Tag Archive | DOH

Government stirs on intellectual property plans

New approach to SA intellectual property 

……sent to clients Aug 1trademark logo6…. The Cabinet has agreed that a new intellectual property (IP) framework is needed and has asked that discussions commence with all stakeholders in order to set out a future IP policy for South Africa.

In 2013 the South African government released a draft IP policy which ran
into heavy weather because of ambiguities and anomalies at law. This previous attempt was rejected by Parliament.

dti-logo2Since that time, the private sector has complained of no movement from the Department of Trade and Industry (DTI) on the subject, or even the Department of Justice and Constitutional Affairs.

Hidden agendas?

Suspicions existed that a lot more was written “between the lines” by DTI in the light of a feeling that government medical authorities, including the Minister of Health and a large number of public sector entities, were favouring the case for making it easier for generics to come on to the market in view of the wish to introduce national health insurance and cheaper medicines.

copyright graphicThe law courts, always sticklers in their respect for the international word of law, favoured, it seemed, external legal international precedent as the basis for a new approach.

Discussions with DTI surrounded their attitudes and their not so transparent views on the Trade-related Aspects of Intellectual Property Rights agreement (TRIPS). However, that approach may have altered with DTI now more openly favouring Bi-lateral Trade Agreements (BITs).

Bad influence

In 2014, the whole question of IP policy became mired in controversy with a statement from a US-based lobby group based from Washington who surprised all by stating they were working with the local pharmaceutical
industry to influence the SA government and also the Department of Health (DOH) in particular in order to gain more ear to the international view. This was subsequently denied by the pharmaceutical world in SA (IPASA).

The whole matter appeared to inflame the incumbent Minister of Health, Dr Aaron Motsoaledi, who will no doubt be a key player in the new discussions.
After this the 2013 proposals seemed to fall away. Parliamentary hearings were at the time controversial, to say the least.

The major complaints boiled down to the fact that there were no time frames in the government proposals; no regulatory impact assessment had been done; and there was no appearance of a follow through of the effect of the Bill on international commercial ties.

Expert patent lawyers complained of ambiguity and lack of clarity at law.

Where it stood

After some heated debates at the time it appears that TRIPS, despite BITs copyright symboleven then being a new DTI “hobby horse”, has been respected by DTI and the generalised view accepted by most that there would be compulsory local patent registration based on a localised validity acceptance and acceptance by a localised body of all medicines dispensed. The query remained, however, on the skills available to undertake such a policy and time lags.

Whether the originally proposed patents tribunal will have final say in dispute or the High Court of SA will no doubt now be debated, as well as the critical issue of the length and duration of registered patents in a transparent manner with experts and a broad based body to represent the private sector.
As before, probably a “workshop” will be called for to air views.
Previous articles on category subject
Impasse on intellectual property rights – ParlyReportSA
Intellectual property law still in limbo – ParlyReportSA
Intellectual Property Laws Bill goes forward – ParlyReportSA
Medical and food intellectual property tackled – ParlyReportSA

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Radical White Paper on NHI published

 Feature article……     

NHI  hoped for over fourteen years….

A White Paper on “The Transformation of the Health System in South Africa”  envisaging a functional National Health Scheme or NHI  has been published forhospital new public comment by Minister of Health, Dr Aaron Motsoaledi.  Radical changes to South Africa’s health service to communities are envisaged over a period of fourteen years.

A White Paper usually precedes legislation on the subject in the form of a draft Bill which is mostly published for comment by the Minister whose department has drafted the law. This is before any final legislation is tabled before Parliament for further parliamentary public hearings and debate. Regulations to govern any new structuring of public health would then follow. Therefore, proposals at the moment are at a very early stage and at departmental level and already the Minister has issued a statement on some of the more impractical issues presented in the Paper

The process in this case will undoubtedly be a long and arduous one for the Ministry, since any Bill makes a call for the Minister proposing such a plan or policy at law to make a clear declaration on the financial implications for the state. The massive cost involved could make this one of the major Cabinet decisions since democratic elections were held and recent financial developments must have made National Treasury look at this White Paper somewhat askance.

Big money

The cost to the fiscus would clearly be in the billions, few countries in the world having successfully negotiated the road leading to an option of free national health care for all. The focus, says the SA White Paper, will be initially upon primary health care and mainly in the districts.

