THE EUROPEAN COMMISSION (DG SANCO)1
‘GREEN PAPER’ ON MENTAL HEALTH – A HERETICAL VIEW Paper given at the conference organised by Centro di Documentazione
di Storia della Psichiatria "San Lazzaro", 4th and 5th December 2006 Charles Medawar – Social Audit Ltd, London, UKA FAR OUT PERSPECTIVE
I first read the Green Paper2 after the consultation period had expired (May 2006), at around the time of its formal adoption (in October) - and might never have read it if I hadn’t been invited to speak here today. But I am glad I was, and found the Green Paper as much a source of fascination as great dismay. It fitted well in the jigsaw puzzle I work on, however depressing to read.Why did this Green Paper all but pass me by? The short answer is that it didn’t at first seem to be directly and specifically relevant in my line of work. All of us have far too much to read, and I am not directly involved in the mental health field. Nor do I have relevant clinical experience
3 or professional qualifications.I am a policy analyst and a reporter
4, mainly concerned with corporate social behaviour and impact, and with a special interest in pharmaceutical medicine. For many years, I have mainly drawn on two elaborate case histories – revolving around medicines for anxiety and depression - to try to understand more about what happens in the major centres of power. What makes Pharmaceutical Medicine tick?That has been the question at the back of my mind when looking even in microscopic detail at the way in which the relevant government, professional and business institutions have dealt with certain serious and long-standing drug problems, and their effects on the health of patients and consumers. This work has involved something like tracing a network of ‘flows’ of ‘power’ and ‘dependence’ of different kinds. Most of these flows filter through government in some way, and those have been the main focus in my work.
In short, by means of two very detailed case histories (revolving around dependence
5 on antidepressants and anti-anxiety drugs), I have tried to identify the main drivers of success and failure in the contribution of government to the quality of public health and standards of living and being.These seem be the three main responsibilities of government in relation to medicines and drugs – for better and for worse, the centrepiece of treatment for mental distress
6:1. To strike an appropriate balance between commercial imperatives and health priorities – especially in EU countries where governments tend to be the major sponsor of both
2. To safeguard public health, notably by ensuring that good medicines are available where needed, and by effectively7 regulating their use; and
3. To operate within a framework of honest science and decent democratic values. Honesty and seeking after truth are the hallmarks of both, hence the essential need for transparency and public accountability.
Over the years, the government institutions most in my sights have been the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Department of Health (DoH), which has political responsibility for its work. I have also sometimes engaged with the European counterparts of these agencies - the London-based EMEA (European Medicines Evaluation Agency), and DG Enterprise, the ‘politburo’ in Brussels.
Though it might seem paradoxical, it is central to my heresy that the MHRA represents itself, and is regarded by many, as one of the very best drug agencies in Europe (and the world). It is also relevant that London (DoH, MHRA) plays a leading part in the European medicines system. This brings us to two key points:
Pharmaceutical products, drug regulation and the implementation of medicines’ policies are harmonised throughout the EU - so common standards prevail, with many specified in EU law. 8
Standards of professionalism, integrity and accountability in the MHRA would be important and quite reliable indicators not only of the highest standards in Europe – but also of the process and thrust of European initiatives in relation to medicines and health.
All this is by way of a preamble to this critique of the Green Paper on Mental Health. Later, I shall comment on its content, but next I want consider the stable from which this document comes, and its track record in the field.
DRUG REGULATION, TRADE AND HEALTH
My heresy is founded on the strongly held and well-documented view that the high reputation claimed by the MHRA (and, by extension, even the best European institutions) is not deserved. In spite of many accomplishments and much good intent, two decades later, I truly view the MHRA as a rather sickening organisation (Social Audit, 1997-2006; Medawar and Hardon, 2004; Medawar 1992). 9Rather than argue the point, let us shortcut to an authoritative source - the report of the UK Parliamentary Health Committee (2005), following its 10-month enquiry into, "The Influence of the Pharmaceutical Industry".
10 It was the first ever public and independent enquiry on such an issue, in all Europe – and this was the Health Committee’s scathing conclusion on the MHRA:"During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust. Nor did we conclude that the MHRA provides the discipline and leadership that this powerful industry needs. We recommend that there be an independent review of the MHRA …" 11
Naturally, the UK Government rejected this recommendation, and the need for such an enquiry has arguably increased since then. Most recently, the influential UK Consumers’ Association – publishers of Which? (October 2006) and Drug & Therapeutics Bulletin - concluded, "the time for an independent review is long overdue". They expressed particular concern about the undue closeness between the regulators and the pharmaceutical industry.
