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Obama and Health Reform in the USA

President Obama’s comments today to the American Medical Association in Chicago represent the slow, but certain, turning off the health reform supertanker that is the US healthcare system.  Despite evidence of the need for improved clinical working practices, use of guidelines, better use of evidence, powerful groups have resisted over the years opportunities for root and branch change.  Speaking to the AMA, Obama identified a few key barriers he sees as crucial to change:

  • eliminate the notion of pre-existing conditions
  • find alternatives to fee-for-service reimbursement
  • share best practice better.

Of course, there are many other moving parts within each of these, and others he mentioned (e.g. generic medicines, clinical IT, etc.).  But these three offer opportunities for substantial realignment with the US.  In turn, and briefly, by eliminating the insurance barrier of pre-existing conditions means adopting population-based health risk.  That moves the US to social insurance models familiar to Europeans.  The problem will be overcoming the problem of free-riders, which be-devil some US policy commentary, but free-riders in automobile insurance claims are not quite the same thing as someone who is poor and in ill-health getting access to healthcare.  Alternatives to fee-for-service opens the door to outcomes-based payment systems, enables better bundling of care across clinical pathways and more closely aligning payment to what actually happens to patients.  By integrating care, financial incentives move closer to actual clinical and hospital work patterns; similarly, with innovative thinking about how to structure reimbursement based on outcomes, payers can more effectively encourage reform with hospitals, to move them away from fragmented care.  Sharing better practice should seem the natural thing to do, given that everyone in the end does benefit when good practices are shared.  But sharing better practice can undermine competitive advantage in market-driven health economies; by shifting to alternative payment systems, sharing practice will make more sense, especially if payers act together.  However, ever mindful of potential for collusion, payment systems and information sharing must enable consumer and payer choice, rather than close down options, in an anti-competitive spirit.

This president is compelling in his expression of the anxiety so many Americans feel about what is wrong with their healthcare system, and he is to be commended for taking this challenge into the heart of the medical community.  In that respect, I am optimistic that some sort of change will come in the US.  More importantly for other countries’ healthcare systems, we see a lesson in a way to conduct health reform.  His big-tent approach is a lesson for other countries that feel health policy and reform comes from aligning the interests of narrow interests, of specialist commentators, academics and civil servants.

One lesson to take away is that health reform is something that must be conducted within the society, with all the key participants engaged.  It is not just the culmination of a rational research study, using contracted experts, who more often than not breathe each others’ air.  No longer, I think, can international observers be critical of US reform intentions.  Indeed, for some countries who think they have a pretty good and publicly funded system, US reform may show them to be small, mean-spirited systems, narrow in focus and costly overall.

E-health and Ontario

From across the Atlantic comes news of apparent financial maladministration at E-Health Ontario, the body charged with implementing the province’s e-health strategy.  It seems to be the usual nonsense of untendered contracts, friends in high places, and chums helping chums.  It is also an example where no one seems to have asked the simple question, “why would you do that?”  — the strategy is a nonsense, and I am surprised that no-one challenged this before the policy had gone this far in implementation.

I would, naturally be more inclined to be concerned if the province’s e-health strategy were actually about e-health, or likely to deliver results worth having, but the $700 million or so per year will be spent on things like a diabetes registry, wait times, electronic prescribing/electronic health records.  Only the last have anything really to do with e-health.  The last can also be procured, so there really isn’t a need to make a supplier meal out of putting something in place.  I will concede though that an EHR is a critical component of e-health, but it isn’t quite the same as e-health — it is a bit like confusing the foundation of a house with the home it will become.  But having worked on eRx,  the province’s failure to prioritise some sort of a patient-held smart card is a mistake as without this it is difficult to deal effectively with identity.

Without system redesign in the province, the e-health strategy is really just throwing good money away and given the current economic (and political) climate, this is no longer an option, if it ever really was.

Two things are of critical importance.  First the province needs to have a thorough-going governance review of e-health Ontario, mainly to determine how to make sure it is fit for purpose in actually providing the leadership for development of an e-health infrastructure service delivery platform.  Secondly, and this is the challenge, it is necessary to make sure that the e-health services are ones that the public will use and value.  The province has failed on both counts.  The next challenge though will be to find people to review e-health Ontario who haven’t been tainted by this scandal and benefited from the feeding frenzy e-health Ontario created. It may require looking further afield, to interested, but uncontaminated parties.  They may even not live in Ontario — golly gosh, so much for made-in-Ontario mediocrity.

So, having vented on that last point,what would an outline e-health strategy look like for Ontario, assuming that some governance arrangements are put in place,.  These are really just illustrations as certainly I would want to get a good understanding of priorities from interested patient groups:

  • There are about 92 rural and small hospitals in the province.  A good plank in an e-health strategy would be to enable them to become a single, integrated, but distributed healthcare provider, perhaps with some sort of local and shared corporate governance.  A distributed healthcare provider, using e-health infrastructure technology would deliver specific outcomes to rural people, such as access to networked diagnostic imaging technologies, electronic prescribing and remote access to health records.  I would certainly save people in Thunder Bay a lot of trouble getting down to Toronto for a scan.  With a little bit of imagination and thought, this could work.
  • About 60% of diagnostic facilities are located in Toronto, but which has only about 25% of the population; these are licensed clinics which often only offer a single procedure.  Using networked imaging technologies, remote diagnostic telecare booths (you can buy one from Cisco) many of these suboptimal centres could be relocated either to the rural network, in the previous plank, or provide a more accessible urban service across the provinces main urban centres.
  • Smart card technologies (whether a smart card or an electronic secure passport) would give a better reason for constructing electronic health records than ones focused on improving data access for health professionals alone.  Patients, when given access to their health information, will have a vested interest in ensuring that the information is correct (my Ontario health record when I lived there had an error showing I had a condition affecting women, but I am a man — I still don’t know if the error was corrected; in an electronic system, that error would have been a problem, but I would have made certain that it was corrected, too).  As an ‘auditor of one’ patients can make sure information is correct, and drive substantial service quality improvements.  This is not to say that health professionals can’t do that, just that the evidence shows it comes slowly and is complicated by cartel-like professional practice barriers.  Start by putting the e-health card in the hands of the heavier users of the health system, to better manage their healthcare, access to information, and gradually as people see their family doctor, or get born, migrate the whole population over.  Of course, this will mean that family doctors, clinics, pharmacies will have to adopt some sort of information system.
  • Don’t do what the English NHS is doing with Connecting for Health, by creating a large-scale government-led initiative.  E-health Ontario’s predecessor took a look at Denmark, but failed to learn the lessons despite what they wrote in their sham of a consultation document — they missed the point partly because they appeared to have another agenda heading toward a particular solution.  Denmark has shown how disparate stakeholder groups can work together to create an information system that works, and does things people value.   Better that than spend vast amounts of money on a grand plan to nowhere.

The general plan is to build an infrastructure that starts with the patient/family as user.  My experience in developing an interactive health television channel showed me the importance of starting there, and defining the benefits from that perspective.  Change will drive from that end too.  Finally, engage all the stakeholders (like the Danes did), find commercial partners with interesting technologies that do things that people value (rather than whizzy technologies), look for alternative systems to pay for healthcare services, as failure to develop a suitable and workable reimbursement system for e-health services is a barrier ( just ask Norway).  Oh yes, don’t forget political will.

Conflict of Interest, Ad Hominem Criticisms, and the search for truth

Within the health research community there is significant concern about the need to disclose sources of conflict of interest. In most cases, this is taken to mean having been paid by the pharmaceutical industry, although conflicts can arise from any paid employment, contractual or not.  Indeed, rarely is it meant to cover work for governments, though that can produce equally troubling conflicts of interest.  The problem is what is in fact a conflict of interest such that bias may be present.  We all have opinions and views on things, and can hardly separate ourselves from the wider part of our lives without some harm to our psyche.

I wrote a commentary on a paper published in the BMJ and which in part dealt with a policy of the Italian government to levy a tax on the pharmaceutical industry, the money being used to fund independent clinical trials.  I said the policy was not a good idea, and that in the end it would do more harm than good.  As I was not retained by any particular private sector client at the time of the writing, I did not declare, within the BMJ guidelines, any conflict of interest; indeed, the views I expressed are hardly favourable to either the government or of industry.

I see the Italian policy as bad policy, and not particularly favourable to the pharmaceutical industry.  But I actually think it is just bad policy!  It will have, I think, perverse consequences and could impact how the Italians improve the quality of their scientific enterprise.  It is perhaps another matter whether the pharmaceutical industry agrees with me or not. So my views are my own based on a pretty bog-standard policy analysis.  A bit like this blog.  But there is some evidence that countries that have weak pharmaceutical industries also have weak biomedical research infrastructures, as this sector of the economy is, in general after the aerospace/defence industry, the largest spender on research and development.  So not having much of one might actually mean something

The problem I have is that no one seems to be able to assess whether the policy is good or bad.  Intervening in their analysis and assessment of my views is whether I have a conflict of interest in those views because at some point I did some work for some or other client. Instead, I find ad hominem criticisms, without addressing whether the points I’m making are cogent.  I believe the BMJ is now moving to remove comments from readers that lie solely in attacks on the authors, and fail to focus substantive issues.

Is this where we have come in the world of academic debate, that one’s views must first be filtered through some politically correct screen to determine whether one is even allowed to hold certain views.  Perhaps more troubling, people assuming that where there is/isn’t a conflict of interest that those views either are or are not acceptable.  So much for truth.  In policy work, political correctness is a hindrance on the search for effective solutions to compelling social, economic and other problems as failure to look the devil in the eye, means that policy developers cannot ’speak truth to power’ and giver policy and law makers real choices.

Health Markets: part 2 — gaming, modelling

Gaming and simulations plus modelling are health markets that look very interesting:

Predictive modelling

  • to help people understand and manage their health better by using modelling to visualise health states using avatars and body-image
  • moving beyond the use of predictive modelling and data mining to find high- or at-risk individuals for case management purposes
  • link modelling to powerful mapping visualisation technologies to enable better decision-making and planning

Simulations and games

  • engaging health professionals and consumers in simulated environments using gaming methods

Other ‘parts’ to come looking at other emerging health markets.