To place the White Paper in its context, Nelson Mandela said, on receiving his PhD at Harvard University, “The greatest single challenge facing our globalised world is to combat and eradicate its disparities” but the major question will no doubt occur when National Treasury, in its future appropriations, decides upon which of the greatest disparities it can afford – whether Constitutional imperatives are involved or not.

Objectives

aaron motsolaediThe White Paper, as distinct from any legislation or new framework that might follow, has its objective stated as: “To present to the people of South Africa a set of policy objectives and principles upon which the Unified National Health System of South Africa will be based.”

Various “implementation strategies” are proposed. However, it is acknowledged in the Paper that in the end everything is related back to cost and the White Paper accepts the fact that any plans made are in the light of “the limited resources available”. Yet, nowhere in the world do free national health insurance plans come cheap in part or holistically despite any plans to change South Africa’s health systems structurally even over a period of time.

The plan in this case is to start preventative health care in broad principle and free primary health care for all first but it appears that a fully integrated system has to be agreed initially so that enlarging the system and planning can follow.

Who pays

The taxpayer will foot the Bill, presumably for running costs. Capital costs will assumedly be in the form of raised funds but the White Paper is by no means a financial model, nor it is it intended to be, it seems.    Nothing specific is given on financial plans but one has to remember that only 2% of the South African population is estimated to pay more than half of income tax.

The history of providing a national health care system goes back to well prior to 1994 when the ANC, emerging from exile, produced such a paper on the subject or probably better referred to as a manifesto. Free health for all has been a refrain of the ANC for many years.

Earlier White Paper

Dr. Nkosazana Dlamini Zuma, when Minister of Health, also produced a White Paper that seems to have struckNkosazana Dlamini Zuma a chord that survived. This was before the outbreak of HIV/AIDS, which occurred in the time of her successor, and this Paper stated frankly but logically that “health strategies had to be based on the belief that the task at hand requires the pooling of both our public and private resources”. Sensible talk at the time.

The goal then was “the creation of a unitary, comprehensive, equitable and integrated national health system”, Dr Zuma said. “The challenge facing South Africans was to design a comprehensive programme to redress social and economic injustices, eradicate poverty, reduce waste, increase efficiency and to promote greater control by communities and individuals over all aspects of their lives.”

She gave warning signals to the private sector at the time, particularly those major players in the life assurance industry and the fewer medical aid societies which then existed, that the status quo as it stood could not continue.

It is reported that there have been over twenty White Papers or manifestos on national health for all over the last thirty years.

Getting nowhere

To the immense irritation of many successive Ministries of Health, and particularly to the incumbent Minster, aarom motsoloadiDr Aaron Motsoaledi, very little of substance has been forthcoming and now, on the subject of national health schemes, a somewhat beleaguered ANC is watching some of the major players opting for overseas development from their profits rather than, in the Minister’s view, by meeting the department of health (DOH) at least half way locally with some of this investment. However, the Paper is somewhat “fuzzy” over the involvement of the private sector.

Bad timing

The launch of the White Paper was an extremely low-key affair considering it followed the shock announcement of Finance Minister Nene’s dismissal. Consequently, Minister Aaron Motsoaledi’s long-awaited presentation went largely without intensive questioning by the media as to its practicality.

To put it another way, since the particular briefing on the White Paper on Health Services Transformation was the first head-on meeting between the media and government minsters following President Zuma’s announcement of the firing of Minister Nene, Minister Jeff Radebe, (ANC -SACP) introduced Dr Motsoaledi to an audience much more interested in questions regarding the shambles in the financial world.

The DOH Director General of Health was not there and a much rattled Minister Motsoaledi presented his plans. No representative of National Treasury was present. The briefing went largely unnoticed by the press therefore.

The central fund

private wardIn essence, the White Paper proposes the establishment of a National Health Insurance (NHI) Fund and a policy requiring substantial changes to the way the current health system works by interlocking or possibly by cooperating with both the private and public health care systems. The exact way this will work is not proposed but in principle referred to. Much is stated on departmental restructuring.

There is clear ideology expressed that that health care should be regarded as a social investment and not subjected toaneurin bevan market forces. The parallel with Aneurin Bevan, the Welsh coal miner’s son who in 1949, who as the Labour Party left wing socialist Minister of Health spearheaded the establishment of the British National Health Service, is self-evident. Dr Motsoaledi’s plan is to do much the same but this is over fourteen years and in three phases.

