Questions & Replies: Health

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2011-11-24

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QUESTION NO. 1979

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 05 August 2011

(INTERNAL QUESTION PAPER NO. 21)

Mr M Waters (DA) to ask the Minister of Health:

(1) Whether all the recommendations stipulated in the Public Protector's report of 2006 on the Compensation Commissioner for Occupational Diseases (CCOD) have been fully implemented; if not, (a) why not, (b) which recommendations have not been fully implemented and (c) by which date were these recommendations expected to be fully implemented; if so, what are the relevant details;

(2) whether any costing has been done to determine the actual cost of implementing these recommendations; if so, (a) what was the cost and (b) how much of this funding has actually been allocated to the CCOD; if not, why not;

(3) whether the CCOD has the necessary funding to implement these recommendations; if not, how will the CCOD implement these recommendations without the necessary funding; if so, what are the relevant details?

NW2084E

REPLY:

(1) All the recommendations have been implemented except for the one recommending that CCOD should accept the affidavits as proof of employment.

(a) The acceptance of affidavits as proof of employment will encourage fraud as these cannot be validated.

(b) and (c) The Adjudicating Committee is in place from the 01st of April 2011, the exercise is expected to take at least three years to conclude.

(2) The costing has been considered when the budget for the year 2011/12 was formulated.

(a) The cost for the project over the three years is estimated to be R900 000.00;

(b) The amount relating to the current year has been provided for in the budget for 2011/12.

(3) The funding is going to be made available on an annual basis and it can be confirmed that for the year 2011/12 the amount has been included in the current budget.

QUESTION NO. 1930

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 29 July 2011

(INTERNAL QUESTION PAPER NO. 20)

Mr D J Maynier (DA) to ask the Minister of Health:

(a) How many (i) international flights and (ii) domestic flights were undertaken by (aa) him and (bb) his deputy minister using (aaa) military aircraft, (bbb) chartered aircraft or (ccc) commercial aircraft during the period 1 April 2010 up to the latest specified date for which information is available, (b) what class did he and his deputy minister travel in each case and (c) what amount did his department spend with regard to each specified flight?

NW2168E

REPLY:

(aa) For the Minister, it was (i) 19 International Flights and (ii) 67 domestic flights.

(bb) For Deputy Minister, it was (i) 5 international flights and (ii) 22 domestic flights.

(aaa) No military aircrafts were used.

(bbb) No chartered flights were used.

(b) The Minister travelled business class for both domestic and international flights with the exception of cases where a particular airline did not have a business class seat, the Minister travelled first class.

The Deputy Minister travelled business class for both domestic and international flights.

(c) Minister

· For international flights, an amount of R694,211.00 was spent for the period 01 April 2010 to 31 March 2011 and an amount of R523,391.00 for the period 01 April 2011 to 31 October 2011;

· For domestic fights, an amount of R284,054.86 was spent for the period 01 April 2010 to 31 March 2011 and an amount of R162,919.52 for the period 01 April 2011 to 31 October 2011;

Deputy Minister

The Deputy Minister commenced her duties with the Department in November 2010.

· For international flights, an amount of R63,568.00 was spent for the period 01 November 2010 to 31 March 2011 and an amount of R132,520.00 for the period 01 April 2011 to 31 October 2011;

· For domestic flights, an amount of R7,590.00 was spent for the period 01 November 2010 to 31 March 2011 and an amount of R124,535.02 for the period 01 April 2011 to 31 October 2011.

QUESTION NO. 1879

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 29 July 2011

(INTERNAL QUESTION PAPER NO. 20)

Mrs J F Terblanche (DA) to ask the Minister of Health:

(1) Whether he has been informed that the Taiwanese government has recalled soft drinks containing the chemical Di (2-ethyexyl) phthalate (DEHP) which has been linked to fertility problems after prolonged exposure; if not, what is the position in this regard; if so, what are the relevant details;

(2) whether any products containing DEHP are manufactured in South Africa; if so, (a) which products and (b) what levels of DEHP do they contain;

(3) whether he intends recalling all of these products; if not, why not; if so, when will they be recalled;

(4) whether he has been informed of any other adverse effects of DEHP; if so, what effects?

NW2117E

REPLY:

(1) Yes, the Directorate: Food Control of the Department of Health, in its capacity as the National Contact Point for the World Health Organisation's (WHO) International Food Safety Authorities Network (INFOSAN), received a food safety alert notification from INFOSAN on 01 June 2011, which provided details of the incident related to the recall of soft drinks containing the chemical Di (2-ethyexyl) phthalate (DEHP) by the Taiwanese government. Details were also provided regarding the export of contaminated product to other countries from Taiwan, which included South Africa in respect of asparagus juice manufactured by Uni – President Enterprises Corporation, with an expiry date indicated on the label as 'before 18 May 2012'. As a result of the INFOSAN alert notification the Directorate instituted the following measures on the same date:

- Issued a food detention notice in terms of the Regulations Relating to the Powers and Duties of Inspectors and Analysts conducting Inspections and Analyses on Foodstuffs and at Food Premises (R.328 of 20 April 2007) to the metropolitan and district municipalities, requesting the Environmental Health Practitioners (EHPs) rendering Municipal Health Services to visit food premises and to seize and condemn any of the implicated products;

- The same notice was sent to the Environmental Health Managers of the nine provinces for the purposes of coordinating the actions of the municipalities in question, as well as to ensure that the Port Health Services rendered by them detain and condemn further consignments of the mentioned product entering the country;

- Requested the industry representative body, the Consumer Goods Council of South Africa (CGCSA), whose members include, among others, mainstream retailers, to request their members to remove any implicated product, as applicable, from their shelves. This request by CGCSA to their members was confirmed in writing on 01 June 2011 to the Directorate: Food Control.

(2) No, the Department is not aware of any locally manufactured products containing DEHP. However, it should be noted that the substance may be present in plasticisers used as food packaging materials from where it may migrate into foodstuffs. As a potential contaminant linked to this situation, DEHP has been evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), as being safe to be present in food packaging materials at: 'The lowest level technologically attainable'.

(3) No, please refer to answers in (1) and (2) above.

(4) No.

QUESTION NO. 1855

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 29 July 2011

(INTERNAL QUESTION PAPER NO. 20)

Mrs J F Terblanche (DA) to ask the Minister of Health:

(1) Whether any complementary products currently on the South African market contain any substances that have been banned by sporting federations and may lead to our sports men and women being disqualified; if so, (a) which products, (b) what (i) banned substances do they contain and (ii) action has been taken against the manufacturer in each case and (c) how long has the product with the banned substance been on the market;

(2) whether his department is taking any steps to reduce the availability of steroids and/or enhancement substances; if not, why not; if so, what are the relevant details?

