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question 1 

Are there scientific and other differences between hES cells and iPS cells?

Answers on which there seemed to be general agreement

Statements or questions that were controversial, unclear or needed further debate / research and more ethical reflection

• There are scientific differences between hES cells and iPS cells, and it is important to discuss the relevance, the magnitude and the depth of these differences.

• Mouse is a great animal model but cannot recapitulate all aspects of diseases in humans.

• The mouse is not a very good model to understand the mechanisms of the Fragile X syndrome.

• In some disorders, especially where the phenotype is epigenetically regulated, the model in iPS cells may differ from that in human ES cells.

• Gene expression signature may distinguish between iPS cells and hES cells.

• iPS cells can be used in personalized medicine (which is planned in the future). But a more realistic way to use human iPS cells in regenerative medicine is by creating banks of stem cell lines.

• More comparative research on disease models for specific diseases is needed, using both iPS cells and hES cells, especially in cases where the phenotype is epigenetically regulated.

• There are very interesting applications of human iPS cells in the area of toxicology, disease modelling, etc. However, should these applications extend to cosmetic ones?

• Standardization of medicinal products based on hES cells on a global scale is a feasible goal. But standardization of medicinal products based on human iPS cells will give rise to difficult problems.

• Benefit sharing schemes aimed at involving patient groups in key decisions along the bench to bedside transition would need to address many different issues

question 2

Are these differences such that we still need to pursue research on hES cells?

Answers on which there seemed to be general agreement

Statements or questions that were controversial, unclear or needed further debate / research and more ethical reflection

• For some tasks iPS cells may be more suitable, while in other cases there is still a need for human ES cells.

• Only a limited number of human tissues are available to serve as models of certain human diseases.

• iPS cells can be used to create cell lines from patients with disorders for which a disease model is needed.

• There are several scientific reasons why we still need hES cell research.

• In view of the challenges of risk management, we have to be aware what we do not at present and of the possible ethical consequences of such gaps of knowledge.

• A moratorium or a funding stop on any type of stem cell research would be premature.

• Technological solutions are not the answer to bioethical problems

• There may also be social and ethical reasons why we still need hES cell research

• There is a well-known and simple principle: Any A and B should be treated differently only if there are ethically relevant differences between A and B. But which differences are ethically relevant? How is this to be decided?

• How should people be included in the decision making?

question 3

which, if any, are the implications of these differences for commercial, regulatory and other aspects, in particular for patenting issues?

Answers on which there seemed to be general agreement

Statements or questions that were controversial, unclear or needed further debate / research, more ethical reflection

• There are different attitudes and regulations in EU-countries concerning human ES cell research. But concerning marketing authorization of embryonic stem cell derived medicinal products, the centralized European procedure applies.

• Unproven therapies are a grey area, and the definition of a hospital and a non-routine manufacturing is done at the level of the member states.

• When dealing with iPS cells and hES cells which have been genetically modified, then therapy based on such research must be considered as gene therapy as well as cell therapy, and it must be taken into account that bankable material is being used.

• Public perception can be manipulated in many ways. It is therefore important that at least some scientists get involved in the public debate to ensure openness, transparency and trust.

• Marketing authorization is probably still years ahead from now.

• iPS cells are not excluded from patentability according to article 53 a or c EPC

• The decision of the enlarged board of appeal of the EPO that human stem cell cultures which can only be obtained by destroying human embryos are not patentable is not concerned with the general question of patentability of inventions relating to human stem cells or stem cell cultures.

• Discrepancies between scientific and legal terminology should be minimized. If the terminology used in regulatory texts is unclear, this will give a lot of power to the courts who can interpret the law in different ways.

• Scientists should be careful when stem cell-based therapies are developed, since the resulting medicinal product will be used on patients. It is also important that clinical trials are started with proper informed consent procedures only after pre-clinical studies have been completed.

• There is a need to set procedures for long-term efficacy and safety follow-up, since these products will be active in a much longer period.

• Reprogramming and differentiation protocols are still in the grey zone and we are far away from understanding what is really going on. EMA wants to make sure that hES cells and iPS cells are safe before they are administered to patients.

• Many terminological and conceptual issues need to be resolved in this area, particularly concerning the interpretation of 'human embryo' and 'uses of human embryos for commercial purposes'.

• It is important to put discussions of technicalities, in particular interpretations of key concepts in this debate, in a wider context including values and societal concerns.

• Stem cell tourism, exploiting vulnerable and suffering persons, is a rising problem, not only in countries far away. It has been dealt with in the ISSCR guidelines. It would be a mistake to fight stem cell tourism by accelerating the start of clinical trials. We must learn from previous mistakes in the history of medicine.

• Intellectual property issues will have to be studied further, since they are likely to have a great impact both on research and on future potential applications of stem cell research.