Date: 29/10/2002 Source: Ministry of Health Title: Second reading
debate in the National Assembly: Medicines and Related Substances
Amendment Bill
Madame speaker,
honorable members,
fellow South Africans,
It is now 9 years since the ANC health plan was developed, which outlined the National Drug Policy. This policy is aimed at ensuring access to medicines that are safe, effective and of consistent quality at affordable prices in a sustainable manner.
This translated into legislative changes that put South Africa on a global agenda on access. And therefore, when we tabled Act 90 of 1997 in this Assembly for your consideration, we were aware of the significance of that action. And though we were disappointed, we were not surprised by the reaction of the pharmaceutical industry.
We are, however, happy that that period of conflict and suspicion seems to be behind us. And on our part, we reiterate our commitment to a strong, principled partnership with the pharmaceutical industry, based on the recognition of the complimentarity of our efforts, but not blind to the contradictions that derive from the mandate we derive from our respective principals and constituencies.
I wish to recognise the constructive dialogue we have had with the pharmaceutical industry since the resolution of the case on Act 90 of 1997, and in the Department, we have already taken steps to lay the foundation for the implementation of the Act.
I know that for those who daily bear the brunt and scars of unaffordable medicines, every minute has been a period of despair. Through our collective effort, however, we can restore their faith and justice in the health care system. And I shall do my part, especially for the children of our country, whom we are celebrating during this month.
I pledge myself on behalf of our government that no child will go without immunization because of the escalating cost of medicines. As a bottom line, we are fully committed to honour our promise of free health care for children and pregnant women. That is our contribution as the Health Department towards poverty alleviation.
Honorable members will recall that Act 90 of 1997 was released from the stranglehold of the courts in April last year. In June we published the regulations that would facilitate the implementation of that Act. It was in part the public response to those draft regulations that necessitated the technical amendments before this House.
We have, whilst working on this Bill, simultaneously been re-crafting the regulations taking into account the public inputs. A joint team between my Department and the Medicines Control Council has all but completed this task.
As soon as Parliament passes this Bill and the President signs it into law, we shall be ready to usher in what surely will be a signal point in our journey of transforming our health system.
Let me remind the house of the key objectives of this policy framework, which remains a cornerstone of development as it touches on health, economic, and national development objectives.
The Health Objectives are:
* To ensure the availability and accessibility of essential drugs to all citizens
* To ensure the safety, efficacy and quality of drugs
* To ensure good dispensing and prescribing practices
* To promote the rational use of drugs by prescribers, dispensers and patients through provision of the necessary training, education and information
* To promote the concept of individual responsibility for health, preventive care and informed decision-making.
The Economic Objectives are:
* To lower the cost of drugs in both the private and public sectors
* To promote the cost effective and rational use of drugs
* To establish a complementary partnership between government bodies and private providers in the pharmaceutical industry
* To optimize the use of scarce resources through cooperation with international and regional agencies.
National development Objectives:
* To improve the knowledge, efficiency and management skills of pharmaceutical personnel
* To re-orientate medical, paramedical and pharmaceutical education towards the principles underlying the National Drug Policy
* To support the development of the local pharmaceutical industry and the local production of essentials drugs
* To promote the acquisition, documentation and sharing of knowledge and experience through the establishment of advisory groups in rational drug use, pharmaco-economics and other areas of the pharmaceutical sector.
In the recent past, we have seen public health issues balanced with trade, the emergence of the Doha declaration, and enormous public response. This has elevated the debates on access to affordable medicines, essential drugs lists and the control of drug expenditures.
The role of medicines in the delivery of health services is key to improving health outcomes, when they are used appropriately and rationally. The provisions to regulate marketing activities of medicines through the development of ethical codes is key to controlling inappropriate use, aggressive marketing and replacing perverse activities with objective and balanced promotion that is informative to the public.
Pricing issues have remained a challenge over the past five years. The existing legislative framework is deficient on providing affordable medicines in this country; even tendering has not achieved lower priced insulin for the diabetic patients in this country. The establishment and appointment of a pricing committee has been prioritized in the implementation process.
The pricing of medicines is highly regulated in Europe and other countries and in countries of the North. Similarly, South Africa must intervene in instances where public health is compromised by high cost of medicines.
We have seen in the recent past challenges faced by South Africa as a result of a weakened inspectorate. This legislation will strengthen and empower the inspectorate to deal with all forms pharmaceutical crime, corruption and diversion through access to records and documentation, and the power to search and seize. All done within the parameters of our constitutional order.
I wish to appeal to fellow South Africans and all health professionals to embrace the changes that are aimed at improving how medicines are prescribed and dispensed.
The pharmaceutical industry has over the years enjoyed enormous benefits, in that a number of services were rendered for the registration of medicines at no cost, despite the high costs of medicines in this country.
An opportunity now exists for extra revenue generation and retention by the Medicines Control Council to adequately fund its operations and extend its services to ensure safety, efficacy and quality are consistently assured.
Madam speaker the amendments that are being introduced are minor and have been formulated to ensure operational feasibility especially in the areas of licensing that require major administrative support.
We have now reached the point where we could proceed with the implementation of Act 90 of 97. This amendment bill facilitates that. This will indeed usher in a new era in pharmaceutical management in our country and establish us firmly as leaders in this area.
It has been a long road but every step was worth the effort. A glorious future beckons for many South Africans and we have to discharge our duties diligently to give effect to our dreams of a better life for all.
Once again, I must thank the Portfolio Committee and in particular the Chairperson, for allowing a vigorous debate on the Bill. And now, Honorable Members, I humbly request you to you're your support to this Bill, which will make quality medicines accessible and affordable, and will improve the health of South Africans.
