Mr Narend Singh, M.P., made a presentation to the Committee on the Medical Innovation Bill. He said that cancer was a growing concern in the world and was predicted to affect one in three people in the near future. He expressed concern over how billions of dollars were being spent to treat cancer. He bemoaned the fact that globally there were lags between research and trial drugs getting to patients because of excessive red tape in the system. There were laws preventing the use of experimental drugs such as cannabis.
The Medical Innovation Bill seeks to establish one or more research centres or hospitals where medical innovation can take place, with particular regard to the treatment and cure of cancer. It also aims to legalise the medical, commercial and industrial use of cannabis, in accordance with emerging world standards. Furthermore, the Bill creates a special legal dispensation, which applies only in research pilot hospitals authorised by the Minister of Health, where medical practitioners are granted greater professional discretion to administer innovative and alternative medical treatments on the basis of the patients’ informed consent. Other progressive countries had begun to legislate to allow these progressive experimental treatments to be able to be accessed by members of the public.
The Members seemed to be unanimous that the Bill had the noble purpose of alleviating the pain of suffering patients in the Republic. However, there were mixed opinions and sentiments about the two main objectives of the Bill -- to make provision for innovation in medical treatment and to legalise the use of cannabinoids for medical purposes and beneficial commercial and industrial uses. While there was general support for innovation in medical treatment, it was felt that there should be extensive professional research into the curative properties of cannabis before the Committee made any decision on the issue.
The Department of Health presented on its first quarter annual progress report. (See document). Members asked about the link between nutrition and child mortality rates, what measures were being taken to prevent the spread of HIV and tuberculosis, what progress was being made with the National Health Insurance scheme, whether Emergency Medical Services response times were improving, what the Department sought to do about the 27 000 vacancies it had in all the province.
Medical Innovation Bill
Mr Narend Singh, Member of Parliament, pointed out that cancer was a growing major global burden. The latest statistics predict it will affect one in three people and it remains the leading cause of death worldwide. Cancer not only costs billions of dollars each year to treat, but more importantly, it affects the quality of life for patients and their families.
Globally, and in South Africa in particular, people have expressed their desire for new, effective and affordable treatments. This had resulted in new and exciting integrative therapies being discovered daily. Despite this progress, ‘red tape’ often prevented them from getting to patients in a timely manner. Most take over ten years to get from the research stage to the patient, a time during which too many cancer sufferers die. A cure for cancer is still to be found, despite the tremendous ongoing efforts of doctors and scientists around the world. The world is changing and scientists and doctors alike are now looking in new directions. The practice of using integrative medicine to treat illness and disease by combining alternative medicine with conventional medicine is the way of the future. It includes treating the whole person by focusing on wellness and health, as well as treating the disease and palliative care.
Under current legislation, medical practitioners are being legally prevented from prescribing and administering effective and harmless treatments, including those involving the use of cannabis, with respect to several life threatening diseases, including cancer, because such treatments have not been approved in terms of the present legally required double-blind in vivo clinical studies. Such clinical studies are often economically unviable, as the treatment or the substances used for it, such as bicarbonate of sodium or cannabis, are in the public domain and not capable of being patented, thereby preventing any relevant party from recouping the costs of such studies from future profits. This results in unnecessary human suffering and death on a mass scale, with consequent immense social and economic costs.
Of importance are the objectives of the Bill. The Bill seeks to establish one or more research centres or hospitals where medical innovation can take place, especially with regard to the treatment and cure of cancer, and to legalize the medical, commercial and industrial use of cannabis in accordance with emerging world standards. Furthermore, the Bill creates a special legal dispensation, which applies only in research pilot hospitals authorized by the Minister of Health, where medical practitioners are granted greater professional discretion to administer innovative and alternative medical treatments on the basis of the patients’ informed consent.
Amendments to the health policy and laws of South Africa with respect to the treatment of cancer and other incurable diseases are proposed by the Bill. The changes sought to be introduced by the Bill would allow doctors to administer conventional treatments, along with innovative complementary therapies and treatment options. It would also empower the Minister of Health to establish one or more medical treatment research centres, where doctors would be allowed, under strict control and regulation, to administer these therapies.
First published in the Government Gazette on 18 February 2014, the Bill was then introduced into the National Assembly by Dr Mario Oriani-Amborosini on 20 February 2014. The Bill, however, lapsed in accordance with National Assembly Rules at the end of the 4th Parliament, and was revived without opposition at the beginning of the 5th Parliament. Upon the passing of Dr Oriani-Ambrosini, MP, the Bill once again lapsed. The Bill was then subsequently adopted and re-introduced by Mr Narend Singh, MP and soon thereafter revived by motion of the Chief Whip of the Ruling Party, and again with no objection from any other political party in the National Assembly.
