National Health Laboratory Service Act [No. 37 of 2000]
GOVERNMENT GAZETTE
KURANTA YA MMU~O
REPAPOLIKI YA AFRIKA BORWA
Registered at the Post O@ce as a Newspaper E Gati~itswe go Kuranta ya Mmu;o
CAPE TOWN, 13 DECEMBER 2000 VOLLIME/VOLOMU 426 No./Nrnr. 21879
MOTSE KAPA, 13 DESEMBERE 2000
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THE PRESIDENCY
No. 1353. 13 December 2000
It is hereby notified that the President has assented to the following Act which 1s hereby published for general information:—
No. 37 of 2000: National Health Laboratory Service Act, 2000.
MO-PRESIDENTEI
Nmr. 1353. 13 Desembere 2000 I
Mo go tsebi~wa gore Mo-Presidente o dumet’)
(:) (YA)
2000 NATIONAI. HEALTH, L,4BORATORY SERVICE ACT, 2000
remunerate any person or persons, for ser~ices rendered in the operation and development of’ the Service’s business: appoint officers and employees at such remuneration and on such conditions subject to the relevant labour legislation; pay gratuities and pensions to its officers and employees; 5 establish and manage pension schemes in consultation with the Minister of Finance, medical aid schemes and other incentive schemes for its officers and employees, and appoint trustees and other officials for such schemes; produce and sell by-products; and general] y, enter into any contract or perform any act, whether within the 10 Republic or outside, as WI1l in the opinion of the Board contribute towards the attainment of the Service’s objectives.
(3) The Service must exercise its functions, powers and duties in the interest of the Service and in accordance with the national health policy.
Control of Service 15
6. ( 1 ) The Service must be controlled by the Board. (2) The Board must—
(a) determine the policy of the Service; (b) do the necessary planning in connection with the functions, powers and duties
of the Service; and 20 (c) perform such other functions as may be assigned to it by this Act.
Composition of Board
7. The Board consists of the following members. appointed by the Minister, taking into account, among other things, the appropriate representation of race, gender and disability— 25
(a) (b) (c) (d)
(e)
(f!
(g)
(h}
the chief executive officer; one member from each province; two members representing the national Department of Health; three members who have special knowledge in— (i) economics, financial matters or accounting; 30
(ii) legal matters; (iii) health research; or (iv) epidemiology; two members nominated by the Council on Higher Education referred to in section 4 of the Higher Education Act, 1997 (Act No. 101 of 1997), who 35 represent university health science faculties and technikons; one member nominated by the national Minister responsible for science and technology; one representative from the South African Local Government Association nominated by the said Association; and 40 one representative from organized labour.
Appointment of members of Board
8. (1) The Minister must appoint the members contemplated in section 7 (b), (c), (e), (f) and (g) after consultation with the relevant bodies and institutions and must ensure that appropriate laboratory professionals are appointed. 45
(2) The Minister must, before appointing the members contemplated in section 7(d), by notice in the Gazetfe and in a national newspaper circulating in every province of the Republic invite all interested persons to nominate, within the period specified in the notice, persons who in the opinion of such interested persons are fit to be so appointed, stating the grounds upon which such opinion is based. 50
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Act No. 37, 2000 NATIONAL HEALTH LABORATORY SERVICE ACT. 2000
(3) lf a suitable person or the required number of persons is not nominated as contemplated in subsection (2). the Minister must appoint an appropriate person or persons who qualify to be appointed in terms of this Act.
(4) The members of the Board may hold office for a period of at least thl-ee years, as the Minister may determine at the time of appointment, but must be eligible for 5 reappointment.
(5) A member of the Board, excluding a member who is in the full-time employment of [he State or the Service, must be appointed on such conditions, as the Minister may, with the concurrence of the Minister of Finance, determine.
(6) If the number of members of the Board is reduced to such an extent that a quorum 10 cannot be obtained, the Minister may appoint any suitably qualified persons on a temporary basis to serve on the Board until new members are appointed in terms of this section,
Chairperson and vice-chairperson of Board
9. (1) In addition to the members contemplated in section 7, the Minister must appoint 15 a chairperson and vice-chairperson of the Board.