NW2092E

REPLY:

(1) The Medicines Control Council (MCC) does not register complementary medicines currently.

(2) Steroids are scheduled medicines and should be registered. Steroids are generally not listed on the labels of spiked complementary products. Draft Regulations for regulating complementary medicines were published for comment on 22nd July 2011.

QUESTION NO. 1854

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 29 July 2011

(INTERNAL QUESTION PAPER NO. 20)

Mrs J F Terblanche (DA) to ask the Minister of Health:

Whether, with reference to his reply to question 1835 on 18 July 2010, any progress has been made in reducing the number of applications before the Medicines Control Council (MCC) with regard to (a) new chemical entities (NCEs), (b) generics and (c) complementary medicines; if not, why not, in each case; if so, (i) what is the current backlog in each case and (ii) how many applications have taken longer than (aa) six months, (bb) one year, (cc) two years and (dd) three years?

NW2091E

REPLY:

The backlog has not been fully cleared, progress is as follows:

(a) NCE – 37 were registered

(b) Generics – 391 were registered

(c) Complementary Medicines are currently not registered.

(i) The backlog on NCEs is 35, seven of which are ready to serve at the next MCC meeting.

The backlog on generic medicines is 1101. Of these:

· 25 are biosimilars that were submitted as generic medicines and applicants have been requested to provide additional clinical data.

· 52 are finalised on technical data but the manufacturing sites are GMP negative.

· 6 have been finalised on technical data but the names have not been approved.

· 8 have been rejected.

(ii) The following table reflects the details

REGISTRATION TIME

NCE

GENERIC

TOTAL

More than 6 months

1

1

2

More than 1 year

4

19

23

More than 2 years

7

126

133

More than 3 years

25

245

270

TOTAL

37

391

428

QUESTION NO. 1851

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 29 July 2011

(INTERNAL QUESTION PAPER NO. 20)

Mrs P C Duncan (DA) to ask the Minister of Health:

Whether the final epidemiological report of the investigation into the death of babies at the Cecilia Makiwane Hospital has been finalised; if not, why not; if so, (a) when was it completed, (b) when will the report be released to the public, (c) what are the names of the persons who conducted the investigation and (d) what are the findings of the report?

NW2088E

REPLY:

The report on the deaths in January 2011 has been completed. A press statement was issued by the Eastern Cape Provincial Department of Health on 25 July 2011.

QUESTION NO. 1847

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 29 July 2011

(INTERNAL QUESTION PAPER NO. 20)

Mr M Waters (DA) to ask the Minister of Health:

(a) What (i) is the name of each entity that is required to pay levies to the Compensation Commissioner for Occupational Diseases (CCOD) and (ii) amount in levies is each entity required to pay, (b) how often are these levies required to be paid and (c) in which province is each of the specified entities situated?

NW2083E

REPLY:

(a) (i) All the mines that have been declared controlled mines by the risk committee are required to pay levies to CCOD. Please refer to the current list which is in Annexure A – list of customers.

(ii) The levies are paid based on the following rates per risk shift worked:

Proposed 2010 Levies (R/risk shift) by mine type

Mine Type

Current rate

New Rate

(2011)

Andalusite

Asbestos

Coal

Copper

Diamond

Flourspar

Gold

Iron

Lead

Manganese

Mica & Felspar

Other

Phosphate

Platinum

Quarries

Unknown

Vanadium

Works

2.57

22.21

0.82

5.02

2.77

2.49

4.08

2.57

2.94

3.80

2.17

5.95

2.49

1.02

4.17

11.95

2.17

4.74

4.50

38.87

1.44

8.79

4.85

4.36

7.14

4.50

5.15

6.65

3.80

10.41

4.36

1.79

7.30

20.91

3.80

8.30

All Mines

3.0625

5.359

(b) These levies are paid on a monthly basis not later than the 20th of each month.

(c) Please refer to the current list which is in Annexure A – list of customers.

QUESTION NO. 1821

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 29 July 2011

(INTERNAL QUESTION PAPER NO. 20)

Mr M Waters (DA) to ask the Minister of Health:

With reference to his reply to question 3143 on 17 December 2010, what is the minimum equipment requirement for (a) ambulances and (b) other emergency vehicles as specified by the Board of Health Care Funders (BHF)

NW1993E

REPLY:

The minimum equipment requirement for (a) ambulances and (b) other emergency vehicles is specified by the Board of Health Care Funders (BHF). These requirements are informed by the scopes of practices or the level of training of pre-hospital care providers operating these ambulances or emergency vehicles. Further, they are aligned to the level of emergency medical care which can be provided by the ambulance or emergency vehicle to a patient. In addition, the vehicle requirements conform to the National Traffic Act requirements for emergency vehicles.

QUESTION NO. 1805

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 01 July 2011

(INTERNAL QUESTION PAPER NO. 19)

Mrs D Robinson (DA) to ask the Minister of Health:

(1) Whether any (a) mines or (b) other work places are in arrears with any levies that they are required to pay to the Compensation Commission of Occupational Diseases (CCOD); if so, in each case, (i) how many are in arrears, (ii) what is the arrear amount, (iii) what interest, if any, has been charged on the arrear amounts, (iv) how many days has the amount been outstanding and (v) what is the name of the defaulter;

(2) whether the CCOD has taken any steps against these defaulters; if not, why not; if so, in each case, (a) what steps have been taken and (b) what was the outcome?

NW2038E

REPLY:

(1) The Compensation Commissioner for Occupational Diseases (CCOD) undertook to their debtors from 2007 to 31 March 2011 which indicated amounts that were not properly accounted for which were adjusted accordingly. This process is planned to end around 15 December 2011. The mines and works will thereafter be notified about the outstanding amounts.

(i) 77;

(ii) The amount that is excessively in arrears amounts to R30,602,514.07;

(iii) The interest is charged as per the Occupational Diseases in Mines and Works Act applying the interest rates prescribed by the National Treasury;

(iv) The table below indicates the days outstanding

120+ days

(R')

90 Days

(R')

60 Days

(R')

30 Days

(R')

Total

(R')

21,480,653,42

1,649,105,06

3,206,848,69

4,265,907,90

30,602,515.07

70.2%

5.4%

10.5%

13.9%

100%

(v) The list of the customers with outstanding amounts is attached as Annexure A.

(2) CCOD undertook to their debtors from 2007 to 31 March 2011 which indicated amounts that were not properly accounted for which were adjusted accordingly. This process is planned to end around 15 December 2011. The mines and works will thereafter be notified about the outstanding amounts.