The long title of the Bill described the function of the Bill -- to make provision for innovation in medical treatment and to legalize the use of cannabinoids for medical purposes and beneficial commercial and industrial uses.
The purpose of the Bill was denoted as follows:
• 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, because the available evidence is insufficient or uncertain;
• enhance certainty and clarity for medical practitioners and others regarding the criteria to be applied in determining whether to innovate in the cases referred to in subsection (1);
• encourage responsible innovation in medical treatment and management by supporting reasonable and logical clinical decisions;
• 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.
South Africans and the international community have rallied behind the Bill, and it has to date received 1 903 public comments displaying a unanimous broad support for the Bill. Some progressive countries are currently regulating Cannabis. Such regulation is found in the following countries: The Netherlands, Canada, Germany, Israel, Australia, Great Britain, Portugal, Uruguay, United States, Spain, North Korea, France, Austria, Belgium, and the Czech Republic.
To conclude, Mr Singh said that the people of South Africa have an opportunity to place South Africa on the world stage as leaders in medical innovative practices. He submitted that the sole responsibility was to provide the thousands of South Africans who otherwise would not have access to options in cancer and other dread diseases, treatment and care.
The Chairperson said that the Committee would deliberate on the presentation. She said that this was a mere presentation, and a lot of work still had to be done.
Dr W James (DA) said that a special mention had to be made of the role of the departed Member, Mr Ambrosini. He made it clear that the discourse that had to be conducted must be one made on the premise of empirical evidence, and not on emotion. The Bill provided for two things – innovation, and the provision of the commercialisation of cannabis. The second goal should be stripped off. A consideration would be made on innovation. On the point of innovation, in terms of molecular cell biology, when you speak about a cure, you must prevent it from occurring. There is a question of treatment as opposed to cure. There is therefore innovation in treatment and innovation in cure. This is what the bill deals with. He noted that the science in terms of a cure had not been advanced. The bill was all about treatment, and not about cure. Despite marijuana’s curative properties, when ingested as food it could lead to severe addiction. He gave a definition of cancer, and explained how cancer was the unplanned duplication of cells in the body. Dr James emphasised that innovation could be used to save lives. He apologised for spending a considerable amount of time defining cancer and explaining about the benefits and the drawbacks of marijuana as a curative drug.
The Chairperson advised members that they need not apologise for raising critical issues and discussion points for the matters at hand. She reiterated the comments by Mr James that the discussion need not be one based on emotion.
Mr I Mosala (ANC) said that with due consideration of the matter, he was of the opinion that the Committee did not have the capacity to reach a final decision on the matter. The duty of the Committee in this particular instance was to open up the process. Once the process was open, it would allow professionals to give their opinion on the matter. He reminded the Committee that South Africa is a highly opinionated nation and hence the public would also love to make a contribution.
The Chairperson thanked Mr Mosala for his insightful remarks and cautioned the Members that what was needed was to obtain all the necessary information and then do the work required. She also stressed that there was a need to get competent people involved in the process.
Mr N Matiase (EFF) welcomed the presentation in which party lines had been lost. He disagreed with Dr James and stated that the two main objectives of the bill should not be changed, for as long the process was not turned into a profit-making business.
Mr I Mosala (ANC) indicated that the bill had a lot of variables that needed to be reconciled. Either a discussion was needed to be conducted on commercialisation or on setting up a research facility/unit. He also raised the question on whether there was empirical data to support the concession that marijuana had medicinal properties.
Mr A Emam Shaik (NFP) said that in his view, any research aimed at enhancing the lives of South African people should be encouraged. The research at this stage was still too much in an early stage for the Committee to entertain the matter. Commercialisation could be undertaken at some stage, but at the moment, space must be given for experts to engage with the bill, and then the Committee could engage in discourse on a perfected product.
Ms C Majeke (UDM) described her personal experience with a certain woman she knew who had been curing people of disease with a marijuana-based drug. Where could this woman take her drug for proper testing?
The Chairperson remarked that the Committee must ensure that the necessary work is done on the matter.
Department of Health: 1st Quarter Progress Report
Dr Malebona Matsoso, Director-General, Department of Health (DoH) gave details on the progress made with the Department’s various programmes.
In Administration, the strategic objective is to ensure effective financial management and accountability by improving audit outcomes. Three provinces received an unqualified audit opinion from the Auditor-General. The Department seeks to implement the Information Communication Technology (ICT) governance framework by focusing on the business continuity plan, which includes a disaster recovery plan. In addition, it would provide support for effective communication by developing and integration communication strategy and an implementation plan. An ICT continuity plan inclusive of an ICT recovery plan has been finalised and approved. A Communication Strategy was also finalised and approved. The draft ICT service continuity plan has developed. Internal IT consultations were also ongoing.
