Medicines and Related Substances Amendment Bill [B6-2014]: Traditional and Natural Health Alliance submission
25 February 2015
Chairperson: Mr I Mosala (ANC)
The Traditional and Natural Health Alliance said that traditional medicine is much safer and healthier than medicine containing drugs. Australia has listed their medicines as either 'registered drugs' or 'listed products' and that their definition of complementary medicine includes herbs, vitamins, minerals, nutritional supplements, homeopathic and certain aromatherapy under the Therapeutic Goods Act 1989. The Act also stipulates the use of each of which has a clearly established identity and traditional use. People should have a variety of medicines to choose from, and in that variety, traditional and natural medicines should be included. The Alliance spoke about the regulation of traditional medicines and how different it is from ‘modern’ medicine; efficacy takes on a different meaning in the integrative and Traditional and Natural Heath medical paradigm. In the biomedical paradigm, efficacy has to do with a single synthetic drug producing a clear intended result by blocking a biomedical process. The current biomedical paradigm is not suitable for traditional and natural medicines but the government still insists on using the same biomedical paradigm although it excludes the majority of the population in terms of preference. The regulations passed for a complementary medicine do not consider that there are different paradigms of medicine and China is the only country which has been successful in protecting both the western and traditional and natural medicines at every level of the health system.
The Traditional and Natural Health Alliance said that in 2013 the Department of Health published Regulations for natural health products which were categorised according to the substance prescribed by the five prescribing professions of the Allied Health Professions Council of South Africa but some categories were omitted, initially the department has published amendments which now include what are termed “health supplements". Section 35 of the Medicines and Related Substances Act was never envisaged by Parliament to regulate traditional medicine but rather have a controlling body to assess, regulate and control. They proposed for the disbanding of the non-representative Complementary Medicines and African Traditional Medicines Committee of the Medicines Control Council and have a more appropriate and rational regulatory system for traditional products, which balances the rights of consumer choice and public safety. They proposed changes to the Board with at least four experts in the traditional and natural health field, there must be a director for both paradigms (biomedical and the natural health paradigm, and there must be transparency in the decision making of the Medicines Control Council. There is no equity with regards to regulation of products, the South African Health and Products Regulatory Authority (SAHPRA) recognises traditional western herbal medicine, traditional Chinese medicine but there is no proper regulation for traditional medicines, and this goes against Section 9 of the Bill of Rights. The appropriate regulation of traditional medicine should be done through an on-going process, and be assessed and monitored by appropriately qualified professionals and experts from the traditional health alliance and manufacturing sector exclusively because the current assessors are neither sensitive nor appropriately trained in the philosophies and practice of traditional medicines. For successful decision-making, people must have both knowledge and authority; appropriate labelling regulations for traditional health products must contain responsible health claims, appropriate warning and dosage information. Consumers should also be provided with a time period on the label where if the health condition does not diminish or reverse, they should seek professional advice.
TNHA mentioned that they had consulted different stakeholders and Bills when compiling their submission. It was dissatisfied with the Medicines Control Council and it hoped that the South African Health and Products Regulatory Authority is not the same as the Medical Control Council. The new body must demonstrate transformation and understanding of the existence of all healing systems as used by our people and their autonomous status, and it was saddened that at a previous meeting held in 2012 only 12 institutions from the previously disadvantaged were invited to make submissions. Section 1 must include a definition for 'African Traditional Medicine' and ‘Traditional Medicine’ which is regulated under the Traditional Health Practitioners Act 22/2007. They called for the amendments to Section 1, 2 and 16 of the Bill.
The Committee was unhappy that the Alliance threatened to take legal action, but made it clear that such threats will not be accepted and it will not persuade the Committee to change their statements. It was asked why the Alliance could not establish their own Councils to regulate their medicines and practices, why are they opposing to having a Chief Executive Officer that is a pharmacist. It was agreed that the Alliance had delivered a better submission. The Committee did, however, urge the Alliance to work with them instead of working against them and said they needed their input in order to finalise the Bill.
