Tag Archives: Policy

Innovation and Academic Health Science Centres: some policy thinking

To some extent Academic Health Science Centres [AHSCs] are caught between the research push and market pull.

If they prioritise technology transfer, they opt for a research push approach that emphasises the availability of technologies or innovations for market-based actors based on potential commercial application. While the university mission within an AHSC will emphasise the quality of the technology rather than end-user or market benefits, this fails to address the adoption opportunities available from the healthcare service mission.

The primary weakness of ‘research push’ is that the acceptance of new technologies generally depends more on social and cultural factors within clinical communities, than on the merits of the technology itself.

On the other hand, the transformation of research into innovations that can be used to solve problems facing practitioners and patients is ‘market pull’, or perhaps more precisely ‘solution’ pull. Internal research and development communities of an AHSC need to be closely linked to the problems faced by practitioners and patients.

However, researchers often lack the inclination to pursue the innovation exploitation agenda. Indeed, a focus on adoption and the translation of research arises precisely because research productivity has in the past been favoured over solving real-world problems. In healthcare, the problems needing solving are swamped by a vast sea of research and many governments continue to fund research and wonder why they slide down the innovation scale – they value academic citations over patents for instance.

Taking these different configurations of AHSCs into account, the organisational options also need to consider how innovations move from bench to bedside. A “gated”1 scientific and market-based review process with in-house industry expertise and a network of extramural experts for assessments would create a degree of granularity, enabling assessment of benefit from the initial insight (pure research) through translation to end-user benefits. Some well-known institutions use gated processes to filter research to identify innovations, or to assess market-readiness of research for commercialisation.

In the absence of internal gated processes, institutions may use external expertise. One example is to out-source to market-facing intermediaries the technology transfer process or to commercialisation agents. This brings knowledge of markets through the retained third party. Appetite for risk in life sciences by the private equity and venture capital communities fluctuates over time, specialist groups are more likely to emerge to act as agents to commercialise intellectual property. Many universities have structured such relationships with firms that develop their intellectual property on a licensing basis, so the commercial benefits accrue to that firm, and less to the university, which may get royalties.

AHSCs, though, combine universities and hospitals, and so they need to harmonise where possible differing conditions of employment as these firms could be seen as exploiting these administrative challenges. The technology transfer route which is very widely used takes the context for commercial and entrepreneurial exploitation away from the AHSC. This means that AHSCs will fail to build internal capacity to assess intellectual property and know what to do with it.

An out-sourcing approach is useful when there is little internal interest or or more likely ability in commercialisation. The critical question for any AHSC is to make sure they have a view of the value of their own work. An intellectual property audit, for instance, is often necessary. If the AHSC lacks the ability to understand this, this would be evidence that it has failed to internalise the clinical service priorities from the hospital partner.

A risk facing any AHSC is whether they are being measured by some innovation metric that tracks spin-outs, licenses, or patents (rather than papers published or citations), as it may encourage premature commercial activity, which can take the form of single-technology companies (“one-trick ponies”). These types of start-up generally have high failure rates, and longer time-to-market; they may also be encouraged by a preference for simple licensing deals, reflecting either commercial naivete, impatience or lack of interest (which could be evidence of complacency). Regretfully, metrics such as these can actually hamper the realisation of the translational research agenda and produce less innovation since it measures the wrong thing – companies – rather than solutions. A gated process would, or at least should, determine whether this were happening.

AHSCs with a strong entrepreneurial perspective may choose to develop their own venture funds to develop and ‘de-risk’ innovations to make them attractive for subsequent acquisition. This is an attractive option as it also encourages the development of a domestic market in which to invest. Whole countries, too, have pursued venture funds as a national strategy with more failure than success.2

The US dominates life sciences research for a variety of reasons. One of these may lie in the institutional flexibility tied to the market, and which may be a partnering factor for AHSCs. Many well-established and highly differentiated not-for-profit research commercialisation institutes have been formed in the US, such as MITRE (from MIT) and SRI (from Stanford University), or endowed facilities have been created, such as Battelle and Howard Hughes Medical Institute, while others have emerged as specialists at exploiting particular knowledge domains such as the Santa Fe Institute for complexity or chaos theory. Comparable facilities in other countries that are separate from government are few, as most are tied in one form or another to state paymasters, such Germany’s Fraunhofer and its constituent institutes.

In many countries, one must wonder why there fails to be greater entrepreneurialism at creating novel organisational entities to take forward innovation agendas, themselves, as what such institutions offer is a better way for bringing innovations to market. The challenge for policymakers, though, is distinguishing between enabling the existence of such institutions and letting them function within a mandate with a high level of autonomy versus government determining what it does.

In the end, the options for AHSCs may be constrained by the public funding rules and have little to do with innovation itself.

Setting the policy agenda for AHSCs

Underpinning the notion of an AHSC as a nexus of innovation is whether such a nexus, will attract talent and entrepreneurial zeal. Obviously a process of development, extending perhaps over a number of years may be necessary.

