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.

Smarter and more Intelligent Healthcare in 2035

The King’s Fund, a UK health charity ran a scenario essay writing competition, and here is the link and of course congratulations to the winner: (winner, runner up and other scenarios, but not mine).

My scenario builds on the notion of service unbundling and draws on strong and weak signals of changes likely to impact health and social care perhaps to about 2035. The scenario is written as a retrospective view from the year 2047. My objective was to avoid a doctrinaire scenario.

Unbundling 2035

Between 2016 and 2035, the way that people worked had substantially changed by widespread digitisation of information. Smart machines and robots had moved from doing physical work to being central to much cognitive work and which led to fundamental restructuring of the economy. By 2035, taxation was changing from taxing people to taxing the work done by devices, cognologies, and robots.

The fault lines between reality and expectations were starkly evident during the 2020s, as public investment in health and social care struggled to cope with the rapidly changing world. People were becoming accustomed to flexible access to personalised services that came to them and expected the same from care provision. Rising displeasure at service decline led to middle-class flight to alternatives with rising use of private medical insurance, progressively fracturing the social contract that legitimated publicly-funded care. Indeed, by 2028, 38% of the population used private care, with over 55% amongst Millennials.

Fearful health and social executives and worried Ministers of Health had reacted to these stresses by pulling the system even more tightly together, to protect jobs and avoid the failure of publicly-funded institutions.

This fed further public displeasure by the dominant middle-aged Millennials who challenged the traditional approaches to health and social care. In the United Kingdom, for instance, this unrest led to the 2028 Referendum on their tax-funded healthcare system, leading to the replacement of this system with social insurers and personal Social and Health Care Savings Accounts.

The process of changes in health and social care around the world has become known as Unbundling. This brief historical retrospective outlines three of the key components of that unbundling.

The 1st Unbundling: of knowledge and clinical work

Professional knowledge was affected by digital technologies which had unbundled knowledge from the expert. This changed how expert knowledge was organised, used and accessed; research institutions and knowledge-based organisations were the first to feel the changes, with librarians being one of the first professions to face obsolescence. Rising under-employment, particularly in traditional male-dominated occupations was still being absorbed by the economy.

Routine cognitive work and access to information and services was increasingly provided by cognologies (intelligent technologies) or personal agents as they were called. Widely used across society, they were embedded in clinical workflow from diagnosis to autonomous minimally invasive surgery. By this time, jobs with “assistant” in the title had generally disappeared from the care system, despite having been seen as an innovative response to workforce shortages through the late 20-teens. These jobs had turned out to be uninteresting, and being highly fragmented, required time-consuming supervision.

The benefits of precision medicine were substantial by this time, enabling earlier diagnosis and simpler and less invasive treatments. Theranostics, the merging of diagnosis and therapy, unbundled the linear care pathway and the associated clinical and support work. This also led to the unbundling of specialist clinical services, laboratory testing and imaging from monopoly supply by hospitals. Indeed, the last hospital was planned in 2025, but by the time it opened in 2033, was deemed obsolete.

The 2nd Unbundling: of financing and payment

The unbearable and unsustainable rise in health and social care costs necessitated better ways to align individual behaviours and preferences with long term health and well-being. Behavioural science had shown that people did not always act in their own best interests; this meant the care system needed people to have ‘skin in the game’, best done by monetising highly salient personal risks.

Existing social insurance systems which used co-payments were more progressive in this direction, while countries with tax-funded systems were forced to reassess the use of co-payments, and financial incentives. The Millennials, having replaced the baby-boomers as the primary demographic group, were prepared to trade-off equity for more direct access to care. It also became politically difficult to advance equity as a goal against the evidence of poorer health outcomes as comparisons with peer countries drove performance improvements.

The use of medical/social savings accounts was one way that gave individuals control of their own money and building on consumerist behaviour, this directly led to improved service quality and incentivised provider performance as they could no longer hide behind the protecting veil of public funding. The social insurers were able to leverage significant reforms through novel payment systems, and influence individual health behaviours through value-based (or evidence-based) insurance not possible under a taxation system.

The 3rd Unbundling: of organisations

With people used to having their preferences met through personalised arrangements, care was organised around flexible patterns of provision able to respond easily to new models of care. This replaced the “tightly coupled” organisational approach known in the early part of the 21st century as “integration”, which we know led to constrained patient pathways, and limited patient choices unable to evolve with social, clinical and technological changes.

The big-data tipping point is reckoned to have occurred around 2025. Because the various technologies and cognologies had become ambient in care environments they were invisible to patients, informal carers, and care professionals alike; this enabled the genesis of smaller and more diverse working environments.

By 2032, medical consultants were no-longer hospital-based, having become clinical care social organisations, with their cheaper, smaller, portable, networked and intelligent clinical resources. Other care professionals had followed suit. These clinical groupings accessed additional clinical expertise on as-needed basis (known as the “Hollywood” work model); this way of organising clinical expertise helped downsize and reshape the provision of care and met patient expectations for a plurality of care experiences.

