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Regulation

Conceptual work by Yves Klein at Rue Gentil-Be...

When rules don’t work [Conceptual work by Yves Klein at Rue Gentil-Bernard, Fontenay-aux-Roses, October 1960, photo by Harry Shunk. Le Saut dans le Vide (Leap into the Void) (Photo credit: Wikipedia)]

 

 

 

 

 

 

Sir Andrew Dillon, the erstwhile leader of NICE as said that it is irrational for the Cancer Drug Fund to pay for drugs that NICE has turned down.

 

He’s right of course, it is irrational. But only if NICE’s logic is compelling.

 

The problem for Sir Andrew, and likemined people, is that there is another logic that trumps NICE’s rational world. Don’t get me wrong. NICE performs a useful, but technocratic, function with analytical assessments that any rational person would indeed want to know. Where we part company is believing that NICE’s logic is the final word on the matter. Which it isn’t.

 

Tasked, perhaps unenviably, with parsing the performance of medicines and clinical practice, cannot also mean that they are above challenge. Many of NICE’s rulings fly in the face, not of logic, but of our beliefs as humans. It is why we do things when the odds are against us, because not to do so would be wrong. If we think of the challenges NICE faces as wicked problems, that is complex problems with a multiplicity of solutions, it becomes self-evident that their logic is just one way of deciding and choosing. We could use other rules, other criteria. The Cancer Drug Fund is just such an approach. It is another matter whether we should have in place alternative funding approaches that individuals can avail themselves of (such as co-payments or co-insurance); for extraordinarily costly therapies, co-funding would not apply, so we’ll back to the problem anyway.

 

NICE has a troublesome relationship with the notion of ‘rule of rescue’ and so has decided to ignore it. There replacement, the “end-of-life premium” is really just a reweighting of the logic they use.

 

You see, the rule of rescue is what we might call a meta-rule — it is a rule that tells us if other rules are working properly, and importantly, as a moral imperative which tells us what to do. The rule is often invoked in a particular form: that people facing death should be treated regardless of cost. The rule as originally formulated is really about assisting identifiable individuals facing avoidable death (Jonson, 1986); the bioethicists and economists have shifted this to a cost-effectiveness approach, making it one about trade-offs instead.

 

The problem for healthcare systems is that all patients are becoming identifiable as medicines become personalised (medicines may become orphan drugs). The problem for the NHS is that it does not allow such people to rescue themselves because it prohibits any sort of co-funding or other arrangements. The only option is an opt-out (and private medical insurance has rules about pre-existing conditions). Given the funding priorities of the NHS, we should be reflecting not so much on how to make the pot bigger, but on using the money that is available better (there will never be enough money), and ways to introduce practical co-funding.

 

Since individuals have no other options in the NHS, the rule of rescue as a moral imperative will be violated and we will act, not out of analytical error (i.e. make a technical mistake), but unethically. You see, the NHS must be the healthcare system of last resort and therefore of rescue, otherwise, identified individuals are destined to a death sanctioned by public policy and is that a policy or healthcare system worth having?

 

We have seen a similar challenge to NHS/NICE logic recently with the King family and proton beam therapy, and the NHS will also use NICE logic to determine access. Whether beams or drugs, it is the same argument.

 

But why cancer? The main public policy question is why should cancer patients be given preferential treatment as against any other deserving group? This may in part be driven by the often astronomical costs of new cancer therapies themselves, which demarcate cancer patients decisively from equally deserving patients with less cost-contentious therapies. I have just finished some work on motor neuron disease, for which there is one specific medicine and life expectancy from diagnosis is 3 to 5 years, with median survival rates that are measured in months. NICE reportedly is developing guidelines for this disease. Costs are considerable, and at least in the UK, highlight the bureaucratic illogic of separate healthcare and social care, but that is another story.

 

The moral dilemma that the economists at NICE are trying to reduce to an equation is whether a new therapy is extending life, or delaying death. The Oregon approach collapsed when the hard choices emerged and people were unable to resolve this dilemma, which is not a quantitative issue, but one of how we value our humanity. Kierkegaard’s Concluding Unscientific Postscript speaks of the leap to faith as involving self-reflection and the emergence of scepticism. It is worrisome that NICE is so confident.

