Medical Schemes Act, Tobacco Act, SAMMDRA: briefing

Meeting report

PORTFOLIO COMMITTEE ON HEALTH; SOCIAL SERVICES SELECT COMMITTEE: JOINT MEETING
29 February 2000
REGULATIONS ON MEDICAL SCHEMES ACT & TOBACCO PRODUCTS CONTROL AMENDMENT ACT, SAMMDRA AND NATIONAL DISABILITY SURVEY: BRIEFING

Document handed out:
Medical Schemes Act, 1998 (See Appendix 1)
Tobacco Regulations (See Appendix 2)
SAMMDRA
National Disability Survey (See Appendix 4)

Chairperson: Ms L Jacobus

SUMMARY
Mr P Masobe gave an overview of the Medical Schemes Act as well as the regulations. This Act establishes a Council For Medical Schemes as a corporate body accountable to the Minister of Health, which in turn strengthen oversight and regulatory capacity. The overall policy direction is an attempt to allow better access to private health care by abolishing restrictions on the basis of age, sex, and state of health.

Ms B Pitt contextualised the Tobacco Products Control Act and summarised the Tobacco Regulations which gives effect to it. This Act will provide strict limitations on the advertising of tobacco products, and smoking in public places. The Regulations are presently in draft form and the closing date for public comment is 3 March 2000.

Ms M Matsoso gave a presentation on the SAMMDRA. She informed the committee that the National Drug Policy is aimed at ensuring patients receive drugs that meet the three criteria of safety, quality and efficacy..

Ms C Kotzaberg presented the results of the National Disability Survey. This is a baseline study to inform other role-players of the status, and to propose a strategy to develop an action plan based on the results of this survey.

MINUTES
Medical Schemes Act
Mr P Masobe (Director of Health,) presented a briefing on the regulations of the Medical Schemes Act. (See Appendix 1) The Act has been passed during November 1998, and was promulgated during February 1999, The regulations have been published for comment in May 1999. The period for comment ended on 7 August 1999, which was reviewedNew draft regulations were finalised during September. (of which year)

The overall policy direction is an attempt to allow better access to private health care, by abolishing restrictions on the basis of age, sex, and state of health.

To prevent opportunists from abusing this, we have to finalise these regulations, and put in place a system that will not prejudice both the people and the medical aid systems." The intended impact of community rating in the private health sector is for people who previously could not gain access to private health care, and to deal with cost shifting from private to public hospitals. Schemes shall therefore not determine contribution on the basis of age nor gender.

Three months has been allotted before a person can have access to medical aid cover. If, however, a medical scheme member switches schemes after two or more years of membership, the waiting period will not apply. Schemes should identify "opportunist behaviour" to avoid penalising everyone; especially those joining late in life. The threshold age for penalty was 35 years old, and a formulation based on years without medical cover after age 30. See appendix 1 for formulation of penalties.

There is an amnesty period for those who previously could not join a scheme. Premium penalties would not apply to that category of people. This period runs from 1 January 2000 - 31 June 2000.

Services should be fully funded in at least one setting, for example, public hospital or managed health clinic. The funding should be provided thourgh the health care provider.
The Act provides the allocation of a personal medical savings accounts to be used for health benefits, with a 25% limitation on annual contributions to this account. The funds of this account belong to the personla member and not the health care provider.

Brokers have to comply with certain conditions to ensure that they are qualified and competent individuals. The qualification threshold for brokers has been liberalised, and a certified apprentice scheme has been introduced to serve as a point of entry for the inexperienced to the employment market. Health advisors need to be accredited by the Council for Health Schemes. The maximum amount of money that can be paid to advisors is 3% plus VAT based on the first year premium payments.

Accumulated funds: The Medical Scheme must at any one time hold 25% of its income/assets in reserve, according to transitory regulations ie 10% in first year, 25% by the fifth year.

Medical Schemes are short term insurers, as they need to make investment liquid quickly. A chapter in the regulations provide a list of investment profiles, and gives the extent to which a scheme can invest.

Questions:
1) Dr Gous (NNP): Is there a definition for the term "opportunistic behaviour", and what impact will it have on costs? Must employers subsidise their employees' dependants?
2) Ms Rabinowitz (IFP): How will dumping be stopped. Is the Act still not discriminating against the elderly, with the penalties suggested?
3) Dr Jassat (ANC): Will the three months waiting period apply to new born babies at birth, or from the beginning of the pregnancy?
4) Ms Gxowa (ANC): What happens to the savings when a member ceases to be a member of the scheme?

Answers:
1) Mr Masobe said that we should look at the way "opportunistic behaviour" manifests itself. The questions should rather be asked, "Do I as a patient have more information of my condition than the insurer?". This is where a condition has been diagnosed or attended to within the last twelve months.

