Archive | Health

Medicinal use of cannabis makes progress

Medical Innovation Bill and cannabis

..sent to clients 18 Dec… Dr Narend Singh who took over the tabling of the Private Members’ Medical Innovation Bill from the late Dr Mario Ambrosini, said that he was so impressed by the progress of the Department of Health (DHA) in their support of the use of cannabis for medical purposes that he could see the possibility arising where he could withdraw his Members’ Bill in favour of broader legislation tabled by the Minister of Health.

He said “there was light at the end of the tunnel” and he himself was on a “high” to learn from Dr Joey Gouws, in charge of regulatory and legislative enforcement at DHA, that regulations on the growing of cannabis, manufacture, dispensing and medical use for medicinal purposes could be in place by the end of 2017 including registration processes and classification systems.

Holistic approach

Dr Gouws was briefing the Parliamentary Portfolio on Health on progress towards the commencement of such a programme and which not only covered the medical use of cannabis as proposed in the Medical Innovation Bill but covered research, registration, manufacture and the scheduling of substances.    Separate legislation would be in parallel amending such Acts as the Drugs and Drugs Trafficking Act.

Regulations were a draft form stage in authorising permits for use by practitioners, analysts, researchers or veterinarians.      In fact, said the DHA team presenting the update to parliamentarians, it might be possible to see certain herbal products with limited THC levels available within three months.

 Worldwide

Dr Gouws said that in the United Kingdom similar legislation, to be enacted, provided for innovation in medical treatment and allowed medical doctors to depart from medical treatments for a condition but the UK Bill did not specially address the use of cannabis. In South Africa, it will be allowed for under specific prescribed conditions for the treatment of certain medical conditions and for education, research and analysis.  Similar legislation in Australia and Canada had been studied.

Patients that are proposed for eligibility are those with severe pain, nausea, vomiting or wasting arising from cancer and HIV/AIDS, including treatment. Muscle spasms and severe pain associated with multiple sclerosis and seizures from epilepsy where other treatment options have failed or have intolerable side effects. Severe chronic pain is included as part of the proposals for indications.

Crop trials completed

The Department of Agriculture, the DHA team said, has justMedicines Control South Africa forwarded the outcome of cultivation trials at four agricultural research facilities jointly overseen by both departments. This would now be disseminated and assessed, which results would form part of the ongoing research by the Medical Research Council and other academic research centres involved in the future clinical use of cannabis.

Currently, cannabis is listed as a Schedule 7 prohibited substance but regulations will shift this towards Schedules 3-6 which are prescription-only medicines with authorised prescribers.   Scheduling decisions involve levels of toxicity and safety; the proposed indication for a substance; the need for medical diagnosis before prescribing; the potential for dependence, abuse and misuse and access disciplines.

Certain cannabis products are prescribed at present but unregulated illegal herbal cannabis, Dr Gouws said, which is grown incorrectly and bought from the black market will have unknown concentrations of THC’s and cannabinoid concentrations combined with potentially harmful ingredients.   Cannabinoid drugs currently used are Dronabinal for loss of appetite during severe illnesses, Nabilone for nausea under similar conditions and Sativex for spasticity.

Conditions of use

If legalised, it will be proposed that objective evidence to support the proposed use of cannabinoids in whatever regulated form must be provided; the manner and duration of treatment provided; a patient must be monitored to ensure efficacy; the treatment outcome reported upon; the physician involved must be a specialist and informed consent by the patient or legal representative obtained.

In questioning the DHA, parliamentarians were particularly concerned that appropriate measures amending the Drugs and Drugs Trafficking Act, the criminal Procedure Act and the Medicines and Related Substances Act were undertaken. One MP remarked that there must be no question of unintended consequences with law enforcement processes in order that criminal procedures under certain circumstances involving cultivation, marketing, administering and research can be clearly separated and easily understood by the South African Police Service.

Dr Joey Gouws said that this matter had already been investigated and the issues involved were with the State Law Advisor at this very moment. It appeared that they were satisfied. The framework for medical use and research had also been submitted, which also included the licensing of growers using controlled cultivation methods for medical, scientific and research purposes. There were various cultivars of cannabis which had different medicinal properties, she said.

Quality controls

The framework being worked to by DHA also includes reaching a standardised, quality assured product for medical use indications, bearing in mind that clinical decision-making in terms of Section 22A(9)(ii) and Section 21 of the Medicines Act must be made to the scheduling of products, Dr Gouws said.

For a while, Dr Joey Gouws said, cannabis as a medicinal drug for pain may remain as a Section 21 drug as things exist until all regulations were in place and registration and classification complete, so that the use could have a controlled start.  Herbal classifications may be allowed far earlier.

ends

 

Posted in Facebook and Twitter, Health, Justice, constitutional, Land,Agriculture, LinkedIn, Security,police,defence, Special Recent Posts0 Comments

Treasury goes with health pundits on sugar tax

Sugar tax threatens jobs say suppliers

With the publication by Treasury of the policy paper on a sugar tax on sugar-sweetened beverages of 2.9 cents percanning gram of sugar, Treasury is set to raise some R3bn from fizzy or carbonated drinks and the possibly of a total R4.5bn from the food and beverage industry as a whole. Others in political circles estimate that revenue could exceed R11bn.

Minister of Finance, Pravin Gordhan, promised that such a tax would be forthcoming in last year’s budget speech. As this figure quoted by the Minister is minuscule in terms of the total country’s overall budget needs and the administration may outweigh the costs of actually collecting it the Minister has pointed out in mitigation that there are easier ways to garner tax revenue.

With that disclaimer, the release from Treasury also says the tax “flows from work undertaken by the health department on non-communicable diseases and obesity.”   They said, “The problem of obesity has grown over the past 30 years in South Africa resulting in the country being ranked the worst in sub-Saharan Africa”.

