Medicines & Related Substances Amendment Bill [B6-2014]: public hearings day 1

Meeting report

The Chairperson welcomed Members and the participants of the meeting. She suggested that the meeting should start straight away as there were a lot of presentations.

Briefing by Roche Diagnostic (RD)
Mr Sello Malete, Roche Diagnostic Head of Department for Compliance and Quality Assurance, explained Roche Diagnostic as the leader in in vitro diagnostics (IVDs) and a pioneer in diabetes management, they are an importer and exporter of IVDs where their business is in the marketing, sales, installation, servicing and supply chain of IVD products. They are a member of the South African Laboratory Diagnostic Association (SALDA) and an associate member of the South African Medical Device Industry Association (SAMED). The diagnostic value chain is an integral part of treatment decision-making; they offer diagnostic tests along the entire healthcare chain - doting the screening, diagnosis, prognosis, stratification and monitoring. The definition of IVDs in Act 72 of 2008 aligns with the globally accepted definition and it must be noted that it includes reagents, calibrators, control materials, specimen receptacles, software and related instruments or other articles. He gave an example of IVD medical devices; self-testing blood glucose meters and pregnancy tests, he also made a list of pictures depicting the difference between IVD test devices, medical devices and medicines. He said the South African Health Products Regulatory Authority (SAHPRA) must be secured through the Bill by ensuring there are multiply products - the Bill must ensure that the system can handle a multiple of products that is appropriate for each type of products. The staff must be able to know the difference between IVDs and medical devices, and recommends separate points for entry for an efficient process. They also recommend at least two Registrars within SAHPRA, a clear classification of products when they arrive at hospitals must be done and unnecessary duplication should be avoided.

The proposed regulatory pathway for IVDs should include assessments by, either, the manufacturer or by another acceptable regulator, there should be a declaration of conformity Therapeutic Goods Administration (TGA) must first license sponsors to ensure they can meet the regulatory obligations and the TGA must process their application through the Australian Register of Therapeutic Goods (ARTG). He explains that there is an overlap of products in the Bill; it makes provision for the inclusion of definitions for Foodstuff, Cosmetics, and Disinfections that were a cause for concern. All such products will now fall under SAHPRA which could substantially increase its workload and exacerbate existing backlogs in regulatory approvals. Scheduled substances must be removed from clause 6, 10 and 13 insofar as it pertains to IVDs and Medical Devices; also remove where appropriate in section 35 of the regulations, the presence of a scheduled substance in or on an IVD or medical device does not fulfil any therapeutic role, therefore the inclusion adds an unnecessary burden on users. Medical devices and IVDs are not "scheduled" nor "prescribed" and do not get classified into pharmacological classes such as in the case of medicines. The laboratory IVD supply chain flows from the manufacturer, the laboratory, the doctor then to the end user (patient) - the Bill should ensure the efficiency of SAHPRA, it must recognise registrations in reputable authorities and sunset or grandfathering clauses. They support a regulatory system that allows for efficient regulation of medical devices and IVDs - separate entry points, separate Registrars because they are different. The supply chain of medical devices and IVDs are different from those of medicines, therefore, changes in sections 22C and 22H must be made. 

Discussion
Mr H Volmink (DA) asked if IVDs required scheduled drugs in the process of making diagnostic tests. In addition, he asked RD to comment on how the registration should be done and if they thought that fast tracking processes will cause strain in the processes.

Dr W James (DA) asked how long it took for medical devices or medicines to be approved.

Mr I Mosala (ANC) asked what changes RD thought should be made to the supply chain process.

Dr P Maesela (ANC) asked if it was possible for the IVDs to be made in South Africa (SA) instead of buying them from overseas companies.

The Chairperson said the RD report suggests training and skills development for regulating the medical devices and medicines. Did SA have skilled people to do the training?