Health Markets: Part 1 — key commercial questions

There is a tension between health systems and their need for innovative technologies and the absorptive capacity of the health system itself to both adopt an innovation and modify existing clinical practice to release the full benefits of the innovation.  From a policy perspective, this presents a variety of problems not the least of which is that it is largely pointless to put more money into unreformed health systems.  From a commercial perspective, how is business to decide what are priorities, what are the innovations to back and what markets will adopt them.  Governments and payers can do much to signal markets what their priorities are and back that with appropriate reimbursement policies to enable these technologies to earn their way in the world.

But it is not that simple, and there is a clear need for policy makers and ‘the market’ to interact productively, so both win.  In the absence of this, we will have the continuing saga of the medico-industrial complex driving technologies forward but with no payers.

Competing interests characterise what people think are healthcare technology priorities.  With the often overbearing weight of government, healthcare technologies often reflect preferences that emerge from the policy priorities of governments  locked in an iron triangle with industry and (usually) doctors.  This medico-industrial complex leads to technologies that are sought by doctors, and when companies seek guidance for their own product development priorities, they consult doctors, and around we go. There is some good reason to do this, as it is widely argued that it is doctors who decide what services, medicines and devices patients will end up using, so it is sensible to ask them what they would like.  The problem with this is obvious, as doctors are not consumers of the functions of the medicines or devices they prescribe.  That countries are invariably forced into some form of economic evaluation of health technologies and the use of prescribing guidelines offer some evidence that doctors, in this case, cannot in the main be trusted to make appropriate decisions in this respect.

Let’s take e-health as a case in point.  Often confusingly called ‘telemedicine’, the priorities range from devices and services that patients may actually use, to technologies to facilitate consultations and information exchange between health professionals.  The latter, though, is really just the automation of existing clinical practice.  The former is far more interesting, and far more disruptive of existing practices — perhaps that is why we don’t have much of it?  Then there are technologies that really have a major impact on disease diagnosis, but which are expensive, but through elaborate clinical protocols are restricted or limited — why not adopt ‘best technology first’ and stop wasting the patient’s time.

The issues that I want to explore in further installments are these:

  1. Following work by Christensen and others, how can health systems identify technologies that will have the positive benefit of disrupting in the nicest possible way stale clinical practices and yield an order of magnitude improvement in health system productivity (with a corresponding decrease in per-capita costs)?
  2. What technologies are most effective from a patient/end-user’s perspective and that they will actually value and use?
  3. What commercial realities are needed to enable sensible reimbursement of e-health services by payors?
  4. How do we research, invest in and commercialise winning technologies and move them very quickly into use?

That is to say,

  • how much do we really want to reform health care delivery using innovative technologies, and what implications will that have on our current approaches and assumptions — this is as much about clinical change as political will;
  • what technologies can we have now, today or soon;
  • how can we use reimbursement/payment systems to encourage use and uptake, and
  • why is healthcare so slow to adopt new technologies?

Stay tuned.

Interventional Radiology: Why the delay in adoption?

Progress in healthcare can come from changes to the way clinical work is done.  An example is interventional radiology, which combines radiological investigation with treatment, in a single step.  It moves radiological technologies, such as MRI, CT, Ultrasound, from being mere diagnostic technologies to integration into the surgical work itself.

So why the slow uptake in the UK where a couple of years ago the Healthcare Commission, in one of its investigations, noted that this approach to treatment would have probably saved lives?

The NHS is a slow and late adopter of technologies.  Difficulties giving the necessary clinical freedom to health professionals means that important leading edge, but proven technologies, are slow to be adopted.  The exploration of novel approaches to offering clinical services, outside of hospitals, for instance, in free-standing “theranostic” (therapy and diagnostic) clinics would not only advance the cause of patients, but achieve a step change in service delivery by NHS providers.  Why aren’t the newly freed Foundation Trusts getting on the business of developing services wrapped around this approach to care?

People are obviously of good intent by urging reviews of funding to elected officials in the suitably hushed setting of the House of Commons, but in the gritty reality of healthcare delivery, creative solutions are needed to address not only the timely implementation of interventional radiology, but alsoovercome the fear of change, of novel technologies and of changes to  clinical practice that change and technology brings.

Ontari-ario: innovator and leader, or just left behind?

A recent two week work schedule in Toronto had me reflecting not only on how much snow there can be in my homeland, but also the need for a real electric charge to the province’s policy making.  The province is facing near meltdown, after an ill-conceived pursuit of manufacturing jobs in the automotive sector, with some 150,000 manufacturing jobs lost over recent years, never to be seen again.  Trying to jump-start this industry with taxpayers’ money seems a bit like investing in buggy whips while watching Henry Ford’s Model T drive you to town for a nice lunch!

Investing in universities and research has been coupled with a punitive tax regime, that drives new businesses into the arms of other provinces, or to the US.  Early-stage venture capital is scarce, and the mandarins on Bay Street that do profess to know what to do are more focused on generating returns to their funds (or these days just keeping the rent going on their plush offices), than on understanding the driving force that is the commercialisation of research.

Brains not brawn should be the cornerstone of provincial policy.  This will become especially important as the US, largest trading partner with a 10:1 ratio of US scientists to Ontario/Canadian scientists ramps up scientific investment after a near-decade of scientific politics under the last elected regime.  That sucking sound you will hear (apologies to Perot) will be American scientists returning home to the US.