This legislation will have a substantially less impact on costs because of the way schemes are managed. It gives the Medical Aid Schemes 25% membership on the Board of Trust`ees, which will in turn significantly decrease costs. Employers are not obliged to subsidise their employees dependants.

2) We do not look at the Medical Schemes Act to stop dumping. We can combat this by improving management in public facilities, and by providing fixed tariffs for medical scheme members who attend public hospitals. A number of mechanisms have been introduced in the Act to deal with this. No clarification of the mechanisms was mentioned. This is a point of contention and needs more attention.

3) A child born into the scheme will have immediate cover.

4) Members can transfer their savings when moving from one scheme to another. If the member leaves the medical scheme environment, they can receive their savings, provided they pay tax on it.

Tobacco Regulations
Ms B Pitt, Director of Health Promotion, summarised the tobacco regulations which give effect to the Tobacco Products Control Amendment Act, 1999 (see Appendix 2). This Act will provide strict limitations on the advertising of tobacco products, and restrict smoking in public places. The regulations are presently in draft form and the closing date for public comment is 3 March 2000.

The schedule in the regulations (No.R.1450) proposes a gradual reduction of tar and nicotine in all cigarettes marketed in this country, namely: 15mg of tar and 1.5mg nicotine by 31 December 2000. A further reduction to 12mg tar and 1.2mg nicotine per cigarette as from 31 December 2001 will follow.

The schedule (R1451) proposes one point of sale for tobacco products in all retail stores, which shall be sign posted showing the availability of tobacco products, the price, and a health warning. Such signs shall only be printed in black and white, and shall not contain any pictorial content, which glamourises tobacco products.

Schedule R1452
All existing contractual obligations with tobacco promoters shall not continue for more than 2 years from 14 April 1999, subject to certain restrictions in the interim period.

Every importer and distributor of books/ magazines etc. to be distributed in South Africa, must submit to the Director-General of Health a list of all the tobacco advertisements contained therein.

R1453 amends Section 2 of the principal Act, which relates to the smoking of tobacco products in public places.

Smoking is permissible in restaurants, bars, shebeens, taverns, pubs, nightclubs, casinos, hotels, guest houses and bed-and-breakfast places, under strict conditions: a separate smoking room (not exceeding 25% of total floor space), with solid partitioning and separate ventilation system, and health messages displayed. The owners of such establishments are responsible for ensuring the implementation of these regulations.

Smoking in all workplaces is banned, except in a designated smoking area.
All employers shall have a written policy on smoking in the workplace and give effect to this policy within 3 months of the commencement of the Act.

Questions:
Ms Rabinowitz (IFP): Is it practical for restaurants and bars to install a solid partition, and will this be implemented? Do you have more detail on a "solid partition"? Who is going to keep all these lists of tobacco articles in publications? Is it practical?
Dr Gous (NNP): These amendments will then make ordinary plain cigarettes illegal. Will cigar manuals be illegal? Tobacco leaves with a lesser yield is a completely different crop. I therefore feel that the time schedules provided in this regulation is too limited, and a longer period than two years is required.
What will happen to those contracts which last longer than two years?
What of the impact on the hospitality and catering industry?
Who will monitor the levels of nicotine and tar?

Answers:
Ms Pitt replied that these regulations are still in draft form and comments are welcomed. The reason for the solid partition is to ensure that tobacco smoke does not circulate the room and filter from the smokers to the non-smokers. The primary purpose of cigar manuals should not be targeted at the South African population, and the whole publication should not be aimed at the sale of cigarettes.

Currently most of our local brand cigarettes already comply with the nicotine and tar content. We welcome submissions from tobacco farmers who feel that this will drastically effect their crops. We do not intend to completely ban cigarettes, but to reduce the harm.

Contracts will be allowed for those two years under strict conditions. The underlying principle is that there should be no sponsorship of addictive, harmful substances. The experience of other countries indicates that total banning is the most effective (as opposed to continued sponsorship but with health warnings).

Enforcement: he Department is conducting community awareness campaigns, encouraging people to be more verbal about their rights as non-smokers.
Environmental Health Officers are being employed to monitor the situation
The owner/leasee of the public premise is responsible for ensuring implementation. There will be fines for non-compliance.

South African Medicines and Medical Devices Regulatory Authority Bill
Ms M Matsoso, Registrar of Medicines, informed the committee that the National Drug Policy is aimed at ensuring that the drugs that reach patients are safe, effective, and meet approved standards and specifications. This has been copied from the presentation which is incorrect.

Their key policy issues is to strengthen the MCC, rationalise drug registration, ensure proper licensing of premises, enhance inspections, and promote quality assurance.