Traditional and Natural Health Alliance submission
Dr Bernard Brom, Chairperson of the Traditional and Natural Health Alliance (TNHA), said drugs must be powerful to treat symptoms by blocking biochemical processes and therefore can have serious adverse effects on the body. Natural health products do no block or interfere with function, but support the innate intelligence of the body to heal, and therefore work differently. There is a vast gap regarding toxicity between drugs and natural medicines that they should not fall under the same regulatory process. Why would any authority want to place green tea, in its leaf form, in a bottle with claims of being an antioxidant, in the same category as aspirin or paracetemol. Clearly there is something seriously wrong in the way natural products are regulated. There is major bias against natural products, and the regulators involved in drawing up the regulations do not have the best interest of the public's health in mind, or understand these remedies at all.
In Australia medicines are classified as either registered drugs or listed products; higher risk medicines must be registered on the Australian Register of Therapeutic Goods (ARTG) which involves individually evaluating the quality, safety and effectiveness of the product. Lower risk medicines containing pre-approved, low risk ingredients and that make limited claims can be listed on the ARTG. The Australian government definition of a complementary medicine is, "Medicinal products containing such ingredients as herbs, vitamins, minerals, nutritional supplements, homeopathic and certain aromatherapy are referred to as 'complementary' under the Therapeutic Goods Act 1989". A complementary medicine is defined in the Therapeutic Goods Regulations of 1990 as a therapeutic good consisting principally of one or more designated active ingredients mentioned in Schedule 14 of the regulations, each of which has a clearly established identity and traditional use. Innovative natural products are modern innovative combination of natural herbs, vitamins, minerals and other nutrients recognised to be important in supporting health functions. They are of special interest to doctors of integrative medicine who specialise in supporting health rather than treating disease. In terms of the present regulation and guidelines these products will be erroneously classified as 'Category A' pharmaceutical drugs and not 'Category D' complementary medicines. Most Traditional and Natural Health Products (TNHPs) cannot be patented because they use natural ingredients and most have minimal double-blind studies to support traditional and empirical health claims. What they do have is many years use by thousands of integrative doctors around the world and used by thousands of patients.
The public has a right to medicines of their choice, especially if these medicines are generally safe and have appropriate Good Manufacturing Practice (GMP) and support health rather than treat disease. Natural products are generally far safer than cigarettes and even many foods such as peanuts. Efficacy takes on a different meaning in the integrative and traditional and natural heath medical paradigm. In the biomedical paradigm, efficacy has to do with a single synthetic drug producing a clear intended result by blocking a biomedical process, e.g. antihistamine, beta blocker and serotonin-reuptake inhibitor. Natural medicines cannot be classified in such simplistic terms; even a relatively simple molecule like magnesium participates in more than 300 enzymatic reactions in the body, is critical to many cellular functions, including energy production, protein formation and cellular replication. The definition of a natural medicine is so inclusive that it could limit the range and increase the cost of many natural products that support the health of the community. Experts from one paradigm, especially those who have been especially vocal against natural medicines, should not be allowed to also regulate this industry. Integrative medical doctors who use complex, mixed innovative remedies should not have those medicines limited by the company's inability to pay for expensive studies here in South Africa, when those studies have already been done in other countries.
The present biomedical paradigm of medicine, regulated by Act 101 of 1965, was for a westernized allopathic medical system which did not include African traditional medicines and other natural health products. This medical system 'Biomedicine' is still the official medical system used in South Africa and excludes the majority of our population, who use African traditional medicine. It is important to broaden our understanding of science to include traditional knowledge systems. Traditional African medicine is backed by science of experience. Medical science's double-blind, randomized, placebo-controlled trials are held up as the gold standard. However there are limitations in their application to traditional and natural health products, yet medical scientists tend to get their way when it comes to defining and regulating traditional and natural health products and expect the research on natural medicines to meet the appropriate standards of their paradigm.
The Bill and the recent regulations passed for 'Complementary Medicines' have not taken into account that one is dealing with two very different paradigms of medicine. The conventional biomedical paradigm which treats disease using drugs and surgery and the traditional medical paradigm which supports health using natural medicines and lifestyle changes. China is the only country in the world where Western medicine and traditional and natural medicines are protected alongside each other at every level of the health system. They are gradually developing a unique 'integrative medicine for that country'. Recognising the value of this submission by the TNHA and the value which it brings to the South African Health and Product Regulatory Authority (SAHPRA) debate, can allow a unique African medicine to emerge for the common good of every ill person in our land.
