Last week I attended a conference of European pharmaceutical executives, legislators, and regulatory officials that focused on the theme “Economics and Ethics.” While the consensus was that ethics are foremost, economics came in a very close second.

 

This was particularly true when it came to a robust debate on “ethical standard based on resources” or in other words, ethics in the reality-based world.

 

We live in a 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.

 

During the conference, one leading consultant suggested that pharmaceutical development programs should not proceed beyond mid-stage clinical trials until the company developing a given drug meets with reimbursement agencies to gauge the likelihood of a positive coverage decision based on clinical endpoints.

 

This I found not only frightening, but wrongheaded. How could such a highly-paid consultant so completely miss the point? Government healthcare systems exist to serve their citizens, not to act as actuarial bean counters. Is financial prudence important? Yes it is, 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 at the conference pointed out that what we really need are better tools to allow smarter development programs that don’t fail in late stage clinical trials as more than half of drugs that make it that far do. In the United States, that means the Critical Path Initiative. In Europe, it’s the Innovative Medicines Initiative. Both initiatives 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, who warned that cost-benefits analysis could become a barrier to patients getting certain safe and effective medicines. "It could come to a situation where we are approving a product based on efficacy, safety and quality,” he said, “…but the patient can't get it because the health technology institute says it is not cost-effective."

 

What he neglected to mention is that that’s already happening.

 

Consider Britain's National Institute for Health and Clinical Excellence or 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.

 

What’s worse than a bad decision in one country? How about a cavalcade of uncoordinated, voodoo cost-based decisions – with one even less patient-centric than the next. Or, as Lonngren commented, “a different decision in each member state because this is not harmonized.”

 

Other countries, including Germany, have recently set up their own versions of NICE and onngren 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 European regulators in designing drug approval programs in future.

 

Is EU harmonization of Healthcare Technology Assessment a good idea, or is it the camel getting its nose under the tent?

 

So what is the distinction between “universal” healthcare and “government” healthcare? In short, there is no difference at all.