In the background

sars logoWhat Minister Gordhan says is usually the truth but most of the influence is more likely to be coming from the Ministry of Health.     At the most, Minister Gordhan says that the idea in Treasury is to “nudge consumers into better choices to fight obesity.”  Whether this move will in fact contribute to a cut in obesity deaths remains in the strange area of whether an increase in the price of whisky reduces the number of whisky drinkers.

Treasury is following the theory that by making the cost of cool drinks higher and thus less affordable, it will make sugar-sweetened beverages (SSBs) less appealing to consumers, a theory also which appeals to the Minister of Health whoaaron motsolaedi has been most vocal on the subject.    Such an idea also conforms to sugar-related food and beverages studies conducted by Wits University, they both say.

Not medically holistic?

Most objectors to the idea of a “sin” tax on SSBs say that if one wishes to really succeed in a fight against high obesity rates in SA, then only a whole package of measures will achieve the desired result.    In the UK apparently, where the argument also raged, it was stated that a sugar tax was an impractical answer without a tax on crisps and snacks, a whole range of harmful foodstuffs and, especially with children, other “goodies” sold to them from tuck shops and cafés.

In SA, many have said that to isolate SSBs, when they are sometimes more available than potable water in a number of rural areas, is counter-productive. There will be more “unintended consequences”, they say.

Who suffers most

From a political viewpoint, the Democratic Alliance (DA) and the Beverage Association of SA both echo the same sentiment that all the tax will do is “hurt the poor and will most likely fail in its objective to reduce obesity”. The debate will obviously become quite intense in this area alone.

The DA has already gone on record as saying “It is difficult to compel consumers to eat healthier foods by making unhealthy foods expensive. There are always cheaper, fizzier and sweeter alternatives on offer.” This does of course make that point that SSBs, in their view, are unhealthy.    The DA added it would reject Finance Minister Pravin Gordhan’s proposed sugar tax if its purpose was “simply to raise more revenue under the fig leaf of a public health benefit”.

The proposed date for the enforcement of such a sugar tax is April 1, 2017, and bottlers such as Coca Cola state thatcoke bottle sugar is in most food and drink and they ask how far this form of tax will go.  Already government has announced regulations restricting the amount of salt in most foods, including bread and processed foods, in an effort to reduce the cost to the State in respect of heart attacks.

Health objectives

Dr Aaron Motsoaledi has set out the intentions of the Department of Health (DOH) to reduce obesity by ten percent in South Africa by 2020.

The DA have argued that by that date any sugar tax would have contributed as a major item in driving drive up food prices, whereas the answer they say lies in a “holistic healthy lifestyle campaign”. They have also said that they  would object to Finance Minister Pravin Gordhan’s proposed sugar tax if its purpose was “simply to raise more sweet counterrevenue under the fig leaf of a public health benefit” but its difficult to see how they could stop the tax as most Bills on tax are incorporated in ‘money’ Bills.

The DOH paper on obesity points to a US report that “sugary” drinks may lead to an estimated 184,000 adult deaths each year globally and that South Africa was ranked second in the world. That seems a rather unsupported figure but is an example of the rather extraordinary claims being thrown around.

World view

Most bottlers seem to have unsweetened versions on the market it is noted, so technically the matter remains a consumer choice but marketing people say people don’t like switching.   Confirmed by Treasury is the fact that other countries such as Denmark, Finland, France, Hungary, Ireland, Mexico and Norway have all levied taxes on SSBs.

The DA point out that Mexico is the only case comparable with South Africa with such a large sector of poor and there the tax has failed to reduce obesity. Treasury disagrees and says “a tax on foods high in sugar is potentially a very cost effective strategy to address diet related diseases”.

Written comment on the proposals is invited until 22 August 2016.
Previous articles on category subject
Sugar tax possibilities – ParlyReportSA
SA health welfare starts in small way – ParlyReportSA

Posted in Health, Home Page Slider, Labour, LinkedIn, Trade & Industry0 Comments

Parliament awaits to hear from Cabinet

Same Parliament, same Cabinet, different mood

..editorial……Parliament has now resumed with the same Cabinet, the same 400 MPs, the same ANC Allianceparliament 6 majority instructed whips and the same names in the party benches but the ambiance is very different.     This subtle fact, however, matters little in the immediate future.   Legislation before the National Assembly (NA) will still be subject to a simple numbers game when it comes to voting. Well, almost.

In the case of a Section 76 Bill, that is a Bill that needs not merely the concurrence of that portion of the 400 MPs that sit in the NCOP but subject to full debate by all nine provinces and a mandate returned in favour or not, there might be the beginnings of healthier opposition. Power at local level has been emboldened since Parliament last met.

So far, matters of consequence have been that the Department of Energy has presented its REIPPP plan with support from most other than Eskom with no Minister present and the Mineral Resources Portfolio Committee has re-endorsed a revised Minerals and Petroleum  Resources Development Amendment Bill for process by the NCOP using its ANC majority. Again no Minister was present. Eskom will be presenting on this and matters regarding coal any day.

Old tricks

jacob zumaHowever, presuming the picture in Parliament stays as it is until the 2019 national election with Jacob Gedleyihlekisa Zuma at the helm as President, it will be interesting to see what type and how much legislation is hammered through the NA by the ANC using the same old tactic of deploying party whips with threats of being moved down on the party list system for a total majority, timed last year in a rush just before a recess.

Notably, now in the case of three Bills sent for assent after being voted through, the three were not signed by President Zuma into law acting on legal advice.

With this trio now back with Parliament on the grounds of either suspected unconstitutionality and/or incorrect parliamentary procedure, the issue is now whether the coterie of Cabinet Ministers that surround the President, with Director Generals appointed by and who report to those Ministers, will take Parliament more seriously.

Not hearing

Good advice is not good advice when it comes in the form of a last minute warning not to put signature to any Bill thereby turning it into an Act of law. Plenty of such advice not do this in respect of a number of Bills was previously given during parliamentary portfolio committee debate, at parliamentary public hearings from affected institutions, business and industry and even earlier in public comment when the Bills were first published by gazette in draft form.