This same issue – some basic conflicts between trade imperatives and health priorities – also greatly concerned the Parliamentary Health Committee. It concluded that the Department of Health could not properly focus on health, so long as it also had formal responsibility for promoting the UK pharmaceutical industry – and that the conflicts of interest seemed, on balance, too great. The Committee recommended that responsibility for representing the interests of the pharmaceutical industry should be moved to the Department of Trade and Industry "to enable the Department of Health to concentrate solely on medicines regulation and the promotion of health":
"During this long inquiry we have become concerned that there is a fundamental weakness in the Government’s dealings with the pharmaceutical industry: that is the Department of Health’s dual role in promoting health and acting as ‘sponsor’ of the industry. These roles have not proved compatible. Health and trade priorities are not always identical and their combination leads to a lack of clarity of focus and commitment to health outcomes …" (Para 392).
This recommendation is especially relevant in the European context, because it is not DG Sanco (the Commission’s health directorate), but DG Enterprise (which is responsible for competitiveness and trade) that plays overwhelmingly the dominant part in the design and implementation of European medicines’ policy. The reasons are historical and come to the core ideal of the whole EU – to establish a common market and to make European businesses globally competitive. The European pharmaceutical sector has a key part to play here, and has traditionally enjoyed many official rights, privileges and protections because of it.
DG Sanco played no significant part in health matters until after the Treaty of Amsterdam (1997) and its responsibilities in relation to anything to do with pharmaceuticals, to this day, remain vestigial. DG Enterprise has taken various initiatives, seemingly to position DG Sanco as a supportive and credible presence, but the reality is that DG Sanco is not a major player in the Commission.12 It operates as a junior partner, if not a willing victim of ‘capture’, in a relationship dominated by DG Enterprise.
The impotence of DG Sanco has seemed especially evident in its recent collaborations with DG Enterprise, to try to change European law, to permit the Direct to Consumer (DTC) promotion of prescription drugs – an unhealthy tendency to be sure.13 I have observed this development at close hand, since 2001; it has persuaded me that DG Sanco, if only by default, may be much more of an obstacle than a prime mover in generating health output.
But is it not a positive sign that DG Sanco has now issued this Green Paper – rather that the Enterprise Directorate, whose mission is to whip up European competitiveness and trade? I think not. I see the Green Paper essentially as a bundle of warm words, an appeal that has all the attractions of motherhood and apple pie, whose main purpose is to position DG Sanco as a significant presence in this field, in spite of the evidence that its capacity to deliver is so deeply compromised by the dominance of DG Enterprise and related factors.
Having said that, it was not surprising that the Green Paper was generally well and warmly received.14 This would be hard to explain on the basis of merit; it would seem more likely to reflect the attractiveness of the proposals for many interested parties. 15
ESSENCE OF THE GREEN PAPER
I come now to the content of Green Paper. What is the proposed rationale for DG Sanco assuming new responsibilities in Mental Health? What specifically does it propose it should do, what might it achieve, and what else lies between the lines?For the most part, the Green Paper enumerates the burden of mental health problems in Europe, as if to suggest [a] to neglect the need would be unacceptable; [b] mental health illness is a Europe-wide phenomenon and therefore a "European" problem; and therefore [c] DG Sanco should get on with it. The Green Paper emphasises not only the negative health impacts, but also the "loss of social capital" resulting from economic and social factors, including stigmatisation and erosion of personal rights. Hence this rationale for DG Sanco’s involvement in relation to EU policy objectives: "a high level of mental health is needed for the transition of the European Union into a dynamic knowledge society". (Ugh).
However, the headline emphasis – " ‘Mental illness is Europe’s unseen killer’ says Marcos Kyprianou"16 – does not in itself prove any case for DG Sanco’s intervention. The evidence of need may be overwhelming, and the prevalence of mental health problems real enough, but the case for involving DG Sanco is also subject to important qualifications:
1. To what extent are pan-European interventions likely to be relevant and effective, given the (apparently) huge variations in morbidity and standards of treatment across the EU, also taking into account the present lack of reliable and comparable data? These obstacles, well detailed in an earlier study commissioned (not owned17) by DG Sanco, are barely mentioned in the Green Paper, but would be basic to the formulation of any coherent European mental health strategy.
At present, relevant data is not collected in a comparable manner across the EU, and "the difference in survey techniques and research methods make real comparisons almost impossible". In addition, the lack of any comparative longitudinal studies, "renders it impossible to compare the evolution of risk factors and to link them to mental health, as well as to any promotion/prevention interventions." 18
2. Is the Commission’s existing mandate relevant and sufficient to effectively address the top priorities in mental health? The question matters, because DG Sanco’s legal remit19 in health affairs is highly circumscribed - absurdly so in relation to the powers of DG Enterprise on drug regulation throughout Europe.