Transformation of MCC has taken place through the establishment of the board (SAMMDRA), which consists of expert and standing committees (multi-disciplinary), and through the process of registration for complementary medicines and medical devices.
The MCC cannot undergo proper transformation or change it's legals status until new regulations and legislation have been promulgated. SAMMDRA has no legal status and was declared null and void by both the High Court and the Constitutional Court a fortnight ago. Therefore the chaos governing the MCC which now has to revert to the use of the orginial Act, namely ACT 101 of 1965
Their goals and objectives are to:
- safeguard public health by controlling medicines
- have an efficient and effective system of medicine regulation
- harmonise regulatory activities within SADC region, and beyond the continent
- build in-house technical capacity
- strengthen pharmaco-vigilance and post-registration activities
- have an effective system of clinical trials regulation
- establish a system for the licensing of premises
- establish a frame-work for the registration and control of complementary medicines, and there is a Bill which has been promulgated to cover this.
- to create a sustainable system of medicine control based on adequate staffing and appropriate skills

Today, they experience various problems such as:
- delays in the registration of medicines
- lack of screening and timelines, poor control of evaluation work,
- lack of guidelines and performance of contracts, unsustainable systems,
- lack of in-house technical capacity,
- no formal programme of training available,
- lack of acknowledgement of international processes, inadequate legislative systems and a lack of re-registration systems.

Their available options were:
- to decentralise the management system
- strengthen pharmacopeo-vigilance
- create 2 distinct units (law enforcement & specialized audits)
- harmonize registration requirements,
- retain revenue coupled with increased fees, and
- expand unit inspectorate

Develop clinical trials.

Questions and Answers:
Dr. Rabinowitz: As the whole process of new legislation had been a shambles
and bedlam, would it not be more appropriate to re-start the complete
process.

She mentioned that she was in negotiations on behalf of the homeopaths and
the registration process here was causing enormous problems. How was the MCC
going to resolve these?

Answer: The MCC was looking at a listing system similar to that of India.
However, investigation was inadequate at present and this had to be
addressed. Dangerous medicines should be listed which are prohibitive.
However, the listing had to have limitations. In the case of ayurevic
medicines the listing is subjective depending on the personal stakes of
various parties.

Dr Gous: The government was morally bound to regulate drug control and meet
the requirements of supplying quality, efficacy and safety in drugs. Price
issues should be controlled by totally separate legislation and not be
included in regulatory legislation.

Answer: Additional funding had to be received to implement new registration
processes and this was through increased charges. She re-affirmed the
concept that fast-tracking had to be allowed and implemented if it was in
the interests of Public Health or to address an urgent medical emergency and
affordable medicine was available. She concluded that not all regulations
had been formulated.

National Disability Survey
Ms C Kotzaberg, (Director of Chronic Diseases, Disabilities and Genetics in the Department of Health) presented the results of the National Disability Survey (see Appendix 4). This is a baseline study to inform other role-players and, to propose a strategy to promote action on the results of this survey. It outlined the terms of reference used, as well as the results of the survey.

Questions:
(1) Dr R Rabinowitz (IFP): What are the reasons for disability in young children?
(2) Chairperson: What linkage does your department have with the President's Office dealing with disability?
(3) Ms Malumise (ANC): Is this research a national one? Is CASE to undertake similar provincial surveys?
(4) Dr Jassat (ANC): Have you considered incorporating the services of occupational therapists in the assessment of disabilities.

Answers:
(1) Ms Kotzaberg replied that the main causes of increased disability in children is illnesses, and issues relating to pregnancy and birth. There are however other external environmental factors.
(2) We do work closely with the President's Office dealing with disability. We compare our studies, and invite them to our meetings.
(3) This is a national research, and many researchers in the country conducted it.
(4) We have a new tool for assessment by the Department of Welfare, which includes physiotherapists, occupational therapists and social workers.

Appendix 1:
Medical Schemes Act, 1998
The story so far:
. Medical Schemes Act passed 1998 during November 1998
. Promulgated during February 1999
. Regulations published for comment on May 1999
. Period of comment ended on 7 August 1999
. Comment reviewed and new draft regulation finalised during September

Overall policy direction: reinforce social solidarity and cross subsidisation
System of Community Rating
Schemes shall not determine contributions on the basis of age, sex, past or present state of health, or claims experience, other than in instances provided for in regulations and aimed at protecting against opportunistic behavior

Intended impact of community rating
· Expand access of those who are currently excluded (e.g. pensioners)
· Protect necessary care, and reduce potential to discriminate by paying for
fewer services
· Effect better cross-subsidisation of sickly by healthy
· Provide incentives to deal with costs directly rather than by excluding those who really require cover

Protections against adverse selection
· Maximum waiting periods for pre-existing conditions
· Open enrollment periods
· Premium penalties within defined bands for those only joining late in life

General Waiting Periods
· three months general waiting period may be applied
· this may be waived through payment in lieu of the waiting period subject to a general limit based on reasonableness
· waiting periods should apply to dependants
· the requirement to waive the waiting period for persons with 2 + year continuos membership is not limited to a single scheme

Pre-Existing Sickness Conditions
· necessary to balance the natural concerns of the medical schemes about the potential for adverse selection against the policy direction of inclusion and community rating
· that a pre-existing condition is one that is present at time of application for which treatment or diagnosis was sought or given is extended during last 12 months
· Exclusions may be applied to both the member and any dependants
· the continuous two year period of coverage required to be exempted from pre-existing conditions can be at one or more schemes.

