Euro-sante/Euro-health

Hospital as Nexus of Innovation

2010-03-04T16:33:00Z

The ERRIN innovation event, The Hospital of the Future, 2 March 2010, explored the future of the hospital as a recipient of financially and environmentally sustainable investment.

The key outcome for me, as one of the moderators of the event, was the emerging view of the hospital as a major innovator within their local/regional economies.

Hospitals are both producers of knowledge and consumers of it. They in effect sit on two sides of the great chasm that separates a great idea with its commercialisation — this chasm is fondly referred to as the ‘valley of death’, and many good small start-ups go there to disappear and their potential benefits lost to society.

We may not think of hospitals in this particularly entrepreneurial manner, but perhaps within their social mandate to provide healthcare, they may be one of the few institutions that are best suited to be research translators.

There is much concern about the general poor ability of universities to commercialise their research. Perhaps we should focus our efforts elsewhere — universities are not really consumers of what they produce; indeed, they can be seen as some of the least innovative institutions in modern society, reforming slowly, adopting novel approaches to teaching as a leisurely pace, and often quite disconnected from the real challenges facing policy makers and decision-makers on a day to day basis. They were innovative when they were invented, but times change (for a take on this see Louis Menand’s The Marketplace of Ideas, reviewed in The Economist)

For healthcare, it may be more sensible to concentrate on building entrepreneurial capacity with institutions that are heavy consumers of innovation, in effect to pull the bench-side research to the bedside, rather than continue to try to turn academics into real-world entrepreneurs.

That means of course that consumers of research need to be freed up to be more innovative and entrepreneurial in order to accelerate the research translation process. Hospitals seem to me to bring together key elements to achieve that goal better than we may have realised and that therefore, the hospital of the future, starting today, should be a nexus for innovation and entrepreneurial activity.

Building confidence for Europe’s entrepreneurs

2010-02-25T18:30:07Z

I had the distinct honour of speaking at and participating in a panel discussion at the European Foundation for Management Development conference at Advancia, in Paris recently. An informed group assembled to hear from entrepreneurs and academics.

I was impressed with the work of Advancia and the support it gets from the Paris Chamber of Commerce. This is an important twinning of interests, and I think a model for other countries. I like institutions that enjoy considerable independence and can forge unique approaches to the challenges of the modern world. Education for entrepreneurs is a major concern and the role of Advancia is to be applauded. I would only add that entrepreneurs also need start-up capital, cash-flow financing arrangements with banks, and of course customers keen to buy from innovators.

That Europe is often compared unfavourably to the US is unfortunate, and perhaps betrays the belief that the US gets it right while the rest of us just muddle along. My view is that Europe has unique strengths (and some worrying weaknesses) that should enable distinctive European approaches to developing entrepreneurs and supporting innovation. Rather than copy Silicon Valley, create another model entirely. I didn’t hear much about how Europe can do this, but I left the event feeling there was life on Planet Europe!

My thoughts coming out the conference are that Europe must be mindful that it not kill off small businesses with heavy-handed social regulation, that drains start-up capital. We hear a lot of talk about jobs and employment, but small and medium businesses are jobs engines and from these small firms grow corporate oak trees. We must also be mindful that while Europeans may feel a perhaps smug complacency at holding the moral high ground on many pressing social issues, this does not help when unemployment is high, with its corresponding economic, social and personal costs.

Whole emerging industries are waiting to be developed, yet more nimble economies may indeed snatch any advantage Europeans may have. Three sectors come to mind: 1. green and environmental technology, 2. electric vehicle technology and 3. sustainable models of industrial growth. No doubt there are many others.

The fear is that even when Europe is ahead, other countries act more quickly to create the sense of urgency needed to fund commercialisation and market adoption of new technologies and services, and once again, Europe may fail to build another global gorilla. Entrepreneurs have a sense of urgency, but systems we design to foster innovation can in the end be bureaucratic and lack timely responsiveness — we do not normally associate entrepreneurialism with the public sector.