Mr Malete replied saying SA has a lack of skills and they have given the Committee a report detailing how to assess what skills SA will need to be able to regulate the devices and medicines - the lack of skills in SA has also been the reason why they are not able to make diagnostic devices in SA. IVDs are not regulated, but Roche does have a medical arm that regulates all their devices. The Medical Control Council (MCC) regulates medicine but devices were not regulated but their industry approval is based on medicine regulations; they support the regulation of devices for the safety of patients. Changes in sections 22C and 22H must be made because medical devices and IVDs are not the same, scheduled substances must be removed from clause 6, 10 and 13 insofar as it pertains to IVDs and Medical Devices; also remove where appropriate in section 35 of the regulations. Section 2A should have the following changes; subsection (1)(a) refers to efficacy, medical devices are not "officious" in regulatory lingua, but rather "perform as intended", this phrase should be included to page four, line five. Subsection 1(b) refers to "transparency" and "timeous", in order to truly secure and ensure this it is proposed they change it to "in terms of timelines and procedures published in regulations". Subsection 1(c) refers to "re-assessment" - this is not a known concept in regulatory practice. It would introduce significant regulatory uncertainty. Section 2A to 21; clause 3; section 3 and clause 4 should ensure that the unique characteristics of various types of products can effectively be regulated through functional separation. The inclusion of complementary medicines into the allopathic medicines framework has not worked. Apart from ensuring requisite technical skills and understanding, functional separation also ensures that challenges in one types of products, example; medicines registration backlogs will not delay medical devices or IVDs.

Briefing by Roy Jobson
Dr Roy Jobson, a Clinical Pharmacologist, said he will cover issues pertaining to advertising, marketing code of practice, medical claim, health supplement, medicine and definitions in the Bill. There are 155 000 complementary medicines on the market that have not been assessed by the MCC for quality, safety and efficacy. The definition of the Advertising Standards Authority (ASA) should be changed because there is a precedent for reference to the ASA in the Electronic Communications Act, 2005 (Act 36 of 2005). The Medicines and Related Substances Amendment Bill does not include a definition of the ASA. The MCC approves the ASA's Code of Advertising Practice. The Act needed to be clear "biosimilar" medicines are not the same as "generic" medicines. The definition in section 1 of the Amendment Bill is ambiguous in paragraph c; the "DNA" could refer to many things such as "recombinant DNA" or "ribosomal DNA". He recommended that this part be deleted as it adds no value to the meaning of "biotechnology-derived medicines". The definition of "complementary medicine" should be consistent with the definition of a medicine in the Act; the definition of a medicine in the "use" based and not ingredient-based. The word "cosmeceutical" should be given the following definition "cosmeceutical means a cosmetic that is used as a medicine" because manufacturers and sellers of foodstuffs that have a medicinal use have renamed some of the products as nutraceuticals. They need to be specified in the Act and regulated as medicines in order to avoid confusion. The Amendment has to be made to affirm that though the intention is to establish SAHPRA outside of the public service, it should still be within the public administration. It will provide for reduction of duplication of effort through recognising work done by other regulators and vice versa by including an enabling clause in the statute.

Discussion
Mr Maesela asked if he believes that all medicines should be regulated before being advertised.

Dr Jobson replied saying products should not be sold without regulation, medicines that are harmful should be removed but it looks like SA has not done anything about this issue. Regulators usually wait for someone to complain before they can take action.

Briefing by Johnson & Johnson
Kirti Narsai, Johnson & Johnson’s Director of Government Affairs and Policy, said there should be Recognition Agreements with Stringent Regulatory Authorities in order to ensure resource optimisation and availability of key therapies to patients, it is important that the new authority is mandated to enter into co-operation, as a key efficiency measure. Currently the Bill make this optional, as per section 2B(2)(a)-(b) and although the introduction of the concept is welcomed, this should not be discretionary power but rather a matter of normal operations to ensure the sustainability of the authority. It is suggested the regulatory framework must; (1) create the scope of the adoption of internationally-aligned medical device regulatory principles (b) recognise work done, in alignment with the device principles, by CAB in SA and elsewhere. Based on the proposed scope of SAHPRA, various types and levels of technical skills will be required to ensure that SAHPRA is able to fulfil its mandate and duties. Therefore, the proposal to to establish a regulatory institute is welcomed since it is critical to the success and sustainability of SAHPRA. It was, however, recommended that requirements for the institute be included in the Bill so as to ensure technical capacity building of various types of regulatory staff necessary for the operations and sustainability of SAHPRA. Lengthy registration timelines have historically been a challenge for both the industry as well as the MCC. The proposed broadened scope to include medical devices and IVDs could potentially exacerbate this situation. This was once again noted in the Parliamentary presentation by the Department which estimates the current backlog for medicines registration at approximately 2900 applications.

