Health Amendment Bill: public hearings Day 2

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Health

15 March 2012
Chairperson: Mr B Goqwana (ANC)
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Meeting Summary

Public Hearings for the amendment of the Health Act continued. Similar threads ran through the submissions of the Laboratory Medicine Group, IMSA and Path Care. They all advocated for the use of one set of standards, the ISO 15189 which was the international standard that the South African National Accreditation System (SANAS) itself used to accredit its laboratories in SA and across the continent. They lobbied against imposing further standards by the proposed Office of Health Standards and Compliance (OHSC) saying that this was unnecessary as the ISO 15189 standard was an international standard that was rigorous and was known to be the best in the world.

The Laboratory Medicine Group recommended that the amendments should seek to avoid duplication and focus on available resources, eliminate conflict with other legislation, clearly define the objectives and functions of the Office for Health Standards and Compliance (OHSC), define ‘quality management systems’ and ‘quality assurance’, ensure independence, guarantee revenue retention, and support mandatory regulations to accredit all laboratories to ensure accurate results.

IMSA limited their comments to what would affect medicine and medicines supply in health establishments based on existing standards used by the Department of Health to accredited health establishments. IMSA recommended that standards needed to be published for public comment prior to their finalisation; that the proposed Section 79 be amended to address harmonisation with the text IMSA had suggested; for OHSC to establish expert committees for advice on matters where they did not have the necessary in-house capacity.

Pathcare recommended that for laboratory medicine, standards would need to be aligned. Accreditation and enforcement of standards would need to be harmonised between, for example, the system envisaged by the proposed medical device licensing regulation, the control of hazardous substances system, ISO accreditation as well as the licensing system referred to in the Human Resources for Health (HRH) strategy.

HASA was concerned about the lack of a definition for ‘norms and standards’, no definition of the process used to define or arrive at the norms and standards. In terms of the purpose, there was insufficient clarity on what the norms and standards would be used for and this related to the multiplicity of interpretations. HASA recommended defining it in relation to the level and quality required to ensure the health and safety of the users – excluding the cost or tariff of health service offered, excluding the treatment process to be followed and clinical standards and clinical pathways relating to a particular diagnosis. Section 79 needed to be strengthened to cater for this.

BUSA said that the establishment of the OHSC and the Office of the Ombud was widely supported by BUSA  members. BUSA was speaking from the perspective of the consumer. The presenter shared insights about the health system in Mexico where the system was used to promote social cohesion and the Government was asked to look into that in its deliberations going forward. Such a system required the involvement of all stakeholders as they had a lot of value to add. the Bill spoke about the need to protect and promote the health and safety of users of health services. In transforming the health care system, the public, civil society, would need to be involved in co-designing and co-ownership of the health care system. BUSA provided the text for proposed amendments for Section 79A(1) on the appointment of the CEO of the OHSC, Section 81(1) on the appointment of the Ombud and Section 81A about the functions of the Ombud.

n the afternoon, the South African Private Practitioners Forum, the South African Medical Device Industry Association and the Pharmaceutical Industry Association of South Africa concerns were also similar and centred around issues of independence and duplication of norms and standards between the OHSC and the current regulatory bodies. They felt that standards and quality issues should be set by law through expert bodies. PIASA recommended direct accountability of the OHSC to Parliament and real independence for the Ombud to make decisions The role of the proposed Ombud was minimal in that it could only make recommendations and not decisions. The Minister was not obliged to consult nor bound by any recommendations of the OHSC.

Meeting report

Laboratory Medicine Group submission
Dr Bruce Dietrich and Dr Kerrin Begg explained their organisation was a voluntary association, representing all spheres of laboratories and covered the whole spectrum of lab medicine in SA. There were 153 million tests and 30 million patients per year. The labs employed 18 000 people. Lab medicine referred to the tests done to monitor health and 70% of diagnoses were informed by lab tests. In SA, only 2.5% of the budget went to lab medicine. It was important that lab test answers were correct as it led to the correct diagnosis and right decisions. It was important to ensure that these many tests were accurate.