Ontario, time to get the boots on, review taxation policy, look to rethinking what the best use for bail-out money really is.  Some industries will go and that is sad, but what will replace it will establish the future credentials for the province for at least this half of the 21st century.

Unless, of course, you like buggy whips.

Paying for healthcare and real choice

The UK is again in the midst of a crisis of purpose as it seeks to understand how to balance the monopoly (under) supply of health care that characterises the NHS, and enabling individuals to purchase (mainly) medicines that are deemed too expensive.  Apart from the argument made in an earlier posting that the NHS cannot get off the hook of paying for high cost healthcare, rationalising the current mix of copayments can only be good.  The effect of enabling top-ups (as if that is really what they are, of course), or more accurately copayments, would actually harness a variety of features that currently elude UK health policy makers.

Enabling wider use of copayments (also apart from the literature which would say they increase social injustice and are an example of a policy zombie), would turn the UK NHS into the French health system — and given the evidence from France, that might not actually be a bad thing.

Such a change would have the effect of clarifying the current dispensing fees for medicines, bundling them with the cost of medicines deemed by NICE to be excessively costly, and enabling payment by individuals through suitably prepared supplementary health insurance — which reversing the senseless actions of the Labour government in 1997 could be made tax deductible.  It would also enable a simplification of the current gap between NHS and private dentistry (by blending entitlements) and enable easier utilisation of the wider healthcare infrastructure of public and private (sorry, not very politically correct here, independent) provision.  Further bundling with individual social care budgets would open the way toward consumer-led purchasing of healthcare, something of considerable interest to people with long-term conditions who no doubt dislike others telling them how to lead their lives.

All this would provide the needed disruptive influence to drive provider reform and improve quality and system responsiveness much faster than would otherwise be the case if the PCTs, ICOs and whatever next crops up, were to try to achieve the same goals through institutional planning processes (not an easy thing to do with complex adaptive systems that in effect ignore the impact of patients in the system).

No need to create a market, no need to fuss about social justice, individuals would be given responsibility for their care and that is a just thing to do. The NHS in its current form  effectively insulates individuals from the consequences of their own poor health and lifestyle choices which only exacerbates injustice to the extent that it undermines individual autonomy.

Rather than copayments having the economic effect that various folk have written about, policy makers would have instead a mechanism by which public health goals could be pursued, through a partnership between the state/NHS and the individual, rather than a partnership between the state/NHS and PCTs/itself, with the patient as an interested, but disenfranchised bystander.

NICE, the Rule of Rescue and Supererogation: or what’s the State for anyway?

NICE’s position on the rule of rescue is incompatible with the purpose of the NHS as a state mandated healthcare system which must at least be the option of last resort for people where social values and preference would provide healthcare — despite NICE’s analysis.  Government cannot let HTA bodies such as NICE ignore the rule of rescue.  NICE argues that it adequately takes account of this — but there is a discontinuity in the applicable decision logic below and above NICE’s QALY threshold.  NICE in effect is applying below the line logic to above the line issues.  The issue of compliance and indeed civil disobedience may be applicable as doctors are prohibited from violating their professional codes of conduct, or acquiescing in acts or procedures that would cause them to violate their ethical code.  A doctor strictly speaking cannot not aid a person caught by the NICE threshold cutoff, where they are able.  The state is obligated to interevene and pay for expensive care as it is not an act of supererogation, but it is the State’s duty. Therefore, the State must act in cases above the line out of duty –  aiding people who might cost a lot by HTA QALY benchmarks but if the state doesn’t act, and who will?  This is especially troublesome in the UK where the NHS is presented as the health provider of last resort — not something NICE has clearly thought through.  Will the politicians allow NICE to wag, so to speak, the objectives of universal healthcare?

When will we build the last hospital?

Central to all healthcare systems is the notion of the hospital.  Are these remnants of industrial-age or can they be rethought and refreshed for the post-industrial and information world we are likely to inhabit for some time?  Foucault spoke of the birth of the clinic (hospital); I will write about its demise.

The logic of hospitals has a lot to do with aggregation of technologies and brains.  It is easier to move the patient to the hospital where integrated systems kick in and provide care, than to have all that expertise go to the patient.  That paradigm is getting tired, but yet our thinking is still hospital-oriented.  What is the way out?

Evolution of artificial intelligence systems, for instance, points to the possibility of remote locations having access to clinical brains, either embedded in portable diagnostic technologies, or through distributed intelligent systems, or even more mundanely at the end of a telephone.  Perhaps it will take time to be comfortable with robotic surgeons, but remote manipulation of robotic surgical equipment is not inconceivable in daily use.

A rather interesting book from the early 1970s, by Maxmen, The Post-Physician Era, offered thinking about the direction of travel.  While getting many things wrong — we still don’t have shopping malls on the moon, he did, given the thinking of the day, accurately identify AI as a challenge to human diagnosis, and saw the obsolescence of the pharmacist through robotic dispensing.

The overall forces at work here are the migration of specialist human knowledge into devices and into software, that can be used by less-skilled people (i.e. not necessarily clinical professionals).  Self-diagnostic testing kits are just a primitive example.  Roll the clock forward with electronic health records, Web  2+.whatever, and advances in materials science, etc, and we have a constellation of factors which form a new pattern for healthcare service delivery.

And when will we build the last hospital?