Mr Anthony Rees, Secretary General of the TNHA, said that the African Traditional and Natural Health Product industry is a multi-billion rand enterprise in South Africa and it manufacturers and distributors have enjoyed unfettered access to consumers throughout the country for hundreds of years. In November 2013 the Department of Health published Regulations for natural health products (Complementary Medicines) which were categorised according to the substance prescribed by the five prescribing professions of the Allied Health Professions Council of South Africa (Western Herbal Medicines, Chinese Traditional Medicines, Unani-Tibb Medicines and Homeopathic Medicines). Some categories were omitted initially and the department has published amendments which now include what are termed “health supplements”. The Committee may believe that the regulation of traditional medicine can be delegated exclusively to the Medicines Control Council (MCC) in terms of its broad vested powers to publish sub-legislation in terms of Section 35 of the Medicines and Related Substances Act (Act 101 of 1965). However, the Act was never envisaged by Parliament to regulate traditional medicine, the spirit and intent of the legislature was for a controlling body to assess, regulate and control novel pharmaceutical drugs which proliferated unchecked.
The TNHA proposes the repeal of the existing regulations for NHPs and the disbanding of the non-representative Complementary Medicines and African Traditional Medicines Committee of the Medicines Control Council. It proposes a more appropriate and rational regulatory system for traditional products, which balances the rights of consumer choice and public safety. The TNHA said they would like the board to be composed in the following manner: there should be at least four experts from the traditional and natural health field; it should also be separated with a pharmaceutical drug (Biomedical paradigm) directorate and a Traditional and Natural Health Products (Natural Health paradigm) directorate. The autonomous directorates should be made up of full time staff who are experts from the categories within the directorates listed; the category sub-committees approve the inclusion of individual substances to the Electronic Listing database. This committee may act as an arbitrator in disputes. The SAHPRA requires fundamental structural re-orientation and unambiguous terms of reference to bring about a meaningful regulatory environment to traditional products. Stakeholders have lost trust in the MCC’s ability to conform to basic constitutional obligations and to make regulations in a non-biased manner. There has been a lack of transparency in the decision making of the Council and its expert Complementary Medicines Committee (CMC) established by selective invitation to one stakeholder group, namely the Allied Health Professions Council of South Africa (AHPCSA).
There is inequality within the Bill because the implementing of a regulation for non-indigenous traditional medicine, vis-a-vis, traditional western herbal medicine, traditional Chinese while there is no concurrent regulatory system for indigenous African Traditional Medicines, creates an 'apartheid' and is therefore discriminatory. The Equality Clause in Section 9 of the Bill of Rights unequivocally states the state may not unfairly discriminate directly or indirectly against anyone on one or more grounds, including race, gender, sex, pregnancy, marital status, ethnic or social origin, sexual orientation, age disability, religion, culture, language or birth. No person may unfairly discriminate directly or indirectly against anyone on one or more grounds in terms of subsection (3). National legislation must be enacted to prevent or prohibit unfair discrimination. Chapter 1 of the Constitution, and specifically Section 2 states: this Constitution is the supreme law of the Republic; law or conduct inconsistent with it is invalid, and the obligations imposed by it must be fulfilled. In recent years the Director General of the Department of Health, Ms Precious Matsoso, and the previous Registrar of Medicines, Ms Mandisa Hela, have continued to unconstitutionally discriminate in their policy directives in this regard. This is not acceptable as the Constitution is the supreme law of the Republic, law or conduct inconsistent with it is invalid. He said they have drawn up legal papers if the Committee refuses to comply with these laws.
Appropriate regulation for traditional medicine can be achieved as part of an ongoing process, and be assessed and monitored by appropriately qualified professionals and experts from the traditional health alliance and manufacturing sector exclusively. The Medicines and Related Substances Control Act (Act 101 of 1965) was never intended for the control of African medicine but rather novel synthetic, man-made molecules and thalidomide tragedy. The MCC ignored the Traditional Alliance, there were only small attempts to regulate the sector over the last 20 years; their current biomedical assessors are neither sensitive nor appropriately trained in the philosophies and practice of traditional medicines, therefore they are not qualified to assess these products. Broad-Based committees must be established made up of experts in traditional products and the disciplines making up the array of products in the categories represented. These committees will assess certain applications where data is lacking, and make recommendation to the inclusion and removal of information relating to the date core of the Electronic Listing System (ELS).