A policy agenda for AHSCs would entail thinking about the following:

Should life science research funding be aligned to favour AHSC-type arrangements?

Obviously this would lead to non-AHSCs losing funding as well encourage migration of researchers toward AHSCs. This may not be compatible with national policy goals on local employment and wealth creation based on simplistic notions of clustering.

While ensuring that other centres do not suffer from a skills drain as the most talented people may be attracted to the special opportunities AHSCs might provide, we need to be mindful that AHSCs can quite easily poach talent as they are more likely to offer superior opportunities. Increasingly “brain circulation” (as talented people move from country to country and perhaps back home again) describes how researchers move about rather than the narrow and parochial “brain drain”. AHSCs are better positioned than other industries to exploit the global mobility of talent, while research funding and innovations forum-shop for the most favourable locations – an AHSC needs to be seen as a most-favoured location.

Should the funding and performance management of higher education and healthcare systems take account of AHSCs tripartite mission?

Since they are expensive, and disproportionately consume the healthcare expenditure budget, they may need to be judged by different performance standards. It might be better that AHSCs are accredited or recognised through explicit criteria rather than a system of self-certification.

Health professions education in traditional teaching hospitals should be replaced by AHSC supervised training arrangements; the logic here is to ensure that students have access to the best and appropriate clinical learning opportunities, within structured “clinical teaching” centres in healthcare providers. That hospitals are monopoly suppliers of clinical placements limits training opportunities but a focus on quality should prune that tree.

In addition, this would enable greater career mobility between academe and clinical service, even if such mobility challenged academic appointment criteria, or public sector employment requirements. Enabling greater flexibility here could encourage more entrepreneurs without losing them from training as well as create greater visibility of the value of entrepreneurialism within professional training.

Are current national restrictions on ownership or management of hospitals, universities hampering the development of AHSCs?

In Europe, universities and hospitals would benefit form new ways of organising their interconnected missions, but there is much to be done to understand how they are evolving and what national forces are shaping them as they are in the main, subject to the will of the state.

Investigation is needed to identify the performance, role and function of AHSCs in Europe, and to understand whether they are in fact a nexus of innovation or a quagmire of bureaucratic interference, as this could be a rate-limiting factor in innovation development. The general poor performance of European universities in international ranking may suggest the latter and a misuse of public money.

The potential scope of AHSCs comprises innovations in technologies impacting clinical care (software, medical devices, medicines), and ways of working (demarcation of health professions, clinical workflow). It is necessary to review relevant policy environments to learn at least [1] whether policies enable or inhibit high performing AHSCs where they exist, [2] whether policies inhibit AHSCs coming into existence, and [3] whether policies have perverse consequences on research and innovation production.

What is the best way to design and constitute an AHSC?

The preferences outlined here seek to understand the form/function balance, but we need more empirical evidence within the models to assess whether there is a critical size below which an AHSC may be ineffective in terms of mission attainment. Size alone may not be as important as the ability to align the various components as needed which is more a function of autonomy.

Nevertheless, size does matter to the extent that a small dysfunctional academic/hospital network or partnership will only become a small dysfunctional AHSC. This gives us one reason we need something better than sui generis self-certification as claims of excellence need evidence.

Notes

1 A ‘gated’ review process involves assessing an innovation at different stages using specific evaluative criteria. Failing to pass a gate is fatal at that stage, so the process passes through to the end innovations that have passed all the gates (which may also be thought of as filters). Gated innovation processes are used by scientifically-oriented organisations such as NASA and military defence agencies. A gated process must have a failure regime to be meaningful, which has consequences for performance assessment of research productivity.

2 See as an example: D Senor, S Singer, Start-up Nation: the story of Israel’s economic miracle. Council on Foreign Relations/Hachette, 2009. This, though, needs to balanced against the more cautionary perspective of the improper role of government in commercialisation in J Lerner, Boulevard of Broken Dreams: why public efforts to boost entrepreneurship and venture capital have failed and what to do about it. Princeton, 2009. A useful comparison of venture funding relevant to this discussion is J Lerner, Y Pierrakis, L Collins, AB Biosca, Atlantic Drift: venture capital performance in the UK and the US, NESTA, June 2011.

Smart anti-counterfeiting: it is all in the system’s design

How can I be sure the medicine I take is genuine?

Counterfeit medicines are a global problem, with trade in the billions of dollars. The World Health Organization estimates 8-10% of all drugs supplied globally are counterfeit.
Counterfeits are a clear and present danger to human health. No country is immune from the risk. 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 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.

The health and medicines regulators had for years believed there wasn’t a problem because there are few cases from their perspective. But today we know better and there have been efforts to address regulatory denial.

Counterfeit medicines are infiltrated into the supply and distribution of legitimate medicines by rogue, criminal organizations and individuals, who specifically target the weaknesses in supply chains, as well as human weakness (bribes and kickbacks) and gaps in healthcare payment systems.