I also worry about the need, particularly at the Commission level, to be fair in allocating grants or funding in general. Capitalism, economic development, innovation isn’t really fair and we can’t always back all the winners and ensure there are no losers. While I endorse fairness as a social good, in matters of investment of innovation, you back winners, and no one really knows which are the winners to back and certainly there is no divining rod in government funding that can accurately ensure funding goes to winners. Losers are inevitable — and we heard of important work at Advancia on bankruptcy law across Europe. We need to learn to tolerate failure if we are in the end to build a Europe fit for the 21st century and more.

Grandes Ecoles: For whom the bell tolls? It tolls for thee.

2010-01-06T09:38:27Z

Writing about health issues also means thinking about how people learn — we all want our health professionals to be highly trained and educated. We are also generally mindful that talent should prevail over privilege. Such appears to be an issue for President Nicholas Sarkozy of France and the elitist Grandes Ecoles that enable the French elite to reproduce their status and privilege.

It is with some disgust that one learns that these institutions of knowledge are fearful that their standards would decline if they admitted people from poorer social backgrounds, and this in the land of equality and fratnernity — perhaps these institutions need a history lesson.

It is a tired and dated rhetoric that income and social background should be determinants of future success. That such institutions in a country with such a commitment to intellectual debate should be fearful tells us more about them, than about France, itself.

As institutions funded from public sources, perhaps even more generously than the underfunded French universities, this should bestow upon them an even greater public duty to find the best and brightest in the land.

Le Monde is undoubtedly right when they say the Grandes Ecoles have had their day. Whether it is right to merge them with weakly performing universities may not be as wise, but redefining their admission practices to better help France meet the needs of the 21st Century would seem to be a priority.

This can be accomplished. The evidence from highly selective institutions of higher learning is to be blind to social factors and sharp-eyed for the bright and talented. Perhaps the continuing decline of much of value in France comes from its ossified system of higher education, which rewards the status quo, and discourages innovation — didn’t someone say the French don’t have a word for ‘entrepreneur’?

I weep not for those who covet privilege. In the end, it is worthless currency and those who seek it will become objects of ridicule. I can hear the bells now.

Regional innovators, European disruptors, world-class leaders.

2009-12-07T08:41:48Z

We are all innovators now. Gone, surely, must be the days of free-riders, of subsidised mediocrity and creative malaise. A new world beckons. But doubts remain.

I had the privilege of moderating an excellent post-Lisbon event on innovation for ERRIN, the European Regions Research and Innovation Network. What was so exciting was to hear from different EU regions what they are doing to drive innovation forward. We learned of the creative use of foresight, to probe where technological innovation was occurring and scientific breakthroughs likely to be. We learned about how to bring a diverse mix of interests around a common table, of industry of academe and of entrepreneurs.

It was refreshingly different, and further evidence that this European behemoth might actually show itself as the global powerhouse that it has the potential to be. Perhaps the G2 of the USA and China should be G3, but that will depend on the EU speaking of course with one voice and the post-Lisbon squabbling is only just beginning.

We also heard Commission thinking on where they saw the landmines in the road to economic recovery and hints of structural reform that would be needed in the near term at least.

For innovation and research and development, if regions are the breeder sites where industry, ideas and money mix to produce economic recovery, how will the wider European project benefit?

Two things come to mind. The first is obviously that we need to celebrate and share the excellent work at the regional level, but we must be mindful that narrow national policies of individual member states may pitch regional advantage into the political mix, to trade regional advantage off against national policies. If regions are to excel and strive for at least European leadership, if not world-class stature, they must be owned but us all in Europe. This is a call perhaps for more European protection for centres of excellence.

The second is that the regions do need to become world-class, and this means that they will need to increase the originality of their innovation plans to embrace the disruptive, challenging and far-reaching. This is to ensure that regions don’t keep reinventing the wheel as similar priority setting processes and strategies risk producing similar technological priorities — Europe won’t excel if all the regions come up with similar priorities. This can be exacerbated by excessive reliance on public sector funding, in part, as this puts the regional process into one which risk narrowing the priorities chosen to ones which meet local/regional political goals, and not necessary the wider interests of Europe. While public funding can be a help, it must not restrict the ability of regions for forge strategies that may not meet the needs of their localities but serve a wider interest. (see Philip Cooke, Regional Innovation Systems, Clusters and the Knowledge Economy, Industrial and Corporate Change, 10-4(2001):945-971)

This means that we need wide coordination of innovation activities and strategies, to share priorities through a clearinghouse arrangement, and to identify emerging innovation area that have not been prioritised by a region. What, indeed, are the Grand Challenges facing Europe, and how can these stimulate regional innovation, for instance.