Similarly, the lesson seems not to be learnt in higher echelons that the independent regulatory entities are also not to be ignored – institutions from the Office of the Public Prosecutor to ICASA, from NERSA through to the board of the Central Energy Fund and from National Treasury to international courts, the UN and international bodies protecting human rights. Parliament is due to hear from ICASA any moment.

Most worrying, however, are the attempts to by-pass Treasury when presenting policy to Parliament. Ideological bullying can bankrupt a country in no time.

Such issues as Minister Aaron Motsoaledi’s National Health Insurance dream and Minister Joemat-Pettersson/President Jacob’s Zuma’s dream of six nuclear energy reactors – plans that the country should not possibly not countenance from a financial aspect – have neither been presented to Parliament in the proper national budget planning form or officially and financially endorsed.

Missing money details

Minister of Health, Aaron Motsoaledi, has gone as far as a White Paper to Parliament on the NHI and Minister Joemat-Pettersson has briefed Parliament on nuclear tendering. Treasury have said nothing about a financial plan in each case. Money is short, as evidenced by Treasury stepping in on the provisions for BEE preferential procurement. Somewhere there is a disconnect.

As for President Zuma’s continued pressure to bring traditional leaders into the equation with what amounts to two separate judicial systems and has even talked of the equivalent of four tiers of government – one therefore not even reporting to Parliament and certainly no idea of local government and nor subject to the PMFA  has its problems. President Zuma has used his ally, the Minister of Justice, to table the Traditional Courts Bill before Parliament. Opposition parties will walk out on that one, we are sure.

The Speaker of the House, Baleka Mbete, as part of the same coterie, has made a mild signal that the days of Cabinet maverick behaviour, even arrogance, towards Parliament and no respect for the separation of powers may be coming to an end. The SACP is clearly not happy. That is where the new ambiance felt in an unchanged Parliament may play an unofficial part and pressure may start building.

 
Previous articles on category subject
Parliament to open Aug 16 – ParlyReportSA
Parliament under siege – ParlyReportSA
Radical White Paper on NHI published – ParlyReportSA
Zuma’s nuclear energy call awaits Treasury – ParlyReportSA
Here it comes again…. the Traditional Courts Bill – ParlyReportSA

Posted in cabinet, earlier editorials, Electricity, Energy, Finance, economic, Fuel,oil,renewables, Health, Justice, constitutional, Trade & Industry0 Comments

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

Posted in Facebook and Twitter, Health, LinkedIn, Special Recent Posts, Trade & Industry0 Comments

South Africa’s IP policy still hidden away

Drug impasse on IP (intellectual property) rights……

patents graphicThe simplistic public platform which is pervading the pharmaceutical debate on the long awaited IP policy – that persistent argument that  South Africa could be a ‘rogue’ state with scant regard for property rights – is constantly coupled with the call by local and international activists for drugs which are affordable to poorer families.

All has been re-heated considerably by protests in Pretoria but nothing has yet reached Parliament in the form of a serious proposal on IP that can be considered by pharmaceutical companies in order to bring certainty.

What now seems to be the situation is that both manufacturers and activists are calling for a fair and legally correct policy document on intellectual property rights which gives certainty but nothing is forthcoming.   At the same time, the claim was made in Parliament some time ago that South Africa just “rubber stamps” patent applications at a vast rate, only 1% going to local innovators.

And yet all know the incredible cost to find a successful HIV/AIDS vaccine. These costs must be recoverable, say pharmaceuticals, or innovation and research will stop. South Africa, like so many countries, is about to step into the unknown.

Problem not with CIPC

According to CIPC the questions of registration of patents is proceeding with new vigour but complainants make the point that no actual testing takes place. Ms Astrid Ludin, current CEO and IT guru was not in Parliament to make any presentations on the specific subject of IP and who remains “on suspension” it appears for some transgression on awarding contracts.

Ludin has an excellent reputation with DTI and in all probability she just wanted to get a job done, at high speed and quickly chose what she thought was the best thing to do. Unfortunately, that is not how red tape works.

Most critical : Invention or intervention?

It appeared some time ago that stakeholders were past the endless argument that South Africa wouldmedicines, pills make the market place unsustainable for pharmaceutical companies with important and much needed drugs if there is disregard for patents lodged after years of painstaking research. But this once again re-emerging.

Over 100 submissions, it is rumoured, were made on the original Policy IP document when it was first submitted for comment, so one assumes that Dr Rob Davies has a fair assessment on how stakeholders are feeling… but his department still refusing to tackle the issue, it appears.

Keeping the same show running

Meanwhile, activists have re-opened their claims that “tweaking” of an expired but well established drug takes place and new patent periods sought for twenty years on the same item, which cuts out the possibility of cheaper generics and innovation. Facts presented at recent conferences on the subject have also re-awakened the premise that South Africa is paying more than most developing countries for drugs.

The background of the delay is provided by a divisive scenario between two government departments – health and trade and industry – the latter department being responsible for the production of the new intellectual property policy stating South Africa’s position.

Too many pokers in fire perhaps

medicine bottleDespite the minister of trade and industry (DTI), Dr Rob Davies, trying to calm waters with the “going nowhere” statement of “We are moving in a direction in striking a balance between innovation, affordable medicines and to modernise our IP regime”, South Africa’s new intellectual policy (IP) policy seems to be sticking at cabinet level.

It is difficult to disregard the much earlier scandal involving the rumoured attempt by a Washington-based PR company to delay and modify the draft IP Policy, a move which infuriated both the minister and the department of health. The anger of minister of health, Dr Aaron Motsoaledi, was patently obvious at the time and there is no doubt that a sour taste in the mouth is left with many in that department.

