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Source: Ministry of Health
Title: M Tshabalala-Msimang: Parliamentary Media Briefing, May
PARLIAMENTARY MEDIA BRIEFING BY MINISTER OF HEALTH, DR MANTO
TSHABALALA-MSIMANG, 27 May 2004
The focus of this media briefing will fall on the implementation of
key legislation and health programmes and will conclude with a
brief overview of legislation that is likely to come before
Parliament during the course of this year. I will talk mainly about
the measures taken in terms of the Medicines Control Amendment Act
and the services established in various provinces to give effect to
the Comprehensive Plan for the Care, Management and Treatment of
HIV and AIDS.
I would, however, like to start with the recent World Health
Assembly, held in Geneva last week.
The World Health Assembly
Every year in May, Health Ministers and senior officials from
around the world constitute the World Health Assembly in Geneva.
The decisions of this assembly provide a political mandate for the
World Health Organisation. In this way, global and international
health initiatives -- such as polio eradication, Roll back Malaria
and the Framework Convention on Tobacco Control -- are adopted and
put into effect by member states, eventually impacting on the
health of millions of people round the world.
This year I have the honour of chairing the Afro Region of WHO and
serving for the year as a vice-president of the World Health
Assembly. The Afro Region has achieved a level of unity that
enables it to speak with one voice in the Assembly thanks to
thorough discussion among us on the issues raised in the
resolutions. As the region with the highest burden of disease and
severe resource constraints, it is important for Africa to
articulate strong and clear positions in the WHA.
Two subjects dealt with by the Assembly this year are of particular
significance to ourselves as a country. These are:
* The question of the migration of health workers from developing
countries to more affluent parts of the world
* The relationship between diet and physical activity and the
prevention of diseases such as diabetes, cardiovascular disease,
osteoporosis and various types of cancer that make-up a huge part
of our total disease burden.
Migration of health workers
The resolution on migration of health workers was proposed by South
Africa and supported by a wide range of countries. It achieves the
* The development of a global code of practice on recruitment of
* The introductions of the principle of compensation when
developing countries are deprived of human resources by more
wealthy countries. (This aspect of the resolution is not binding,
although member states are urged to abide by it. We will strive to
have it firmed up as a convention in years to come.)
* The focus of WHO's considerable research and technical resources
on this problem of adequate human resource development for health.
The global health theme for 2005 will be Human Resources for Health
It is worth noting that the Royal College of Nursing in Britain
released a report earlier in May that estimated that the National
Health Service in that country recruited 40 000 nurses from abroad
over a three year period and that about 45% of this number were
from the Philippines, South Africa, Australia and India.
South Africa already has a bilateral agreement with the British
Government that provides ethical workforce policies and practices.
This arrangement goes a long way in reducing the brain-drain from
South Africa while at the same time ensuring that health
professionals from both countries have an opportunity to get
international exposure. Further discussions will be held with
British Health Secretary John Reid when he visits South Africa this
Global Strategy on Diet and Physical Activity
The resolution endorsing a Global Strategy on Diet, Physical
Activity and Health is a response to the fact that about 60% of all
deaths across the world and 47% of the burden of disease can be
attributed to non-communicable diseases such as diabetes,
cardiovascular diseases, osteoporosis and cancers. About two-thirds
of deaths linked to these diseases occur in the developing world.
The major risk factors are poor diet and physical inactivity and
the associated condition of obesity.
In South Africa we have long recognised that, in addition to the
huge challenge of communicable diseases such as TB, AIDS and
malaria, non-communicable diseases constitute a major public health
problem. Our mortality statistics are imperfect, but they show that
cardiovascular disease is a significant cause of death among women
of all races. Our first Demographic and Health Survey revealed
extremely high rates of obesity in our population -- and we expect
that this will be confirmed by the results of our second survey,
which are expected in the next three to four months.
It is worth noting that the Assembly's position on HIV and AIDS is
fully consistent with South Africa's approach as formulated in the
Comprehensive Plan adopted by Cabinet last year and was, indeed,
influenced by our approach in respect of nutrition and gaining a
better understanding of traditional medicines and their interaction
with commonly used drugs, including antiretrovirals (ARVs)
We regret that a resolution on the feeding of infants and young
children was not passed by the Assembly. In South Africa, we will
be finalising regulations on the labelling and advertising of
infant formula later this year after a process of extensive
The WHO continues to focus strongly on global polio eradication. In
South Africa we have reached the final leg of the process of being
declared polio free in 2005. The last push involves a mass
immunisation campaign against polio and measles in July and August
this year. The recent detection of a case of polio in Botswana,
apparently caused by cross-border infection, should be a warning to
us. Our best protection against the transmission of diseases across
borders is to maintain the highest possible rate of immunisation
among our people and in the Southern African region.
Our cooperation as SADC Health Ministers continues. As a country we
have entered into several bilateral agreements with our SADC
neighbours leading to joint initiatives like the use of DDT to
massively reduce prevalence of malaria working together with
Mozambique, Swaziland and Zimbabwe.