The process in the White Paper is described as “unifying the fragmented health services at all levels into a comprehensive and integrated health service”. This implementation process will be undertaken by “six work streams” which are stated as already have been set up, the first being to set up an NHI Fund, the “big pot” that pays for all the services provided. Other teams are to deal with such issues as accreditation of providers and the key to service delivery of an NHI, the beefing up of district health systems.

Health mirrors social success

stethoscopeIn passing, it is noted that that the White Paper is careful to integrate its goals with that of the Reconstruction and Development Plan (RDP). The Paper sees itself as the litmus test of developmental issues to redress the past in water, sanitation, electricity connections and health education, all factors leading to better community health.

The Paper enlarges on this parallel with the statement, “With the RDP’s focus on meeting basic needs, the development and improvement of housing and services like water and sanitation, the environment, nutrition and health care represents its most direct attack on ill health.”

“It follows that trends in health status during and following the implementation of the RDP will be amongst the most important indicators of the success of the entire programme. The Department of Health aims to ensure that the health sector succeeds in fulfilling this vital role in ensuring progress.” Obviously an attempt to get higher up in the queue for funds.

The three tiers

township housesThe White Paper emphasises that the “health sector must play its part in promoting equity by developing a single, unified health system” and also stresses that “the three spheres of government, NGOs and the private sector will unite in the promotion of common goals.”    Hence, the first phase is very much focused upon the delivery of free primary health care at district level and at “at first point of contact” by the patient.

There are some twenty-four chapters for the technically minded and medical professionals to pour over but in theory the country will be divided into “geographically coherent, functional health districts. In each health district, a team will be responsible for the planning and management of all local health services for a defined population in each.”

In passing the Paper notes that peri-urban, farming and rural areas will fall within the same health district as the towns with which they have the closest economic and social links. “The fragmentation and inequity created by the past practice of separating peri-urban and rural health services from the adjacent municipal health services must be eradicated”, the Paper says.

National pay parity

The Paper lays down that “There will be parity in salaries and conditions of service for all public sector health personnel throughout the country”, adding also “which will include appropriate incentives to encourage people to work in under serviced areas.

The whole idea would seem to involve many billions of rands per year from the taxpayer, the taxpayer presumably having options to re-structure their own insurance cover bearing in mind the eventual “free” system.   This is aside from a massive CAPEX call to build the system. The details of either are not indicated, this stage not having been reached assumedly where any further infrastructure build is being considered, so commentators have found it difficult to draw conclusions without knowing the financial burden other than its enormity in the long-term.

As its so happens, South Africa’s  current private hospital system is rated the fourth best in the world but the moral point is made again and again in the White Paper that the current system is only for those who can afford good medical intervention. Options on how the private sector will be accommodated are not debated in any detail.

U-Turn

However, in a recent media interview, Dr Motsoaledi backtracked on the inference that all had to use the NHI and that only small sections would be left open for medical aid schemes to negotiate with the public.

The impracticality and overwhelming costs of this must have got home to the Minister, probably in debate with stakeholders, and the general direction seems to be to leave the choices as they are. Rather the impetus will be to focus the White Paper conclusions towards the re-building of primary health care systems and the establishment of improved health care in the more underdeveloped provincial zones and under-serviced particularly rural areas.

The big factor

On the private medical profession itself, the Paper says, “Private health practitioners should be integrated with the public sector with regard to the provision and management of services”. Policies adopted “should apply to all private practitioners including private midwives, general medical and dental practitioners, specialist obstetricians and gynaecologists, paediatricians and private pharmacists.

doctor consulting roomServices delivered by occupational health practitioners, and prison and military health authorities, should be subject to the same principles.” Once again, Dr Motsoaledi has toned this down somewhat in subsequent statements but some sort of pooling of resources is envisaged.

 

Accreditation according to DOH “rules”

The White Paper stresses that all institutions and health practitioners will have to be accredited to an Office of Health Standards Compliance (OHSC) “based on set criteria” and therefore it follows that only those that are accredited by the OHSC as providers, whether suppliers or medical practitioners, will get payment from the NHI Fund, the Paper says.

