Tag Archives: technology

Regulating internet pharmacies at the European level is necessary

Various prescription and street drugs may caus...

Available over the internet

It would be a serious mistake not have an EU-wide regulatory framework for internet pharmacies.  Not achieving one would be just more evidence of the politics that infects all discussions of cross-border healthcare to the detriment of the patient and health consumer.  Illegal drugs, fake drugs, reimported drugs, counterfeit drugs, substandard drugs, legitimate drugs — how is a consumer to tell the difference on the internet?

We need an EU-wide regulatory framework for a few pretty sensible reasons:

  • EU wide standards would ensure a common standard of practice, and European citizens should expect no less.
  • A key element of internet pharmacies is their cross-border character, and indeed whether they are inside or outside of the EU itself; the provenance of a medicine is integral to knowledge about its legitimacy and by breaking the information flow about specific medicines in a cross-border environment, the EU is putting people’s lives at unnecessary risk.
  • Price differentials within the EU actually encourage internet pharmacy sales, as it is these price differentials that make internet medicines attractive to consumers, and which create the risk of buying counterfeits in the first place. It is also known that the cash market in medicines underlies the opportunities for criminal elements to insert fakes into the medicines supply chain.  This will only become easier to do and harder to detect.
  • Cross-border trade in medicines involves a lot of repackaging, relabeling, etc., which destroys or confuses such information as batch numbers and point of origin.  This is essential core EU-wide information.

Leaving all this to different national regulators will simply play to the regulatory patch-work that characterises medicines regulation in the EU, and ensure that consumers will be confronted with varying degrees of protection, information and risk.

Despite protections from other EU directives on cross-border sales, medicines and the risk of counterfeits put the issue into a different situation as the efficacy of the medicines may only be determined after the patient has experienced the consequences to their health from the purchase of a fake medicine.

Member states are not that good at organising multi-lateral arrangements, so why should we expect them to be any better on medicines trade in a cross-border world?  The complexity of the EU will now be sustenance to those who would wish to contaminate the medicines supply chain.

I am obviously trying to decouple the problem from the issue of parallel trade, and focus on the core elements of cross-border regulation.  Parallel trade would be caught by a simple internet regulatory framework.

What would a solution look like?

Well, the opportunity to establish an EU Internet Pharmacy Imprimatur will be lost, as it would have been a key element in the solution.  It would have established basic information about the legal status of the internet provider, and its legal dispensing practices, including handling of prescriptions.  It would have given us pooled knowledge about all medicines, whether legal or not, with their origins and destinations being available in an EU-wide systematic manner.  With common regulation would come shared knowledge of all regulated and licensed firms operating in the very complex medicines supply chain; this information is not shared across borders, with obvious consequences.

The push-back from industry on the technological side is understandable but to be regretted.  it is possible to establish common technologies, and common data-gathering to make a sensible system work where costs are not onerous and patient safety is assured.  The outcome to be achieved is common knowledge across the whole medicines supply chain in a cross-border world. In addition to the much-talked about radio frequency tags, and barcodes, there are other methods available or in development which offer additional opportunities and are likely to alter the impact of costs on industry.  The current technologies are hardly longer term solutions anyway, but industry will need reasons to explore them.

A common regulatory framework for cross-border medicines trade over the internet is sensible, and does not really need the problem of counterfeits to be justified.  Industry resistance needs to understand that consumers, who will be in the main buying these medicines, need assurances of appropriate dispensing, quality of the medicines, proper shipping, and expiry dates,for example.  They also need to have named individuals if there are concerns, as mistakes can happen such as the wrong dosage being provided.  As well, there are naming differences amongst member states of similar medicines, dosages and methods of delivery differ (e.g. tablets, suppositories, soluble, all in the same medicine reflecting cultural preferences), and so on.

European Health Technology Assessment: time for Euro-NICE?

Sommelier F.I.S.A.R.

Quality control

NICE is the health technology assessment [HTA] agency in England, the one upon which others in many countries are modelled.  More generally, HTA is increasingly being used by governments for more than simple economic evaluation of medicines and devices, but is being used as a form of rationing of access to technologies (medicines or devices are considered technologies in this sense), and for budgetary control.  The more mundane scientific assessment of technologies alone, required for licensure, is gradually being replaced across Europe with a patchwork of regulatory HTA systems.  Their operation has a direct bearing on what technologies enter health system use in specific countries and therefore what benefits patients and clinicians derive from the use of those technologies.

So much is not new.

With release of the Commission’s findings in its Pharmaceutical Sector Inquiry Report, 9 July 2009, there is the opportunity to reflect further on HTA methods across Europe. The report notes that one reason given by industry why fewer novel medicines were reaching the market was uncertainty about financial rewards (a factor in whether technology assessment would lead to regulatory and reimbursement approval).  The report notes that with prescription medicines the patient is not the ultimate consumer, it being the doctor or pharmacist; to some extent this is true, but these clinicians are making decisions based on what products are on the market at any one time, and it is regulatory systems and the structure of formularies that determine this.  In more extreme cases, decisions are embedded in prescribing guidelines and substitution protocols, which a child could follow.