Has to come to a head

medicines sans frontWith Treatment Action Campaign and Médecins Sans Frontières ratcheting up their campaigns – the latter specifically naming Pfizer on TB drugs that cost R10 in India and R600 in SA – and DTI’s minister Davies at present in the USA arguing on GAT agreements, the much needed IP policy will probably remain on the backburner for a short while longer.

Two things will happen eventually. Either the government publishes a gazette calling for comment on yet a further draft IP policy or an ATC notice is issued by Parliament announcing its tabling as a paper for debate.

Either way, minister Davies is likely to call a media briefing first.

Other articles in this category or as background
Intellectual property law still in limbo – ParlyReportSA
Intellectual Property Laws Bill goes forward – ParlyReportSA
Medical and food intellectual property tackled – ParlyReportSA
Medicines Bill: focus on foodstuffs – ParlyReportSA

Posted in Facebook and Twitter, Health, Justice, constitutional, LinkedIn, Special Recent Posts, Trade & Industry0 Comments

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/

Posted in Earlier Stories, Facebook and Twitter, Health, LinkedIn, Public utilities, Trade & Industry0 Comments

Parliament puts use of cannabis on hold

Evidence on cannabis needed…

cannabis drinksFor the moment at least, the possibility of the legal medical use of cannabis by injection or oral dose, the medical manner in which drugs are used to reduce pain and suffering, is out of the question.    This was decided at parliamentary portfolio committee level recently, the matter not going for vote or recommended for passage to the National Assembly.

Nevertheless this does not mean, in the long term, that the matter has been totally rejected by Parliament. IFP member, Dr. Narend Singh, in the last meeting of the portfolio committee on health before the recent short recess, introduced a Private Members Bill known as the Medical Innovation Bill.

Despite the Bill at this stage having been rejected at this stage by the committee, many tributes were paid to the late Dr. Mario Oriani-Ambrosini, IFP, who had tabled the idea in the last Parliament and formulated the original wording.

Basics first

Parliament, after debate at committee level, has suggested that more international opinion on the subject is garnered and the results of any further medical research is considered before parliamentarians are asked to consider laws on the subject.   They concluded that regulations, following such a law, would be difficult to enforce; that more work had to be done on broad legal considerations and that decisions, which would be difficult, must not be based upon emotion but empirical evidence.

Considerably more public and professional opinion locally had to be sought as well, they said, but the door was not closed on the issue. Most MPs referred to the possible unintended consequences of such a law where the legal use of such powerful drugs entering into the crime world and general abuse by habitual drug users was a distinct possibility.

Implementation of a change in government health policy towards cannabis, commonly referred to as marijuana, is allowed by the proposed Bill with a change at law to the approach in the treatment of cancer and other incurable diseases suggested.

Best practice guides

Existing treatments alongside such “innovative complementary therapies” were recommended to be administered only at “nominated medical treatment research centres”. The Bill, amongst its objectives, proposed to “codify existing best-practices to allow decisions by medical practitioners to innovate in cases where evidence-based treatment or management is not optimal or appropriate or because the available evidence is insufficient or uncertain.”

The Bill also seeks to “deter reckless, illogical and unreasonable departure from standard practice and legalise and regulate the use of cannabinoids for medical purposes and for beneficial commercial and industrial uses.”

Underworld the enemy 

The DA opposition stance on the issue was that despite the possible treatment properties for cancer, any such drug when ingested as a food into the stomach could lead to severe addiction and therefore much criminal abuse if such a manner of formulation became accessible via the underworld to the wider public.

Dr W James (DA) said the Bill was really about innovative approaches to cure and treat and consequently any parliamentary debate had to be about medical innovation as such.   Referring obviously to cancer he said, “in terms of molecular cell biology, a cure had to prevent the problem from re-occurring.  Unfortunately, science in terms of finding a cure as such had not advanced in the case of cancer.”  Therefore treatment, he said, was a completely different subject for consideration, especially in the case of cancer.

Consensus across party lines indicated that whilst the proposals would legitimise the intended purpose of alleviating the pain and suffering of patients, with such a change would also come the import or local manufacture of cannabis for medical purposes in terms of commerce, with a consequent difficult accompanying regulatory process.

Input needed

Bearing in mind the unintended consequences of such a proposal, MPs generally felt there had to be a lot more professional opinion on the subject. Parliament was not the forum for such a debate, at least not without more input from science-based research and advice on the subject of how to regulate, it was decided.

Finally, it was felt that the medical profession should be the final arbiters on scientific exactitudes and whether such an innovation should be adopted and how. Only then should the proposals be considered by Parliament. One ANC member remarked that “as South Africa was a highly opinionated nation such a matter should be opened up much more for more public consultation and advice.”

Dr. Narend Singh, when asked if he was dissapointed that the Bill had been rejected at this stage, replied that the tabling of the Bill had been part of a process. “The matter is now on the backburner”, he said, “I am very happy that  this should be the case. I would have be most surprised if matters had gone further at this stage. We will hear more though in due course, now that we have laid a foundation”.

Posted in Facebook and Twitter, Health, LinkedIn, Trade & Industry0 Comments

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.

Other articles in this category or as background
http://parlyreportsa.co.za//health/medicines-related-substances-bill-tabled/
http://parlyreportsa.co.za//health/nhi-focus-better-nursing-says-doh/
http://parlyreportsa.co.za//health/sa-allow-avoidance-medical-patents/

Posted in Facebook and Twitter, Health, LinkedIn0 Comments

road accident bill South Africa

Road Accident Benefit Bill changes everything

Road Accident victims paid out regardless of fault…

A draft Road Accident Fund Scheme Bill was recently published for comment by the department of transport (DoT) as part of the new “no fault” scheme of benefits, the Bill establishing an office of an administrator to implement and subsequently administer the scheme of injury and death benefits.

The idea of a no-fault approach to compensation, says DoT, is in part to respond to the problems identified with the current fault-based approach, and also to improve and simplify claims procedures so that claims are more speedily dealt with.

