Belgium Draws a Clear Line on "Right-to-Try"–and Backs Research Independence


Applied Clinical Trials

An additional light has been shone on the "right-to-try" debate in Europe by a strongly-worded statement from Belgium's feisty health minister, Maggie De Block.

An additional light has been shone on the "right-to-try" debate in Europe by a strongly-worded statement from Belgium's feisty health minister, Maggie De Block. I alluded in an ACT blog last month to the case of a young British patient seeking access to cannabis oil as a therapy for epilepsy-an option denied to her by UK legislation. Now the Belgian authorities find themselves swept up in the controversy, after reports that De Block had suggested to the girl's mother that she should move abroad to obtain the treatment.

This Belgian eddy in the debate has become tangled by personalities and local politics, to the extent that De Block felt obliged to put out a formal communiqué in late April clarifying her position. But her public statement also offers an insight into how one of Europe's more prominent health ministers views the discussions now underway across the developed world on where and how to draw the line between patients' rights and public duties.

De Block flatly denies having advised the mother to take the child to a different country in pursuit of cannabis oil. But more interestingly for the wider world, the minister goes on to make a strong defense of the concept of government action to protect the public against unlicensed treatments.

"Simply legalizing cannabis oil would pose a danger to public health", she said boldly, cutting straight through the personal dilemma to the core of regulatory responsibility. "As minister of health, but also as a physician and a mother, it is my duty to protect all children and all citizens in general."

While cannabis oil may help some children, she conceded, "it is very harmful, and even deadly, for others." She expanded on that specific point to draw a broader generalization: "That's why we need irrefutable evidence that cannabis oil is safe for health and its effects are beneficial for everyone. This applies to all medicines, so also to cannabis oil. To make an exception would mean a huge risk to the health of all Belgians."

De Block was careful to take account in her argument of some of the tensions underlying the provision of novel treatments. She noted that cannabis can be marketed as a licensed drug for the treatment of some specified conditions, such as to treat spasms and pain in multiple sclerosis, and "we have also designed the legislation to be open to new forms of medical use whose effects are scientifically proven."

But, she added, the unfortunate reality is that unmet need continues to exist. Effective pain relief is not available for all cases and conditions, and "international drug research is not always progressing as quickly as we would like. It often takes a very long time to reach a scientific breakthrough." Her conclusion is crystal clear-and will offer some comfort to drug developers facing dirigiste pressures from regulators or governments keen to dictate research agendas.

"It is not the authorities who lead scientific research or who develop drugs. For this we depend on pharmaceutical companies and the academic world," said De Block. "It is, of course, not possible to force science to progress and no single country can dictate the research agenda of the pharmaceutical sector."

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium 

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