Negotiating the new medicines regulatory framework: Some basic facts and observations

Abstract

After many years, the controversial provisions of the Medicines and Related Substances Control Amendment Act, 90 of 1997, are finally coming into full force. The brakes were first put on Act 90/1997 in early 1999, when the Pharmaceutical Manufacturers' Association, (PMA) and most of its members took government to court. In that application, which was finally abandoned in April 2001 following civil society intervention and international outrage, the PMA had sought to prevent the law from coming into force. It took a further 2 years before most of the law, by now slightly amended by the Medicines and Related Substances Amendment Act, 59 of 2002, came into force. On 2 May 2003, most provisions of Act 90/1997 came into effect, as did the General Regulations Made in Terms of the Medicines and Related Substances Act, 1965 (101 of 1965), as amended. These general regulations fleshed out much of the detail in respect of the legislative provisions in question. There were a number of reasons why the full regulatory framework did not come into effect last year. First, Act 59/2002 expressly delayed the coming into effect of certain provisions of the law until 2 May 2004. Second, a further set of regulations dealing with medicine prices could not be drafted until the Pricing Committee had made recommendations to the Minister in this regard, and the committee could only be established once certain provisions of Act 90/1997 had come into effect. The Regulations Relating to a Transparent Pricing System for Medicines and Scheduled Substances thus only came into effect on 2 May 2004. While all the relevant laws and regulations have finally been promulgated, the complete package of regulatory reform is still not fully operational. While certain aspects of the pricing regulations came into force immediately upon promulgation, others will take from 1 to 3 months to become operational. In addition, the provisions of the legislative framework dealing with dispensing health practitioners will only come into effect 2 June 2004 (in terms of an order of the Pretoria High Court of 1 June 2004 in case No. 1908/2004).