Counterfeiting had originally been viewed as a patent issue legal advisors took a purely legalistic interpretation. It was not until the problem of counterfeiting was presented as a risk to human health and people’s lives that the dead end logic of patent protection was dropped. But why did the lawyers fail understand the context in which the problem existed? New legislation is always being introduced, such as the EU’s Falsified Medicines Directive, but the criminals will find a way to game this, even though this directive was apparently ‘gamed’ by developers using the French problem with the drug Mediator. However, gaming policy for developmental purposes also needs people to think like a criminal.

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, and packages that cross borders are opened for repackaging and labelling. Indeed, 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 these apparently highly regulated systems. Many countries are net importers of medicines as they lack sufficient domestic manufacturing capacity or the medicine is complex and is manufactured in only a few places. This makes these countries vulnerable to supply chain interference.
While international trade in medicines trade has often focused on internet pharmacies, the real problem is that the online mail-order environment is a counterfeit drug delivery system into every home on the planet.

Healthcare systems themselves must address perverse incentives that drive criminal behaviour; keep in mind that criminals exploit weaknesses in supply chains, laws and regulations, and respond to unmet demand for a product (from toasters to cars, there are illegal markets everywhere and not just for drugs) resting on common incentives. A major driver for criminals is the existence of cash markets for their products (they tend not to take cheques), and one of the largest cash markets is people without adequate health insurance cover and reimbursement systems that do not cover the full cost of medicines, or fail to insulate patients from high drug costs. In addition, as information on medicines can now be widely salient through internet social media, a country failing to license a medicine that some people would value opens a door to counterfeiters to exploit a patient demand for that medicine.

What Cognology says.

Catching crooks with counterfeit drugs is also a problem of finding them. Using advanced intelligent technologies (cognologies as in the name of this blog) means that surveillance can be smarter and less distracted by false signals.

Small might be smarter, think hive mind for innovation

Healthcare systems are often seen as requiring an economy of scale. This in part is a function of how prevalent diseases are, such that in some small countries they would have one case in 2 years, rather than one case per million of population. Healthcare technologies can be incredibly pricey; for instance, a proton therapy facility will run between €100 and €200 million to set up. Healthcare buildings and research infrastructure are expensive to build and run. Health professionals can be expensive to train and employ and are generally globally mobile.

Associated with investment in healthcare within the EU, we find that almost every region or member state has life sciences, in some form, in their top 5 or so areas of national priority. Life sciences is challenging and demanding, and requires high degrees of global visibility and connectivity to other researchers. Commercialisation of life sciences in Europe is not great; the EU’s research budget does not strictly speaking focus on research translation and there is precious little to help good ideas bridge the ‘valley of death’ where unfunded good ideas go to die. Financing for life sciences developments consume vast quantities of risk capital, some of which will be unlikely to return any value for a decade or more. The problem is not for the EU, but for the risk appetite in member states: it is difficult to raise more than €30 million or so in venture funding in Europe. The brooding presence of state interference in entrepreneurial start-ups can be discouraging. And with the UK leaving the EU, a liberal enterprising culture will be lost within the EU. Statist solutions in Europe tend to dominate.

Many EU countries try to avoid downside risks of failure by punishing it, rather than creating opportunities to learn. Countries that encourage risk taking, and make it easy to start and close down companies, with associated flexible labour practices, will outstrip protectionist fearful countries. Many countries protect jobs not workers, so actually create unemployment and discourage job creation. Life sciences is one such area that requires particular flexibility owing to the nature of the work.

Small countries are particularly interesting. In one of the EU’s small states, there has been active progress developing a bioscience research and commercialisation centre (partly funded by the EU, thanks for that). Higher education is active across life sciences, though the research is of middling status globally, but that is typical of most of Europe’s universities. The country has a well-developed and well-financed healthcare system, recognised as one of the best globally based on outcomes.

Building life science (or any research-based commercial capacity for that matter) means that setting priorities is more important the smaller you are, as you can’t do everything. That means grappling with disappointment as not everything can be done, and if trying to do everything, mediocrity abounds. It means, too, that infrastructure projects are precious, as they are enablers of future potential — the longer term vision must be sustainable, as getting it wrong can be expensive — research buildings don’t make very good hotels and what do you do with failing science parks like we see across Europe.

What Cognology says.

