Commonwealth Consolidated Acts

RESEARCH INVOLVING HUMAN EMBRYOS ACT 2002

TABLE OF PROVISIONS

           Long Title

   PART 1--PRELIMINARY

   1.      Short title  
   2.      Commencement  
   3.      Object of Act  
   4.      Operation of Act  
   5.      Act to bind the Crown  
   6.      External Territories  
   7.      Definitions  

   PART 2--REGULATION--OF THE USE OF EXCESS ART EMBRYOS AND OTHER MATERIAL

           Division 1--Interpretation

   8.      Definitions  
   9.      Meaning of excess ART embryo  

           Division 2--Offences

   10.     Offence--use of excess ART embryo  
   10A.    Offence--use of other embryos  
   10B.    Offence--certain activities involving use of human eggs  
   11.     Offence--use of embryo that is not an excess ART embryo  
   11A.    Offence--use of material created under mitochondrial donation licence  
   12.     Offence--breaching a general licence or mitochondrial donation licence condition  
   12A.    Person not liable for conduct purportedly authorised  

           Division 3--Embryo Research Licensing Committee of the NHMRC

   13.     Establishment of Committee  
   14.     Functions of Committee  
   15.     Powers of Committee  
   16.     Membership of Committee  
   17.     Terms of appointment  
   18.     Annual report  
   19.     Reports to Parliament  

           Division 4--General licences

   20.     Applying for a general licence  
   21.     Determination of application by Committee  
   22.     Notification of decision  
   23.     Period of a general licence  
   24.     Conditions of general licences  
   25.     Variation of a general licence  
   26.     Suspension or revocation of a general licence  
   27.     Surrender of a general licence  
   28.     Notification of variation, suspension or revocation of a general licence  

           Division 4A--Mitochondrial donation licences

              Subdivision A--Kinds of mitochondrial donation licences and what they authorise

   28A.    Kinds of mitochondrial donation licences  
   28B.    Carrying out activities authorised by mitochondrial donation licences  
   28C.    What a pre - clinical research and training licence authorises  
   28D.    What a clinical trial research and training licence authorises  
   28E.    What a clinical trial licence authorises  
   28F.    What a clinical practice research and training licence authorises  
   28G.    What a clinical practice licence authorises  

              Subdivision B--Applying for a mitochondrial donation licence

   28H.    Applying for a mitochondrial donation licence  

              Subdivision C--Determining applications for mitochondrial donation licences

   28J.    Determination of application by Committee  
   28K.    Notification of decision  
   28L.    Matters to be specified in a mitochondrial donation licence  
   28M.    Period of a mitochondrial donation licence  

              Subdivision D--Conditions of mitochondrial donation licences

   28N.    Conditions of mitochondrial donation licences generally  
   28P.    Additional condition of clinical trial licences and clinical practice licences--Committee approval before creation or placement of embryo  
   28Q.    Other conditions of clinical trial licences and clinical practice licences  

              Subdivision E--Ongoing requirements for holders of mitochondrial donation licences

   28R.    Clinical trial licences and clinical practice licences--information about donors and children  
   28S.    Clinical trial licences and clinical practice licences--requirement for ongoing monitoring protocols and to notify adverse events  
   28T.    Record - keeping obligations for all holders of mitochondrial donation licences  

              Subdivision F--Variation, suspension, revocation and surrender

   28U.    Variation of a mitochondrial donation licence  
   28V.    Suspension or revocation of a mitochondrial donation licence  
   28W.    Surrender of a mitochondrial donation licence  
   28X.    Notification of variation, suspension or revocation of a mitochondrial donation licence  

           Division 5--Protection and disclosure of information

   29.     NHMRC Licensing Committee to make certain information publicly available  
   29A.    Mitochondrial Donation Donor Register  
   30.     Confidential commercial information may only be disclosed in certain circumstances  

           Division 6--Review provisions

   31.     Meaning of terms  
   32.     Review of decisions  

   PART 3--MONITORING--POWERS

   33.     Appointment of inspectors  
   34.     Identity card  
   35.     Powers available to inspectors for monitoring compliance  
   36.     Monitoring powers  
   37.     Power to secure  
   37A.    Monitoring warrants  
   37B.    Details of warrant to be given to occupier etc.  
   37C.    Announcement before entry  
   37D.    Occupier entitled to be present during search  
   38.     Inspector must produce identity card on request  
   39.     Consent  
   40.     Compensation for damage  
   41.     Extended operation of Part  

   PART 4--COMMONWEALTH--/STATE ARRANGEMENTS

   42.     Operation of State laws  
   43.     Conferral of functions on Commonwealth officers and bodies  
   44.     When duty imposed  
   45.     Review of certain decisions  

   PART 5--MISCELLANEOUS

           Division 1--Arrangements relating to clinical trials of mitochondrial donation techniques

   46.     Arrangements relating to clinical trials of mitochondrial donation techniques  
   46A.    Terms and conditions relating to clinical trial arrangements  
   46B.    Minister or Secretary may delegate powers in relation to arrangements  
   46C.    Relationship of this Division with the Public Governance, Performance and Accountability Act 2013  
   46D.    Executive power of the Commonwealth  

           Division 2--Other miscellaneous matters

   47.     Interaction with the Gene Technology Act 2000  
   47A.    Immunity from civil actions relating to mitochondrial donation licences  
   47B.    Review of operation of Act every 7 years  
   48.     Regulations