The Lab Medicine Group recommended that the amendments should seek to avoid duplication and focus on available resources, eliminate conflict with other legislation, clearly define the objectives and functions of the Office for Health Standards and Compliance (OHSC), define ‘quality management systems’ and ‘quality assurance’, ensure independence, guarantee revenue retention, and support mandatory regulations to accredit all laboratories to ensure accurate results.

Discussion
Ms D Robinson (DA) asked for clarity on what “guarantee revenue retention’ meant.

Dr Begg explained that in relation to independence and fee retention, organisations declared under Section 3 of the Public Finance Management Act (PFMA), such as the South African National Accreditation System (SANAS), could retain their fees which meant they could be sustainable in their own right.

Ms M Segale-Diswai (ANC) asked for clarity on the statement “to avoid duplication and eliminate conflict with other legislation”. She asked if talking about independence might set a precedent like the SA Medicine Council. She also asked if skills and capacity had been considered in terms of independence.

Dr Begg replied that standards under health compliance had a different way of operation, hence the potential conflict with other pieces of legislation.

Ms B Ngcobo asked where SANAS featured in the Act.

Dr Dietrich replied that SANAS had been set up ten years before by Department of Trade and Industry and they had already developed a system which accredited labs and factories using a specific number of requirements. What they were asking was that if it was accredited by SANAS, then it should be exempted by OHSC.

The Chairperson thanked the presenters saying that their points would be taken into consideration

Mr Mbara responses to questions
Mr Siwaphiwe Mbara returned to the meeting to answer some questions posed to him regarding the submission he presented on 13 March. These questions included how best to apply employment and equity and affirmative action, why powers should be dedicated such as those of the Minister in the appointment of the executive, why he was suggesting privatisation and talking about savings at the same time.

In relation to the issue of affirmative action and equity, Mr Mbara indicated that he suggested not to use them as it was not yet possible to determine when one was no longer disadvantaged. He suggested that the positions of CEO and that of the Ombud were brands and there was a need to be conscious of the reputation of those who occupied them. Privatisation would avoid politicisation of the posts.

Mr Mbara said that in terms of bridging the skills act, most blacks were disadvantaged but less skilled people could not be allowed to hold high positions. He referred to a statement made by the Minister of Health sometime before that graduates needed to come out of university with qualifications and experience. He suggested that the Department of Health needed to develop a programme to plough back graduates into the communities especially those who utilised state funds for their education.

Ms Dube raised a point of order asking the Chairperson if the meeting was there to get a lecture or to focus on the amendments.

The Chairperson pleaded with the members to allow Mr Mbara to utilise the rest of his allocated submission time.

Mr Mbara said that the State needed to develop programmes like the ones in the public sector to ensure graduates go through the employment progression before entering senior positions and that they needed to understand the public sector before they get into the high posts.

Ms Ncobo assured Mr Mbara that the programmes he was talking about already existed where graduates worked in the communities to get experience.

The Chairperson reiterated Mr Mbara’s points that health was a right not a commodity and therefore the people in power governing the country needed to ensure that people who did not have money would have access to good health care and not necessarily leave everything to the private sector. Changing the Act was a way to help all people have access to good health care.

Innovative Medicine
Ms Shakira Ramlakhan of Innovative Medicine South Africa (IMSA) presented the submission for IMSA which commended the institutionalisation of quality through the establishment of the OHSC. They limited their comments to what would affect medicine and medicines supply in health establishments based on existing standards used by the Department of Health to accredit health establishments. IMSA recommended that standards needed to published for public comment prior to there finalisation; that the proposed Section 79 be amended to address harmonisation with the text IMSA had suggested; for OHSC to establish expert committees for advice on matters where they did not have the necessary in-house capacity.

Discussion
The Chairperson said that the submission was also alluding to the conflicting requirements mentioned in the previous submission.

