Reaction to announcement paving the way for law change

Reaction to the announcement by the Chief Medical Officer, Professor Dame Sally Davies that there is support for a change in the law, which would allow an IVF technique to eliminate inherited mitochondrial disease, and pioneered at Newcastle University, to be used in patients.

Dr Catherine Elliott, Director of Clinical Research Interests, Medical Research Council, said:
“From very early on we believed it important to fund both the excellent science in this area, and the ethical framework in which it could develop. UK scientists are now at the exciting point of being able to turn these techniques into a means of preventing these appalling diseases. After the carefully considered public dialogue on the issue, we’re extremely pleased that the government has moved that goal an important step closer.”

Professor Robin Lovell-Badge, Head of Developmental Genetics, MRC National Institute for Medical Research, said: “This is excellent news for women at risk of having children with severe mitochondrial disease due to mutations in mitochondrial DNA. There is nothing in the science conducted to date to suggest that the new techniques (maternal spindle transfer, MST, or pronuclear transfer, PNT) are unsafe, indeed when considered in the context of what happens to children born with these diseases, it is difficult to imagine that the new techniques will be anything but a better option to allow these women to have their own genetic offspring. Moreover, there is no reason why the regulations should not be accepted in parallel to, or even in advance of, the remaining experiments that are required to give additional confidence in the methods. It will of course be a brave decision for the first families, and for the HFEA as the regulator, to decide to go ahead once the regulations are approved by Parliament, but more often than not, progress requires some element of bravery.”

Sarah Norcross, Director of the Progress Educational Trust, said: “UK Scientists are leading the way worth their research to avoid inherited mitochondrial diseases and the UK Government is emulating them. The Government looks set to become the first in the world to lay down regulations allowing techniques involving genetic material from three people to be used to avoid the transmission of mitochondrial diseases in clinical trials and in practice. The combination of the regulatory framework already in place for IVF and the public support for the techniques to be allowed means that the Government can act confidently and quickly and not impede scientific progress from delivering its promised benefit.”

Robert Meadowcroft, Chief Executive, Muscular Dystrophy Campaign, said: “It is extremely positive news that the Government has responded to public support for this IVF technique and has decided to draft new regulations, bringing it one step closer to clinical trial. It is encouraging that this follows open and frank dialogue with the public – we respect that the development of this technique is a sensitive issue eliciting strong views on both sides.

“We may now be on the path to offering women living with extremely cruel, unpredictable and devastating conditions the invaluable choice of bearing their own, unaffected children. There is still work to be done in developing the technique, but both the commitment and funding are available to take it forward.

“We now urge the Government to move with haste and to draft regulations to share with the public.”

Sharmila Nebhrajani, Chief Executive, the Association of Medical Research Charities, said: "Mitochondrial diseases are some of the most debilitating inherited conditions, affecting children and adults, for which there are few therapies and no cures. Acknowledging the need for treatments to be proven safe and effective, and for the public to feel comfortable with the implications of new scientific techniques such as mitochondrial transfer is important; but that proper caution must not prevent us from taking bold steps in the adoption of such potentially life-saving advances in the clinic"

Sir John Tooke, President, Academy of Medical Sciences, said: “The Academy is delighted that the Department of Health is taking steps to ensure that techniques which could reduce the number of children born with rare mitochondrial diseases can move closer to being used in the clinic.

“Introducing regulations now will ensure that there is no avoidable delay in these treatments reaching affected families once there is sufficient evidence of safety and efficacy.

“It is also a positive step towards ensuring the UK remains at the forefront of cutting edge research in this area.”

Alistair Kent, Director, GeneticAlliance UK, said: "We are pleased that the Government has listened to the overwhelming positive message from the recent public consultation. Couples at risk of having a child with a mitochondrial disease caused by mitochondrial DNA will be delighted that they are one step closer to being able to access this therapy.

“Mitochondrial replacement has the potential to offer a life-changing option to couples who wish to avoid the birth of a child affected by a mitochondrial disease. The proactive introduction of regulations now means that when the science is ready, the regulators will be ready, allowing couples to access the treatments they have been waiting for with no further delays.

“With all of the discussion about the ground-breaking science that has brought mitochondrial replacement within reach, it is easy to forget the impact that mitochondrial disease can have on children and their families. Many of these conditions are so severe that they are lethal in infancy, creating a lasting impact upon the child's family. An added option for families at risk of having a child with such a condition is welcome."

Dr Ted Bianco, Acting Director of the Wellcome Trust, said: “As a funder and advocate of this cutting edge research, we are extremely pleased to see the Department of Health keeping regulation apace with research developments. This will ensure families affected by mitochondrial diseases are able to access these technologies in the clinic at the earliest opportunity if they are shown to be safe, giving them hope of having children free from these devastating disorders.”

Here is a link to some of the work hosted by the Science Media Centre:
http://www.sciencemediacentre.org/mitochondrial-dna-2/

published on: 28 June 2013