The White Paper admits that because of potential problems envisaged with a too rapid introduction of OHSC accredited private provider systems, public facilities will remain the dominant public health care providers funded by the government for the first few years. Accredited private providers will be introduced gradually, particularly in currently under-serviced areas, the Paper continues.

Where full and/or part-time OHSC practitioners are in short supply, DOH say that private practitioners’ services will be used through referral contracts, and patients will be referred to a general practitioner by the public health system it seems.

Health for all

The White Paper as published sees the end game as an NHI Fund being “financed” by compulsory means from all citizens and permanent residents and the fund will purchase a range of health services from accredited public and private health institutions, as well as contracted private health practitioners.

The end-scenario in the White Paper as published is that all citizens and permanent residents will be able to access the NHI Fund for health services without further payment. Dr Motsoaledi has clearly recognised that such a  journey for his Ministry is going to be a long one.

Whilst, again this rather unclear document sees medical schemes as only being allowed to offer “complementary services” not provided by the NHI system this is where the Minister has backtracked even further.

 Even specialists handled by NHI

Access to specialists will be dealt with by the NHI system according to diagnosis and needs, says the Paper.  Whether DOH has the competency, skills and follow through, even if over fourteen years, and whether doctors, GPs and medical professionals “buy in” to the idea will no doubt be the subject of much media comment before the matter gets to Parliament.

Opposition members have already discounted the programme as “reckless”, probably voicing the opinion of many of those who prefer the current system with their medical aid schemes and the reliability of service they get as a result.

Bodies such as the Free Market Foundation have stated that the State would be better occupied worrying about leon louwhealth services for the poor and not overextending State finances on grandiose schemes. Even the trade unions seem unhappy, who have spent many years to achieve medical aid cover as part of their pay packages, it is reported.

Big plans, big obstacles

No doubt matters regarding the White Paper will emerge in the business programme of the Portfolio Committee on Health, once Parliament re-opens – perhaps with a workshop. In all, the White Paper outlines some undeniable health system needs in South African  but at the same time the Paper seems very low on the issues of practical application. Probably also the Minister will have to make a lot more adjustments as National Treasury hopefully dig South Africa out of its financial constraints, at long last recognised.

Previous articles on category subject
New health regulations in place soon: DoH – ParlyReportSA
Health dept winning on HIV/AIDS therapy and TB – ParlyReportSA
SA health welfare starts in small way – ParlyReportSA
Parliament told of lack of doctors – ParlyReportSA

Posted in Health, Labour, Trade & Industry0 Comments

New health regulations in place soon: DoH

Must precede world health HIV/AIDS conference….

precious matsosoDr  Precious Matsoso, Director General, Department of Health (DoH), has told Parliament that it is essential to have the South African Health Products Regulatory Authority (SAHPRA) in place before South Africa hosts the World AIDS Conference.

On the health agenda also in South Africa, she added, is a World Hospitals Conference and Regulatory Agencies Conference, in which case the existence of a working SAHPRA was almost obligatory.  Dr Matsoso was in Parliament to brief MPs on the DoH fourth quarter results.

Dr Matsoso has recently been elected as an Executive Board Member of the World Health Organisation (WHO) and, in addressing the portfolio committee on health, all MPs congratulated her They expressed value of her appointment to South Africa in the context of promoting health on the sub-continent.

Minister absent

Dr Aaron Motsoaledi, the Minister of Health, was away an overseas visit for what is undoubtedlyamotsoaledi DoH’s most important presentation of the year, the last quarter, and both departmental officials presenting and responses from parliamentarians were relatively upbeat on improvements in DoH performance results.

In reporting on the final quarter as far as performance and finance was concerned, Dr Matsoso advised that in the year under review, aggregate pre-audited spending so far was at 98.4% of the total budget of R30.8bn, i.e. R30.3 bn. The R489m not spent in the year was for a number of reasons but mainly because of staffing vacancies provided for but not filled.

In general, she said there had been “an overall improvement in spending and compliance, and tightened monitoring and evaluation both at national and provincial level.”

New drive for medical staff

hospital newAttracting qualified staff to serve in government health was still a major problem but she stated that DoH intended to publish magazines and undertake promotions that were to be part of a new image intended to represent the changes that were taking place in public health.