QUESTION NO. 1763

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 01 July 2011

(INTERNAL QUESTION PAPER NO. 19)

Mr J J van der Linde (DA) to ask the Minister of Health:

With reference to his reply to question 476 on 15 March 2011, (a) what amount of money has been allocated toward the 2011 SA Demographic and Health Survey (SADHS), (b) on what date is the 2011 SADHS expected to (i) commence and (ii) be completed and (c) when is the 2011 SADHS expected to be released to the public?

NW1990E

REPLY:

(a) The South African Demographic and Health Survey (SADHS) is being integrated into two surveys to be conducted by the Human Sciences Research Council (HSRC). The Department of Health has committed to contribute a total amount of R10 million to the funding of the South African National HIV, Behaviour and Health Survey (SABSSM) and the South African National Health and Nutrition Survey (SANHANES). SADHS also has funding commitments (in terms of technical support) from some development partners (including US CDC and UNICEF) which were secured before the integrated approach to national health surveys was designed.

(b) The expected dates of commencement and completion of the SABSSM are August 2011 and March 2012 respectively. The expected dates of commencement and completion of the SANHANES are October 2011 and April 2012 respectively.

QUESTION NO. 1762

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 01 July 2011

(INTERNAL QUESTION PAPER NO. 19)

Mr M Waters (DA) to ask the Minister of Health:

(1) Whether the Council for Medical Schemes was approached with a settlement proposal on behalf of a certain medical insurance scheme (name furnished); if not, what is the position in this regard; if so, (a) by whom and (b)(i) on what basis and (ii) in which capacity did the specified person present the settlement;

(2) whether the said person was remunerated for this service; if not, what is the position in this regard; if so, what amount was paid as remuneration?

NW1989E

REPLY:

The legal matter between the Council for Medical Schemes and Bonitas has been ongoing for almost two years now. The matter relates to governance transgressions in the manner in which the trustees handled the members' finances as well as the decision by the Registrar to place Bonitas under curatorship as a result of these transgressions.

(1) According to information obtained from the Registrar's Office, the Council has never been approached with any settlement proposal with regard to the legal matter involving Bonitas Medical Scheme. As a matter of fact, all parties involved with the case mutually agreed on a negotiated settlement that was made a Court Order by Judge N. Willis on 27 May 2011. The Council is still waiting for a properly typed Court Order but in its absence, the Registrar's Office has been furnished with a document that suffices for this purpose in the interim. Copies of this document can be obtained by contacting the Registrar's Office.

(2) Apart from the professional legal fees payable to the firms representing different parties in the settlement agreement and the finalisation of the Court Order, no person was remunerated for the presentation of a settlement proposal to the Council.

QUESTION NO. 1761

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 01 July 2011

(INTERNAL QUESTION PAPER NO. 19)

Mr T D Lee (DA) to ask the Minister of Health:

(1) Whether, with regard to his reply to question 448 on 15 March 2011, he has taken any steps to ensure that all provinces adhere to standard waiting times; if not, why not; if so, what steps;

(2) whether any costing of the standard waiting times was conducted by his department and the subsequent funding given to provinces; if not, why not; if so, (a) what was the cost for each province and (b) when was the costing done?

NW1988E

REPLY:

(1) Provinces are well aware of the standard waiting times required and are attempting to meet these standards. The National Department of Health has reinforced the need to address backlogs with provinces. The two constraints to achieving these times are funds (for which there are many competing priorities) and availability of trained personnel. Provinces have endeavoured to increase budgets wherever possible and to fill vacant posts. The table below illustrates the costs of backlogs previously reported to Parliament, current budgets and the budget from the previous year for comparison. This illustrates that many provinces have increased their budgets to assist with meeting standard waiting times.

(2) (a) Yes, costing of the standard waiting times for addressing backlogs was calculated and reported to Parliament in our response to Question 448. Many Provinces have made additional funding available in the current financial year as seen in the following table:

Province

Cost implications of backlog

R000

Budget 2010/11

R000

Available budget 2011/12 for old and new cases R000

Eastern Cape

12 200

13 900

14 323

Free State

12 700

7 311

8 973

Gauteng

3 400

15 000

29 771

KwaZulu/Natal

11 900

29 094

26 900

Limpopo

Meeting standard waiting times

13 800

10 800

Mpumalanga

3 430

8 700

7 500

North West

20 750

14 340

14 800

Northern Cape

810

3 300

3 800

Western Cape

4 000

31 847

35 881

(b) Costing was done at the beginning of 2011.

QUESTION NO. 1760

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 01 July 2011

(INTERNAL QUESTION PAPER NO. 19)

Mr T D Lee (DA) to ask the Minister of Health:

Whether any reports from the National Health Insurance Ministerial Advisory Committee (NHI MAC) included the costing of the NHI; if so, (a) what is the estimated cost and (b) how will the cost be covered?

NW1987E

REPLY:

The Honourable Member is kindly advised to refer to the NHI Green Paper gazetted on 12 August 2011.

QUESTION NO. 1759

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 01 July 2011

(INTERNAL QUESTION PAPER NO. 19)

Mr T D Lee (DA) to ask the Minister of Health:

(1) Whether monies have been paid to any (a) consultants, (b) members of the National Health Insurance Ministerial Advisory Committee (NHI MAC) and (c) any other person in any specified capacity; if so, in each case, (i) what amount was paid, (ii) to whom and (iii) for what work with regard to each specified contract;

(2) whether the National Health Insurance Ministerial Advisory Committee (NHI MAC) has reverted to him with regard to reports on NHI; if not, when does he expect a response; if so, what are the relevant details?

NW1986E

REPLY:

(1) (a) There are a number of consultants appointed to the National Health Insurance Ministerial Advisory Committee (NHI MAC) working on various technical aspects of NHI funded by the Department of Foreign International Development (DFID). United Kingdom's government policy does not break commercial in-confidence rules and therefore unable to provide individual consultancy rates, but it has however provide the Department of Health with expenditure incurred on the various technical areas of NHI that the consultants services were enlisted for from 01 January 2010 to date :

Technical work

Consultants

Cost

PHC Costing

Mr B Childs

Dr Ken Grant

145 100,00

NHI Communication Strategy

Meropa Communications

404 000,00

Purchasing and procurement

Dr Jane Doherty

Mr Dan Whitaker

Dr Jacqui Moit

659 150,00

NHI Project Management Unit Support

Mr Julius Katzke

97 500,00

Basic Packages of services

Dr Ken Grant

Dr Kenny Jacobs

Dan Whitaker

Dr Lahla Ngubeni

Dr Gugu Ngubane

102 300,00

TOTAL

1,408,050,00


(b) Members of the Ministerial Advisory Committee are entitled to remuneration for attending meetings at the rate of R 1.766 per meeting and R219 per hour for preparatory work done per meeting attended. These rates are in accordance with Section 20.2.1 – 20.2.3 of the Treasury Regulations (2000). The remuneration is adjusted annually based on determinations made by the Treasury.