Ms Ngcobo asked if the areas IMSA mentioned could be covered in the regulations, as adding them all to the law would be too cumbersome.

Ms Ramlakhan said that she agreed with the Member that the section they proposed needed to be further refined and shortened.

Ms Kenye asked for clarity if IMSA wanted Section 79 to be rephrased. In terms of areas of conflict, she asked which areas were affected and how they could be rectified.

Ms Ramlakhan confirmed that it IMSA advocated for Section 79(2)(e) to be rephrased, the reference was not ‘keeping with the law’ as there were two laws of equal standing. IMSA was asking for acceptance of certificates of compliance issued by the various councils and to be guided by the time limits on those certificates. The conflicts they were referring to applied to all councils and professional bodies that had standards.

Ms Dube asked for clarity about the proposal to establish expert committees.

Ms Ramlakhan replied that they were referring to the internal committees of the OHSC

Ms Segale-Diswai said that her understanding was that the office was not setting their own standards but following those of professional bodies, therefore she was confused about the conflict.

Ms Ramlakhan said that IMSA was saying that there only needed to be one set of standards.

Path Care submission
Dr Kerrin Begg, Chief Operations Officer and Head of Strategy and Policy, and Dr Younus Essack, Chemical Pathologist, explained that Pathcare was a South African healthcare entity that employed over 2 500 people and provided laboratory services to over 3.2m South Africans per year. Pathcare welcomed the establishment of the OHSC as a mechanism to ensure the quality of service would never be compromised and that the services would be used effectively and safely.

Pathcare recommended that as far as laboratory medicine was concerned, standards would need to be aligned. Accreditation and enforcement of standards would need to be harmonised between for example, the system envisaged by the proposed medical device licensing regulation, the control of hazardous substances system, ISO accreditation as well as the licensing system referred to in the Human Resources for Health (HRH) strategy.

Pathcare raised a concern about the word ‘independence’ saying that the Act would need to be explicit about its intentions for independence given reference that the OHSC could conduct independent oversight with or without reference to the Minister yet would report to the Minister. Pathcare also proposed that the retention of funding and fees at source be worded differently, in order to ensure that the objective would be achieved. Duplication also needed to be avoided through the way OHSC would be organised. Pathcare pointed out that Section 79(2)(e) recognised the potential for conflicting legislative mandates and noted the suggestion for the OHSC to negotiate cooperative agreement to harmonise jurisdictions. Such important work should not be done as such and they proposed that the Portfolio Committee request an analysis of such potentially overlapping and/or conflicting laws, and work in clear provisions on the delineation of mandates. They provided the suggested wording in their submission. They advocated for the use of ISO 15189 standard as the only standard to be used as it was international and also was the best in the world. Requiring certification by OHSC as proposed in the Bill would create unnecessary duplication.

Discussion
Ms Ngcobo said that she was getting more confused and suggested that perhaps the word ‘establishment’ would need to be defined. Once it was redefined, what the Bill was trying to sort out was what was happening in the hospitals and clinics. There were patients who had problems and the intent of the Bill was to address those areas. She emphasised that health care in SA was not good and that the Bill in discussion sought to change the state of health care in the country.

Dr Begg agreed with the speaker saying that the intent of legislation was to fix the quality of care in public sector institutions. She clarified that in looking at the definition of health establishments, they were trying to get across that one should be exempt if one was already accredited to a body that was more applicable.

Ms Dube asked why SANAS needed to be protected and defended.

The Chairperson explained that in talking about norms and standards, the presenters were saying, they agreed there should be an office of standards, but a law had been passed by DTI to have an accreditation body which was SANAS who had already done the work.

Dr Begg said that SANAS was the statutory body certified by International Laboratory Accreditation Cooperation (ILAC) to certify laboratories on the ISO standards. They were experts and those standards were applicable as they did them according to international standards and they applied to all laboratories.