Major items covered in the DoH presentation included the overall integration of health services on a national basis; progress with the ten National Health Insurance (NHI) pilot programmes; the situation with regards to HIV/AIDS; improved access to community-based primary health care facilities; and progress with legislation, particularly the Medicines and Related Substances Amendment Bill.

Getting to grips with HIV virus

HIV and AIDS, TB and maternal child and women’s health was a separate programme  and DoH hadhiv aids logo recorded over 9.5 million HIV tests in the year under review. The year ended with a total of 3,103, 902 clients now registered on anti-retroviral treatment (ARVs).

In discussion with concerned MPs, it emerged the number of HIV positive cases was increasing.  The department acknowledged that was always going to be the case until changes occurred in people’s habits, the largest problem sector in the fight against HIV/AIDS. The highest incidence of HIV was amongst women between the ages of 15 and 24.

Clearly, the country was on top of AIDS as a disease with the use of ARVs but the unknown and major worry was incidence of unaware persons not knowing or not caring on how to avoid becoming victims of the HIV virus.   This was due to a variety of reasons, Dr Matsoso said, and she told members that “DoH had started a project aimed at showing young women how to take charge of their lives; how to negotiate with older men; and how to take decisions.”

TB prevalent but under control

On TB, the most worrying issue was the much publicised multi-drug resistant virus. Over 120 professional nurses in service had been trained to initiate MDR TB treatment. Matters were now under control.  In general terms on TB treatments, fifty  hospitals had been assessed on TB criteria and diagnosis.

In passing, Dr Matsoso added that 90% of correctional services centres were now conducting routine TB screening.  TB was still mainly associated, she said, with impairment of the immune system as a result of being HIV positive or for nutritional reasons, both issues being usually coupled together when dealing with those below the breadline.

Community stress factors

high blood hungerIn the area of primary care, various DoH heads of departments reported  and it became apparent that 169,418 people had been counselled and screened for high blood pressure, a major problem in high stress and impoverished  communities.

A start had been made on mental disorders by commencing a registry system and a mobile SMS application was being piloted in the three districts to improve reporting times for ARV treatments to chase up on irregular calls for treatment.

One system, also at pilot level, was called “MotherCall” and dealt with mother care and maternity issues on an SMS basis, especially where calls to clinics by patients were needed on a regular basis but this was found to be somewhat restrained by cell phone coverage in the deeper rural areas.

Almost malaria free

Only one malaria endemic district had reported any malaria cases, which had been dealt with withinmalaria 24 hours of diagnosis. In all areas, 837 645 high risk individuals had been vaccinated against influenza. A draft model for rehabilitation and disability services had been developed and was ready for discussion with stakeholders and presentation to the National Health Council.

There had been 985 cataract surgery operations for the poor without medical aid cover but this area was a growing problem and the cost of spectacles added to eyesight impairment issues, affecting mainly the poor as far as education was concerned.

Mum on NHI

Dr Matsoso seemed somewhat reluctant to talk on the monitoring and evaluation that had taken place in ten NHI pilot districts, probably because DOH had not finalised its White Paper on the subject and conducted its talks with National Treasury. She conceded, however, that recruitment of various categories of health practitioners needed for the NHI pilots had been below expectations.

A departmental spokesperson confirmed that a dispensing and distributing system for centralised chronic medicine had been implemented for three-quarters of the facilities in all ten NHI districts. A system was also being tested whereby monies paid by patients was retained by the unit involved in a self sustaining exercise and not remitted to National Treasury.

He said that in the past three years of the particular pilot, R1.3bn had been collected by 13 hospitals, R450.6m being collected and held for the year under review.

Infrastructure build

primary care clinicIn general, 700 primary health care facilities were under construction or being opened in the ten NHI districts and some 3,500 computers on LAN equipment had been distributed and installed amongst the pilot areas enabling systems to work in individual clinics and hospitals with networking within their particular environment.

Further on primary care and in order to reduce the maternal mortality rate, a 53.9% rate of ante-natal first visits before 20 weeks of pregnancy had been achieved, against a target of 65%. The actual maternal mortality rate had been 132.5 per 100 000 live births. This was very much a question of education programmes.