Further reading

 

Cookson R, McCabe C, Tsuchiya A. Public healthcare resource allocation and the Rule of Rescue. J Med Ethics. 2008 Jan 7 [cited 2014 Sep 4];34(7):540–4.
Jonsen, AR 1986, Bentham in a box: technology assessment and health care allocation, Law, Medicine and Health Care, Vol 14, pp172–4.
Richardson J, McKie J. The rule of rescue, working paper 112, Centre for Health Program Evaluation, Monash University
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It is reassuring that the UK’s Telegraph (see for instance the Telegraph) is maintaining in its pages the stories that Google is removing from seach.

What a right to be forgotten looks like.

What a right to be forgotten looks like.

The European Court of Justice’s illiberal ruling has reminded us that the digital media are in the end ephemeral, easily deleted and perhaps unreliable. The hard copy newspapers are proving themselves what we had forgotten they were — a way of archiving history. If digital storage becomes so corrupted by selective amnesia caused by deletion of links to stories, it will prove unreliable in the end, and undermine the whole point of search.

In that respect, the ECJ’s ruling is regretfully Luddite. It assumes that a right to be forgotten really makes sense. We can instead still hunt through back copies of hard copy journals, newspapers and pamphlets and see both the good, the bad and the ugly of history. Efforts to redraft the historical record by authoritarian regimes now appear to pale when compared to the ECJ’s ruling.

Clearly, there really is no right to be forgotten, otherwise editors and librarians would be far too busy with their physical scissors cutting out references to people and events from their collections. And we all know what history looks like when regimes do that.

There is a view called ‘internet exceptionalism’, that the internet changes everything, and in many respects it has, but we cannot define our fundamental rights solely on the contingent features of a particular technology. I have experience with this in terms of public access to health information over the internet. There have been efforts to censor false and misleading information on the internet, without also noting that much of that same information is available in hard copy in libraries, and bookstores. The spread of ill-informed medical opinions on internet chat rooms is hardly a reason to censor content any more than the state should eavesdrop on private conversations in case someone gives inaccurate medical advice. The world just doesn’t work like that and freedom won’t permit it.

There is another view, ‘technological agnosticism’, that says that we should not construct laws in such a way that they depend on a particular technology which can change, rendering the law meaningless or hard to enforce.  In terms of access to health information, since patients can buy books in bookstores that are just as unreliable as information on the internet, why pick on the internet when the problem lies elsewhere.  The key is to focus not on what the technology does but whether what is perceived to be the problem can be solved without specific reference to the technology. This cannot be done ‘forgetting’, hence there can be no right to enforce it without crossing the line into censorship — and there is no way to square the circle when it comes to censorship.

Unfortunately, we now have a silly ruling that seeks to treat the internet exceptionally, and in an uninformed way.  Indexed library holdings or the table of contents of a newspaper archive not subject to that ruling since putting the index online should not cause that information suddenly to be censorable and in and of itself create a right to be forgotten. But, that appears to be the consequences of the ECJ’s illogic.

So, thank goodness there still exists hard copies of things and that the legitimate press are working to protect access to these stories. As they say, what goes around comes around. If people find that digital archives are being selectively censored, they will lose their value, and with that will come the loss of confidence in the new media, itself. The snake devours itself.

Time to pick up my copy of today’s paper.

Domino Spiral

Death spiral or solution? (Photo credit: FracturedPixel)

There is a flurry of alarmist writing on the financial state of the NHS at the moment. Solutions are usually three: spend more, spend less, find money from other places.

These are not solutions but facts of state involvement in healthcare. While I would not disagree that financing issues are important, they do not alone define the problem. Choices of funding mechanisms are essentially political in most countries and hence reflect the usual rhetoric of political positions. Is there another way forward?

Let me begin by saying that many problems arise because of the descriptive models used and which limit creativity. The NHS has been compared to a supertanker, hard to turn around — so change the story to a school of fish (in organisational terms: greater autonomy and decision-making within smaller functional units). Candace Imison at the King’s Fund wrote recently on her blog that NHS reform was like ripping up plants in a garden and then sticking them back (or in policy terms: reform was careless and presumably didn’t pay enough respect to the fabric of the garden itself). Models such as this summarise a position, without the necessity of intellectual substance. May we be delivered from this.

