Tag Archives: European Union

“Triple Aim” for regulation

We are awash with regulation. Healthcare and medicines are particularly affected.

For instance, in their wisdom, European lawmakers have deemed it inappropriate for medicines to be advertised. And this in the 21st century, with open information access, calls for transparency and the empowered and informed patient. Of course, the logic of such restrictions reflect real-world anxieties, but they also reflect the anxieties of another age. If we examine regulatory practices, we’ll find that in the main they use instruments that would have been popular in the 1950s and 1960s. Today, more subtle and information rich tools are available.

We regulate to coerce people and organisations to behave in certain ways that they would not, of their own volition, otherwise do. This coercion is legitimate if it arises through due process and democratic accountability, and not just the whim of the regulator or government. Sometimes this coercion has perverse consequences, such as with medicines where the legitimate manufacturer of a product is prohibited from publicising a product, but all manner of snake-oil salesman can make all manner of inappropriate claims for medicines, each pits or peanut butter as a sunscreen! The truth lies somewhere but regulations make truth-telling more difficult and not always in the public interest.

What I want to propose draws its inspiration from the US, with Don Berwick and colleagues suggested Triple Aim tool for determining high-value intervention targets (the three are: quality of care, patient satisfaction, and cost).

The Regulatory Triple Aim would comprise three tests, the simultaneous failure of which would indicate that the proposed regulation should not be considered further.

  1. Will the regulation produce poor quality or substandard outcomes? This is likely to be measured through evidence or insight into perverse consequences, weak enforcement, lack of suitable performance data, etc.
  2. Will the regulation produce dissatisfaction amongst the regulated? This is comparable to the patient satisfaction and goes to whether the regulation is appropriate and proportionately coercive and will it enjoy high degrees of compliance.
  3. Are there avoidable costs associated with the regulation? This is an interesting test as it actually asks two things: [1] is there an incremental burden of costs associated with regulation and [2] is the cost proportionate to the benefits.

As a formula, we have Quality (#1) + Satisfaction (#2)  divided by Costs (#3) = Value for Money.

We need ways to sharpen our focus on regulation, and we need to ensure that there is not too much of it for the value we seek to achieve.

Let’s test it with the regulation that was intended to control refillable olive oil containers or pots in restaurants, something that more insightul minds eventually decided was a silly thing to do (I’ll wager though that has just gone into hibernation while a study is commissioned to find evidence that such refillable containers are full of fake olive oil or somesuch and then it will re-emerge), but it did get a long way along the regulatory process without anyone (group think?) challenging it — are people really that dumb? I wonder how that happened — did no one apply a Wilson matrix to this to see if the distribution of costs and benefits was properly understood? Anyway, back to Triple Aim.

Olive Oil in Refillable Pots or Containers

Would regulating olive oil in refillable pots or containers …

1. … produce poor quality or substandard outcomes?

2. … produce dissatisfaction?

3. … create avoidable costs?

Triple failure, meaning answering YES to each question, would suggest this would not be a good idea.

Post your assessments and comments. Obviously, if you’ve got better examples, (such as regulation of clinical trials or whatever) please feel free to expand the scope.

 

 

“Triple Aim” for regulation

We are awash with regulation. Healthcare and medicines are particularly affected.

For instance, in their wisdom, European lawmakers have deemed it inappropriate for medicines to be advertised. And this in the 21st century, with open information access, calls for transparency and the empowered and informed patient. Of course, the logic of such restrictions reflect real-world anxieties, but they also reflect the anxieties of another age. If we examine regulatory practices, we’ll find that in the main they use instruments that would have been popular in the 1950s and 1960s. Today, more subtle and information rich tools are available.

We regulate to coerce people and organisations to behave in certain ways that they would not, of their own volition, otherwise do. This coercion is legitimate if it arises through due process and democratic accountability, and not just the whim of the regulator or government. Sometimes this coercion has perverse consequences, such as with medicines where the legitimate manufacturer of a product is prohibited from publicising a product, but all manner of snake-oil salesman can make all manner of inappropriate claims for medicines, each pits or peanut butter as a sunscreen! The truth lies somewhere but regulations make truth-telling more difficult and not always in the public interest.