Premium Penalties for Persons Joining Late in Life
· the threshold age for penalties was put at 35 years of
· the formulation is based on years without medical cover after age 30
· 5-9 @ 1.05 of community rate
· 10-19 @ 1.25
· 20-29 @ 1.5
· > 30 @ I .75
· Late joiner penalties may apply both to members and to adult dependants
· Pre-existing conditions limitations will also apply
· However, there is "an amnesty period" of at six months for people to join without facing the premium penalties. After that point, individuals will be liable for permanent late joiner penalties if they did not purchase medical cover early in life

Option-Hopping
· a minimum of three months notice to the should be provided by members wishing change and the change must take place the month of January
scheme to during
· no new waiting periods or exclusions may be applied to members switching schemes

Prescribed minimum benefits
· Policy concern - to prevent unfunded use of public hospitals, and to encourage efficiency
· relates to essential and cost effective cover only
· services comparable with what a public hospital would ordinarily provide
· will be prescribed in regulations after consultation with industry
· ANNEXURE A spells out the conditions I treatment pairs for minimum benefits
· these services have to be fully funded in at least one provider setting - and in the public sector at all times to prevent dumping

Personal Medical Savings Accounts
· Act provides for allocation of personal medical savings accounts to be used for health benefits
· Limit on such accounts to be defined in regulations
· A process was begun to discuss this issue with industry before finalisation of regulations
· 25% limit on annual contributions to personal medical savings accounts will be retained
- consistent with policy direction of encouraging pooling of risk
- ensuring that members receive sufficient protection and purchasing support from their medical scheme
· Personal medical savings account funds are considered to belong to the member. Members will be allowed to take balances as a cash payment on disenrollment and/or transfer to a scheme without a MSA provision.

Conditions to be Complied With by Brokers
· ensure that individuals serving as brokers are qualified and well trained, and that competent individuals currently providing quality services are not be penalized by newly applied guidelines
· threshold qualifications for brokers have been liberalized, and a certified apprentice scheme has been introduced to serve as a point of entry to the employment market for the inexperienced
level,
· the required education will be at the Grade 12 with two years of experience (or a two year apprenticeship) required before full accreditation as a broker is possible
· fees for introduction of members to medical aids will remain at a maximum of 3% + VAT of contributions payable by members introduced
· Schemes may apply a sliding scale for payment, subject to above
· fees for ongoing services will not be covered by these regulations, except insofar as a contract exists between the broker and administrator

Conditions for Providing Managed Care
· regulation in this area are meant to support the principles of managed care while safeguarding from abuse
· not meant to preclude the use of capitation as a form of payment or the reasonable application of criteria addressing both quality and need in the establishment of networks
· deal with termination of network arrangements with providers, and confidentiality of information
· consultations with medical schemes, managed care organizations and provides will continue to appropriately interpret and apply the regulations

Accumulated Funds
· Maintain at any time accumulated funds of 25% i.r.o gross contributions
· i.e. nett asset value
· Excluding funds set aside for specific purposes
· Excluding unrealised non-distributable reserves
· Transitional arrangements
- schemes - comply within 5 years
year 1 - 10%; year 2 - 13.5%; year 3 - 17,5%

Limitation On Assets
· Scheme to hold assets of kinds & categories specified
· Aggregate fair value not less than aggregate fair value of liabilities on that day; and minimum accumulated funds
· Assets may not exceed % specified
· Fair value excludes:
- premium other than reinsurance premium
- unpaid amount after 12 months due & payable
- admin & business extension expenses
- liability I reinsurance contract held by scheme
- encumbered assets

Accreditation of Administrators
· Act requires that administrators be accredited by Council
· Objective standards for accreditation to be developed jointly with administrators
· Accounts to be paid within 30 days

Role of Auditor
· Auditor to review system of internal financial control of administrator - moderate assurance
· Review engagements in accordance with statements of SA Auditing Standards
· Review opinion intended to assess adequacy of internal financial control system for size & complexity of scheme(s) administered
· Audit opinion on financial statements of administrator - results of operations
· Management representation letter to registrar.

Strengthen oversight and regulatory capacity
· Act establishes Council for Medical Schemes as a corporate body accountable to Minister of Health
· Significant improvements in staff of Council is envisaged
· It is envisaged that Council will be funded largely through levies on medical schemes, and Department of Finance is supposed to introduce Levies Bill before end of the year

Appendix 2:
Tobacco Regulations

Introduction
I will briefly by way of introduction contextualise the Tobacco Regulations which give effect to the Tobacco Products Control Amendment Act no 12 of 1999 and continue my presentation with an overview of the regulations, making reference to sections within the Amended Act as I proceed with this section of my presentation.