Against this background, what exactly is DG Sanco now proposing to do, to "add value" to national actions on mental health? The Green Paper seems very vague on this point, but a fair synthesis might be as follows: "to take action at strategy/strategic level to promote, develop and support a policy framework for cooperation, and a platform for exchange of appropriate information, knowledge and research on mental health."
OK, those weren’t the exact words, nor are they perfectly ranked or statistically meaningful. But here is the evidence of those objectives, illustrated with word counts from the text of the Green Paper: to take action (56) at strategy/strategic level (34) to promote (57), develop (31) and support (17) a policy (32) framework (14) for cooperation (9), and a platform (6) for exchange (4) of appropriate (6) information (15) knowledge (10) and research (18) on mental health (166).
In short, the Green Paper proposals are sufficiently broad and vague, as if to please most of the people, most of the time – though what is really on offer seems much more modest. Elsewhere, Commissioner Kyprianou has explained that, mainly because of its limited remit:
"the Commission will focus its actions mainly on two areas: mental health information, and mental health promotion together with the prevention of mental disorders"20
What kind of information and health promotion might DG Sanco have in mind? The Green Paper identifies depression (26), stress (14), suicide (13) and stigma (9) as the greatest concerns, and mentions a range of other disorders (28) as well. In most such cases, drug treatment would be prescribed as the norm, yet the Green Paper doesn’t mention the words, pharmaceutical and medicines, even once.
DISCUSSION
Beyond the irony, is there not some whiff of a rat? The
treatment of mental health problems throughout Europe overwhelming revolves around
prescribed drugs, yet drug regulation in Europe is in the hands, not of DG Sanco, but of
DG Enterprise - a powerful directorate whose main legal remit is to promote the global
competitiveness of the European pharmaceutical industry. Now here is DG Sanco proposing
that it develops an integrated strategy on mental health. It doesn’t bear thinking
about.
My reading of the politics of the Green Paper is that DG Sanco is now seeking a mandate that has been carefully crafted to complement (never conflict with) the objectives of DG Enterprise, and specifically geared to promoting health messages directly to patients and consumers. DG Sanco’s proposed alliance with patient and civil society organisations, in pursuit of that goal, is not reassuring. Many of the most prominent and pushy European patient groups are closely (financially and otherwise) linked to the very pharmaceutical companies whose products underpin the treatment of mental distress.21
This Green Paper needs to be understood in the content of the closer relationship that has developed between DG Sanco and DG Enterprise in the past few years. The relationship clearly began at the instigation of DG Enterprise, to lend credibility to its own endeavours and specifically to push through the all-important "Pharmaceutical Review" (2002-2004).
Enterprise and Health now operate as co-figureheads in the newly-established Pharmaceutical Forum, a body with substantial pharmaceutical industry representation. Its main objective appears to be legitimise direct-to-consumer health promotion: "Patients want to have accurate, objective and understandable information about pharmaceuticals, and … industry can help to provide information that is trusted." 22
This Green Paper makes quite similar proposals – but goes further. It also positively seeks a mandate (via the consultation) for DG Sanco to go ahead. If it did, I would expect that its output would simply add to the considerable amount of "disease awareness" activity and disease mongering there already is. The extent and threat of that have already spurred concerted opposition, so far in the shape of a powerful joint statement issued by leading independent consumer and professional bodies.23 I strongly support their view.
Is this heresy? Is it not plainly absurd for the Green Paper to propose the building of a strategy for European mental health, leaving totally out of consideration the role and impact of drug treatments? How is the European Commission ever going to create useful, integrated mental health policies, when Enterprise rules, and Health is out on a limb?
