Download OUTLINES of PREMILINARY BY-LAW DRAFT GOVERNING STEM

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
1- Definition 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