This is distinct from the present “insurance-based” procedure where the question and quantum of liability can drag on for years in the courts, the department says in its background document.

Social security first

The Bill seeks to provide for a social security scheme for the victims of road accidents for bodily injury or death and will exclude liability of certain persons otherwise liable for damages in terms of the common law.

DoT says the proposals state that “no civil action for damages in respect of bodily injury or death”, in the case of a road accident, be pursued against any owner’s vehicle involved, drivers or employers of drivers.  Rather, payment is made in terms of the defined benefits of the new scheme regardless of who caused the accident.

DoT says the new Bill forms part of an initiative to replace the third party compensation method with a system that is “reasonable, equitable, affordable and sustainable”.

Public comment was open on the new draft Bill until early September and considerable debate will probably ensue in parliamentary hearings on the question of the extent of the benefits schedule and quantum.

 

Posted in Facebook and Twitter, Health, LinkedIn, Transport0 Comments

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.

Standards

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.

Overview

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.

HIV/AIDS

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.

TB

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.

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

Posted in Facebook and Twitter, Health, LinkedIn, Public utilities, Special Recent Posts0 Comments

SA to get coastal management underway

Coastal management includes cities and rural areas …

South Africa’s National Coastal Management Programme (NCMP) is now underway with the publication of working proposals by the department of environmental affairs (DEA) which was accompanied by a call for public comment.

The estimated contribution of coastal resources to the South African economy is in the order of some R5bn and coastal zones, the document says, are estimated to provide approximately 35% of the country’s GDP.   The major coastal cities of Cape Town, Port Elizabeth, East London, Durban, and Richards Bay are affected, all four having experienced the fastest economic growth of all cities in the country.

Preservation and good management of the national coastal areas, says DEAT, is therefore essential if South Africa is to continue to provide the roots for economic development, expansion of the tourism industry and the continued provision of recreational needs.   All these factors are created in areas with a very delicate balance of biodiversity, says DEAT.

Economic reasons

Maintaining this balance into future generations is seen by DEAT as one of its major challenges, not only for environmental reasons but for economic reasons as well. A further important objective of the NCMP is to maintain the coastal environment to the benefit of threatened poorer communities and to protect their livelihoods.
DEAT says in its forward to the NCMP that South Africa has chosen to embrace a holistic approach, known as integrated coastal management (ICM), which sets out objectives, management procedures and contains the kind of definitions, norms and standards that enable a basic environmental regulatory process to happen.

The purpose of the anchor ICM Act is to maximize on the eco-benefits provided by coastal zones and to minimize the conflicts and harmful effects of human activities upon each other, both in terms of resources that could be lost and any surrounding environmental damage.

Pointers only

The NCMP, DEAT says, is a working document to assist in implementing ICM objectives and lays out in its 106 pages a deliberate programme of national management actions. It is not regulatory but a working guide.

First, it contains a detailed situation analysis related to coastal management in South Africa across the full spectrum of zones within the country’s 3,000 kms of coastline. Then the document looks at the current threats to ecosystems followed by a study of existing localised and national environmental management programmes.

In providing a “national vision”, the NCMP provides a structured approach to engage with the stakeholders, DEAT says, and “a template for future cooperative governance”.   It also suggests ways to integrate ICM programmes with localised government, the NCMP therefore expanding with practical programmes based on the ICM Act.

However, DEAT makes it clear in a disclaimer that what is published is neither an amending Bill nor a legal or regulatory process but a guide to programmes which are seen by DEAT as the route to take and which can be necessary in the common interest.

Complimentary to NEMA

To emphasise the co-operative nature of what is put forward, DEAT says in the frontispiece to the NCMP, “This document does not in any way have legal authority or take precedence over the National Environmental Management: Integrated Coastal Management Act but rather serves as a guideline to the development of coastal management programmes, expanding on the provisions of the Act”.

Public input on this plan is therefore called for by DEAT. Comment can be made until the end of June.

Concurrently, DEAT has also published its White Paper on National Management of the Ocean, the acronym for which is appropriately NEMO.

This, DEAT says, aims to promote the protection and conservation of South Africa’s ocean environment, as well as promoting sustainable development for present and future generations. It refers in its pages to the extent of South Africa’s ocean environment and deals with issues concerning protection and conservation of the ocean environment and resources of the sea.

The White Paper says the department’s approach to the subject will promote and expand sustainable development and optimise investment in managing the large ocean space which is accessible to the country.
Other articles in this category or as background
http://parlyreportsa.co.za//energy/fueloilrenewables/coastal-management-bill-stirs-waters/
http://parlyreportsa.co.za//health/coastal-environment-proposals-getting-clearer/

Posted in Enviro,Water, Facebook and Twitter, Health, Land,Agriculture, LinkedIn, Special Recent Posts, Trade & Industry0 Comments

Sugar tax possibilities

Once again, a tax on sweet drinks and beverages arises….

sugar_caneProfessor Melvyn Freeman, head of non-communicable diseases, department of health (DoH), says the department is re-looking at the issue of introducing a sugar tax to encourage South Africans to consume less sugar.

His comment comes as a result of the publication of the World Health Organisation’s Global Cancer Report 2014, which reports that tobacco, alcohol and sweet drinks are driving a rapid growth in preventable cancers.

More than 30% of cancer deaths could be prevented by modifying or avoiding key risk factors, says the fact sheet, and these include tobacco use; being overweight or obese; unhealthy diet with low fruit and vegetable intake; lack of physical activity; alcohol use; sexually transmitted HIV-infection; urban air pollution and indoor smoke from household use of solid fuels.

Poor countries worst hit

More than 60% of world’s total new annual cases occur in Africa, Asia and Central and South America. These regions account for 70% of the world’s cancer deaths. It is expected that annual cancer cases, WHO says, will rise from 14 million in 2012 to 22 within the next two decades. Obesity, particularly with schoolchildren, is considered a problem by DoH locally, according to an earlier report to Parliament by minister of health, Dr Aaron Motsoaledi.