The Chairperson opened the floor to the public to ask questions saying that he had received a letter from a member of the public who asked what the point of public hearing was when they could not speak in Parliament.

A representative of SANGOCO and the Health Forum expressed her concern about the Ombud’s position being irrelevant to the National Health Act. She said the Western Cape had tried the same thing and it had not worked as there was no Terms of Reference and no standards and procedures. She said it was important to think about the relevance of the Ombud to the country.

Hospital Association of SA (HASA) submission
Dr Dumisani Bomela, HASA Chairperson, explained HASA represented over 200 hospitals which amounted to approximately 31 000 beds in the country. HASA supported the Bill to promote patient health and safety. They were concerned about having no definition for ‘norms and standards’, no definition of the process used to define or arrive at the norms and standards. In terms of the purpose, there was insufficient clarity on what the norms and standards would be used for and this related to the multiplicity of interpretation. HASA recommended defining it in relation to the level and quality required to ensure the health and safety of the users - excluding the cost or tariff of health service offered, excluding the treatment process to be followed and clinical standards and clinical pathways relating to a particular diagnosis. Section 79 of the Bill needed to be strengthened to cater for this.

The OHSC would need sufficient checks and balances to ensure legality, compliance of constitution and administrative law, integrity to have independence from political influence and other external influences to ensure neutrality and transparency, competence and effectiveness. HASA proposed a board of health standards that would be both politically independent and neutral, eliminating any potential bias towards either public or private sectors.

Discussion
Ms Segale-Diswai asked why the private sector should be given special treatment in the proposed hospital board of standards where HASA proposed four representatives from the private sector and four from other sectors.

Dr Bomela suggested that they were suggesting a two tier board structure. Neutrality referred to the purpose of the community.

Ms Dube was worried about the composition of the proposed hospital board and suggested that the patients have someone to represent them as well especially given that the patients suffered the consequences of a lot of wrong decisions. She also asked for clarity on the word neutral.

Ms Ngcobo asked if there would be a representative from civil society as it seemed like there was no room for them in the proposal.

Dr Bomela replied that three names would be handed to the Minister for consideration for the board. Such individuals would have gone through a rigorous selection process.

Ms C Dudley (ACDP) said she was not clear about the need for definition.
Dr Bomela said that the purpose for which office intended to use norms and standards should be clear and they should be the minimum of what should be achieved and not a ceiling which would allow aspiration for excellence.

Ms Kenye asked for clarity if HASA was saying that it should be ruled by the Board and not by the Minister.

Dr Bomela explained that HASA’s view was related to the structure of the office that complaints for example would need to be disposed by the office in terms of the CEO and Ombud. They had proposed earlier to bring in the appeals committee as a powerful part of the structure.

Business Unity SA (BUSA) & Financial Planning Institute SA (FPI)
Mr Almo Lubowski , a FPI Technical Manager, explained that FPI was the premier independent professional body in financial planning and the setting of standards. It was affiliated to the Financial Planning Standards Board internationally and had over 7 000 members. Mr Andre Jacobs, Chair of the Health Committee for BUSA, said that the establishment of the OHSC and the Office of the Ombud was widely supported by BUSA members. BUSA, in its submission, was speaking from the perspective of the consumer. Mr Jacobs shared some insights about the health system in Mexico where the system was used to promote social cohesion. He requested that government look into that system in its deliberations going forward. Such a system required the involvement of all stakeholders as they each had a lot of value to add. BUSA provided the drafted text for proposed amendments for Section 79A(1) on the appointment of the CEO of the OHSC, Section 81(1) on the appointment of the Ombud and Section 81A about the functions of the Ombud.

Discussion
Ms P Kopane (DA) asked how BUSA saw the powers of the Ombud.

Mr Jacobs replied that there were already a few Ombuds in SA which worked well. He said that the Ombud’s decisions would need to have teeth

Ms Segale-Diswai asked why BUSA suggested consultation with NEDLAC where there was mention of the Minister following public procedures.