I prefer to start my policy analysis at the other end, so to speak. What results do we want from healthcare systems and what do we need to realise those results. Keep in mind the current underlying logic of the NHS policy stems from a period that the majority of the population have no experience of, when the UK faced existential risks and government had almost no policy levers to do what needed to be done, except to take over and run the whole show. While evolved over the years, the essential organising logic of the NHS has not changed. Today, though, we have more nuanced policy instruments available, including much better educated clinical expertise, public literacy, higher general standards of education, better ways of looking after the health of people (not perfect, just better) and importantly the ability (not yet realised) of using information better, in real time, predictively, and to anticipate rather than react to healthcare needs of people.

What we do need to do is avoid the death spiral into thinking healthcare is only about funding (“health economics does not equal health policy” hard though that may be for some). Funding is in fact a policy tool, not an outcome. Regardless of how the money is provided, how it is used is what matters.

My suggestion to avoid this dealth spiral is to think about why disconnects arising from financial handoffs cause such major problems with service, impact patient care so badly and contribute to poorer rather than better outcomes. Indeed, my view is that there is enough money (the evidence is pretty clear that outcomes do not correlate with percentage of GDP spent, but on the organisation of care itself) but it will never actually be enough, so we need to be creative, not profligate.

One way forward is to embed payment in the patient, who is the only person to actually experience integrated care (i.e. care that is not disintermediated by funding gaps). The logic of patient action triggers connectivity amongst disparate providers and the patient takes on the responsibility for the stewardship of their own care. The NHS trivialises the potentially disruptive impact of patient choice by financially disempowering that choice as policymakers fear the consequences of disruption more than poor care. Many of the disconnects in NHS and social care are constructs of policy logic constrained by untenable premises. This is not so much about patient empowerment, but the consequences to the structure of healthcare delivery when patient actions determine the funding flows. Berwick and colleagues Triple Aim, which I have operationalised into a decision tool [email me], depends on the ability to intervene and set priorities within a whole-system view of healthcare. This is not hard. The will to do this is.

Organisational logic and clinical will-power alone will not be sufficient to integrate care — if that were true, then the last 20 years in the NHS should be the golden age of integrated care! But what is necessary (but not sufficient) is the ability to redesign and flexibly innovate and introduce change in service structure locally. We will no doubt hear a lot about accountable care organisations from the US, and like in so many cases, UK folk will flock off on site visits to tour these (stopping off for some shopping along the way). ACOs are interesting because they are an organisational solution to care integration (they are also a response to how provider performance will impact their income so survival is part of the logic here). There is nothing difficult about merging health and social care, as long as the providers of these can merge. It is, in this case, not about the money, but about the logic of organisational design for purpose. Regretfully, for the NHS, there is a fear of disruptive new entrants into care delivery. Policy objectives are constrained by two rules: the first is that there is no real (by that I mean meaningful)  failure regime (which is really a set of rules about financial viability) and second that there is a general avoidance within NHS policymaking of the creative destruction of publicly funded institutions (which is a rule about the prudential use of taxpayers’ money).

One last point is about the patient’s entry point to healthcare itself and the logic of general practice as a policy instrument to deliver primary care. I am worried that there are untested assumptions about general practice. I have asked whether general practice is fit for purpose, taking into account questions about what purpose general practice is supposed to have. If general practice is to meaningfully achieve its potential, then we need to see greater care integration around the general practice itself. This is a simple logic that suggests that services should migrate to the point at which they are most used or needed. Obvious examples are at least three. The first is that public over-reliance on accident and emergency (or emergency rooms) reflects a lack of timely resource availability in general practice. (US research shows that emergency room users have insurance and could use their GP, but for the lack of being open). So there is some logic in anchoring around GPs emergency care services. Hospitals, with their own integration logic, can extend their services into general practice (I worked in a hospital that did just that) — this is called the innovator’s dilemma and reflects the inability of incumbents (GPs) to meet their own challenges but we are faced with the fear of disruptive new entrants. The second is that patients often experience a diagnostic revolving door between GPs and hospitals/specialists, until they get a diagnosis and treatment. UK evidence is stark here with delayed diagnosis for many cancers, and I’ll highlight ovarian cancer, cardiovascular disease, and neurological disorders. What we need in general practice is direct access to specialists such as oncologists, neurologists and cardiologists and break the monopoly control by hospitals of these services. The third is whether there is an appetite for general practice to unbundle acute services into primary care, or for hospitals to vertically integrate into primary care. Some wil say, ah, polyclinics, tried that. Well, they weren’t tried. In fact many innovations from abroad have been tried and failed because of the failure of the system to alter its underlying assumptions. The Evercare programme from the US failed in the UK because the test sites would not send cardiologists into people’s homes — the essential enabling logic of the Evercare programme itself. Failure dogs NHS innovations because of the inability to alter assumptions (perhaps the new CEO of NHS England Simon Stevens will reflect on how his former employer, UnitedHealthcare achieved such good results over such a long perid of time and why the NHS failed). (have a look at this for some evidence)