  • build on what you already are doing well as that is evidence you have the expertise, networks and working practices in place
  • keep in mind that life sciences is much, much more than drugs; progress may be quicker in other areas, such as informatics, telecommunications, bio-engineering, materials science, agricultural biotech, etc.
  • you can’t sensibly do life sciences with a weak university, so this entails difficult and hard rethinking of priorities and a sensible review of research productivity
  • you can’t sensibly do life sciences without a teaching hospital; the academic health science centres in the US account for over 80% of productive life sciences research, so the infrastructure should enable closer collaborations and alignment between university and hospital and industry; this may, by the way, raise real issues for government if the teaching hospital(s) is state run and therefore subject to bureaucratic overhang
  • you can’t sensibly do life sciences without understanding the logic of ‘bench to bedside’; productive work lies in translational research and solving clinical problems; this can challenge academics whose careers are rewarded from the production of papers and volume of research funding rather than solving problems; in life sciences, solving problems is paramount; understand what the Grand Challenges in life sciences are and see which one(s) you can focus on and ignore the rest
  • you’ll need to consider the economic developments that come with building a life sciences sector to energise high net worth individuals in the country to develop a risk appetite for national investments along with a cadre of managerial expertise to take start-ups forward; I’d discourage doing this through the public sector hiring as it disincentivises university graduates from pursuing entrepreneurial careers (there is good global evidence that this can be a problem, so don’t make that mistake); best role for government is ensuring a flexible corporate start-up environment, a non-punitive bankruptcy regime, sensible taxation of start-ups, and seed funding; it might also be a good idea to give away all that publicly owned intellectual property
  • finally, the good news is that size doesn’t matter for innovation; there is no correlation between the size of a country and the ability of the country to innovate; many very large countries have clumsy policies that disincentivise and frustrate; the EU is full of them and in the main, the governments have assumed the wrong type of highly interventionist policies rather than creating an enabling culture that does not punish failures and really does reward success.

Live short and don’t prosper: post-Brexit healthcare and life sciences

This is a summary of some emerging and salient issues related to the UK departure from the EU.

Workforce

It is estimated that the UK recruits 7000 nurses and 2000 doctors annually from the EU. The UK is currently unable to meet its workforce requirements for the NHS from its domestic higher education system. To do this it will need to create around 5 medical schools and a dozen nursing schools, not to mention the unmet needs for other health professionals such as pharmacists, physiotherapists, and so on.

The UK will be unable to widen recruitment from outside the EU without drawing people from countries which really need their own domestic supply; as well, non-EU migrants need to meet a points-based system, which also includes an income test, and many healthcare workers in nursing homes, for instance, earn less that this amount — EU recruits are exempt from this test.

The UK will likely need to repudiate the mutual recognition of qualifications if it also repudiates free movement of labour. Individuals acquiring new qualifications from the various Royal Colleges, for instance, will not be certain that those qualifications will be recognised should they return to the EU at some point.

Research

We’re hearing a lot about research as the UK is a major participant in EU research funding rounds. Academics in the UK will become third country researchers after Brexit and there is no guarantee that they will be able to lead major projects, but only be participants.  The loss annually is about one billion euros or so in R&D funding. While the UK is an attractive place to do research, the gradual erosion of this pre-eminent position is likely if UK researchers lead fewer major research programmes and the universities are unable to recruit from the EU — again, mutual recognition of qualifications may also be a consideration.

Drugs and Devices

The European Medicines Agency will need to relocate to within the EU. While this is perhaps 800-900 jobs at EMA, there is a large regulatory eco-system around EMA that will also need to move. Perhaps less noticed, though, is that the UK will need to duplicate EMA’s regulatory functions meaning that all pharma and device companies will need to file applications to the UK quite separately to the EU. Pharmacovigilance is one area that will need to be duplicated as EMA requires the competent authority to be inside the EU.

Drug and device prices themselves should rise as the UK exits the single market. That the UK is already a difficult market for market access, might lead to fewer drugs being launched in the UK.  While these factors are hard to quantify, but in the absence of alternatives, the NHS drug budget might go up by 10% (the tariff rate), while new products might be delayed; that they are launched in the EU would not provide market access to the UK under the free movement rules. The UK might become a low priority country for new products.

Patients

All these considerations will have an impact on patients who will lose access to portability of healthcare benefits provided by the EHIC (European Health Insurance Card) system. As well, the A1/S1 arrangements will disappear. This has some important implications for both the UK and EU states and their citizens.

France and Spain have a large number of Brits living there, while tourists travel all over. For instance, Malta receives about 1.5 million tourists a year, 500,000 of which are from the UK and access Malta’s healthcare system through the EHIC with the UK paying the bills to Malta. By losing the post-retirement S1 arrangements, individuals will need private health insurance, while tourists will need to buy medical travel insurance. Medical travel insurance is a very poor substitute for EHIC as it excludes pre-existing conditions and is not a substitute for statutory cover. Business travellers will also need to carry private travel insurance. [Note: see my FT comment describing this type of insurance as a money pump, following Tim Harford.]

EU citizens travelling to the UK will need to have travel insurance covering third countries or take out private insurance while in the UK. The UK’s private medical insurance industry offers very poor value products and importantly does not offer an equivalent substitute for NHS or social insurance cover, because of their failure to cover pre-existing conditions; with their additional limitations, access to care would be very difficult if individuals relied on a UK insurance product.