The TNHA believes a similar 'listing system' can be adopted by a capable Directorate for traditional medicine under SAHPRA. A similar system was mooted between 1996 and 2008, and was originally proposed by the Health Products Association. The chief architect of the local system which was proposed, Mr Peter Kreft has indicated to the TNHA that he is happy to avail himself to get a pilot system up and running in the matter of six months at a cost of +/- R150 000 for the IT development. The TNHA is in the position to source much of the Natural Health Product data from both Health Canada and the Therapeutic Goods Administration (TGA) in Australia if required. There are some 600 African traditional medicine monographs already published by our local research institutions and universities. These substances and their information can also be plugged into this 'listing system' with ease, and provide an equal opportunity for previously disadvantaged South Africans to access safe, quality and effective indigenous health products. Informed choice is fundamental to all medicines; the TNHA believes that a growing number of South African TNHA customers are intelligent and independent to make the right choices with respect to their health. To ensure successful decision-making, they felt people must have both knowledge and authority; appropriate labelling regulations for traditional health products must contain responsible health claims, appropriate warning and dosage information. Consumers should also be provided with a time period on the label where if the health condition does not diminish or reverse, they should seek professional advice.
Ms Phephsile Maseko, Executive Committee member, said they have consulted with different medical bodies and legislation to compile the report, such as the National Reference Centre for African Traditional Medicines - a South African Model (2010), the National Health Charter (2011), as well as the current BB BEE Charters. She said the MCC lacked fairness, respect for dignity of Africans, the right to choice, right to information, and right to cultural and freedom of association. They feel that they must avoid replacing the MCC with a "similar monster" and that the new structure, SAHPRA, must demonstrate transformation and understanding of the existence of all healing systems as used by our people and their autonomous status. They have noted with sadness that at a meeting held on 15 March, 2012, only a group of 12 previously disadvantaged institutions were invited to make resubmissions on this new body and thereby unconstitutionally ignoring the interest of about 72 percent of South Africans that consume African medicines. In the definitions, Section 1 must include 'African Traditional Medicine' and it should read as follows: "An African healing system utilised or administered to human beings or animals to diagnose and treat/manage diseases, prevent or reverse a disease state and to maintain a good health or good look and (b) used for sanitation (insecticides)". Another definition for ‘Traditional Medicine’ should be included in the following manner "an object or substance used in Traditional Health Practice for - (a) the diagnosis or prevention of a physical or mental illness; or (b) any curative or therapeutic purpose, including the maintenance or restoration of physical or mental health or wellbeing in human beings but does not include a dependent-producing or dangerous substance or drug. And (c) is used in accordance with the practice of the professions regulated under the Traditional Health Practitioners Act 22/2007". Section 1(d) should include the definition for World Health Organisation (WHO), Section 2B should have the phrase "as long as it does not undermine our sovereignty" inserted. In Section 2C (2A), the Board was too skewed in favour of allopathic medicine. Clinical trials should be considerate of the history, disciplines and research methodology of both African Traditional Medicine and Complementary and Alternative Medicines. These should be included in the group of experts. Section 16C should have inserted that the Board will have to consult with the relevant expert committee.
The Acting Chairperson said he would like to make a few corrections that were in the submission before Members start asking questions. Dr Gwen Ramokgoba is no longer the Deputy Minister of Health and the Parliamentary Monitoring Group (PMG) is not part of Parliament, it is an independent/private organisation and is in no way affiliated to Parliament.
Mr Rees responded saying that he only referred to a statement which was published by the Parliamentary Monitoring Group and was in no way affiliating it with Parliament.
The Chairperson replied saying he was making the correction so that they understand that PMG and Parliament have different roles and PMG is not part of Parliament.
Mr C Volmink (DA) asked why they recommended that the Registrar should not be a pharmacist; how would this be a problem for the Alliance?
Ms N Ndaba (ANC) said Ms Maseko's submission does not in any way speak to the Bill - we had agreed in the last meeting with the Alliance that they should go through the Bill and come back with recommendations but she is happy that they have separated and stipulated the difference between Western and traditional medicine; this will indeed help the Committee with finalising the Bill. She does not remember the meeting which Mr Rees is referring to that took place on 3 September, 2014 and the Committee does not appreciate the proposed legal action - it is not acceptable because the Committee was willing to give them a second chance to make a submission. She also asked what they mean by the Bill being a "bad Bill".
