Medicines & Related Substances Amendment Bill [B6-2014]: public hearings day 2
31 October 2014
Chairperson: Ms M Dunjwa (ANC)
The Portfolio Committee met to continue its public hearings on the Medicines and Related Substances Amendment Bill.
The Pharmaceutical Society of South Africa (PSSA) said they understood and supported the Bill but they had some concerns. PSSA supported the replacement of "products" with "medicines" when it was appropriate. Section 6 (Medicines Act) should be amended to make provision for products (medicines, schedules substances and medical devices) to be registered. The re-introduction of "practitioners" was welcomed but PSSA felt that veterinarians should also be included in this section because they too, issued out medicine to patients. The Director General, under the Act, had been given authority to issue exports permits for products but this was already done by SAHPRA. This had the potential to cause conflict since there were two entities which provided the same service. If this will be kept the way it was, then the Bill should make provision for such a function so that it was clear.
During the discussion which followed the presentation, the Committee felt the presentation gave good direction. Did PSSA work with generic products? Members asked for clarity on what "community retailers" meant and what new aspects should be changed. The aspects that needed attention were the technical areas and this would help to deal with the daily activities.
The Pricing Committee requested for a transparent pricing system as defined as "the only price at which manufacturers shall sell medicines and schedules substances to any person other than the state", they deal with issues pertaining to the sales of products and pricing of medicines in the private sector. They proposed changes to section 36 (2) and from section 18A and 22G and will also recommend these changes to the Minister. The word "product" also needed to be removed, replaced, with "medicine and schedules substances" and required access to an inspection that would enforce pricing regulations, as well as an Appeals Committee.
Committee Members was asked what the appeals committee's function would be. The Pricing Committee replied saying the appeals committee would look at issues of safety, efficacy on medicine and the quality of medicine.
The Allied Health Professionals Council to the South Africa (AHPCSA) is a statutory health body that controlled all allied health professionals. AHPCSA was concerned that the SAHPRA board did not have someone who had knowledge of complementary medicines they deal with and his could affect the practices of practitioners registered with AHPCSA. The definition of complementary medicines in the Bill was inadequate because it excluded large numbers of complementary medicines from being registered due to source as mentioned in section (a). There was no mention of the treatment of diseases, therefore they requested the word "supplementary" be removed from section 22C (2).
The Committee asked if AHPCSA had the same principles as the TNHA and why the word "supplementary" should be removed. AHPCSA replied that it was not affiliated with TNHA but are aware of the alliance, and the removal of "supplementary" would make it easier for students to be registered as practitioners as it is expected that they study courses relating to complementary medicines which they have already done in their undergraduate and SA did not have courses in these fields.
The Pharmaceuticals made in South Africa (Pharmisa) represented over 307 of the total SA pharma market and over 507 in volume. Pharmisa registered approved medicines and the concerning issues in the Bill are the backlogs, timelines of pathways, accountability and transformation. The registration does not provide information to how long the process would take, attracting skills is important to ensure SAHPRAH meets its mandate and local products should be granted first priority when it comes to registration. They proposed a third party of evaluators for preview processes, a funding model to attract employees, regulations should contain clear statements and there should be an enabling relationship between the regulator and the regulated to give stability and certainty to the regulated. Approval delays should be communicated to the regulated with clear indications as to why there is a delay.
Committee Members said the report would be relevant once the board had been set up. Pharmisa made it clear that before the regulating organisation can be effective; the board had to be effective first, hence they had concentrated more on the technical side.
Innovative Pharmaceutical Association South Africa (IPASA) supports the basic principles of Act 72 and Bill 6 and the establishment of SAHPRA. Accountability should consist of organs like SAHPRA reporting to Parliament on performance and oversight, the roles and responsibilities of the board need to be defined. The systems and processes need to be improved to allow SAHPRA to be efficient; the implementation of a risk based assessment, quality screening of all submissions and rejection of inferior submissions and a separation of product reviews to benefit from specialized skills. The introductory paragraph must be deleted as it is not an integrated preface containing the purpose of Act 101, Act 72 and the Amendment Bill 6. Complementary medicine's definition must be aligned with the finalised Complementary Medicines guideline. The roles and responsibilities of the members and committee of the board, meeting frequencies, committee structures and functions must be clarified in the Regulations to the Act. Section 2A should be rewritten, they also proposes for the deletion of subsection (b) as it contradicts the provisions of subsection (a) in terms of timelines for submission and timelines for the application of subsection 1.