It takes perhaps 3-5 years to plan a hospital and a couple to build one.  It is also critical in the design to take into consideration the evolution of use, changing demography, etc, to perhaps 20 years into the future.   I think by 2025 we will acknowledge that the existing hospital infrastructure should not be replaced, but slowly wound down as useful clinical environments.  Given the average useful lifespan of anything from 25 to 100 years, we need to be thinking the thoughts about the last hospital within the next 5 to 7 years.  There are, no doubt, hospitals in the early planning stages, that when built will be instantly obsolete.

Tempus fugit.

A federal approach to cross-border healthcare in the European Union


With the release of the European Commission’s communication on cross-border health services [Communication from the Commission, follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM(2004) 301 final, 20 April 2004] and the proposed services directive which will implement the various rulings of the European Court of Justice on cross-border health care [Proposal for a Directive of the European Parliament and of the Council on Services in the Internal Market, COM(2004) 2 final, 13 January 2004], momentum will now build to really understand the potential for a European health system.  While a wholly integrated “European Health Service” seems unlikely, the status quo is also not sustainable.  So what is to be done?  One approach is to learn from countries with federal health systems, where responsibilities are split between the national/federal government and lower levels of jurisdiction, and how they accommodate the different objectives of service delivery at one level, and integration of systems at another.

Canada offers a particularly interesting example since its highly decentralised health system is composed of the autonomous health systems of the provinces, with a federal Canada Health Act [Canada Health Act, 1984] to enshrine particular national standards.  Such an approach offers a way forward for the EU since it recognises that there are legitimate issues that overarch the responsibilities of member states, yet accords to the member states their own sphere of autonomy.

The Canada Health Act sets out specific standards which form the cornerstone of the health system’s national design:

  1. public administration: the administration of the health care insurance plan of a province or territory must be carried out on a non-profit basis by a public authority;
  2. comprehensiveness: all medically necessary services provided by hospitals and doctors must be insured;
  3. universality: all insured persons in the province or territory must be entitled to public health insurance coverage on uniform terms and conditions;
  4. portability: coverage for insured services must be maintained when an insured person moves or travels within Canada or travels outside the country; and
  5. accessibility: reasonable access by insured persons to medically necessary hospital and physician services must be unimpeded by financial or other barriers.

The important step that the EU must take is to move beyond the development of a purely bureaucratic approach to cross-border health care (by simply making existing regulations more complex [Council Regulation (EEC) No 1408/71 of 14 June 1971 on the application of social security schemes to employed persons and their families moving within the Community]) and embrace a few good principles.  I would propose the following as a starting point, to create a simple basis (no mean feat in European affairs!) for member states, the Council of Ministers and the Commission to establish the basis for an agreed approach:

  1. portability: insured individuals may seek health services throughout the EU in a uniform manner;
  2. accessibility: reasonable access is assured to insured individuals to medically necessary health care with fair administration of cross-border entitlements;
  3. comprehensiveness: all medically necessary care that meets international standards is covered;
  4. accountability: consistency of services and adherence to standards across the EU is provided by public bodies.

It would be a good founding agenda for the new ”High Level Group on Health Services and Medical Care” to explore whether principles such as these might provide a cornerstone for cross-border health services in Europe.

Learning from federal health systems will reveal the potential scope for a European agenda, driven by shared values and principles.  It is important and timely for health care professionals, policy makers and everyone concerned with health to understand the implications of greater Europeanisation of health care as it will drive much of the logic around quality, standards and accreditation to the EU level.  But this will also require greater scrutiny that can only come from a single, EU-level tier.  That is why key design principles, such as the ones suggested, are needed.

Having a set of guiding principles will help to ensure that future European health care developments are sensible, productive, transparent and benefit us all, while respecting national and European interests.

Counterfeit medicines are a global threat to human health


How can I be sure the medicine I take is genuine?  In some countries, there is an almost even chance that it is counterfeit; not just a cheap substitute, but a real fake,  ineffective,  probably harmful, and maybe fatal.  Some counterfeit medicines were found in Hamilton, Ontario, earlier this year and the pharmacist has now been charged by the RCMP.

Counterfeit medicines are a global problem, with trade estimated to exceed US $36 billion a year.  The World Health Organization estimates 8-10% of all drugs supplied globally are counterfeit.  The European Union estimates counterfeit drugs cost their health systems €1.5 billion annually. 

Counterfeits are a clear and present danger to human health.  Africa is threatened by counterfeit AIDS drugs, while in Haiti, Nigeria, and Bangladesh almost 500 mainly children were killed from fake paracetamol syrup.  Perhaps 192,000 people were killed in 2001 in China from counterfeit medicines.  Counterfeits circulate in the European Union, with two recent cases in the UK alone.  And Canada

Fake medicines are hazardous, with documented toxicity, instability and ineffectiveness but few people are experts in pill authentication (even pharmacists get fooled).  Counterfeit drugs are easier to make — in portable cement mixers – and fake than money.  But there is little patients can do but rely on assurances by others that drugs are genuine.  That may not be good enough.

Our health and medicines regulators believe there isn’t a problem because there are few cases.  But recent research in Europe counters this regulatory denial with evidence that regulators have little hard evidence on the scale of counterfeiting.  Problems with medicines are rarely associated with the drug being fake.