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NOTES AND REFERENCES
[1] The Directorate-General for Health and Consumer Protection is generally known as ‘DG Sanco’ BACK
[2] Green Paper: Promoting the Mental Health of the Population. Towards a Strategy on Mental health for the European Union (Brussels: Health and Consumer Protection Directorate-General, 14 October 2005, COM(2005)484) (The term, “Green Paper” is distinctly British English for a consultation document. Formal policy proposals may then follow in a “White Paper”, before Parliament considers any draft law.) BACK
[3] Perhaps I shouldn’t discount experience as a patient. There have been times of seemingly unmanageable wretchedness when I have sought help from health professionals. Treatment standards ranged in quality from inferior to inspired – the best of it on the NHS from two GPs. Both appreciated the great value and many limitations of the drugs they sometimes prescribed – and know the relative importance of non-drug solutions. I would guess such professional quality is far from unique, but far too rare. BACK
[4] I now write mainly on the website, www.socialaudit.org.uk . Operating since 1998, it now gets well over 500,000 visitors each year. BACK
[5] I’m not going to get into formal definitions, nor describe how they became officially corrupted over the years. I refer simply to the problems users often face when they try to stop taking these drugs. Vast numbers of people (egged on for years by dominant opinion in Pharmaceutical Medicine) have inferred the efficacy of these drugs from the mental distress that many users experience when they try to stop taking them – unaware that they are in the grip of drug withdrawal symptoms. A growing proportion of users (more recently through the Internet) attest to their severity and significance. BACK
[6] I deliberately use the term “mental distress” rather than “mental health” – and use ‘treatment’ in the broadest sense – to acknowledge that alcohol and many other (mainly illicit) drugs are so used. Drugs are the main ‘treatment modality’ for ‘mental health’ professionals, also the major resource for many (most?) individual Europeans. There are obvious overlaps between licit and illicit psychotropic drug use: either way, people use them to enhance their experience of reality and/or find refuge from it, in moments of (sometimes desperate) personal need. BACK
[7] The question of balance arises again here: effective regulation should always promote rational and ethical drug use, but never stifle useful drug innovation. BACK
[8] The prevalence of common EU standards does not mean they are matched by performance: country quality is quite variable and can be very poor. BACK
[9] See
www.socialaudit.org.uk (1998-2006)
[10] Declaration of interest: The author was involved in this enquiry, as one of four specialist advisers to the House of Commons Health Committee. BACK
[11]
House of Commons
Health Committee: The
Influence of the Pharmaceutical Industry, Fourth Report of Session
2004–05, Volume
I, Report,
together with formal minutes
[12]
The appointment of Commissioner Kyprianou to DG Sanco perhaps gives evidence of the
Commission’s lack of emphasis on health. Kyprianou was appointed in 2004, when
totally new to the EU – nominated by
[13] See briefing paper at http://www.socialaudit.org.uk/5111-005.htm#HEALTH BACK
[14] See http://ec.europa.eu/health/ph_determinants/life_style/mental/green_paper/consultation_en.htm on the DG Sanco website. BACK
[15]
The consultative process attracted over 200 responses and included a structured
consultation involving a coalition of some 30 interested parties meeting as, “The EU
Consultative Platform on Mental Health”. It credits DG Sanco’s management of the
consultation process – if not the Green Paper – that this group came up with a
number of sharp points that most others missed or ignored. For example: “It would
be unfair to call the Green Paper suggestions complacent given its strong premise, but its
subsequent description of relatively modest, project based, variable quality and sometimes
unevaluated actions is disproportionate to the scale of the problem and the instruments
potentially available at EU level. Actions should match words.” See: Report and
recommendations of the EU consultative platform on mental health: Response to the EC Green
Paper, COM (2005) 484 http://ec.europa.eu/health/ph_determinants/life_style/mental/green_paper/report_%20recom.pdf
BACK
[16]
European Commissioner for Health and Consumer Protection, European Commission Press
release IP/05/27,
[17] This disclaimer is presumably significant; why else would it be there? “Neither the European Commission nor any person acting on its behalf is responsible for any use that might be made of the following information …. The information contained in this publication does not necessarily reflect the opinion or the position of the European Commission…” BACK
[18] Health and Consumer Protection Directorate General: The State of Mental Health in the European Union (ISBN-894-8320-2) European Commission, 2004. This study was done before the later expansions of the EU, so the reported variations between Member States would now tend to be greater than before. BACK
[19] Article 152 of the EU Treaty refers. It defines the Communities role as subsidiary to those of Member States, and requires the focus to be on health prevention, not healthcare. More specifically, Community action “shall cover the fight against major health scourges, by promoting research into their causes, their transmission and their prevention, as well as health information and education.” BACK
[20] Kyprianou M
(European Commissioner responsible for Health and Consumer Protection): Promoting mental
health in the European Union, speech at the WHO European Ministerial Conference on Mental
Health , “Facing the Challenges, Building Solutions” – SPEECH/05/15
Helsinki, 14 January 2005.
[21] See for
example: Does the
European Patients’ Forum represent patient or industry interests? A case
study in the need for mandatory financial disclosure.
[22] Kyprianou M:
Delivering better information, better access and better prices. Address to the Members of
the Pharmaceutical Forum,
[23] Relevant Health Information for Empowered Citizens – joint declaration of HAI Europe, ISDB, AIM, BEUC, Medicines in Europe Forum, 2006. BACK
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