(2) Whenever the chairperson of the Board is absent or unable to perform his or her functions as chairperson, the vice-chairperson must act as chairperson and, if the vice-chairperson is absent or unable to act as chairperson the Minister must designate another member of the Board to act as chairperson until the chairperson or 20 vice-chairperson is available.
(3) Any person acting as chairperson of the Board in terms of subsection (2), must exercise all the powers and perform all the functions and duties of the chairperson.
Disqualification from membership of Board and vacation of office
10. (1) A person may not be appointed as a member of the Board if that person— 25 (a) is not a South African citizen and ordinarily resident in the Republic; (b) is an unrehabilitated insolvent; (c) has at any time been convicted of an offence involving dishonesty, whether in
the Republic or elsewhere, and sentenced to imprisonment without the option of a fine; or 30
(d) has been removed from an office of trust. (2) A member of the Board must vacate his or her office if—
‘(a)
(b) (c)
(d)
(e)
(f)
he or she becomes disqualified in terms of subsection (1), from being appointed as a member of the Board; he or she submits his or her resignation to the Minister in writing; 35 he or she is declared by the High Court to be of unsound mind or mentally disordered or is detained under the Mental Health Act, 1973 (Act No. 18 of 1973); he or she has, without the leave of the Board, been absent from more than two consecutive meetings of the Board; 40 the Minister withdraws the appointment because in the opinion of the Minister, and after consultation with the Board, the member is incompetent or unfit to fulfil his or her duties; or he or she ceases to be ordinarily resident in the Republic.
(3~If a member of the Board dies or vacates his or her office in terms of subsection 45 (2), the Minister may, subject to section 8, appoint a person to fill the vacancy for the unexpired portion of the period for which that member was appointed.
Act No. 37, 2000 NATIONAL HE.41.TH LABOR,4TORY SERVlCEACT.2000°
Meetings of Board
11. (1) The meetings of the Board and the conduct of business at meetings must be prescribed by the rules.
(2) A quorum for a meeting of the Board is the majority of its members. (3) A decision of the majority of the members of the Board present at any meeting
constitutes a decision of the Board and, in the event of an equality of votes, the member presiding at the meeting must have a casting vote in addition to his or her deliberative vote.
(4) A decision taken by the Board or an act performed under the authority of the Board is not invalid by reason only of a vacancy on the Board, or that a person who is not entitled to sit as a member of the Board sat as a member at the time when the decision was taken or the act was authorised, if the decision was taken or the act was authorised by the requisite majority of the members of the Board who were present at the time and entitled to sit as members.
(5) Minutes of the proceedings of every meeting of the Board must be prepared and entered in a book kept for that purpose.
(6) Minutes of the proceedings of each meeting must be submitted at the next meeting of the Board and, if passed as correct, must be confirmed by the signature of the chairperson or other member presiding thereat and may, when so confirmed, be evidence in a court of law of the proceedings of the first-mentioned meeting.
(7) In the absence of the chairperson or the person acting as the chairperson from a particular meeting of the Board, the members present at that meeting may elect one of their number to preside at that meeting.
Committees of Board
12. (1) The Board may appoint one or more committees from among its members to assist it with the performance of its functions and exercise of its powers.
(2) The Board may appoint one or more specialist advisory committees consisting of members other than members of the Board, to assist it with the performance of its functions and exercise of its powers.
Executive management committee
13. (1) The Board must appoint an executive management committee, which consists of—
(a) the chief executive officer, who must act as chairperson; and (b) as many other employees of the Service as the Board may deem necessary.
(2) The executive management committee is responsible for the management of the Service in accordance with the policy of the Service.
Staff of Service
14. (1) The Service may. subject to relevant labour legislation, from time to time and on such conditions as it may determine, appoint such officers and employees as it may deem necessary to assist it in the performance of its functions.
(2) The Service may in the performance of its functions. in addition to or in the place of the officers and employees referred to in subsection (1), make use of—
(a) officers and employees placed at its disposal in terms of the Public Service Act, 1994 (Proclamation No. 103 of 1994); or
(b) persons in the employment of any other body or person, placed at its disposal in terms of an agreement between the Service and such body or person.