We also need to see much closer working between private equity and venture capital and the work of the regions. Where are the venture capitalists when regional innovators meet?

Regulating internet pharmacies at the European level is necessary

2009-10-02T19:20:31Z

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

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

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

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

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

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

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

What would a solution look like?

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

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

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

New directions for a productive and innovative European biopharma industry

2009-09-01T16:32:44Z

Recent research suggests that the European pharmaceutical industry is more productive than the US one. Euractive reports on this here: article-184974.

A few things to consider. Light’s work is a reanalysis of existing data. His conclusions are based on using the head-office of the company discovering the drug as determining the country of origin. He is trying to distinguish between drugs that are important, and add clinical value, and those that are ‘me to’ drugs. He notes that the reimbursement system in the US favours me-to drug development. This drives a logic that drugs that are top-selling are also important — this is the so-called blockbuster model of drug development and sales. The European Commission still thinks this is a sensible way to measure innovation.

This model is tiresome and bankrupt. We are in paradigm shift in the medicines industry which few in policy circles seem to have noticed. And of course the major pharmas will be the last ones to admit it. One major pharma CEO is reported to have said that they are going to ride this baby (blockbusters) until the wheels fall off. Well, someone should tell this person, the wheels are falling off.

Light’s point is a simple one really. The value-add of research spending on pharmaceutical research should produce better medicines, with improved clinical value, not me-to’s. Europe appears to be better at doing this. The Commission’s plans to work with the pharmaceutical industry should pay attention to this. Indeed, there are lots of medicines around, just not as many of the ones we really need. And of course, big pharma isn’t the same as little pharma or biotech pharma, and the latter are the disruptive players. Medicines are moving away from blockbuster drugs administered to millions and sold in vast quantities toward personalised medicines, focused on specific categories of patients. [Keep in mind, that in clinical trials, many of these subgroups of patients could be discarded from the trials as they were too small and skewed the studies. Now of course, by data-mining past clinical trials we can identify subgroups of patients with specific response characteristics that a tailored medicine will do. But that doesn't produce sales in the billions.]

Of course, Light’s work lumps all the countries of Europe together. There are free-riders on that innovation claim, EU member states with small and probably ineffective pharmaceutical research and development capabilities, while there are a few world-class countries. Certainly, the big players are those countries with the big companies, but also the ones with policies which make it productive for pharma research to be done in the first place, e.g. Germany, Sweden, UK. I might add France, but it isn’t particularly good at commercialisation of its research. One could add a couple of others. I would like to have seen the disaggregated country-by-country data, in the same way as disaggregated US data would have shown which US states are the real drivers and which are the free-riders.

In the end, comments will fall on either sides of the issue. Industry will point to claims of innovation based on sales, while others will point to importance. Methinks the Commission and Europe generally should align its policies around importance. That way the goals are over quality not quantity.

Regional Advantage or Parochial Mediocrity?

2009-08-03T07:37:17Z

Annalee Saxenian, an astute observer and analyst of the regional advantage of Silicon Valley, observes in her book, The New Argonauts, that the Valley has gained as its home-grown entrepreneurs have built overseas businesses in China, India and elsewhere. She notes: “By promoting the development of local capabilities in Tel Aviv, Hsinchu, Shanghai, Bangalore, and other technology clusters while also collaborating with entrepreneurs and investors in Silicon Valley, the New Argonauts have initiated a process of reciprocal regional transformation that is shifting the global balance of economic and technological resources. Silicon Valley, once the uncontested technology leader, is now integrated into a dynamic network of specialised and complementary regional economies.” [page 325, The New Argonauts, Harvard, 2006]

The point here is that building regional economies is now as much about local capabilities as integration with other centres of innovation and development. It is no longer enough to be good enough for the home crowd.

