblová, Professor Dorte Sindbjerg Martinsen, Dr Reini Schrama and Dr Bruno Nikolić.||Health Policy in the EU – Journal of Health Policy, Politics and Law special issue panel|
|Dr Thibaud Deruelle (ESPOL)||Is the COVID-19 crisis a catalyst for the institutionalization of a European Public Health policy? The recent development of health threats management in the EU in the balance|
|Professor Johan van de Gronden (Radboud)||The impact of the EU rules for patient mobility on national health insurance: the case of the Netherlands|
|Solvita Olsena Dr.iur., MD, Associate Professor, University of Latvia, Faculty of Medicine
Laura Kadile Mg.iur., Doctoral Researcher, University of Latvia, Faculty of Medicine
|Challenges to patient’s cross-border rights in EU posed by national restrictions due to Covid- 19|
|Dr Ivanka Antova (QUB)||Responsibilised patients in England and Northern Ireland? Drawing insights from street legal ethnography|
|Dr Mechthild Roos (Augsburg)||Regulator, standard setter, scapegoat? The (construed) role of the EU in national policies on asylum seekers’ and refugees’ access to health care|
JHPPL Panel discussion
A new special issue of the Journal of Health Politics, Policy and Law brings together a wide range of topics regarding Health Policy in the EU – from fiscal governance and health governance, via the effects of integration in Central and Eastern Europe, Health Technology Assessments, and the applicability of competition law to health “Brexternalities”.
Join us for a panel discussion about the special issue and the recent German presidency’s intent to think more widely about “European” health care – with JHPPL contributors Professor Katherine Fierlbeck, Dr Tomislav Sokol MEP, Dr Eleanor Brooks, Professor Tamara Hervey, Dr Olga Löblová, Professor Dorte Sindbjerg Martinsen, Dr Reini Schrama and Dr Bruno Nikolić.
Is the COVID-19 crisis a catalyst for the institutionalization
of a European Public Health policy?
The recent development of health threats management in the EU in the balance
Dr Thibaud Deruelle (ESPOL) – 27 January
The question of the institutionalization of public health policy in the EU has never been more topical than in the COVID-19 era. One European agency in particular has come to the fore from a position of relative obscurity: the European Centre for Disease Prevention and Control (ECDC). While the virus knows no border, the ECDC’s mandate is limited to coordinating the surveillance of risk. The decision to coordinate a common response remains ultimately, in the hands of member States through a specific formation of the Council of the EU: The Health Security Committee. If this system of soft governance has proved itself (relatively) satisfactory over the last 15 years, the unprecedented severity of COVID-19 has led the European Commission to propose an extension of the mandate of the ECDC to formally involve the Centre in issues of risk management.
A year after the initial outbreak, this article builds on the literature on EU agencies to take stock of the future of the governance of health threats. We look at the role of ECDC´s role in risk management activities and assesses both the expansion of its formal mandate, as well as the development of its informal one. Crucially, this article addresses the expansion of a policy area that historically did not leave much leverage at EU level, and addresses an important aspect of the current COVID crisis in the light of other EU-level crises occurred in the past years : the need for policy-coordination at the EU level through the construction of well-functioning EU capacities. We thus ask: what is the role of the COVID-19 crisis in explaining institutional innovations in the management of health threats in the EU? Building on the European health policy literature, we find that the institutionalization of a European public health policy is a product of crises, but that different forms of institutional innovations are at play amid crisis as opposed to post crisis. While crises foster a change in practice, post crisis, we observe the layering of new rules onto existing ones. 15 years after the emergence of the EU’s governance system coordinating health threats management, we observe an emerging pattern for the institutionalization of a public health policy in the EU.
The impact of the EU rules for patient mobility on national health insurance: the case of the Netherlands
Professor Johan van de Gronden (Radboud) – 10 February
Recently, the Commission has launched a consultation process on the Directive on patients’ rights in cross-border healthcare. The aim of this directive was to codify the ground-breaking case law of the CJEU in judgments, such as Smits-Peerbooms, Müller-Fauré and Watts. In these judgments the CJEU has set out under which circumstances patients are entitled to reimbursement of the costs of treatments received in other Member States. One of the problems with the CJEU case law was, however, that cross-border healthcare was not only assessed under the Treaty provisions on the free movement of services but also under the EU Social Security Coordination Regulation. Whereas prior authorisation schemes dealing with cross-border care costs is considered as a restriction in free movement law, patients seeking treatment abroad are required to apply for such an authorisation according to the relevant provisions of the Regulation. The authorisation scheme is an administrative mechanism facilitating patients seeking cross-border healthcare in the Regulation, while such a scheme is regarded as an obstacle that must be justified under the EU rules on the freedom to provide services. By simply copying the case law on the free movement of services, the Directive has recycled this tension in the legal framework introduced by it. Consequently, the question raises whether this problem should be solved in the upcoming review process of the Directive.