In terms of process the Tobacco Act of 1999 follows as an amendment to the Tobacco Products Control Act no 83 of 1993.

The purpose of the Principle Act was to:
· Prohibit or restrict smoking in public places
· to regulate the sale and advertising of tobacco products in certain respects and to prescribe what is reflected on the packages.

The purpose of the amendment to the '93 Tobacco Act was to:
· insert certain definitions;
· to provide for the prohibition of advertising and promotion of tobacco products;
· to provide further for, the prohibition of advertising and promotion of tobacco products in relation to sponsored events;
· to prohibit the free distribution of tobacco products and the receipt of gifts or cash prizes in contests, lotteries or games to or by the purchaser of a tobacco product in consideration of such purchase;
· to provide for the maximum yields tar, nicotine and;
· to increase fines

The Tobacco Regulations which give effect to the Tobacco Products Control Amendment Act no 12 of 1999
No.R. 1450 relates to the maximum permissible yields of tar and
Nicotine:-
(p.5 in the Amendment - follows section 3 and becomes 3A in Principle Act)

Tar is regarded as the major carcinogenic component of tobacco smoke. Reductions in tar levels is seen as a means of reducing harm caused by tobacco smoke. Nicotine on the other hand is the addictive component -reducing nicotine makes cigarettes less addictive.

The schedule in this notice proposes a gradual reduction of tar and nicotine in all cigarettes marketed in the country - namely 15mg of tar and 1.5 mg nicotine by the 31 December 2000. This will be followed by a further reduction to 12 mg tar and 1.2 mg nicotine per cigarette as from the 31 December 2001.

The implementation of the proposed 15 mg upper limit for nicotine will affect only
% of cigarette brands.

In the EU the tar yield of manufactured cigarettes was not to exceed 12mg per cigarette by 1997. The EU is currently considering lowering the tar and nicotine levels even further.

No.R 1451 relates to the point of sale advertising of tobacco products
(p.4 / 3(3) in the Amendment -part of section which substitute section 3 in the principal Act)

Proposes one point of sale for tobacco products in all retail outlets, which shall be signposted showing the availability of tobacco products, its price and a prescribed health message and/ or warning. Such a sign shall not be more than a metre away from the point of sale, shall be legible and readable and be printed in black and white only. Such signs shall not contain any pictorial presentation or images which glamorises tobacco products.

Notwithstanding the aforesaid, it will remain an obligation of the manufacturer or retailer of tobacco products to warn the public of the damage caused by using cigarettes.

(point - better control of sale restriction to those over the age of 16 years avoiding glamorising a product that kills one in three of its users.)

No.R. 1452 relates to the provision of exemptions for advertising with unintended consequences or the phasing out of existing sponsorship or contractual obligations.
(p.4/3(1&2) in the Amendment - which refers to the phasing out of "Advertising, sponsorships, promotion and required information in respect of packages of tobacco products - substitutes section 3 in the principle Act.)

1. This schedule proposes that all existing contractual obligations, sponsorships or promotion of any organised activity by a tobacco manufacturer, importer, retailer or distributor shall continue for not more than 2 years from the 14 April 1999 and be subject to the following conditions in the interim period:

2 · Prescribed health messages take up 30% of any print or outdoor communication about an organised activity for which consideration is derived from a tobacco manufacturer, importer, distributor or retailer.
· For every three electronic communications about such an organised activity, there shall be one communication of equal length and prominence providing health messages - rotated on a quarterly basis.
· Any communication in the aforesaid shall consist of written words-black and white - no pictorial content.

3. Copies of such contracts or if in oral a sworn statement signed by the parties and further specifying the duration of such a contract/agreement shall within one month of the proclamation of the Amending Act be lodged with the office of the DG - health.

4. Exemption is provided for advertising on the grounds that the principle purpose of imported publications or electronic transmissions is not to promote of the use of tobacco or tobacco products or is targeted primarily at South Africans.
To allow for monitoring the report of such published material, the DG-health shall be supplied with a list of such publications or electronic transmissions.

No.R 1453 relating to smoking of tobacco products in public places. Amendment of section 2 in the principal Act.
· This section declares where smoking in public places is permissible and the conditions subject to which smoking may take place.
· Smoking is permissible in retail tobacco stores that deal exclusively in the sale of tobacco.

