4 June 2001
Draft regulations under the Medicines and Related Substances Control Amendment Act (No 90 of 1997) were published for comment in a special Government Gazette (No 22235) on Friday 1 June.
The Medicines Control Amendment Act was the focus of international attention less than two months ago when multinational pharmaceutical companies moved to have it struck down by the Pretoria High Court. On April 19, they withdrew their action at the last moment, against a background of mounting public pressure.
The Act was passed by Parliament in 1997. But it was not promulgated and regulations were not published at the time because of an interim interdict restraining Government from implementing most of the Act until the court case was finalized.
There is a common misconception that the Medicines Control Amendment Act deals with the importation or manufacture of generic alternatives to drugs that are still patent-protected in South Africa. This process in fact falls within the ambit of the compulsory licensing provisions of the Patent Act.
The most controversial aspect of the Medicines Control Amendment Act was section 15c that provides for parallel importing - that is, purchasing a patented drug on the international market instead of using the local supplier of that patented product. It is not an uncommon practice in other countries.
The regulations published today are wide-ranging. They cover sections of the principal Act (the Medicines and Related Substances Control Act, No 101 of 1965) as well as the Amendment Act, including:
A three-month period has been provided for interested parties to submit comments to the Minister of Health, Dr Manto Tshabalala-Msimang.
"We would like to encourage interested parties to make their written submissions within the first six weeks so that we can interact with them, on the basis of their submissions, in the last part of the comment period," said Dr Tshabalala-Msimang. "This is the understanding we reached with some of the major pharmaceutical manufacturers when we met them in England last month - and we believe it would be a good approach to all parties."
Dr Tshabalala-Msimang added that the Department had addressed relevant regulations in the same spirit as it had passed the Amendment Act itself.
"At all times we have been mindful of balancing our international responsibilities in terms of the TRIPS provisions with our central objective of accessing more affordable medicines to benefit our people," she said. "We have not worked in a vacuum - we have considered international practice and we have drawn on widely accepted definitions of key concepts.
"The issue of maintaining high quality drugs while opening up to new markets has been a major consideration. The regulations envisage a considerably expanded role for the Medicines Control Council which currently protects the public's interests in terms of drug safety and efficacy."
Copies of the draft regulations can be obtained from the publication section of the Government Printer in Pretoria
Also in the Gazette of 1 June is the draft Medical Schemes Amendment Bill, which has been published for one month's comment.