What I want to propose draws its inspiration from the US, with Don Berwick and colleagues suggested Triple Aim tool for determining high-value intervention targets (the three are: quality of care, patient satisfaction, and cost).

The Regulatory Triple Aim would comprise three tests, the simultaneous failure of which would indicate that the proposed regulation should not be considered further.

  1. Will the regulation produce poor quality or substandard outcomes? This is likely to be measured through evidence or insight into perverse consequences, weak enforcement, lack of suitable performance data, etc.
  2. Will the regulation produce dissatisfaction amongst the regulated? This is comparable to the patient satisfaction and goes to whether the regulation is appropriate and proportionately coercive and will it enjoy high degrees of compliance.
  3. Are there avoidable costs associated with the regulation? This is an interesting test as it actually asks two things: [1] is there an incremental burden of costs associated with regulation and [2] is the cost proportionate to the benefits.

As a formula, we have Quality (#1) + Satisfaction (#2)  divided by Costs (#3) = Value for Money.

We need ways to sharpen our focus on regulation, and we need to ensure that there is not too much of it for the value we seek to achieve.

Let’s test it with the regulation that was intended to control refillable olive oil containers or pots in restaurants, something that more insightul minds eventually decided was a silly thing to do (I’ll wager though that has just gone into hibernation while a study is commissioned to find evidence that such refillable containers are full of fake olive oil or somesuch and then it will re-emerge), but it did get a long way along the regulatory process without anyone (group think?) challenging it — are people really that dumb? I wonder how that happened — did no one apply a Wilson matrix to this to see if the distribution of costs and benefits was properly understood? Anyway, back to Triple Aim.

Olive Oil in Refillable Pots or Containers

Would regulating olive oil in refillable pots or containers …

1. … produce poor quality or substandard outcomes?

2. … produce dissatisfaction?

3. … create avoidable costs?

Triple failure, meaning answering YES to each question, would suggest this would not be a good idea.

Post your assessments and comments. Obviously, if you’ve got better examples, (such as regulation of clinical trials or whatever) please feel free to expand the scope.

 

 

Medical Debts and the Euro-zone Crisis

The financial markets have broadly spoken and find the leaders of the Euro-zone patently unable to implement the solutions to the crisis.  Knowing what the problem

Confused Man Reading a Bill or Bank Statement

Where did it all go wrong? I thought there was enough money…. (Photo credit: s_falkow)

 

really is is very important and it now appears that the core structural reforms necessary seem too hard for doctrinaire European thinking. If you keep trying to implement the same solutions and keep getting the same results — namely a sovereign bailout — that is a rational clue that you are doing the wrong thing.

Medical indebtedness is a big part of the problem, as much of the debt arises from state controlled or funded health systems, and therefore the payment from public funds to pharmacists, doctors, hospitals, etc. adds to the debt load. Indeed, going forward, the debt rating of Euro-zone countries may be in part determined by their ability to handle these types of debts. So far, though, the prognosis is not good.

A summary: figures arising in the period February 2012 to date [Sources: Financial Times, Reuters]

  1. overall, pharmaceutical companies are owed €12 billion in unpaid bills for medicines (debts more than 30 days unpaid).
  2. about €6 billion of that is apparently in Spain; overdue bills in Spain are approaching 800 days unpaid; recently, though, the Spanish central government found €17 billion euros to pay suppliers of the autonomous communities — 73% of this amount was for unpaid medical bills
  3. medical device makers are owed about €4 billion
  4. one device company recently took back about €4 million in unpaid inventory
  5. an insulin supplier shifted to cash on delivery for Greece and has threatened to withhold new drugs from the market
  6. many pharmaceutical companies are reprofiling their product portfolio in high risk payment countries, with a focus on medicines where there is no alternative source of supply or where there is higher clinical need
  7. there is in some cases a broad strategic shift away from customers who don’t pay their bills (e.g. hospitals) to the patients, thereby avoiding high risk local or regional government payers
  8. many health industry intermediaries are diversifying their business away from this sector
  9. some companies have written down their debt selling sovereign bonds; amounts in the tens of millions of Euros are involved.
  10. some of Greek national debt arose from hospital capital expenditure and the failure to properly account for these in national accounts, despite the fact that their hospitals are in poor physical condition; there is a comparable risk associated with capital expenditures across the Euro-zone as it generally involves public bodies and public debt
  11. and so on….