Flying in the face of this is the fear over the Community Patent. In the 25 July edition of The Economist [page 67] is a telling commentary. The Economist notes: “Less innovative countries are unlikely to back a strong European patent, since their governments fear that companies which rely on imitation would lose market share to more inventive foreigners. National patent offices do not want to give up power.”

The point here is that parochial thinking such as this will only lead these economies down the path toward mediocrity. It is a separate question whether there is any power in a national patent office of a failing innovator.

My concern is that the national governments involved will fail to grasp the deep underlying power of Saxenian’s logic in defining the behaviour of innovation systems across the world. These fearful nations will only in the end hasten their slide into mediocrity and economic irrelevance.

It would be better to embrace the wider agenda and understand that Europe’s regional innovation powerbase lies in its international linkages. The ability of regional innovation centres to act as ‘breeder sites’ for innovation elsewhere leads to greater, not less economic and development gain.

Having a European Community Patent is just one sensible step to creating not just a level playing field, but one which will ultimately reward the dynamic opportunities on offer. Those who want world-class innovation centres, driving economic growth, will seek not just the Community Patent, but also to export themselves through powerful relationships in the world stage.

Review of European Research Council: more like a midwife?

2009-07-29T11:08:27Z

The review of the European Research Council paints at times an ugly picture of a bureaucratic mess. In search of simpler solutions of state run/owned type bodies, bureaucratic distance might be the best thing. Otherwise known as autonomy, the ERC could still act in the interests of the European Union, but without all that bureaucratic overhead, and chummy photo-ops.

Make the ERC a charitable foundation, give it a bag of money, and tell it to get on with the business of supporting research. Give it sufficient guidance to ensure alignment with sensible research goals, and from time to time, top up its funding, so that in time it operates with financial security. Let it in effect be owned by everyone.

Staffed with world-class scientists, committed to a process of transparency and funding excellence, there is no reason to assume that it would fail to achieve any founding objectives associated with creating a uniquely European research funding organisation.

And if the Commission wanted the ERC, as a foundation, to pursue specific objectives, then these would above-board and clearly defined.

With this autonomy would come different forms of public accountability, indeed it would be accountable to more than the Commission, but to the wider standards of research excellence that it should be seeking in the public interest.

Let us, in the end, be clear. The ERC is not an innovative organisation, despite the words in the evaluation report. It is simply a research funding body that seeks to link pots of money, specific research objectives and researchers, though some process of peer-review, assessment and analysis. In the end, its success is measured not in money dispensed, or programmes in existence, but the results of research funded. The ERC should think of itself more like a ‘midwife’, who can take little credit for the resulting offspring, but they can be assured that they did help.

European Health Technology Assessment: time for Euro-NICE?

2009-07-10T15:41:05Z

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

So much is not new.

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

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

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

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

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

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

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

Swedish Presidency: innovation

2009-06-26T15:12:43Z

Sweden is home to the Karolinska Institute, one of the most effective bio-medical institutions in the EU. The worst thing the EU could do would be to copy Sweden; they are exemplary.

What should be left behind at the end of December is a commitment by member states to unleash the creativity in their research communities by doing three things:

1. government should broadly get out of the business of owning research infrastructure such as state-owned research laboratories (give them away to universities), and remove civil service status to many of its researchers; there is ample evidence of government failure in research commercialisation (Futuroscope anyone?)

2. stop hoarding publicly-funded intellectual property, and let industry acquire and commercialise more easily; the Commission has recognised the game-changing impact in the US of the Bayh-Dole Act;

3. recognise that competition between EU member states only fragments research infrastructure, undermines synergies and in the end causes researchers and investment capital to flee to other areas; however, while efforts to knit researchers together in pan-EU research communities only works up to a point — world-class research infrastructure may not work in quite that way, and this is a challenge to the use of research funding as an instrument of European integration– it may in the end make people feel good, but may not be value for money if competitiveness and innovation are the end goals.

There is an international market in good ideas, and research, while investment money does not respect national borders. The sooner Europeans understand this, the more sense they can make of innovation and competition in the modern world.

It seems to me that no one is breaking down the EU’s research doors to get in!