The Medicines Control Amendment Act
Two aspects of the Medicines Control Amendment Act have caused a
great deal of debate and have drawn quite determined opposition
from a number of quarters. These are the requirement that all
health professionals (other than pharmacists) who dispense
medicines must acquire a licence to do so and the regulations on
the pricing of medicines and the fees for dispensing
Some of the opposition was expected -- after all, a major aim of
this law is to make medicines more affordable to the people of our
country and therefore the financial interests of those in the
supply chain are inevitably going to be affected. We have sought to
retain reasonable financial returns all along the supply chain --
but it would be a miracle if all interest groups thought we had
achieved the right balance.
Our mandate as government is to increase access to health care for
all South Africans and we remain firmly committed to goal of
reducing the price of medicines. This legislation is a serious
attempt to ensure that ordinary South Africans can afford essential
health care. And we have to suffer some bumps and bruises in
achieving that goal - we are prepared to do so.
Licensing of dispensing professionals
The heated response to the licensing of dispensing doctors (and
other health professionals) is less easy to explain. This is, after
all, a measure designed to promote the standard of health care
services and we would have expected professional organisations to
take a more responsible position on this.
It is unfortunate it took so long for the South African Medical
Association to finally encourage its members to enrol for the
mandatory dispensing course and apply for the licence. SAMA's
original call to doctors to defy the law has cost us valuable time
and has potentially to negatively affect patients and general
There are essentially three steps in the licensing process:
* The applicant has to complete a course on dispensing
* He or she has to submit the licence application form together
with a fee
* And an advert must be placed in a newspaper advising of the
licence application so that interested parties can submit comments
if they wish to.
It appears that about 500 health professionals will have completed
the course and obtained licences to dispense by the deadline of 2
June 2004. This is despite the best efforts of the Department for
several months to encourage health professionals to register and
complete the course. In cases where individuals submit their
licence applications while doing the dispensing course, the
decision on awarding the licence can be finalised within 48 hours
of submission of proof that the course has been completed.
We believe that the thousands of professionals who have registered
for the dispensing course have every intention of complying with
the law in the next month or two. We therefore appeal:
* To health professionals to complete the course as speedily as
possible. This is a distance-learning course where the pace is
determined by the individual undertaking it
* To all parties concerned -- doctors, patients, pharmacists,
public health services and medical schemes -- to deal with the
period immediately after 2 June (before widespread licensing kicks
in) as constructively as possible.
There is still legal action pending in the High Court on this
matter. The National Convention on Dispensing is challenging the
licensing provision on constitutional grounds and the hearing is
set down for next Monday. As Government we are defending the action
because we believe that the provision on dispensing licences cannot
be construed as an infringement of the fundamental rights of health
The second area is regulating the prices of medicine.
There is general agreement that South Africans have been paying
more for medicine compared to similar markets in other parts of the
world. This is admitted by all the parties in the drug supply chain
- manufacturers and importers, wholesalers and distributors as well
as retail pharmacies and dispensing health professionals.
The parties in this industry differ on who is responsible for
exorbitant prices blaming each other along the supply line with the
consumer being the main if not the sole casualty. Our intervention
as government have been guided by the principles of creating a
transparent pricing system
Central to the system is a single exit price set by the
manufacturer for every medicine. Equally important, is the
introduction of a maximum professional fee for dispensing services
replacing a system of commercial mark-ups. The regulations also
carry a strong theme of mandatory disclosure of information
relating to pricing.
We adopted this approach after an extensive consultation with the
industry both inform of written submissions and presentation to the
Department of Health. If you compare the draft regulations
published in January and the final version as they came out at the
end of April, it is clear that we did considered the valuable
In general, the drug manufacturing industry has been supportive of
the process by beginning to register single exit price. This single
exit price includes the wholesaling and distribution costs. The
regulations make provision for the Minister to specify maximum
distribution fees when this is necessary for public health
The introduction of section of these regulations prohibiting
"discounting" has caused unnecessary uncertainty on the prices.
Pharmacies have a three months period within which to clear their
stock. There is no reason for this stock to be sold at higher
Consumers should be paying the same amount they were being charged
before 2 May or even less.
From 2 June 2004 a single exit price will be introduced but becomes
compulsory by 2 August. Manufacturers will have to set one price at
which medicine will be sold to all parties minus cost of
discounting, bonus deals, rebates and other incentives. The
pharmacist will in addition charge a dispensing fee of up to 26% of
the single exit price of less than R100 and maximum of R26 from the
single exit price of more than R100.
The introduction of the single exit price is expected to bring a
saving of up to 15% on branded products and up to 30% on generic
Private health Sector
The Department of Health is committed to work with the private
health sector to ensure that we develop synergies with the public
health sector. I held a meeting with senior representatives of the
private health sector last month where we agreed that there was
much common ground between ourselves, as government and the private
sector. The most critical decision we took was to agree to develop
a health charter. I will ensure that this process is completed by
the end of this year and that the charter clearly sets out the role
of the private health sector in our country.
