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Biotechnology Authority Bill, 2005 (HB 11, 2005)
the National Biotechnology Authority Act
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Biotechnology Authority Bill, 2005
This Bill establishes the National
Biotechnology Authority, a statutory body which will be responsible for
managing the import, research, development, production, use and release
of all biotechnology techniques, processes and products, ensuring that
such activities do not cause adverse effects on health, the environment,
the economy, national security and social norms and values. In more detail
the Bill provides as follows:
of the Bill deals with preliminary matters, i.e. the title of the Bill,
date of commencement and the interpretation of terms.
In Part II
of the Bill, clause 4 provides for the establishment of the National
Biotechnology Authority which will be a body corporate with the usual
features of such corporations. Clause 5 details the functions
of the Authority. Central to these functions is to regulate, supervise,
co-ordinate, promote and develop biotechnology having regard to the need
to maintain safety in the import, export, or manufacture or processing
of any biotechnology product. The Authority will be responsible for advising
the Minister on matters of national policy in biotechnology..
Clause 6 constitutes a board which will be entrusted with directing
and controlling the affairs of the Authority.
Clause 7 sets out the general disqualifications for appointment
as members of the Board and persons who already serve as members of two
or more statutory bodies will not qualify as members of the Board. Clauses
8 to 17 are standard provisions dealing with conditions of service
of members of the Board, committees of the Board, the holding of meetings
and the appointment of the chief executive, etc. Clause 18 provides
for the appointment and functions of a chief executive officer. Clause
20 requires the Authority to submit reports to the Minister and the
Minister may give directions on matters of policy to the Board (clause
of the Bill makes provision in clause 22 for the control and
monitoring of use of products of biotechnology. Of importance is the issuing
by the Board of biotechnology guidelines and standard procedures which
are binding on all users of product of modern biotechnology. The Board
will also establish a register for the purpose of registering facilities
utilised for the development, production or use of biotechnology (clauses
23-25). Furthermore, the Board shall appoint inspectors whose main
purpose is to inspect any activity or process carried out in or upon premises
in connection with the use of any product of biotechnology.
of the Bill makes provision in clause 30 for the establishment
of biosafety committees, which shall ensure that any biotechnology guidelines
or standards and the terms and conditions of registration are complied
with by all persons engaged in biotechnology research, development and
application. Every project at each biotechnology research institute shall
be monitored by a project supervisor.
of the Bill makes provision in clause33 for the appointment of
inspectors of the Authority.
of the Bill makes provision in clauses 34-42 for the management
of the financial affairs of the Authority. Significant is clause 34
under which the main source of the funds of the Authority will include
Parliamentary appropriations and grants from the Fund as may be determined
by the Minister. The rest of the provisions in this Part are standard.
of the Bill provides in clauses 43 to 48 for the National Biotechnology
Fund. Clause 43 establishes the Fund which will be vested in
the Minister as trustee. Central to the objects of the Fund is to promote
the marketing and production of, stimulate demand for, research into modern
biotechnology. It will also be the purpose of the Fund to ensure that
personnel are appropriately trained to fulfil the objects of the Fund
and the Authority. Under clause 44, the Fund will consist mainly
of levies which will be collected in terms of this Bill and of Parliamentary
appropriations. Under clause 45, the Fund will be administered
by the Authority on behalf of the Minister and in accordance with instructions
given by the Minister. Clause 46 sets out the purposes to which
the Fund will be applied. Grants will be made to the Authority from the
Fund for the purposes of the functions of the Authority. The Fund will
also be applied to meet its objects as set out in clause 44.
The cost of administering the Fund will also be met out of the Fund. The
financial year of the Fund will be the same as that of the Authority (clause
47) and the Authority will maintain its accounts. The Fund will be
audited by the Comptroller and Auditor General in terms of the Auditor
and Exchequer Act [Chapter 22:03].
of the Bill provides for the imposition of levies under clauses 49
to 51. Under clause 49, the Minister is authorised, for
the benefit of the Fund, to impose levies on producers, processors and/or
buyers of any product of biotechnology. The details as to how this will
be carried out will be prescribed in a statutory instrument to be made
by the Minister. Clause 50 provides for the suspension or increase
of levies as may be necessary and clause 51 requires that consultations
with organisations of producers, processors and buyers of products of
biotechnology be held before the imposition, withdrawal, suspension or
increase of levies. Failure to pay a levy will be an offence (clause
52) and outstanding levies will be a debt to the Fund, attracting
interest or a surcharge and may be sued for in court (clause 53).