What Cognology says

No doubt as Brexit gets closer, the real risks will become salient and my guess is they’ll favour Remaining. The dumb money I suspect is on Leave, as meeting the needs of politicians still living in the past, and voters who wish they lived in the past or hope that Leave will make their lives better. I doubt the latter. All this could have been known from the very beginning without Brexit and people advised what the consequences will be before they voted. But then that would have been the smart thing to do.

 

Patience and the political process

While folks have been quick to jump on the results of the referendum as evidence of democracy at work, (and perhaps that is partly true), a few days later we see the consequences. Economic challenges anew, social discontent in the UK (racism and xenophobia legitimated by the exit vote) and political meltdown in the UK’s parliament.

I want to focus on process. The Commission president wants the article 50 triggered essentially now. Of course, Juncker’s call is just more evidence of his fundamental autocratic ways; he did say he dislikes referenda as do I, but I suspect for him it betrays a disregard for democratic process in favour of bureaucratic expediency. Tusk says that the UK is the one that must act and the rest of the EU must wait. This shows a much more nuanced understanding of democracy and is only right.

Until the UK signals otherwise, it is still a full member of the EU within the meaning of Article 1 of the Treaty on European Union. The UK’s Commissioner was hasty in his departure, and today’s display at the European Parliament unbecoming but feeds the egos of MEPs who tear down more often than they build up.

But process matters. The UK’s Parliament must receive formally the advice it sought from the referendum, which is non-binding. Few countries would dignify the results of a referendum of this magnitude with a simple majority, but require perhaps 75% with some turnout requirement (even compulsory voting for that matter). The UK prime minister is not the government; the UK Parliament is what is sovereign, so it must actually pass a bill in Parliament and that is what can only trigger Article 50 (it may help to read the Lisbon wording).

In the UK, no parliament can bind a successor parliament; therefore, a general election would in effect return a new parliament which can simply ignore the referendum results. Indeed, such a general election would likely be fought over the terms of departure and that isi probably the right thing to do. Converting the referendum votes into constituency votes would likely lead to a minority of MPs being elected that would have supported a Leave position anyway. Given the chaos we see coupled with voter regret, it is unlikely a Leave position would be politically successful.

Furthermore, Parliament must be satisfied that the referendum actually is the will of the people. Given what has been a shambolic campaign, we now see the Leave campaign rowing back from their pledges, while much of the evidence presented by the Remain campaign is coming true. In the end the result is suspect. Granted the vote revealed underlying divisions within UK society, but that is not what the referendum was asking. Parsing the vote in those terms is disingenuous.

It is clearly not in the EU’s interests to see the UK leave, despite what appears to be the fond wishes of some authoritarians in the Commission. Indeed, the leave vote may in fact trigger the sorts of EU reform that was not possible before; nothing like having the chickens come home to roost! It would be a tragedy for the EU to lose the UK just when it would be implementing reforms that would not just reassure the UK, but also deal with the more widespread Euroskepticism and nationalist threats to European unity itself. And of course, it would be a Pyrrhic victory for the UK.

The EU needs to help the UK government chart its way through the process, to understand the process that must be followed and not hasten the UK’s demise within the EU through impatience or intemperate comments. Restraint at the political level across the EU will do more to support the UK find its way out of this mess.

What Cognology says

The EU and UK need the outcome to be a win:win. A UK exit is not that. But perhaps being a loser is a type of winning for populists.

 

 

“I told you so”: post-Brexit access to medicines and medical device technologies

Continuing the theme of looking at life sciences, healthcare implications for the UK exiting the EU.

  1. The NHS, the UK’s public healthcare system, procures medicines in many cases through the benefits of the single market. While it is not clear what impact an exit will have on pricing itself, failure to ensure access to that single market will inevitably lead to the increase in drug costs. I’d hazard a guess of 10%. Given the difficult financing circumstances of healthcare expenditure in the UK, an increase of this magnitude, will have a knock-on effect on patients and their care.
  2. Apart from the price impact, UK patients may find access to medicines and medical devices restricted as the UK exits the wider European market overseen by the European Medicines Agency. The UK is not every companies’ first choice of a market to launch a new medicine or device, but with an exit, it clearly will drop further down the queue. Excluded from products launched in the rest of the EU, the UK can only wait for companies to ‘get around’ to including the UK.
  3. And apart from the loss of a degree of certainty of access to medicines and devices within the EU, a UK exit, the UK will need to introduce a separate regulatory scheme to replace the European Medicines Agency approach, adding costs and an additional regulatory hurdle for companies. The UK can, of course, try to harmonise itself with EMA, but in the end, departing EMA will reduce patient access to medicines.
  4. Is the UK market big enough to make a difference? Perhaps for some, but I suspect the economics coupled with the overall difficulty new products face contesting the UK market points to a general decline in product availability. At least with the EU, access to medicines and devices could be compared to other EU states; with an exit, the UK stands alone and does not look particularly welcoming.
  5. Of course, the NHS could have a rethink as is slowly underway and move to ensure access to new medicines and technologies. But that may require a different assessment whether the current way of financing the NHS itself is sustainable and that has really little to do with leaving the EU, although the EU does offer a safety value for patients denied care by the NHS. All this is now in jeopardy.
  6. The European Medicines Agency will need to leave the UK, and with it will go not just those jobs, but a whole domain of expertise. That expertise with EMA made the UK within the EU, one of two global centres of excellence in medicines regulation, along with the US FDA, Few people outside this area will appreciate the consequences of EMA departing, but it will be felt within pharmaceutical who maintain many high-paid and knowledgeable staff focused on medicines regulation. All this expertise goes and with it a capability within the UK that can never be regained. Whoever gets the agency, Sweden, Denmark, elsewhere, will be a net gainer of  talent from which to build tremendous domestic capabilities.

