STATEMENT BY DR OLIVE SHISANA, DIRECTOR GENERAL OF HEALTH THURSDAY 21 AUGUST 1997
"The new Medicines Bill introduced in Parliament this week will result in a substantial reduction in medical costs to the consumers whilst providing adequate protection against unsafe products," says the Director General of Health, Dr Olive Shisana.
The Department of Health is committed to the delivery of afford- able health care to the entire South African population. The very high costs of medicines have been identified as one of the major reasons why ordinary consumers find it increasingly difficult to meet their medical bills.
At the same time the Department has a duty to protect the consumer against any unsafe medicines that may appear on the South African market.
"We believe that the new Bill (The Medicines and Related Substances Control Amendment Bill) meets both criteria. It will reduce the costs of medicines and at the same time protect the public against harmful products," says Dr Shisana.
The Bill introduces several measures aimed at reducing the costs of medicines and to bring it within reach of the entire population. This include generic substitution, international tendering, parallel importation, the licencing of dispensing doctors and regulating the ownership of pharmacies.
A greater utilisation of generic drugs and a system that allows for the parallel importation of medicines are but two of the measures decided upon by government to reduce the costs of medicines to the consumer.
In the case of generic drugs the aim of the legislation is to promote the usage of such medicines that contain the same active substances and are identical in strength or concentration, and dosage as the innovator medicines that are often prescribed by medical practitioners. This is a common practice throughout the world and encouraged by the World Health Organisation where it is referred to as interchangeable, multi-source pharmaceutical products (IMPP).
Where generic drugs are available their dispensing should be encouraged because they are far cheaper for the consumer whilst achieving exactly the same therapeutic results. The Medicines Control Council will ensure that the quality standards of the generic drugs are no different to their innovator counterparts.
The Bill also provides for the parallel importation of drugs under very strictly controlled circumstances. "It has never been the intention of the Department to allow for the unbridled importation of drugs or the flooding of the market with unsafe products," says Dr Shisana.
In fact the Bill clearly states that the Minister will prescribe the conditions under which imported medicines may be placed on to the South African market. Such medicines will need to meet exactly the same quality standards as that of other medicines already registered in South Africa.
These issues have been discussed at length with stakeholders across the entire health care system - including representatives of the pharmaceutical industry.
"It is simply untrue to state that there was inadequate consultations on the issue. And we believe that we are not violating any international agreement."
"It is a pity that the aims and objectives of the entire Bill has been overshadowed by a misinterpretation of one clause. There are numerous other measures aimed at benefitting the consumer through easier access to pharmaceutical services and tightening up controls over the distribution of drugs," says Dr Shisana.
The Bill creates a pricing committee that will monitor the price of medicine and make recommendations to the Minister on the eventual introduction of a transparent pricing system.
It provides for a Code of Ethics relating to the marketing poli- cies of pharmaceutical companies and will prohibit the practice of sampling of medicines which can be used to influence the prescrip- tion of certain, more expensive products.
"The aims of the Bill remain to make medicine more affordable to the public. One would expect that the entire medical industry - including the manufacturers - would support these noble goals.
"The Department of Health has a simple duty towards all consumers of medical products - to implement measures that will bring down the cost of health care without jeopardising the safety of the consumer.
"We believe that the Bills presented to Parliament this week will achieve these goals and that the ordinary public will soon see the benefits of these provisions through a reduction on their medicine expenses," says Dr Shisana.
Issued by: Dr Olive Shisana, Director General - Department of Health Tel 021 451-4362