· Smoking in restaurants, sports bars, bars, pubs, shebeens, taverns, nightclubs and casinos are permitted subject to the following conditions:
(a)(i) that smoke in the designated room is not recirculated to the rest of the building but ventilated to the outside through a separate ventilation system.
(ii) the designated smoking area/room is separated from the rest of the public place by a solid partition and displays the sign "smoking room
· restaurants with more than 35 seats may designate a maximum of
25% of the seating as a designated smoking area
· The designated smoking area of hotels, guesthouses, bed and breakfast places, game lodges and other places of accommodation must
not exceed 25% of the total floor area.
· Passenger ships registered in South Africa may allocate 10% of the total cabin space of as designated smoking areas on condition that cigarette smoke is ventilated to the outside.
· Passenger trains may allocate entire carriages or compartments as designated smoking areas provided that such areas do not exceed 10% of the total number of carriages.
· An employer, owner, lessee or person in control of a public place or workplace shall be responsible for enforcing these restrictions on smoking.

All employers shall have a written policy on smoking in the workplace and give effect to this policy within 3 months of the commencement of the Act.

Appendix 3:
PRESENTATION ON SAMMDRA by Ms MP MATSOSO, REGISTRAR OF MEDICINES
National Drug Policy
· Aim:
To ensure that drugs reaching patients are safe effective and meet approved standards and specifications

· Key Policy Issues:
The Strengthening of MCC
Rationalization of Drug Registration
Licensing of premises
Enhancement of inspections
Promotion of quality assurance

· Review of MCC
Recognition of Complementary medicines
Sources of funding (Revenue Retention)
Multi-disciplinary team
Spread of regulatory knowledge
Harmonization of Regulatory activities
Mutual recognition of registration decisions
Accumulation of Backlog
Conflict of interest
Revision of Legislation

· Transformation of MCC
Establishment of the Board (SAMMDRA)
Expert and standing committees (multi-disciplinary)
Strengthening of Clinical trials and Adverse event monitoring
Transformation of MCC
In-house technical capacity
Strengthening of appeal process
Additional source of revenue identified
SAMMDRA Legislation recommended
Process for registration of Complementary medicines and Medical devices

· Goal and Objective
To safeguard public health by controlling medicines
To have an efficient and effective system of medicine regulation
To harmonize regulatory activities within SADC region, Afro and beyond the continent
To build in-house technical capacity
To strengthen pharmaco-vigilance and post-registration activities
To have an effective system of clinical trials regulation
To establish a system for the licensing of premises
To establish a frame-work for the registration and control of Complementary medicines
To create a sustainable system of medicine control based on adequate staffing and appropriate skills

· Today's Situation
Delays in the registration of medicines
Lack of screening
Lack of timelines
Poor control of evaluation work
Risk approval system
Lack of guidelines
Lack of performance contract
Systems not sustainable
Lack of in-house technical capacity
Technical expertise restricted to a few
no formal programme of training available
Lack of acknowledgement of international processes
inadequate legislative system
Lack of re-registration systems

· Available Options
Decentralised management system
Creation of CDCC
Creation of Amendment section
Strengthening of Pharmaco-vigilance
Revamping of clinical trials unit
Create 2 distinct units (Law enforcement & Specialized audits)
Revise legislation and regulations
Implement guidelines and SOP's
Project Plan
Recommendation
Harmonization of registration requirements
Decentralised management system
Retention of Revenue coupled with increased fees
Expansion of the regulatory capacity
70% in-house technical work
1-year registration time-frames
Expansion of Pharmacopeo-Vigilance unit inspections and clinical trials

Appendix 4:
RESULTS OF THE NATIONAL DISABILITY SURVEY

INTRODUCTION
The National Disability Survey is a baseline study. This is just a beginning of the disability interpretation process.

In 1996 South Africa and Flanders agreed to co-operate in the development of a community based rehabilitation strategy for South Africa. The Flemish Government then approved a grant of R2,5m for this project. It was also agreed that the project will be in the form of a disability survey with the primary objective of establishing the prevalence of disability in South Africa.

In December 1996 the tender to conduct the project was advertised. After a series of delays the tender was finally awarded to Community Agency for Social Enquiry (CASE) in June 1997. CASE's tender proposal was endorsed by Disabled People South Africa (DPSA) and other prominent disability groupings in South Africa. CASE's partners from the research fraternity included the Medical Research Council (MRC).

Between October 1997 and March 1998 CASE held workshops with stakeholders and reference group meetings with experts from research organisations and the disability groupings, as well as disability programme managers from relevant government departments. Meetings of the reference group were to become a permanent feature of this project.

The pilot was done between March and May 1998, followed by the fieldwork proper in June. The national survey included 10 000 households ( 42 974 individuals) covering all provinces, four race groups, rural, urban and metropolitan areas plus key demographic variables. A sample of 1 703 disabled people had been interviewed regarding disability specific issues. In November 1998 a workshop was held with all the stakeholders, including the disability sector to look at the first preliminary results. In March 1999 CASE presented the preliminary results to the Management Committee of the Department of Health. In May 1999 an intersectorial meeting was held to define the context of the results.