Nursing practices and qualifications

On nursing generally, a further departmental spokesperson on the issue confirmed that four regional nursing training centres, or pilot “colleges”, had been established and were functional in Mpumalanga, Limpopo, Gauteng and North West. However, no public nursing colleges had yet been accredited in terms of the new system announced since  the whole question of accreditation was still being debated with both stakeholders and nursing bodies. Most of this debate involves whether nurses in training should get or not het  “field training” after each level of training.

A Chief Nursing Officer had now taken on her duties in a new DoH post who had the critical job of dealing with the major investment and finance required to “train the trainers” bearing in mind all colleges must fall into the Higher Education specifications now required. The entire matter was going forward, however, she said.

NHI still in principle is alive and well

precious matsosoOn legislation, Dr Matsoso reported that the draft white paper on the forthcoming NHI Bill was ready to go to Cabinet; the Medicines and Related Substances Amendment Bill had been tabled and was going through the parliamentary process with public hearings completed; and amendments to the Traditional Health Practitioners Act had been proposed.

A regulatory impact assessment was being conducted on the draft Control of Marketing Alcohol Beverages Bill.

MPs raised the question of schools feeding which they stated was not ideal from a nutritional aspect.  Dr Matsoso agreed and said it was important to change the school feeding programme, as children should not be served just soup and bread. There was a need to look at whether the nutrition provided at ECDs, crèches and pre-schools was appropriate generally. She said she was aware of the problem and it was to be addressed.

The larger picture of health in SA

schools feedingAlso, at schools generally, she said, over 200,000 learners had been screened with resultant indications that as many as 54,000 schoolchildren with some sort of health problem or impairment existed that could affect basic education. These students could suffer in their approach to matriculation and subsequent job attainment. Nutritional problems and troubled backgrounds were at the forefront.

Drug “stockouts” still there

Dr Anban Pillay of DoH addressed the issue of “stock outs” and drug shortages and said that, on the whole, DoH facilities were unfortunately geared nationally just to treat patients, rather than explaining to them how the treatment programme worked. This was being addressed.

Dr Pillay said stock outs could be supplier problem, as well. There had been a time when suppliers were unable to supply as many as 168 items and there were was a contractual agreement in place usually requesting suppliers to advise immediately when they anticipated problems. In this case, the 168 items that suppliers were unable to supply were not available either in the private or public sectors.

Online with the world

medicines, pillsHe said that DoH had approached the WHO for a list of pre-qualified suppliers outside South Africa that could be considered and some stocks like Benzylpenicillin and Atropine had had to be flown in from other places. Dr Matsoso commented that in some cases the U.S., Canada, Australia, Europe and the U.K. could indicate that there was a general stock out problem worldwide.

In most cases, however, Dr Pillay said that stock outs were as a result of a local facility forgetting to order and would run out between orders but barcode systems and central stock controls had been upgraded and the whole question of stock outs was improving, he said.

A system on stock control using cell phone technology was expected to take over the manual system completely but currently, 600 clinics were linked to the SMS system and more would be linked. A call-free line for patients had been established for any patient to advise if they could not get drugs from a particular clinic. Over 20 000 items were stored in an emergency “buffer stock” in Centurion, Pretoria.

Other stock outs could occur when pharmaceutical manufacturing companies closed for factory maintenance at the same time resulting in shortages and DoH representatives said that this could be solved by common negation on maintenance certificate timings.

Ebola never an SA issue 

ebola SAFinally, Dr Matsoso  commented on the outbreak on the continent of Ebola.

DOH, she said, had provided humanitarian financial assistance for the recruitment of Cuban doctors to provide health services in Sierra Leone and had established a knowledge and information sharing platform on various areas of collaboration with Botswana, Uganda, Namibia and Ghana.

In local terms, DoH Primary Health Care Services had seen over-expenditure due to the appointment of 25 local environmental health practitioners in response to the Ebola outbreak as a precautionary measure.

Other articles in this category or as background
Health dept winning on HIV/AIDS therapy and TB – ParlyReportSA
State acknowledges responsibility to increase health staff
Competition Commission promises health care inquiry – ParlyReportSA
SA health welfare starts in small way – ParlyReportSA

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Medicines Bill : focus on foodstuffs

DOH responds on new Medicines Bill……

patientDr Anban Pillay, DDG of the department of health (DoH), has made it quite clear in answering public comments on the proposed amendments to  the Medicines and Related Substances Act  that their concerns regarding foodstuffs are not just confined to the labelling of food and providing a list of the contents of any food products but also the actual food content itself contained in the product and any harmful effect it might have on the consumer.

