n South African Law Journal - Ensuring access through the Medicines and Related Substances Amendment Act 72 of 2008 - another lost opportunity? : notes




Medicines are crucial to the effective delivery of health care services. It has failed to introduce greater transparency and accountability in the regulatory process, has failed to safeguard the autonomy of the regulatory authority from interference by the executive, has not promoted measures in the medicines' registration and delivery process which promote access, and not removed those which impede it. Dispensed properly, they can literally save lives; but if they are misused or abused, the result can be serious ill-health, or even death. It is for this reason that in South Africa, the government rightly plays a role in regulating the availability, safety and quality of medicines. But given that a medicine is a very special type of commodity, the role and involvement of scientific experts is central to the process of regulating medicines.

With the approval of the Medicines and Related Substances Amendment Act 72 of 2008 (the 2008 Amendment Act (the date of commencement of this legislation is, at the time of writing, yet to be proclaimed)) Parliament has lost yet another opportunity not only to dispense with the old apartheid-era paradigm governing our medicines regulation, but also to align the law with the ethos and values of the Constitution of the Republic of South Africa, 1996 (the Constitution) in several respects. By contrast, several laws passed under the constitutional era are explicitly committed to the promotion of human rights and democratic values and are redistributive in character : to name a few examples, the Competition Act 89 of 1998; the National Health Act 61 of 2003; and the Promotion of Access to Information Act 2 of 2000.


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