The DoH also seeks to ensure efficient and responsive human resource services through the implementation of efficient recruitment processes and a responsive human resource support programme. This would be measured against average turnaround times for recruitment processes. Average recruitment turnaround times will be at an estimated four months. To date, the Department has managed to operate within the four months turnaround time.
The Department also seeks to provide support for effective communication by developing an integrated communication strategy and implementation plan. In this regard the department has implemented the Wellness Management Pillar, where various employee wellness and health activities were conducted. The DoH also strives to facilitate and coordinate evidence-based planning for all the levels of the health care system, aligned to the health sector’s ten-point plan and service delivery agreement. Nine provincial performance plans were developed and nine provincial performance plan reviews and feedback were provided. Draft guidelines were developed and circulated to provincial departments for inputs. The Department also sought to ensure the establishment of fora for consultation with stakeholders on identified legislation, regulations and policy processes. One national and nine provincial fora had been created to date.
The second programme was the National Health Insurance (NHI), Health Planning and Systems Enablement. One of the strategic objectives of the programme is to achieve universal health through the phased implementation of the NHI. Currently the annual performance evaluation report has been prepared, approved business plans made available, and scheduled visits on first quarter performance of NHI projects will be conducted in the second quarter. A consolidated performance report for the first quarter will be prepared in the second quarter.
The DoH also seeks to set up a National Health Insurance Fund. Phase 1 of the implementation of NHI had been initiated through the creation of a project management team and various activities for the "shadow process" of the NHI Fund had started. Further, funding modality for the NHI Fund, including budget reallocation for the district primary health care (PHC) personal health services, had been developed. The DoH also seeks to regulate health care in the private sector by establishing the National Pricing Commission and legislating methodologies for calculating fees. The draft National Pricing Commission Bill has been gazetted for consultation with a systematic survey for the dispensing fee completed for the 2015/16 cycle. The approved dispensing fee was published on 13 June. The Department also seeks to improve management and control of pharmaceutical services, central chronic medicine dispensing and distribution, and develop business and enterprise architecture for e-health. It will establish a national health research observatory, and develop and implement an integrated monitoring and evaluation plan aligned to health outcomes and outputs contained in the health sector strategy. The Department further seeks to establish a coordinated disease surveillance system for notifiable medical conditions, monitor HIV prevalence, domesticate international treaties, and implement bilateral cooperation on areas of mutual benefit.
Programme 3 considers HIV and AIDS, tuberculosis, and maternal, child and women’s health. The programme strives to scale up a combination of prevention interventions to reduce new infections, increase the number of HIV people who are managed so that they do not contract opportunistic infections, improve the effectiveness and the efficiency of the routine TB control programme to increase the identification of TB patients, and to ensure that these take and complete their treatment of tuberculosis. The programme also seeks to improve the functioning of the multi-drug resistant (MDR) TB control program including earlier initiation and decentralised treatment.
The DoH also needs to ensure that all correctional services facilities have appropriate services and that all TB inmates have access to treatment services and care. There are also plans to reduce the maternal mortality ratio to under 100 per 10 000 deaths, reduce the neonatal rate to under six per 1 000 live births, and improve access to sexual and reproductive health services by increasing the availability of contraceptives. The programme would also like to see the extension of the prevention of mother to child transmission (PMTCT) coverage to pregnant women, by ensuring that all HIV positive clients are placed on ARV’s and reducing the positivity rate to below 1%. Strides are being made to reduce the under-five mortality rate to less than 23 per 1 000 deaths, and contribute to the health and wellbeing of learners by screening for health barriers to learning. A contribution can also be made health and wellbeing of learners by screening for health barriers to learning.
The fourth programme involves primary health care services. It seeks to improve district governance, establish an inter-sectoral forum, and improve environmental health services in all 52 districts and metropolitan municipalities in the country. The DoH also seeks to eradicate malaria by 2018, improve South Africa’s response to non-communicable diseases, increase access to and quality of mental health care in South Africa, improve access to rehabilitation services through the implementation of the framework and model for rehabilitation and disability services, and ensure access to efficient and effective delivery of quality of Emergency Medical Services (EMS). The Department is also working on improving chemistry laboratory turnaround times for alcoholic, toxicology and food samples.
The fifth programme deals with hospitals, tertiary services, and workforce development. Key strategies include increasing the capacity of central hospitals to strengthen local decision-making and accountability to facilitate the semi-autonomy of ten central hospitals, ensuring equitable access to tertiary services through the implementation of the National Treasury Services Plan, ensuring quality health care through improving compliance with national core standards at all central, tertiary, regional and specialised hospitals. The DoH also wants to develop health workforce staffing norms and standards, ensure that the number, distribution, quality and standard of health facilities are in compliance with norms and standards, and improve the quality of health infrastructure by ensuring all new health facilities are compliant with health facility standards and norms.