Provision must be made for (a) abbreviated reviews, (b) expedited reviews, and (c) listing for products that do not pose significant risks and are of a low risk in class in the case of medical devices and IVDs - such systems also exist in other jurisdictions for complementary medicines and low-risk medical devices. It is important that there is recognition for the fundamentally different regulatory pathways for different product categories and appropriate criteria  and process should to be applied when regulating these products. A clear transition plan of action for the current MCC to address legacy issues, such as the existing registration backlog and inclusion of other product categories into the same regulatory system, is necessary. Without this, the success of SAHPRA hangs in the balance.

Discussion
Mr Volmink asked if it was possible to include medical and IVDs in the regulations, since the Act would contain the principles.

Mr Mosala said they should have included their proposed amendments in the presentation as well because their intentions are not coming out clearly.

Mr N Matiase (EFF) said he disagreed with Mr Mosala because their presentation did in fact give them direction, it also proposed functions for the Department. It had identified internal areas which related to evaluating and ensuring efficacy.  

Mr Maesela said they had represented themselves as global leaders in health but is not sure if this is a statement or a fact. Are they a local or a global company?

Ms Narsai replied saying they do support the regulation of products for the patient’s safety and health. She suggests that the Bill must outline the principles of appropriately for regulation of the various product categories and mentioned that the original Act was intended to only regulate medicines and not medical devices as well, when it broadens its scope, including medical devices and IVDS, it will have to take into consideration the different types of regulatory pathways required. The regulatory timelines have been a challenge; they have to deal with the appropriateness of the review of products. They see themselves as a broad-based healthcare company with experience in many countries and fee that they are able to assist based on their regulatory experiences in different countries. They are happy to share their expertise with the regulatory authority. They want to contribute to the broader public interest and not only think about the interest of their company, they want to contribute to the success of the new regulatory authority.

Briefing by Self Medication Manufacturers Association of South Africa (SMASA)
Dr Deepa Maharaj, SMASA Vice Chairperson said the Bill should create structures within SAHPRA that were appropriate for each product, ensure adequate and fair representation of all products within SAHPRA board, committees and technical structures. A registration flow and criteria appropriate to the type of product should also be created. The Department published various sets of draft and final regulations; Draft Regulations Relating to the Labelling and Advertising of Foods, Draft Medicines and Related Substances Act and Complementary medicines regulations incorporated into the existing allopathic medicines regulations, with Draft Medicines and Related Substances Act. In addition, the MCC has published two guidelines applicable to medical devices to be up for comment by December 2014. The implications of the aforementioned is that secondary Legislation and Guidelines are being proposed, and have to be commented on, without the overarching empowering frameworks, which include not only Medicines Act, but also the Foodstuffs, Cosmetics and Disinfectants Act 72 of 1954, as well as the Hazardous Substances Act 15 of 1973, being aligned.

Clause 2B (3) clearly attempted to remove products from the regulatory scope of the Foodstuffs and also the Hazardous Substances Act, without proposing and amendments to such laws. Bill 6 will have to be addressed together with the other empowering laws as its scope now overlaps with that of Foodstuffs, Cosmetics and Disinfectant Act 54 of 1972 and the Hazardous Act, without any clear delineation as to when a product would follow which regulatory route. The inclusion of "scheduled substance" in this definition can create confusion in industry as these substances can be incorporated into IVD reagents as well as cosmetics. If a product contains a scheduled substance it does not necessarily mean that it needs to be registered. Clarity is required as to the difference between a medicine containing a scheduled substance and a scheduled substance and the reasoning behind the inclusion of scheduled substances in this definition. It should also be noted that the definition of a complementary medicine in clause 1(d) should be changed to accommodate the new proposed definition as published on 15 September 2014. The Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972 refer to the definition of a foodstuff. There is however a gap in terms of food supplements. Since foodstuffs may fall under the ambit if SAHPRA, we recommend, in addition to the definition of a foodstuff, a definition of food supplement is included in the Act. They recommend that the definition for food supplements would read as follows "food supplement' means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms or liquids and powders designed to be taken in measured small unit quantities".