The Comprehensive HIV and AIDS Plan
The Comprehensive Plan for Care, Management and Treatment of HIV
and AIDS is being implemented in all provinces. The Plan has a dual
focus on building the capacity of the health system to deliver
complex programmes of care and provision of the range of services
specified in the Plan.
The aspect of antiretroviral treatment for people who have AIDS and
whose immune systems have been severely depleted has required
special preparation. While other aspects of the plan - such as TB
treatment and nutrition - build on existing services, ART has not
been offered previously in the public sector. It is a treatment
that requires good patient record systems, effective laboratory
services and pharmaceutical supply systems that are reliable and
secure. It also depends to a huge extent on engaging the patient as
a partner in treatment.
All provinces have made progress on providing the ART option to
patients who meet the medical criteria for treatment. However, the
pace has differed from area to area - in accordance with the amount
of groundwork that had to be done to meet the national standards
set for designated service points.
The provinces of Gauteng, KwaZulu-Natal and Western Cape have
fairly large numbers of patients receiving ART. The numbers for the
respective provinces are: Gauteng - about 940, Western Cape - about
2 500 (these include patients who were previously treated under
other programmes) and KwaZulu-Natal - 153 (plus patients treated on
established programmes funded from sources outside the public
The other provinces are not yet providing antiretroviral drugs to
patients on any significant scale (although some have a small
number of patients on ART). They are all actively enrolling
patients. This means conducting tests, counselling and educating
patients in preparation for ART, a process that takes several
An indication of the volume of patients being enrolled across all
nine provinces is the fact that 11 800 CD4 tests were done during
April. Of the patients tested, 6 700 had CD4 counts under
Because the tender process for ARVs is quite complex and lengthy,
interim arrangements were made for provinces to purchase initial
supplies of the drugs. The interim measures have not been entirely
problem free. The range of generic drugs currently available is
limited and this means prices have been relatively high. And long
lead times between order and delivery have imposed constraints. The
paediatric drugs are in particularly short supply and provinces are
experiencing problems accessing them.
As a result, provincial health departments have taken a cautious
approach to initiating treatment, knowing that it is dangerous to
The tender process for long term supply of ARVs is well underway.
The next step will be for the 10 short-listed companies to make
presentations. Companies will be selected from this group to make a
final bid for the contracts. Clearly several suppliers will be
awarded contracts - because of the range of drugs involved in the
treatment and because of the need to ensure large, uninterrupted
It is expected that the number of generic suppliers will increase
in the near future, as the fast track registration process of the
Medicines Control Council will be is concluded later this week and
as more manufacturers secure voluntary licences.
Other developments in the implementation of the Comprehensive Plan
* A national indaba, involving all provinces, to strategise for
better TB control
* The award of major tenders to continue the Khomanani Campaigns,
dealing with communication on a wide range of prevention, care and
* The installation of testing equipment for viral loads at 26 out
of 27 hospital sites and the completion of training of laboratory
* The unfolding of the training programmes for health
* The introduction of a standard computer based patient record that
facilitates national analysis of data on the programme
* Increased purchasing of supplementary meals by the provinces for
use in accordance with the Plan
* Progress in relation to research of traditional medicines
commonly used by people living with HIV and AIDS.
The Global Fund to Fight HIV, AIDS, TB and Malaria
I take issue with suggestions by Dr Richard Feacham, director of
the Global Fund, that South Africa is failing to utilise money
allocated to it by the Fund. As a Board member of the Fund I am
fully aware of its policies and approach and I am convinced that
South Africa is administering funds with appropriate attention to
its fiduciary duties.
* Every dollar received by Treasury and the Department of Health on
behalf of South African recipients of Global Fund grants has been
passed on to the organisations in question
* Steps have been taken to secure the second disbursement from the
Fund, taking care to prevent the possibility of "double-dipping" by
LoveLife, which is also funded by Government
* Further transfers of moneys - in terms of grants made in rounds
two and three - depends not on actions of the South African
Government but on the Fund's own agents in this country.
Dr Feacham's statements suggest a departure from the Fund's
commitment to respecting the sovereignty of recipient countries and
the need for strong country coordination.
The following pieces of legislation are expected to be before
Parliament before the end of 2004: * An amendment to the Tobacco
Products Control Act. The main purpose is to strengthen certain
provisions in the earlier Act and to ensure our law is fully
compliant with the Global Framework Convention on Tobacco Control
so that South Africa can ratify the convention later this
* An amendment to the Medicines and Related Substances Control Act
in order to deal more appropriately with the classification and
registration of complementary medicines.
* The Traditional Health Practitioners Bill, which will provide for
the registration and self-regulation of traditional health
* The Nursing Bill, which will replace the Nursing Act. The Bill
focuses on the Nursing Council, its powers and functions and
governance processes. The idea is to create a structure better able
to perform its role as a "public watchdog" and keeping with trends
in public administration.
* Amendments to the Health Professions Act and the Dental
Technicians Act, with many of the same aims as those that underpin
the Nursing Bill.
* Amendments to Choice on Termination of Pregnancy Act, (to provide
for increased access to services) and to the Sterilisation Act, to
facilitate a more individualised approach to sterilisation of
intellectually handicapped young women under the age of 18