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Date: 27/05/2004
Source: Ministry of Health
Title: M Tshabalala-Msimang: Parliamentary Media Briefing, May 2004


PARLIAMENTARY MEDIA BRIEFING BY MINISTER OF HEALTH, DR MANTO TSHABALALA-MSIMANG, 27 May 2004

Introduction

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 following:

* The development of a global code of practice on recruitment of health workers
* 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 Development.

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 year.

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 consultation.

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 medicines.

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 public.

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 professionals.

Medicines pricing

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 inputs made.

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 benefit.

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 prices.

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 medicine.

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 health sector).

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 weeks.

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 200.

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 interrupt it.

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 supplies.

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.

Additional developments

Other developments in the implementation of the Comprehensive Plan include:

* 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 treatment matters
* The installation of testing equipment for viral loads at 26 out of 27 hospital sites and the completion of training of laboratory personnel
* The unfolding of the training programmes for health professionals
* 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.

Furthermore:

* 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.

Legislation

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 year.

* 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 practitioners.

* 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 years.

Issued by: Ministry of Health
27 May 2004

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