WYA engages the EU debate on Advanced Therapies

WYA Europe invites you to take a stand in the EU debate on advanced therapies! 
On January 30th the European Parliament Committee for Environment and Public Health (ENVI) approved a report on: “The proposal for a regulation of the European Parliament and of the Council on advanced therapy medicinal products”.  Amendments to the report and the final report itself are now due to be voted on by Members of the European Parliament (MEPs) during a Plenary session of the Parliament in Strasbourg in April. We need your help to make our concerns known to all of the Members of the European Parliament over the coming month.

The aim of the proposed Regulation is to create a single European authorisation process for the placing of advanced therapy medicinal products on the market under the single market provisions of the European Treaties. This Regulation will cover new forms of treatment, including gene therapy, cell therapy and tissue engineering. Any types of products that are excluded from this regulation will be less attractive for research and development. By upholding fundamental ethical principles and calling for the exclusion of certain types of products from the scope of the Regulation, we can make our contribution to ensure that the Regulation will not be used in a way which undermines human dignity and fundamental values.

The ethical issues surrounding the authorisation of advanced therapies have already been hotly debated in the ENVI committee. The text of amendments which must be voted on by MEPs provoked heated discussions on the following topics:
1.The principle of non commercialisation of the human body & the right to the integrity of the person
2 EU authorisation of products that involve germ-line modifications
3.EU authorisation of products derived from chimeras and human-animal hybrids
4.The principle of subsidiarity 

How would you like your MEPs to vote? Should the EU put ethical limits on research? Why? How does the principle of subsidiarity apply to this discussion? Why are chimeras and hybrids against human dignity? Why is germ line intervention dangerous? Is it possible to differentiate between germline intervention and eugenics?


1. The non commercialisation of the human body. Right to the integrity of the person.

“In the field of medicine and biology, the following must be respected in particular …the prohibition on making the human body and its parts as such as a source of financial gain.” Article 3.2, Charter of Fundamental Rights of the European Union

Rapid developments in biotechnology and biomedicine must not be allowed to compromise the protection of fundamental rights. These rights of which one of the most important one is the right to the integrity of the person are laid down in and in the EU Charter of Fundamental Rights and in the Council of Europe’s Oviedo Convention: Art. 1 refers to the need to “..protect the dignity and identity of all human beings.. “. Art. 21 calls for: “Prohibition of financial gain. The human body and its parts shall not, as such, give rise to financial gain.

These standards should be upheld within the regulation of tissue and cell-based advanced therapy medicinal products.  Where an advanced therapy medicinal product contains human tissues or cells, the authorisation procedure should be carried out in accordance with the principle of non-commercialisation of the human body or its parts as such.

2. The exclusion of products that involve germ-line modifications: genetic identity.

What does it mean to modify the human germ line? Germ line intervention means the manipulation of human germ cells e.g. egg and sperm cells, in a way that changes the genetic heritage of human beings. The consequences are as yet unforeseeable: germ line intervention affects not only the individual originating from the germ cell but also future generations and descendants. Germ line intervention may lead to the genetic breeding and manipulation of human beings. How will these interventions affect future generations? We cannot possibly ask for their consent. Is this a new form of eugenics? Note “…the prohibition of eugenic practices.” in Art. 3.1 of the Charter of Fundamental Rights of the European Union. Who will determine which types of intervention are therapeutic? If necessary restrictions on such research are lifted, and new incentives given, it is clear that this research may be used for eugenic ends which are contrary to human dignity.

3. Ban on products creating chimeras and human-animal hybrids

The creation of human-animal hybrids or chimeras is a threat to the right to integrity of a person and a violation of human dignity. A chimera is defined as: an embryo into which a cell of any non-human life form has been introduced or an embryo that consists of cells of more than one embryo, foetus or human being.

A hybrid is defined as: a human ovum that has been fertilised by a sperm of a non-human life form an ovum of a non-human life form that has been fertilised by a human sperm; a human ovum into which the nucleus of a cell of a non-human life form has been introduced an ovum of a non-human life form into which the nucleus of a human cell has been introduced; or a human ovum or an ovum of a non-human life form that otherwise contains haploid sets of chromosomes from both a human being and a non-human life form.

Furthermore the general consensus in the European Union is to prohibit the production of animal-human life forms, e.g. of embryos containing human as well as animal germ cells (see e.g. patent directive). In research centres (especially in Great Britain) the production of mixed animal-human life forms (also called hybrid animals or chimeras) is being considered. One possible application of such research is the production of the embryonic stem cells without human egg cells, e.g. through the production of the embryo which is composed of a pig’s egg cell and human DNA. Other ideas are to produce mixed life forms out of a human being and a pig in order to grow organs which would be less easily repelled than organs obtained from a pig. The proposed ethical amendments would not prohibit the transplantation of animal cells into human bodies. Rather, they aim to prevent the creation of life forms which can no longer be distinguished as human or animal.