The proposed Methodology for International Benchmarking of Prices of Medicines and Scheduled Substances in South Africa seeks to introduce an addition to the state’s regulatory tools used to ensure that medicines are appropriately priced in South Africa. As a public interest law centre that seeks to influence, develop and use the law to protect, promote and advance human rights, SECTION27 welcomes the publication of the proposed methodology and this opportunity to make further submissions to the Department of Health (DoH).
As the AIDS Law Project (ALP), we made two previous submissions on international benchmarking to the DoH: a joint submission with the Treatment Action Campaign (TAC) on 10 March 2006 in respect of Government Notice 2007 of 2005; and a second submission on 11 April 2007 in respect of Government Notice No. R. 1211 of 2006. In this submission, we do not intend to repeat any of the concerns raised in our previous submissions. Instead, we focus on new issues raised in the document published for public comment.
This submission takes as its starting point that the proposed methodology – whilst somewhat modest in its aims – will in the main be easy to understand, use and implement: it makes it clear how the prices of existing and new “originator” medicines are to be determined; and the timelines within which these determinations are to be made. In recognising that it is just one of a range of “reasonable legislative and other measures” that the state seeks to implement to discharge its constitutional obligations in respect of medicines access arising from section 27(2), we welcome the following aspects of the proposed methodology:
- It is – in the main – easy to understand, use and implement;
- It has been proposed after a careful consideration of a wide range of regulatory mechanisms ordinarily employed by those countries in which the prices of medicines are regulated and published;
- It applies only to originator medicines;
- It is to be phased in for medicines already on the market;
- It is intended to bring the prices of medicines down – and not to permit price increases for those medicines that are already on the market; and
- It makes provision for exemptions in “exceptional circumstances”.
That said, we have identified a number of issues in the schedule setting out the proposed methodology that give us cause for concern. In the main, however, our concerns – if addressed – would leave the proposed methodology largely untouched. Instead, they would help to strengthen the basis underpinning the proposed methodology, to place it in its appropriate legal and policy context, and to set the stage for legislative reform that is necessary to ensure that the promise inherent in section 27 of the Constitution is indeed realised. Put differently, this submission seeks to strengthen and build on the proposed methodology.