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Regulators scramble to catch up with innovation

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Be it CRISPR designed babies or new age medical devices, where is the line in the sand? And who will draw it?

A Chinese researcher He Jiankui’s claim to be the creator of the world’s first “designer babies” using gene editing tool CRISPR has reignited the debate on ethics of genetic research. It has also shown how ill equipped regulatory agencies are, when faced with the fast pace of scientific research and technology.

Medical researchers and the clinical community believe that their priority is healing their patients. If gene editing can prevent a person from becoming a patient, does it justify the risk of the unknowns in the technique? Let’s not forget that CRISPR is still at research stage and researchers are not able to predict or control the gene editing process completely.

The scientific community were not convinced  that Dr He’s achievement passed muster even after he presented his work at a conference following his announcement. In fact, they pointed out that he had breached protocol on several counts: not completely informing his institution nor his team working on the project. There is also doubt that he got proper informed consent from the subjects of this research project. He has already admitted that CRISPR has not acted uniformly on the twin girl’s DNA. It is now a concern if this will create other problems in the children’s future health.

It is but natural that regulations will always lag research and technology but the sad part is that even when we do have regulations, they are not implemented effectively. Neither do regulators have the capacity to respond fast enough. For instance, take the ongoing Implant Files investigation.

As I write this, the International Consortium of Investigative Journalists (ICIJ) and 59 media houses including The Indian Express, are in the midst of revealing the results of an investigation, called the Implant Files, which detail the lack of effective regulatory systems for most medical devices.

The investigation once again alludes to the alleged links between companies and doctors as well as unprepared regulators unable to keep pace with technology. Medical device manufacturers are in crisis management mode but what about the patients? Will all this attention get them justice and compensation commensurate with their pain and suffering?

As the blame game continues, the larger and longer term question is, will we learn from these reports?

The issue of poorly regulated medical devices is not new, and not restricted to India. Just two days after the Implant Files story broke across the world, the US Food and Drug Administration (FDA) went on record to say that it was planning to update its  medical device clearance process to address the complexity of new technologies. Can we hope for the same review and revamp from our regulators in India?

Thanks to patient groups and select media houses, such incidents will hopefully continue to be highlighted. Because the wheels of justice turn slowly. There is no conclusion yet to the JNJ ASR knee replacement issue, even though  months after the news first broke.

Thus as the Express Healthcare team wishes all our readers all the very best for 2019, we also hope for more responsive policy makers as well as a more responsible industry. The patient community in India and across the world, has discovered its voice and will stay silent no longer.

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