What does this mean?

Consequences to health systems are unlikely to be short term. The suppliers are bearing the costs of granting credit to governments with increasingly fragile credit ratings. They are going to be more cautious in future, no doubt. But a few consequences can be anticipated based on current actions:

  1. There is an evident shift from state payers to patients, forcing patients to pay full costs and then recover these costs from payers. This can be serious hardship for some patients. To some extent, increasing copayment/full payment increases price awareness amongst patients, and increases their awareness of true costs and medicines or device availability. Where national policies may act to suppress introduction of innovative products, public salience of this will rise. Increased public salience will have the effect of limiting the ability of governments to act to constrain costs and availability. This alone could lead to calls for radical reform of state controls in health systems.
  2. Innovative medicines and devices are unlikely to be supplied to at-risk countries until there are assurances of payment. Indeed, medicine reimbursement policies which seek to drive down medicines prices or encourage generic substitutions are likely to have a perverse consequence as industry has the option of restricting to supply to manifest demand, or delaying the introduction of innovative medicines for fear not only that they won’t get paid, but the price paid may be punitive.
  3. Infrastructure renewal in the healthcare system will come under considerable scrutiny. Do we need to renovate hospitals; should new ones be built or should we be looking at newer ways to deliver healthcare at lower costs (e.g. e-health), and how will the vested interest groups (health professionals) react to far reaching system reform to reduce the capital costs of hospitals?
  4. Reduction in availability of supplies has a variety of consequences: shortages of medical/surgical supplies delay operations; shortages of gloves can increase the risk of spread of hospital infections (which can cost upwards of €100,000 per incident to clean up, a lot more than gloves cost); general cost containment can compromise linen supply and sterilisation, increase the risky use of reusable surgical instruments and encourage staff to take risks with reusing equipment in general; given the scale of infrastructure, staff shortages (not hiring replacements) can lead to increased patient loads for health professionals and thereby shorten time available for patient care. This list can go on and on.

The point is that healthcare is a system, and shocks to that system, whether unpaid medicine bills, staff shortages, hospital infections, whatever, have consequences throughout and many of these consequences are likely to be far more costly than the savings and could lead to widespread risks to public health.

Solutions? In my view, the time is ripe for the at-risk countries, in particular, to reflect on the cost-drivers in their systems and focus on substantial reform of the delivery system, as well as the financing itself. Long-term sustainability is needed, so short-term or ill-thought through reforms will only make things worse. We’ve already seen the consequences of that with current Euro-zone leadership.

Email me your suggestions and let’s start building a list of possible solutions that protects the integrity of the public’s health without bankrupting the country.

/p

Healthy Ageing

Mike moderated the session on “Healthy Ageing” at the 2nd European Innovation Summit in Brussels, 11-12 October 2010. The event, held at the European Parliament and includes participation of secondary school students as part of the programme’s “Europe’s Future Nobel Prize Winners”.  The overall goal of the event is to focus on innovation in Europe, global leadership and innovation partnerships.

Specialist sessions, in addition to the one I moderated, are Efficient Energy Provision, Sustainable Food Security, Urban and Regional Mobility within the EU, Sustainable Production for the Quality of Life, EU Copyright Law, International Innovation Cooperation.

The Healthy Ageing session is hosted by Antonio Fernando Correia de Campos, MEP.

More information is [HERE]

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The Cognologist’s European Blog is rated influential in Europe

Visualization of the Influence Landscape

Visualising Influence

The Policy Cognologist also maintains a European policy blog, Euro-Sante/Euro-Health. Waggener-Edstrom Worldwide conducted a study of the most influential policy oriented blogs in Europe and I am delighted that my blog was rated amongst the most influential specialist blogs.

There is also activity on Twitter about the influence of the blogs in the study in the EU at #bbs10. You can also request a copy of the report with ratings of all the blogs, specialist and general at Waggener-Edstrom.