The Committee said the presentation lacked detail and Members doubted if there was still enough time to review the Bill, as IPASA had recommended.
The Medicines Sans Frontiers (MSF) said public health should be the cornerstone of the Act; it should increase access to treatments to save lives for in ways of fast tracking of new treatments of public health significance, harmonising of information with other Stringent Regulatory Authorities (SRA), open and transparent applications with agreed timelines and explicit provision for affordability as section 21 criteria. Section 15 (2) (b) requires timelines that are explicit with information about timelines for those that do not comply. Section 2B (2) (a) requires SRA findings that can be used to speed up the registration process. Section 22 needs a formal provision of dates of when regulations are done, their expected prices and current status of application.
The Committee asked how MFS would rank South Africa's interest of public health and detrimental health impact and why the linezolid drug had not been registered. Why was it possible for the drug to be effective in one part of the country and not in another?
Briefing by Pharmaceutical Society of South Africa (PSSA)
Ms Lorraine Osman of the Pharmaceutical Society of South Africa (PSSA) said they understood the Bill and supported its intention as it is critical that progress should be made in finalising the structure and operation of the South African Health products Regulatory Authority, but they had some concerns. The support the replacement of the word "products" with "medicine" and the expression "scheduled substances: when it is appropriate to use both. There is, however consistent application of this intention, as the word "products" remains unchanged in a number of sections of Act 72 of 2008. Section 6 proposes that section 13(1) of the Medicines Act should be amended to require registers for medicines, schedules substances, medical devices and IVDs. It would be appropriate to use only "medicines" in this section, as including a register of "schedules substances". They support the re-introduction of practitioners into this section; however, it is noted that veterinarians are not included and regulated in the same way as all the other health professionals who sell and dispense medicines and schedules substances. Act 101 of 1995 provides for the control of medicines intended for both human and animal use, and it is therefore proposed that veterinarians should be included in the section. Section 22A of the principle Act provides for the Director General to issue similar exports permits for products mentioned in section 15(a) and subsection (1) (b). The Act would therefore provide for two different legal entities to have similar function, which could be a potential source of conflict. The words "schedule 1 and higher" should be inserted before the word "medicine" in section 15(a) Certain distributors such as Makro and Cash and Carry, who carry schedule 0 only medicines will be obliged to fully comply with all the requirements for a wholesaler who sells the full spectrum of medicines and schedules substances. They will also need to be registered with the South African Pharmacy Council. Section 15 (a) of the Bill provides for the substitution of section 22c, authorising the Authority in sub-section (1) (b) to issue inter alia a permit to import or export the listed products.
Mr I Mosala (ANC) was impressed with the presentation as it gives direction to what needs to be changed. He asked if veterinarians should be included in the Act too.
Mr N Matiase (EFF) asked if PSSA had people who work with generic products.
The Chairperson asked if "community retailers" refers to chemists and how do they plan on controlling the spaza shops who buy medicines from wholesalers to sell.
Ms Osman replied saying that veterinarians should in fact be included because they also give medication to patients and doctors must be included in the formation of the Bill to ensure their medicines are still valid. All schedules substances should be included in the Bill and there should be a register for such; their intention is not to stop the rotation of generic medicine. Indeed, "community retailers" does refer to chemists; the names may have changed over the years but she still refers to them as that.
Ms C Ndaba (ANC) asked what aspects PSSA was referring to under the slide "the way forward".
Ms Osman replied saying many of the aspects are technical but they need the regulatory authority to be involved. It will help them deal with day-to-day activities and scrutinise procedures.