The dichotomy caused by the Directive and the Regulation amounts to serious problems in Member States having a market based healthcare system, such as the Netherlands. Purchasing markets play a key role in the Dutch healthcare system. Accordingly, this system is based on the distinction between contracted and non-contracted care. How does this sit with the EU rules on authorisation schemes? Should attention be paid to the distinction between contracted and non-contracted care in the review process of the Directive? The presentation will discuss the tensions resulting from EU and national health law and will suggest some steps that could be taken for addressing these tensions.
Challenges to patient’s cross-border rights in EU posed by national restrictions due to Covid- 19
Solvita Olsena Dr.iur., MD, Associate Professor, University of Latvia, Faculty of Medicine
Laura Kadile Mg.iur., Doctoral Researcher, University of Latvia, Faculty of Medicine
This study describes legal framework and practices employed by the Member States of EU to secure provision of cross-border patients’ rights in case of Covid 19. The paper is based on legal analytical and empirical research done within the research project “Impact of COVID 19 on the health care system and public health in Latvia, ways in preparing the health sector for future epidemics VPP-COVID-2020/1-0011”. Application of cross-border patients’ rights was studied by investigating the content of recommendations issued by the European Commission as well as by analyzing information provided to cross border patients by Nacional Contact Points of all EU Member States in respect to Covid 19 diagnostics and treatment. Additionally, provision of cross border patients’ rights to those who are living with chronic diseases such as HIV/AIDS in situations when they were limited to return to their residence country due to travel restrictions were studied.
EU Directive 2011/24/EU and Regulation (EC) No 883/2004 provides rights of cross-border patients to receive Covid 19 diagnostics and treatments while staying in another Member State without discrimination, based on standards and guidelines on quality and safety laid down by the Member State of treatment. A National Contact Point and health care institutions are obliged to provide relevant information to cross-border patients to help an individual patient to make an informed choice on Covid 19 health care.
Our empirical research data provide that information provided by National Contact Points to cross border patients concerning Covid 19 related health care in many countries is limited and presents various barriers to access of Covid 19 testing and treatment. There are barriers for provision of cross border patients’ rights to those who are living with chronic diseases if they are limited to return to their residence country due to travel restrictions. The barriers to cross-border patients’ rights revealed in this study will be presented in the Health in Europe Virtual Discussion series.
Responsibilised patients in England and Northern Ireland?
Drawing insights from street legal ethnography
Dr Ivanka Antova (QUB)
Responsibilisation is widely recognised as a key strategy and theme of health governance, through which individuals are to bear responsibility for their health. According to Rose, the concept links ‘self-mastery of the individual’ with the ‘imperatives of good government’. This pаper contributes to broader discussion of responsibilisation, in health governance and beyond, by underscoring its central role as a theme in the Long Term Plan for the National Health Service (NHS) in England (LTP), and using new ethnographic data to illuminate how individuals may respond to this theme and participate in shaping health governance.
Delivering the LTP was made part of broader promises on post-Brexit governance in a speech made on 25 September 2019 in the House of Commons by Prime Minister Boris Johnson. He declared that his government wants to ‘to put Brexit behind us and focus on the NHS, on violent crime and on cutting the cost of living’. In his words, the Queen’s Speech presented a ‘programme for life after Brexit.’ The Queen’s Speech delivered on 14 October 2019 referred to the LTP as the key policy focus for the period after the United Kingdom’s withdrawal from the European Union (Brexit), promising that ‘new laws will be taken forward to help implement the National Health Service’s Long Term Plan in England’. While the LTP emerged against the background of Brexit, and has been linked to it in the programme for government in England, it will shape health governance there, and is likely to inform debate on its organisation elsewhere in the United Kingdom, and perhaps beyond, for years if not decades to come.
