European health regulation on lab tests, the final round?

Medical devices: Council getting ready for talks with EP

Last June 15th, there was a small but significant step towards the final agreement on Medical devices and in vitro diagnostics regulation in Europe. The need for reform has been widely requested but the lack of political consensus and the low priority given to the issue has delayed its approval in many ocasions. It seems that now is the right opportunity, however if finally passes, it will be applied on 2020!!!. It really sounds weird that it would take 5 years to be fully developed.
Anyway, if you want to have a look at the details check here and here. Right now, the lobbies are not on vacation, they are fighting against some provisions that limit their current freedom of market access. Pay attention to final result, just to check who wins and who loses, and the current state of power balance between society and the lobbies.

 



NESBITT, Lowell. Dos ponts a Nova York, 1975

Exhibition at Espai Carmen Thyssen. San Feliu de Guixols

The size of income inequality

 

Income declared to tax authorities, not actual income. Selected statements:

• 3% of citizens account for 30% of tax collection!
• In 5 years, plutocrats have decreased by 50%!
• In 5 years, average work income has plummeted 3,6% and taxes jumped to 9,5%!

My congratulations, tax authorities!

 

 



The price of cancer drugs, where is the limit?

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Stratified medicine: defining the size of the market

AN OVERVIEW OF THE STRATIFIED ECONOMICS OF STRATIFIED MEDICINE

Trusheim and Berndt provide an excellent overview of the economics of stratified medicine. I have reviewed the topic before and specifically in this post. An ideal companion diagnostic perfectly identifies and distinguishes treatment responders from those who will not.Unfortunately, in practice no diagnostic performs ideally. All diagnostics experience some level of error. In the case of a companion diagnostic, some patients will receive false positive results, scores indicating they will respond, but will not when treated. Other patients will receive false negative results, scores indicating they will not respond, but if treated they would.
So what? The key issue is about the setting of the cut-off that will define the size of the market:

Under competition, three essentially identical drugs may receive dramatically different labels, incremental cost-effectiveness ratio (ICER) justified pricing, and market positioning depending on their stratification approach. It appears superior to use an imperfect biomarker to none at all. It is less obvious whether patients, payers and firms prefer the same cut-off values for the companion diagnostic, or even whether each stakeholder a priori prefers the high, low or perhaps some other CDx cut-off value.
The competing development teams may face a version of the game theory ‘prisoner’s dilemma’ in which the optimal result for patients and all firms would be to select a low or mid companion diagnostic cut-off value but the advantages of a potentially differentiating high efficacy claim may drive developers to select a high cut-off value. If all choose this approach, overall value may be reduced with many patients excluded from treatment. But the potential advantage of a higher cut-off value may prove too alluring, or the fear of a competitor selecting one, may drive all to do so. Each situation will depend on the specific facts of the indication, therapeutic, companion diagnostic and competitors

The implications for regulating and financing of companion diagnostics are immediate. In Europe current legislation is as old as of 1998, the year that Herceptin entered into the market and the begining of stratified medicine. New regulation is still pending and there are  no perspectives about a unified approach to lab tests assessment. European regulator is still on vacation.

Lab on a chip concept, the future of diagnostics?

Future vision: next generation lab on chip concept from imec on Vimeo.
Imec develops the next generation of “lab on a chip” concepts. The idea is that such a disposable chip could be loaded with a sample of blood, saliva or urine and then quickly analyzed using a smartphone, tablet or computer, making diagnostic testing faster and easier for applications such as disease monitoring and management, disease surveillance, rural health care and clinical trials.

The market for health insurance price comparison

Internet has provided multiple option for price comparison through website aggregators. On health insurance you can find several alternatives. Is this market competitive? Who wins and who losses?. This is the question asked in a recent article in The Economist:

Consumers should celebrate that; the firms’ losses are their gains. But there is a catch. Comparison sites, whether for insurance or something else, introduce a new layer of costs, including their own splashy advertising campaigns. In theory, competition in the market for comparison sites ought to keep those costs down. But in a recent paper, David Ronayne of Warwick University argues that consumers often lose out from comparison sites. They earn a commission for each shopper who uses them to buy insurance. That referral cost is incorporated into the price the consumer ends up paying. If the increased costs outweigh the saving the comparison enables, consumers end up worse off.

And the proposal:

How can you ensure the market for price comparison is competitive? Asking consumers to check multiple websites defeats the point of using them. One solution is to have only one site, but regulate it as a public utility. Alternatively, the government could run the site itself—much as the American government now runs comparison websites for health insurance under Obamacare.

I think that this is the right approach, why not apply it here?

Regulating sugar sweetened beverages

Searching for Public Health Law’s Sweet Spot: The Regulation of Sugar-Sweetened Beverages

Nowadays, obesity prevention lies at the heart on any public health policy. If sugar sweetened beverages contribute decisively to obesity, then something should be done. What?. A recent PLOS article explains the options:

The main regulatory approaches are taxes, restrictions on the availability of SSBs in schools, restrictions on advertising and marketing, labeling requirements, and government procurement and benefits standards.

On taxes:

Savvy regulatory design has tremendous potential. For example, there is growing evidence that taxes that are more salient to consumers, such as those included in a good’s posted price (rather than being levied at the register), are more likely to influence purchasing behavior

On public procurement, a practical suggestion for immediate application:

Restrictions on which beverages may be purchased using government funds are a less visible form of regulation, but one with potential to change the consumption patterns of large numbers of people. Outside public schools, these standards are most germane in two areas: procurement standards for public institutions (e.g., government agencies, hospitals, and prisons) and restrictions on what recipients of government benefits for the indigent may buy with those funds.
The UK’s Government Buying Standards prohibit central government bodies from  procuring SSBs larger than 330 ml and encourage the wider public sector to follow the guidelines. Massachusetts  and many US counties and cities have adopted nutrition standards for government contracts, but most apply to a limited set of institutions, such as childcare facilities or youth centers.

PS. My former posts on the same topic.
PS. Article: The impact of sugar sweetened beverages on depression risk in adults.
PS. Report: Scenarios of Macro-economic Development for Catalonia on Horizon 2030
PS. Report: FBBVA Essential Public Services.
PS. Report: Chronicle of a premeditated offensive.