Speech by James Ngculu, Chairperson of the Health PC, during the debate on the Medicines and Related Substance Amendment Bill

23 September 2008

I rise here in support of the Medicines and Related Substance Amendment Bill. This Bill seeks to establish the South African Health Regulatory Authority that will replace the Medicines Control Council and for the appointment of the CEO of this authority and for registration of medicines, medical devices and certain foodstuffs and cosmetics, which contain a scheduled substance.

This is necessitated by the recognition of the fact practice has proven that the Medicines Control Council, due to a variety of reasons, chief among them the lack of fulltime CEO and staff and inefficiencies in the registration of medicines and medical devices. This has resulted in a number of problems whereby the registration process became long drawn process and thus at times denying people access to essential drugs and conversely being a disincentive to the scientific researchers.

This Bill now will establish a single process of registration based on efficacy, quality and safety, that is, any drug or medicine to be registered will only be governed by scientific rules and nothing else. The CEO shall be appointed for a period of five years and renewable once. This is designed to give confidence to the industry as a whole and to society that the person so appointed as the CEO will try to his/her work without favour or fear and will be governed by the rules such as the PFMA.

There are rules set in terms of how the CEO can be removed from office based on objective grounds rather than subjective or shall I say political grounds. Such rules cover matters of misconduct, permanent incapacity or engaging in activity that is reasonably capable of undermining the integrity of the Authority.

What gives confidence to those involved in research and development of medicines or medical devices is the fact that the processed to consider applications for registration of medicines has been well streamlined to only apply to complying with set rules such as payment of fees, provision of particulars and samples, the Authority, after investigation or enquiry and satisfies itself that the said product:

  • Is suitable for purposes for which it is intended
  • Complies with the prescribed requirements
  • Is safe and of good quality; and
  • Is efficacious

It shall register the medicine or medical device. This section goes a long way in addressing undue delays and frustrations many people experienced in the past.

The appeal process allowed is against the decision of the Authority if any person is aggrieved by its decision and such a person will do so within 30 days of becoming aware of such decision. In this case the CEO shall first attempt try resolve matter with only the appellant with no legal representative present. This is meant to allow amicable resolution and process of clarification of matters especially if they involve administrative matters. Should such a mediation or negotiation fail the appellant shall within 30 days of being notified and upon payment of a prescribed fee, request the CEO in writing to convene an appeal committee. It must be stressed here that this appeal committee is only there to clarify matters of either administrative or other grievances and doesn't deal with matters of science. The hearing shall be resolved within 30 days from the day it first meets to hear the appeal. This appeal process is protected from frivolous appeal by the requirement to pay prescribed fee and thus avoid people simply clogging the system.

What can be adduced here is that there is a conscious effort in this Bill to correct the mistakes of the previous Council. Everything is now designed to be dealt with in speed and judiciously without prejudice to the parties concerned.

Allow me to thank members of the DOH led by the DG for their sterling work and diligence. We sat together navigating this Bill which sometimes we all felt that we may not find easy solutions but ultimately together we were able to produce a good legislation which even members of the public and industry that witnessed our sweat, hailed this our work and patience.

I would like also to thank members of the Portfolio Committee for hard work and preparedness to complete our work yet ensuring the quality of work not being compromise.

I thank you!