(3) (a) The Service must reimburse the State or the employer in respect of every officer, employee or person placed at its disposal in terms of subsection (2)(a) or (b) for every amount paid by the State or employer in respect of such officer, employee or person.
(b) The provisions of paragraph (a) apply for as long as such officer, employee or person is placed at the disposal of the Service.
(4) The Service may for the purpose of the performance of any of its functions and duties enter into an agreement for the—
(a) execution of a particular task; or
—
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(b) furnishing of particular services. with any person who, on account of his or her qualifications or special knowledge, is. in the opinion of the Service, suitable to execute such a task or to furnish such services.
Purchasing of services
15. (1) Public health sector service providers must purchase laboratory services from 5 the Service.
(2) Private health sector service providers may purchase laboratory services from the Service.
Rendering of laboratory services to foreign countries
16. (1) The Service may, in addition to the powers conferred to it by section 5, and 10 subiect to prior approval by the Minister—
(a)
(b)
(c)
(d)
(e)
~ender i~borator~ services in the Republic on behalf of any country which has requested a laboratory service; render laboratory services in any country outside the Republic which has requested a laboratory service; 15 collect specimens for the purposes of testing them in the Republic, in any country which has requested a laboratory service; import any human tissue or any blood, blood product or gamete in terms of section 25 of the Human Tissue Act, 1983 (Act No. 65 of 1983), for the purposes contemplated in paragraph (a), (b) or (c); and 20 import any human waste products and any live or preserved agent responsible for or involved in disease transmission for the purposes contemplated in paragraph (a), (b), (c) or (d) and section 5(2)(a), (b) or (c).
(2) This Act must apply in connection with the rendering of services in terms of subsection (1)(b) or (c) as if such services were rendered within the Republic for the 25 public health sector.
(3) The Minister may with the concurrence of the Minister of Finance, indemnify the Service against any losses the Service may incur as a result of services rendered in terms of this section.
Discoveries, inventions and improvements by employees of Service and other 30 persons
17. (1) The ownership of intellectual property rights in all discoveries, inventions and improvements in respect of processes, apparatus, machines and medicines made by—
(a) employees of the Service in the course of such employment; (b) persons assisting the Service with any investigation or research; or 35 (c) persons to whom bursaries or grants-in-aid have been granted by the Service
in the course of any research in respect of which such a bursary or grant-in-aid was received,
must be determined on a case-by-case basis, taking into account— (i) the general principles of intellectual property law; 40
(ii) the nature of the intellectual property concerned; (iii) the parties involved in the creation of such intellectual property; (iv) contractual rights and obligations of all the parties referred to in paragraph
(iii); (v) the financial contribution of all parties to the creation of the intellectual 45
property; (vi) the intellectual contribution of all parties to the creation of the intellectual
property; and (vii) any other relevant factors.
(2) The Service may make the discoveries, inventions and improvements referred to 50 in subsection (1), and the rights arising therefrom, available for use in the public interest subject to such conditions and the payment of such fees or royalties as the Service may determine, but must ensure that such availability will also be in the interest of persons who made such discoveries, inventions and improvements.
(3) Where the rights referred to in subsection (2) are vested jointly in the Service and 55 one or more other parties, the Service and such other party or parties must reach
I () N(), 21879 GOVERNMENT G,4ZETH+ 13 DECEM13ER 2000
.4ct N(). 37, 20(Kl NATIONA1. HEALTH LABORATORY SERVICE ACT. 2000
agreeme]lt on how to mde the discove]-ies. ini’entions and improvements referred tO in subsection ( 1 ) available for use on the conditions and on payment of fees or royalties msociated therewith,
(4) In respect of rights which are vested in the Service in terms of subsection (1), the Service may reward the person responsible for the discovery, invention or improvement to the extent that it deems fit, or make provision for financial participation by such person in the profits derived from the discovery, invention or improvement to such extent as the Minister, with the concurrence of the Minister of Finance, may determine,
(5) (a) Where patent rights are vested solely in the Service, the Service may apply to register for a patent right in respect of any discovery. invention or improvement referred to in subsection ( 1).
(b) For the purposes of the Patents Act, 1978 (Act No. 57 of 1978), the Service must be regarded as the assignee of the discoverer or inventor in question.