Below is detailed information regarding the members who were remunerated for work related to the NHI MAC:

Member's name

Amount remunerated

Reasons for payment

1. Ms. Evangelina Mabusela

R 15, 948.31

Attendance of meetings and preparatory work

2. Mr. Suleman Suleman

R 41, 727.74

Attendance of meetings and preparatory work

3. Professor Diane McIntyre

R 59, 225.25

Attendance of meetings and preparatory work

4. Professor William Pick

R 18, 923.79

Attendance of meetings and preparatory work

5. Dr. Leonard Sizani

R 54, 271.37

Attendance of meetings and preparatory work

6. Ms. Sheila Barsel

R 15, 894.00

Attendance of meetings and preparatory work

7. Dr Charles Hongoro

R 69 528.00

Attendance of meetings and preparatory work

TOTAL

275,518,46

The NHI MAC members serve on 14 subcommittees as guided by the respective subcommittees Terms of References which show their tasks and responsibilities.

(2) The NHI MAC submitted a number of reports to the Minister of Health in July 2010 based on the work completed on the various technical aspects of the NHI, specifically relating to Costing, Primary Health Care, Economic Benefits, Communication Strategy and Transitional Arrangements. These reports formed part of the documentation that was referred to the Inter-Ministerial Committee on NHI for further consideration prior to the submission of the revised NHI Policy document to Cabinet.

QUESTION NO. 1758

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 01 July 2011

(INTERNAL QUESTION PAPER NO. 19)

Ms E More (DA) to ask the Minister of Health:

Whether, with reference to his reply to question 80 on 8 March 2011, his department has completed the (a) GIS-based model and (b) costing model with regard to the ratio of ambulances and other emergency medical vehicles to the population they are supposed to serve; if not, (i) why not and (ii) when will both models be completed; if so, what are the relevant details?

NW1985E

REPLY:

(a) The Department has completed a GIS based model based on urban and rural response times of 15 minutes and 40 minutes respectively, bearing in mind that this would apply to the highest level of emergencies and the fact that it would be totally unaffordable to expect this at this point in time.

(b) The costing has also been completed, and this will determine the optimal placement of emergency medical service bases and historical data will be utilised to calculate the number of ambulances and other emergency medical services vehicles at each base.

It must however be borne in mind that it is not reasonable to expect one norm for the whole country as provinces themselves differ, for example the demographic profile of the Northern Cape province is far different from that of the Gauteng province.

This exercise is presently being reviewed as it requires the idiosyncrasies of each province to be taken into account and for the costing estimation to be completed. The application of the result will depend on fiscal funding and will need to be based on clear business case stretching over a long period.

It must also be noted though, that the improvement of emergency medical services has been a focus of both this Department and National Treasury and the following table will bear this out:

YEAR

2007/8

2008/9

2009/10

2010/11

2011/12

MTEF (000,000)

2,586

2,883

3,237

3,600

4,000

The costing model is also included in the review process.

The current ratio of ambulances and other emergency vehicles to population (based on the current statistics SA, 2011 population figures) is detailed in the following table:

PROVINCE

RATIO OF EMERGENCY VEHICLES TO POPULATION

Western Cape

1: 29 541

Eastern Cape

1: 37 527

KwaZulu Natal

1: 41 137

Gauteng

1: 33 916

Mpumalanga

1: 36 571

Free State

1: 23 190

Limpopo

1: 19 421

North West

1: 34 246

Northern Cape

1: 9 880

A practical application of the model will be based on the model requirements and consideration of specific needs of each province.

(i) Not applicable.

Both models will be completed by December 2011.

QUESTION NO. 1757

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 01 July 2011

(INTERNAL QUESTION PAPER NO. 19)

Ms E More (DA) to ask the Minister of Health:

(1) With reference to his reply to question 3441 on 17 December 2010, in respect of (a) KwaZulu-Natal, (b) Western Cape, (c) North West, (d) Eastern Cape, (e) Limpopo, (f) Mpumalanga and (g) Northern Cape, (i) where are all mental health hospitals situated, (ii) what is the (aa) optimal and (bb) actual number of beds at each facility, (iii) what is the budget for each facility, (iv) what is the (aa) optimal and (bb) actual staffing levels at each facility and (v) on what date was each facility last inspected;

(2) with regard to each health establishment in each province, on which date has he received the latest report by each Member of the Executive Council on the activities and findings of Inspectorate for Health establishments in each province?

NW1984E

REPLY:

(1) The full details of this part of the question were responded to in reply to question 3441. Additions with respect to whether hospitals met the required standards are contained in response to question 81 asked by Honourable Duncan.

(2) Chapter 10 of the National Health Act that would require each Member of the Executive Council to report on the activities and findings of Inspectorates for Health Establishments was not promulgated. Therefore there is currently no statutory obligation for annual reporting by Members of the Executive Council. In the Department of Health budget vote speech that I delivered to Parliament on 14 June 2011, I indicated that I had introduced the National Health Amendment Bill and among other things substituted Chapter 10 of the principal Act to provide for the establishment of the differently conceived Office of Health Standards Compliance. The new provisions will allow us to remedy the shortcomings that we have identified with the current health facility monitoring system.

QUESTION NO. 1756

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 01 July 2011

(INTERNAL QUESTION PAPER NO. 19)

Ms E More (DA) to ask the Minister of Health:

Whether, with reference to his reply to question 96 on 8 March 2011, he will give the assurance that the review of the possible closure of the register for (a) basic ambulance assistance (BAA), (b) accident emergency assistant (AEA) and (c) critical care assistant (CCA) will include colleges that run these short courses, or their association, in order to ensure that the review is not conducted solely by the Health Professions Council of SA (HPCSA); if not, (i) why not and (ii) who does he intend to consult; if so, what are the relevant details?

NW1983E

REPLY:

We wish to give the assurance that all the relevant stakeholders would be consulted in the process of reviewing the current registers for Emergency Care Personnel.

QUESTION 1755 NW1982E FOR WRITTEN REPLY

Mr M Waters (DA) to ask the Minister of Health.