Mr Jacobs replied that the Bill spoke about the need to protect and promote the health and safety of users of health services. In transforming the health care system, the public, civil society, would need to be involved in co-designing and co-ownership of the health care system.
 

Ms Kenye asked if the Ombud would need to consult with the Commissioner.

Mr Jacobs replied that the Consumer Protection Act was an important piece of legislation in SA and he believed that there was consumerism in the Health Act. They wanted to suggest a formal structure where the consumer would be consulted. It was a formalisation they were suggesting and not a restriction of roles.

Ms Ngcobo asked why consult one specific person and not consult with the appropriate structures.

Mr Jacobs explained that the underlying motivation was that the consumer was at the end of the chain and they would either experience good or bad service. BUSA was asking the Committee to consider the focus be on consumers.

Ms Kopane asked about BUSA’s view on independence.

Mr Jacobs replied that it was important to talk about co-ownership, co-management, co-partnership, co-design so that all who participate in the system might take responsibility and would be part of the problem and the solution.

Mr Lubowski added that the principle remained that it was inclusion of the people in the running of the system that was needed and SA needed to look at some international models.

Afternoon session

South African Medical Device Industry Association (SAMED) submission
Ms Tanya Vogt, SAMED Chief Operations Officer, explained that SAMED was a non profit organisation established in 1985 with a membership of 141. It aimed to promote patient interests and better health outcomes and it was responsible for the ethical advancement of medical technology. SAMED had a diverse group of products which were vital across the health services, from low end to cutting edge such as bandages, syringes, scanners and heart stents. The services of SAMED were used by healthcare professionals and patients every day.

Looking at the Bill, she pointed out the significant risk of standard conflicts. There were looming overlaps and duplication or conflicts on norms and standards.

Clause 79(1)(f) on assurance and quality management systems was too general in its drafting. In South Africa there were agents but very few manufacturers of medical high-tech devices. The device manufacturers were responsible for safety and performance and also provided access to product information. The manner in which the Section 79 was phrased was likely to lead to duplication and conflicting standards and assessment. On the independence of the OHSC, her concern was that the Ombud could only make recommendations not decisions. There were also provisions for the Minister to prescribe standards without public input. SAMED proposed that standards and quality issues should be set by law through expert bodies after consultation.

Safety of medical devices was the regulatory requirement that should be governed by means of regulations. The manufacturers were responsible for training users of medical devices to ensure correct use. SAMED proposed that all standards be published in draft format prior to finalisation.

South African Private Practitioners Forum submission
Mr Chris Archer, SAPPF CEO, said that SAPPF was established in 2008 and was a voluntary association representing more than 2 500 members. The organisation was governed by a board and was accountable to members. The organisation was playing a vital role in the health care system, as specialists performed independent oversight of health care.

SAPPF’s concerns about the Bill were the reporting lines, determinations of norms and standards and funding of the body. SAPPF felt that the Ombud should be established by separate statute and the OHSC should report to Parliament. The Minister was not obliged to consult nor was he bound by any recommendations of the OHSC. The Ombud should avoid conflict with standards set in current legislation, ethical rules, guidelines and protocols on clinical care treatment.

SAPPF felt that peer review should be done by peers and international bodies, independent of government. The funding model of the body was not clearly explained, except to say that the fees and services rendered would provide the funding. SAPPF felt that greater clarification should be provided with respect to funding. The media had released statements that suggested that the private sector was expensive, and that was a distortion of truth. SAPPF did not support the accreditation of individual doctors by another entity other than Health Professions Council of South Africa (HPCSA). The South Africa private sector was more cost effective than the majority of international public health sectors. The worldwide medical CPI index was 3% higher than the national inflation rate. Malpractice costs were up by 650% over 15 years while procedure fees rose by only 88%. He reiterated his position on the independence of the OHCS to avoid duplication.