The final programme deals with health regulation and compliance management. Amongst other issues, it seeks to regulate Complementary and Alternative Medicines (CAMS), medical devices, in-vitro diagnostics and African traditional medicines in South Africa, improve the efficiency of the Regulator through restructuring, by establishing the South African Health Product Regulation Authority (SAHPRA) as a public entity, and strengthen food safety through expanding testing capabilities for adulterants (colorants, protein, and allergens). It also aims to improve registration of response times for anti-retrovirals, oncology, TB medicines and vaccines used to treat high burden diseases, improve oversight and corporate governance practices by reviewing the governance framework and implementation plan biennially, and enhance governance and management by establishing all committees at the Compensation Commissioner for Occupational Diseases (CCOD)/ Compensation Commissioner for Occupational Diseases). The programme seeks to establish occupational health services within the public health system, and provide for coordinated disease and injury surveillance and research by establishing a National Public Health Institute of South Africa (NAPHISA). The programme also seeks to monitor the existence of, and progress on, annual and regular plans that address breaches of quality, safety and compliance in all public sector establishments.
Dr James asked whether child mortality and malnutrition was a problem that could not be solved. He did not consider malnutrition problems were so severe that it necessitated mortality.
Dr Matsoso said that on the coming Friday they would be evaluating the programme for under-fives.
Mr H Volmink (DA) asked about HIV prevention and what the capacity for data collection and analysis was. He also enquired about what had been done to improve the emergency medical services (EMS) response times and the barriers in pharmacy.
Dr Matsoso said that in terms of chronological data, the department was establishing a Public Health Institute that would deal with surveillance. She hinted that the body currently dealing with this, the National Health Laboratory Services (NHLS), was a pathology diagnostic service and was not equipped and best suited to handle the process.
Mr I Mosala (ANC) said that South Africa was a land of milk and honey and there was no reason why there should be so much suffering and hunger. Maybe it was time for a more holistic look to be taken. He also urged the Department to focus on nano-technology.
Dr Matsoso said that at this specific stage in time, she could not say what the NHI funding model would be. They had to be guided in this process by the National Treasury.
Mr Shaik Emam advised the Department that before they could rollout some of their projects, it needed to consult with the various stakeholders. He raised concerns about people selling expired drugs, the need for focusing on prevention rather than treatment, and the need for less dependency.
Mr A Mahlalela (ANC) asked what provisions or systems had been put in place for data assessments. He also asked how many pilot sites the Department had, and questioned it on the EMS response times. He questioned what data the DoH was using on obesity.
Dr Matsoso said that the Department had all the necessary data on obesity and had put the necessary systems in place.
She said that the Department had 11 pilot sites.
In terms of EMS response times, the Department did not have legislation for the entire country. This was a highly decentralized forum. She invited the Committee to look at Kwazulu-Natal and the Western Cape, which had working systems. In KZN, the system allowed them to track ambulances wherever they were.
Mr Mosala asked what was being done about only three provinces getting unqualified opinions from the Auditor General.
Ms C Ndaba (ANC) asked whether any progress had been made on mental health. She also asked whether the Department was compromising on the issue of male circumcision. She recommended that the focus be given to the training of nurses and paramedics.
Dr Matsoso said that the Department had made significant strides on mental health.
Ms M Scheepers (ANC) asked what contribution the private sector was making. What was the progress in terms of delivery of medicines?
Dr Matsoso said the DoH had been engaging with general practitioners on making a contribution.
Mr S Jafta (AIC) asked about vacancies in the Department.
Dr Matsoso said that in order to fill the 27 000 vacancies, the DoH had to work with the National Treasury, bearing in mind the provincial budgets. She said that in due time she hoped the vacancies would be filled and the problem would be solved.
Ms Jeanette Hunter, Deputy Director-General: Primary Health Care, said chronic diseases was a Presidential priority, and the DoH had blue prints in place.
Professor Shabir Banoo, a member of the Central Drug Authority, said that there was indeed an issue in terms of prescription drugs. However, the solution was in monitoring and putting systems in place. He commented that the situations raised were exceptions, rather than the norm.
Adoption of minutes
Mr H Volmink moved the adoption of the minutes of 3 September. Mr I Mosala seconded. The minutes were adopted.
The meeting was adjourned.
- PC Health: Medical Innovation Bill: briefing by Mr N Singh MP; Department of Health 1st Quarter Performance 2
- PC Health: Mr N Singh, MP and Department of Health on Medical Innovation Bill 2
- PC Health: Mr N Singh, MP and Department of Health on Medical Innovation Bill 1
- PC Health: Medical Innovation Bill: briefing by Mr N Singh MP; Department of Health 1st Quarter Performance 1
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