(1) With reference to his reply to question 2000 on 13 September 201 0 (Annexure J),

(a) what steps are in place to ensure that hazardous health care waste that is not being collected from hearth care facilities for disposal is being burnt on site and

(b) how many health care facilities are affected;

(2) Whether any other Provinces does not collect medical waste from all their health care facilities for disposal; if so,

(a) which province(s),

(b) (i) what type of medical waste and

(ii) how many healthcare facilities are affected and

(c) what are the reasons in each case for not collecting the health care waste?

REPLY

The Eastern Cape, Free State, Gauteng, KZN, North West, Northern Cape and Western Cape Provinces do collect medical waste from all their health care facilities for disposal.

In the Limpopo Provinces a Service Provider was appointed by the Department to collect all waste from health care facilities with a schedule to ensure all health care facilities are serviced and no wastes accumulates at the facility.

In the Mpumalanga Province the Provincial Department signed the service level agreement on 12 August 2011 with a Service Provider for the collection and disposal of health care waste.

The full Provincial responses are attached as follows:

Annexure A:

Annexure B:

Annexure C:

Annexure D:

Annexure E:

Annexure F:

Annexure G:

Annexure H:

Annexure I:

QUESTION NO. 1753

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 01 July 2011

(INTERNAL QUESTION PAPER NO. 19)

Mr M Waters (DA) to ask the Minister of Health:

(1) Whether the conditional grants of (a) National Tertiary Services Grant and (b) Professions Training and Development Grant have been reviewed by his department; if not, why not; if so, (i) when was each grant reviewed and (ii) what was the outcome in each case;

(2) whether these specified conditional grants have been evaluated by the Financial and Fiscal Commission; if so, what was the outcome of the commission's evaluation in each case;

(3) whether his department has formally (a) written or (b) responded to the Financial and Fiscal Commission regarding their reviews of the conditional grants; if not, why not, in each case; if so,

(4) whether he will table copies of these responses in the National Assembly; if not, why not; if so, when?

NW1979E

REPLY:

(1) Yes, the review of both grants was done. In 2009 during 10 x 10 budget discussion, the Department of Health submitted two proposals to National Treasury for additional funding on National Tertiary Services Grant (NTSG) and Health Profession's Training and Development Grant (HPDTG). Both proposals were intended to redress the challenges of underfunding in these grants and also in complying with conditions of both grants as outlined in the conditional grants framework that there will be annual reviews. The reviews confirmed that both grants are under-funded but were rejected by Treasury. Please note that the review of Health Professions Training and Development Grant was conducted by the department whilst National Treasury contracted the Health Sciences Review Committee to conduct a parallel review process for the same grant. This review was completed in 2010 and the recommendations are still under review by both Ministers (Health and Higher Education).

(2) Since 2008 there was never a review conducted by Financial and Fiscal Commission on NTSG and HPTDG. However, in their submission to the Division of Revenue for 2012/13, they have proposed that the finding of health sector must be reviewed and these two grants (NTSG & HPTDG) must be considered for review.

(3) The Department of Health has not responded to the FFC as there is no formal proposal tabled, but ideas highlighted in the Division of Revenue 2012/13. These ideas will be formally submitted to the Department through the normal channels. However, the department has embarked in the review of both grants and to consider the possibility of integration as they both finance the tertiary platform. It is expected that this review will be completed by 2012 and will form part of discussions with National Treasury during the 2012 budget process

(4) Yes, the Department of Health will table comments to the Appropriations Committee and Standing Committee upon requests from these Committees.

QUESTION NO. 1752

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 01 July 2011

(INTERNAL QUESTION PAPER NO. 19)

Mrs H N Ndude (Cope) to ask the Minister of Health:

Whether any traces of the new sub-strain of e-coli or super bug have been found in South Africa; if so, what are the relevant details?

NW1978E

REPLY:

No, the Entero-haemorrhagic E coli strain, EHEC 0104:H4, that caused the recent outbreak in Germany, has not been observed in South Africa.

QUESTION NO. 1693

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 24 June 2011

(INTERNAL QUESTION PAPER NO. 18)

Mr I M Ollis (DA) to ask the Minister of Health:

(1) What is the detailed expenditure breakdown for the Ministry sub-programme under Programme 1: Administration in the (a) 2007-08, (b) 2008-09, (c) 2009-10 and (d) 2010-11 financial years;

(2) (a) what was the actual budget increase each year, expressed as a percentage, for funds allocated to this sub-programme and (b) how is the increase for each specified financial year justified?

NW1907E

REPLY:

(1) Details are listed in the table below. Information of the 2007-08 financial year is not readily available because access to the previous version of the Basic Accounting System first needs to be gained in order to request the relevant reports.

Expenditure items

2007-08

2008-09

2009-10

2010-11

Compensation of employees

Awaiting 2007-08 information

R2,579,862.61

R3,398,734.37

R4,620,547.77

Goods and services

Awaiting 2007-08 information

R12,986,986.54

R7,382,415.81

R8,950,685.01

Transfer payment

Awaiting 2007-08 information

R325.00

-

-

Total

Awaiting 2007-08 information

R15,567,174.15

R10,781,150.18

R13,571,232.78

(2) (a)

Expenditure items

2007-08

2008-09

2009-10

2010-11

Budget

Awaiting 2007-08 information

R13,683,000.00

R14,580,000.00

R17,628,000.00

Percentage increase/(decrease)

Awaiting 2007-08 information

Awaiting 2007-08 information

6,55%

20.9%

(b) Budget increase of 6.55% from the 2008-09 financial year to the 2009-10 financial year represents the inflationary increase.

Budget increase of 20.9% from the 2009-10 financial year to the 2010-11 financial year is justified as a result of the filling of vacant posts within Ministerial Services.

QUESTION NO. 1675

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 24 June 2011

(INTERNAL QUESTION PAPER NO. 18)

Ms E More (DA) to ask the Minister of Health:

(1) Whether, with reference to his reply to question 2100 on 14 September 2010, the World Health Organisation (WHO) has issued minimum standards with regard to the ratio for each specific category of health professional to population; if not, when are they expected to be published; if so, what are the relevant details;

(2) whether the Human Resource for Health Plan, which was set to be produced in March 2011, has been completed; if not, (a) why not and (b) when will it be released; if so, (i) when will it be released to the public and (ii) what are the relevant details of the report?

NW1888E

REPLY:

(1) As indicated in the response to Question 2100 on 14 September 2010, due to the fact that countries and contexts are different, the WHO has not issued specific minimum standards in respect to specific categories of health professionals. Rather, the Department of Health intends to use the ranges of indicative population-based ratios for health professionals for health system planning purposes using rational benchmarks.

(2) The national Human Resources for Health Strategy incorporating a national plan will be completed before the end of September 2011. A draft has already been approved by the National Health Council.