Counterfeit medicines don’t just show up in the local pharmacy, they are infiltrated into the supply and distribution of legitimate medicines by rogue, criminal organizations and individuals, who specifically target the weaknesses in this system.  But counterfeiting is seen as a patent issue not the criminal act it is.

Once a medicine has been factory sealed by the pharmaceutical manufacturer, there is no assurance that it will reach the patient unopened; a pharmacist and doctor can open it.  However, there are companies with the licensed authority to repackage factory-sealed medicines with new labels in new languages.  Unscrupulous distributors can conceal the illegal substitution of counterfeits within our apparently highly regulated system.  Canada, a net importer of medicines, is vulnerable from this as it imports medicines from countries that are known sources of counterfeit medicines.

While US/Canada medicines trade has focused on internet pharmacies, the real problem the internet is also a counterfeit drug delivery system and a real problem by the US, which views Canada’s system as easily compromised by counterfeiters.

Therefore, we need to ensure that any tampering with a product’s factory packaging is clearly evident to others.  Using ‘drug provenance’ would show who has handled, opened or repackaged a product; another way is to use advanced ‘track-and-trace’ technologies such as radio-frequency tags (RFIDs) to track shipments of medicines and determine if they have been tampered with.  However, there are stricter controls in place to deal with the movement of cattle than medicines.

Nevertheless, things are slowly improving, with the US FDA promoting the use of RFIDs by 2007, and efforts to improve data collection on counterfeiting.  But there is little public awareness of this global threat, as regulators focus on the operation of pharmacies rather than the origin and safety of the medicines themselves.  Legal sanctions are often weak, or inappropriate, considering the grave health risk counterfeit medicines represent.

The way forward will require ‘counterfeit proofing’ the supply and distribution of medicines.  The criminal law needs rethinking to link human health and counterfeit medicines.  Good data is needed to inform our actions and understanding to ensure appropriate regulation.  Finally, the problem must be viewed as a global one and Canada could show international leadership in proposing solutions in an area were there is common cause amongst regulators, health professionals, pharmaceutical companies, and healthcare organizations.

The health system works on the basis of trust, and patients must trust that the pills in that little bottle are what they are supposed to be.  But while the vast majority of drugs are perfectly legitimate, a more comprehensive solution to the problem of counterfeits is needed.

More on Courts and Health Reform


The Supreme Court ruling on private health insurance has alerted us that individual rights do matter and now they matter in health care, more than people had thought.  Traditionally, health care decisions revolve around money, how much who gets and how; Canadian health politics is littered with the wrangles between the federal government and the provinces, and where has it got us?  Years of polemic perhaps about fiscal priorities, but perhaps little mileage on how to ensure Canadians get the health service they are paying for.  Other countries have been rudely awakened from this complacent slumber and found themselves faced with a steep challenge; in the UK, government spending on their National Health Service is being virtually doubled, to bring average UK spending in line with average spending in the other European countries.  Indeed, it used to be a hallmark of the venerable NHS that is was parsimonious in delivering health care, but the social costs in waiting times and waiting lists became politically unacceptable when compared with the rest of Europe.  Canadians of course compare Medicare to that the US system, and thank heaven that we don’t do that here!  But reality is of course much different, and we are learning daily now that there are things our mother never told us about Canadian Medicare, and finally perhaps the public is asking, “so, remind me again, what is we have been paying for all along?”

 

How do we know if we are getting a decent health system for our money?  The answer is not easy, but there are some clues.  Unfortunately, waiting lists and waiting times are indicators of resource shortages, not necessarily whether the health system is working well.  It’s a bit like heading into Home Depot to buy some paint, they may have lots of paint, great variety in the catalogues, but you need to line up to discuss the colour with one person, line up to get the cans from someone else, and third person to mix them for you, and you still haven’t paid for the paint!  Canadian health care is fascinated with hospitals, the most expensive, inefficient and labour intensive institutions known to modern society.  Not noted for being particularly safe, people get sick there while they’re recuperating from being sick.

 

One way to make sense of how well as health system works is to look at how well it treats new entrants, i.e. babies.  Infant mortality is a measure of the deaths of newborns, up to 1 year of age, and measured as a death rate per 1000 live births, so a number of 5 means 5 infants died in year for every 1000 babies born alive (i.e. not still births). High death rates pick up on problems associated with access to health care facilities, medicines, as well as maternal knowledge of child-rearing, diet and hygiene.  Low rates suggest the opposite.  

In 1996, Newfoundland had a rate of 6.6, compared to the Canadian average of 5.8.  Nova Scotia had a rate of 4.9, while Nunavik Region in Quebec had a rate of 22.9.  In Ontario, Quinte area, rated by some as one of the best places in Ontario to live, had a rate of 6.8, Northwestern Ontario at 8.6 with the lowest being Halton/Brant at 3.9.  As we head west, Manitoba sits at 7.3, Saskatchewan, the birth place of socialized medicine at 8.7, Alberta, the new driver of health system reform at 6.1 and BC at 5.3.  Nunavuk is 17.9 and the Yukon 8.7.  Quite a spread.  To put it into a different perspective, the infant mortality rate in 2003 in Austria is 4, Finland 3, Romania and Argentina 17 and Colombia at 21.