SMASA sought clarity on what it means if an entity is "within the public administration" but outside of the "public service". Section 197 of the Constitution of the Republic of SA stated that there was, "within public administration" a "public service". This statement had far-reaching implications for holding staff of SAHPRA accountable under Public Service legislation. SMASA welcomes and supports and enhanced regulatory framework and urges the National Department of Health to consider existing frameworks, such as Canada's approach to the regulation of Natural Health Products use of monographs. They are happy to partner with the Department to ensure legal framework that is appropriate, and efficiently functioning.

Discussion
The Chairperson asked why SMASA have made examples of international countries who had successfully implemented their regulatory procedures. Examples from the African continent should have been included in the report.

Mr Matiase asked why SMASA had depicted the Department or the Bill as an octopus.

Dr Maharaj replied saying many of the successful implementations of regulatory bodies has been in either Europe or the Unites States, African countries have not yet entirely got it right when it comes to skills and resources. The octopus was used to depict the Bills complexity - it has covered every health area but it has not been done the correct way. They should think about regrouping some sections in the Bill, ot completely delete some.

Briefing by South African Medical Device Industry Association (SAMED)
Ms Anele Vutha, a member of the South African Medical Device Industry Association (SAMED) proposed for the removal of medical devices and IVDs under clauses that previously only pertained for medicines, which will cause practical problems and unintended consequences for supply. Medical devices registered via other local regulatory bodies under legislation are not accommodated. Absent from the transitional measures is the alignment of other legislation with the envisaged new dispensation. Criteria for evaluation and medical devices and IVDs remain aligned with medicines. The important differences relating to labelling, use of scheduling, supply chain differences and data requirements for medical devices have not been taken into account. All pricing, tenders, procurement and essential lists will now have to fall under registration legislation. Scheduled substances should not be subjected to registration as scheduled substances are not sold, only medicines and medical devices are. This would drag the registration of medical devices that contain scheduled substances into inappropriate registration requirements. There is no rationale for its registration and inclusion in a number of proposed sections, as it is not sold or used on patients and only forms part of products. Time frames provided for companies to obtain required establishment licences and registration must take into account the need for some companies to obtain quality management systems and the vast volumes and variants of medical devices. The legislation should ensure the independence of SAHPRA as an organisation, with control only over the budget and service delivery so as to prevent a backlog of submissions, evaluations and final registration once registration of medical devices and IVDs commences. A Chief Executive Officer will replace the Registrar, therefore, it must be submitted that there would still be a need for Registrars who were technically conversant on the various subject-matters whilst the CEO should take general operational responsibility.

The inclusion of foodstuffs, cosmetics and disinfectants into the ambit of the Act is problematic and would exacerbate the current backlogs experienced in the MCC. It is also not possible to amend the regulatory scope and powers in the Foodstuffs, Cosmetics and Disinfectants Act, by reference to it in the Medicines Act. SAMED strongly recommended that grandfathering and sun-setting clauses for products already on the market when the Bill comes into effect and the MCC and SAHPRAH should present a transitional plan to Parliament for scrutiny before the Bill is finalised. This will allow Parliament to assess whether there are any legislation gaps and aspects that have not been considered, and which should be in the legislation. 

Discussion
Mr Mosala said the report should have been presented to the Department and not the Committee. He would have liked them to include the consequences of not making the changes they are proposing.

Mr Volmink said it seems that medical devices are broad and what do they consider as being devices and medicines.

Mr Maesele said they should have included their proposed amendments and they have no evidence that the Department has not been working.

Ms Vutha replied saying they propose for the fast regulation of medicines and a broadened scope to include medical devices and IVDs. They also made provisions of the abbreviated reviews and how MCC should address legal issues. 