It takes time to shift from the reliance on monopoly supply of care from hospitals in those countries that continued to pursue a state monopoly role in care provision. However, most repurposed themselves quite quickly as focused factories, while the more research-oriented specialised in accelerating the translation of research into daily use, helped along by the new research discovery tools and the deepening impact of systems biology which was making clinical trials obsolete.

What Cognology Says

This Unbundling arose as a product of the evolution of social attitudes, informed by the emerging technological possibilities of the day. The period from 2016 to 2025 was a critical time for all countries, exacerbated by shortages in the workforce coupled with economic difficulties and political instability.

Today, in 2047, we are well removed from those stresses that caused such great anxiety. We must marvel, though, at the courage of those who were prepared to build what today is a leaner, simpler and more plural system, removed from politicised finance and management decisions.

It is hard to imagine our familiar home-based theranostic pods emerging had this trajectory of events not happened. As our Gen-Zeds enter middle age, they will, in their turn, reshape today’s system.

Plus ça change, plus c’est la même chose.

27 December 2047

Note on the Scenario

This scenario is informed by strong and weak signals, including:

Ayers A, Miller K, Park J, Schwartz L, Antcliff R. The Hollywood model: leveraging the capabilities of freelance talent to advance innovation and reduce risk. Research-Technology Management. 2016 Sep 2;59(5):27–37.

Babraham Institute. The zero person biotech company. Drug Baron. http://drugbaron.com/the-zero-person-biotech-company/

Cook D, Thompson JE, Habermann EB, Visscher SL, Dearani JA, Roger VL, et al. From ‘Solution Shop’ Model to ‘Focused Factory’ in hospital surgery: increasing care value and predictability. Health Affairs. 2014 May 1;33(5):746–55.

Cullis P. The personalized medicine revolution: how diagnosing and treating disease are about to change forever. Greystone Books, 2015.

Does machine learning spell the end of the data scientist? Innovation Enterprise. https://channels.theinnovationenterprise.com/articles/does-machine-learning-spell-the-end-of-the-data-scientist

Eberstadt, N. Men without work. Templeton, 2016.

Europe’s robots to become ‘electronic persons’ under draft plan. Reuters. www.reuters.com/article/us-europe-robotics-lawmaking-idUSKCN0Z72AY

First 3D-printed drug just unveiled: welcome to the future of medicine. https://futurism.com/first-3d-printed-drug-just-unveiled-welcome-future-medicine/

Ford M. The rise of the robots: technology and the threat of mass unemployment. Basic Books, 2015.

Frey BC, Osborne MA. The future of employment: how susceptible are jobs to computerisation? Oxford Martin School, Oxford University, 2013.

Generation uphill. The Economist. www.economist.com/news/special-report/21688591-millennials-are-brainiest-best-educated-generation-ever-yet-their-elders-often [accessed December 2016]

Lakdawalla DN, Bhattacharya J, Goldman DP. Are the young becoming more disabled? Health Affairs, 23(1-2004):168-176.

Susskind R, Susskind D. The future of the professions: how technology will transform the work of human experts. Oxford UP, 2015.

Topol E. The creative destruction of medicine: how the digital revolution will create better health care. Basic Books, 2012.

With Samsung’s ‘Bio-Processor,’ wearable health tech is about to get weird. Motherboard. http://motherboard.vice.com/read/with-samsungs-bio-processor-wearable-health-tech-is-about-to-get-weird

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.

Chromophilia

My solo exhibition, Chromophilia, was held at the Evegate Art Gallery from 3 to 24 December 2016. Works are on paper and wood. The gallery is open from 1000 to 1500 Monday to Saturday (but not Sundays).

repurposing history 2

repurposing history 2 SOLD

Evegate Art Gallery is in the Evegate Business Park, which includes retail shops and restaurants. It is located off the A20, East of Ashford, Kent. For the GPS, the postal code is TN25 6SX.

The image is an example of the work. This is acrylic (sfumato technique) on 450 GSM paper, 56x76cm.

Turps Art School 2016-2017

300px-Pyrrole_Red_Dab

Go!

Departing from my usual commentary on arts subjects, I would like to let folks know that I have been accepted into the 2016-17 Turps Art School Correspondence Course.  This will be a challenging opportunity and I look forward to working with my mentor/tutor. At this time, I don’t know who the other artists are in the course but I am sure we are all interested in each others’ artistic journeys and sharing of perceptions, perhaps through joint activities.

As a painter of abstractions, I focus on the materiality of visual perception, by giving physical presence to ideas. This has been the drive of human creativity since the first marks on stones or we made the cave paintings, and has inspired artists to consider alternative realities. Cubism for instance is the materiality of Einstein’s relativity theory. Malevich understood this as did the Futurists. Exuberant exploration is found in the Abstract Expressionists and thoughtful work since then, not just in painting but in sculpture (despite some distractions along the way when artists lost their way and their voices).

No doubt I will post further as the course proceeds.

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.