Discussion
Ms D Robinson (DA) said that the submission was clear and most of the submissions had similar concerns regarding the Bill.

Mr Archer explained that there had been an escalation of litigation against doctors by lawyers as the general population was becoming aware of their rights. There were high expectations when people visited their doctors even though doctors do not know everything. He cited an example of a baby born with brain damage. The blame was always put on the doctor even though the baby was brain damaged before she was even born. The number of medical practitioners was small compared to the number of cases against them.

Ms B Ngcobo (ANC) asked for clarity on the norms and standards that should be determined by professionals.

Mr Archer replied that norms and standards were set by clinicians, and doctors were not allowed to work before being approved by the Medical Council which had specific standards for health practitioners.

The Chairperson said the Committee would look at the recommendations made in the different submissions.

Pharmaceutical Industry Association of South Africa (PIASA) submission
Ms Kirti Narsai, Head: Scientific and Regulatory Affairs, said that PIASA was the longest established trade association in South Africa representing pharmaceutical companies. It represented 18 multinational and local companies operating in South Africa, supplying 25% of medicine in the public and private sector. She noted that PIASA fully supported the implementation of standards aimed at ensuring quality of care and optimal compliance. Her organisation felt that inspection and enforcement mechanisms already exist for medicines, therefore there might be areas of overlap between OHSC and other regulators. Systems already existed to monitor compliance across the value chain managed by the regulatory bodies. Areas of overlap were on patient rights on access to information regarding their treatment. The Consumer Protection Act and the Medicines Act were very clear on patient rights.

On patient safety, clinical governance and clinical care the MCC required reporting of adverse reactions related to medicines by healthcare professionals and manufactures of medicines within specific timeframes in a specified format. Core Standards stipulated that adverse events or patients safety incidents were promptly identified and managed to minimise patient harm. These events should be routinely analysed to prevent recurrence.

On patient rights, PIASA stipulated that Medicines Act made provision for package inserts for medicines in its regulations. Package inserts were approved by the Medicines Control Council. The Medicines Control Council and the Consumer Protection Act both played a crucial role. The core standards of the Bill stipulated that patients should be given the information regarding their treatment, care and participation in research.

On the destruction of medicines, MCC guidelines were specific on the presence of a qualified pharmacist during the destruction. The Bill specified the presence of the Environmental Health Inspector under the OHSC. This led to an overlap with MCC requirements.

PIASA recommended direct accountability of the OHSC to Parliament and real independence for the Ombud to make decisions rather than reporting to Parliament via OHSC through the Minister’s office. The Pharmacy Act and the Medicines Control Act provided norms and standards, monitoring compliance, inspections and enforcement. The Bill was simply duplicating what already existed. PIASA proposed that the Medicines Control Council and the South African Pharmacy Council should be excluded and where necessary be called upon to evaluate non compliance with standards. Specialised skills were required for monitoring and inspection to ensure compliance to standards. Inspectors had to undergo specialised training to conduct inspections. PIASA recommended that areas of overlap between OHSC, Medicines Control Council and Pharmacy Council be carefully reviewed in order avoid duplication to protect patients.

Discussion
Ms Dube asked the reason that PIASA required the exclusion of OHSC on compliance.

Ms Narsai explained that the Medicines Control Council and the South African Pharmacy Council had the necessary skills to evaluate non compliance with specified standards and norms.

Ms Ngcobo raised her concern that more than three quarters of the population hardly read the instructions on medicines.

Ms Narsai agreed that that very few people read the instructions on medication. Patient counselling played a bigger role when they were handed their medicines by a health professional. The Medicines Control Act recommended the use of plain language for all medicines.

The Chairperson raised his concern about the other stakeholders who did not turn up for the hearings. He said that the Committee would be meeting during the extended Committee session. Most stakeholders wanted amendments around independence, duplication and inspection. The Committee would consider all the recommendations. Everybody agreed about the need to reform the health sector. He thanked the stakeholders.

The meeting was adjourned.

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