Clause 54 grants the Minister additional powers regarding the
imposition or increase of a levy for a period of six months, and the manner
in which this must be done, in the event of an emergency in the biotechnology
of the Bill deals with general matters pertaining to confidentiality on
information acquired in the exercise of functions in terms of this Bill
and payment of fees for registration in relation to foreign research.
Clause 58 provides for appeals against decisions of the chief
executive and the Board to the Minister and the Administrative Court.
Clause 59 provides for the Minister’s powers, in consultation
with the Board, to make regulations on a wide range of matters relating
to the implementation of this Bill. Clause 60 provides for the
repeal of The Research (Biosafety) Regulations, 2000, published in Statutory
Instrument 20 of 2000.
Biotechnology Authority Bill, 2005
Arrangement of Sections
1. Short title and
date of commencement.
3. Application of Act.
NATIONAL BIOTECHNOLOGY AUTHORITY
4. Establishment of Authority.
5. Functions and powers of Authority.
6. Board of Authority.
7. Disqualifications for appointment as member.
8. Terms and conditions of office of members.
9. Vacation of office by appointed members.
10. Suspension of appointed members of Board.
11. Filling of vacancies on Board.
12. Meetings and procedure of Board.
13. Committees of Board.
14. Remuneration and allowances of members of Board and committees.
15. Disclosure of interests by members of Board and committees.
16. Minutes of proceedings of Board and committees.
17. Validity of decisions and acts of Board and committees.
18. Appointment and functions of Chief Executive Officer of Authority.
19. Execution of contracts and instruments by Authority.
20. Reports of Authority.
21. Minister may give Board directions on matters of policy.
CONTROL AND MONITORING OF BIOTECHNOLOGY
22. Power of Board to regulate biotechnology practices.
23. Register of facilities and permits.
24. Certain facilities and research to be registered or permitted.
25. Application for and grant or refusal of registration or permission.
26. General duty of care to be observed by users of products of biotechnology.
27. Notification of releases and accidents.
28. Returns to be furnished by registered users.
29. Interpretation in Part IV.
30. Biosafety Committees.
31. Project supervisors.
INSPECTORS OF AUTHORITY
32. Appointment and functions of inspectors.
FINANCIAL PROVISIONS RELATING TO AUTHORITY
34. Funds of Authority.
35. Investment of moneys not immediately required by Authority.
36. Financial year of Authority.
37. Accounts of Authority.
38. Audit of Authority’s accounts.
39. Powers of auditors.
40. Authority to make certain charges to revenue account.
41. Establishment and operation of general reserve.
42. Meeting of deficiencies.
43 Establishment and object of Fund.
44. Composition of Fund.
45. Administration of Fund.
46. Application of Fund.
47. Financial year of Fund.
48. Books of account and audit of Fund.
49. Imposition of levies.
50. Withdrawal, suspension or increase of levies.
51. Consultation and approval required for imposition, withdrawal, suspension
or increase of levies.
52. Failure to pay, collect or remit levies.
53. Recovery of unpaid levies
54. Minister’s powers in respect of levies in case of emergency.
55. Conflicts of interests.
57. Fees for registration or permission in relation to foreign research.
60. Repeal of regulations made under Part VA of Cap. 10:22
SCHEDULE: Powers of Authority.
Presented by the Minister
of Science and Technology Development
establish the National Biotechnology Authority whose function shall be
to support and manage biotechnology research, development and application;
to provide for the constitution of a board of the Authority; to provide
for the establishment of the National Biotechnology Fund for the development
of the products of biotechnology; to provide for the fixing of standards
of quality and other matters relating to products of biotechnology produced
in Zimbabwe; and to provide for matters connected with or incidental to
ENACTED by the President and
the Parliament of Zimbabwe.
1 Short title
and date of commencement
(1) This Act may be cited as the National Biotechnology Authority Act
(2) This Act shall come into operation on a date to be fixed by the President
by statutory instrument.
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