Finances of Service
18. The funds of the Service may consist of— (a) income earned from fees for services rendered in terms of section 20; (b) income earned on surplus moneys deposited or invested: (c) money appropriated by Parliament on such terms and conditions as the
Minister, with the concurrence of the Minister of Finance, may determine: (d) grants, donations and bequests made to it; (e) royalties; or (j9 money received from any other source.
Defrayment of expenditure
19. (l) All expenditure incurred by the Service under this Act must be defrayed from the funds of the Service, including expenditure—
(a) in connection with the performance of its functions by the Board; (b). incidental to the payment of remuneration and allowances to members of the
Board and the executive management committee. (2) Any surplus remaining at the end of the financial year of the Service may be
utilised for any expenses in connection with the exercise of its powers or the performance of its functions, provided that the provisions of the Public Finance Management Act, 1999, are complied with.
Charges for services
20. (1) (a) The public health sector and foreign governments that purchase laboratory tests from the Service must pay such prescribed fees as determined from time to time by the Service after consultation with the Minister.
(b) The Minister must consult with the Members of the Executive Council responsible for health, the Treasury and the provincial treasuries in respect of fees for the public health sector.
(2) The private health sector that purchases laboratory tests from the Service must pay such prescribed fees as determined from time to time by the Service after consultation with the Minister.
(3) The Service may decrease or increase its charges in respect of services rendered in terms of subsection (1),
Borrowing powers of Service
21. (1) The Service may from time to time borrow money as authorised by the Minister of Finance in terms of section 66 of the Public Finance Management Act, 1999.
(2) The Minister may issue a guarantee, indemnity or security which binds the Service in accordance with the provisions of section 70 of the Public Finance Management Act, 1999.
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Act Nc. 37,2000 NATIONAL HEALTH LABORATORY SER\~ICE ACT, Z(K)O
Accounting records
22. The Public Finance Management Act, 1999, must. with the necessary changes, be applied in respect of the keeping of financial records by the Service.
Audit
23. (1) The Service must consult the Auditor-General on the appointment of auditors 5 to examine the financial statements of the Service.
(2) The annual financial statements of the Service must be audited by a person registered in terms of section 15 of the Public Accountants’ and Auditors’ Act, 1991 (Act No. 80 of 1991), as an accountant and auditor, and engaged in public practice as such.
(3) The Service must produce and submit to the auditors all its accounting records 10 with all vouchers in support thereof, and all relevant books and documents in its possession or control.
(4) For the purposes of the audit an auditor — (a) is empowered to administer an oath and take an affirmation; (b) may hear and receive evidence upon oath or affirmation; and 15 (c) may issue summons under his or her hand requiring such persons as he or she
may think fit, to appear personally before him or her at a time and place stated in the summons and produce all such books, papers, documents and objects as may be necessary for such audit.
(5) The auditors must certify at least once a year to the executive management 20 committee whether or not—
(a) they have examined the financial statements of the Service; (b) the financial statements fairly present the financial position of the Service and
the results of its functions in the manner required by this Act. The Public Finance Management Act, 1999, must also apply in respect of financial 25 statements of the Service;
(c) the value of the assets and liabilities of the Service have been correctly stated; and
(d) all of their requirements and recommendations as auditors have been complied with and carried out. 30
(6) The expenses of any audit must be borne by the Service.
Annual reports
24. The Board must, on or before 31 August of each year, submit to the Minister a report on the affairs and functions of the Service during the previous year ending on 31 March. 35
Proceedings by Minister for non-compliance with Act by Service
25. (1) If at any time it appears to the Minister that the Service has failed to comply with any of the requirements of this Act, he or she may by written notice require the Service to remedy the default within a specified time.
(2) The Minister may apply to a High Court having jurisdiction for an order 40 compelling the Service to remedy the default if the Service fails to comply with the terms of a notice referred to in subsection (1).
Delegation of functions by Board
26. (1) (a) The Board may, by resolution, delegate any of its powers, with the exception of powers referred to in sections 6 and 27, to— 45
(i) a committee appointed under section 12; (ii) the executive management committee or any member thereofi or
(iii) any officer or employee of the Service. (b) The Board may delegate its powers subject to any conditions it may determine. (2) When a power has been delegated under subsection (1) the Board may, by 50
resolution and on conditions as it may determine, authorise the further delegation of the
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.4ct No. 37.2000 NATIONAL HEALTH LABORATORY SER\’lCE ACT, 200(1”
power concerned by a committee appointed under section 12. the executive manage- ment committee or anv member thereof or any officer or employee of the Service.