In any case, I hold little hope for disruptive entrants or solutions that challenge the NHS paradigm. The strenght of the funding glue is far too great to let that happen.

In these days of trying to better understand the determinants of rising healthcare expenditure, it is productive to look in the waste bin, to see what is being thrown away. Let’s look in the waste bin and see what medicines we find.

Medicines waste is medicines given to patients that they do not take. But this needs to distinguish between actions taken by the patient, and other factors since not all wastage is patient non-adherence.

The costs include the cost of the medicine itself, but also the changed procedures in pharmacies to reduce patient-related waste (procedural costs drive duplicate medicines ordering on hospital wards, for instance). There is also the costs associated with safe disposal of the medicine waste itself and how patients dispose of unwanted/unused medicines. Environmental contamination by pharmaceuticals is of rising concern. [Pharmaceuticals in the Environment, European Environment Agency, 2010].

Considerable medicines waste arises because the patient has died and correlates with condition: 100% return for anaesthetic drugs, 60% for drugs used in immunosuppression/malignant disease, 26% for cardiovascular conditions, 19% for drugs used for infections. This suggests that gross wastage data needs to be viewed with some care.

Reducing the stock held by patients in the home shifts the stocking costs to pharmacies. UK evidence suggests that “if all repeat prescriptions in 2008 had been issued at just 28 days, then total pharmacy costs would have been even higher – around £2.3 billion, or 28% of the net cost of medicines dispensed.” [Gilmour review on prescription charges, “Medicines Wastage” Prescription charges review: implementing exemption from prescription charges for people with long term conditions, May 2010] This suggests that included in wastage costs are pharmacy dispensing charges.

As in all cases of healthcare expenditure, the challenge involves a complex mix of activities and stakeholders. We need much better tracking of waste, if only to ensure we do not inappropriately target expenditure of medicines without first ensuring that medicines that are being bought are properly used. Industry, healthcare and regulators can usefully work together here.

I haven’t mentioned the environmental impact of flushing unused medicines down the toilet. I’ll let your imagination go to work on that one.

Want to know more?

Evaluation of the Scale, Causes and Costs of Waste Medicines, Final Report, York Health Economics Consortium/School of Pharmacy, London, 2010. This has a good international literature review of costs, but caution is needed in the context of the comments below.

Kummerer K, Hempel M (eds) Green and Sustainable Pharmacy, Springer 2010. See page 170 in for a table of waste by country, but not costed.

In Canada, healthcare in British Columbia is slowly coming apart because of the existence of a private health clinic.

Canada

Afraid, very afraid.

This link is to a legal foundation that takes on legal cases such as this and provides a reasonable overview of the situation: LINK

In Canada there is continuing debate whether the Canada Health Act‘s language that healthcare be publicly administered, means that it must be government-run. A Senate report (LINK here to the final report) of some years ago drew the view that this one of the great myths of Canadian healthcare, but the more publicly acceptable Romanov report caved in to political correctness and said that people preferred a government monopoly.

There is, however, an interesting problem that state monopolies can cause: namely that they may be manifestly unable to provide the services that they monopolise. That is to say, the government controls the whole healthcare system in some form (what in Canada is referred to in part as a single payer system, but in the case of providers, excludes providers that are emantions of the state — i.e. publicly mandated in some form) and in so doing does not provide the range of services or access provisions to meet those obligations. Now, at a simple level, would a rational person accept to buy a service from an organisation acting as a monopoly that could not meet their needs? Unlikely and we’d most likely find somewhere else to get what we needed; but what if you have no choice? This is the essence of the problem in Canada.