Through our examination of the LTP, we identify responsibilisation as part of its normative content, and argue that the LTP requires patients to take greater responsibility for themselves instead of relying on the State and its health institutions to look after them. We further argue that the LTP and its implementation may not be entirely successful in responsibilising patients; nor may it be readily accepted and internalised by them. To advance this part of our argument, we draw on ethnographic data gathered through more than 400 informal ‘street’ conversations.
This data suggests that responsibilisation is overshadowed by concerns about the NHS and the future post-Brexit. The data evidences responsibilisation through individuals actively taking part in shaping post-Brexit health governance. Individuals do so by engaging in what have been described as the ‘multiple contestations, shaping, or even taking pleasure in governance’. Crucially, however, our data suggests that many people are neither readily opening themselves to responsibilisation, nor do they appear to accept responsibilisation for their health. Instead of ‘consumer-patients’ or ‘responsible patients’, our data sheds light on mainly frustrated individuals with no great confidence in the NHS, and who are creating contingency plans for managing their health during the uncertain post-Brexit reality.
Regulator, standard setter, scapegoat?
The (construed) role of the EU in national policies on asylum seekers’ and refugees’ access to health care
Mechthild Roos (Augsburg)
Refugees’ and asylum seekers’ access to health care is an important aspect of their mid- to long-term integration into host countries’ societies – or of political endeavours to keep them at the margins of society, based on different conceptions of these persons, for instance as temporary residents or as future citizens of the host country. Although the legal regulation of asylum seekers’ and refugees’ incorporation in national health-care systems remains largely a national competence, both the areas of health and asylum policy have experienced increasing – if still fragmented – integration at the EU level over the past three decades. These integration processes have not only forced national legislators to adapt policies and laws in order to abide to EU standards and laws, but they have also prompted national governments to shift the responsibility for policy reforms to the EU – even in cases where not all aspects of such a reform would have been required based on EU legislation.
This presentation sheds light on the roles, both positive and negative, attributed to ‘the EU’ by national governments – e.g. as regulator, standard setter, or scapegoat – in order to justify policy reforms at home. It does so by applying the theoretical concepts of claims (Ruedin 2017) and frames/framing (Sainsbury 2012), which allow in-depth scrutiny of governments’ presentation of, and reference to, the EU as suggested unitary actor with an increasing impact on national incorporation and health-care regimes. The dataset at the basis of the analysis consists primarily of policy documents such as draft bills, government declarations, statements by ministries and responsible state agencies, and speeches by members of government during parliamentary plenary sessions.
As starting point of a larger cross-country comparison, this paper studies the roles attributed to the EU in the political regulation of refugees’ and asylum seekers’ access to health care in Germany and Sweden. It focuses thus on two countries which stood out in various ways during the recent so-called ‘migration crisis’. Namely, both countries underwent similar processes of initial demonstrative openness to incoming refugees, presenting themselves as ‘moral superpowers’ (Bradby 2019) in comparison to other EU member states, and taking in high numbers of people, but later changing their stance towards refugees and asylum seekers under (perceived) pressure through a shift of public opinion. These similar reactions are particularly remarkable considering the fundamental systemic and normative differences between Sweden’s and Germany’s incorporation, welfare and health-care regimes, concerning e.g. issues of centralisation, the relevance of citizenship and individual contribution, and the respective legal preconditions for the utilisation of health and welfare services (Sainsbury 2012).
|Dr Eleanor Brooks (Edinburgh), Dr Mary Guy (Lancaster), Dr Diletta Danieli (Verona), Dr Kristin Edquist (Eastern Washington), Professor Johan van de Gronden (Radboud University Nijmegen), Dr Thibaud Deruelle (ESPOL)||The Future of EU Health Law and Policy – Health Economics, Policy and Law special issue panel|
|Dr Charlotte Godziewski (Aston)||Towards a Healthy European Semester through ‘Green and Inclusive Growth’? A Research Agenda|
|Dr Chloé Bérut (Pacte – Grenoble)||The use of EU soft law in the making of domestic eHealth policies: from Electronic Health Records to Covid-19 contact tracing applications|
|Dr Anniek de Ruijter (Amsterdam) and
Dr Sharon Baute (Amsterdam)
|EU Health Solidarity in Times of Crisis: Explaining Public Preferences Towards EU risk Pooling for Medicines|
|Dr Tomislav Sokol (Zagreb)||Europe’s Beating Cancer Plan: Is it Fit for Purpose?|
|Dr Theodosia Stavroulaki (DePaul) and
Dr Pinelopi Giosa (Portsmouth)
|Hospital Mergers in the Aftermath of COVID-19|
|Dr Ollie Bartlett (Maynooth)||If Europe can Beat Cancer, then why not Addiction? An exploration of the rationale and opportunities for building a European Strategy on Addiction|
|Professor Katherine Fierlbeck (Dalhousie), Professor Emeritus Joel Lexchin (York), Dr Jennifer Miller (Yale) and Dr Kim Boesen (Meta-Research Innovation Center Berlin)||What progress in achieving transparency in pharmaceutical regulation?|
The Future of EU Health Law and Policy
14 April 2021
A new special issue of Health Economics, Policy and Law marks the culmination of the British Academy-funded project, EU Health Law and Policy – Shaping a Future Research Agenda.