What Cognology says

Perhaps, I told you so?

UK out of EU: healthcare implications

The British public in the Referendum on the EU has voted for the UK to relinguish membership in the EU. This, in time, will be seen as a mistake for various reasons and of course it will take some time to come to pass.

While I have been from time to time critical of the EU, I think it has brought significant benefits to everyone in the healthcare arena, restrictions on competencies notwithstanding.

The Referendum choice is not without consequences for the UK. I for one do not expect the UK to be given an easy time by its former EU partners, but the risk is that in the end, a congenial arrangement will be needed, if nothing else, to offset the risk of isolationism in the UK, which would do no one any good. While it may be seen as an example of democracy at work, the Referendum ended up really being a political punching match amongst the political parties and not really about the EU membership itself. The Prime Minister Cameron failed to act in the country’s best interests by trying to ensure the focus was on membership issues and not political infighting but he had by mid-campaign lost any influence as jingoist sloganeering took over from reasoned discourse. It is not wonder that the public voted as they did, and made the referendum a vote of non-confidence in the government instead. As they say, now repent at leisure.

That said, there are a few areas to reflect on which a strict exit would involve and which we should really try to protect.

  1. The ability of UK citizens to have access to healthcare services when travelling in the EU, through the EHIC arrangement will at some point end. It may be protected should the UK decide to accept free movement of people. It is not a good situation for countries so close and where people move so easily across borders not to have a mutual arrangement for healthcare. This must be protected in some form, as there could be public health risks on the one hand, and avoidable suffering for people who become ill. Absent that, UK citizens will require some sort of medical travel insurance which is never a good deal at the best of times. I doubt anyone really thought of that.
  2. Reciprocal arrangements for providing access to a country’s social security/healthcare system (the S1/A1 forms) will also in time cease. This will impact people retiring, but also people working, even temporarily, in an EU state. I doubt anyone running a workshop in another state worries about whether they’re carrying the EHIC, S1/A1 or their social security cards, but for the British, where no cards are required, this will present a new requirement and added business costs if nothing else. As many European countries do offer considerable lifestyle benefits, Brits will still likely wish to retire in an EU state, whereever family or friends are or where their heart is. While it is sensible to have controls in place to ensure proper system funding, it should really be a matter of priority to ensure that retirees at least enjoy some measure of security. There are comparable arrangements worth looking where similar circumstances exist (e.g. Canadian “snowbirds” and Florida).
  3. UK research is, at least according to the domestic crowd, pretty good, and does stand up to international scrutiny with many UK universities in the top tier. But much of the research funding comes from EU sources and has supported academics, departments and much intra-EU research collaborations. Life sciences research in particular benefits and it is unlikely the UK government will in any form be able to replace the lost funding. The implications are on the order of fewer institutions actually do the high standard of work, simply because there is less money, some universities will for forced to scale down their research, becoming smaller and perhaps marginalised or just focus on teaching. But the UK university system is research driven and universities that do little research are low rated anyway. I do really worry that universities and research will suffer in the UK and hope that the UK continues to be an active participant, even if at arm’s length.
  4. We heard a lot about immigration during the Referendum, but more of the xenophobic sort without actually grappling with the value to the UK that immigrants bring. Past the rhetoric, the UK has been a good destination for people to build their careers. Many have come to work in the UK’s National Health Service (about 4% of the NHS workforce is from the wider EU). Will this stop or shrink? The UK does not have the educational production capacity to replace the loss of immigrants with skills for healthcare, such as doctors, or nurses. With the exit likely having a profound impact on public finances, it is unlikely either that the UK will be able to afford to build the necessary capacity to make up for the loss. This will further reduce the standards of care as staff shortages bite even harder. Of course this might change, but the NHS has had staffing shortages for decades, and manifestly under-produced graduates in healthcare professions, so it is not clear why they would suddenly find the money that wasn’t there before. The UK will likely either opt back into the single market / free movement of the Norway sort, or go its own way with some point-based system to control immigration. The latter will only lead to tit-for-tat retaliation by the EU, which is to no-one’s benefit.
  5. Without listing them all, the UK is part of so many networks in healthcare areas, from research communities, to health technology assessment, to rare diseases and public health surveillance and so on. One must assume that these will scale down unless efforts are made to ensure they are protected in some form. In the end, though, the UK will be the loser as will the EU. A brain-drain toward the EU is not unimaginable and indeed for many people likely. The US will clearly beckon and the EU member states should also consider the implications. The UK will not like this, but this may be a good example of the consequences of the referendum decision. A brain-drain, while asset-stripping the UK, will require I suspect some reform of domestic employment systems, but with high unemployment in some EU countries, why would they want to give jobs to “foreigners”. Of course, EU institutions might change their own employment policies to make it easier to employ folks from the UK and many would likely gladly move. I know I would.

