Medical Law Update – Deneys Reitz

by Donald Dinnie
Published: April 1st, 2011
Donald Dinnie

1. Health:  Medicines and Related Substances Act

The health department published three key regulations pertaining to a transparent pricing system for medicines and scheduled substances in the Government Gazette during December.

The regulations were published in terms of the Medicines and Related Substances Act.

The first notice deals with the methodology for international benchmarking of prices of medicines and scheduled substances in South Africa.
Written comment was invited until 11 March 2010.

The document focuses on:

· International and local context for the international benchmarking recommendations

· Aims and objectives of international benchmarking

· Rationale for international benchmarking

· The proposed approach to benchmarking

· Selection of benchmark countries

· Identification of comparator product and price

· Methods used to calculate the benchmark price

· International benchmarking of combination products

· Evaluation of policy outcomes

· According to the document, the aim of international benchmarking is to eliminate price distortions and thereby protect the local health system from paying distorted prices for medicines.

Also outlined are the key elements of the pricing committee’s recommendations.

The pricing committee makes recommendations to the minister of health on a particular medicine’s value for money. For example, it looks at the cost-effectiveness of a product in comparison to alternatives in the market place.

The second notice deals with an amendment to regulations relating to a transparent pricing system for medicines and scheduled substances.

The amendment refers to the dispensing fee to be charged by persons licensed in terms of section 22C (1) (a).

The notice can be viewed on Sabinet’s government gazette database:-(GG 33906, GN 1256, 2010-12-24).

The third notice deals with draft guidelines for pharmacoeconomic evaluations of medicines and scheduled substances.
Written comment is invited until 18 March 2010.

The objectives of the guidelines are to:

· Outline the application process

· Establish which medicines need to be evaluated

· Describe the appraisal process

· Set up a forum to provide an objective and independent review of the value of medicines

· Clearly explain what criteria and information are required

In essence, the guidelines seek to put in place a framework to determine the cost-effectiveness of medicines.

All cost-effective medicines are registered on the health department’s website.

The notice can be viewed on Sabinet’s government gazette database:- (GG 33914, GN 1265, 2010-12-31).

2. Health:  Draft National Health Amendment Bill

The health department has published the draft National Health Amendment Bill in the Government Gazette for public comment.

The notice points out that the minister of health intends tabling the bill in Parliament this year.

Written comment is invited until 18 April 2011.

In a statement, the department indicates that the release of the bill is an important development in terms of the proposed establishment of the office of health standards compliance.

The bill seeks to amend the National Health Act in order to allow for the setting up of the office.

“The establishment of the office of standards compliance follows government’s commitment to improve the quality of healthcare in public health facilities and the strengthening of the health system’s effectiveness through enhanced accountability”.

In terms of the minister of health’s performance agreement, a number of priorities to improve conditions in public hospitals have been identified.

The priorities are:

·         Safety and security

·         Long waiting times

·         Drug availability

·         Nursing attitude

·         Infection prevention and control

·         Values of staff

The office of health standards compliance will aim to

·         Ensure that complaints are properly and independently investigated

·         Advise the minister on development of norms and standards for health system

·         Advise the minister on quality management systems

·         Inspect and certify health institutions

·         Monitor potential risks to the system

The office will be headed by a qualified executive director. Inspectors will be able to enter any health-related premises to monitor compliance with the norms and standards.

The office is seen as playing a vital role in the setting up of the envisaged national health insurance (NHI).

According to the statement, a key objective of the NHI is to facilitate quality care in South Africa. The proposed office will help in this regard.

3. Health:  National Health Insurnace

The treasurer-general of the African National Congress (ANC), Mathews Phosa, has revealed that a white paper on the national health insurance (NHI) will be ready for public comment in February.
Speaking to a provincial meeting of the ANC in the Eastern Cape, Mr Phosa declared that government wanted to roll out the NHI programme as soon as possible.

The inter-ministerial committee on the NHI has been instructed to complete its work and submit the necessary report to cabinet.
The formulation of a white paper would indicate that the legislative process was on track.

Mr Phosa added that a successful NHI would help government deliver on its “undertakings on creating a better life for all”.

In October last year, the health department announced that the NHI would be implemented over a period of 14 years, starting in 2012.

At the time, the department declared that the proposed NHI was founded on the constitutional right of all South Africans to quality health care.

Part of the plan would involve improving the quality of healthcare in public hospitals.

4. Health:  Department Performance Plan

The Department of Health has published an annual performance plan for 2011/12 to 2012/13.

The plan includes a situational analysis, programmes and sub-programmes.

According to a foreword by health minister Aaron Motsoaledi, in response to a “public outcry” about the spiralling cost of health care in the private sector, his department will be exploring ways of closing the gap between public and private health care as well as between health care in urban and rural areas.

This will form part of the process of preparing for the introduction of a national health insurance system.

Workforce norms and standards are being developed targeting “provider behaviour” at both individual and group levels.

The plan can be found on the department website.

With acknowledgement in respect of all the above to Sabinet.

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