The European Court of Justice rulings have caused so much change in access to healthcare across Europe but the really important, in my view, relevant to healthcare actually aren’t about healthcare.  In some work I did a few years ago, some ECJ cases are instructive and may serve to help Canadian authorities identify key factors for their own decision making; the last one of the list is the one that is most interesting:

  • CBEM v CLT and IBP Case C 311/84 [1985] ECR 3261: statutory monopolies have a dominant position in the market
  • Bobson v Pompes Funebres des regions liberyees Case 30/87 [1988] ECR 2479: states may not use a dominant economic position to fix prices and restrict market entry of competitors
  • RTT v GB-INNO Case C 18/88: public undertakings operating public infrastructures abuse their dominant position by excluding third-party service and content competitors
  • Merci Convenzionali Porto di Genova SpA v Siderurgica Gabrielle Case C 179/90: dominant positions are not in illegal, but undertakings may not be created which cannot help but abuse that dominant position in what they are tasked to do by the state
  • Hofner and Elser v Macrotron GmbH Case C 41/90 [1993] 4 CMLR 306: states may not create economic entities with dominant positions that are unable to meet the demand for services, or distort the competitive structure of economic markets.

Now, the ECJ rulings may or may not interest folks in Canada as this would not necessarily present a ‘made in Canada’ solution. It is a sine qua non of Canadian healthcare that the state edifice, constructed by the Canada Health Act, protects Canadians from healthcare costs and trades off greater choice and service access (i.e. waiting times) for that benefit.

Of course, one might argue that healthcare isn’t an economic market, but in fact it is hard not to think of it as such for a number of reasons. It accounts for about 10% of most economies, perhaps 5% of the workforce is employed in healthcare, it comprises provider and payer bodies that interact with each other through contractual arrangements of one sort or another, and there are user fees/copayments, or reimbursements to patients which clearly suggest some sort of economic transaction. Keeping things simple helps, and avoiding the usual arguments that patients are unable to make informed choices or generally do not as such ‘choose’ healthcare as a consumable good, but are forced into a transaction by their liver or heart or an accident. How we get their seems irrelevant: it would be like arguing that the housing market wasn’t a market because people are ‘forced’ into needing housing, or even food….

In my view it is time for the Canada Health Act to be interpreted in the form that Kirby and others in their Senate report urged and enable greater contestability of the provision of healthcare, as long as the basic underlying principles of community risk sharing on the payment side isn’t compromised. It is this latter point that was the essence of the ruling of the US Supreme Court (the bit about mandates and whether payment was a tax or a penalty).

No country today sensibly tries to restrict provision so long as they have control of the payment levers. However, and here austerity raises an ugly presence, healthcare is the biggest item in the provincial budgets and unless the provincial governments figurer out how to bend the cost curve down, this cost area will continue to consume a larger and larger chunk of provincial expenditure. Solutions lie, in part, in creating conditions for consumer (patient) driven reforms; there are no incentives for health professionals to do things differently (i.e. less expensively) when the state decides the structure and capacity of the healthcare system, which might actually under specify what is needed, but overpay for that capacity. Across Europe, healthcare costs are included in the national debt restructuring but we don’t see enough reform efforts as the bulk of the research has focused on state-mandated health reform so little is know about how to take apart a health system. The same holds true in countries like Canada. Sclerotic administrative practices and controls that manifestly restrict freedom of consumers to choose and those choices to lead to system reform need rooting out.

Regretfully, it appears, like in all things that really matter, the courts will force the health reform debate.

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Régulation de la machine à vapeur Merlin

If only it were that easy. (Photo credit: zigazou76)

There have been quite a few cases of late of regulatory failure by the Care Quality Commission [CQC] in the UK.  How can regulatory performance be monitored and improved?

The first thing to realise is that regulators are monopoly suppliers of regulation; that means, that if they don’t do a good job, the regulated don’t have a choice.