Mr Mahlalela asked why have they made more references to Western countries that practice traditional medicines and not to any African countries because there is not much similarity between the Chinese and South African traditional medicines. He would have like the Alliance to give examples of how other African countries regulate their traditional medicines. He made it clear that the Chief Executive Officer will not be put as the Registrar and they will appoint someone that has experience and is able to run the Regulatory Authority. A Council was established in 2007 by the Traditional Health Products Alliance because they did not want to be under SAHPRA - what are the problems of the current Council that they cannot practise and regulate products on their own?
Dr James said they should not see the Committee as their enemy as it has given the organisation a second chance to make a submission. They should also realise that threats of court cannot be made to the Committee but to the department. The Committee has given them a chance and threatening Members to get its way is not the right way to do things.
Dr P Maesela (ANC) said there is a better understanding of what they want from the Bill, and making threats will not bring about solutions. He asked if they had consulted with other Traditional Medicine organisations, and suggested that in the future they must include opinions of other organisations in their submission to the Committee.
Ms Maseko replied saying it was never their intention to cause tension between the Committee and themselves, they are only trying to help the Committee understand traditional medicine and finalise the Bill and move forward faster. They do not want the CEO to be an expert in allopathic medicine but rather someone who has experience in all the areas of medicine. There are not many African countries that implement and regulate traditional medicines, and if there are they are not in the proper stage of regulation. The Alliance chose to make an example of China because it has established councils that help with the management of traditional medicines. It is preferable that the Registrar should be someone who is not a pharmacist because they have had bad experiences in the past, and they do not want to be part of SAHPRA but the Bill has stated that all medicines must be classified under SAHPRA. With this said, they want to establish conditions under which they want to exist in SAHPRA.
Dr Brom said they want the Regulatory Authority to recognise that there are different medicine paradigms and they must all be considered.
Mr Rees said the Committee was informed that traditional medicines will be regulated by SAHPRA but there is no proper functioning there for traditional medicine. He added that the reason why they feel pressured is that they have been requesting these changes to be made but no one has taken them seriously so far.
Ms Maseko said they have consulted with other traditional medicine bodies although their submission was not sent to all bodies in the provinces for them to comment.
Dr James said that the Ambrosini quote in their submission was a statement about the Protection of Information Bill and not the Medicines Bill as indicated in their submission.
Mr Volmink said the Bill must contain facts which are able to be backed up when needed, hence they have included information from WHO and its definition, which is a credible source that invests time in research.
Ms V James (DA) said the Bill may seem "bad" to them but it however needs their inputs to make it better suitable for everyone. It would be easier for the Alliance to recommend amendments so that no one will be threatened about taking legal action.
Ms Ndaba asked what role do they want the Committee to play in customers having access to traditional medicines.
Dr P Maesela (ANC) said they should not separate traditional and modern medicines because before they are formulated they are ingredients, hence they are the same. If products can be found on the shelf then it means they have been formulated and regulated, but if a product has been placed on the market illegally it is not the Committees or SAHPRA's responsibility because they are only responsible for regulations.
Dr Brom replied saying once you process a plant into a drug it becomes a different kind of medicine, hence the differences between the two need to be communicated and stipulated in the Bill.
Ms Maseko said SAHPRA’s research on traditional medicine needs to be appropriate, especially in terms of the methodology. The Alliance wants the Committee to consider the fact that there are two paradigms of medicine, and they were never consulted about the Bill, knowing very well that certain parts of the Bill may affect them.
Mr Rees withdrew the Hon. Ambrosini quote. There was no communication between the Committee, department and the Traditional Healers stakeholders regarding the inclusion of traditional medicine in SAHPRA.
The Acting Chairperson said they had invited all members of the public to make submissions to the Committee regarding the Bill and it is unfortunate that they did not get the opportunity to do so. He thanked the members for their inputs and putting their trust in him as the Acting Chairperson.
The meeting was adjourned.
James, Dr WG
James, Ms LV
Maesela, Dr P
Mahlalela, Mr AF
Mosala, Mr I
Ndaba, Ms CN
Scheepers Ms MA
Volmink, Mr HC
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