Hancock seeks reforms to genetic data use and commercial genomic testing

Out-Law News | 22 Mar 2019 | 2:45 pm | 3 min. read

Rules on access to and use of genetic data need updating to support the growth of genomics medicine, the health secretary in England has said.

Matt Hancock used a speech on Wednesday to highlight the UK's world leading role in both predictive and diagnostic genomic testing, but said current restrictions on access to data is hindering research and that new ethical rules are needed to govern the editing of human genomes and support the treatment of diseases.

Genomics is the study of the human genome, which is a double string of DNA that carries all of the genetic material that makes up a particular individual, including its genes and their functions.

"We’ve got to get the data rules right," Hancock said. "After all, genomic sequencing is really just revolutionary amounts of data. It’s why I’m so frustrated at data blockage."

"We can’t currently test for all cancers, because too often, the data is locked away. Sometimes there are good ethical or scientific reasons, and strong privacy rules are vital. But it’s outrageous that too often, anonymised data, paid for by taxpayers, donated by the public, can’t be used for research. We will unlock that data because we know it saves lives," he said.

In his speech, Hancock highlighted the potential of genomic testing to "make cancer screening more targeted and more effective", and to "help people at higher risk earlier". "I see it as a game-changer for cancer screening in the NHS, and I’m determined that we harness this technology to save lives," Hancock said.

The minister also spoke about whole genome sequencing, another form of genomics, which he said can help combat rare diseases.

"Whole genome sequencing is life-changing because it is a diagnostic test of absolute certainty, and early diagnosis can have a massive, immediate impact on improving someone’s chances," Hancock said.

However, Hancock acknowledged that whole genome sequencing raises ethical questions.

Life sciences expert Helen Cline of Pinsent Masons, the law firm behind Out-Law.com, said the debate over the regulation of companies offering commercial genomic testing has been happening for years, but that the issue has come to the fore as the capability of genomic science has been enhanced by improvements in technology in recent times.

"At the moment the regulatory environment for direct to consumer genetic testing companies is uncertain," Cline said. "Better checks and balances are needed to ensure that patients receive the correct support throughout the process,"

According to Cline, ethical issues in genetic screening have been debated for more than 25 years.

In 1993 the Nuffield Council on Bioethics published a report on the issue, and followed up with a supplement to that publication in 2006.

More recently, the long term plan for the NHS in England set out plans for direct-to-consumer genetic testing within the NHS. "The NHS will be the first national health care system to offer whole genome sequencing as part of routine care," it said.

A new inquiry into commercial genomics was also opened by a group of MPs, following a recommendation by the Nuffield Council on Bioethics last year.

The Science and Technology Committee said that as part of its inquiry it will look at "what safeguards need to be put in place to protect those who get tested". The Committee said concerns have been raised about "the potential risks associated with genomic tests being made directly available to consumers, including on the test’s reliability and accuracy, the support available to consumers for understanding and acting on results, and the impact of these commercial tests on the NHS".

Last year the UK government updated the Code on Genetic Testing and Insurance to prevent life insurance companies from forcing customers to disclose their genomic data when taking out policies with them.

A new national genomics healthcare strategy is currently being prepared by the government.

Last year a Chinese scientist claimed he had used gene-editing technology to alter the DNA of two new babies in China. The revelation sparked international condemnation from the scientific community. China suspended all research into human gene editing in the aftermath of the news, while the World Health Organisation set up an expert panel to examine the issues around human gene editing.

Hancock said he does not believe in "a blanket ban on genome editing research", but said people's fears and concerns need to be allayed with the development of a new ethical framework to govern such activities.

"Understanding the human genome raises profound new ethical questions, and we need to get the ethical rules right, both for diagnostic and predictive genomics, and even more so when it comes to the emerging science of editing the human genome," Hancock said.

"We need a clear framework so that we, as a society, can make active choices over how the science is used," he said.