Faint Ripples of Support Detected in Europe for High-Tech Drug Development

The message is starting to get through in Europe that high-quality drug development depends on high-technology approaches as well as high-quality science. A specialized European Parliament committee on cancer started work in mid-July on a report that explicitly urges national governments to take molecular genetics seriously. That may seem a bit of a belated call on a matter that should have been taken for granted. But the reality is that the advocates of deploying advanced technology in Europe's healthcare system have long complained—and are still complaining—that official resistance is hampering wide-scale take-up, and consequently depriving European citizens of the benefits that precision medicine that offers.

This is why the draft report from the parliament's cancer committee is noteworthy. It points out that "huge advances in biology have revealed that cancer is an umbrella term for more than 200 diseases, and that precision or personalized medicine can be made available through the drug targeting of various mutations." Pretty obvious to readers of ACT—but not so obvious to the myriad bodies that control Europe's complex mix of national healthcare systems. Not yet necessarily to everyone in the European parliament either. This is only a draft report. It still has to be adopted by the cancer committee, and only then will be submitted—later this year—to the parliament as a whole for full endorsement.

Even if everything goes smoothly, that will only be part of the battle. The parliament has no power to instruct national governments. It can exert pressure on a political, even sometimes on a moral, level. But the best it can hope for is that its message is backed by the European Commission (which can and does propose rules that bind the member states), and ultimately by the Council (which consists of the member states themselves). That is why the text of the draft report, while arguing that "precision or personalized medicine, consisting of a treatment choice based on individual tumor biomarkers, is a promising way to improve cancer treatment," can go no further than to "encourage" member states "to promote the implementation of regional molecular genetics platforms and facilitate equal and rapid access to personalized treatment for patient."

Similarly, the parliament can do no more than call for "the full and rapid application" of the EU's 2014 regulation on clinical trials on medicinal products for human use—and that seven-year delay (and counting) is another measure of the relative impotence of the parliament, as well as of the intrinsic complexity of the regulation itself and the low level of priority attached by member states in implementing it. "The application of the regulation would facilitate the launch of large clinical trials carried out in a harmonized, efficient and coordinated manner at European level in order to facilitate research into cancer drugs and improve cancer patients’ and their families’ quality of life," the parliament's draft report adds, plaintively.

The needs that draft report's author highlights extend beyond molecular genetics and the 'new' CT regulation. Véronique Trillet-Lenoir, a prominent French medical oncologist who won election in 2019 and sits with the liberal Renew group in the parliament, is seeking backing from fellow MEPs on the committee for the development of clinical trials on the use of new cancer drugs in adults and children. And she wants to see "a more sustainable environment for conducting research into the repurposing of medicines for cancer treatment and for the creation of an additional project that uses high-performance computing to rapidly test existing molecules and new drug combinations, starting with treatment for cancers with a poor prognosis and rare cancers."

That's not all. She wants the EU to ensure "rapid, equal and sustainable access to cancer innovations for cancer patients," and for "a large consortium of public authorities, private companies and NGOs, including patient associations, to work together to guarantee the accessibility and affordability of cancer treatment options requiring complex technologies." This, she says, should take advantage of new possibility through cellular therapy and CAR T cells, adoptive immunotherapy through the use of tumor genome extracts and messenger RNA, and nanotechnologies.

The fact that, in the lower reaches of the European political machinery, support is stirring for advanced technology in drug development may provide a crumb of comfort for those working in the field. But it may equally provide a shock of disappointment that well into the third decade of the 21st century, it should even be necessary for such an appeal to be made.