Analysts say, while it is important for governments to encourage people to take responsibility for their own health and make changes to their diet and lifestyle, regulators should consider controlling alcohol and sugar consumption in the same way as tobacco products.

“There is no final decision on a sugar tax as yet, but it is an option that is being considered and we are assessing all relevant factors around this,” says Prof. Freeman. The R12bn South African sugar industry is cost-competitive, consistently ranking in the top 15 out of approximately 120 sugar producing countries worldwide.

Also the sugar industry provides employment in job starved regions often in deep rural areas where there is little other economic activity or employment opportunity. Opportunities for this industry lie ahead and include biomass for renewable energy. In addition, the SA sugar industry has transferred 21% of freehold land under cane from white to black owners since 1994 off a base of 5%.

Sweet story

The South African sugar industry generates an annual estimated average direct income of over R12 billion. Sugar is manufactured by six milling companies with 14 sugar mills operating in the cane-growing regions.  The industry produces an average of 2,2 million tons of sugar per season.  About 75% of this sugar on average is marketed in the Southern African Customs Union (SACU). The remainder is exported to markets in Africa, Asia and the USA.

University of the Witwatersrand School of Public Health director Karen Hofman said it was not clear if a tax on beverages would be feasible, but even if it were, it should not be seen as a silver bullet. “Any regulatory effort will only ever be part of the solution. People should be free to eat and drink what they like, but they need to have a full understanding of what they are consuming,” says Hofman.

She adds that she is unaware of a specific tax on sugar anywhere in the world. “We do know that taxes have been successfully introduced in several countries, including France and Mexico,” says Hofman. Such taxes have been introduced on those who use sugar in some form of manufacturing or food and beverage supplies.

Obesity and SSBs

In the USA, the term sugar-sweetened beverages, or SSBs, is used – which are drinks sweetened with sugar, high-fructose corn syrup, or other caloric sweeteners. They are a significant source of nutrition-less or “empty” calories in the American diet, say some, and a significant contributor to the current obesity epidemic there. In the USA, researchers say that if the taxes are large enough they could reduce consumption and the revenue from these taxes to be used on obesity prevention.

Here in South Africa, Discovery health representatives has publicly cautioned against placing too much emphasis on the link between sugar consumption and preventable cancers.  Their Derek Yach says, “Tobacco remains by far the most powerful single determinant of cancer, accounting for 90% of the lung cancer cases and about a third of all cancer deaths.” He calls for all resources to focus on this area.

In a country like South Africa, with limited financial resources, he says, “a focus on taxes on sugar to reduce cancer is a misplaced policy which will have little impact on cancer incidences and distract people from the major diet issues – which are to increase healthy food intake.”
Previous articles in this category or as background
http://parlyreportsa.co.za//cabinetpresidential/sa-health-welfare-starts-in-small-way/

Posted in Facebook and Twitter, Health, Land,Agriculture, LinkedIn, Trade & Industry0 Comments

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/

Posted in Health, LinkedIn, Special Recent Posts0 Comments

Medicines and Related Substances Bill tabled

Idea is to speed up registration of medicines….

doctorA new Bill has been tabled in Parliament, the Medicines and Related Substances Amendment Bill which proposes to replace the existing Medicines Control Council with a new body that will reflect better, it says, the many changes that have occurred in the industry.

It is proposed that the minister of health and therefore the department (DoH) will  have a far wider scope of regulatory control and adds the expression ‘complimentary 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 take place.

Committee experts

A new body of committees made up of experts and specialists will assist DoH with such process, the Bill says, but the decision making processes of the committee on the subject of registration of new drugs will still be kept  private as is the case in the principal Act since the proposals are silent on this issue.

The new body will be called the South African Health Products Regulatory Agency (SAHPRA) and according to the proposals will have a far wider regulatory mandate on activities across a broader spectrum of medical products. It will extend the base of control and its services to cover foodstuffs, cosmetics and the newly embraced complimentary medicines.

Business Day reported that experts from the US were assisting in the setting up of SAHPRA but gave no details of where these experts emanated from.
Previous articles in this category
http://parlyreportsa.co.za//health/pharmacies-labour-relations-changes/
http://parlyreportsa.co.za//health/sa-allow-avoidance-medical-patents/

Posted in Facebook and Twitter, Health, LinkedIn, Trade & Industry0 Comments

Pharmacies get labour relations changes

More controls for pharmacies to consider…..

pharmacy blacksAn amended set of rules for pharmacies relating to good pharmacy practice  were published for public comment by the South African Pharmacy Council, mainly related to labour relations and supervisory regulations regarding jobs and regulations are forthcoming.

The amendments are made in terms of the Pharmacy Act (1974 and refer to minimum standards and job descriptions for pharmacy technicians, pharmacy technical assistants and pharmacy general assistants.

In amending the “rules of good pharmacy practice”, the procurement, storage and distribution of “thermolabile” pharmaceutical products is set down in terms of cold chain storage; issues such as  pharmacy courier services and even name tagging of pharmacy assistants set out and further regulations regarding the calculation of, dispensing fees outlined.

Pharmacies complain that they recently have been under severe strain recently in the light of new regulations on controlled pricing, with smaller pharmacies under extreme pressure to continue in operation against major retail chains opening dispensaries. The days of the “family chemist” are seeing their last, as owners become more involved in government’s stated policy to reduce the price of medicines.

Now introduced are issues on HIV testing carried out by many pharmacies countrywide. Associated bodies and stakeholders had until late December 2013 to submit public comment. The new regulations are awaited.

previous articles on this subject

http://parlyreportsa.co.za//uncategorized/next-for-pppfa-preferential-procurement-are-pharmaceuticals/

Posted in Facebook and Twitter, Health, LinkedIn, Special Recent Posts, Trade & Industry0 Comments

SA to allow avoidance of medical patents

SA copying Brazil by ignoring patents….

pillsGovernment’s Bill on changes to the Intellectual Property Act, not assented to yet by the President but passed by Parliament, is under major attack by overseas pharmaceutical companies who complain that the proposals to allow SA to bypass patent laws are badly drafted; just simply favour local generic manufacturers who have put no R&D into development and further confuse an already obtuse enforcement system of medical patents in South Africa.