Regulators often find reasons to expand their remit (regulatory creep) and because they are prima facie trusted to do their work, regulatory overseers’ consent. Tight performance expectations coupled with effective oversight helps, as does conducting regulatory benchmarking exercises to assess comparative performance with other regulators. This helps keep regulators focused and not get drawn into expanding, like a gas, from what they need to do essentially.

The people who work as regulators invariably derived there expertise from the industry area being regulated. In the case of the CQC, people who had worked in hospitals. This creates an obvious risk in terms of ‘regulatory capture’ by the regulated. The NHS used to speak of being a ‘family’, all cosy, and as we all know, in families it is important to support each other and suppress dissent — paternal/maternal models of behaviour dominate.

But, regulators need to learn how to adopt new behaviours from what got them the job in the first place; much organisational failure arises from failure of people alter their behaviour as roles change. The relationship between regulatory and regulated cannot be chummy; it must be built on evidence that the regulator knows what they are doing and are not going to be compromised by past relationships or a need to be ‘liked’ by the regulated. The selection of the ‘great and the good’ to act as chairpersons and chief executives risks individuals putting their own reputation ahead of the need to regulate with vigour. Sometimes, as the NHS is learning, regulators have to have the teeth to do what needs to be done.

Perhaps more relevant is how regulatory inspectors use their knowledge when inspecting a hospital. While one hopes they use their knowledge well, they are not immune from making assumptions that something is happening (because in their experience seeing ‘A’ means ‘B’ is happening, when in fact it may not). I recall doing some performance work in a UK NHS hospital, and as I was walking through A and E and noticed that guideline posters were both out of date and not dated.  I was told they would change that immediately. Well, mundane stuff making sure guidelines are current, and dated as such, but pretty sloppy. Perhaps a regulator might assume that staff would know what to do. A risky assumption.

Regulatory inspectors need to be able to test all the systems to ensure the are working together. This means, for instance, taking a patient chart at random from the records and tracking the patient care through to discharge, and perhaps follow up at home.  I did a review of discharge on an NHS hospital and was looking at the charts and asked the ward staff about discharge plans for various patients. I was told for some of them that they didn’t have target dates, but that they made up dates for patients to keep them quiet. I asked what the patients thought of this and they said they usually forgot anyway. Needless to say, this sort of dishonesty is easy to catch (the staff thought I was ‘like them’ and would understand the need; I wasn’t and I didn’t); doing good chart audits of this sort are part of a detailed hospital regulatory inspection. Are the staff still dishonest, though? Let’s just say they didn’t do very good care planning as they had no target dates for discharge against which to calibrate resource use and then review when things didn’t happen as planned. Easy to pick up. With better care planning, it is easier to be honest with the patients.

I take a leaf from the nuclear industry regulatory inspection process. A basic assumption is that the regulated have good reasons to conceal, mislead and hide relevant information.  Since the stakes are high that poor inspection leads to system problems (think Japanese report on Fukushima nuclear site), starting from a position of doubt about the veracity of information enables a more robust approach to regulation.

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Genie

Image via Wikipedia

Does the proposed amending directive on providing medicines information to the general public (sometimes thought of as advertising) actually enhance patients’ rights? Will it lead to good regulation? The document in question can be found here.

I’ll grant that a lot of people have been involved in this, so there must be some consensus, but is the proposed directive strictly in the patient’s best interests and how are we to truly cost the benefits?

The document itself is cumbersome as if trying very hard to close off any possible loop-hole in case advertising disguised as information might slip into the hands of an unsuspecting patient. To do this, a variety of tests are proposed, a net through which information must pass, presumably though, not advertising, that might meet these tests:

  • objective
  • unbiased
  • evidence based
  • up to date
  • reliable
  • factually correct
  • not misleading
  • understandable
  • meet patients’ needs and expectations

These tests are all good things, and I have no issue with them as such; certainly one would not wish to be in favour of subjectivity, bias, opinions full of errors and likely misleading, despite being incomprehensible — I suppose much like an insurance contract.

If I prioritise the last though, meeting patients’ needs and expectations, information would need to pass these tests for a reason other than internal scientific tests, namely, that it be useful. My fear is this process will produce information that may struggle meeting the test of being understandable. The reason for giving the information itself is to help the patient after all, so starting with their needs seems to me to the test against which I would assess everything else. Of course, little in this world passes these tests anyway, or if it does only for a very short space of time, and even then, facts can be in dispute and there are differences of opinion over how to interpret them. What we are left with in this proposal is a technocratic solution for what in the end is a human need for information.

