Tag Archive | portfolio committee on health

Medicines Control South Africa

Medicines and Related Substances Bill tabled

MCC to go….

The parliamentary portfolio committee on health recently called for written comments on the recently tabled Medicines and Related Substances Amendment Bill which proposes to replace the existing Medicines Control Council with a new entity called the South African Health Products Regulatory Agency (SAHPRA).

The new entity with a new body that will reflect better, the proposals suggest, the many facets and changes that have occurred in the industry.

The Bill also seeks to amend existing legislation to replace the word “products” with the word “medicines” and defines the expression “scheduled substances” in order to more correctly reflect what the anchor Act is in his view trying to achieve, the background to the Bill states.

Complementaries now included

It is also proposed that the minister of health and therefore the department (DoH) will have a far wider scope of regulatory control and the Bill also adds the expression ‘complementary medicines’ to its definitions.

The Bill has the intention, DoH says, of speeding up registration of medicines and will allow ‘mutual agreements’ with other worldwide drug registration institutions to enable the process of acceptance or rejection to take place. It is in this area that opinion from stakeholders is expected to be submitted.

A new body of committees made up of experts and specialists will assist DoH with such a process, the Bill says, but the decision making processes on the subject of registration of new drugs appears to be remaining a private matter within the department.

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NHI to focus on better nursing, says DoH

Pilot NHI facilities to get IT systems

amotsoalediAn impassioned plea in Parliament by minister of health, Aaron Motsoaledi, when presenting the strategy and annual performance plan of the department health (DoH), that nursing in South Africa should return to “the old days” was received well across party lines during a meeting of the portfolio committee on health.

He said he did not like the current system whereby nurses were trained at university, gaining all their four coloured bars in one learning process before gaining practical experience in the various disciplines. What is going to happen he said, is to encourage a heightened understanding of patient care with more bedside experience during training, This led to a round of vocal support from all parliamentarians in the newly elected committee.

Practical qualifications

Dr Motsoaledi said that many nurses with four bars on their shoulder-tabs often had less practical nursing experience than some who only had one bar, meaning that less experience in the real basics of proper nursing care was becoming prevalent.

Change was now being instituted whereby each specialist phase in knowledge attainment would be coupled with a period of field training experience to gain a bar in order to return nursing to proper holistic care principles. Nursing training was to be returned to a seven year period to incorporate periods of field experience, rather than the current crash course system of four years.

He said to MPs that it was “very difficult to send a new highly qualified nurse on bedpan duties for her first duty.”   He received a strong endorsement of the new approach from a cross spectrum of all members. He told parliamentarians that five public nursing colleges would be accredited to offer nursing qualifications under a new system in 2014/5.

NHI will meet world standards

heathpatientDr Motsoaledi detailed all eight strategic goals of DoH and referred immediately to the national health scheme, the implementation of which he said was not “if” but “when”. South Africa’s NHI would meet international standards and use internationally accepted regulations, he said, but he did not answer directly a member’s question on a date when the pilot would end.

However, he expanded on the fact that the current NHI project, a project which involves 700 public health facilities, would be the subject of new patient registration systems with IT backup and electronic health care data collection.   The revised administration systems would reduce patient waiting time, he said, and in addition a mobile phone data collection and communication system was to be introduced.

He also said it was the intention of DoH to have a functional national pricing commission in place by 2017 in order to regulate health care in the private sector.   DoH would again revise methodology and also legislate for the determination of pharmaceutical dispensing fees.

Dr Motsoaledi told the committee that an Institute of Regulatory Sciences was to be introduced and regulations for the function of an Office of Health Standards Compliance to prescribe norms and standards brought into being.

He was adamant that nearly 4,000 primary health care facilities with functional committees and district hospital boards would be in place by 2018/9 and said that 75% of all primary health care clinics in the 52 health districts would qualify for the international terminology of “ideal” by the same date.


This involved a clinic or facility passing a test based on a regimen of some 180 standards, from infection control to waiting room facilities.   He was candid enough to say that a major issue was now to control a leaning by both municipalities and local government to build new infrastructure to meet patient demand and NDP targets, rather than maintain and improve existing services which had exactly the same result.

He also wanted to see standards developed countrywide on building costs per square metre since, he complained, a building going up in one province can vary by 100% from another province.   He said DoH had little power to influence the activities of health MECs and wanted to see a list created of “non negotiable items” so that some DoH control could be exercised over municipal budgets and spend.