(3) When a power has been further delegated under subsection (2). the committee appointed under section 12, the executive management committee or any member thereof, or the officer or employee of the Service concerned may—
(a) at any time uithdraw such delegation and such delegation does not prevent the exercise of the relevant powers by such committee, the executive manage- ment committee or such member, officer or employee; and
(b) set aside or \rary any decision by an officer or employee of the Service made in the exercise of the power delegated to him or her.
(4) The Board may, by resolution and on conditions as it may determine, authorise any committee appointed under section 12, the executive management committee or any member thereof. officer or employee of the Service to perform any duty assigned to the Service or the Board by this Act.
(5) When an authorisation has been given in terms of subsection (4) the Board may, by resolution and on conditions as it may determine, authorise the committee, the executive management committee or any member thereof, or officer or employee of the Service concerned to further authorise any officer or employee of the Service to perform such duty.
(6) When an authorisation to perform a duty has been further authorised under subsection (5), the committee, the executive management committee or any member thereof, or the officer or employee of the Service may—
(a) at any time withdraw such authorisation and such authorisation shall not prevent the performance of the relevant duty by such committee. the executive management committee or such member, officer or employee; and
(b) set aside or vary any decision by an officer or employee of the Service made in the exercise of the power delegated to him or her.
(7) The Board may at any time by resolution withdraw— (a) a delegation under subsection (l); or (b) an authorization under subsection (2),(4) or (5).
(8) The Board may set aside or vary any decision made in the exercise of any power delegated by it under subsection (1) or by virtue of an authorisation under subsection (2), including a decision setting aside or varying a decision under subsection (3)(b) or (6)(b).
Rules
27. (1) The Board may make rules not inconsistent with this Act relating to the— (a)
(b)
(c) (d)
(e)
(f)
(g)
(h) (i)
proceedings a; meetings of, and the business of, the Board, ‘committees appointed under section 12, and the executive management committee; period for which members appointed to the executive management committee in terms of section 13 must hold office; duties of officers, employees and other persons in the employ of the Service; delegation to any particular officer of powers of appointment and dismissal and such rules must comply with the relevant labour legislation; disciplinary rules that establish the standard of conduct required of their employees within the parameters of the relevant labour legislation: salary, wages and other remuneration of persons in the employ of the Service, and the contributions to be paid by the Service to any such persons towards any pension, medical aid or other incentive scheme established by the Service in accordance with relevant labour legislation; construction, alteration, operation, protection and inspection of works, plant, machinery, apparatus, appliances and equipment required for the testing of laboratory specimens and the running of laboratories by the Service; fees to be charged by the Service under this Act; payment and collection of moneys due for the rendering of laboratory services and fines and penalties for overdue payments;
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Act No. 37.2000 NATIONAL HEALTH LABORATORY SERVICE ACT. 2000
(i)
(k) (1) (In)
(77)
( o )
(P)
granting of discounts and other incentives for prompt payment by purchasers or the making of additional charges or the payment of interest in respect of delayed payments; suspension or termination of any laboratory tests for non-payment of charges; receipt and utilisation of grants, bequests and donations of any kind; 5 composition, quorum, functions, powers and duties of committees appointed by the Board under section 12; determination and setting of internal quality assurance standards; process for the preparation for, and authority for application for accreditation of the laboratories in the Service; or 10 conditions for the participation of the Service in the conducting of clinical trials, either on its own or in partnership with a tertiary education institution or private company.
(2) Any rule made under subsection (1) is of no force until approved by the Minister. (3) The Board must, not less than three months before any rule is made under 15
subsection (1), cause a copy of the proposed rule to be published in the Gazette together with a notice declaring its intention to make that rule and inviting interested persons to furnish the Board with their comments thereon or any representations they may wish to make in regard thereto.
