Turning European HTA Reform Into Level for Controlling Drug Developers


Applied Clinical Trials

Peter O'Donnell discusses the EU's bid to improve the HTA and weighs in on a report made by Soledad Cabezón's.

At first glance, there would appear to be nothing remarkable in the following statement about health technology assessment (HTA): "HTA should be instrumental in promoting innovation which offers the best outcomes for patients and society as a whole."

What makes it remarkable is its prominent place in the latest contribution to Europe's increasingly heated debate on reshaping HTA for the future. It comes in the first paragraphs of a document from the European Parliament, drafted by the member of parliament who has been appointed to oversee the discussions of the proposed new scheme. 

Soledad Cabezón, the MEP in question, is no great admirer of the pharmaceutical industry, and the report she has drafted displays her skepticism about the motivation of the European Union's bid to improve HTA. The European Commission's proposed regulation to ensure greater EU-level coordination is, in her view, focused too much on industry, enterprise, and markets­­-to the detriment of wider patient and public interests.

That is why she wants to modify the wording of the proposed regulation, which says: "The development of health technologies is a key driver of economic growth and innovation in the Union." For Cabezón, the emphasis should be on people, not production.

The rest of her draft report reinforces this approach.

At present, she says, "the main barriers to access to medicines and innovative technologies in Europe are the high price of medicines, in many cases without these being of added therapeutic value, and the lack of new treatments for certain diseases." And that, she suggests, is the consequence of insufficient control of what drug developers are doing.

She remarks that in the European pharmaceutical market: "A high percentage of marketing authorizations are not accompanied by a comparative effectiveness study." It is, of course, true. But it is, in effect, a truism. Because European legislation on the grant of marketing authorizations makes no provision whatever for comparative effectiveness studies.

The three criteria for approval remain uniquely quality, safety, and Efficacy-just as they have been since the first EU legislation on the subject in the 1960s. Comparative effectiveness may well enter into the reflections of national authorities when they make their own national decisions on price or reimbursement status of a medicine, but the marketing authorization-which is covered by EU rules-does not require this.

She asserts that "a very high percentage of new medicinal products brought on to the European market offer no advantage over existing products." She is also critical of current clinical trials arrangements. "Of the clinical trials approved in the EU, only 30% involve more than 1,000 patients and a monitoring period longer than a year," she says.

Worse, "more and more medicinal products are securing early authorization, and those products are six times more likely to be withdrawn from the market and four times more likely to trigger significant alerts, and three times as many are withdrawn from the market," she claims.

So, she wants to see the EU HTA discussion veer away from the Commission's aims of streamlining and reducing duplication and unnecessary divergence, and instead toughen up controls on clinical trials and drug development.

She is calling for "the tightening of the rules on clinical evidence, including a coordinated procedure for the authorization of multi-center clinical research; the tightening of post-market monitoring requirements for developers of technology; and the improvement of coordination mechanisms in the fields of surveillance and market monitoring."

And "in order to guarantee the quality of the process," she envisages the introduction of "a sanctions mechanism in the event of non-compliance by the technology developer with the requirements."

There's plenty more where that came from in her 87-page report. And discussion will start in the Parliament's health committee in early June. Watch this space!


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