I attended an interesting meeting of the Health Portfolio Committee this week. Decisions are being taken that will shake up the way in which medicines in use in South Africa are regulated.
At present, the process of regulation is long winded and inefficient. The big problem is that the responsibility for regulation is lodged with the Medicines Control Council (MCC), a body which is not really equipped to do its job efficiently.
Policies which were implemented in 2003 with the noble aim of improving access had an unforeseen consequence – an exponential increase in the number of applications for registration. An influx of generics resulted in long delays in evaluation. Exacerbating the problem is the fact that the structure of the MCC relies heavily on external experts who have primary jobs elsewhere. It may have worked in 1965 when the MCC was set up, but it is no longer appropriate.
In 2006 the Cabinet resolved that the challenges of the MCC should be addressed. The result was the Amendment Act 72, which calls for the establishment of a full – time South African Health Products Regulatory Authority (SAHPRA) as a Government Agency accountable to the Minister.
The new body would streamline the Appeal process. Its functions would be expanded to include regulation of foodstuffs in relation to food safety aspects, medical devices and in vitro diagnostics, complementary and alternative medicines, African traditional medicines, cosmetics and blood derived products.
The Amendment Act 72 was passed in parliament but it has not yet been implemented.
The current amendment needs to be accepted and implemented
- To strengthen governance of the proposed South African Health Products Regulatory Authority (SAHPRA), as a Schedule 3A Public Entity instead of the existing MCC structure of 24 experts who meet every 6 weeks;
- To provide for the establishment of a Board instead of an Advisory Committee;
- To provide for the functioning of the SAHPRA under the control of the Board;
- To define functions and responsibilities of the Board;
- To include provisions that enable the recognition of work done by selected regulators in order to reduce duplication of effort in the statute;
- To strengthen transitional measures in order to facilitate the migration of the MCC to SAHPRA;
- To provide for consequential amendments that replace the MCC with SAHPRA where applicable;
- To provide for consequential amendments that replace the MCC with the Board e.g. in relation to meetings, appointment of chairperson and vice chairperson of the Board, disqualification of members, quorum;
- To replace the word “products” with medicines and scheduled substances to ensure precision and technical correctness;
- To more explicitly define the functions of SAHPRA within the statute;
- To more explicitly provide for the regulation of biological medicines inclusive of plasma-derived and animal products, biotechnology-derived medicines as well as products developed through human gene therapy;
- To strengthen sections relating to the regulation of complementary & alternative medicines;
- To regulate devices;
- To affirm that though the intention is to establish SAHPRA outside the public service, it should still be within the public administration; and
- To provide for reduction of duplication of effort through recognising work done by other regulators and vice versa by including an enabling clause in the statute.
This is a move in the right direction and will make sure we are able to protect our citizens to the massive influx of medical remedies and supplements and it will help protect the public against devices and other areas listed which at present are not subjected to much scrutiny and oversight.
Lastly the present structure results in a big backlog. At present there are over 2900 applications. This is mainly the result of the number of generic applications and also certain companies submitting similar products but each application requires the same amount of work to complete the application and research and assessment. This seems to be a scheme to hedge their bets and sometimes they get approval and then make a few changes to increase the price they could charge. Once again a few greedy individuals are blocking the system for all.
Health is a social good and we have to find a way to find common ground and understanding that it is not just a commercial product to enable you to maximise greedy profits. What about the needs of the citizens and patients?