Join us for a panel discussion with HEPL contributors on papers in the special issue and where EU health law and policy can go from here.
Confirmed speakers: Dr Eleanor Brooks (Edinburgh), Dr Mary Guy (Lancaster), Dr Diletta Danieli (Verona), Dr Kristin Edquist (Eastern Washington), Professor Johan van de Gronden (Radboud University Nijmegen), Dr Thibaud Deruelle (ESPOL)
Towards a Healthy European Semester through ‘Green and Inclusive Growth’? A Research Agenda
28 April 2021
Dr Charlotte Godziewski (Aston)
The notion that health is shaped by broader socioeconomic conditions is widely accepted. In the EU, this awareness is reflected in, for example, the ‘Health in All Policies’ agenda which seeks to mainstream health in other policy areas. The implementation of ‘Health in All Policies’ in areas like the EU economic governance, however, has been limited. In an attempt to reach those areas with the least perceived relevance to health, but which nevertheless shape public health by impacting socioeconomic inequities, some health advocates and policymakers are adapting their message. The role of the economy itself, and the need for it to place wellbeing, health, and sustainability at its centre (for example: ‘wellbeing economy’), now features more prominently. The European Green Deal, for example, is the new growth strategy of the European Commission, and it emphasises the need for economic growth to be environmentally sustainable as well as fair and inclusive. Sustainability and inclusivity, according to the strategy, is to be reflected in the economic governance tools, including the European Semester. The concept of ‘green and inclusive growth’ however, is contested and remains vague. This agenda outlines the need for more research into the discursive and ideational dynamics that shape the meaning of what constitutes ‘inclusive growth’, and the concrete ways in which it is supposed to improve public health through economic governance tools.
The use of EU soft law in the making of domestic eHealth policies:
from Electronic Health Records to Covid-19 contact tracing applications
5 May 2021
Dr Chloé Bérut (Pacte – Grenoble)
Over the past years, the European Union (EU) has supported the use of Information and Communication Technologies (ICTs) within healthcare systems through the development of numerous ‘soft’ instruments. Thus, the European Commission advocates for the development of eHealth policies within member states, but also works on the creation of an interoperability space at the EU level, with the aim of ensuring the compatibility between various eHealth state-owned devices. As of today, guidelines were published in order to allow for the transfer and translation of electronic patient summaries (a summary of patients’ key health information) or of ePrescriptions between member states. More recently, because of the Covid-19 crisis, the European work on these devices has become more and more considerable: guidelines are now produced for contact tracing applications or for electronic Covid-19 immunization status certificates.
The aim of the qualitative research presented here is to understand how and why European soft law matters in the making of domestic eHealth policies, despite eHealth being a member state competence. The analysis of three cases (France, Austria, and Ireland) shows that through actors’ uses of European instruments, the EU is likely to affect various dimensions of the domestic policy work. To take into account the empirical variety of EU usage, a new model providing an accurate definition of EU influence based on John W. Kingdon’s Multiple Streams Framework will be presented.
EU Health Solidarity in Times of Crisis: Explaining Public Preferences Towards EU risk Pooling for Medicines
12 May 2021
The COVID-19 outbreak in Europe has brought attention to EU health policy as a focal point for solidarity, particularly as it concerns access to medicines. Against the backdrop of policy proposals for EU joint procurement of medicines, this article expands our understanding of public opinion towards this particular aspect of European integration. Drawing on data from a conjoint experiment in five EU countries, the study investigates the extent to which citizens’ preferences concerning alternative policy designs for EU joint procurement of medicines are either structured along a pro-EU versus anti-EU or ideological divide, or are crisis driven by the perceived COVID-19 threat. The analysis reveals that individual preferences over the design of EU risk pooling for medicines are most strongly explained by Euroscepticism, while egalitarian ideology plays only a modest role. How citizens’ perceived threat of COVID-19 affects their preferences for this form of EU risk pooling is dependent on the national context.