In this regard, Dr Pillay has said there was to be much closer contact between DoH and the department of Agriculture, Forestry and Fisheries (DAFF), the lack of co-ordination becoming apparent during the recent scandal when horse meat and donkey meat had been discovered in the contents of named foodstuffs brands without any public awareness to this effect.

This and many other comments were made on submissions recently put before the parliamentary portfolio committee on health during the debate on the Medicines and Related Substances Amendment Bill.

No separation from cosmetics

Dr Pillay also made it quite clear that comments in submissions suggesting that food stuffs and cosmetics be isolated into separate legislation parallel with medicines and related substances was a non-starter.  DoH, he said, had already recruited 25 new permanent staff members that would be working for the South African Heath Products Authority (SAHPRA) who were in the process of considering a food agency, food being very much within the ambit of the one Act.

A good number of the changes in the Bill before Parliament arose in the area of vitro diagnostics (IVD), or tests with equipment which assisted medical diagnosis by sampling body tissue and fluids.    In this regard, the wording of international medical regulatory bodies had been used whereby such equipment had to meet certain performance requirements. This was in contrast to medicines and related substances issues which dealt primarily with matters of efficacy.

Big retailers excluded

On the question of the issue of licences to trade issued by the new Medical Control Council (MCC), it had been conceded that retailers dealing exclusively with bulk products classified as unscheduled medicines did not have to comply with all SA Pharmacy Association requirements or obtain a licence from the MCC.

Comments in submissions had been made and by the opposition that the regulating body would find it difficult to exercise its authority with regard to product advertising in all forms of electronic media, particularly if it extended to social media.  Dr Pillay said that this was acknowledged but he asked for his detractors to note that advertising and marketing world was an ever-evolving subject and attempts had to be made to deal with false claims and failure to meet requirements in all forms of advertising media whatever the problems of doing so.

Debate on medical devices

Regarding criticism on the descriptions and definitions in the amending Bill with regard in the approval of medical devices and the ambits of inclusion and exclusion, Dr Pillay said DoH had fallen back on an updated version agreed upon by the International Medical Device Regulatory Forum, which was more appropriate, he said.

Considerable debate took place upon the issue of controls on pricing, raised in a number of written submissions. DoH had agreed that the amendments would clearly state that the agreed pricing committee would be the final body to make recommendations on such matters to the minister of health. Meanwhile, the MCC would confine its activities to quality, safety and efficacy, not pricing.

Furthermore, Dr Pillay confirmed it was the pricing committee alone who were to “pronounce on marketing, bonusing and pricing matters”, bonusing usually being related the incentives to doctors to recommend certain medicines in relation to price.

Traditional medicines

As expected, the EFF and the ANC raised the question of traditional medicines and asked why there was no reference to such in the “description of medicines and products”.  On this, Ms Malebona Matsoso, DG of DoH, replied that department was fully aware of the need to incorporate traditional medicines.

She said that DoH was now distributing a booklet on the process they intended to use to regulate for traditional medicines and how DoH planned to carry out any regulations. The booklet was not available at the time but would be sent to parliamentarians, she said.

The DG, DoH, said that eventually SAHPRA would regulate all products that were processed in laboratories as well as the plants that were used during the process of making medicines. She explained that one of the main drivers for the establishment of SAHPRA was that MCC appointed members were contributors from different industries and not only public servants.

The establishment of SAHPRA therefore would be on a permanent DoH staff member basis and would deal with this as well as foodstuffs and cosmetics in terms of “products” under the Bill. Ms Matsoso confirmed again that traditional medicines and products had not been excluded under the Bill since the Bill included all products. How the regulations were to be extended to include traditional medicines was now being established, she said, and university research particularly from the University of the Western Cape and UN World findings would be used.

Animal world

Despite some objections in written submissions, DoH was insistent that veterinarians had to ensure that they were issued with licences wherever medicines were either compounded or dispensed. Also, Dr Pillay pointed out that the new Bill would not regulate for electronic-medical and radiation devices, the worry of one submission, and hence the question of the Hazardous Substances Act did not arise, he said.

