Submission on the Medicines and Related Substances Amendment Bill, 2002

On 19 April 2001, the Pharmaceutical Manufacturers’ Association of South Africa (PMA) and numerous multinationalbrand-name pharmaceutical companies abandoned their legal challenge to the Medicines and Related Substances Control Amendment Act, 90 of 1997 (the Medicines AmendmentAct). This came a little over six weeks after the Pretoria High Court had admitted the Treatment Action Campaign (TAC) as amicus curiae in support of the legislation then under attack. It is widely recognised that TAC’s intervention – which included significant local and international mobilisation – was central to the abandonment of the case.

Speaking at a press conference shortly after the abandonment of the case, the Minister of Health stated as follows:

We regard today’s settlement as a victory in the sense that it unfreezes our law and restores to us the power to pursue policies that we believe are critical to securing medicines at affordable rates and exercising wise control over them.

Government will now go ahead and promulgate the law and within a few weeks draft regulations relating to various aspects of the Act will be published for public comment.

Certain aspects of the Act will kick in automatically with promulgation. In addition, we will move speedily to:

  • Set up the Pricing Committee whose job will include the gathering of pharmaceutical intelligence and advising the Minister on a transparent pricing system for medicines.
  • Activate the system of generic substitution, which will have major benefits for consumers in the private health care sector – and especially medical schemes.

Despite the Minister’s stated commitment to speedy implementation, the legislation has yet to be promulgated and regulations have yet to be issued. Instead, Cabinet decided on 15 May 2002 to approve the Medicines and Related Substances Amendment Bill (the Bill), which amends both the Medicines and Related Substances Control Act, 101 of 1965 (the principal Act) and the Medicines Amendment Act. The Bill was thereafter published for comment on 22 May 2002, the Minister’s intention being to table the Bill in Parliament this year.

Medicines and Related Substances Amendment Bill – 2002 – Joint TAC ALP.pdf