Ms Ndaba further asked whether it was better to change the Bill or make the regulatory authority function better.
Ms Osman replied saying one needs to constantly review Acts because they will not always be perfect, there needs to be an on-going evaluation of the Act although regulators are a lot easier to change. Medicines are always changing every day, this also gives reason as to why regulations are needed.
Briefing by Pricing Committee
Ms Fatima Suleman of The Pricing Committee said the Committee consists of members from all professionals; Finance, Pharmacists, Law, Consumers and Academics. They propose for the transparent pricing of medicines for the ability to track prices from manufacturer to patient. The transparent pricing system was based on "a single exit price" defined as "the only price at which manufacturers shall sell medicines and schedules substances to any person other than the state". In 2014 alone they managed to save R2.06 billion on medicine expenditure. The pricing Committee is provided for in the Act and deals with the issue of sales and pricing of medicines in the private sector; section 18A - bonusing, sampling and other perverse incentives, section 22G - pricing regulations such as single exit price, dispensing fee and pharmaco-economic guidelines. The proposed for changes in section 36(2) notwithstanding subsection (1), the exclusion or exemption of any (product) medicine or schedules substance from the operation of sections 18A and 22G shall be on the recommendation of the pricing Committee to the Minister. The word "product" in the Bill, section 18A, needs to be replaced with "medicines and schedules substances" and the end of (2) needs to have "in consultation with the pricing Committee" added to it once the Act is promulgated. The pricing Committee required access to an Inspectorate to enforce regulations as well as a dedicated Appeal Committee process.
Dr P Maesela (ANC) said all the presenters mentioned how worried they were about the delays of the medicines but they do not understand that delays are caused by regulations. The medicines have to be checked for efficacy.
Ms Ndaba asked what the advantage of having an Appeal Committee was.
Ms Suleman replied saying the Committee will look at safety, efficacy of medicine; whether the medication is in good quality. It will also look at whether pharmaceuticals were complying with the Bill or not. It will, especially, look at prices of medicine and if the prices are within the legislation.
Mr Matiase asked who the Pricing Committee was accountable to.
Ms Suleman replied saying they are a ministerial appointment and are chosen from all professionals and are an independent firm who make recommendations to the Minister, therefore, they are accountable to the Minister.
Briefing by the Allied Health Professionals Council to the South Africa (AHPCSA)
Mr Graig Wright of AHPCSA said the Allied Health Professionals Council to the South Africa is a statutory health body that was established in terms of the Allied Health Professions Act, 63 of 1982 in order to control all allied health professionals. They were concerned that there is no representation on the proposed composition of the SAHPRA board for a complementary medicine expert and the decisions of the SAHPRA board will affect both the practices of practitioners registered with the AHPCSA and the complementary medicines products industry. It is imperative that a person with expert knowledge of complementary medicine be appointed to the SAHPRA board, this will ensure that any matters considered by the board are considered appropriate against an expert contribution as SAHPRA board level. They note that the principle Act already provides for "practitioner" and the proposed amendment is therefore unnecessary, it remains their policy as communicated to the Department that is it important that they register diagnostic practitioners who either dispense, or compound and dispense, complementary medicines be required to hod such a licence. The definition of a complementary medicine in the Bill inadequate since it would exclude large numbers of complementary medicines from being registered; it would exclude certain complementary medicines from registration due to source, this is mentioned in section (a). It makes no mention of the treatment of diseases and it does not allow for products related to other disciplines other than those regulated by AHPCSA and the registration of health products that are linked to other disciplines. It is understood that the addition of the word "supplementary" was intended to provide regulation for those persons for whom education and training in dispensing, or compounding and dispensing, did not exist in primary medical qualifications. They requested the word "supplementary" be removed from section 22C (2), or clarification added for "practitioners" as defined.
Mr Mosala asked if traditional healers were also within the allied council because they have similar appeals and also wish to be part of the board.
Ms Ndaba said it looked like the presenters want to be part of the SAHPRA board and wonders how many people the board will have since there had been so many requests.