That’s a short list of a few things, on this day of days I would have wished were otherwise.

Does the European Commission ‘game’ the member states?

It is in the interests of the Commission to play countries off against each other in order to demonstrate the inescapable logic of the “European project”. The Commission suffers from the so-called “secretariat problem”: it is not a member state but a “secretariat” for the member states, and in this way pursues its own interests despite having been established by its members to further their own objectives. Secretariats do this, and take on a life of their own.

Various treaty language broadly excludes healthcare from EU policy making. The European Court of Justice has defined cross-border consumer rights. The European Commission, mindful of these, walks a thin line creating policy in the interstitial spaces that have the indirect effect of wagging the member state dogs. But that is the Commission defines its role in the absence of countervailing and/or collective action by member states. Consistent with bureaucratic behaviours, it focuses on technical issues, which in time come to define and constrain the policy spaces that member states have to deal with. The result is that member state autonomy and decision-making is constrained by prior technical issues.

The challenge is altering or indeed revoking the European Commission pan-European agenda set by the treaties, and which gives them license to literally expand like a gas into adjacent policy areas (arguing expediency rather than formal competency). This behaviour is well known in bureaucracies. It is not helped by the Commission being a monopoly supplier of legislation. Monopolists always do this.

What is more perverse is that the Commission has the mandate for ever closer union, which operationalises activities which undermine inter-state cooperation and collective or joint initiatives, undermines national interests, or more strongly, replaces the national interest with the “closer union” logic.

We now know that ever closer union cannot be an operational goal as it only feeds greater justification for the Commission to act — remember it is a monopolist defining its own scope of practice. When the Commission acts, members states must react.

What Cognology says

In these days of the UK in/out referendum (23 June 2016), it is timely to review the functioning of EU institutions including the fundamental logic of the Commission.

 

When underperformance is policy

With the release of the latest analysis from the King’s Fund (here), heightened attention is being paid to NHS performance. It may only be a coincidence that an election is looming in which the NHS may be an election puppet. The King’s Fund report includes in the title that it an assessment of the NHS under the coalition government. While to some extent this is true, the NHS performance is not really about the actions of the government, but how policy direction is implemented by NHS providers and the system for commissioning care and the role of Monitor. Gosh, so many moving parts. By the way, I have no real criticism of the methodology used in the report; it is always about what conclusions we draw that matters.

The Report takes performance since 2010 for a baseline. Any numerate person knows that choosing your starting point is important in supporting conclusions about performance. We have had a recent report on blood transfusion in the NHS in the 1970s and 1980s, which had folks then known how poorly the NHS performed would likely have led to mass emigration; at that time, many of the people now in advisory or senior roles were learning their jobs and establishing their preferences and politicians were unable to imagine alternatives.

All governments of any political persuasion have acted to protect the NHS from direct litigation; the effect of this is to indemnify managerial inaction and poor treatment of patients. For example, in the early 1990s it became known that the deaths from hospital acquired infections exceeded road traffic accidents. This produced better infection control methods but didn’t improve patient safety. Had the NHS providers been subject then to pretty standard accreditation methods used in Australia, Canada and the US, it would have likely shuttered half of the NHS hospitals as dangerous to the public.

So, one conclusion might be that the NHS isn’t doing that poorly when put against its historical legacy of significant underperformance, and inefficiencies. Despite the domestic mythology that the NHS is/was the envy of the world, it is/was the universality of it that folks admired, not its waiting lists and high clinical death rates. During the debates on the implementation of what is known loosely as Obamacare, referring to the NHS or the UK health system was avoided as a political red flag; the country that was viewed favourably was the Netherlands.

The Report usefully looks at resources available. What needs to be appreciated in understanding resource use, is whether the resources are where they need to be. NHS hospitals are monopoly suppliers of specialists, labs and imaging services and a lot of services that are run from hospitals really don’t even need to be there (think ophthalmology, diabetic care, much physiotherapy); NHS hospitals reluctantly give up clinical control of patients receiving homecare and so on.