(a) Not applicable;

(b) (i) The strategy and plan will be released to the public after stakeholder consultations on the Strategy are completed – by the end of 2011.

(ii) The plan and Strategy include interventions which will be used to strengthen the management, planning, development, retention and utilisation and allocation of health professionals in order to achieve the health outcomes which are desirable for our country.

QUESTION NO. 1671

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 24 June 2011

(INTERNAL QUESTION PAPER NO. 18)

Mr M Waters (DA) to ask the Minister of Health:

Whether the Eastern Cape department of health is paying or intends paying any of the legal fees of a certain person (name furnished) that have been incurred in the past three financial years; if so, (a) on what basis and (b) how were these legal fees incurred?

NW1884E

REPLY:

According to the Eastern Cape Province, no amount was paid for legal costs of the person in question.

QUESTION NO. 1670
DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 24 June 2011
(INTERNAL QUESTION PAPER NO. 18)
Mr M Waters(DA) to ask the Minister of Health:

(1)Whether any of the (a) national or (b) provincial health departments are currently facing any lawsuits; if so, (i) how many lawsuits is each health department facing, (ii) what are the reasons for the lawsuits in each case and (iii) how many of these lawsuits are being defended;

(2)whether any of the specified health departments have lost any lawsuits in the past three financial years; if so, (a) how many lawsuits did each specified health department lose, (b) what amount of money was paid in each case and (c) on what grounds did the specified health department lose the lawsuit;

(3) whether any of the specified health departments have lodged appeals against these judgments; if not, why not; if so, (a) which health departments, (b) against which judgments and (c) on what basis was the appeal lodged in each case? NW1883E

REPLY:

(1)-(3) Yes there are currently lawsuits that have been brought against both the National and Provincial Departments of Health. I can confirm that the lawsuits are increasing exponentially at a disturbing rate.

Both public and private sectors are experiencing this upward trend.

The approach of provinces to these lawsuits vary considerably. The information given in terms of amounts claimed is sometimes completely out of line.

Hence I have put up a Task Team that consists of medico-legal experts, specialists, medical protection society and representatives from the medical profession to look closely at this issue and compile a reliable data and statistics.

As soon as the Task Team reports back, I will be able to provide reliable responses.

Please bear with me for not being able to provide reliable figures for now.

QUESTION NO. 5 (written 1665 transferred)

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 24 June 2011

(INTERNAL QUESTION PAPER NO. 18)

Questions Day: 02 November 2011

Mr D A Kganare (Cope) to ask the Minister of Health:

Whether any chief executive officer (CEOs) at any hospital have been found to be (a) unqualified or (b) lacking the relevant qualifications as a result of an investigation by the Development Bank of South Africa (DBSA); if so, (i) how many in each province, (ii) what is their wage bill and (iii) how were they appointed?

NW1874E

REPLY:

CEOs are appointed based on the Public Service Regulations related to the requirements of the job. The job requirements determined the qualifications in line with stated regulations. The terms of reference for the DBSA were forwarded to this parliament in as a response to Question 2183 by Hon Waters. The DBSA work helped the National Health Council to effect the National Health Act provisions for norms and standards for the designation of health facilities minimum requirements for management for such.

QUESTION NO. 1635

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 17 June 2011

(INTERNAL QUESTION PAPER NO. 17)

Mr G R Morgan (DA) to ask the Minister of Health:

(1) Whether his department has reviewed a new study by the World Health Organisation (WHO) into the possible effects of radiofrequency electromagnetic fields on humans as included in the WHO International Agency for Research on Cancer (IARC) press release on 31 May 2011 (copy furnished); if so, what are the relevant details; if not,

(2) whether his department will review the study; if not, why not; if so, what are the relevant details;

(3) whether, with reference to his reply to question 2088 on 16 September 2010, it remains his policy position that there are no health risks associated with the public's exposure to cell phone masts and base stations; if not, why not; if so, what are the relevant details;

(4) whether, with reference to his reply to question 2088 on 16 September 2010, he intends imposing minimum buffer zone requirements for cell phone masts and base stations; if not, why not; if so, what are the relevant details;

(5) whether his department intends discussing the conclusions of the WHO study with the Department of Environmental Affairs; if not, why not; if so, what are the relevant details?

NW1840E

REPLY:

(1) The Department is informed of the recent expert WHO review of the subject and the 2011 report by the IARC on this matter. The main conclusion from the review is that the evidence is "limited among users of wireless telephones for glioma and acoustic neuroma, and inadequate to draw conclusion for other types of cancer" (Press Release No. 208, May 2011).

(2) The Department has examined the review of studies conducted and agrees with the conclusion of the committee that additional research should be conducted. The findings suggest that radiofrequency electromagnetic fields could possibly be carcinogenic to humans but as yet there is no conclusive evidence that requires government intervention.

(3) It remains the policy position of the Department of Health that there are no scientifically confirmed health risks associated with the public's exposure to cell phone masts and base stations. In the IARC press release of 31 May 2011 it is stated that the evidence from environmental exposures (e.g. cell phone masts and base stations) was judged to be inadequate, i.e. the available studies were of insufficient quality, consistency or statistical power to permit a conclusion regarding the presence or absence of a causal association between exposure and cancer, or no data on cancer in humans were available. Also, following the WHO IARC press release, the WHO International Electromagnetic Fields Project produced an updated Fact Sheet on "Electromagnetic fields and public health: mobile phones" in which it is stated: "To date, no adverse health effects have been established as being caused by mobile phone use."

(4) No, the Department of Health does not at this stage intend imposing minimum buffer zone requirements for cell phone masts and base stations, because no scientifically confirmed evidence currently exists which would support such a step.

(5) The Department will await further, more conclusive research prior to engaging with the Department of Environmental Affairs.

QUESTION NO. 1629

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 17 June 2011

(INTERNAL QUESTION PAPER NO. 17)

Dr P J Rabie (DA) to ask the Minister of Health:

Whether the pharmaceutical industry has been engaged/consulted by the Medicine Control Council with regard to recalling drugs in order to prevent future conflict with the National Consumer Council which has also been given the authority to recall drugs under the Consumer Protection Act, Act 68 of 2008; if not, (a) why not and (b) what measures will be put in place to ensure that this industry is engaged/consulted; if so, what (i) are the details of the engagement/consultations with the pharmaceutical industry and (ii) measure have been put in place to deal with this situation?

NW1834E

REPLY:

No.

(a) The Medicines Control Council (MCC) will meet with the Commissioner of the National Consumer Council on 30 August to discuss areas of cooperation and overlap.

(b) (i) and (ii) It is after this meeting that an engagement with the pharmaceutical industry will be considered.