The report also misunderstands how HTA works, and this may reflect the fact that member states pursue HTA for various reasons.  Using the rather oblique term “added value” they see HTA as essentially linked to the “budgetary situation and health priorities of each member state”.  This is, of course, precisely the problem.  HTA IS an economic assessment, based on value add, but it is NOT defined purely in terms of affordability.  It provides information to decision-makers about what the economic and social costs are for different thresholds of health outcome — a polite way of pricing rationing.  In other words it informs decision-making, it does not determine it.  It is quite possible to arrive at a Europe-wide HTA finding on anything you like, and leave it up to member states to quantify in their own terms where this sits within their own national system of affordability and a desired health benefits.

I doubt the pharmaceutical industry would think of advocating for a European Health Technology Assessment Agency, using consistent scientific and economic standards applicable to all countries, thereby simplifying their own regulatory hurdles (HTA is referred to as a 4th hurdle), because they dislike the 4th hurdle in the first place.  But HTA is not going to go away, but misuse and abuse of HTA methods will likely continue.

My view is that the industry should advocate for such a system.

The argument is straight-forward.  A “Euro-NICE” would bring order to the HTA process, and establish EU-wide standards for the application of HTA methodologies and enhance regulatory certainty which industry should like.  It would have the additional benefit of creating a level-playing field amongst the different health systems, which would be a general benefit to patients.

It is important to understand that the pharmaceutical industry and individual member state health systems are locked in a very tight embrace, helped along by a country’s regulatory system and medicines pricing mechanisms.  Movement by either has an impact on the other — reimbursement policies signal industry behaviours, availability of medicines determines what clinicians get to use and the medicines budget, regulatory ‘style’ links to investment in research, research investment acts to attract the big brains.  It is a complex system, not a simple set of linear relationships (an impression one gets from the Commission Inquiry, unfortunately).  And complex systems can cause perverse behaviours, which are invariably embedded in the rules themselves, and particularly important rules are HTA practices, not codified with in the formal medicines regulatory system, but which condition different member state markets.

While there is action on European HTA, through EUnetHTA, it is necessary to distinguish between doing HTA itself, and how HTA is used in decision-making within national policy systems, and regulation.  A Euro-NICE would provide consistency in the former, to ensure transparency with the latter.

E-health and Ontario

The wordmark of the Government of Ontario, fea...
Waiting for the e-health revolution

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 90 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.

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Gaming and predictive modelling: potential healthcare disruptor technologies

There is no consensus on how closely the brain...
Prediction, intelligence and cognition: convergence a real possibility

Gaming and simulations plus modelling are health markets that look very interesting and offer considerable opportunity for disruption of existing knowledge processes in healthcare:

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
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Innovation in healthcare: finding the disruptive winners

Innovation
Wait for it…!

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.

Some priorities for further thought:

  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?
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Interventional Radiology: Why the delay in adoption?

Magnetic Resonance Imaging. Timing Diagram for...
MRI timing diagram for spin echo pulse sequence (don’t ask)

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 also overcome the fear of change, of novel technologies and of changes to  clinical practice that change and technology brings.

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Greedy governments, poorer societies

Beggar in Venis, May 2008

Government greed at work

Greedy governments stifle innovation by reserving all the intellectual property of publicly funded research for their own use.  The problem is that governments are not very good at knowing what to do next, and invariably tie up valuable innovation in bureaucratic process, without adding any social value at all.

The Eurocrats like US comparisons, so here is a good one.  In 1945, the US Government commissioned Vanevar Bush to review the role of science in post-war America.  His report founded the US National Science Foundation.  It was, however, not until US scientific pre-eminence in patents began to flag when compared to Japan and others, that US legislators realised that they were hogging all the innovation.  The result, the Bayh-Dole Act (the University and Small Business Patent Procedures Act) in 1980 gave US universities and businesses ownership of the discoveries resulting from US government-funded research.  The result is what we have today, and why the EU compares unfavourably.

The whole EU labours under mistaken beliefs about the central role of government in adding value.  In this case, getting the dead hand of the state off the bright ideas of the research community galvanised the US academic and commercial communities into entrepreneurial development which continues to this day.

Some EU members are very good at converting research into commercial products, have vibrant venture capitalists who are knowledgeable in finding winners, coupled with entrepreneurial research communities.  Others, of course, are laggards, or worse, deadwood.  The Biopolis report is a useful map of the terrain in one area.  Sitting at the heart of the issue, though, is the academic culture itself which in many countries lacks an entrepreneurial dimension, with inappropriate incentives and featherbedding of senior academics.  Perhaps the greatest threat to innovation besides greedy governments, is academic tenure.

The race these days goes to the smartest.  Let’s hope the Commission’s Communication on Pre-commercial Procurement will actually drive innovation.

When will we build the last hospital?

A small village clinic in Veliky Vrag, Nizhny ...
Hospital of the future?

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.

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