Briefing by Traditional and Natural Health Alliance (TNHA)
Dr Bernard Brom, Dr Anthony Rees, Phephsile Maseko and Adv Robin Standsham-Form all presented as each one had a separate section in the presentation.

Dr Brom said SA has chosen, in the way it has formed its Constitution, to be an example to the rest of the world of fairness, allowing each person the right of choice and freedom in all spheres, including religions, social and economic spheres. But in medicine this choice is being taken away. As in religion, the practice of medicine and healing is not uniform. There were a number of different models or paradigms. The conventional Biomedical is only one model, but this model has assumed a power unprecedented in the short time it has been in existence. This despite the fact that ill-health has continued to increase: heart disease which was almost unknown 100 years ago is now the most common cause of ill-health and death; diabetes has become as serious today as the plague was in the middle ages, with predictions that one in two adults in the United States will be affected in the year 2020. The cost of medical treatment is bankrupting nations, and ill-health due to drugs, medical investigations and treatments is now the 3 to 4th most common cause of ill-health and death. Despite all this, the Biomedical model continues to dominate all regulatory and administration processes regarding anything which could be called a medicine.

On the 15 November 2014, the Department sidestepped this Parliament and the democratic process by unilaterally gazetting General Regulations for "Complementary Medicines" in Regulatory Notice R 870, in terms of section 35 of the Medicines and Related Substances Act, said Dr Rees. These regulations were without any enabling definition or a pre-definition category in the principal Act. There was little or no broad-based stakeholder consulting the MCC and Minister promulgating the said regulations. Instead, there were selected invitations extended to pre regulatory interest groups. The TNHA believes that the inclusion of section 1(d) of the Bill is a desperate attempt to patch up this fundamental procedural flaw in the gazetting of Regulatory Notice R870 for "Complementary Medicines", which in their opinion should have never been gazetted without the exercise of the MCC and Ministers' constitutional and administrative justice obligations to consult with all affected stakeholders, and create an appropriate regulatory system for complementary medicines and African Traditional Medicines in an equitable, non-discriminatory and transparent manner.

Ms Maseko said TNHA had 72 000 direct membership and contributes R3 billion to the Gross Domestic Product (GDP) of SA, it employs 133 000 people and the majority of them being rural women. It has four categories of Traditional Healers Organisation - namely; diviners (isangoma), herbalists (ochaya), traditional birth attendants (babelethis) and traditional surgeons (iingcibi) as determined by the Traditional Healers Practitioners (THP) Act of 2007. Their constituency comprises about 27 million sovereign souls to whom it is their duty to minister from time immemorial.

Adv Standsham-Form said the definition of medicine includes pharmaceuticals, biologicals, complementaries, traditionalists, medical devices, procedures - even food and cosmetics, and is over-broad as it relegates us to an Alice-in-Wonderland-world where "words mean what I say they mean" without referring to healing. The entire Act needs to be rewritten taking into account different paradigms, appointments to the SAHPRA Board must reflect the wide constituency of traditional, including African traditional practitioners, and integrative doctors on a representative basis. It is proposed by the TNHA that the entire Medicines Act should be rewritten to take into account the rights of all traditional doctors, and their constituency, and the new Act should take them right into the core of the Act.

Discussion
Mr Volmink said the TNHA presentation sounded like they were looking into going to war with the Department over the Bill. This should be the time for all stakeholders to stand together, but it seemed like they were ready to take the Department to court.

Mr Mosala said TNHA did not indicate which parts of the Bill hinders their work, or did not allow them to do their work. They cannot suggest the Bill be rewritten. TNHA should rather make amendments to the parts they were not happy with.

Mr Matiase said TNHA should not forget that the Committee was clueless about traditional medicines and they should, therefore, give them alternatives to the Bill.

Dr Rees replied saying TNHA felt like they were being ignored by the Department and the reason why they did not add amendments to the Bill is because they know it will not be taken seriously, like it had been before.

Ms Maseko asked the Committee if it was possible for TNHA to go back and make amendments and present to the Committee again.

The Chairperson replied that it was not possible at the moment but the Committee had run out of time for the hearings.

The meeting was adjourned.