OUTLINES of PREMILINARY BY-LAW DRAFT GOVERNING STEM

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OUTLINES of PREMILINARY BY-LAW

DRAFT GOVERNING STEM CELL USES IN

JORDAN

Abdallah Abbadi.MD.FRCP

Professor of Medicine, Hematology & Oncology

University of Jordan

Presidents/ CEO Cell Therapy Center, University of

Jordan

The Current Situation In

Jordan/2011

1- No Specific law/by-law on stem cell (SC)use

2- No adopted legal Definition of SC and their subtypes

3-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 law

4- licence to establishments (private sector) are issued by MOH

5- 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….2

6- Desciplinary actions against medical practioners is regulated by the medical association (syndicate) law and “medical ethics” law

7- 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 laws

9- Organ donation/ transplant is regulated by

“organ transplant “ law.

Suggested Areas of What the By-Law should regulate

A- Embryonic Stem cells

B- Induced Pluripotent Stem cells (iPS)/ gene manipulation.

C- SCN transfer

D- Allogeneic and Autologous SC “products”

E- What is research and what is “approved” practice

F- Storage and Processing of Cord blood/ tissues from living or deceased individuals

G- “commercialization” / sales of products

Embryonic Stem cells: areas which need to be defined

1Definition of embryonic stem cell

2- 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 law

2- 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 Autologous

1- 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-laws

2- Use of “solid” tissues/ organs generated in the lab from nonautologous 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 allowed

5- 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 drugs

3- Need for modified requirements for registration of a product of SC which is different from the current one used for “drugs”

Final Points

1- The by-law should be flexible enough to allow for research in vitro with very few restrictions

2- Research on humans should be allowed providing the facility safe handling and appropriate system of approval is established

3- 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

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