What are policy makers afraid of in drafting this directive? What do they fear should patients have more information? And have they fully costed this approach?

It all seems to very old-fashioned and dated. Like trying to put the genie back in the bottle, I think this in time will prove to be the actions which caused more harm than good. Indeed, it may be that the benefits are less than the total system wide costs.

The question, then, to ponder further, is what decisions by patients are enabled through this directive, how does it specifically enhance the rights and needs of patients (keep in mind that most health systems neither respect nor completely understand what these mean). Certainly, taking a decision-based approach, perhaps a ‘decision architecture’ which determines what information in what form is needed to help patients make what sorts of choices, then we might know better what degree of ‘coercion’ is needed, if any — but can you give me an example where it is even ethical to withhold information from a patient?

Of course, such an approach would would be in conflict with this directive which builds on the view that only health professionals know best. Hardly a firm foundation for legislative reform of this magnitude. But we need to think of whole-system regulation and the distribution of costs and benefits on that basis, and not just the information issue itself.

I am not surprised that it has come to this, as there is a sort of ‘consensus’ amongst professional vested interests that an information and advertising free for all would lead to chaos, loss of control of drug budgets, and a flood of advertising on our televisions and newspapers about drugs influencing hapless patients and consumers (as though advertising to doctors didn’t achieve similar effects). But compared to the monastic model we have now, where patients know less about the drugs they take than the amount of fat in a kilo of ground meat, it would serve to open up to greater scrutiny industry claims and counterclaims. This lack of knowledge itself has a cost and serious consequences for the costs of healthcare systems.

Recently, the Economist has noted in an article on red tape in Washington how the various costs of regulation are identified, and how wider public benefits are calculated or missed. The US Congressional Budget Office has speculated that a moratorium on DTC would likely have perverse consequences and be unlikely to lower drug prices, and only shift advertising toward physicians. This of course challenges the narrower focus (not meant pejoratively) of the Directive which clearly fails to take account of wider regulatory costs, which are ignored as they fall outside EU competency. These regulatory costs include but are not limited to:

  • the potential beneficial impact on treatment costs and compliance with medicines regimes arising from wider engagement of patients in their care
  • the potential corresponding (and likely beneficial) challenges to the authority of health professionals (but ignoring that many countries are seeking to encourage patient selfcare which is designed to achieve just this result), who are influenced in other ways in their choice of medicines, with considerable evidence of irrational and inappropriate prescribing, despite efforts to counter this
  • greater awareness by the public of national medicines policies which may actually encourage greater cost efficiencies, such as trade-offs between medicines and inpatient care, as well as greater public scrutiny of how new drugs gain market access (a process which the public has little knowledge of and which has perverse consequences in many cases for patient access to new medicines — something an informed patient may wish to have a view on)
  • greater public awareness of the decisions of health technology assessment agencies, which may raise serious social and ethical issues
  • the possibility that the costs of regulation and claimed benefits to the health system may lead to the loss of research productivity and innovation from a more open environment; indeed the losses here may swamp the regulatory benefits.

I think keeping patients in the dark, as some have written, leads to greater system costs, and perverse consequences and incentives, than full and open disclosure to the public of medicines information, and indeed, even advertising. In an open environment, claims are tested in the real world and can be taken into account in whole-system benefits realisation, not exactly something that is designed to create an additional layer of regulation. In the end, the patient is excluded from playing an informed role in their own healthcare.

Want to know more?

Keeping Patients in the Dark, by Cardy, Edwards and Gay, Civitas, 2000. (Amazon sells it)

Benefits and harms of direct to consumer advertising: a systematic review, Gilbody, Wilson, Watt, Qual Saf Health Care, 2005 Aug;14(4):246-50.

Direct to Consumer Advertising is legal in the US. This is some material from the FDA: Information for Consumershttp://www.fda.gov/Drugs/ResourcesForYou…

US Congressional Budget Office, Potential Effects of a Ban on Direct-to-Consumer Advertising of New Prescrption Drugs, May 2011, Economic and Budget Issue Brief.