From the middle of 1999 CASE held provincial workshops to try and unpack results of the survey so that provinces could be able to interpret and use them. The final report was presented to the Minister in the same month. In January 2000 the results were publicised through the media.

The purpose of the study is to allow service providers to address the needs of the disabled population in a focussed way, to promote local action research and to promote and protect the rights of people with disabilities.

The purpose of this presentation therefore is to inform other role-players and to propose a strategy to promote action on the results of this study.

2. TERMS OF REFERENCE
The survey was guided by the following terms of reference:-
1 A review of the literature available on the subject to create a body of working definitions of different disabilities and terminology,
2 An analysis of all disabilities ranked according to prevalence,
3 An analysis of the causes of disability across different age groups and geographical locations,
4 An analysis of the source and amount of funding of services for people with disabilities,
5 A quantitative and qualitative analysis of the resources available including their distribution and their accessibility,
6 An analysis of felt service needs of people with disabilities,
7 An analysis of the needs of service providers,
8 An indication of the need for assistive devices for independent living and the accessibility thereof.

3. RESULTS OF THE SURVEY
3.1 Prevalence of disability as reported by disabled people themselves or proxy reporters
The prevalence of moderate to severe disability nationally is 5,9% with the following provincial breakdown:-
Western Cape 3,8%
Eastern Cape 8,9%
Northern Cape 4,5%
Free State 5,8%
Kwazulu Natal 6,7%
North West 3,1%
Gauteng 5,2%
Mpumalanga 4,5%
Northern Province 6,3%

This prevalence is in line with the census results of 6,6%, October 1995 household survey indicating a prevalence of disabilities as 4,7% and the 1999 World Disability Report by the International Disability Foundation reflecting a prevalence figure of between 4,5% to 7,7% globally.

The question that is frequently asked is why has the prevalence of disability gone down from 10%. What people do not consider is that the figure of 10-12% was an estimate by WHO in the 1980s. This estimate per definition included impairments, chronic illnesses, all older persons (>65 years) and terminally ill persons.

This issue highlights a fundamental point that disability is relative and depend on the definition used and the individual's experience of the activity limitation/disability.

The study analysed prevalence rates in terms of province, race, age and type of disability. Overall, Africans have a significantly higher prevalence rate than other races. Disability also varies significantly across age groups. There is a steady increase in the prevalence rate between the ages of 0 and 10 (from 1,6% to 3,3%) and between the ages of 35 and 60 (from 5,1% to 14%), whereas the disability rate rises sharply after the age of 70 (13% for the category 71 - 75 to 24% for the 80 + category).

The specific reasons for the difference in prevalence of Provinces have not been determined.

Most of the findings in this section can be used to develop action plans. Information on the causes of disability and age of onset is useful in developing the disability prevention strategy. Almost all the variables that have been analysed can inform action plans in one way or another.

Numbers only tell half of the story. Numbers do not explain individual experiences and therefore quantitative methods were included (biopsychosocial model).

3.2 Severity of disability
The provision of assistive devices and personal assistance have a highly significant impact on how respondents rated their disability or activity limitation. The number of respondents who said their disability was severe was 58% with no assistance. When an assistive device was used the number rating their disability as severe dropped to 5%. When assistance from another person was provided the severe category reduced from 58% of respondents to 12%. When both an assistive device and personal assistance were provided the severe category was reduced from 58% of respondents to 4%.

The number of disabilities a person has influences the degree of severity when no assistance is provided. However, when an assistive device and /or personal assistance is provided the severity is greatly reduced for all people no matter how many disabilities they have.

These results provide clear justifications for providing assistive devices or personal assistant services.

3.3 Services needed and received by disabled
Respondents were asked whether they had needed any services in the past or presently, and whether they had received any services whether they needed them or not. Health services are the most received and needed service, and welfare and educational services are the least received services.

Health, medical rehabilitation and assistive devices services were the service reported as needed most often. Of those respondents who said they needed a service, the best served were those requiring health and traditional healer services where three-quarters and two thirds respectively, received these services. The quality of the services received was not reported on. Only two out of every five persons needing medical rehabilitation and assistive device services actually received the service. Less than a fifth of people needing educational, counselling, welfare and vocational training services actually received these services.

Whites and Indians were the most likely race groups to receive medical rehabilitation services, Indians the most likely to receive assistive devices services, and Whites to receive educational services. These differences highlight the unequal provision of services across the race groups. Females are more likely to receive assistive devices than males but reasons for this are not clear.

The majority of respondents depend on the State for services rendered. Whites are more likely to make use of private services as opposed to Africans, Coloured and Indian respondents, who are more likely to make use of government services.

Services being too expensive and people not having money ( to pay for services or transport) are seen by respondents as the biggest problems experienced with services.

3.4. Assistive devices
Assistive devices (AD) are a crucial component of service provision for disabled people. The rate of severity of disability decreased significantly through the use of assistive devices and there is an increasing need for assistive devices with increasing age.