QUESTION NO. 1611

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 17 June 2011

(INTERNAL QUESTION PAPER NO. 17)

Mrs S V Kalyan (DA) to ask the Minister of Health:

(1) Whether he has been informed of a complaint by a certain person (name furnished) regarding artificial additives and dairy substitutes; if so,

(2) whether he has launched an investigation into this complaint; if not, why not; if so, what are the relevant details?

NW1814E

REPLY:

(1) Yes, the Directorate: Food Control of the Department of Health has received a complaint by email message from the said person, regarding artificial additives and dairy substitutes.

(2) No, following a discussion which took place in June 2010 with colleagues of the Department of Agriculture, Forestry and Fisheries (DAFF), who also received the same complaint from the same person, it was established that the matter relating to diary substitutes is specifically covered by the legislation that DAFF deals with, namely the Regulations Relating to Dairy and Imitation Dairy Products (R.2580 and R.2581 of November 1987, as amended), published by the Minister of DAFF in terms of the Agricultural Products Standards Act, 1990. The mentioned Regulations require, among others, that dairy substitutes products should comply with all the relevant requirements of the regulations published by the Minister of Health in terms of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972), such as the regulations relating to food additives and the new regulations relating to the labelling and advertising of foodstuffs, which comes into effect on 01 March 2012. It was therefore agreed that officials of DAFF will continue to investigate the matter and if needed, take remedial action, as well as further liaise with officials of the Department of Health.

It has come to the attention of the Department of Health that Honourable Kalyan asked the Minister of Agriculture, Forestry and Fisheries the same question (Question No. 1612), and that DAFF provided in their reply, full details of their investigation into this matter.

QUESTION NO. 1608

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 17 June 2011

(INTERNAL QUESTION PAPER NO. 17)

Mrs H Lamoela (DA) to ask the Minister of Health:

(1) With reference to his reply to question 980 on 15 December 2010, (a) which specified hospitals did not have financial managers (i) in the (aa) 2007-08, (bb) 2008-09, (cc) 2009-10 and (dd) 2010-11 financial years and (ii) during the period 1 April 2011 up to the latest specified date for which information is available, (b) in which province is each specified hospital situated, (c) what were their respective budgets in each specified financial year and (d) who is responsible for the finances of each specified hospital in the absence of a financial manager;

(2) whether any of the specified hospitals exceeded its budget in the (a) 2007-08, (b) 2008-09, (c) 2009-10 and (d) 2010-11 financial years; if not, what is the position in each case; if so, what are the relevant details in each case;

(3) whether any of the specified hospitals experienced shortages (a) in the (i) 2007-08, (ii) 2008-09, (iii) 2009-10 and (iv) 2010-11 financial years and (b) during the period 1 April 2011 up to the latest specified date for which information is available; if not, what is the position in each case; if so, what are the relevant details in each case;

(4) (a) why did his department fail to employ a full-time financial manager in each case and (b) when will his department employ such a person in each case?

NW1811E

REPLY:

The Honourable Member's question is based on my response to Question 980 on 15 December 2010. I am attaching my response to that question.

It was about CFOs and not financial managers.

All hospitals do have financial managers.

QUESTION NO. 1607

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 17 June 2011

(INTERNAL QUESTION PAPER NO. 17)

Mr T D Lee (DA) to ask the Minister of Health:

(a) How many people in his department are allocated to ensuring that all foodstuffs on the market are safe and that the public is not mislead, (b) what are their respective positions and (c) at which laboratories are they situated?

NW1809E

REPLY:

(a) The number of officials allocated within the Department of Health to ensure that foodstuffs on the market are safe and that the public is not mislead, are employed in the following Directorates of the Department of Health:

(i) Directorate: Food Control: 11, including 2 vacancies currently in the process of being filled;

(ii) Directorate: Forensic Pathology Services (Food Sections of the Forensic Chemical Laboratories); Cape Town: 13, including 7 vacancies advertised in May and Pretoria: 6, including 1 vacancy to be filled 01 August 2011.

(b) (i) The positions of the officials of the Directorate: Food Control are:

- Director

- Deputy Director: Biological Safety & Programme Support

- Deputy Director: Inter-Agency Liaison & Regulatory Nutrition

- Deputy Director: Chemical Safety

- Assistant Director: Food Additives & Ingredients

- Assistant Director: Pesticide Residues & Genetically Modified Organisms (GMO's)

- Assistant Director: Microbiological Standards & Food Hygiene (vacant)

- Assistant Director: Food Monitoring & Information, Education, Communication (IEC)

- Assistant Director: Food Labelling & Nutrition

- Senior Medical Naturalist Scientist: Food Labelling (vacant)

- Senior Medical Naturalist Scientist: Contaminants & Packaged Waters

(ii) The positions of the officials of the Directorate: Forensic Pathology Services employed within the Food Sections of the Forensic Chemical Laboratories in Pretoria and Cape Town are:

Pretoria Laboratory

- 1 Assistant Director

- 1 Chief Forensic Analyst

- 2 Forensic Analysts Grade II (1 vacant)

- 2 forensic Analysts Grade I

Cape Town Laboratory

- 1 Assistant Director

- 2 Chief Forensic Analysts (1 vacant)

- 6 Forensic Analysts Grade II (5 vacant)

- 4 Forensic Analysts Grade I

(c) The officials of the Directorate: Forensic Pathology Services are situated at the following Forensic Chemical Laboratories: (i) Pretoria- a number of 6 analysts and Cape Town –a number of 13 analysts.

The officials of the Directorate: Food Control are situated at the offices of the National Department of Health in Pretoria.

QUESTION NO. 1606

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 17 June 2011

(INTERNAL QUESTION PAPER NO. 17)

Mr T D Lee (DA) to ask the Minister of Health:

(1) Whether his department has carried out continuous comprehensive inspections on all foodstuffs in the (a) 2006-07, (b) 2007-08, (c) 2008-09, (d) 2009-10 and (e) 2010-11 financial years in order to ensure their safety and verify that the contents is the same as what is stated on the packaging; if not, (i) why not and (ii) how does his department ensure that all food is safe for human consumption and that products contain what manufacturers claim they contain; if so, (aa) what process is followed and (bb) how frequently are food products analysed;

(2) whether his department has found any food products in the (a) 2006-07, (b) 2007-08, (c) 2008-09, (d) 2009-10 and (e) 2010-11 financial years (i) to be unsafe and (ii) not containing the exact proportions of ingredients as advertised; if so, in each case, (aa) which products, (bb) on what basis did the specified product fail the comprehensive inspection and (cc) what action was taken against the specified manufacturer?