GPs and their patients must be fitted into the hospital’s service capacity in order to receive much care. Anyone who has had to wait for a scan will wonder why. As resource utilisation dictates whether outcomes are achieved and directly impact quality of care, the bottlenecks created by monopolistic practices in the NHS will only lead to greater risk of declining performance. People who hit the 4 hour A&E target who need some imaging, will of necessity get admitted, otherwise they are on the out-patient list (which can extend into months). All this is avoidable.

So not having the right resources available at the right time isn’t a crisis of funding, it is a crisis of management and system design.

The proof is always in the pudding. The Macmillan folks released a report on cancer survival (here), with their conclusion that cancer survival in the UK is stuck in the 1990s. Despite years of extra money, what is going wrong? A paper in the International Journal of Cancer (Moller H, et al Breast cancer survival in England, Norway and Sweden: a population-based comparison, 127, 2630–2638 (2010)) concluded:

“[if cancer patients in England are presenting at more advanced stages of cancer], then the main public health implication is that any strategy for improvement should include as a primary focus symptom awareness among middle-aged and older women and their primary care professionals, with an aim to facilitate early diagnosis and treatment.”

The implication for the NHS and belatedly recognised by NHS England, is that poor cancer outcomes come from the inability of patients to access oncologists directly in a timely manner. This arises from the hospital’s monopoly control of specialists and the inability of oncologists to establish direct access to full-service oncology services for patients when compared to access in the countries highlighted in the Macmillan report. The same can be said of many other clinical areas which hospitals monopolise. The disruptive forces at work in other sectors of our society are muted when it comes to healthcare — in part because politicians fear the failure of publicly funded institutions.

What Cognology says

One can only be optimistic that new types of provider (such as the Vanguard sites) and other organisational redesign of clinical workflow will be successful and that the current problems are not a collective, unconscious, conspiracy of inaction within the NHS to shift responsibility onto politicians rather than taking direction action themselves.

The policy space for the NHS under the coalition government has removed considerable barriers to innovation, which should point to underperformance as a matter of design, not money.

Political football

Political manifestos that promise to spend more money are failing to grapple with the powerful underlying forces at work in healthcare. Indeed, they may be ignoring these in order to score (cheap?) political points with voters.

There is clear evidence of failure to use good practice, of time-wasting clinical workflow and excessive political and bureaucratic overhang. Granted the UK state (in its components) is justified seeking a form of accountability for the vast expenditure of public money, but this does not necessarily entail control of how the money is spent and this particular debate is questionable given the performance of other countries’ health systems (e.g. the Dalton review). Historical evidence would show that public control of expenditure in many areas leads to “rent-seeking” behaviours by public servants at the expense of service quality.

Governance arrangements such as proposed at Greater Manchester look little different from the NHS as a whole and I fear will lead to excessive wasteful bureaucracy at the expense of front-line service quality (seen from the patient’s perspective not the bureaucrats).  I wonder if they will achieve the same degree of performance as the Swedish county councils.

The power shift that is underway in healthcare, with its consumerisation through digital technology, publicly accessible performance information, and priority on value-for-money (which are not bad things) wrong-foots policy positions that seek to exert the role of the state at the expense of individual patient control and choice. And going forward, it is hard to justify disenfranchising patients from control of their healthcare when so much of their lives is under their control.

Whole Person Care as a Labour political slogan may play well in the press, but creating it requires thinking about how whole systems of care integrate and this will challenge the dysfunctional fault line running through some parties’ politics on the role of the private/independent/voluntary sectors.

This thinking is absent (at this stage) from the Greater Manchester MOU, meaning the capacity of the private and independent sectors is not included in their total health system capacity planning. But failing to grasp the needs of other than NHS organisations is not limited to this, but extends to workforce planning, which must also satisfy the needs of the private sector across a wide range of workplace settings. One may not like private healthcare, but it is irresponsible to ignore its existence.

We know that quality may be poor and performance reporting and information virtually impossible to obtain from private providers but there are reasons for this. From the position of a patient, NHS commissioners should be agnostic on the fitness of a provider and this would have the benefit of integrating care and quality across the patient treatment pathway and incorporate all possible sources of capacity and service delivery. It is the failure to normalise the role of the private and independent/volunteer sectors within total health system capacity that causes considerable fragmentation to patient care, and contributes to political posturing on the back of patient care. It would be wrong to assume failure is unique to the private sector and no political party can ignore the failures of the NHS (Bristol, Mid Staffs, and so many others).

In part this has been caused by the Department of Health traditionally insulating NHS providers from quality reporting and the consequences of failure. All governments have a problem to imagine the failure of publicly funded organisations (in any sector), but they do happen and require serious action to fix. Regretfully, there is evidence that local authorities exhibit the same behaviours.

What Cognology says

In the end, the disinfecting light of public scrutiny is the solution, not more money. The NHS still avoids formal provider accreditation, instead opting for a (complex and troubled) inspection system through CQC which only now appears to be understanding the importance of provider failure — but failure in a complex care system is about people failing to act, of systems that are dysfunctional, and yes, driven by a focus on wrong-headed targets and a focus on pleasing political masters.