The report makes for interesting reading. One observation is the relative greater influence of generalist policy blogs over specialist ones; the highest rated is written by someone from the BBC. Others by folk with less illustrious affiliations, but no less important things to say.

I am pleased though to be counted amongst such company.

Overall, the blogs represent efforts by many people across Europe to put ideas forward with varying degrees of success or recognition. The world wide web creates amazing opportunities for fresh ideas to be presented in easy and accessible forms. Blogs can be updated quickly and with RSS feeds, interested individuals can receive notifications of new posts. Whether internet search engines effectively identify blog entries is another matter. Blogs operate in the real world in real time and with rankings such as Waggener-Edstrom’s, the task is much easier for bloggers with important things to say to be heard.

On a cautionary note, policy processes within the EU and government depend on having accessing to fresh ideas and knowledgable people. But in my experience, they can fail to engage with emerging influencers, as well as with individuals who lack official, recognised or organisational positions to give them ‘organisational cover’ as it were. Influence and quality of thinking depends more on the cogency of the writer’s knowledge and ability to craft succinct argument, than the reputation of their employer (and perhaps the EU puts too much emphasis on the latter).

Time to stop unpaid internships

The Treaty of Rome signing ceremony, at the Pa...

Unpaid interns taking notes?

I was looking over a list of jobs with various agencies in Brussels. A large number of these sought ‘interns’, for unpaid positions. The UK’s Tatler magazine recently had an article called The Interns: Never have so many battled to get coffee for so few.

The Tatler article puts the issue into a social context, as the only people who can really afford to be an unpaid intern are those who already have some financial backing (from more affluent parents, usually).

The longer term impact of the unpaid use of people in this way is to make it harder for people from less affluent backgrounds to get their foot on the employment ladder. And in the end, that is a loss not just for that person, but for us all and our general sense of fairness suffers.

It is now time to stop the use of unpaid interns across the European Union, and in particular its practice in Brussels where a vast army of such people go to ‘work’ everyday right under the noses of the very people who should be most concerned.

The many agencies and firms, and they know who they are, should be held accountable for the use of unpaid individuals in this way which could be seen as bordering on exploitation.

Clients of these firms should similarly beware of the implications of the use of unpaid expertise, for which the firms in the end are paid, but the benefits of which are not passed on to the interns.

And what about the interns themselves, who are exploited in this way, as they try to establish their careers? It is hardly a good introduction to the world of work.

Active steps people can take:

  1. Firms that use interns should be required to identify their use in contracts with clients and identify the economic value of these individuals and whether interns were paid or unpaid; clients can then decide whether to engage these firms knowing that some of the work will be done by people who will not be paid.
  2. Any contracts awarded by official European agencies should require an ‘internship disclosure statement’ identifying the use of interns in the work, and whether any were unpaid; this would apply in particular to reports and studies prepared by agencies for official European agencies and the Commission where interns may have undertaken research or similar work.
  3. The Member States  should consider requireing that official European organisations and the Commission do not permit the use of unpaid interns who are citizens of a Member State in any work commissioned by those official bodies from suppliers located within the European Union.

There are other actions possible, for instance to disclose workplace protection and support to unpaid individual, their care and welfare while unpaid but on company business, and so on. Careful thought will no doubt produce a productive way forward to ensure that individuals can still start their careers through internships, but do not suffer from any corresponding exploitation. We must ensure that if internships are to be of value, they actually contribute to career development in a meaningful way.

Comment on this post with your experiences  and thoughts. Or email me in complete confidence.

Entrepreneurialism

Mike spoke at Advancia in Paris on 22 February on challenges facing entrepreneurs, with a particular emphasis on healthcare. Healthcare faces many challenges, but perhaps the greatest is how to deal with the future: the impact on health from climate change, demography, food production, and technology. Email Mike if you want a copy of the slide presentation.

Agricultural Innovation

Mike recently discussed commercialisation of agricultural innovation in Canada. There are real problems in this sector, not just how to feed the future and changing dietary patterns. Agricultural innovation tends to focus on new seed varieties as these can be commercialised, but we also need to look at a whole range of other issues, but research funding for soil science for instance, is small compared to other areas.