OUTLINES of PREMILINARY BY-LAW DRAFT GOVERNING STEM CELL USES IN

JORDAN

Abdallah Abbadi.MD.FRCPProfessor of Medicine, Hematology & Oncology

University of JordanPresidents/ CEO Cell Therapy Center, University of

Jordan

The Current Situation In Jordan/2011

1- No Specific law/by-law on stem cell (SC)use2- No adopted legal Definition of SC and their subtypes3-No rules concerning embryonic sc,but the fatua by shariah scholars representing a consensus of muslim scholars ,is accepted as basis for treatment and research on ESC 3- Medical practice in Jordan is regulated by public health law4- licence to establishments (private sector) are issued by MOH5- Licence for public (government or semi-goverment) institutions are automatically included in the laws governing these institutions. This may include research and treatment using stem cells.

Current Situation….26- Desciplinary actions against medical practioners is regulated by the medical association (syndicate) law and “medical ethics” law7- A practice in health care may generate a complaint to be considered as “malpractice” or criminal act. No clear borders between “medical malpractice” and criminal action 8- Pharmeceutical Drugs/ Medicines are regulated by the JFDA + drug and pharmacy + drug studies laws9- Organ donation/ transplant is regulated by “organ transplant “ law.

Suggested Areas of What the By-Law should regulate

A- Embryonic Stem cellsB- Induced Pluripotent Stem cells (iPS)/ gene manipulation.C- SCN transferD- Allogeneic and Autologous SC “products”E- What is research and what is “approved” practiceF- Storage and Processing of Cord blood/ tissues from living or deceased individualsG- “commercialization” / sales of products

Embryonic Stem cells: areas which need to be defined

1- Definition of embryonic stem cell2- Definition of embryo? What is the cut off time/viability and function or time: 0 day, 14 days, 56 days or120 days. Excess embryos from IVF: the Shariah Fatua or something else?. Who owns these?3- If there is a spontaneously aborted “product of conception” Can it be used for “therapeutic” or research purposes?4- The Placenta and cord “Wharton” jelly.5- Prohibition of financial gains of donors from permitting the use of the above or ?only under special considerations.

IPS and Gene manipulation

1- Is gene(s) addition/ deletion in somatic cells allowed for therapeutic puropses? 2- Is epigenetic manipulation of cells allowed for therapeutic purposes?3- What vectors are allowed for therapeutic IPS?4- Is the generation of “asexual” embryos by IPS techniques allowed for therapeutic purposes?5- What is the limit for “commercialization” of IPS products?

Somatic Cell Nuclear Transfer (SCN)

1- Prohibited by Shariah law2- Are there exceptions? 3- Can they be used for “life Saving” therapies or treatment of severe handicaps?4- What are limits of commercialization?

Allogeneic and Autologous1- Hematopoeitic stem cell transplantation where the origin is Bone marrow/ peripheral blood or cord blood for the established indications should not be a subject of the proposed by-law. This is regulated by existing laws and by-laws2- Use of “solid” tissues/ organs generated in the lab from non-autologous source without gene manipulation should be regulated by guaranteeing safety of the facility (GMP or similar) and the appropriate consent forms.? Any additional restrictions?3- Use of the above in 2 generated in the lab from autologous source without gene manipulation need to be allowed. (GMP or similar) of the facility is needed to ensure safety from infection/ contamination. No additional restrictions providing they are used on the donor.

What is research and what is “ practice”

1- Research study on humans is regulated by public academic institutions laws ( Jordanian universities/ higher education law) and by the JFDA and drugstudies laws, this may include clinical research in stem cells/ same laws should apply to private or nonacademic institutions.2- Only evidence based therapeutic methods should be considered “practice” with the full privilege that they entail. 3- Laboratory research, not involving humans, is not part of this by-law.4- Chimeric research between class or phylum or kingdome should be allowed5- Safe Chimeric SC products use on humans should be allowed.

Storage, Processing of Stem cells and Cord Blood

1- Previously drafted by-law that regulates the collection, storage, testing , documentation and distribution of cord blood should be modified slightly and adopted in great part.2- Tissue banking facilities for use on humans should be subjected to GMP or similar and appropriate consent.3- Appropriate documentation, testing , and release should be clearly stated and inspected.4- Need to regulate use of tissues from deceased persons. 5- Need to regulate importation for human use of stem cells and their products not falling under the term “therapeutic” drugs.

“Commercialization” / sales of products

1- Charge for autologous products used for the donor should not be considered “commercial”2- Charge for non-autologous approved products should be allowed in accordance with the current pricing system of drugs3- Need for modified requirements for registration of a product of SC which is different from the current one used for “drugs”

Final Points1- The by-law should be flexible enough to allow for research in vitro with very few restrictions2- Research on humans should be allowed providing the facility safe handling and appropriate system of approval is established3- Commercialzation of non-autologous products is to be regulated with modification of the current laws. 4- Additional “guidelines” or instructions can be generated as needed.For more on Jordanian laws: http://www.lob.gov.jo/ui/laws/listall.jsp