Transitional provisions
28. The transitional provisions substantive provisions of this Act.
Short title and commencement
20
in the Schedule must be read and applied as
29. (1) This Act is called the National Health Laboratory Service Act, 2000, and comes into operation on a date fixed by the President by proclamation in the Gazetre. 25
(2) Different dates may be determined in terms of subsection (1) for the commencement of different provisions of this Act and dates so fixed may differ in respect of different provinces and bodies affected by this Act.
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,ict No. 37, 2000 NATIONAL HEALTH LABORATORY SERVICE AC1. 2000”
Schedule
(Section 28)
TRANSITIONAL PROVISIONS
Definitions
1. In this Schedule— (i) “Department” means the Department of Health;
(ii) “d6mmencement date” means the date determined in terms of section 29(2) on which this Act comes into operation;
(iii) “designated employees” means— (a) the employees in the employ of the department at the commencement
date as designated by the Minister in terms of item 3(1); or (b) the employees in the employ of the provincial health department at the
commencement date as designated by the Member of the Executive Council responsible for health in the provinces in terms of item 3(2): and
(iv) “South African Institute for Medical Research” means the South African Institute for Medical Research, and its laboratories, that were established by the State and the mining industry in the Founding Statement of 1917.
Abolition of the bodies and laboratories
2. The following bodies and laboratories must cease to exist, and together with their employees be incorporated into the Service from the commencement date:
(a) South African Institute for Medical Research; (b) National Institute for Virology; (c) National Centre for Occupational Health; (d) forensic chemistry laboratories owned by the State; and (e) all provincial health laboratory services.
Persons in service of State
3. (1) The Minister of Health must, at least 30 days before the commencement date, designate every employee of the Department who is engaged in the provision of laboratory services as employees to be transferred to the Service.
(2) The Member of the Executive Council responsible for health, must, at least 30 days before the commencement date, designate every employee of the provincial department of health who is engaged in the provision of laboratory services as employees to be transferred to the Service.
(3) An employee contemplated in subitems (1) or (2) must, as soon as possible after designation, be informed in writing of such designation.
(4) The transfer of designated employees must be done in terms of— (a) the relevant labour legislation; (b) the Public Service Act, 1994; and (c) any collective agreement reached between employers and employees.
(5) Any designated employee who disputes a transfer to the Service may refer such a dispute to the Commission for Conciliation, Mediation and Arbitration in terms of Chapter VII of the Labour Relations Act, 1995.
Rules and regulations
4. Rules or regulations made by the bodies referred to in item 2 which are in force on the commencement date remain in force after the commencement of this Act in so far as they deal with any matter in respect of which the Board may make rules under section 27, until they are replaced by a rule made under section 27.
f\ct No. 37, 2000 N.ATION,41 F{ E,ALTH LABORATORY SERVICE ACT, ?000”
Assets and liabilities
5. (1) Immovable property owned by -- (a) the South African Institute for Medical Research; or (b) the State, but which was used for purposes of a public health laboratory. is
transferred to the Service. (2) The registrar of deeds must register the property referred to in sub-item (l) and
make such entries or endorsements in any relevant register, title deed or other document. (3) No duty fee is payable in respect of a registration in terms of sub-item (2). (4) On production of a certified register by a competent authority that movable
property that constitutes part of the resources of the public health laboratory service is owned by the South African Institute for Medical Research or the State, the Service must make such entries or endorsements in or on any relevant register or other document to register that movable property in its name, and in the case of a government department, such department must remove the asset from its asset register.
(5) From the commencement date all contractual rights, obligations, assets and liabilities of the bodies referred to in item 2. are transferred to the service.
Fees to be charged for laboratory services rendered by Service
6. The fees to be charged by the Service for laboratory tests rendered to purchasers in the public health sector must, from the commencement date, be as contained in the schedule of standard prices in force and used by the South African Institute for Medical Research immediately before the commencement date until they can be determined in terms of section 20.
Debt owing to SAIMR and other bodies and laboratories to be abolished
7. (1) All debt owing to the South African Institute for Medical Research and all bodies and laboratories to be abolished by this Act, immediately before the date of commencement, is payable to the Service and must be managed under the same conditions that applied immediately prior to the commencement date.
(2) The Board may alter the conditions under which the debt is managed after giving the debtors three months notice of the proposed changes.