In an earlier meeting with the DoH, also led by Dr Anban Pillay, the portfolio committee debated the section of the Medicines and Related Substances Amendment Bill that covered the formation and running of SAHPRA. What SAHPRA would do and the manner it would operate in the industry, he said, would be dealt with by the regulatory process to be devised.

Other articles in this category or as background
http://parlyreportsa.co.za/health/medical-food-intellectual-property-tackled/
http://parlyreportsa.co.za/health/sa-allow-avoidance-medical-patents/
http://parlyreportsa.co.za/health/medicines-and-related-substances-bill-now-tabled/

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Parliament told of lack of doctors

NHI threatened by lack of doctors, professionals….

aaron motsolaediLack of doctors and nurses in public health institutions still bedevils South African the public health system and could stymie plans to instigate a national health insurance programme as part of the plan to  re-engineer the primary health system and to introduce quality health systems.

This was said by Dr Aaron Motsoaledi when updating members of the portfolio committee on health on the state of progress with National Health Insurance (NHI) pilot projects, these being eleven selected health areas which included both full hospitals and clinics in the Eastern Cape, Free State, Limpopo and Mpumalanga.

Health building programme going well

After dwelling on the successes of the department of health enumerated by President Zuma in his State of the Nation Address, including the 300 new health facilities built over the last five years, including 160 new clinics and the fact that 2.4million people were initiated on antiretrovirals, Dr Motsoaledi turned to what he referred as “the major problem facing health in South Africa”, the inability to retain the services of doctors and nurses.

He said that sub-Sahara Africa was now nominated by the World Health Organization as a crisis area simply because this is where the paucity of doctors and nurses was being felt most. He said the inability to pay the right kind of money to attract highly retained staff was a common problem to many countries.

He quoted Canada which he, had recently visited who were losing staff, he said, in great numbers to the USA but said they were lucky inasmuch as professionals from Africa were filling those gaps. Dr Motsoaledi said that the problem of lack of doctors had to resolved before the NHI was rolled out, South Africa having one of the lowest patient to doctor ratios worldwide.

“No steal” agreements

He said that Middle East countries and the USA had to agree not to include on their recruitment agendas professional medical staff from countries such as South Africa where health was in a developmental stage and such fragile staffing ratios existed.

hospital newDr Motsoaledi spent considerable time updating members of parliament on the process of grading hospitals and clinics, where maintenance of facilities was a critical issue. “If a facility is maintained properly within a cyclical programme of repairs and replacements, then we shall be able to expand our services but if not, we shall go downhill on this issue”

He quoted statistics which showed a cost R2 for each rand of original cost of repairs if maintenance were performed on schedule each year as against R60 rand per rand of original cost if nothing was done to a particular facility for ten years. He showed breakdowns of the hospitals and clinics in the NHI test area where in many areas, either electrical, plumbing or inability to generate hot water was leading a facility to be condemned.

He said the infrastructure build and repair and maintenance programme were part of a SIP programme generated by the current presidential priority build programme to correct this and he was confident that breakthroughs would be made. Innovative ways, he said, were being found to solve problems such as new types of lesser cost buildings and by contracting GPs to work in public clinics.

Previous articles in this category
http://parlyreportsa.co.za//health/health-dept-winning-on-hiv-aids-therapy-and-tb/
http://parlyreportsa.co.za//uncategorized/state-acknowledges-responsibility-to-increase-health-staff/
http://parlyreportsa.co.za//uncategorized/competition-commission-promises-health-care-inquiry/

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HIV/AIDS gets the attention of SA Parliament

Parliamentary oversight into the fight against HIV/AIDS…………….

Parliament has issued a statement  that it has formed a joint committee on HIV and Aids to specifically focus on the pandemic, a “joint committee” being the coming together of members of both the National Council of Provinces and the National Assembly.

The statement issued said that the move “was born out of a decision by the sub-committee on the Review of Joint Rules and was an attempt to prevent the pandemic from spreading.”

The committee, said the statement, would act as an advisory, influential and consultative body and would monitor and evaluate the implementation of government’s strategy, policy and programmes on HIV and Aids.

Its activities will include introducing an HIV and Aids-related focus in parliamentary activities — including programming of debates, monitoring parliamentary oversight and ensuring that HIV/AIDS prevention and treatment are priorities on the national agenda.

The committee will also examine and evaluate the legal framework and make recommendations on existing and proposed legislation coming from the department of health.

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