I Thank You!
Madame speaker,
honorable members,
fellow South Africans,
It is now 9 years since the ANC health plan was developed, which outlined the National Drug Policy. This policy is aimed at ensuring access to medicines that are safe, effective and of consistent quality at affordable prices in a sustainable manner.
This translated into legislative changes that put South Africa on a global agenda on access. And therefore, when we tabled Act 90 of 1997 in this Assembly for your consideration, we were aware of the significance of that action. And though we were disappointed, we were not surprised by the reaction of the pharmaceutical industry.
We are, however, happy that that period of conflict and suspicion seems to be behind us. And on our part, we reiterate our commitment to a strong, principled partnership with the pharmaceutical industry, based on the recognition of the complimentarity of our efforts, but not blind to the contradictions that derive from the mandate we derive from our respective principals and constituencies.
I wish to recognise the constructive dialogue we have had with the pharmaceutical industry since the resolution of the case on Act 90 of 1997, and in the Department, we have already taken steps to lay the foundation for the implementation of the Act.
I know that for those who daily bear the brunt and scars of unaffordable medicines, every minute has been a period of despair. Through our collective effort, however, we can restore their faith and justice in the health care system. And I shall do my part, especially for the children of our country, whom we are celebrating during this month.
I pledge myself on behalf of our government that no child will go without immunization because of the escalating cost of medicines. As a bottom line, we are fully committed to honour our promise of free health care for children and pregnant women. That is our contribution as the Health Department towards poverty alleviation.
Honorable members will recall that Act 90 of 1997 was released from the stranglehold of the courts in April last year. In June we published the regulations that would facilitate the implementation of that Act. It was in part the public response to those draft regulations that necessitated the technical amendments before this House.
We have, whilst working on this Bill, simultaneously been re-crafting the regulations taking into account the public inputs. A joint team between my Department and the Medicines Control Council has all but completed this task.
As soon as Parliament passes this Bill and the President signs it into law, we shall be ready to usher in what surely will be a signal point in our journey of transforming our health system.
Let me remind the house of the key objectives of this policy framework, which remains a cornerstone of development as it touches on health, economic, and national development objectives.
The Health Objectives are:
* To ensure the availability and accessibility of essential drugs to all citizens
* To ensure the safety, efficacy and quality of drugs
* To ensure good dispensing and prescribing practices
* To promote the rational use of drugs by prescribers, dispensers and patients through provision of the necessary training, education and information
* To promote the concept of individual responsibility for health, preventive care and informed decision-making.
The Economic Objectives are:
* To lower the cost of drugs in both the private and public sectors
* To promote the cost effective and rational use of drugs
* To establish a complementary partnership between government bodies and private providers in the pharmaceutical industry
* To optimize the use of scarce resources through cooperation with international and regional agencies.
National development Objectives:
* To improve the knowledge, efficiency and management skills of pharmaceutical personnel
* To re-orientate medical, paramedical and pharmaceutical education towards the principles underlying the National Drug Policy
* To support the development of the local pharmaceutical industry and the local production of essentials drugs
* To promote the acquisition, documentation and sharing of knowledge and experience through the establishment of advisory groups in rational drug use, pharmaco-economics and other areas of the pharmaceutical sector.
In the recent past, we have seen public health issues balanced with trade, the emergence of the Doha declaration, and enormous public response. This has elevated the debates on access to affordable medicines, essential drugs lists and the control of drug expenditures.
The role of medicines in the delivery of health services is key to improving health outcomes, when they are used appropriately and rationally. The provisions to regulate marketing activities of medicines through the development of ethical codes is key to controlling inappropriate use, aggressive marketing and replacing perverse activities with objective and balanced promotion that is informative to the public.
Pricing issues have remained a challenge over the past five years. The existing legislative framework is deficient on providing affordable medicines in this country; even tendering has not achieved lower priced insulin for the diabetic patients in this country. The establishment and appointment of a pricing committee has been prioritized in the implementation process.
The pricing of medicines is highly regulated in Europe and other countries and in countries of the North. Similarly, South Africa must intervene in instances where public health is compromised by high cost of medicines.
We have seen in the recent past challenges faced by South Africa as a result of a weakened inspectorate. This legislation will strengthen and empower the inspectorate to deal with all forms pharmaceutical crime, corruption and diversion through access to records and documentation, and the power to search and seize. All done within the parameters of our constitutional order.
I wish to appeal to fellow South Africans and all health professionals to embrace the changes that are aimed at improving how medicines are prescribed and dispensed.
The pharmaceutical industry has over the years enjoyed enormous benefits, in that a number of services were rendered for the registration of medicines at no cost, despite the high costs of medicines in this country.
An opportunity now exists for extra revenue generation and retention by the Medicines Control Council to adequately fund its operations and extend its services to ensure safety, efficacy and quality are consistently assured.
Madam speaker the amendments that are being introduced are minor and have been formulated to ensure operational feasibility especially in the areas of licensing that require major administrative support.
We have now reached the point where we could proceed with the implementation of Act 90 of 97. This amendment bill facilitates that. This will indeed usher in a new era in pharmaceutical management in our country and establish us firmly as leaders in this area.
It has been a long road but every step was worth the effort. A glorious future beckons for many South Africans and we have to discharge our duties diligently to give effect to our dreams of a better life for all.
Once again, I must thank the Portfolio Committee and in particular the Chairperson, for allowing a vigorous debate on the Bill. And now, Honorable Members, I humbly request you to you're your support to this Bill, which will make quality medicines accessible and affordable, and will improve the health of South Africans.
I Thank You!
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