Europe’s Beating Cancer Plan: Is it Fit for Purpose?
19 May 2021
Dr Tomislav Sokol (Zagreb)
According to the estimates of the Joint Research Centre, in 2020 about 2.7 million people were expected to be diagnosed with cancer in the European Union, and nearly 1.3 million to die from it. This makes cancer the second leading cause of death and one of the biggest public health problems in the EU. Increased political focus on this issue at the time of European elections of 2019 has had concrete policy and institutional repercussions, namely the adoption of the Europe’s Beating Cancer Plan by the European Commission in February 2021 and the creation of the Special Committee on Beating Cancer (BECA) of the European Parliament which is due to deliver its report on the Plan in mid-2021. In addition to battling the COVID-19 pandemic, the Plan is the main pillar of the European Health Union announced by Ursula von der Leyen, President of the European Commission in October 2020.
The aim of this presentation is to lay out the main elements of the Europe’s Beating Cancer Plan and to determine whether the measures envisaged by the Plan will be able to deliver on its main goals, namely that patients across the EU can benefit from better care and treatment, but also to improve prevention, early detection and quality of life of cancer patients and survivors. It will show that the Plan represents a first systematic strategy of tackling cancer, but also point out to areas where improvements are necessary.
If Europe can Beat Cancer, then why not Addiction?
An exploration of the rationale and opportunities for building a European Strategy on Addiction
16 June 2021
Dr Ollie Bartlett (Maynooth)
The Beating Cancer Plan is one of the von der Leyen Commission’s flagship efforts in the health field, and one of the key pillars of the evolving European Health Union. However, while some elements of this strategy are new, some are not. In particular, the prevention section of the strategy in only appears to maintain the EU’s contribution to alcohol, tobacco and unhealthy food policy, with few elements that could be considered a major leap forward. The consumption of these products collectively constitutes the biggest cancer risk factor that society faces, and addictive consumption accounts for a large proportion of this. Yet, the Beating Cancer Plan does not make a single mention of either addiction or dependence. This must be seen as an opportunity missed, given the significant role that addiction plays in driving the prevalence of cancer in Europe. This paper argues for a greater focus on the issue of addiction by Europe’s policymakers. While it is impossible to truly ‘solve’ the problem of addiction, due to the immense complexity of the phenomenon, it is possible to identify the various factors that contribute to it. The law is one of those factors – the legal environment currently exacerbates the probability that individuals who are vulnerable to developing an addiction will do so. This paper will attempt to outline some of the ways in which European law in particular is ‘addictiogenic’, and will reflect upon the potential reforms that might be undertaken to lessen this impact.
What progress in achieving transparency in pharmaceutical regulation?
23 June 2021
This panel discussion celebrates the recent publication of Transparency, Power, and Influence in the Pharmaceutical Industry: Policy Gain or Confidence Game?and brings together Professor Katherine Fierlbeck (Dalhousie), Professor Emeritus Joel Lexchin (York), Dr Jennifer Miller (Yale) and Dr Kim Boesen (Meta-Research Innovation Center Berlin) to discuss pharmaceutical regulation in Europe, the US and Canada.
Professor Lexchin’s talk will examine how transparent Health Canada is in its communications about a variety of regulatory issues including clinical trial inspections, the information and decision-making behind drug approvals, the safety of drugs once they have been marketed, problems with the way that drugs are promoted and the conflicts of interest of people who serve on Health Canada’s advisory committees and panels. Although there have been improvements in a few areas, in general Health Canada is still deserving of the “Code of Silence” award that it received in 2004 from the Canadian Association of Journalists.
Dr Miller’s presentation will discuss new expansions made to the Good Pharma Scorecard, a ranking of pharmaceutical companies on their clinical trial transparency and data sharing practices. Company performance on a series of transparency measures related to clinical trial registration, results reporting, publication, data sharing, and compliance with US reporting requirements in the FDA Amendments Act (FDAAA) will be reviewed. Variations in transparency practices by product type, company size, and company location will also be discussed.