Mr Wright replied saying they had no affiliation with the Traditional and Natural Health Alliance (TNHA) but they do register practitioners who are trained in traditional medicines from Asia. Unlike them, the TNHA is financed by Parliament, therefore they cannot comment on the alliance.
Dr W James (DA) asked why they requested the removal of the word "supplementary" from the Bill.
Mr Wright replied saying students struggle to find an academic course that will teach them supplementary subjects because South Africa does not have an institution that has those programmes.
The Chairperson asked if it would be a good idea to have an institution that had supplementary courses.
Mr Wright replied saying it is not necessary because they already have a supplementary course in their undergraduate, it does not make sense for a student to repeat it again, whether it is compound or dispense courses.
Briefing by Pharmaceuticals made in South Africa (Pharmisa)
The presentation by Pharmaceuticals made in South Africa (Pharmisa), done by Ms Gina Partridge and Mr Stavros Nicolaou, outlined that Pharmisa was one of four South African Pharma Trade Associations. It represented over 30% of the total SA pharma market in value and over 50% in volume and are the largest exporter of medicines. Their mandate is to register and approve medicine, monitor and evaluate for public safety and protection. The key issues in SA are radical economic transformation, job creation, scrutiny of medicine supply, investor and international community perceptions of SA are important. The key issues in the Bill are the backlogs, timelines of pathways, accountability and transformation; the registration does not give account to how long the process will take and when it will be done. The retention of skilled employees is very important and they proposed that a remuneration package to part of the Bill for the attraction of skills and talent. Local products should be granted registration priority to attract investments and be consistent with re-industrialisation objectives.
Ms Partridge proposed that there should be a third party of evaluators who will be responsible of the pre-review process, and there should be a funding model to attract scarce skills. All regulations should contain a clear statement of purpose, expressed in clear and plain language, to guarantee the understanding of the regulations and aid effective compliance. The relationship between the regulator and the regulated should be enabling as well and regulation should be predictable in order to give stability and certainty to the regulated. Reasons should be provided to the regulated party when the specified timeline cannot be achieved. Where regulatory approval for an activity is required from more than one regulator, where possible, provision should be made for regulatory processes to proceed in parallel in both time and process, so that a reasonable turnaround time can be maintained for the effective approval of the activity.
Mr Matiase said the presentation would be relevant once the board has been set up because it proposals are for the functions of the board than anything else. He also asked what medicine they were exporting.
Ms Ndaba asked what other ways of motivation would they propose other than money because some will not be motivated by money.
Mr Mosala agreed with Mr Matiase saying the presentation was focused on the structure and not the processes.
Ms Partridge replied saying the board has to be effective before all the other components of the authority are; there has to be co-ordination amongst the board members as they will give direction.
Briefing by the Innovative Pharmaceutical Association South Africa (IPASA)
Ms Abeda Williams of Innovative Pharmaceutical Association South Africa (IPASA) made the presentation. IPASA supported the basic principles of Act 72 and Bill 6 and the establishment of SAHPRA. Accountability, as mentioned in section 2 (b) and (c) and 2A to I, should consist of organs like SAHPRA reporting to Parliament on performance and oversight, the roles and responsibilities of the board need to be defined, for example, who will be responsible for the technical or advisory oversight of committee. The systems and processes need to be improved to allow SAHPRA to be efficient, they also need to be reviewed and changed in the following ways; the implementation of a risk based assessment, quality screening of all submissions and rejection of inferior submissions and a separation of product reviews to benefit from specialized skills. The introductory paragraph must be deleted as it is not an integrated preface containing the purpose of Act 101, Act 72 and the Amendment Bill 6. The definition of "complementary medicine" must align with the finalised Complementary Medicines guideline, therefor, the definition contained in the Act must be deleted as it is not finalised with the Complementary Medicines guideline. The roles and responsibilities of the members and committee of the board, meeting frequencies, committee structures and functions must be clarified in the Regulations to the Act. It is not clear whether this term relates to administration committees or to technical committees. It is recommended that section 2A should be written as follows "The objectives of the authority are to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, schedules substances, clinical trials, and medical devices and IVDs and related matters in the public interest". IPASA also proposes for the deletion of subsection (b) as it contradicts the provisions of subsection (a) in terms of timelines for submission and timelines for the application of subsection 1. An overview of legislation is needed to avoid any conflicts to allow structures to execute duties with an appropriate legal framework.