Minister of trade and industry, Rob Davies, who was unusually involved in health matters when he recently made statements to the media, “We are the world capital of HIV/AIDS and we have serious burden of TB linked to that … and we have to have the freedom and ability to use the policy space that’s been made available to us under the world health agreement TRIPS ( Trade Related Aspects of Intellectual Property Rights) and public in the interests of the nations that we should take that option.”

South African generics being scouted

However, in this case, the minister was referring to the new government policy on intellectual property (IP), currently under discussion where the minister is saying his department of trade is dealing with “innovative pharmaceutical companies” involved in the production of cheaper drugs. IP is a DTI matter whether it involves health or not.

Briefing journalists on the response to the original draft policy and now the Bill, which elicited submissions representing more than 300 stakeholders, Davies said his department’s fight was “to strike a balance between the needs of public health and the interests of pharmaceutical companies”.

It came out in the questioning with DTI’s spokesperson, MacDonald Netshitenzhe, that the Doha agreement on TRIPS and public health allows countries to break patents by issuing compulsory licences to local manufacturers of generic medicines. These provisions are intended to be used in a public health emergency, and have been used by countries such as Brazil and Thailand to break patents on HIV medicines.

The doctor weighs in with comment

Dr Aaron Motsoaledi, minister of health, has taken the opportunity to declare that South Africa has indeed such an emergency (how much of it caused by the famed past health minister nicked named “minister beetroot” after she called for all to substitute beetroot and garlic for ARV’s aws not mentioned) but minister of trade and industry Rob Davies has added that there are many other areas in health where the poor are not able to begin to afford the menu of drugs on the market.

Commentators are saying  “emergency in HIV/AIDS” referred to by cabinet ministers was caused by government itself in the years of denial over AIDS and quote was activist Zachie Achmat of TAC when  government was refusing to import antiretrovirals (ARVs) some seven years ago, putting South Africa way back in the fight against HIV/AIDS and related diseases such as TB.

Now Zachie Achmat has joined the government call for cheaper drugs and to follow government moves. Other activist groups such as Medicines sans Frontiers have seen the new government policy as an opportunity to push for measures they believe will lower the price of medicines and have said so, particularly influencing Parliament when the matter was in earlier debate there.

An  outcry has grown since the new IP Bill was debated in Parliament, despite the lone voices declaring that the policy that ignoring worldwide patent rights would simply put to risk those investments already made in South Africa by overseas pharmaceuticals.

This charge was led by Wilmot James, shadow minister of trade and industry, and supported, strangely, by ANC Alliance partner, COSATU, for reasons that jobs would be lost.  Wilmot James called the document “remarkably unimpressive”, suggesting “the drafters appear not to fully understand intellectual property law”. Calling the DTI’s document “legally illiterate”, James said that the policy “lives up to the mediocre standard that we have come to accept from the intellectual property division of the department of trade and industry’.

The Doha declaration also allows parallel importation of medicines, which means a company or nongovernmental agency can import a patented drug from another country where the same product is sold at a lower price.

Davies has been quoted by the media as saying “Although we’ve been a major champion of all these processes internationally we haven’t necessarily incorporated them into domestic law. That’s one of the issues that we need to follow through.”

Copyright legislation needed to be brought in line with recent World Intellectual Property Organisation treaties, including the Beijing treaty and the Marrakesh treaty, he said. He was quoted as saying that government was looking at the issue of collective management of royalties in view of complaints from industry stakeholders.

All of this comes in the light of a government health policy to introduce a free national health scheme.  Netshitenzhe of DTI explained that after the public comment period was concluded, the amended document, including comments, will be brought to Cabinet, who may suggest further changes before giving its approval.

Once the policy is finalised, the department of trade and industry will draft legislative amendments to be vetted by Cabinet and Parliament, ideally in March of next year 2014.     Most of the public debate took place in the media whilst Parliament was closed.

Internationals are “satanic” says Motsoaledi

Dr Aaron Motsoaledi weighed in further with the comments to Mail and Guardian, stating “I am not using strong words; I am using appropriate words. This is a conspiracy of “satanic magnitude”, calling on all South Africans to fight “to the last drop of their blood”. Most feel that Motsoaledi will stay as minister of health when the new government is formed in April/May next year.

When the final document re-appears in the public arena in the form of the amended Act in what has become a very heated debate, some watering down may have taken place but what was at first taken to be a simple document protecting indigenous medical practices, has obviously international implications for both local and international partners in the pharmaceutical manufacturing industry and those with head offices outside the country.
Previous articles on this subject

http://parlyreportsa.co.za//finance-economic/intellectual-property-laws-amendment-act-law/
http://parlyreportsa.co.za//finance-economic/promotion-and-protection-of-investment-bill-opens-major-row/
http://parlyreportsa.co.za//health/medical-food-intellectual-property-tackled/
http://parlyreportsa.co.za//uncategorized/next-for-pppfa-preferential-procurement-are-pharmaceuticals/

 

Posted in Facebook and Twitter, Health, LinkedIn, Special Recent Posts, Trade & Industry0 Comments

Promotion and Protection of Investment Bill opens up major row

New DTI Investment Bill disliked as damaging to FDI……

A draft Promotion and Protection of Investment Bill has come under serious fire from not only South African business groups but from foreign firms operating in South employing large numbers of local employees. Most have described the proposals as adding woes to an already damaged South African investment picture, adding yet further risk to the current economic downturn

Promoted by minister of trade and industry, Dr Rob Davies, the Bill will enable South Africa to trade ignoring existing bilateral investment treaties (BITs) between South Africa and other countries in the EU whilst extending protection to new investors from all other countries.