His discussion with parliamentarians and his briefing for new MPs roamed over a wide range of health subjects, from female contraception and cancer screening to child health and on the issue of HIV/AIDS, he focused on the need to encourage breast feeding at the expense of formula feeding.    He complained that breast feeding was as low as 8% nationally and wanted to see more, even amongst HIV positive mothers.  He gave outcome figures to support his view.

Dr Motsoaledi spent some time detailing the moves by DoH to introduce more emphasis on preventative health care and education by going to the root of the problem rather than chasing curative health targets, stating that education towards better diets had to become a part of an SA way of life.

He said that for each person who died in South Africa, eight were in hospital and that preventive health care education starting nationally at school age was the only way in his view to reduce poor health in a substantial manner.    A post of an advisor to the deputy minister of health was to be established on this subject and a White Paper on affordable heath care produced.


red_aids_ribbon_hi-resOn the subject of HIV/AIDS, he repeated the statement which he said he had made on a number of occasions to the effect that children born to HIV positive mothers should, by law, be tested for mother-to-child transfer of the disease.   This should happen if child mortality in South Africa was to be tackled successfully, he added.   He did not discuss the constitutional issues involved.

He said the total number of people remaining on ARVs was targeted by DoH at 5.1m for the end of 2018/9, the current figure for 2014/5 being 3m. He added that some 2.4m were currently on the regimen.    DoH targets for HIV tests among the population aged between 15-19 years are targeted at 10m annually, he advised.


On TB control programmes, Dr Motsoaledi said a 79% treatment would be reached for 2014/5 and this was to be targeted at 85% by 2018/9.   The TB defaulter rate was 6% presently and this was to be reduced to 5% over the same period.    He advised that there were over 400,000 TB cases recorded in correctional service facilities and a focus was now to give inmates the correct kind of increased TB and HIV diagnosis and better treatment services.

He emphasised that DoH had to ensure regular TB prevention, screening and treatment carried out by mines by enforcement of compliance regulations for approximately 600,000 miners and employees of associated industries.    He said that DoH was to “heighten” diagnosis and treatment of TB in peri-mining communities “in six districts with a high concentration of mines using DoH TB and HIV mobile units”.

Dr Motsoaledi continued that life expectancy of South Africans had to be raised by 2030 to 70 years, at present being dragged down by HIV/AIDS and TB into the ‘fifties, after having reached 60% at one point recently.

In general, however, there were more people living as well as more people living longer.   The cure rate in Western Cape and Gauteng had now reached 81% but it was slower in other areas, averaging at 74% for the country.    The national target was an 85% cure rate.

Preventable health care

However, on non-communicable diseases, Dr Motsoaledi said that the rise in hypertension numbers was “explosive” and high blood pressure problems were therefore very much part of the preventative health care plan.    5m people were targeted for counsel and screening for high blood pressure in the next four years and a further 5m for raised glucose levels.

Obesity was also a major problem and this was targeted to be reduced by 55% for women and 21% for men in the next four years. This was currently being started with school programmes. There was also a DoH programme in place reduce injury through, accidents and violence by 50% from the high levels of 2010.

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Health dept winning on HIV/AIDS therapy and TB

At last getting there on HIV/AIDS…

red_aids_ribbon_hi-resOn the subject of the department of health (DOH) budget vote, minister of health, Dr Aaron Motsoaledi, indicated to the parliamentary portfolio committee that DOH were getting on top of South Africa’s HIV/AIDS problem and he praised the doctors and nursing staff in government service for making this possible.

He said that South Africa faced the problems of increased life expectancy coupled with extra burden of having to reduce maternal and child mortality; reduce the burden of disease from HIV/AIDS and TB and, critically, improve the effectiveness of the health system.

HIV positive persons on therapy increases

aaron motsolaediHe told parliamentarians that under a programme called NIMART, or Nurse Initiated Management of Antiretroviral Therapy, that health facilities providing antiretrovirals (ARVs) to HIV positive persons had increased from only 490 in February 2010 to 3,540.  In the same vein, the number of nurses trained and certified to initiate ARV treatment in the absence of a doctor were increased from 250 in February 2010 to 23 000.

Under NIMART, the number of people on treatment went from 923 000 in February 2010 to 1,9 million to date – which meant a doubling the number on treatment. “This does not mean that any other epidemics in South Africa are less important, it simply emphasises that the central driver of morbidity and mortality in South Africa is largely HIV and AIDS and TB”, he said.

Groundbreaking single dose pill

Minister Motsoaledi also pointed out that DoH had recently introduced the “ground breaking” single dose combination or FDC pillstherapy. For this over 7,000 health workers had to be trained but the windfall was that whereas it used to cost DoH R314.00 per patient per month to provide ARVs that now, with the single dose treatment, the cost is R89,00 per patient. “This means we can treat many more with the same money that needed to treat one person in 2009”, he said.