Indian and White disabled people are more likely to be using assistive devices than Africans and Coloureds with disability. The majority of AD users live in formal metropolitan and urban areas. These results reflect the fact that access to services through finance and awareness are strongly linked to the ability to obtain and maintain assistive devices.

Children attending special schools ( primary and secondary levels) are more likely to access and use assistive devices than those attending mainstream schools. However, it should be remembered that only very few disabled children attend special schools and that those who do also tend to be more advantaged, and hence, are more likely to also be AD users.

3.5 Education
The figures on school attendance indicate that primary school is the most accessible education level with 79% of respondents attending mainstream primary school and 12% special school, and only 5% not attending school at this level. Preschool and high school are generally not accessed well, with 40% and 44% of respondents attending mainstream schools at these levels respectively. A similar number of disabled children attend special schools for preschool and high school as for primary school (10% and 9% respectively).

This does not in any way mean that, just because many disabled children attend school in the mainstream system, that inclusive education has been achieved or that disabled children have been catered for. As pointed out by the National Committee on Educational Support Services (NCSNET/NCESS), this inclusion is an ad hoc solution which does not deal with the issues of special educational need nor disability. There are just no other services and so disabled children are on the whole 'dumped' onto the mainstream schools whether by their parents or the education system.

3.6 Employment
All respondents who were 15 years or older at the time of interview were asked the question on employment. The total sample size for this section is 1448 out of the 1703 sample of disabled people.

The data on employment indicate that race, sex, number of disabilities and age of onset all play a significant role in whether a person is employed or not. Whites are more likely to be employed, women are less likely to be employed, and people with more than one disability or who have an early onset of their disability are all less likely to be employed. The overall employment figures are low at 12% being less that a third of the employment rate for the general population. Of the total number of disabled people 15 years or older, 88% were economically inactive and/or unemployed but looking for work compared to 63% of people in the general population in a similar position. These data indicate that disabled people face serious barriers to employment.

Nineteen percent (19%) of White disabled people are employed in full-time position compared to Africans (6%), Coloureds (4%) or Indians (9%). The employment rates for disabled women is 11% compared to 15% for disabled men and 80% of disabled women are economically inactive compared to 74% of disabled men.

3.7 Transport
All respondents were asked about the main form of transport they use as well as what they think would be the best form of transport to provide for people with disabilities. No questions were asked about the frequency of use and the accessibility of the transport used.

The data show that:-
The majority of respondents make use of public transport but with no indication of whether this type of transport is accessible or not,
The majority of respondents think special transport is the best way to provide transport for disabled people; this result could be seen to indicate that the public transport system is so inaccessible that the only solution to provide transport is through special transport,
Respondents in rural areas are more dependent on public transport than respondents in urban and metropolitan areas;
More advantaged respondents are more likely to make use of cars as their mode of transport.

Further research is required to complement the survey data. This would include looking at the accessibility of public transport and the frequency of use by people with different disabilities.

3.8 Level of integration within family
There are a number of factors that are important in determining whether a person experiences high, medium or low levels of integration. A log-linear analysis was undertaken to determine which of these are the most important. The results show that age of onset and number of disabilities are the two most crucial variables determining the level of integration of a disabled person within his or her family. The earlier the onset and the greater the number of disabilities, the less integrated the person is likely to be within their family. The later the onset and the less the number of disabilities, the more likely the disabled person is to be integrated within their family. Of respondents with one disability, 67% had a high level of participation compared to 49% of those with three disabilities or more. Of respondents with age of onset before two years of age, 41% had a high level of participation compared to 66% of those with age of onset after 19 years of age.

These two factors override the effects of race, type of disability and sex in determining level of integration. These findings highlight the overarching disadvantage caused by being disabled no matter what race or sex a person is nor the type of disability the person has. When disadvantage due to race is added onto being disabled ( i.e. African disabled people), the discrimination is further increased or aggravated.

3.9 Social Security
WHAT RESULTS CAN BE USED FOR IMMEDIATE ACTION :
· causes of disability
- prevention policy and services improvements of quality of care

· assistive and personal assistant services
- increase provision
- encourage interdepartmental collaboration

· lack of services + inequality
- decentralisation of medical rehabilitation and CBR services
- increase environmental and built environmental accessibility
- integration of services

· PHC package lack of integration/barriers
-awareness programmes,
- attitudinal change,
- inclusion of disability issues on all agendas in planning process,
- empowerment and capacity building,
- enforcement of current Acts, strategic etc.

· encourage further research

LIMITATION OF STUDY
1. Did not include impairments e.g. chronic illness, genetic diseases, etc,
2. Did not specifically identify temporary disabilities which will need immediate action to prevent progress to permanent disability,
3. Mild disabilities were very difficult to identify.
4. Study provides a national picture.