Mr H Volmink (DA) said the presentation was good but it lacked detail, he could not clearly understand what they were unhappy about.
Ms Ndaba, referring to page ten of the presentation, asked the Department still had time have an overview of the legislation.
Ms Williams replied saying there was indeed still time to have an overview because it is still an Act.
Briefing by Doctors without borders (MSF) South Africa
The Medicines Sans Frontiers (MSF) projects started in South Africa in 1999 and it was largely in response to the HIV epidemic. Today the projects include HIV/TB projects in Khayelitsha and treatment as prevention projects in KwaZulu Natal. Public health should be the cornerstone of the Act; it should increase access to treatments to save lives for in ways of fast tracking of new treatments of public health significance, harmonising of information with other Stringent Regulatory Authorities (SRA), open and transparent applications with agreed timelines and explicit provision for affordability as section 21 criteria. Section 15 (2)(b) amendments require specific timelines with explicit penalties of authorities for non-compliance. Section 2B (2)(a) requires formal mechanism where other SRA findings can be utilised in order to speed up registration. Section 22 which speaks of open and transparent needs a formal provision to require the authority to make public the date of application submission, name of medicine in question, expected price and current status of application, section 21's amendment requires an extension of provision to formally allow the Department and medical NGO's to obtain section 21 exemption on the grounds of affordability restricting access to life saving treatments.
Mr Volmink asked what criteria would they rank the interest of public health and detrimental public health impact in South Africa and asked them to elaborate what the Brazil Model would operate in SA if it had to be implemented.
Ms Ndaba asked why the linezolid generic was not registered.
Mr Andrew Mews replied saying with respects to priorities one would look to a mixture of factors; the burden of disease, the abilities and benefits, the effectiveness of the disease and the current options.
Dr Amir Shroufi replied saying It is very important that one looks at the health legislation and the needs of today; the reality is that HIV and Tuberculosis is still an emergency and are such high burden diseases.
Mr Mews said they had brought brochures with them that would give the Committee more detail about the Brazil model and they are happy to discuss it in more detail. They also have a team in Brazil that would be glad to brief them on the model. They have also been wondering why the linezolid generic drug is not registered, but what they know is that there seems to be a lack of transparency in the Medical Control Council (MCC)
Mr Mosala said how it was possible that the linezolid generic drug was not available in Khayelitsha but it was available in the Northern Cape Province and it was working well for the people who received the drug.
The Chairperson said that MSF did not need to answer the question but rather take note of what the Member said because the drug cannot be available in one place and not be available in another. This was something the Department should definitely look into.
The meeting was adjourned.
- Innovative Pharmaceutical Association South Africa (IPASA) presentation
- Innovative Pharmaceutical Association South Africa (IPASA) submission
- Medicines & Related Substances Amendment Bill [B6-2014]: Pharmaceutical Society of South Africa
- Presentation by the Pricing Committee
- Pharmisa: Presentation to the Portfolio Committee on Health
- Medicines & Related Substances Amendment Bill: Protecting Nation's Health: Doctors without borders SA
- Innovative Pharmaceutical Association South Africa (IPASA) submission
- Guidelines for the examination of pharmaceutical patents: Developing a public health perspective.
- The Allied Health Professionals Council to the South Africa (AHPCSA) presentation
- The Allied Health Professionals Council to the South Africa (AHPCSA) submission
Dunjwa, Ms ML
James, Dr WG
James, Ms LV
Maesela, Dr P
Matiase, Mr NS
Mosala, Mr I
Ndaba, Ms CN
Volmink, Mr HC
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