Dr Boesen’s presentation will briefly outline the structure of the regulatory system in Europe and highlight differences between the European Medicines Agency and the national drug regulatory agencies. Dr Boesen will outline the pathways for decision-making and drug authorisations, how to access clinical trial data, and upcoming changes in the new EU Trial Regulation. Those particularly interested in transparency and access to clinical trial data can take a look at the open letter Dr Boesen recently submitted to the Heads of Medicines Agencies (see link below).
Professor Joel Lexchin is currently working on two projects investigating the relationship between Canadian patient groups and pharmaceutical companies including how much information is revealed on groups’ websites with respect to donations from companies and whether groups have conflict of interest policies to ensure their independence from companies. He is also analyzing Health Canada’s proposed changes that are designed to achieve “agile” regulation. His recent publications deal with a wide variety of pharmaceutical policy issues.
Dr Jennifer E. Miller is an Assistant Professor in Yale School of Medicine, Director of the Good Pharma Scorecard, and Founder of the nonprofit Bioethics International. She is also a member of the World Economic Forum’s biotechnology council. Dr. Miller’s current work centers on bioethics, equity, and social responsibility in drug development, the pharmaceutical industry, and health data sharing as well as on using metrics to enhance accountability in healthcare. Prior to joining Yale’s faculty, Dr. Miller was as Assistant Professor at NYU School of Medicine. She completed her training in physics, business ethics, bioethics, and regulatory governance at Fordham University, Regina Apostolorum, Duke University, and Harvard University.
Dr Kim Boesen is a Postdoctoral fellow at the Meta-Research Innovation Center Berlin (METRIC-Berlin) where he works with improving access to data from clinical trials. Dr Boesen has a medical degree from University of Copenhagen and did his PhD at the Nordic Cochrane Centre in evidence-based medicine.
Professor Joel Lexchin:
‘Time to marketing of generic drugs after patent expiration in Canada’ ; ‘Achieving greater independence from commercial influence in research’ ; ‘Regulators, pivotal clinical trials, and drug regulation in the age of COVID-19’ ; ‘Are academia-pharma partnerships essential for novel drug discovery in the time to the COVID-19 pandemic? Expert Opinion on Drug Discovery’ ; ‘Clinical practice guidelines and managing financial conflicts of interest’ ; Quality of advertisements for prescription drugs in family practice medical journals published in Australia, Canada and the USA with different regulatory controls: a cross-sectional study ; Health Canada’s proposal to accelerate new drug reviews ; Drug promotion in India since 2000: problems remain ; Financial ties between leaders of influential US professional medical associations and industry: cross sectional study ; The rise and fall of the neurotic housewife: patient sex in psychotropic drug advertising to physicians 1946-1990 ; The “nuts and bolts” of opioid marketing: promotional messages to family doctors in Sacramento, Vancouver, Montreal, and Toulouse ; Does an orphan drug policy make a difference in access? A comparison of Canada and Australia
Dr Jennifer Miller:
Axson, S., Mello, M., Lincow, D., Yang, C., Gross, C.P., Ross, J.S. Miller J.E. (2021). Clinical Trial Transparency and Data-Sharing Among Bio-Pharmaceutical Companies and the Role of Company Size, Location, and Product Type: A Cross-Sectional Descriptive Analysis. BMJ Open. Forthcoming August 2021; Evaluation of Drug trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs ; Clinical Trial Data Sharing and Results Reporting Practices Among Large Pharmaceutical Companies ; Delays in the Publication of Important Clinical Trial Findings in Oncology ; Measuring Clinical Trial Transparency: An Empirical Analysis of Newly Approved Drugs ; Clinical Trial Registration, Reporting, Publication and FDAAA Compliance: A cross-sectional analysis and ranking of new drugs approved by the FDA in 2012
Dr Kim Boesen:
Open letter. Proposal to the Heads of Medicines Agencies to improve harmonisation of access to Clinical Study Reports across National Competent Authorities ; Cross-sectional study of medical advertisements in a national general medical journal: evidence, cost, and safe use of advertised versus comparative drugs ; EMA and FDA psychiatric drug trial guidelines: Assessment of guideline development and trial design recommendations ; Feedback on the ‘Revision of the EU general pharmaceuticals legislation ; The US Food and Drug Administration’s authorisation of Purdue’s controlled-release methylphenidate for adult ADHD: comments on the regulatory practice ; Depot aripiprazole: subverted trials and authorization of a best-selling drug