“I wish to take this opportunity to thank all the health workers for this sterling performance – especially the nurses without whom this numbers would have been impossible to achieve. The results we achieved from these endeavours are very sweet indeed.”

TB still the big enemy

tbHe went on to tell parliamentarians that some four weeks ago, the Statistician-General had released StatsSA’s yearly figures on the causes of death from disease in South Africa. “They could only release at that stage the 2010 figures, but TB was found to be the number-one killer in the country – not surprising given the synergistic relationship between TB and HIV/AIDS.”

“Into this area of medicine, DOH has recently introduced what is known as GeneXpert technology, the last time any country having any new technology to diagnose TB being over fifty years ago. Before GeneXpert technology, it used to take us a whole week to diagnose TB”.

He said that DoH could now diagnose for TB and get a result in only two hours. This was critical when dealing with patients who have travelled miles or who had no money for transport to return, if they did at all.

Minister Motsoaledi said, “Since its unveiling on 23 March 2013, we have distributed 242 GeneXpert units around the country. This number constitutes 80% of all facilities we would like to cover.”

Worldwide help

aids sickHe said, “ We had spent R117 million shared by the National Department of Health, the Global Fund and the Center for Disease Control in the USA, to achieve this 80% coverage. We have conducted 1,3 million tests using this technology since 2011 and this constitutes more than 50% of the total tests conducted in the whole world.”

He continued, “In five months’ time, we will achieve 100% coverage of all the district hospitals with this system and then we shall move to the big community health centres.”

“ The biggest of these machines, that can diagnose forty-eight patients at a time and I am pleased to say that two have placed, one at Ethekwini Municipality and the second in the Cape Metro at Greenpoint, both areas being the epicentres of TB at the moment.”

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New anti-smoking legislation generates queries

In a story which goes back to 2008, when the previous minister of health introduced the second round of major changes to the Tobacco Products Act, saying at that time that tobacco was the second leading preventable cause of death in South Africa and that 40% of smokers would die before reaching retirement age, a new and further set of smoking prohibitions have now been devised.

Earlier than 2008, legislation had already been extended to include a comprehensive ban on advertising, promotion and sponsorship by tobacco products manufacturers and a smoking ban in public places was instituted, with  penalties for offences.

 The 2008 amendment Bill extended the advertising ban to include a further ban on all commercial communications of any kind designed to promote sales; the age restriction was increased to 18 years of age for buying and selling tobacco products and sales were banned through the post or by internet.   In addition, any donations made by manufacturers had to be made anonymously.

“Cigarette parties” were stopped through banning the distribution of free products and no non-tobacco products allowed in tandem for sale on cigarette vending machines, already restricted by earlier legislation where they were to be placed.

The new prohibitions gazetted by Minister Aaron Motsoaledi virtually ban all indoor smoking, even in previously designated smoking areas, it would seem, and even extends to smokers having to distance themselves from all others on a beach.     However, once again the anti-smoking prohibitions have drawn a line between public and private places.


The new proposals read:-

  • No person may smoke any tobacco product in any public place.
  • No person may smoke any tobacco product in the following outdoor public places:

(a) stadiums, arenas, sports facilities, playgrounds, zoos;

(b) premises of schools, or child care facilities;

(c) health facilities;

(d) outdoor eating or drinking areas;

(e) venues when outdoor events take place;

(f) covered walkways and covered parking areas;

(g) service areas and service lines; and

(h) beaches where public bathing is permitted, not less than 50 metres away

from the closest person near the demarcated swimming area.

As far as restaurants and bars are concerned, aside from creating separate designated “outdoor” smoking areas, it is not clear whether all existing “internal” smoking areas must be closed down with the new provision of disallowing smoking in all public places.

The proposals are that no food or refreshments can be served to the designated outdoor area; ashtrays must be installed and regularly cleaned; no entertainment can be provided (presumably meaning a TV set or monitor) and a call is made that smokers are to be “discouraged from remaining in the area longer than is necessary to smoke a cigarette”.

Warning notices on fines if smoking rules are not followed have to be installed.

On the subject of signage, all owners of buildings that are used by the public without exception must install or erect “no smoking” signage and in all workplaces, the signage being the internationally accepted red circle with a cigarette and line across the circle.

The new proposals have generated considerable comment, primarily regarding their enforceability by owners and from some parties, on their constitutionality.

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