 

So, once we survive that first year, how long will we live?  In Canada it is about 78.3 years of disability free life (1996 data).  But the best place to live if you’re a woman is BC with 81.8 years, and the worst place is Nunavut for men at 69.8.  Does the health system have any impact on how long we live?  Probably not, as most people’s encounters with the health system are around accidents and child birth, and the regrettable tenure we endure in our final days when the system’s heroic efforts to keep us alive gradually fail.  Most health system expenditure is incurred within the last 6 months of life, we just know when those last 6 months are.

Does money matter?  Well, you’d think it did, but there isn’t really any accepted correlation with how much a country spends on health care and the results it gets for its spending.  Canada spends a lot of money percapita (per person).  Newfoundland is the biggest spender, at $2151 per person along with BC at $2157, and PEI the smallest at $1718 and Quebec at $1760.  This money is being used to buy the same sorts of things in all these provinces, with varying degrees of success in meeting public expectations and service standards.  But it is how we organize those resources, well or badly, that determines whether we get good value for our spending.  The case may be building that the problems with Medicare are problems with design, the choices we’re made on how to organize it.  The main problem in my view being this fascination with hospitals and the bottlenecks created through them in accessing diagnostic tests for example.  Most countries trying to reform their health system, believing it will improve the statistics mentioned above, are trying to reduce expenditure and use of hospitals, and move resources into the community where the focus is on greater real-time engagement with people to help them maintain their health, rather than respond with a ‘sickness service’. 

Health Reform and the Courts


The ‘perfect storm’ as the CMA so wisely observed, gathers strength, most recently with the endorsement of private health insurance. Health system leadership and politicians have let the system fail on their watch; we face disrepair, and the risk of catastrophic failure.  Canada’s relatively unique position, with a front window view of the US health system, has dulled our creative thinking and we have fallen into a false complacency, deaf to the cacophony of reform happening in other parts of the world.  Perhaps, they were paralyzed by the fear of creating a US-style health system.  But times change.

 There are two lessons from the Supreme Court’s ruling on Chaoulli v Quebec.  The first is the failure of expert testimony to the Court to provide any evidence from any other health system in the world (!) that private health insurance should be avoided at all costs.  World renowned expertise failed to provide the evidence that health systems with private health insurance were to be avoided: just tell that to the Dutch, the French, the Germans, just about anyone else for that matter.  But perhaps not the Norwegians, who have a 100% publicly funded health system, and the longest waiting lists in Europe, so long in fact that they have a so-called ‘patient bridge’ programme to fly patients to Germany for treatment.

The second is that government policy can be tested against the Charter.  To paraphrase Richard Titmus, the sociologist and political theorist, a health system is a poor one when it fails to meet the needs of all.  The collectivist rhetoric that has characterized much health debate in Canada, and is a broad theme running through the Romanov work for example, conceals an important shift in contemporary values which has not been fully grasped in Canada.  Perhaps until now, that is.

Other countries have had to come to grips with changing public thinking and are making the movement, albeit slowly, and not always happily, to a new interpretation of the social contract: namely, that governments have no pre-emptive right to deprive individuals of their constitutional rights just to achieve collective social objectives, such as Medicare, and, perhaps more subtly, governments have no right to create monopoly suppliers of public services that manifestly fail to meet the needs of the public.  So services that are underfunded, underbuilt, but publicly funded or delivered are no longer defensible simply because they are public!  Therefore, governments have a new problem, concealed within this Supreme Court decision, that of learning how to provide services that the public will value and use.  It is no longer sufficient to argue that the proper role of the state is to provide public services, if they cannot do it well.

I’d like to think that this new world would be liberating for governments, but perhaps they like to meddle and tinker rather than provide strong leadership and direction, and importantly social purpose to public service institutions, like health care for example.  As was said it seems so long ago, by Osborne and Gaebler in their book Reinventing Government, governments should steer and not row. Put more elegantly by Mario Cuomo, former governor of New York: “it is not government’s obligation to provide services, but to see that they’re provided”.

The debate over private health insurance must not conceal the real problem, that the public purse is financing at federal and provincial levels, health systems in the various provinces that are manifestly failing to deliver value for money, or indeed a service Canadians will value and use. 

Where can we look for some ideas?  Often a source of inspiration in welfare state reform, the United Kingdom has embarked on changes that will virtually reinvent the public service ethos there.  Under the banner of ‘consumer choice’, they are reinventing their National Health Service by giving consumers choices in how, when and from whom they receive public services, largely putting to rest the many tired arguments about whether patients cannot exercise informed choice in health care.  One consequence of this is greater private and voluntary sector involvement in service provision. In health care, the shift is virtually seismic, with the dismantling of the NHS as a ‘provider driven service’, characterized by services dictated by what the hospitals and other care providers can or want to do when and how they want to do.  The new ‘patient-led” NHS is focused on buying (what the British call ‘commissioning’) those services, responsible for doing what Cuomo says: ensuring that the health services that are provided are timely, convenient, and to high standards.  We in Canada have a lot to learn from this, as we try to avoid consumer demand, or protect acute care hospitals from the primary care revolution.

