Desideria Mini

Demand European Union to fund the research on embryonic stem cells and on genome modification in germ-line

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Desideria Mini
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We, citizens of different countries, believe that the criteria for funding biomedical scientific research must consider all those researches that can protect and promote scientific progress in the treatment of serious diseases in order to guarantee the primary interest of patients and future generations of Mankind.

Therefore European institutions should not exclude a priori funding for the most promising frontiers of medicine and biology like studies about regenerative therapies or about preventive medicine in the future of medically assisted procreation.

Scientific evidences show that research on embryonic stem cells and on human embryos with related genome editing are among the most promising techniques respectively to find cures for several types of severe diseases and to prevent inheritable ones in the offspring.

For these reasons we think the article 14 of the Horizon Europe proposal for funding research in the European Union from 2021 to 2027 must be changed.

The totipotent or pluripotent embryonic stem cells show their effective therapeutic usefulness.

Unfortunately, due to the patient's immune response, it is not always possible to resort to stem cells extracted from supernumerary embryos (embryos left by medically assisted procreation cycles).

However the transfer of the nucleus of a somatic cell of a patient into an egg cell deprived of its nuclear genetic material would allow the production of embryonic stem cells compatible with the patient's own immune system, in order to avoid the transplant rejection.

So, for not to limit the research of effective treatments and the application of the valid therapies that derive from it, we believe that funding should also be allowed including the somatic cell nuclear transfer for the purpose of stem cell procurement.

We also think the article 14 of the Horizon Europe proposal for funding research should not exclude activities intended to modify the genetic heritage of human beings, which could make such changes inheritable, if, for now, these are carried out in vitro for pure research purpose.

About 8000 monogenic diseases are known and each individual, often without knowing it, is a carrier of various mutations that can cause a genetic disease.

Today, fortunately, the new medical advances sometimes allow people affected by a hereditary genetic disease which reveals itself (or which anyway revealed itself) at young age to live (longer) and have a healthier life and this often allows them also to get to have children. Thank to research, in the future, this will be even more true, and for an increasingly number of hereditary genetic diseases. Obviously all that is a good news but this also means that harmful genetic variants are and will be always passed to children and therefore (also) to future generations.

So, due to medicine, natural selection is and will be missing in human species. This will have serious consequences, especially in the long term. Indeed the harmful genetic mutations inevitably accumulate in the absence of the natural selection, because harmful mutagenic events occur more frequently than beneficial ones. So, considering all that, about those (many) hereditary genetic diseases whose onset occurs (or may also occur) before or during the usual reproductive period of the individual's life, it is more than predictable that, moreover, their incidence in the human population over the generations will tend to increase, even up to a "point of unsustainability".

Similar principle apply to some chromosomal diseases.

Unfortunately, pre-implantation genetic analysis of embryos (on its own) has limits that do not always make it sufficient or useful to deliver a "healthy" child and, in any case, a child not carrier of a dangerous genetic or chromosomal variant inherited from her\his parents and, in turn, transmissible to her\his future children.

If appropriate basic research were carried out on human gametes precursor stem cells (spermatogonia or reprogrammed induced pluripotent stem cells), “fertilized oocytes”, zygotes, and very early embryos one day predictably it may become possible to modify the human genetic heritage through genome editing with safety and efficacy.

Only then would be right to radically change the second part of article 90 of EU Regulation 536/2014 on clinical trials of medical products for human use, to allow the modification of the germ-line in order to reduce the incidence of hereditary diseases. But before doing that researches must be are first carried out in vitro also on human cells, otherwise this will never be possible.

Indeed we believe that in the future safe and effective inheritable treatments for hereditary diseases should be allowed (and perhaps also encouraged, at least for more serious them) because they would prevent the disease for all the descendants. That would avoid having to cure and heal people for each generation, something of which, moreover, there would be need more and more.

We do not claim that this line of research is superior to others or that research into somatic genetic therapies should not be funded. We just want to say that in vitro research on "germ-line genome editing" will be complementary and very important so that such research should not be excluded a priori from funding.

For now the research must confined to laboratory but, for all the expressed reasons, we also believe that funding should also be allowed whenever it is directed to activities intended to modify human genetic heritage, when the research is conduced in vitro.

It is also important that in the future the results of all these researches are shared among the people and benefit the entire world population.

For this reason we also believe that it is wrong to let these researches take place only outside the European Union.

We urge Members of the European Parliament, EU Commissioners and Governmental representatives to revise the criteria for "Eligible actions and ethical principles" for funding biomedical researches of the Horizon Europe 2021 – 2027 in line with the present petition.

So we ask to emend the letters (b) and (c) of Article 14 of the Horizon Europe 2021 – 2027 as follow:

(b) activities intended to modify the genetic heritage of human beings which could make such changes heritable, except for in vitro research;

(c) activities intended to create human embryos through fertilization solely for the purpose of research or for the purpose of stem cell procurement, /------/.

Finally, we believe that the second part of article 90 of EU Regulation 536/2014 on clinical trials of medical products for human use (which prohibits modification of the germ-line) should be retouched to allow mitochondrial replacement techniques (MRTs), better known to the public as "mitochondrial donation".

We understand the precautionary spirit of this part as we agree that the genome editing techniques are not yet ready to be applied to the germ line in the clinic (as they still require a long phase of improvement with basic and preclinical experimentation) but some mitochondrial replacement techniques are.

Article 90 could have the perverse effect of blocking also clinical trials of MRTs. These are totally different from genome editing. MRTs "by replacing mitochondria replace their DNA without directly altering the sequence (with chemical reactions)", unlike genome editing. MRTs have already successfully passed both basic and preclinical trials. Not only. Some of them have already been tested in the clinic leading to the birth of children. Although there are very few cases, these children are all healthy. MRTs are the only concrete possibility available to date capable of preventing the transmission of mitochondrial DNA related diseases from mother to her children and from her daughters to future generations. MRTs clinical trials must not be blocked.

Therefore, for now, we also propose only the following reformulation of the second part of article 90 of Regulation 536/2014:

No gene clinical trials may be carried out which result in modifications to the human germline genetic identity, except by mitochondrial replacement techniques for preventive purposes.”

We, the undersigned.

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