Davis says bi ltateral treaties irrelevant

Davis says that the new Bill if passed as it stands “will enable a comprehensive and uniform legal framework to govern investments in the country”.  He said a review of South Africa’s bilateral investment treaties had found that there was no correlation between the existence or absence of a bilateral treaty with a particular country and the flow of foreign direct investment (FDI) from the country.

Minister Davies has been warning for some time that such a review would take place and the draft, just closed for public comment, indeed makes a number of radical changes to South Africa’s  trading relations, which many trade law experts say brings further uncertainty to the investment climate when least wanted by the country.

Listing the uncertainties to FDI

The first of the many changes is that investors no longer have recourse to international arbitration. Under BITs at present, trading investors are allowed to have arbitration proceedings as laid down by World Bank rules.   International arbitration, for obvious reasons, is preferred by investors as it is impartial and not in the hands of the country invested in, as is promoted the Promotion and Protection of Investment Bill making it local.

The second major change relates to the compensation paid in the event of expropriation. The new Bill simplistically says that  “compensation must be just and equitable”, clearly creating uncertainty in the light of known statements by cabinet ministers and senior ANC politicians in South Africa on the subject of expropriation.

Events in other parts of Africa will no doubt leave investors uneasy despite the promises of minister Rob Davies that “protection for overseas investors will be in terms of South Africa’s Constitution”, which he said “provides significant and robust protection for investors and for property both domestic and foreign.

All local foreign investors, even those with a half acquired knowledge of South Africa’s political development, will have watched the appointment of a state market valuator to handle land reform expropriation.

Finally, an uneasy point for many is that the new draft Bill fails to provide the normal provision of a BIT with what is considered by most internationals as the necessary affirmation that investors will enjoy fair and equitable treatment. Therefore they might feel that without the full protection that is enjoyed by any South African investor in the country, they might feel in jeopardy without the normal assurances of equal competition or against local protection.

amchamlogo2One such critic of the new Bill is the South African structured American Chamber of Commerce (AmCham) instituted by South Africans in Johannesburg some thirty years ago. AmCham represents some 250 American multinationals registered to do business in South Africa, eighty of the biggest contributing R233bn to the SA economy in 2011, and employing some 150 000 employees, either directly and indirectly.

They say they know where the minister is coming from but agree with all the points made by trade law experts, confirming their deep concern that the draft Bill states compensation will be an “equitable balance between the public interest” and the party that is involved.

This is totally unsatisfactory, they say. Reducing compensation or describing compensation in a manner as proposed in the Bill will increase the risk for investors, the paper says. The AmCham submission, available on their website, says that the state’s ability to undertake acts harmful to an investment’s profitability or property rights in the manner described appears to provide less protection than the Constitution itself affords.

They add that there is a perception given by the proposals that fair and reasonable treatment between local and international business issues will not be provided. AmCham goes on to state “any investment that violates domestic legislation or foreign agreements should be dealt with through legal channels available, without limiting the rights or protections of the investment.”

Jeff Nemeth

Jeff Nemeth – President AmCham

AmCham says, “Clear assurances that capital relating to investment and returns can be repatriated is not given and the investor should not lose their basic rights as is proposed under this law”. They add, “Investors are jittery of the slightest possibility of expropriation of assets by government which is perceived, rightly or wrongly, to be a very real possibility in relation to the South African government’s priority objectives of industrial development; public welfare objectives and black economic empowerment.”

“This perception should be decisively addressed by government and should be firmly dealt with in the Protection of Investment Bill.  In its current form, the draft Bill does not offer investors assurance that predictable and stable policies are a government priority”, AmCham concludes.

Davies said both his ministry and department of international relations “have been engaging with those European countries with whom South Africa has bilateral investment treaties to inform them about the country’s plan to introduce the Bill and the termination of the BTI only takes place six to 12 months after, depending on the agreement in place.”

The minister recently told a meeting that South Africa had significant  foreign direct investment from the US, Japan, Malaysia, India and other countries, “and we have no bilateral investment treaties with them”.

AmCham and others say this is not the point and now is not the time to tinker with the investment climate, thus providing less clarity and less security for FDI given the current downturn in economic factors.

Posted in Facebook and Twitter, Finance, economic, Health, LinkedIn, Trade & Industry0 Comments

This website is Archival

If you want your publications as they come from Parliament please contact ParlyReportSA directly. All information on this site is posted two weeks after client alert reports sent out.

Upcoming Articles

  1. MPRDA : Shale gas developers not satisfied
  2. Environmental Bill changes EIAs
  3. Border Mangement Bill grinds through Parliament

Earlier Editorials

Earlier Stories

  • Anti Corruption Unit overwhelmed

    Focus on top down elements of patronage  ….editorial….As Parliament went into short recess, the Anti-Corruption Unit, the combined team made up of SARS, Hawks, the National Prosecuting Authority and Justice Department, divulged […]

  • PIC comes under pressure to disclose

    Unlisted investments of PIC queried…. When asked for information on how the Public Investment Corporation (PIC) had invested its funds, Dr  Daniel Matjila, Chief Executive Officer, told parliamentarians that the most […]

  • International Arbitration Bill to replace BITs

    Arbitration Bill gets SA in line with UNCTRAL ….. The tabling of the International Arbitration Bill in Parliament will see ‘normalisation’ on a number of issues regarding arbitration between foreign companies […]

  • Parliament rattled by Sizani departure

    Closed ranks on Sizani resignation….. As South Africa struggles with the backlash of having had three finance ministers rotated in four days and news echoes around the parliamentary precinct that […]

  • Protected Disclosures Bill: employer to be involved

    New Protected Disclosures Bill ups protection…. sent to clients 21 January……The Portfolio Committee on Justice and Constitutional Affairs will shortly be debating the recently tabled Protected Disclosures Amendment Bill which proposes a duty […]