NW1808E

REPLY:

(1) No. The Department of Health does not deal directly with the issue of the inspection of foodstuffs. (i) The responsibility to carry out continuous, comprehensive inspections on all foodstuffs in order to ensure their safety is that of the metro and district municipalities rendering Municipal Health Services as stipulated in the National Health Act, 2003 (Act 61 of 2003), and dually authorized by the Minister of Health in terms of Section 23(1) of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972). In respect of imported foodstuffs, the Port Health Services rendered by the nine Provinces are, inter alia, responsible for dealing with this matter. The verification of whether the contents of foodstuffs are the same as stated on the packaging under the list of ingredients of pre-packed processed foodstuffs is not part of the inspection services rendered by the mentioned municipalities. The reasons for this are: (a) the exuberant cost associated with the analyses of all the foodstuffs concerned for this purpose, which will require an extensive budget currently not available; (b) the unavailability of laboratory facilities to conduct tests on the composition of foodstuffs, taking into account the extensive list of ingredients used in the manufacturing of all foodstuffs on the shelves in South Africa; (c) taking note that based on the afore-mentioned reasons, globally countries, including developed countries, do not include this aspect in their routine food inspection programmes, mainly due to the fact that such analyses serves no purpose related to the food safety aspect of the products concerned; and, (d) taking note that the Department of Agriculture, Forestry and Fisheries (DAFF), administer the Agricultural Products Standards Act, 1990, which provides the relevant Minister with the authority to regulate, inter alia, quality standards of food products. These standards relate to the composition applicable to the classes/grades of certain categories of food products, for example, milk and dairy products. (ii) The technical staff members of the Directorate: Food Control supports the Environmental Health Practitioners (EHPs), rendering Municipal Health Services and Port Health Services. This support includes, inter alia, dealing with queries received from EHPs related to the clarification of the interpretation and application of the legislation concerned, with specific reference to the contents of the regulations published under Act 54 of 1972, as well as to present information sessions to groups of EHPs on topics such the legislation in question.

(2) Yes.

(i) The results of the samples submitted by the municipalities and provinces to determine the safety of the foodstuffs concerned, analyzed by the Forensic Chemical Laboratories of the Department of Health, which did not comply with the provisions of Act 54 of 1972, with specific reference to the relevant regulations published under the Act, are available.

(ii) The results of the samples mentioned under point (2)(i) do not include the analyses of samples for compositional verification, for the reasons stated under point 1(1), second paragraph.

(aa) and (bb) Details of the products that failed are provided in the attached schedules, those of 2006-2007 in Appendix 1; 2007-08 in Appendix 2; 2008-09 in Appendix 3; 2009-10 in Appendix 4; and 20010-2011 in Appendix 5.

(cc) It is not expected that details of whether any action has been taken against any producer whose product failed testing be provided to the Department of Health by the municipalities and provinces concerned and the information in question is therefore currently not available.

QUESTION NO. 1605

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 17 June 2011

(INTERNAL QUESTION PAPER NO. 17)

Mr T D Lee (DA) to ask the Minister of Health:

Whether the World Health Organisation (WHO) had invited his department to respond to the WHO survey of member states regarding public health pesticide registration and management practices; if not, what is the position in this regard; if so, why did South Africa not respond?

NW1807E

REPLY:

Yes, the World Health Organisation (WHO) did invite the Department of Health in 2010 to respond to the WHO survey of member states regarding public health pesticide registration and management practices. The WHO representative for South Africa was contacted and made mention that the questionnaire was forwarded to the Department of Health's Directorate: Malaria and Other Vector Borne Diseases, as well to the Department of Agriculture, Forestry and Fisheries in which it was completed.

For further information, the details of the WHO representative is as follows:

Ms Mary Ann Groepe

NPO / Malaria

Tel: 012 305 7700

Fax: 012 305 7729

Cell: 079 880 0142

Email: Groepem@za.afro.who.int

QUESTION NO. 1601

DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 17 June 2011

(INTERNAL QUESTION PAPER NO. 17)

Mr M Waters (DA) to ask the Minister of Health:

(1) Whether there is a statutory body that regulate the (a) importation, (b) manufacturing and (c) use of all medical devices; if not, (i) why not and (ii) how is the safety and efficacy of each medical device ensured; if so, (aa) which statutory body, (bb) how many medical devices have been approved in each of the past three financial years, (cc) what is the current backlog for the approval of medical devices and (dd) how many medical devices are currently on the South African market;

(2) how does his department ensure that all (a) end of life, (b) expired and (c) internationally recalled devices are no longer used?

NW1803E

REPLY:

(1) Currently there is no statutory body that regulates the -

(a) importation,

(b) manufacturing and

(c) use of all medical devices.

Some medical devices are however regulated as follows:

A. Radiation emitting devices

These are regulated by the National Department of Health (NDOH) in accordance with the Hazardous Substances Act 15 and Regulation R1302 of 1991.

(a) and (b) The Radiation Control unit of the department controls the importation and manufacture (in RSA) of electromedical devices. The NDOH licenses manufacturers and importers of electromedical devices. The importation of any pre-owned listed electromedical device is strictly prohibited, except if such a device is to be fully refurbished in South Africa. In as far as importation is concerned,

(ii) the importer and manufacturer must prove that the product complies with the European Commission market authorization safety and performance standards, specifically EC Directive 93/42/EEC or 90/385/EEC.

(aa) For electromedical devices, The European Commission Standards (EC) standard is used.

(bb) The NDOH licences models of electromedical devices. 1966 licenses for different models of such devices were issued over the last three financial years.

(cc) As medical devices are not all regulated yet, we cannot define or quantify the backlog.

(dd) This is unknown as devices are currently not all regulated

B. Combination devices

The Medicines Control Council regulates medical devices that are impregnated with medicines. The evaluation is however largely on the medicinal and clinical aspects of the device and not on its design.

The department has however published draft regulations for the control of safety, performance, quality and use of medical devices on 21st July 2011 for public comment. These draft regulations include combination devices.

(2) (a) Global manufacturers interact with local branches or distributors.

(b) End of life In Vitro Diagnostics have an expiry date.

(c) The US FDA and some member states of the EC e.g. Swissmedic, the Netherlands, France etc. advise the MCC on international recalls. The MCC passes these on to the relevant unit in the department for further processing. The department then follows up with the manufacturer or importer whether there are still stocks in the country. The company then arranges a recall procedure and informs the department on the details. Such notifications from other countries normally indicate the countries to which stock was distributed.

With global manufacturers, the overseas mother body notifies the South African branch which proceeds with the recall and destruction. If the product is licensed, the licensing body is informed on all steps of the recall.