Governments can only tax with the will of the people, and when taxes produce substandard levels of service, inconvenience and delay, the public is right to call the government of the day to account.  Increases in taxes cannot be justified unless there is demonstrable improvement in service, and increased value for money. The UK is exploring this new territory, and rethinking in particular how its health service will work.  Funnily enough, much of the impetus for this also came from rulings of the European Court of Justice.  What they have learned, though, is that the government has no moral right to be a monopoly supplier of public services.  Choice is the hallmark of public sector reform there, and offers Canada lessons for its own restructuring.

Will an emphasis on private health insurance be the solution?  To adopt the position that private health insurance is the solution to a failing public system is to abandon the principles that are the logic of an effective system of health care. But countries which have wide-spread use of private insurance, such as Netherlands, Germany or France, also have integrated principles of private insurance into their national health system.  Interestingly enough, these countries also show the value in putting money into the hands of patients and consumers to reinforce the value of their health care decision-making  The private insurance market in the UK is an opt-out from the national system, not a complement to it, and as the reform of the NHS has quickened, the private health market has shrunk.  Other countries have had more success with mixed insurance models and do not appear to have fallen apart or suffered from widespread social inequality, indeed, the WHO rankings would suggest the opposite, with Canada ranked well down after France, Spain, and Italy.

The best direction for new thinking, therefore, is to look for reforming ideas which endorse greater consumer choice, greater consumer purchasing power whether through private insurance or through commissioning reform.  But purchasing choices require greater flexibility in how health services are delivered and this debate is, as Senator Rigby as observed, full of mythology.  In the end we need a fully integrated public/private health system.

Groping for Direction: a view of Canadian Healthcare Reform


Reflecting on my recent visit to Canada, and discussions with many key people on challenges facing Canadian health care, I am struck by the extent to which Canadian policy makers are groping for direction, with both feet firmly glued to the floor!

New ideas abound, and intelligent and thoughtful people are proposing challenging ideas, but at the same time, I find a narrowing in the solution space — changes are needed and quickly, but we can only go so far, or do so much. Perhaps whilst a mood of crisis pervades some circles, complacency prevails?

Andrew Cohen, in his While Canada Slept: how we lost our place in the world, has cogently articulated a malaise in the Canadian self-image. Senator Michael Kirby and his colleague Senator Wilbert Keon, have proposed the introduction of competition into Canadian health care, and not the least challenged the prevailing mythology that surrounds our health care system. As legal challenges to the Canada Health Act proliferate and the Supreme Court reflects on the way ahead, it is worth noting that regardless of the legal outcomes, there will be ructions at the policy level, and we need to anticipate them. Experience in Europe, where the European Court of Justice rulings have altered the cross-border health care environment to the surprise and denial of the member countries, should suggest that it is time to shelve the mythologies in Canada.

My discussions with my colleagues in Canada suggest that some key issues are paramount, and I share these as much to offer these thoughts to others as to suggest they offer a framework for a policy agenda:

  • Learn from others

Canadians are not learning from the experiences of other countries and may have retreated to certainty of the mythologies. Sure, people make the pilgrimage to selected reforming systems, and some folk bring their hot ideas to Canada, but sustained international engagement on practical learning is weak. Perhaps it is the fear/fascination with the US that says that Canadian health care is at least “not like that!”, but much can be learned from other systems and the agenda for learning needs to take into account the strengths of the Canadian system, and the weaknesses of others. Countries with strong policy-driven reform programs attract interest like bears to honey, but in many cases deficiencies in the service delivery system undermine these plans. What is needed is greater engagement internationally at all levels of the service delivery sector, and in particular major reform of health management training is needed.

  • Disrupt the existing service delivery paradigm

The hot money is that competition is the way forward, and as Kirby and Keon have also suggested deal with labour market rigidities. But let’s look at competition. Raw, brute competition between hospitals in Canada is most likely to occur on University Avenue in Toronto, and probably no other place. The public’s interest is is service. If we start with the disruptive potential of patient choice, we find that it is not competition between providers that will improve services and drive efficiencies, but competition around quality, service options, and the opportunity of new providers to enter the market easily and offer services people want. Ministers of Health who profess to protect the public interest by blocking service innovation at the Rainbow Bridge, are shielding us from service improvement by playing to the bleachers. Labour market rigidities exist partly because health care professionals have become institutionalized around their roles and now successfully protect this, cartel-like. But patient-centric reform will call on these same professionals to explore how they can be leaders and innovators. Why bother try to improve services if you can’t create that service because of systematic barriers to service-led reform?

We only need one thing: Innovative Contestability: permit innovators to drive service-focused reform to challenge the existing service providers; this will unbundle service configurations as patients vote with their feet for the service that meets their needs.

  • Develop citizen-centred e-health

The concern that health system productivity is not improving is widespread and is caused in part by the failure of the service delivery paradigm to be able to reform. Central, though, to this thinking, is the view that new information and communication technologies will drive productivity and service improvement. Why should that be true? In other sectors of the economy, massive investment in information technology has taken in some cases decades to get to work properly, and most major projects generally fail to deliver the benefits that were breathlessly promised. What industry does know, though, is that a focus on service improvement and productivity is led through customer responsiveness, not an internal focus on organizational change. Customer engagement in health care will drive productivity improvement, and e-health technologies that fail to start with patient use as a key driver, will not lead to productivity gains. Patient access though to their electronic health record or prescription database will ensure that it is accurate, complete and current, as this quality inspector of one has a greater vested interest in its accuracy than any health professional.