Last week I attended a conference of European pharmaceutical executives, legislators, and regulatory officials.
The theme was “
Economics and Ethics.”
While the “universal” consensus was that ethics are primary – economics came in a very close second. One robustly debated theme was the idea of “an ethical standard based on resources.”
In other words, reality.
We live in the real world where increasing drug development costs and shrinking resources for reimbursement (government-paid in the case of the Europeans) cannot be ignored when it comes to either green-lighting a development program or making an access decision based on healthcare technology assessment (HTA).
One leading consultant suggested that pharmaceutical development program should not proceed beyond Phase II until the company met with reimbursement agencies to gauge the likelihood of a positive coverage decision based on clinical endpoints.
Frightening that such a highly paid consultant could so completely miss the point – that government healthcare systems exist to serve their citizens, not to act as actuarial bean counters. Financial prudence? Cetainly. But not at the expense of the right medicine for the right patient at the right time. That’s a medical decision. That’s ethics.
Many present pointed out that what we really need are better tools to allow smarter development programs that don’t fail in late Phase III (as over 50% do today). In the US that means the Critical Path. In Europe it’s the Innovative Medicines Initiative. Both are predicated on patient-centric care.
But when a healthcare system is a government-pay model, the cost-based versus patient-centric momentum seems unstoppable.
Consider the remarks last week of Thomas Lonngren, executive director of the European Medicines Agency (EMEA),
"It could come to a situation where we are approving a product based on efficacy, safety and quality ... but the patient can't get it because the health technology institute says it is not cost-effective."
Note to Tom – already happening.
Consider Britain's National Institute for Health and Clinical Excellence (NICE) and the series of high-profile disputes in which new drugs for conditions such as cancer and rheumatoid arthritis have been turned down for use on the state health service.
And what’s worse than a bad decision in one country? Correct – a cavalcade of uncoordinated, voodoo cost-based decisions -- with one even less patient-centric than the last. Or, as Lonngren commented,
"… a different decision in each member state (of the European Union) because this is not harmonized.”
Other countries, including Germany, have recently set up their own versions of NICE and Lonngren said the emergence of such health technology institutes posed a challenge for drug manufacturers since these bodies often required additional research, and he suggested there might be scope for cooperation with the EMEA in designing drug approval programs in future.
Is that a good idea, EU harmonization of HTA? Or is it the camel getting its nose under the tent?
That, ladies and gentlemen, is the distinction between “universal” healthcare and “government” healthcare. In short –no difference at all.
